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AESGP Euro OTC News
Issue 292 | May—June 2017
Medicines
Regulatory News
▪ SMEs 3
▪ BREXIT 5
▪ Notes of CMDh-IP meeting on 16 May 6
▪ CMDh February 2017 Minutes 7
▪ CMDh March 2017 Minutes 7
▪ CMDh April 2017 Report 8
▪ HMA-EMA Big Data Workshop
– 27 June 2017 10
▪ EMA Management Board – Minutes
from March 2017 meeting 11
▪ EMA 2016 Annual Report 12
▪ EMA CHMP - Work Plan 2017 12
▪ EMA Report on CHMP Pilot Project on
the involvement of patients in discussions
on benefits & risks of medicines 13
▪ Environment 14
▪ Documents for comments 14
Pharmacovigilance
▪ Official launch of the enhanced EudraVigilance
system 15
▪ PRAC meetings 16
Herbal News
▪ Final Public Statements on Paeoniae radix
alba & Paeoniae radix rubra 16
▪ Documents for comments 17
Homeopathic News
▪ Regulation (EU) 2017/852 of the European
Parliament and of the Council of 17 May 2017
on mercury, and repealing Regulation (EC)
No 1102/2008 17
AESGP 53rd Annual Meeting
Conference Report included
Self-Care in a Changing World
30 May—1 June 2017, Vienna
EFSA
▪ EFSA Summary of the 2016 Data Collection
on Contaminant Occurrence Data 18
▪ EFSA Guidance on the risk assessment of
substances present in food intended for
infants below 16 weeks of age 18
DRV’s
▪ Public consultation on EFSA Scientific
Opinion on DRVs for riboflavin 19
Food Additives
▪ EFSA Re-evaluation of fatty acids (E 570)
as a food additive 20
▪ EFSA Re-evaluation of sorbitan monostearate
(E 491), sorbitan tristearate (E 492), sorbitan
monolaurate (E 493), sorbitan monooleate
(E 494) and sorbitan monopalmitate (E 495) 21
▪ EFSA statement on validity of conclusions
of mouse carcinogenicity study on
sucralose (E 955) 22
▪ Update on food supplements for infants
and young children 22
▪ Update on the reevaluation of iron
oxides (E 172) 23
▪ Reevaluation of Propyl gallate (E 310), Octyl
gallate (E 311) and Dodecyl gallate (E 312)
– Call for data 24
Food Supplements
▪ Maximum amounts for vitamins and minerals -
EU Court Judgment clarifying conditions under
which EU Member States are entitled to set
their own limits 24
▪ Belgium notifies amendment regarding
substances other than nutrients and
plants or plant 25
▪ Italy - Updated guidelines on nutrients and
other substances 26
Novel Food
▪ EFSA updated opinion on safety of
EstroG-100™ (extract of a mixture of three
herbal roots) 26
▪ EFSA opinion on alginate-konjac-xanthan
polysaccharide complex (PGX) 26
▪ EFSA opinion on cranberry extract powder 27
Health Claims
▪ EFSA opinion on Condensyl® and decreases
sperm DNA damage which is a risk factor for
male infertility 27
▪ EFSA Opinion on Curcumin and the normal
functioning of joints 28
Food
2 AESGP Euro OTC News | Issue 292
Medical Devices Regulation
▪ Regulation (EU) 2017/745 published on
5 May 2017 29
Cranberry Products
▪ Committee on Medical Devices voted on
draft decision on 19 May 2017 29
▪ AESGP comments on the JRC process for
developing device-specific guidance
documents (DSG) 30
▪ AESGP Medical Devices Committee
meeting on 2 June 2017 in Vienna 30
Medical Devices
3 AESGP Euro OTC News | Issue 292
Medicines
Regulatory News
■ SMEs
The Directorate-Generate (DG) for Internal Market, In-
dustry, Entrepreneurship and SMEs from the European
Commission has published an inception impact assess-
ment concerning the revision of the EU SME definition
for a 4-week consultation i.e. until 6 July 2017.
Inception Impact Assessments aim to inform stakehold-
ers about the Commission's work in order to allow them
to provide feedback on the intended initiative and to
participate effectively in future consultation activities.
Stakeholders are in particular invited to provide views
on the Commission's understanding of the problem and
possible solutions and to make available any relevant
information that they may have, including on the possi-
ble impacts of the different options.
The SME definition, as provided in Recommendation
2003/3618/EC is the structural tool to identify those
enterprises which are confronted with market failures
and particular challenges (e.g. access to finance) due to
their size, and therefore are allowed to receive preferen-
tial treatment in public support. It is a widely used tool
in EU policies and is relevant in the context of some Eu-
ropean administrative exemptions and reduced fees,
such as for the REACH regulation of chemicals. Current-
ly, around 100 EU legal acts contain a reference to the
SME definition.
The Commission works to create favourable framework
conditions for SMEs through their consideration across
all relevant policy fields and through its support pro-
grammes considering the importance of those compa-
nies for the economy and their specific, size-related dif-
ficulties.
The Recommendation in its general structure and scope
has been confirmed at several instances. However, over
time, some specific issues have been identified. They will
be assessed against the current business and financing
environment in the context of the evaluation of the per-
formance of the Recommendation.
Such concerns mainly relate to:
Financial thresholds: The current financial thresholds
(annual turnover and balance sheet total) were set in
2003 when the Recommendation was adopted. The
above-mentioned reports considered an update of
these thresholds not yet warranted. The thresholds set
by the Recommendation could lead to certain lock-in
effects that would discourage SMEs to scale-up by
fear of losing the support that the SME status pro-
vides. European SME associations claim that approxi-
mately 70% of SMEs prefer to maintain the SME status
rather than growing fast and thus creating growth and
jobs.
Legal certainty: On 15 September 2016, the Court of
Justice ruled on 2 cases against administrative deci-
sions of ECHA (European Chemicals Agency) involving
the SME definition and, more precisely, the independ-
ence of enterprises (Art. 6). The Rulings brought to the
Commission's attention that the said article is not for-
mulated in a clear way and can, in practice, lead to
granting the status of SMEs to groups of enterprises
whose real economic power exceeds that of genuine
SMEs. In addition, twelve years of implementing this
Recommendation has shown that a number of con-
4 AESGP Euro OTC News | Issue 292
cepts used in the text could be better described or
clarified in order to leave less room for interpretation
and thus simplify the practical application of the defi-
nition.
The overall objectives of the inception impact assess-
ment are to:
Ensure that available support and special measures to
reduce administrative burden are focusing on those
enterprises that are most in need of it.
Increase business predictability and legal certainty for
enterprises by making the SME definition clearer and
leave less room for interpretation.
Create a level playing field for EU-based SMEs within
the Internal Market by fostering equal treatment for
SMEs throughout the EU with regard to their access to
public support and finance.
The specific objectives are to:
ensure that the SME definition is fit for purpose and is
updated to the current economic conditions.
provide clear legal certainty and avoid companies
that in practice do not face the difficulties of typical
SMES to use loopholes in the definition to benefit
from SME status.
ensure that sector-specific particularities are suffi-
ciently considered when identifying SMEs.
The retrospective evaluation will assess to what extent
the Recommendation is fit for purpose and, on the basis
of the results, the Commission might decide to adapt
the legal text to take into account the current economic
and legal situation as well as solve the issues the evalu-
ation will have detected, if appropriate.
The following options could be considered:
Option 1: Baseline scenario: no change to the Recom-
mendation (i.e. the Court Judgement applies).
Option 2: A targeted intervention to keep the SME
definition up-to-date with economic developments,
enhance its user-friendliness and the legal certainty it
provides to enterprises.
Without prejudging the results of the retrospective
evaluation, possible sub-options are:
Adapt the financial thresholds included in the defini-
tion: turnover, balance sheet total, participation of
business angels, and budget of local public entities;
Clarify the wording and concepts, particularly in art. 6
to better reflect its original purpose to identify enter-
prises that are part of a larger group;
Introduce additional considerations to the benefit of
start-ups and scale-ups could also be envisaged.
These could, inter alia, concern enhanced participation
of venture capital or extension of the 2-year period
during which scale-ups would still maintain the SME
status.
Other options could be considered, based on the out-
come of the evaluation and/or public consultation.
Under option 2, in addition to revising the SME defini-
tion, Omnibus Act(s) would be prepared to amend the
legal acts that refer to the Recommendation.
The online tools that are currently available for enter-
prises to do a self-assessment or apply for funds or
grants, will be updated according to the chosen option.
An evaluation and an impact assessment will be pre-
pared "back-to-back" to support this initiative and to
inform the Commission's decision on the options. The
results of an external study will feed into both exercises.
The formal open online public consultation of 12 weeks
on the issues, objectives and policy options set out
above will be launched early 2018.
Additional input will be gathered through surveys and
interviews, and bilateral ad hoc contacts with key stake-
holders, representative business associations and Mem-
ber States' competent administrations
Stakeholders' input will be used both in the evaluation
and in the impact assessment of the policy options that
will be carried out back-to-back. The Commission will
report on the feedback received through the various
consultation activities.
Position papers of business associations and other
stakeholders will be taken into account.
5 AESGP Euro OTC News | Issue 292
On its side, the EMA published an Action plan for small
and medium-sized enterprises (SMEs) aiming to foster
innovation and support SMEs in the development of
novel human and veterinary medicines.
The action plan, which builds on the experience gained
and addresses the challenges identified by SMEs in a
report published by EMA on the 10th Anniversary of the
SME initiative, also takes into account EMA’s
new framework for collaboration with academia and the
new EU Innovation Network.
The plan covers four key areas and lists a series of new
and enhanced actions:
Awareness of EMA’s SME initiative: actions include
stepped-up engagement with actors in the pharma-
ceutical innovation environment such as incubators,
universities and investors.
Training and education: actions include training for
SMEs and academia, and expanding the EU Network
Training Centre.
Support the development of innovative medi-
cines: actions include maximising the use by SMEs of
regulatory tools to support the development of and
access to medicines for unmet medical needs; provid-
ing assistance to academia; and enhancing coopera-
tion with EU partners on projects subject to EU fund-
ing.
Engagement with SMEs, EU partners and stakehold-
ers: actions include contributing to the development
of the EU Innovation Network, EU initiatives support-
ing SMEs and start-ups in relation to funding and ad-
ministrative burden (Europe's next leaders: the Start-
up and Scale-up Initiative), and interacting with inter-
national regulatory authorities.
The EMA has also published its SME office 2016 annual
report which provides an overview of SME-related activ-
ities in 2016 and highlights incentives and platforms
that SMEs can leverage to advance innovative develop-
ments and regulatory strategies.
■ BREXIT
The EMA organised an information meeting with mem-
bers of its Management Board and heads of the Nation-
al Competent Authorities (NCAs) of the EU/EEA Member
States. The goal was to start discussing how the work
related to the evaluation and monitoring of medicines
will be shared between the Member States in view of
the United Kingdom’s (UK) withdrawal from the Europe-
an Union.
Although negotiations on the terms of the UK's depar-
ture have not yet officially commenced and one cannot
prejudge their outcome, work will now start on the basis
of the scenario that foresees that the UK will no longer
participate in the work of EMA and the European medi-
cines regulatory system as of 30 March 2019.
General principles for workload distribution will include:
ensuring business continuity;
maintaining the quality and robustness of the scien-
tific assessment;
continuing to comply with legal timelines;
ensuring knowledge retention, either by building on
existing knowledge or through knowledge transfer;
assuring an easy implementation and medium- and
long-term sustainability.
It is expected that all National Competent Authorities
(NCAs) will contribute to EMA activities as per the ca-
pacity and capability of each authority, to ensure an
optimised and robust allocation of the workload across
the network.
The envisaged working methodology will include a
mapping of current and future capacity and expertise in
the network and the identification of potential gaps.
This could help the network to increase its capacity in
selected areas and would be supported with enhanced
training opportunities.
Based on the general principles, EMA, its scientific com-
mittees and working parties, together with the NCAs,
will now assess the different options for workload distri-
bution. A follow-up meeting will take place on 5 July
2017.
The press release is available here.
6 AESGP Euro OTC News | Issue 292
The European Commission and EMA have published a
Notice to marketing authorisation holders of centrally
authorised medicinal products for human and veterinary
use, to remind them of their legal obligations in prepa-
ration for Brexit.
The United Kingdom submitted on 29 March 2017 the
notification of its intention to withdraw from the Union
pursuant to Article 50 of the Treaty on European Union.
This means that unless the withdrawal agreement estab-
lishes another date or the period is extended by the Eu-
ropean Council in accordance with Article 50(3) of the
Treaty on European Union, all Union primary and sec-
ondary law ceases to apply to the United Kingdom from
30 March 2019, 00:00h (CET). The United Kingdom will
then become a 'third country'.
In this regard, marketing authorisation holders of cen-
trally authorised medicinal products for human and vet-
erinary use are reminded of certain legal repercussions,
which need to be considered:
EU law requires that marketing authorisation holders
are established in the EU (or EEA);
Some activities must be performed in the EU (or EEA),
related for example to pharmacovigilance, batch re-
lease etc.
Preparing for the withdrawal is therefore not just a mat-
ter for European and national administrations, but also
for private parties. Marketing authorisation holders may
be required to adapt processes and to consider changes
to the terms of the marketing authorisation in order to
ensure its continuous validity and exploitation, once the
United Kingdom has left the Union. Marketing authori-
sation holders will need to act sufficiently in advance to
avoid any impact on the continuous supply of medicines
for human and veterinary use within the European Un-
ion.
In particular, the Commission and the European Medi-
cines Agency expect marketing authorisation holders to
prepare and proactively screen authorisations they hold
for the need for any changes. The necessary transfer or
variation requests will need to be submitted in due time
considering the procedural timelines foreseen in the
regulatory framework.
The EMA and the European Commission have published
guidance – in the form of a questions-and–answers doc-
ument – to help pharmaceutical companies prepare for
the United Kingdom's withdrawal from the European
Union.
The guidance relates to both human and veterinary
medicines and concerns information related to the loca-
tion of establishment of a company in the context
of centralised procedures and certain activities, includ-
ing the location of orphan designation holders, qualified
persons for pharmacovigilance (QPPVs) and companies’
manufacturing and batch release sites.
The EMA is preparing a series of further guidance docu-
ments which will be published on EMA’s dedicated
webpage on the consequences of Brexit.
■ Notes of CMDh-IP meeting on 16 May
Five AESGP delegates participated in the joint CMDh-
Industry meeting at the EMA premises in London on 16
May 2017.
On the topic of ‘agreeing the name of the products dur-
ing the procedure’, the CMDh stated that the CMDv
approach could not be taken up and that it was up to
the applicant to try and find an agreement on the name
with the competent authority during the European
phase of the MRP-DCP also taking advantage of the
clock-stop.
On the pilot on merger and splitting, the CMDh ex-
pressed its disappointment concerning the lack of pre-
paredness from the industry (the cases were not good
candidates for the pilot). The CMDh door is not closed
but their expectations were clearly not met.
There was a very long discussion concerning Brexit and
how to best prepare for the unknown. The UK is not
giving signs to endorse any of the existing scenari and
therefore a hard Brexit is likely. Marketing Authorisation
Holders (MAHs) have to get ready and prepare their
contingency plans. If the UK is the RMS, then the RMS
has to be transferred to one of the CMSs of the proce-
dure; if no CMSs agree to become the RMS, the CMDh
can be contacted. The guidance on the change of RMS
has been updated for this purpose as will be the case
7 AESGP Euro OTC News | Issue 292
for the variation grouping guideline. The transition peri-
od is the negotiation time; no other transition period is
foreseen.
The other topics for discussion included the availability
issue of paediatric medicines, the implementation of the
falsified medicines directive and e-submissions.
■ CMDh February 2017 Minutes
Brexit
The Chair presented a draft CMDh Brexit White paper.
The discussion aimed to collect a list of tasks to be ad-
dressed and to assess the impact on the workload with-
in the network to ease resource planning. Member
states were invited to comment on the document. The
CMDh agreed to have a monthly updated list with on-
going procedures in the Communication Tracking Sys-
tem (CTS). The UK stated that it will complete the as-
sessment of all applications for which it is acting as RMS
and which have not been finalised when the Article 50
procedure concludes.
OTC miconazole oral gel – contraindication with
Warfarin
UK informed the CMDh of their intention to contraindi-
cate OTC miconazole oral gel containing products in
patients taking warfarin, in view of reports of serious
bleeding events in patients taking OTC miconazole oral
gel and warfarin concomitantly. The CMDh agreed that
the introduction of the contraindication is only relevant
to the OTC supply of miconazole oral gel in the UK, as
the interaction is well known and it is already included
in warfarin-containing products.
■ CMDh March 2017 Minutes
The outcome of the meeting discussions was highly
relevant for the self-care sector.
First the report of the Maltese delegates of the HMA/
AESGP meeting held in Malta on 20-21 February 2017
was noted. The CMDh members were informed about
the discussed topics on the HMA agenda and the rele-
vant updates from the meeting discussions.
The EMA then relayed the information given at the
AESGP/HMA February meeting in Malta on the Joint
EMA/CMDh Multi-stakeholder Scientific Advice proce-
dure for OTC switches. The HMA had already en-
dorsed the initiative as a principle with details to be
further discussed with Member States.
The proposal aims to use the current existing Scientific
Advice procedure. This initiative falls under the HMA/
EMA Network Strategy to 2020 objective ‘Ensure time-
ly access to new beneficial and safe medicines for pa-
tients’, to apply the most appropriate legal classifica-
tion to products, to ensure that the mechanisms for
allowing those that can be safely reclassified as non-
prescription medicines are in place, effective and be-
ing used, thereby improving patient access.
A Workshop with stakeholders is intended to be or-
ganised in the second half of 2017 to discuss the ex-
pectations from regulators and industry, the composi-
tion and functioning of the OTC expert forum and
how to effectively run a joint EMA/CMDh multi-
stakeholder Scientific Advice Procedure.
The CMDh will further explore these concepts in the
Non-Prescription Medicinal Products Task Force.
The Chair of the Non-Prescription Medicinal Products
Task Force reported that two case studies where the
Brass model was used were discussed. The TF noted
that the model may be useful for companies in the
selection of products that may be suitable for non-
prescription supply. However, the TF also noted that
applications (marketing authorisations or variations)
proposing non-prescription supply also need to take
into account the existing Commission guidance for
changing supply classification.
Dr Martin Huber (BfArM/Germany) was elected at the CMDh
May 2017 meeting as Chair of the Non-Prescription Medicinal
Products Task Force in replacement of Virginie Bacquet (ANSM/
France). Dr Huber also represents BfArM in the EMA Pharma-
covigilance Risk Assessment Committee (PRAC) and is the head of
unit ‘PRAC and other committees’ at BfArM. He previously was a
pharmacovigilance assessor.
!
8 AESGP Euro OTC News | Issue 292
The TF received a presentation on the task performed
by the EDQM Committee of Experts on the classification
of medicines as regards their supply.
The CMDh nominated Peter Bachmann and Sophie
Colyn as CMDh representatives in Regulatory Optimisa-
tion Group (ROG). The CMDh discussed the need for
back-ups of the CMDh representatives and nominated
four CMDh members as back-ups in case the above rep-
resentatives should not be available to participate in a
ROG meeting. The AESGP representative in the group is
Andrew Thornley, who is now part of the AESGP team.
In addition, Brexit was also a topic on the agenda. The
CMDh discussed the comments received on the CMDh
Brexit White paper and appointed rapporteurs for some
of the tasks to be addressed. Germany, UK and Sweden
will work on simplifying the renewal procedure and
have a complete overview of the pending procedures.
MSs were requested to identify submitted renewal pro-
cedures not entered in CTS and send them to Denmark
for compilation. The CMDh agreed that the Variation
Working Party could explore the options on how to cov-
er Brexit related changes in the dossier, and if there is a
possibility to group variations. The CMDh proposed that
the October 2018 CMDh meeting would be the deadline
to stop appointing UK as Lead Member State (LMS) for
pharmacovigilance activities, subject to the outcome of
the negotiation and assuming a 24-month negotiation
time after Article 50 is triggered. At that point in time a
decision would need to be taken to appoint MSs for
new procedures and reallocate procedures where UK
has been appointed as LMS.
■ CMDh April 2017 Report
The CMDh has published the report from its meeting
held on 18-19 April 2017.
Among the items reported, the following may be not-
ed:
Revision of CMDh Standard Operating Procedure
(SOP) on decision-making process for new active
substance status or extension of marketing protec-
tion or data exclusivity
The CMDh agreed on a revision of the CMDh SOP on
the decision-making process for new active substance
status or extension of marketing protection or data
exclusivity. The SOP has been updated to also apply for
decisions on one year of data protection according to
Art. 74a of Dir. 2001/83/EC (change of classification of
a medicinal product).
Updated CMDh SOP on decision-making process for
new active substance status or extension of market-
ing protection or data exclusivity (clean / track
changes)
Follow-up of CMDh position on PSUSA procedure
for budesonide
In the January 2017 CMDh press release, following the
adoption of the CMDh position for the PSUSA(*) on
budesonide, the CMDh requested marketing authori-
sation holders (MAHs) of corticosteroid-containing
medicinal products to implement the outcome of the
PSUSA assessment with regard to “Blurred Vision” and
“Central Serous Chorioretinopathy”, which has been
identified as class risk effect of corticosteroids. MAHs
are reminded that the same wording as agreed in the
PSUSA should be implemented for all pharmaceutical
formulations. However, the frequency of the adverse
reactions mentioned in the PSUSA outcome is only
applicable to budesonide. For other corticosteroids
and/or formulations not covered by the PSUSA, the
frequency “not known” should be mentioned. The
MAHs should adapt the frequency for their products in
the future. For the implementation, the same timelines
as for the PSUSA apply.
(*) A PSUR is a pharmacovigilance report submitted
regularly by a marketing-authorisation holder at de-
fined time points following a medicine's authorisation.
A single assessment of related PSURs (PSUSA) is car-
ried out for medicines that contain the same active
substance or combination of active substances, as in-
cluded in the list of EU reference dates (EURD list).
! Budesonide (nasal) has non-prescription legal status in the UK,
Sweden and Denmark]
It was explained at the CMDh meeting with Interested Parties
on 16 May 2017 that this was a very specific case, not illustra-
tive of the normal process.
9 AESGP Euro OTC News | Issue 292
Working Party on Harmonisation of SmPCs
The CMDh agreed to disband the Working Party on
Harmonisation of SmPCs. The Working Party was al-
ready temporarily suspended since 2015. Since then,
discussions related to the harmonisation of SmPCs
have taken place in the CMDh plenary. This practice
will continue. The subpage of the working party on the
CMDh website will be deleted. Relevant documents will
be moved to “Product information, Harmonisation of
SmPCs – Article 30 referrals”.
Update of Question & Answer documents
A new Q&A on the use of the European reference me-
dicinal product has been added to the Q&A on gener-
ics (clean / track changes) to recommend the use of
the ERP in the RMS. In the case of a Reference Medici-
nal Product (RMP) (or originator product) never author-
ised in the chosen Reference Member State (RMS) or
the chosen Concerned Member State(s) (CMS), an RMP
authorised by another national competent authority or
by the European Commission can be chosen. This RMP
is the so-called European Reference Product (ERP).
A new Q&A has also been added to the Q&A docu-
ment on applications for marketing authorisation
(clean / track changes). The new Q&A outlines the pre-
requisites for extension applications when these
should be included in an existing marketing authorisa-
tion.
The Working Group on Active Substance Master File
(ASMF) procedures has prepared an update of Q&As
on ASMF (clean / track changes). Several questions
have been updated to clarify the guidance given. The
revised document was adopted by the CMDh via writ-
ten procedure.
MRP
10 AESGP Euro OTC News | Issue 292
DCP
■ HMA-EMA Big Data Workshop – 27 June 2017
A workshop, the purpose of which is to enrich the work
of the HMA/EMA Joint Task Force on Big Data with con-
tributions from relevant stakeholders, is planned for 27
June 2017. The EMA has invited maximum 3 representa-
tives per industry association to this meeting to inform
the work of the taskforce. Participants with expertise in
data sources, bioinformatics or experience in the inte-
gration of heterogeneous and disparate data sources
are particularly welcome in addition to those with a vi-
sion as to how Big data may be applied meaningfully
across the product life cycle from drug development
through to post authorisation. AESGP has nominated
three lead experts in their respective field for this work-
shop.
The draft agenda includes an update on international
developments on Big Data with participation of Health
Canada and the US FDA, round table discussion on
mapping of relevant data sources and format and round
tables discussion on usability and application of data.
An HMA/EMA Joint Task Force on Big Data was established earlier
this year as the joint response from HMA and EMA to the chal-
lenges presented by Big Data. Indeed, data provenance and quality and
the methodologies to integrate disparate datasources is less assured
and the “signal to noise” ratio is likely to be much larger and uncertain
than currently. In addition, the explosion in use of so-called
“wearables” capturing various health data has created an entirely new
setting in which enormous real-time data sets emerge on large popula-
tions.
The task force has as its mandate not only to explore the emerging
challenges presented by big data but also to identify the likely uses and
applicability across the product life cycle. As such the deliverable of this
task force will be a set of recommendations regarding e.g. legislation,
regulatory guidelines, ethical considerations and competencies as well
as an evaluation of the usefulness of big data in the regulatory setting.
In the process of developing a set of recommendations, the task force
will:
Map relevant sources of big data and define the main formats in
which they are expected to exist;
Identify the usability of big data;
Describe the current state, future state and challenges with regard to
e.g. regulatory expertise and competences, need for legislation and
guidelines, and responsibility for raw data analysis;
Design a big data roadmap.
Further information on the task force can be found on the HMA web-
site and on the EMA website.
i
11 AESGP Euro OTC News | Issue 292
■ EMA Management Board – Minutes from March 2017 meeting
The EMA has released the Minutes from the March
2017 Management Board meeting.
Brexit
The EMA Executive Director stated that the implemen-
tation of the 2017 Work Programme is progressing
broadly in line with expectations for 2017, however the
Agency is ready to reallocate or reprioritise resources
should the need arise as a consequence of an im-
portant staff loss and will inform the board according-
ly.
The European Commission representative insisted on
the fact that the relocation of the European Medicines
Agency should be carried out without any business
disruption.
The representative of the UK offered full cooperation
until arrangements for leaving the EU are put in place,
referring also to the expression of interest by the Sec-
retary of State on future close cooperation with EMA.
The representative of the European Commission invit-
ed all to focus on the preparation that is needed in
order to ensure continuity and effectiveness of EMA
operations. In particular, Member States will need to
build up their capacity to compensate for the contribu-
tion by the UK once it is no longer part of the EU. The
EMA confirmed that the list of EMA criteria for the re-
location will be shared with the board once they have
been transmitted to the European Commission.
The EMA Management Board was updated on the
work done by the Operations and Relocation Prepar-
edness Task Force (ORP) which, amongst others, un-
dertook activities including identifications for remedial
solutions also in collaboration with the European Insti-
tutions and the Scientific Committees of the Agency,
development of a dedicated Brexit BCP (Business Con-
tinuity Plan) in case of staff loss and of a physical relo-
cation BCP, development of a dedicated recruitment
and selection strategy and of a ‘Relocation transition’
package for staff, conduct of two staff surveys and
continuous provision of up- to-date information to
staff, development of arrangements for requests for
information and for visits to EMA to increase under-
standing of the operations and functioning of the
Agency.
The board expressed its wish for an early decision on
the relocation of the Agency and welcomed the oppor-
tunity that will be provided to discuss more in depth
also matters concerning workload and resources. A
reprioritisation impacting on Work Plan deliverables
will be discussed and agreed by the board. Members
expressed their commitment to increase their contri-
bution to scientific work and called for an orchestrated
approach, that will allow single NCAs to invest in areas
where resources need to be usefully allocated.
EU/US Mutual Recognition Agreement (MRA) on
pharmaceutical Good Manufacturing Practices
(GMPs)
The Agreement, which was concluded on 1 March, is to
be considered a real accomplishment by all parties
involved. Now the focus should be on the implementa-
tion of the Confidentiality commitment to be signed
by EC/EMA and the FDA, and on the completion of the
assessments of the Member States in order to meet
the deadline for recognition of inspections from 1 No-
vember 2017 onwards. It is therefore important that
Member States ensure sufficient resources for the sub-
mission of the necessary information to the US and
meet key dates in the agreement.
Update on PSUR Repository
The board heard an oral update on the PSUR Reposi-
tory maintenance phase. Introduced by the EU phar-
macovigilance legislation, the PSUR repository is a sin-
gle, central platform for periodic safety update reports
(PSURs) and related documents to be used by all regu-
latory authorities and pharmaceutical companies in the
EU. The PSUR Repository provides an important simpli-
fication for marketing authorisation holders allowing
them to send all PSURs and related submissions to a
single recipient. After beginning of its mandatory use
in June 2016 it is now in the maintenance phase where
usability releases ca. every 2 months ensure that con-
tinuous development takes place. The system is con-
sidered to be intuitive and fit for purpose, as shown by
a steep decrease in technical queries by NCAs and In-
dustry since its mandatory use, and by the high vol-
ume of use since its go-live. All in all the system has
delivered all benefits that were envisaged, and its user
friendly interface is appreciated.
12 AESGP Euro OTC News | Issue 292
■ EMA 2016 Annual Report
The EMA has published its 2016 Annual Report (+ An-
nexes) which was adopted by the EMA Management
Board at its March 2017 meeting.
The following points from the report may be worth not-
ing:
The EMA recommended 81 medicines for human use
for marketing authorisation (compared to 93 in 2015).
A total of 32 referral procedures started in 2016 (there
were 21 in 2015), among which 6 were pharmacovigi-
lance-related (under Articles 31, 20 or 107i), and 19
were finalised.
The report also highlights some of the main projects,
initiatives and achievements in 2016, among which:
▪ Evaluation and monitoring of medicines
▪ Advancing human health, with amongst others
the PRIME scheme, the continuation of the
adaptive pathways pilot project, smart regula-
tion for safer medicines and the publication of
clinical reports
▪ Communication, including a strengthened en-
gagement with stakeholders
▪ International collaboration through bilateral and
multilateral interactions
As for herbal medicines, it is stated that in 2016, the
assessment of 10 new herbal substances was com-
pleted – leading to the publication of 8 final European
Union monographs and 2 final public statement. In
addition, 9 monographs were updated and revised in
the frame of the systematic review of monographs.
A related press release has also been published.
A referral is a procedure used to resolve issues such as concerns
over the safety or the benefit-risk balance of a medicine or a
class of medicines. The matter is ‘referred’ to the European Med-
icines Agency so that it can make a recommendation for a har-
monised position across the European Union. Article 107i proce-
dures are triggered because of safety issues, Article 20 proce-
dures are triggered when there are quality, safety or efficacy
issues with centrally authorised products, and Article 31 proce-
dures are triggered when the interest of the Union is involved,
following concerns relating to the quality, safety or efficacy.
i
■ EMA CHMP - Work Plan 2017
The EMA published the 2017 Work Plan of the Commit-
tee for Medicinal Products for Human Use (CHMP).
Among the envisaged CHMP activities for 2017, the fol-
lowing may be noted:
Multi-stakeholder consultation to facilitate optimi-
sation of clinical evidence generation in drug devel-
opment programme
Establishing the modalities to provide multi-
stakeholder consultation on OTC switch applications
involving “switch bodies”. This will be done through
the Scientific Advice Working Party (SAWP) and refers
to the proposal for a joint EMA-CMDh multi-
stakeholder scientific advice for OTC switches, which
was briefly presented at our bilateral meeting with the
EMA on 11 January 2017. This was also the subject of
the presentation given by Zaide Frias/EMA at the
AESGP Conference in Malta in February 2017.
Benefit/Risk methodology
Monitoring the implementation of benefit-risk tem-
plate structure and guidance.
Further exploring the application of benefit-risk meth-
odologies for decision making and communication
(e.g. output of IMI-PROTECT), including visual displays
and value elicitation, in co-ordination with relevant
EMA scientific committees (linked to Patients involve-
ment in assessment work topic).
Quality assurance of SmPCs
Maintaining and developing guidance and other tools
(training material, checklist, metrics or labelling review
guide) supporting SmPC review such as those pub-
lished on the EudraSmPC webpage (which aims to
facilitate a harmonised review of SmPC within the reg-
ulatory network and its public interface).
13 AESGP Euro OTC News | Issue 292
Generating the reports of revised processes to ensure
scientific committees' labelling review based on the
scientific assessment and to the development of met-
rics.
Providing support and training on any matters related
to SmPC.
Preparing an annual report on the related activities.
Considering the recommendations of the Commission
report on "Shortcomings in the SmPCs and the pack-
age leaflet".
Monitoring the need for stakeholder involvement with
regard to the product information.
Supporting a consistent approach in the process of
defining therapeutic indications to ensure their clarity
for stakeholders.
To continue and monitor the pilot on the wording of
the therapeutic indication.
Interface of precision medicines and diagnostics
Defining the scope of diagnostics or diagnostic meth-
ods to be included.
Exploring how characteristics/features of diagnostics
used in pivotal trials can be made transparent.
Exploring how the dependence of a medicine’s benefit
-risk balance from the accuracy of the crucial diagno-
sis can be described.
The EMA Pharmacovigilance Risk Assessment Committee
(PRAC) will liaise with the CHMP on the following:
Pharmacovigilance activities
Engaging with the Scientific Advice Working Party
(SAWP) on the need for specific registries at the prod-
uct level.
Identifying or further developing a guideline/guidance
on the best use of registries (taking into account exist-
ing guidance, engagement with patient registries).
Ongoing work with the Pilot phase, (4 candidates se-
lected, 17 pending consideration), evaluation of rele-
vant registries and desired characteristics of a modi-
fied/new registry as applicable.
Geriatric medicines strategy
Developing a geriatric Good Pharmacovigilance prac-
tise (GVP) module (PRAC involvement).
Continuing the pilot on 10 products with revised geri-
atric Assessment report (5 products have been final-
ised).
Adopting the final points to consider on frailty (public
consultation ended).
Completing the Quality Working Party (QWP) geriatric
packaging and formulation guideline.
Monitoring the geriatric medicines strategy.
■ EMA Report on CHMP Pilot Project on the involvement of patients in discussions on benefits & risks
of medicines
The EMA has informed on the publication of a final re-
port on the experience gained during its pilot project to
involve patients directly in the assessment of the bene-
fits and risks of medicines in its Committee for Medici-
nal Products for Human Use (CHMP).
The report concludes that the overall feedback received
from both the CHMP/EMA members and the patients
involved during the pilot is very positive and reflects the
usefulness and benefit of including patients within
CHMP discussions when there is an opportunity to en-
rich the benefit/risk (B/R) discussions with a patient per-
spective. Patients report a very positive experience; they
felt listened to and included and this increases transpar-
ency and trust in the work of the Agency. The CHMP
members felt that it was ‘important’ and ‘very helpful’ to
have the patient input during the oral explanation and
subsequent discussions.
At the end of the pilot phase and the analysis of the
feedback received, it was proposed to continue to invite
patients to oral explanations on a case-by-case basis
(when input could be valuable to the assessment), but
also to use additional methods and consult patients on
a more regular basis. This could include participating in
CHMP discussions by teleconference or through written
consultations at any time during an evaluation (respond
to specific pre-defined questions). These options allow
for consultations to be conducted outside of plenary
meetings and not limited to oral explanations, they also
give the opportunity to gather feedback from a larger
number of patients, when required. Elicitation of patient
preferences is also another patient engagement meth-
odology which the committee and the EMA is currently
investigating.
The CHMP members agreed unanimously on the pro-
posed way forward as it is clear that the inclusion of a
AESGP Euro OTC News | Issue 292 14
patient viewpoint enriches the overall evaluation of the
benefit and risk of the medicine.
It was also felt that the learnings from this pilot could
be shared with other committees, for example the Phar-
macovigilance Risk Assessment Committee (PRAC)
which also evaluates B/R, with a view to making more
use of this mechanism during such assessments.
■ Environment
A Roadmap for the Commission's
initiative on a strategic approach to
pharmaceuticals in the environment
has been published for a 4-week
consultation period.
The main objectives of the initiative
will be to:
identify remaining knowledge
gaps and uncertainties, and pre-
sent possible solutions for filling
them;
explore how to address the chal-
lenge to protect the environment
(and human health via the envi-
ronment) and at the same time
safeguard access to effective and
appropriate pharmaceutical treat-
ments for human patients and
animals, considering inter alia the
opportunities for innovation.
The strategic approach will aim to
address pharmaceuticals in the en-
vironment generally, meaning
largely but not only the water envi-
ronment, in order to cover the re-
quirements in the water and phar-
macovigilance legislation, noting
that the latter refers also to soils. It
could include policy options relat-
ing to a number of different areas,
given that emissions of pharmaceu-
tical substances to the environment
occur during their whole lifecycle,
i.e. from production through con-
sumption to disposal.
The Commission will reflect on poli-
cy options already identified in a
report and on outputs from a Com-
mission workshop held in Septem-
ber 2014 at which participants dis-
cussed a range of options from that
report. It will also consider possible
additional options identified during
the course of a supplementary
study to support the development
of the strategic approach. Finally, it
will include feedback from a Com-
mission public consultation.
Possible options include the stimu-
lation of voluntary initiatives at EU
or national level, as well as manda-
tory measures. In view of the need
to take into account the outputs of
the supplementary study, it is
premature to identify the options
that might be included in the stra-
tegic approach.
This document was circulated to
the AESGP pool of experts Environ-
ment for feedback until 19 May
2017. AESGP is participating in the
regular joint Inter Association Phar-
maceuticals in the Environment
(PiE) task force teleconferences
aiming at putting together the in-
dustry response. Most of the estab-
lished Ecopharmacostewardship
(EPS) documents will form the basis
of the industry response.
Further details on the initiative, in-
cluding comments already sent to
the Commission, are available here.
■ Documents for comments
DOCUMENT AESGP DEADLINE FOR
COMMENTS
EMA Guideline on Good Clinical Practice compliance in relation to trial master file (paper and/or elec-
tronic) for content, management, archiving, audit and inspection of clinical trials 21 June 2017
Inter-association TF on pharmaceutical in the environment (PIE) on extended Environmental Risk As-
sessment (eERA) review groups SWOT analysis and essential attributes 26 June 2017
WHO draft monograph on Capillary Electrophoresis 3 July 2017
EMA Concept Paper on the revision of the guideline on the role of pharmacokinetics in the develop-
ment of medicinal products in the paediatric population 5 July 2017
AESGP Euro OTC News | Issue 292 15
DOCUMENT AESGP DEADLINE FOR
COMMENTS
EMA Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical
trial protocol 14 July 2017
EMA Draft guideline on multiplicity issues in clinical trials 8 September 2017
EMA Guideline on equivalence studies for the demonstration of therapeutic evidence for products that
are locally applied, locally acting in the gastrointestinal tract as an addendum to the guideline on the
clinical requirements for locally applied, locally acting products containing known constituents
8 September 2017
Pharmacovigilance
■ Official launch of the enhanced EudraVigilance system
Further to the conclusions of an independent audit and
a subsequent favourable recommendation from the
EMA Pharmacovigilance Risk Assessment Commit-
tee (PRAC), the EMA Management Board has confirmed
that the updated EudraVigilance system has achieved
full functionality.
The EudraVigilance system, i.e. national competent au-
thorities, marketing authorisation holders and sponsors
of clinical trials, have to make final preparations to en-
sure that their processes and local IT infrastructure are
compatible with the new system and the internationally
agreed format.
The enhancements for reporting and analysing suspect-
ed adverse reactions of the new EudraVigilance system
will support better safety monitoring of medicines and a
more efficient reporting process for stakeholders. Ex-
pected benefits include:
Simplified reporting of individual case safety re-
ports (ICSRs) and the re-routing of ICSRs to Member
States as marketing authorisation holders will no
longer have to provide these reports to national
competent authorities, but directly to EudraVigilance,
which will ultimately reduce duplication of efforts. An
ICSR provides information on an individual case of a
suspected adverse reaction to a medicine;
Better detection of new or changing safety issues,
enabling rapid action to protect public health;
Increased transparency based on broader access to
reports of suspected adverse reactions by healthcare
professionals and general public via
the adrreports.eu portal, the public interface of
the EudraVigilance database;
Enhanced search and more efficient data analysis ca-
pabilities;
Increased system capacity and performance to sup-
port large volumes of users and reports (including
non-serious adverse reactions originating from the
EEA);
More efficient collaboration with the World Health
Organization (WHO) as EMA will make the reports of
individual cases of suspected adverse reactions within
the EEA available to the WHO Uppsala Monitoring
Centre (UMC) directly from EudraVigilance; Member
States will no longer need to carry out this task.
The enhanced EudraVigilance system will be launched
on 22 November 2017, i.e. six months after the func-
tionalities of the EudraVigilance database have been
established and have been announced by the Agency.
Together with the launch, the obligations set forth in
the following legal provisions will become applicable to
the mandatory electronic reporting through EudraVigi-
lance:
Section 1 “Recording and reporting of suspected ad-
verse reactions” of Chapter 3 “Recording, reporting
16 AESGP Euro OTC News | Issue 292
and assessment of pharmacovigilance data” under
Title IX “Pharmacovigilance” of Directive 2001/83/EC3,
and
Articles 24(4), 28(1), 28a(1)(c) and 28c(1) of Chapter 3
“Pharmacovigilance” under Title II “Authorisation and
supervision of medicinal products for human use” of
Regulation (EC) No 726/2004
The reporting of adverse reactions by patients and
healthcare professionals to national competent authori-
ties based on local spontaneous reporting systems will
remain unchanged. There will also be no changes to the
reporting of suspected unexpected serious adverse re-
actions during clinical trials until the application of the
new Clinical Trial Regulation.
Training & Support
The Agency will support national competent authori-
ties, marketing authorisation holders and sponsors
of clinical trials in the EEA through targeted e-learning
and face-to-face trainings, webinars and information
days. Users can trial the new functions of
the EudraVigilance system and the internationally
agreed format for ICSRs in a test environment as of 26
June 2017. Further information is available on
the EudraVigilance training and support webpage.
Signal management process associated with the new
Eudravigilance system was the main focus of the 11th
Pharmacovigilance industry stakeholder platform held
on 2 June 2017. AESGP was represented by 7 delegates.
■ PRAC meetings
At the PRAC meeting of 6-9 June, levonorgestrel (signal
follow-up), orlistat (follow up to PSIR/PSUSA procedure)
and ulipristal (interim results of PASS) were discussed.
In addition the PRAC continued its review of the parace-
tamol-modified release under the article 31 referral.
The PRAC also decided it will hold its very first public
hearing on 26 September 2017 at the Agency’s premises
in London, in the context of the safety review of the use
of valproate-containing medicines in the treatment of
women and girls who are pregnant or of childbearing
age. EU citizens will be invited to share their experiences
with these medicines so that this can be taken into ac-
count in the Committee’s recommendation. Valproate-
containing medicines are approved nationally in the EU
to treat epilepsy, bipolar disorder and in some countries,
migraine.
Herbal News
■ Final Public Statements on Paeoniae radix alba & Paeoniae radix rubra
The EMA HMPC has published the final Public State-
ments on Paeonia lactiflora Pallas, radix (Paeoniae
radix alba) and Paeonia lactiflora Pall. and/or Paeonia
veitchii Lynch, radix (Paeoniae radix rubra) respective-
ly which were adopted by the HMPC at their meeting
on 31 January 2017.
No changes were made compared to the draft ver-
sions circulated for comments on 17 February 2016
(AESGP did not send any comments as no input was
received). The conclusion for both Public Statements
remains that a European Union herbal monograph
cannot be established at present.
The final Public Statements, together with their final
Assessment Report and List of references, are availa-
ble respectively on the ‘Paeoniae radix alba’ page and
the ‘Paeoniae radix rubra’ page, under the ‘All Docu-
ments’ tab.
Paeonia lactiflora
17 AESGP Euro OTC News | Issue 292
■ Documents for comments
DOCUMENT AESGP DEADLINE FOR
COMMENTS
EMA HMPC draft European Union herbal monograph on Melilotus officinalis (L.) Lam., herba
(Rev.1) 23 June 2017
EMA HMPC draft European Union herbal monograph on Arctostaphylos uva-ursi (L.) Spreng.,
folium (Rev.2) 23 June 2017
Homeopathic News
■ Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 2017 on mercu-
ry, and repealing Regulation (EC) No 1102/2008
Regulation (EU) 2017/852 of the Eu-
ropean Parliament and of the Council
of 17 May 2017 on mercury, and re-
pealing Regulation (EC) No
1102/2008 has been published on 24
May 2017 in the Official Journal of
the European Union (L 137/1).
Article 3 (export restrictions) and
article 4 (import) are the most im-
portant one for the homeopathic
industry:
Article 3
The export of mercury shall be
prohibited.
The export of the mercury com-
pounds and of the mixtures of
mercury listed in Annex I shall be
prohibited as from the dates set
out therein.
By way of derogation from para-
graph 2, the export of the mercury
compounds listed in Annex I for
the purposes of laboratory-scale
research or laboratory analysis
shall be allowed.
The export, for the purpose of
reclaiming mercury, of mercury
compounds and of mixtures of
mercury that are not subject to
the prohibition laid down in para-
graph 2 shall be prohibited.
Article 4
The import of mercury and the
import of the mixtures of mercury
listed in Annex I, including mercury
waste from any of the large sources
referred to in points (a) to (d) of
Article 11, for purposes other than
disposal as waste shall be prohibit-
ed. Such import for disposal as
waste shall only be allowed where
the exporting country has no access
to available conversion capacity
within its own territory.
Without prejudice to Article 11 and
by way of derogation from the first
subparagraph of this paragraph, the
import of mercury and the import
of the mixtures of mercury listed in
Annex I for a use allowed in a Mem-
ber State shall be allowed where
the importing Member State has
granted written consent to such
import in either of the following
circumstances:
a) the exporting country is a Par-
ty to the Convention and the
exported mercury is not from
primary mercury mining that is
prohibited under Article 3(3) and
(4) of the Convention; or
(b) the exporting country not
being a Party to the Convention
has provided certification that
the mercury is not from primary
mercury mining.
Without prejudice to any national
measures adopted in accordance
with the TFEU, a use allowed pur-
suant to Union legislation shall be
deemed to be a use allowed in a
Member State for the purposes of
this paragraph.
The import of mixtures of mercury
that do not fall under paragraph 1
and of mercury compounds, for
the purpose of reclaiming mercu-
ry, shall be prohibited.
The import of mercury for use in
artisanal and small-scale gold min-
ing and processing shall be prohib-
ited. 4.Where the import of mercu-
ry waste is allowed in accordance
with this Article, Regulation (EC)
No 1013/2006 shall continue to
apply in addition to the require-
ments of this Regulation.
It should be noted that mixtures are
defined as “mixtures of mercury with
other substances, including alloys of
mercury, with a mercury concentra-
tion of at least 95% weight by
weight”.
18 AESGP Euro OTC News | Issue 292
Food
EFSA
■ EFSA Summary of the 2016 Data Collection on Contaminant Occurrence Data
EFSA has published its analysis of the 2016 annual col-
lection of analytical results on chemical contaminants in
food and feed covering the sampling year 2015.
Data are submitted annually to EFSA by European data
providers to support EFSA’s work programme in the
area of contaminants. Overall, 837 154 analytical results
were submitted. The analyses were performed on 124
987 samples collected by different European organisa-
tions. The data providers were governmental and com-
mercial organisations; more than 93% of the data were
analytical results submitted by governmental organisa-
tions. The report provides an overview of the number of
results reported by substance, country of the data pro-
vider and FoodEx1 food or feed group; the distribution
of results by country of the data provider is also pre-
sented.
■ EFSA Guidance on the risk assessment of substances present in food intended for infants below 16
weeks of age
The EFSA Scientific Committee (SC) published its Guid-
ance on the risk assessment of substances present in
food intended for infants below 16 weeks of age
For the purpose of this guidance, the term 'infants be-
low the age of 16 weeks' was used to describe the par-
ticular infant subpopulations where health-based guid-
ance values (HBGV) had traditionally not been consid-
ered applicable. This population includes preterm neo-
nates receiving enteral feeding.
In preparing this guidance, EFSA’s SC considered the
physiological, developmental and nutritional aspects
that are specific for infants below 16 weeks of age, with
particular attention to the latest scientific develop-
ments in the field. The EFSA SC notes that during the
period from birth up to 16 weeks, infants are expected
to be exclusively fed on breast milk and/or infant for-
mula. The EFSA SC views this period as the time where
HBGVs for the general population do not apply with-
out further considerations.
In its approach to develop this guidance, the EFSA SC
has taken into account the following:
for the exposure assessment it is taken that in non-
breastfed infants, formula is expected to be the only
source of nutrition for the first 16 weeks of life;
the overall toxicological profile of the substance
identified through the standard toxicological tests,
including critical effects;
toxicokinetic data, especially:
the absorption of the substance from the GI
tract
impaired renal excretion
The composition of foods intended for infants and young
children is regulated at EU level and such rules include re-
quirements concerning the use and/or presence of substances
such as food additives, pesticide residues, contaminants and
substances migrating from food contact materials in those
foods. Adopting legal provisions on those matters that are in
line with the current scientific knowledge requires a compre-
hensive evaluation to be carried out by EFSA on a number of
aspects, including the appropriateness of health-based guid-
ance values for infants below 16 weeks of age. Of particular
relevance for the food supplements sector, the safety of food
additives necessary for the formulation of food supplements for
infants will be assessed under this guidance.
i
19 AESGP Euro OTC News | Issue 292
metabolism in the neonatal organism com-
pared with the adult;
knowledge of organ development (critical windows)
in human infants;
the effects of exposure of neonatal animals at equiv-
alent life stages of human infants;
the relevance for the human infant of the neonatal
animal models used and of the reported effects in
toxicological testing;
whether additional relevant effects are revealed or
whether the effects occurred at lower doses in the
neonatal animals, by comparison with standard toxi-
cological studies.
The EFSA SC concludes that:
High infant formula consumption per body weight is
derived from 95th percentile consumption and the
first weeks of life is the time of the highest relative
consumption on a body weight basis. Therefore, when
performing an exposure assessment, EFSA SC propos-
es to use the highest consumption figures reported
for the period of 14 to 27 days of life, i.e. 260 mL/kg
bw per day. This approach would cover acute toxicity
and consider potential periods of high sensitivity for
other toxicity endpoints.
A decision tree approach is proposed that enables a
case-by-case risk assessment of substances present in
food intended for infants below 16 weeks of age.
(Figure 7 on page 39)
DRV’s
■ Public consultation on EFSA Scientific Opinion on DRVs for riboflavin
EFSA Panel on Dietetic Products, Nutrition and Allergies
(NDA) launched a Public consultation on the draft scien-
tific opinion on dietary reference values for riboflavin.
Following a request from the European Commission, the
NDA Panel proposes Dietary Reference Values (DRVs)
(*) for riboflavin. The Panel considers in this Scientific
Opinion that vitamin B2 is riboflavin.
The Panel concluded that:
Average Requirement (ARs) and Population Reference
Intakes (PRIs) for riboflavin can be derived for adults,
pregnant women, lactating women and children over
1 year of age.
For infants aged 7–11 months, no sufficient data are
available to set an AR, thus the Panel sets an Ade-
quate Intake (AI), based on upward extrapolation by
allometric scaling from the estimated intake of ribofla-
vin of exclusively breastfed infants from birth to six
months.
Summary of DRVs for riboflavin
Riboflavin or 7,8-dimethyl-10-ribityl-isoalloxazine, is a water-
soluble compound naturally present in food of plant and animal
origin as free riboflavin and, mainly, as the biologically active deriv-
atives flavin mononucleotide (FMN) and flavin adenine dinucleotide
(FAD).
Riboflavin is an integral part of the coenzymes FAD and FMN that
act as the cofactors of a variety of flavoprotein enzymes such as
glutathione reductase or pyridoxamine phosphate oxidase (PPO).
FAD and FMN act as proton carriers in redox reactions involved in
energy metabolism, metabolic pathways and formation of some
vitamins and coenzymes. In particular, riboflavin is involved in the
metabolism of niacin and vitamin B6 and FAD is also required by
the methylenetetrahydrofolate reductase (MTHFR) in the folate cycle
and thereby is involved in homocysteine metabolism. Signs of ribo-
flavin deficiency are unspecific and include a sore throat, hyperae-
mia and oedema of the pharyngeal and oral mucous membranes,
cheilosis, glossitis (magenta tongue), and normochromic normocytic
anaemia characterised by erythroid hypoplasia and reticulocytope-
nia. No Tolerable Upper Intake Level has been set for riboflavin.
i
Age AR (mg/day) PRI (mg/day)
7–11 months - 0.4 (Adequate Intake)
1–3 years 0.5 0.6
4–6 years 0.6 0.7
7–10 years 0.8 1.0
11–14 years 1.1 1.4
15–17 years 1.4 1.6
≥ 18 years 1.3 1.6
Pregnancy 1.5 1.9
Lactation 1.7 2.0
20 AESGP Euro OTC News | Issue 292
(*) For ease of reference please see below the following
definitions:
Dietary Reference Values (DRVs) - quantitative refer-
ence values for nutrient intakes for healthy individuals
and populations which may be used for assessment and
planning of diets.
Population Reference Intakes (PRI) - the level of
(nutrient) intake that is adequate for virtually all people
in a population group.
Average Requirement (AR) - the level of (nutrient)
intake that is adequate for half of the people in a popu-
lation group, given a normal distribution of require-
ment.
Adequate Intake (AI) - the value estimated when a
Population Reference Intake cannot be established be-
cause an average requirement cannot be determined.
An Adequate Intake is the average observed daily level
of intake by a population group (or groups) of appar-
ently healthy people that is assumed to be adequate.
More information can be found in the EFSA Scientific
Opinion on principles for deriving and applying Dietary
Reference Values (2010).
Food Additives
■ EFSA Re-evaluation of fatty acids (E 570) as a food additive
EFSA has published its Opinion re-evaluating the safety
of fatty acids (E 570) as a food additive.
The Panel concluded that the food additive fatty acids (E
570) was of no safety concern at the reported uses and
use levels.
According to the conceptual framework for the risk as-
sessment of certain food additives re-evaluated under
Commission Regulation (EU) No 257 /2010 (EFSA ANS
Panel, 2014) and given that:
the safety assessment carried out by the Panel was
limited to the use and use level s received from indus-
try in eight food categories out of 67 food categories
in which fatty acids (E 570) is authorised;
fatty acids used as a food additive (E 570) were ab-
sorbed in the same way as the free fatty acids from
the regular diet;
fatty acids used as a food additive (E 570) were me-
tabolised in the same way as fatty acids when derived
from lipid molecules present in the regular diet;
the toxicity database was limited, however, no adverse
effects were observed in subchronic toxicity studies up
to 10% in the diet (equivalent to 9,000 mg lauric acid/
kg bw per day);
there was no genotoxicity concern for these fatty ac-
ids;
the contribution of fatty acids (E 570) represented on
average only 1% of the overall exposure to saturated
fatty acids from all dietary sources (food additive and
regular diet);
Recommendations
The Panel recommended that:
the European Commission considers lowering the cur-
rent limits for toxic elements (arsenic, lead and mercu-
ry) in the EU specifications for fatty acids (E 570) in
order to ensure that fatty acids (E 570) as a food addi-
tive will not be a significant source of exposure to
those toxic elements in food;
i
Fatty acids (E 570) is authorised as a food additive in the European
Union (EU) in accordance with Annex II and Annex III to Regulation
(EC) No 1333/2008 on food additives and specific purity criteria
have been defined in the Commission Regulation (EU) No
231/2012. Currently, fatty acids (E 570) is included in the Group I of
food additives authorised atquantum satis (QS). The EU Scientific
Committee on Food in 1991 established a group acceptable daily
intake (ADI) ‘not specified’ for four fatty acids(myristic-, stearic-,
palmitic- and oleic acid). The Panel noted that that caprylic acid,
capric acid and lauric acid, which can also be present in the food
additive E 570, were not included within the fatty acids considered
in the Scientific Committee on Food (SCF ) evaluation in 1991.
21 AESGP Euro OTC News | Issue 292
since only data for eight out of the 67 food catego-
ries in which fatty acids (E 570) is authorised were
available, more information on uses and use levels
should be made available to the Panel in order to
perform a more accurate exposure assessment.
The data AESGP submitted in response to the call for
data (Batch 4) have been taken into account by EFSA
in its exposure assessment.
■ EFSA Re-evaluation of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan
monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495)
EFSA has published its Opinion re-evaluating the
safety of sorbitan monostearate (E 491), sorbitan tri-
stearate (E 492), sorbitan monolaurate (E 493), sorbi-
tan monooleate (E 494) and sorbitan monopalmitate
(E 495) when used as food additives.
The Panel concluded that:
the exposure at the mean and the 95th percentile
level, using non-brand-loyal scenario, did not ex-
ceed the ADI in any of the population groups.
on the request for an amendment of specifications
regarding the removal of ‘congealing range’, this
removal would result in less characterisation of the
various sorbitan esters of saturated fatty acids, but
this identification parameter could be replaced by
another one such as melting point.
The Panel noted that after oral administration sorbi-
tan monostearate can be either hydrolysed to its fatty
acid moiety and the corresponding anhydrides of
sorbitol and excreted via urine or exhaled as CO2 or
excreted intact in the faeces.
The Panel considered that sorbitan esters did not
raise concern for genotoxicity.
The Panel concluded that:
there is no need for a separate ADI (E 493 and E
494) and established a group ADI of 10 mg/kg bw
per day, expressed as sorbitan, for sorbitan esters
(E 491, E 492, E 493,E 494 and E 495) singly or in
combination based on the NOAEL of 2,600 mg sor-
bitan monostearate/kg bw per day identified in a
long-term toxicity study in mice , taking into ac-
count the ratio between the molecular weight of
sorbitan monostearate (430.62 g/mol) and sorbitan
(164.16 g/mol ) and applying an uncertainty factor
of 100.
considering the non-brand-loyal scenario, the
mean and the 95th percentile level did not exceed
the ADI in any of the population groups and that
there is no safety concern for the use of sorbitan
esters (E 491, E 492, E 493, E 494 and E 495) as
food additives at the reported uses and use levels.
on the request for an amendment of specifications
regarding the removal of ‘congealing range’, this
removal would result in less characterisation of the
various sorbitan esters of saturated fatty acids, but
this identification parameter could be replaced by
another one such as melting point.
Sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbi-
tan monolaurate (E 493), sorbitan monooleate (E 494) and sorbi-
tan monopalmitate (E 495) are authorised as food additives in
food supplements in accordance with Annex II to Regulation (EC)
No 1333/2008 on food additives and specific purity criteria have
been defined in the Commission Regulation (EU)No 231/2012.
Toxicological data for sorbitan monostearate (E 491), sorbitan
tristearate (E 492), sorbitan monolaurate (E 493), sorbitan
monooleate (E 494) and sorbitan monopalmitate (E 495) were
evaluated by the Scientific Committee on Food (SCF) in 1978. The
Committee established an acceptable daily intake (ADI) of 25 mg/
kg body weight (bw) per day for sorbitan monostearate(E 491),
sorbitan tristearate (E 492) and sorbitan monopalmitate (E 495)
singly or in combination. The SCF also established a separate
group ADI for sorbitan monolaurate (E 493) and sorbitan
monooleate(E 494) singly or in combination of 5 mg/kg bw per
day calculated as sorbitan monolaurate. The latest evaluation of
sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbi-
tan monolaurate(E 493), sorbitan monooleate (E 494) and sorbitan
monopalmitate (E 495) by Joint FAO/WHO Expert Committee on
Food Additives (JECFA) was done in 1982 where an ADI of 0–25
mg/kg bw per day were confirmed.
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22 AESGP Euro OTC News | Issue 292
■ EFSA statement on validity of conclusions of mouse carcinogenicity study on sucralose (E 955)
EFSA Panel on Food Additives and Nutrient Sources
added to Food (ANS) has published its Statement on
the validity of the conclusions of a mouse carcinogenici-
ty study on sucralose (E 955).
The Panel concluded that the available data did not
support the conclusions of the authors (Soffritti
et al., 2016) that sucralose induced haematopoietic neo-
plasias in male Swiss mice.
Taking into consideration the publication from Soffritti
et al. (2016), the technical report and additional infor-
mation provided by the Ramazzini Institute and other
information available for sucralose (E 955), the Pan-
el noted:
the design of the bioassay that considers exposure
from gestation up to natural death of animals implies
an increase in background pathology that results in
the possibility of misclassifications and a difficult in-
terpretation of data, especially in the absence of both
an appropriate concurrent control group and a recent
historical database;
the lack of a dose–response relationship between the
exposure to sucralose and incidence of lymphomas
and leukaemias (combined);
the lack of a mode of action and failure to meet all
the Bradford-Hill considerations for a cause–effect
relationship between intake of sucralose and the de-
velopment of tumours in male mice only;
a comprehensive database was available for sucralose
and no carcinogenic effect was reported in adequate
studies in rats and mice. Moreover, there was no reli-
able evidence of in vivo genotoxicity.
Sucralose (E 955) is currently authorised in all forms of food sup-
plements at various maximum levels under the Food Additives
Regulation 1333/2008. According to Commission Regulation (EU)
No 257/2010, the full re-evaluation of sucralose shall be com-
pleted by December 2020.
i
■ Update on food supplements for infants and young children
Further discussion took place on the use of additives
in food supplements destined at Infants and Young
Children at the food additives Working Group meet-
ing on 4 May.
Although no draft proposal from the Commission has
been presented to the Working Group, the Commis-
sion has explained its approach and listed the addi-
tives that it is intending to permit or not permit in
supplements containing nutrients that have been rec-
ommended by Member States’ health authorities.
The Commission has divided the additives into 3
groups – green – acceptable use, orange – case by
case assessment and red – unacceptable use.
Please note that this classification takes into account
if an additive 1) is a group I food additive or not, 2) is
currently authorised in food category 13.1 of Annex II
of Regulation 1333/2008/there is an evaluation for its
use in food for the age group of infants and young
children, 3) the latest scientific opinions of EFSA re-
garding the re-evaluation of some of the food addi-
tives included in this list and 4) the targeted age
group (e.g. from birth onwards, for young children
only, etc.).
AESGP has collected and submitted to the Commission such justi-
fication in May 2016 in response to the Commission’s call for data.
In response to this call, we understand that the Commission has
received information about more than 100 formulated products
containing a very high number of additives. The Commission has
been filtering the list by double checking the national supplementa-
tion policies in place and that the list of additives requested in the
corresponding food supplements is justified and can be supported by
existing safety assessment for this age group (taking notably into
the outcome of the EFSA reevaluation opinion). Since the Member
States without supplementation policies in place are really reluctant
to authorise food additives in food supplements for infants and
young children, the list to be approved by the majority of the Mem-
ber States has to be restricted to the minimum number of additives
required to formulate the food supplements necessary to meet the
national supplementation policies and for which no further safety
assessment by EFSA is required. The other additives not included in
that list will be required to go through an individual authorisation
procedure.
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23 AESGP Euro OTC News | Issue 292
There is a total of 21 food additives distributed as
follows:
green (4) - E306 Tocopherol-rich extract, E307 Al-
pha-tocopherol, E330 citric acid, E 570 Fatty acids
orange (11) – E310 propyl gallate, E339ii disodium
phosphate, E392 Extracts of rosemary, E413 Traga-
canth gum, E415 Xanthan gum, E421 Mannitol,
E422 Glycerol, E433 polysorbate 80, E463 hydroxy-
propylcellulose, E470b magnesium salts of fatty
acids, and E551 Silicon dioxide, and
red (6) – E 160a(I) Beta-carotene, E172 Iron oxides,
E202 Potassium sorbate, E211 Sodium benzoate,
E950 Acesulfame potassium, E955 Sucralose.
As indicated above, the “orange” additives are to be
permitted on a case by case basis. Regarding poly-
sorbate 80, the EFSA opinion on its reevaluation has
shown an exposure issue. Regarding silicon dioxide, it
is included in category 0 of Annex II meaning that it
is authorised in ‘All categories of foods excluding foods
for infants and young children, except where specifi-
cally provided for’. Regarding the gums, due to the
risk of choking hazards, their use in dehydrated foods
for kids is very carefully considered.
As regards the “red” additives, the recent EFSA re-
evaluation reduced the ADI for sorbic acid to a tem-
porary one of 3 mg/kg bw/day rather than the previ-
ous ADI of 25.
In light of the classification criteria listed above, the
Commission has asked the Member States to provide
by the beginning of June a sound justification
(supporting data on e.g. case of need, exposure data)
for the use of the additives in the food supplements
containing nutrients that have been recommended
by their national health authorities.
On the basis of the information received, the Com-
mission will further work on a refined draft list for
discussion at the following Working Group meeting
at the end of June.
■ Update on the reevaluation of iron oxides (E 172)
Business operators are invited to submit the scientific
and technical data needed to address issues identi-
fied by EFSA in the re-evaluation of the safety of iron
following the call for data published by the Commis-
sion in December 2016. AESGP will submit data on
actual use levels of yellow iron oxide, red iron oxide
and black iron oxide in food supplements.
Iron oxides producers interested to submit the tech-
nical and scientific data are now to confirm the sub-
mission of the required data and to determine dead-
lines and milestones for such submission by 19 June
2017. In that regard, AESGP participated in a meeting
with suppliers to discuss the call for data on 11 May
2017. The main objective of the meeting was for the
major producer for food applications to present to
the participants its approach of the call for data and
the results of the time and cost evaluation it has
commissioned as well as to share some thoughts on
the size and purity determination. On 22 May, an offi-
cial request from the iron oxides producers was sent
to all downstream users (DU) including AESGP to col-
laborate to collect and/or generate the data required
by EFSA or to participate in the sharing of cost to
generate the EFSA required data. AESGP members
interested in this initiative were kindly requested to
express their feedback by June 8, 2017 sending back
the dedicated template to the producers’s designat-
ed contact person.
While AESGP agreed position in response to the offi-
cial request from the iron oxides producers is not – as
an association – to take part in the collaboration initi-
ative, AESGP will participate in the meeting organized
on June 15, 2017 by the iron oxides producers in
Brussels keeps its members informed of the status of
the initiative.
24 AESGP Euro OTC News | Issue 292
■ Reevaluation of Propyl gallate (E 310), Octyl gallate (E 311) and Dodecyl gallate (E 312) – Call for data
The European Commission has published a Call for
scientific and technical data on the permitted food
additives Propyl gallate (E 310), Octyl gallate (E 311)
and Dodecyl gallate (E 312).
The first two steps of the process are as follows:
Step 1: Registration of the contact details of business
operators interested in submitting data must be
completed by 7 July 2017. The list of interested busi-
ness operators will be available after completion of
step 1.
Step 2: Confirmation of data submission, deadlines
and milestones will then be required by 30 Novem-
ber 2017. The list of data that will be submitted,
deadlines and milestones will be available after com-
pletion of step 2
NB: Unlike for iron oxides and hydroxides (E 172),
there is no request for data on actual use levels of gal-
lates in food therefore AESGP does not intend to ex-
press interest under Step 1 to submit data.
Food Supplements
■ Maximum amounts for vitamins and minerals - EU Court Judgment clarifying conditions under which
EU Member States are entitled to set their own limits
The European Court of Justice has issued its Judgment
in Case-672/15 opposing the French Public Prosecutor
to the food supplement distributor Noria Distribution
SARL.
No EU maximum levels have yet been set under the
provisions of the EU Food Supplements Directive
2002/46, meaning EU Member States are entitled, in
principle, to set their own limits under certain condi-
tions to comply with EU law.
By this judgment, the Court of Justice generally con-
firms the opinion of the Advocate General and clarifies
these conditions.
The Court makes clear that national rules setting
maximum levels must comply with EU law (in partic-
ular the treaties and the Food Supplements Di-
rective) as well as with EU settled case law on the
free movement of goods and principle of mutual
recognition. Accordingly, national legislation (like
the French Order at issue) which does not provide
for a procedure for the placing on the market (…) of
food supplements whose content in nutrients exceeds
the maximum daily doses set by that legislation and
which are lawfully manufactured or marketed in an-
other Member state is precluded. Such a procedure
must be one which is readily accessible and can be
completed within a reasonable time, and, if it leads
to a refusal, the decision of refusal must be open to
challenge before the courts. Further, an application
to obtain the authorisation to market those supple-
This case follows Case C-446/08 opposing Solgar Vitamin’s
France and other seven food supplements manufacturers to the
French Ministry of Economy on related questions concerning
the compatibility of French Order of 9 May 2006 with EU law.
The Judgment of the Court of 29 April 2010, in this case, is
available here.
Following that 2010 CJEU judgment, the French referring court
(Conseil d’Etat) had to assess on a case-by-case basis if the
setting of the maximum amounts of concern in the French
Order could be justified by taking into account the criteria in
Article 5(1) and (2) of Directive 2002/46 and if such setting
complied with the principle of proportionality.
By a judgment of 27 April 2011, the French court - taking into
account the servings recommended by the manufacturer -
annulled the Order of 9 May 2006 in so far as it determines, in
its Annex III, the maximum daily dose that can be used in food
supplements, for vitamins K, B1, B2, B5, B8 and B12. However,
the French court did not annul the Order as regards the maxi-
mum daily dose for phosphorus, copper, manganese, selenium,
molybdenum, vitamins B3, C, E and B6.
On the basis of the 2011 judgment of the French court, the
referring court in this new case C-672/15 considers that ques-
tions remain concerning the compatibility of the French Order
of 9 May 2006 with EU law, and, by a judgment of 3 March
2015, referred its questions to the CJEU.
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25 AESGP Euro OTC News | Issue 292
ments may be refused by the competent national
authorities only if those supplements pose a gen-
uine risk to public health. (The Court refers to
previous cases where French legislation was chal-
lenged for similar reasons such as the one on pro-
cessing aids). (Emphasis added)
The Court also gave directions as to how maximum
levels of minerals and vitamins should be set: on a
case-by-case basis and taking into account all of
the elements in Article 5(1) and (2) of that directive,
in particular of the upper safe levels established, with
respect to the nutrients at issue, after a comprehen-
sive scientific assessment of the risks for public
health, based not on general or hypothetical consid-
erations, but on relevant scientific data. (Emphasis
added)
Finally the Court ruled that the scientific assessment
of the risks (…) prior to the establishment of upper
safe limits which must in particular be taken into ac-
count in order to set the maximum amounts (…), be
carried out solely on the basis of national scien-
tific opinions, even though recent international sci-
entific opinions concluding in favour of the possibility
of setting higher limits are also available on the date
of the adoption of the measure at issue. (Emphasis
added)
It is now for the French referring court to apply the
answer given by the Court in its final judgment and to
decide whether it further annuls the French Order of 9
May 2006 still in force for the remaining maximum dai-
ly doses set.
■ Belgium notifies amendment regarding substances other than nutrients and plants or plant
Belgium has notified its draft Ministerial decree amend-
ing the Ministerial Decree of 19 February 2009 regard-
ing the manufacture and marketing of food supple-
ments that contain substances other than nutrients and
plants or plant preparations to the European Commis-
sion through the TRIS procedure (*).
The standstill period (**) will end on 11 August 2017.
Further information on this notification is available here.
The draft defines the minimum and/or maximum values
of four substances to be consumed per day in food
supplements, namely:
caffeine: maximum 80 mg/day
lutein: between 2 and 10 mg/day
lycopene: between 2.5 and 15 mg/day
red yeast rice or any other source of monacolin K:
maximum 10 mg/day of monacolin K
In order to ensure safety, a compulsory warning shall be
introduced for caffeine and red yeast rice, which must
appear on the product labelling:
caffeine: ‘Unsuitable for children or pregnant or lac-
tating women.’
red yeast rice: ‘This product is unsuitable for preg-
nant or lactating women, children and adolescents,
those over 70 years of age, those with liver, kidney or
muscular problems, those taking medicinal products
liable to interact (e.g.: cholesterol-lowering drugs) or
those intolerant to statins. If in doubt, please seek
advice from your doctor or pharmacist.’
As a transitional measure, food supplements that do
not meet the provisions of the draft decree but do meet
the provisions of the existing decree may continue to
be traded or labelled until [publication date + 10 days];
those which do not meet the provisions of the latter
may continue to be marketed until stocks have been
exhausted or until [signature date + 1 year], with the
exception of products based on red yeast rice for which
the decree shall be effective immediately, due to the
increasing evidence of adverse effects.
Background on the 2015/1535 procedure (formerly known as
98/34 procedure):
(*) It allows the Commission and the Member States of the EU to
examine the technical regulations the Member States intend to
introduce for products (industrial, agricultural and fishery) and for
Information Society services before their adoption. The aim is to
ensure that these texts are compatible with EU law and the Internal
Market principles. It applies in a simplified manner to the European
Free Trade Association (EFTA) Member States which are signatories
to the Agreement on the European Economic Area (EEA) and to
Switzerland and Turkey.
(**) Starting from the date of notification of the draft, a 3-month
standstill period – during which the notifying Member State cannot
adopt the technical regulation in question – enables the Commis-
sion and the other Member States to examine the notified text and
to respond appropriately. More information on this procedure and
what happen next can be found here
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26 AESGP Euro OTC News | Issue 292
■ Italy - Updated guidelines on nutrients and other substances
The Italian Ministry of Health has
recently revised the following
guidelines (only available in Italian):
Guideline on permitted daily lev-
els of vitamins and minerals
The revision concerns the increase
of the maximum levels for the fol-
lowing vitamins to:
vitamin D: 50 µg per day
vitamin K: 180 µg per day
vitamin B12: 1000 µg per day
The levels are regularly changing to
reflect the most recent scientific data
on safety.
Guideline on nutrients and other
substances with a nutritional or
physiological effect
The following modifications have
been brought to the guideline:
the warning statement for food
supplements containing creatine
has been reworded; the maxi-
mum level of 3 g, however, re-
mains unchanged
the newly listed substance Pal-
mitoylethanolamide (PEA) has
been added to list 3 of permitted
substances for use in food sup-
plements without a defined max-
imum limit
Novel Food
■ EFSA updated opinion on safety of EstroG-100™ (extract of a mixture of three herbal roots)
EFSA Panel on Dietetic Products,
Nutrition and Allergies (NDA) just
published a statement on the safety
of EstroG-100™ as a novel food pur-
suant to Regulation (EC) No 258/97.
Following a request from the Euro-
pean Commission, the NDA panel
was asked to update its scientific
opinion on the safety of EstroG-
100™ as a novel food (NF) in the
light of additional information sub-
mitted by the applicant.
In its previous scientific opinion of
2016, the Panel concluded that Es-
troG-100™, which is a hot-water
extract of a mixture of three herbal
roots, is safe for the use in food
supplements at the maximum intake
level of 175 mg/day in post-
menopausal women, which is lower
than the maximum intake level pro-
posed by the applicant (514 mg/
day). The Panel reached its conclu-
sions based on the effects of EstroG
-100™ on liver and haematology as
observed in several oral toxicity
studies, the lack of information on
liver and haematological parameters
in human studies and the absence
of chronic toxicity data. In view of
the Panel's conclusion on the safety
of EstroG-100™, the applicant has
now provided additional infor-
mation on haematological and liver
parameters for the human interven-
tion study with EstroG-100™ and
historical control data related to the
subchronic 90-day oral toxicity
study with EstroG-100™.
After assessing the additional infor-
mation provided by the applicant,
the Panel considers that the conclu-
sion of the scientific opinion on the
safety of EstroG-100™ does not
need to be revised, and thus, the
Panel reconfirms that the NF is safe
for the use in food supplements at
the maximum intake level of
175 mg/day in post-menopausal
women.
■ EFSA opinion on alginate-konjac-xanthan polysaccharide complex (PGX)
EFSA Panel on Dietetic Products,
Nutrition and Allergies (NDA) has
published its opinion on the safety
of alginate-konjac-xanthan polysac-
charide complex (PGX) as a novel
food pursuant to Regulation (EC)
No 258/97.
The panel concluded that the safety
of the novel food, PGX, for the in-
tended uses and use levels as pro-
posed by the applicant, has not
been established.
The NF is an off-white granular
powder composed of three non-
starch polysaccharides (NSP): konjac
glucomannan, xanthan gum and
sodium alginate. These NSP are
mixed in a specific ratio, which has
been claimed proprietary and
confidential by the applicant and
processed by a proprietary process.
The information provided on the
composition, the specifications, the
batch-to-batch variability and the
stability of the NF is sufficient and
does not raise safety concerns. The
production process is sufficiently
27 AESGP Euro OTC News | Issue 292
described and does not raise con-
cerns about the safety of the NF.
The applicant intends to add the NF
to a variety of foods such as yo-
ghurt, bread, biscuits, cereals, pasta
and juices. The applicant also in-
tends to market the NF in capsules
(750 mg NF per capsule). The rec-
ommended maximum daily intake
of the NF from fortified foods and
food supplements is 15 g.
The target population proposed by
the applicant is adults from 18 to 64
years of age.
Considering the NOAEL of 1.8 g/kg
bw per day and the highest mean
and 95th percentile anticipated dai-
ly intake of NF from fortified foods
the margin of exposure (MoE) is 12
and 6, respectively, whereas the
MoE for the NF from food supple-
ments is 9. The Panel considers that
the MoE for the NF at intended uses
and use levels is not sufficient for
the target population.
■ EFSA opinion on cranberry extract powder
EFSA published its Scientific Opin-
ion on the safety of cranberry ex-
tract powder as a novel food ingre-
dient pursuant to Regulation (EC)
No 258/97.
The EFSA Panel on Dietetic Prod-
ucts, Nutrition and Allergies (NDA)
concludes that the cranberry extract
powder is safe as a food ingredient
at the proposed uses and use levels.
The novel food (NF) contains about
55–60% proanthocyanidins (PACs).
The Panel considers that the infor-
mation provided on the composi-
tion, the specifications, batch-to-
batch variability and stability of the
NF is sufficient and does not raise
safety concerns.
Cranberry extract powder is pro-
duced from cranberry juice concen-
trate through an ethanolic extrac-
tion using an adsorptive resin col-
umn to retain the phenolic compo-
nents. The Panel considers that the
production process is sufficiently
described and does not raise con-
cerns about the safety of the novel
food.
The NF is intended to be added to
beverages and yoghurts to provide
80 mg PACs per serving. The target
population is the adult general pop-
ulation. The mean and 95th percen-
tile estimates for the all-user intakes
from all proposed food-uses are 68
and 192 mg/day, respectively, for
female adults, and 74 mg/day and
219 mg/day, respectively, for male
adults.
Taking into account the composi-
tion of the novel food and the in-
tended use levels, the Pan-
el considers that the consumption
of the NF is not nutritionally disad-
vantageous. While no animal toxico-
logical studies have been conducted
on the NF, a number of human clini-
cal studies have been conducted
with cranberry products. Consider-
ing the composition, manufacturing
process, intake, history of consump-
tion of the source and human data,
the Panel considers that the data
provided do not give reasons for
safety concerns.
Health Claims
■ EFSA opinion on Condensyl® and decreases sperm DNA damage which is a risk factor for male in-
fertility
EFSA Panel on Dietetic Products, Nutrition and Allergies
(NDA) has published its opinion on the scientific sub-
stantiation of a health claim related to ‘Condensyl® and
decreases sperm DNA damage. The scope of the appli-
cation was proposed to fall under a health claim refer-
ring to disease risk reduction (Article 14 of the NHCR).
The Panel concludes that a cause and effect relationship
has not been established between the consumption of
Condensyl® and reduction of sperm DNA damage in
the context of reducing the risk of male infertility.
The food which is proposed by the applicant to be
the subject of the health claim is Condensyl®, a tab-
let containing a fixed combination of opuntia fruit
dry extract (Nopal pulpe violin powder) (100 mg) ,N-
acetyl cysteine (250 mg), zinc (15 mg), nicotinamide
(16 mg), vitamin E (succinate) (12 mg), vitamin B6
(pyridoxine) (1.4 mg), vitamin B2 (riboflavin) (1.4 mg),
folic acid (0.40 mg) and vitamin B12
(cyanocobalamin) (2.5 mg). Nopal (Opuntia ficus indi-
ca (L.) Mill.) powder is standardised for the content of
quercetin (5 mg/100 g), indicaxanthin (13.2 mg/100
28 AESGP Euro OTC News | Issue 292
g) and betanin (28.8 mg/100 g). The Panel considers
that the food/constituent Condensyl®, which is the
subject of the health claim, is sufficiently character-
ised.
The claimed effect proposed by the applicant is
‘reduction of sperm DNA damage (sperm nuclear
decondensation index and DNA fragmentation in-
dex), high sperm DNA damage being a risk factor for
male subfertility/infertility’.
The proposed target population is ‘males in repro-
ductive age with unknown reason leading to subfer-
tility’. The Panel notes that the term ‘ subfertility’ has
not been defined by the applicant. The Panel also
notes that infertility is clinically defined by the failure
to achieve a clinical pregnancy after 12 months or
more of regular unprotected sexual intercourse. In
this context, the Panel assumes that the disease that
is the subject of the application is male infertility and
that the target population for the claim includes
males wishing to increase their fertility but excludes
males with clinical infertility.
The Panel notes that the applicant did not provide
evidence to establish that a reduction of sperm DNA
damage decreases the risk of male infertility. There-
fore, the Panel considers that the reduction of DNA
sperm damage is a beneficial physiological effect in
the context of reducing the risk of male infertility, as
long as evidence is provided that Condensyl® induc-
es a reduction in both DNA sperm damage and male
infertility.
The applicant provided four human intervention
studies as being pertinent to the claim. The Panel
notes that all these studies were conducted in males
with established clinical infertility and that they relate
to the treatment of the disease, and therefore, the
effect of the intervention on the incidence of male
infertility cannot be assessed. In addition, the Panel
notes that two of these studies had no control group
and that a third study was conducted with a product
not complying with the specifications of the food for
which the claim is proposed. The Panel considers that
no conclusions can be drawn from these studies for
the scientific substantiation of the claim. In the ab-
sence of evidence for an effect of Condensyl® in re-
ducing sperm DNA damage and the risk of male in-
fertility in vivo in humans, the studies provided by the
applicant on the proposed mechanisms by which
Condensyl® could exert the claimed effect were not
considered by the Panel for the scientific substantia-
tion of the claim.
■ EFSA Opinion on Curcumin and the normal functioning of joints
EFSA Panel on Dietetic Products, Nutrition and Allergies
(NDA) has issued its Opinion on the scientific substanti-
ation of a health claim related to the claimed effect
‘Curcumin contributes to the normal functioning of
joints’.
The Panel concludes that a cause and effect relationship
has not been established between the consumption of
curcumin and maintenance of joint function.
The Panel considers that curcumin is sufficiently char-
acterised.
The claimed effect proposed by the applicant is
‘normal functioning of joints by reducing the bi-
omarkers of inflammation’. The target population
proposed by the applicant is the general population.
Upon a request from EFSA to clarify whether the
claimed effect is related to the normal function of
joints or rather to the reduction of inflammation, the
applicant did not address this issue in the reply.
The Panel assumes that the claimed effect refers to
the maintenance of joint function.
The Panel considers that maintenance of joint func-
tion is a beneficial physiological effect.
The Panel considers that no conclusions can be
drawn from 15 human intervention studies conduct-
ed in patients with osteoarthritis or rheumatoid ar-
thritis and from one study in obese subjects on se-
rum cytokines for the scientific substantiation of the
claim.
In the absence of evidence for an effect of curcumin
on the normal function of joints in humans, the re-
sults of the human studies on curcumin pharmacoki-
netics, safety and mechanistic studies, the animal
studies and the in vitro studies submitted by the ap-
plicant cannot be used as a source of data for the
scientific substantiation of the claim.
29 AESGP Euro OTC News | Issue 292
i
Medical Devices
Medical Devices Regulation
■ Regulation (EU) 2017/745 published on 5 May 2017
The MDR has been published in the
EU Official Journal on 5 May 2017
Regulation (EU) 2017/745 of the
European Parliament and of the
Council of 5 April 2017 on medical
devices, amending Directive
2001/83/EC, Regulation (EC) No
178/2002 and Regulation (EC) No
1223/2009 and repealing Council
Directives 90/385/EEC and 93/42/
EEC.
The MDR will:
enter into force on 25 May 2017
be applicable (= actually put the
requirements into daily practice)
from 26 May 2020 (subject to the
derogations listed in Article 123).
The IVDR has also been published:
Regulation (EU) 2017/746 of the
European Parliament and of the
Council of 5 April 2017 on in vitro
diagnostic medical devices and re-
pealing Directive 98/79/EC and
Commission Decision 2010/227/EU.
Cranberry Products
■ Committee on Medical Devices voted on draft decision on 19 May 2017
The Committee dealing with the Draft Commission Imple-
menting Decision on the group of products whose princi-
pal intended action, depending on proanthocyanidins
(PAC) present in cranberry (Vaccinium Macrocarpon), is to
prevent or treat cystitis met in the format of the Regulato-
ry Committee on Medical Devices (foreseen under the
Medical Devices Directive) on 19 May 2017. This meeting
took place on the same day as the (first) meeting on
‘MDR Future Implementing Acts’ that seems to be the
first meeting of the ‘Committee on Medical Devices’ set
up by the MDR.
AESGP submitted detailed comments in March on this
draft decision under the 4-week ‘feedback procedure’*
and urged the Commission together with the Member
States not to proceed with its adoption.
Although an overview of the feedback received by the
Commission (22 feedbacks in total) was expected to be
presented to the Committee dealing with this decision,
the Commission dedicated webpage only confirms that
the Regulatory Committee on Medical Devices voted on
19 May in favour of the Commission decision on the qual-
ification of cranberry products.
Regarding the timing for the formal adoption and publi-
cation of the decision, we understand that they are ex-
pected in the coming weeks.
*Background on the feedback procedure:
As part of its better regulation agenda, the Commission wants to
listen more closely to the views of citizens and stakeholders. To do
so, the Commission created a space where they can share their
views on:
roadmaps and inception impact assessments, which set out
ideas for new laws and policies, or for evaluations of existing ones
legislative proposals and accompanying impact assess-
ments, once they have been agreed on by the Commission and
put forward to the EU Parliament and Council
draft delegated and implementing acts, which either amend
or supplement existing laws or, set the conditions for existing laws
to be implemented in the same way across the EU
While the Commission will not provide an individual response, the
feedback is expected to be taken into account by the Commission
when further developing the act. An overview of the feedback
gathered will be presented to the committee dealing with this act.
A summary of the discussion will be included in the summary
record, which is published in the comitology register.
30 AESGP Euro OTC News | Issue 292
■ AESGP comments on the JRC process for developing device-specific guidance documents (DSG)
In its comments, AESGP appreciates the emphasis the
document places on giving a prominent role to stake-
holders in the process and highlights that full transpar-
ency from regulators is a crucial element when adopting
Device Specific Guidances (DSG): this concept should be
related not only to clinical evaluation and investigation,
but to all the guidance documents issued by the Com-
mission and relating to technical aspects on medical
devices. While AESGP fully supports the principle of ob-
jectivity, it believes that the overall process should in-
clude targeted mechanisms for stakeholder engage-
ment, while preserving the independence and transpar-
ency of the process. Like EU agencies such as European
Food Safety Authority (EFSA) and European Medicines
Agency (EMA), AESGP would like to encourage the JRC
to broaden the range of sources of scientific input it
relies on as well as to engage more widely with stake-
holders who can bring experience from the field.
DSG documents are primarily aimed at manufacturers (MFs) and
notified bodies (NBs) and concern the evaluation of clinical data on
medical devices (typically of high risk). DSG documents are intend-
ed to provide guidance for MFs and NBs with regard to clinical
investigations and the subsequent evaluation of all clinical data as
legally required. DSGs should further be used by NBs as part of
their Design Dossier review or Type Test certification and any sub-
sequent significant change notifications. Finally, DSGs are also
intended to support Member States Competent Authorities when
verifying that the device meets the essential requirements relating
to post market surveillance.
i
■ AESGP Medical Devices Committee meeting on 2 June 2017 in Vienna
Following the publication of the Medical Devices Regu-
lation, the Committee met on 2 June in Vienna in con-
junction with the 53rd
AESGP Annual Meeting taking
place from 30 May to 1st June 2017. The Committee no-
tably discussed:
Burning interpretation issues under the MDR;
AESGP priorities regarding the implementation of the
Regulation in light of the Commission work program;
AESGP positioning at the upcoming meetings of the
working groups and taskforces planned for the sec-
ond semester of 2017;
the latest developments regarding MDR EUDAMED
and the ongoing work of the EUDAMED steering
Committee and ad-hoc working groups.
1
Conference report
The 53rd AESGP Annual Meeting - the annual gathering of the self-care sector in Europe – was held in Vien-
na, Austria from 30 May – 1 June 2017. Entitled “Self-Care in a Changing World”, the conference looked at
this overarching theme from three angles: marketplace, regulation and policy covering non-prescription
medicines – including herbal medicinal products – food supplements and self-care medical devices.
Around 350 representatives from the industry and many stakeholder organisations attended the meeting.
The first day of the conference heard success stories, delved into how the industry is doing with the recent
unprecedented level of consolidation in the pharmaceutical sector including the consumer health industry
and gave an overview of the changing environment for health care professionals.
Opening Evening
Birgit Schuhbauer, President of the Association of the
European Self-Medication Industry (AESGP), and Global
Vice President of Johnson & Johnson’s OTC Franchise,
welcomed delegates to the 53rd AESGP Annual Meeting
in Vienna, Austria, in a speech at the opening evening in
the Vienna City Hall.
She applauded the progress made in self-care in Europe
from “both on the regulatory side and political side”
since the launch of the association’s Agenda 2020 last
year.
“I feel particularly encouraged by the recommendations
on the future of self-care submitted to a European Un-
ion (EU) project by the European Umbrella Organisation
of Medical Doctors, the CPME,” she stated.
Details of the CPME’s recommendations on the future of
self-care would be presented during the conference, she
explained, by the organisation’s President Jacques de
Haller.
Globalisation, mergers and acquisitions, the role of
health professionals, social media and big data, would
also be high on the conference agenda, she pointed
out, along with new legal and regulatory developments
for non-prescription medicines, food supplements and
self-care medical devices.
Birgit Schuhbauer
2
It was important to keep in mind, she said, that the
meeting was “taking place against a background of un-
precedented debates on the future of Europe – with
new hopes after the elections of this year but also dis-
appointing votes in 2016”.
“Let me clearly say that we would like to see a strong
Europe,” she insisted. “‘Single Market’ is not a very pop-
ular phrase these days, but is still high on our agenda.”
Pointing out that it was only eight years since the
AESGP had held its Annual Meeting in Vienna,
Schuhbauer said that the choice recognised the 50th
birthday of the country’s local association IGEPHA, and
the organisation’s efforts to improve self-care in the
country.
Also speaking at the Vienna City Hall opening evening,
Dr Gerhard Lötsch, President of IGEPHA, the Austrian
Self-Care Association, said the Austrian healthcare sys-
tem was a good one, but healthcare systems cost mon-
ey. IGEPHA could offer viable solutions, he maintained,
by providing methods to help improve health literacy as
well as inexpensive but effective ways to treat oneself.
IGEPHA is also keen to work with regulators, he added,
to widen access to medicines.
Former President of the Austrian Self-Care Association,
Alfred Grün, was thanked for his 25 years of service
within the AESGP Economic Affairs and Public Relations
Committee (ECOCOM). Schuhbauer remarked that “for
most us, you were always there”, noting the “significant
impact” of Grün’s work for “a quarter of a century”.
Taking over in 2010 as Chair of the ECOCOM from Brian
McNamara – now Chief Executive Officer at GSK Con-
sumer Healthcare and Chair of the World Self-
Medication Industry (WSMI), Grün’s contribution
“became even more evident.” Alfred Grün’s role was
however not limited to the AESGP as he also served as
President of the Austrian Self-Care Association (IGEPHA)
from 2007 to 2014. In this function, he also represented
IGEPHA on the AESGP Board, a function which he had
kept until now.
“Thank you on behalf of all of us for your outstanding
work, the great achievements, but above all your excel-
lent leadership and personal friendship,” Schuhbauer
said, joined by the applause of the 300 guests attending
this evening at the Vienna City Hall.
Gerhard Lötsch Alfred Grün
3
Global Changes and their Implications on Consumer Healthcare
In her opening remarks, the session moderator Cathy
Smith introduced the theme of the conference. Self-
care and the self-care industry are changing massively,
and over the coming days, speakers will provide an
overview of general trends, changes in the digital space,
where the scope is for innovation, and update on new
regulatory developments. The focus of the first session
was global developments and its implications for Eu-
rope as a whole and the provision of healthcare.
Global economy and the impact on con-
sumer spending
Nenad Pacek, President of Global Success Advisors,
began by acknowledging the difficulties with budgeting
and predicting where markets are going. He explained
how declines in sales growth, for example, in Saudi Ara-
bia, are often difficult to predict. The reason, he ex-
plained, resides in the fact that the financial industry has
“hijacked” deregulation; there is massive speculation in
commodity and currency markets but also in buying
government bonds of Ghana/ Brazil or treasury bills of
Indonesia. “No one is attempting to regulate those ac-
tivities whatsoever,” he went on to explain. “Less than
3% of all oil trading in the world is done by countries
and people who need oil. This raises budgeting con-
cerns for markets and territories and often the changing
external environment is to blame.
He recognised that this has gotten worse over the last
ten years, as we are living in the aftermath of the 2009
financial crisis. The year 2009 saw the biggest global
crisis in 80 years, and its consequences can still be felt
today.
In the US, half of the money from quantitative easing
programs ended up in financial institutions, and some
were used to buy government bonds in South Africa.
Emerging markets were doing well thanks to cash from
the US leading to inflation of assets. When there was an
outflow of capital in 2015 and 2016, all commodity mar-
kets went down – Latin America, the Middle East, Aus-
tralia, Indonesia and Russia. The quantitative easing pro-
grammes created a large amount of volatility in the US
since 2010.
“We are now recovering from this,” Nenad explained.
“The US economy following this huge money printing
will continue to grow, consumer spending is recovering,
unemployment rates are low, and the federal reserve
will have increase interest rates (which he noted, are
signs of a recovering economy).
“The Eurozone is having its best year since 2007 and
2008,” he commented. The EU has its own quantitative
easing program since 2015, which made the euro
cheaper, making European exports more competitive.
“Exports are doing well,” he remarked, and this is lead-
Cathy Smith
Nenad Pacek
Conference report
4
ing to improved consumer spending.” Lending is also
improving banks now have freshly printed cash.” He
explained that most countries except Greece have easy
access to finance, so governments can spend more
freely instead of having austerity programmes in place.
“This strong performance in the Eurozone is helped by
the weak global commodity prices, which means that
there is no inflation and interest rates will remain low.”
“When the quantitative easing programme ends in
2017, we will start to see the first increase in interest
rates in 2018,” he warned, which may affect the con-
sumer. “For the next 12 months, however, consumer
spending should remain robust,” he reassured.
Labour shortages in central Europe are driving wages
up, and driving retail sales. In the East, Russia is barely
growing, but volume growth is coming back in local
currency. In Russia, 2/3 of its exports are hydrocarbon
related, and the country relies a lot on commodities.
A growth of 6% is the forecast for emerging countries in
Asia. In China, “local players are gaining an upper hand
over multinationals.” Japan is trying to escape deflation
with falling prices. The Middle-East is struggling as oil
prices are low, even in markets not driven by oil such as
Egypt. Pakistan is doing well, with a double-digit market
growth. Brazil is experiencing the worst recession in 80
years.
“Competition will get worse as well.” From a competi-
tion standpoint, he described four threats: large multi-
nationals which are better and better organised around
the world, the threat from emerging markets, the threat
from small, medium-sized companies and the rise of
family business. “The external environment will be vola-
tile from a macroeconomic side,” he added.
“Innovate more,” he urged, “but make these innovations
deeply relevant to the local market. Ensure your product
and marketing mix is right, do frequent consumer re-
search as the consumer is changing in this volatile world
and don’t get lazy with your marketing messages.”
“The traditional distributor model is dying,” he said.
“You must be present in the market. Look at your oper-
ations and ask if you have enough local people in place
to get the insights into the market you need,” he ad-
vised. “The quicker you localise the better.” He ex-
plained that centralising operations and leaving prod-
ucts in the hands of local distributors was a model that
would no longer work, especially in volatile emerging
markets.
Simplify to improve switch
Karl Broich, Director General, Federal Institute for
Drugs and Medical Devices (BfArM), Germany gave an
overview of global developments from a European and
German authority perspective. He explained that in Eu-
rope there is a centralised marketing authorisation
route for non-prescription medicines leading to a har-
monised marketing authorisation and the decentralised
procedure. However, there are different approaches
used across Europe. Therefore, the Co-ordination Group
for the Mutual Recognition and Decentralised Proce-
dures-Human (CMDh) established a European platform
for non-prescription medicines to get more harmonisa-
tion around non-prescription status.
The Non-Prescription Medicinal Products Task Force, he
explained, aims to explore new ways to improve conver-
gence on evaluation and facilitate access to safe and
effective OTC products for EU citizens. Efforts to im-
prove the functioning of the marketing authorisation
system for non-prescription medicines along the lines of
the AESGP Self-Care Agenda 2020 will be a further key
element. The Task Force will provide recommendations
to the CMDh and the Heads of Medicines Agencies
(HMA) on matters relating to OTC products, explore
best practices both at the level of national competent
authorities (NCAs) and industry, revise the Best Practice
Karl Broich
Conference report
5
Guide on the Decentralised Procedure (DCP) for non-
prescription medicines and engage with relevant trade
associations to discuss OTC status at European level.
The Task Force is constituted for the period of time
needed to complete tasks committed by the CMDh. It is
composed of members of the CMDh or experts from
NCAs and BfArM is actively involved with German
CMDh member participated from the beginning and
Martin Huber as the recently elected chair of the Task
Force. Non-European Union countries may also partici-
pate if they are prepared to sign confidentiality agree-
ments.
Another committee at European level is the Committee
of Experts on the Classification of Medicines as regards
their supply set up by the Committee of Ministers under
Article 17 of the Statute of the Council of Europe. Its
tasks include reviews on classification practices, underly-
ing rationale, develop and promote good classification
practices, monitor trends and the impact of the classifi-
cation of medicines on medicines’ safety and accessibil-
ity to the patient and develop further and coordinate
the updates of a web published database presenting
the classification status of medicines in the Member
States (MELCLASS database).
In Germany, he explained, a substance-based classifica-
tion system is laid out in the German Medicines Act
(‘Arzneimittelgesetz’), and decisions are taken by the
Ministry of Health in a legal act. Except in cases where a
substance is not generally known – where it is automati-
cally subject to medical prescription – prior consultation
of an Expert Advisory Committee is warranted. The
committee is composed of stakeholders and experts in
the field (academia, clinical practice etc.) BfArM acts as
the secretary/contact point for this committee and hosts
the meeting.
The National Switch Committee meets twice a year. A
company or any other party can submit an application
for a change of the legal classification, and the applica-
tion is then sent to BfArM for validation and scientific
assessment, which will then go to the Expert Advisory
Committee.
He explained that more and more, BfArM are consider-
ing the international experience with the usage of a
medicine in an OTC setting outside Germany and out-
side the European Union. The application together with
the BfArM assessment is then being considered by the
Expert Advisory Committee. The committee can consult
further external experts on a case-by-case basis for spe-
cific topics. The committee then issues a recommenda-
tion as to whether the legal status should be changed.
The recommendation is addressed to the Ministry of
Health which takes the final decision.
He stressed that a standardised approach to future sub-
missions to change legal status should be put in place.
Although it is always a case-by-case assessment, the
“Brass et al. benefit-risk model and methodology pro-
vides an established standard for evaluating and decid-
ing on switch applications in Europe.”
He also urged industry to make use of the improved
level of OTC expertise at national agencies and engage
with these agencies prior to filing, noting that in line
with the AESGP 2020 agenda, BfArM had the ability to
offer scientific advice and preparatory meetings on
switch proposals before an application was made.
“We should be more visible as regulators,” he remarked.
On the issue of transparency regarding the criterion
used to evaluate products and changes in classification
status as described in the AESGP 2020 agenda, he ex-
plained that detailed guidance on switches is available
on the BfArM website. Procedural clarification meetings
are also provided. He believes that the same standards
for safety should apply regardless of prescription status,
“without being too risk-focused”.
He concluded with BfArM’s future priorities, which in-
clude further interaction and exchange of views with
stakeholders within Europe and outside Europe,
strengthening expertise in the field of OTC medicines,
optimising Scientific Advice regarding OTC switches
(both at EU and national level) and the use of other data
sources (e.g. digital media) in the decision-making pro-
cess.
Trust driving the Self-Care Agenda forward
Brian McNamara, Chief Executive Officer, GSK Consum-
er Healthcare and Chair, World Self-Medication Industry
(WSMI), gave his perspective on how both GSK and the
industry are serving consumers and driving the self-care
agenda forward.
OTC contributes over 100 billion dollars per year in the
US - $7 is saved for every $1 of OTC sales. In Spain,
€835 million euros could be saved each year by switch-
ing 5% of prescription medicines to OTCs and in the UK,
£2 billion could be saved each year in reduced doctors’
6
visits for minor ailments were self-treated with OTCs,”
he quoted. “Reacting to the changing environment,
there is a huge opportunity to increase access and drive
the safe use of consumer healthcare products,” he ex-
plained.
Against a backdrop of Brexit and uncertain elections
across the continent - France, Netherlands, Germany,
Austria, the US/Trump administration and drama in
North Korea businesses need to navigate through the
challenges of emerging markets slowdown and high
volatile, tightening government and household budgets,
drug pricing focus, demanding capital markets and a
trust deficit.
At the same time, there is clear interest and opportunity
in self-care. Google searches for ‘self-care’ have reached
a five-year high immediately after US election last No-
vember. “As we deal with the challenging environment,
it’s important to put consumers at centre of all we do,”
he explained. “By placing the consumer at the centre of
what we do,” he insisted, “we can further build trust in
products and brands and drive forward the self-care
agenda.”
“GSK has three priorities: innovation, performance and
trust.” Performance, he explained, is about consistently
delivering on consumer needs, which allows GSK to con-
tinue to invest in their brands and people. Innovation is
the “life-blood of our industry - and goes beyond prod-
uct innovation to packaging, claims and experience.”
He also believes that the interaction between the con-
sumer and pharmacists is critical, and will become more
important with enhancements from digital and data.
“Earning and retaining the trust of consumers will be the
key to expanding the consumer healthcare market,” ac-
cording to Brian McNamara.
Public trust in systems of government and in business
was at an all-time low, but in the portfolios of consumer
healthcare companies around the world, there were
brands with a great deal of loyalty and trust. To grow
the industry, he added, this asset needs to be leveraged.
“Industry, by doing business the right way - ensuring
quality, efficacy and safety – can leverage the trust in
the brands that have been in people's lives for many
years,” he said.
He concluded by stating his belief that “the success of
self-care is founded on three fundamental pillars: one,
putting consumers at the centre; two, enabling self-care
to improve health and healthcare systems; and the final
pillar, building trust in our products and brands. These
are the building blocks of serving consumers and mov-
ing the self-care agenda forward.”
Brian McNamara
7
Performance of the Self-Care Industry
Merger and Acquisition trends and “The
Year of the Deal”
Fuad Sawaya, Co-founder and Managing Director,
Sawaya Segalas, a New York-based global boutique in-
vestment bank which exclusively serves clients in the
consumer industry, began his presentation by providing
his perspective on Merger and Acquisition (M&A)
trends. The year 2014 saw deal values greater than the
last seven years combined. This was followed by a di-
gestion year in 2015, and increase in M&A activities in
2016/2017. There has been a record number of scale
transactions and transaction multiples have peaked and
then stabilised somewhat. The entrance of generic com-
panies into the OTC industry have been met with mixed
successes, private equity has become active again and
under the radar, an aggressive consolidator (Prestige
Brands) is on the move that has emerged as a global
top ten, sourcing from private equity, large pharmaceu-
tical companies and from family businesses. He explains
that until this year, the two largest deals involved the
$16.6 billion Pfizer deal back in 2006 and the more re-
cent Bausch & Lomb sale to Valeant. Since then, 5 of
the top 7 deals in size were done in the last 3 years and
it is not just the big pharma companies that are in-
volved in these transactions. There have been asset
swaps, strategic collaborations, private equity involve-
ment and the generic entry with the Omega Pharma
deal. “In the last three years, 13 transactions were in
excess of 500 billion Dollars”.
He notes that in 2017, M&A activity has not been ag-
gressive/active like it was in 2014 which was driven by
higher stock prices. He asks what will come next since
most of the chess moves were already played in 2014
and 2016. He adds that “focus and prioritisation is the
way forward for the big players. Focusing on the big
ideas, leveraging R&D, putting resources behind them
and making them happen.”
“We are at an inflexion point. We have not seen an ac-
celerated pace for traditional OTC portfolio optimization
-its very ad hoc”. He explains the percolating im-
portance of “following the consumer” in the industry
and as a result, there is an evolving definition from OTC
to consumer healthcare. As a result of the expanded
definition, there are new competitors and new entrants
looking at the industry from a different perspective.
“From a divestment standpoint, we have had three large
deals and very little come out of it” However, according
to Mr Sawaya, this may change.
Looking at the industry construct there are 10,000
brands with 50 million Euro or less out there which will
be a source of an extensive trail that will be available for
M&A going forward. In his view, Europe is most likely to
see the most action in the future in terms of those di-
vestitures.
There are increased blurred lines between OTC and con-
sumer health (including functional foods, devices, infant
nutrition, light therapy). FMCG (fast moving consumer
goods) leadership is coming into pharma companies,
and pharma leadership is coming into FMCG compa-
nies, which brings new thinking. For example, in GSK the
combined OTC and FMCG market has been dubbed
FMCH (fast moving consumer healthcare). M&A is now
following those expanded category definitions. For
Reckitt Benckiser, 7 out of their top 10 power brands
focus on healthier lives and more and more companies
are converging towards this messaging.
He concludes by stating that consolidation trend is like-
ly to continue, but will also evolve. He does not antici-
pate more mega deals. However, he believes that as the
financial characteristics of the industry are quite unique,
the industry offers tremendous opportunity.
Fuad Sawaya
Conference report
8
Developing regions drive growth
Andy Tisman, Global Senior Principal, Consumer
Health, QuintilesIMS gave his insights on the consumer
market. The global OTC market continues to grow at
solid mid-single-digit rates. Pharma growth has
dropped, and it is expected that the OTC market may
overtake pharma again in the next year or so. The
strong start to cough/cold in 2016/17 winter season (10
-15% growth), has not been maintained through Q1
dropping to less than 5%. He explains that growth is still
driven by emerging markets and developing economies.
Developing regions contributed 82% of the growth of
the global OTC market that exceeded €100 billion for
the first time in 2016. This was despite them only having
a 50% share of the market that grew by 4.6% to 101
billion Euro at manufacturers’ selling prices. Two re-
gions, in particular, are growing very strongly – CEEMEA
(Central and Eastern Europe, Middle East and Africa)
and APAC (Asia-Pacific). In contrast, sales growth has
dropped closer to share growth in Latin America and
China. This has had a knock-on effect on other countries
dependent on China for their growth such as Australia
(which had a buoyant market in the last few years due
to its exports to China).
Market leader Sanofi with a 5.1% share had outstripped
the others with a 3.6% growth in the OTC market (albeit
slightly under the market growth rate) due to recent
asset swap with Boehringer Ingelheim, propelling it
ahead of both Bayer and GlaxoSmithKline that had
grown by 1.0% and 2.3% respectively. Their 4.8% market
shares were larger than Johnson & Johnson’s 4.0% in
fourth place, despite a stronger 3.1% sales rise during
the year. However, he noted that only PGT (which in-
cludes P&G North America), Reckitt Benckiser and No-
vartis had grown ahead of the market growth rate. In
9
Europe, only Stada and PGT grew ahead of the OTC
market in Europe in the first quarter of 2017. Novartis,
Sanofi and Reckitt Benckiser approached market
growth. Noting that the extent and timing of the cough/
cold season remained a strong influence on the mar-
ket’s performance – the first quarter of 2017 had damp-
ened a buoyant fourth quarter of 2016 – and he points
out that none of the world’s top four OTC companies
had done better than the market as a whole.
Outside of top 10 Abbott, Stada and Menarini achieved
strong global growth. Abbott’s OTC sales had risen by
9.5%, Stada’s increased by 8.4%, while Menarini’s rose
by 7.9%, driven by the focus areas in their portfolio.
In Europe, France had performed better in 2016 than its
growth rate over the previous three years (due to a
buoyant analgesic market), but Germany, Italy, Spain
and the UK had not done so well. In Central and Eastern
Europe, there is a stronger growth picture driven by
Russia, Turkey and Kazakhstan (local currency growth),
except for Poland which lagged slightly behind.
From a category view, cough, cold, respiratory and vita-
mins and minerals grew ahead of the Europe’s OTC
growth, while pain and digestive products continue to
see strong growth.
On M&A, he reports that the Sanofi and Boehringer
Ingelheim deal created the No. 1 player in 4 regions and
gives Sanofi consumer health care a strong presence in
Japan. The deal was well matched in terms of comple-
mentary businesses. Within respiratory Sanofi’s strength
is in anti-allergy, while Boehringer Ingelheim’s is in ex-
pectorants. And in the gastrointestinal category, Sanofi
core brands in liver remedies, antidiarrhoeals and probi-
otics complement Boehringer Ingelheim’s core brands
in Laxatives and Inflammatory Bowel Disease (IBS). Their
businesses are also synergistic from a regional perspec-
tive.
He points out that the Reckitt Benckiser acquisition of
Mead Johnson Nutrition extended its focus on ‘mums’
to include babies, recalling the keynote address of CEO
of Reckitt Benckiser, Rakesh Kapoor, from the AESGP
Annual Meeting London 2014 that it’s all about “mums
not molecules.”
He observes that overall, there is fragmentation in the
market, and a polarised picture, with consolidation at
the top and fragmentation, lower down, as local and
regional player continue to grow strongly and take
shares from the mid-tier players. As a result, the gap
between the market leader and No.10 continues to
grow, illustrating the difference in scale, as the big play-
ers become enormous. There has also been a lot of pri-
vate equity interests, interested in the OTC space.
He notes that innovation remains the key growth driver,
particularly in developed countries (where there tends
to be base volume decline). New products, market ex-
tensions, and OTC switches remain the only way of driv-
ing value in the market. Globally OTC is 41% bigger than
it was 5 years ago in 2011, with 29% growth being
through new products/line extensions, 9% through price
increases of existing products and 3% through volume
increases of existing products.
Looking to the future, Tisman highlighted the
“increasing leverage” of combining research and devel-
opment and consumer insights to drive differentiation
and growth. “Switch is being leveraged as a growth driv-
er with successes and failures. “The market continues to
broaden from OTC to health and wellness,” he observed,
“with medical devices potentially offering a faster ‘go-to
-market’ innovation route.” Chanel mix and go-to-
market continue to be important and companies contin-
ue to face the challenge of resource splitting between
the direct-to-consumer, the healthcare professional and
the trade customer.
“Overlaying all of that”, he says is “the rise of digital
which is playing an ever more important role, both in
terms of promotion and a route of distribution for prod-
ucts”. He also notes that increasingly companies see the
value in open innovation.
Andy Tisman
Conference report
10
He concludes by stating that the OTC market continues
to show steady growth and attract new competitors.
Mega-deals have driven corporate growth. The question
is how can those in the “middle ground” avoid the
squeeze as the local and regional players continue to
grow strongly.
Market perspective
Chris Slager, Global President, Pfizer Consumer
Healthcare presented his perspective on the OTC busi-
ness coming from a food industry background. He be-
gins by comparing and contrasting the two industries
with some market fundamentals. Looking expansively,
he comments that both are very large. The food indus-
try is a $3 trillion market. OTC Health and Wellness is
about $2.5 trillion and incorporates functional nutrition,
personal care, hygiene, wellness services, consumer
health equipment and wearables.
Both have similar global compound annual growth rates
(CAGRs). There are mid-single digit CAGRs which con-
tinue to grow. Both industries have a diverse set of
competitors. Who really is the competitor is changing
everyday as the consumer’s perspective changes. He
also notes that regulation is another area where the
food and consumer healthcare businesses overlap.
Both businesses are characterised by significant pricing
and margin pressures given retail consolidation. He
points out that increasingly, we can see consolidation in
food and OTCs as a way to gain scale and manage
costs/profitability. One significant difference between
businesses is the prescription to OTC switch. “In the
food industry”, he concedes, “the ability to dramatically
increase revenue and income doesn’t exist”.
The biggest trend in both businesses is the growing
interest in wellness and the consumer’s focus on well-
ness is blurring the lines between OTCs and food as
consumers are seeking wellness solutions. Consumers
are looking for a quality experience which he describes
broadly with the terms “trust, ingredients, and conven-
ience.” He explains that consumers want brands they
can trust against the backdrop of a global decline in
institutional trust.
Trust is higher with small businesses than big ones and
the gap is widening. According to the Gallup poll, confi-
dence in small business has increased by 6 percentage
points between 2014 and 2016, while confidence in big
business has declined by 3 points. He explains that the
same trend is evident in the food industry. He explains
that Nielsen data show how these trends are impacting
Chris Slager
11
the processed food business. Small and medium brands
account for 35% of sales, but an overwhelming 75% of
growth. While the top 50 brands still account for the
majority of sales, it is smaller brands that account for
growth in the market of the top 50% of brands account-
ing for only 3% of growth.
When consumers trust a brand, they try more, buy more
and pay more, which leads to a greater market share for
smaller companies. He explains that this trust is chang-
ing the way “consumers vote with their dollars day in
and day out.”
From an ingredients standpoint, consumers are looking
for more accessible information. Consumers gravitate
towards buzz words like “organic” because of connota-
tions of trust and a quality experience. Consumers also
want convenience. E-commerce and the growth of mo-
bile shopping and options such as “click and collect”
indicate where investors see the future of retailing.
He remarks that the theme of the conference “Self-care
in a changing world” is very appropriate, given trends in
the market; focus on wellness; the blurring of lines be-
tween food and OTCs; and consumer’s desire for brands
they trust, leading to a demand for a quality experience.
“Our consumers are shaping this”, he says and “we need
to keep a focus on consumer’s needs.” “Thinking
through how to build trust, better ingredients and deliv-
er convenience”, he says “will help us to deliver self-care
in a changing world.”
How to Be Successful in Self-Care
Olaf Schwabe, Chief Executive Officer, Schwabe, de-
scribed the history of his company, Schwabe, which cel-
ebrated its 150th
anniversary in 2016. It was founded by
Dr Willmar Schwabe who was his great great grandfa-
ther in Leipzig. In 1878, the first phytopharmaceutical
product, Hametum, was developed. In 1946, the compa-
ny relocated to Karlsruhe and, in 1961 DHU, which is
specialised in homoeopathic products, was founded.
Schwabe has a presence in all five continents. Relevant
Research and Development (R&D) investment takes into
account the focus on self-care. Home market sales grew
by 11 % from 2013 to 2016 and international sales grew
in the same period by 42 % - now representing 3/4 of
Schwabe Group sales. It had seen major growth in
North America and China. Tebonin®
is their biggest
brand with approximately 30% of the total sales volume.
Launched in Germany in 1965, Tebonin®
– the first ever
Ginkgo medicine – gained the number one position in
the German pharma market in the 1980s and is the
number one Ginkgo brand worldwide. Ginkgo biloba
Special Extract EGb 761®
is approved for the treatment
of cognitive disorders, tinnitus and vertigo. “Analysis
over 10 years and almost 400 batches of EGb 761®
found that it has a unique, consistent composition,
while other ginkgo extracts differ significantly,” he said.
Schwabe has its own Ginkgo plants and decades of ex-
perience in creating batch to batch consistency for EGb
761®
with a patented 20+ step extraction process.
”More than 50 randomised controlled clinical trials with
more than 7.000 patients and several meta-analyses
confirm efficacy”. Tebonin®
is included in therapeutic
guidelines related to their indications in many countries
in Europe as well as outside Europe.
All non-prescription medicines in Germany were exclud-
ed from reimbursement by public health insurances in
2004 following a package of cost containment measures
which were a significant threat to Tebonin®
, as more
than 60 % of sales came from prescription. However,
Schwabe was able to even increase sales with a two-
Olaf Schwabe
Conference report
12
step strategy: Medical doctors were re-assured of the
therapeutic benefits of Tebonin®
and convinced to fur-
ther recommend Tebonin®
(without reimbursement or
only coverage by private insurance) and investments in
direct to consumer communication were increased (e.g.
TV promotion). Schwabe also extended its business in-
ternationally to become less dependent on the home
market.
Tebonin®
is now available in more than 50 countries.
The most recent countries include India and Israel. Inter-
national sales have almost doubled in 5 years. He ex-
plained that the success is based on the fact that it is of
high quality and clinically tested. Manufacturing takes
place in Germany and, by that, an excellent quality is
produced close to the customer.
“To further remain successful, it is important to identify
relevant consumer needs and trends and adapt accord-
ingly.” There is no doubt that health will remain a mega-
trend – especially as the global population gets older. In
less than 30 years more than 1 billion people will be
over the age of 65. Often the industry is asked to offer
convenient solutions for different health issues. But he
explained that the 65-year-olds of the year 2050 are
today in their early 30s and in many ways they will be-
have differently – not only in media usage but also in
expectations towards a more individualised medicine.
He explained that this is one of the reasons why we
need to transform, “from being a manufacturer and
marketer of medicines to a company that offers individ-
ual health solutions.”
“Digitalisation will be key” in this process,” he said. He
gave the example of a newly developed Tebonin App
with exercises for Vertigo sufferers. This innovative solu-
tion ensures an individualised exercise programme that
reflects the specific needs of the user. It was launched in
Germany at the beginning of this month and will be
rolled out in Europe soon.
The Schwabe business has significantly changed in the
past 150 years. He concluded by saying that, as a family
company, Schwabe will continue to strive for innovative,
efficient and safe solutions for various health issues with
products from nature according to their vision: From
nature. For health.
Succeeding in smoking cessation through
consumer insight and innovation
Catherine Devine, Global President, OTC Franchise,
Johnson & Johnson, gave an example of a success story
based on consumer insights and partnering with the
consumer. Rather than focusing on the functional char-
acteristics of its products, Nicorette’s mission is “to save
the lives of consumers by being the partner of choice to
help smokers take control of their quit journey and
break free from tobacco for good.”
“The smoking cessation category is important, as there
is still a significant number of smokers in the world – in
total 1.4 billion – which is the current population of Chi-
na.” Contrary to all political efforts, smoking is expected
to continue to rise in the next 20 years. Smoking has a
known and significant negative impact on health. The
World Health Organisation (WHO) cites six million
deaths from tobacco and causes hundreds of billions of
dollars of economic damage worldwide each year. “If
current trends continue, by 2030, tobacco will kill more
than 8 million people worldwide”, she quoted. “86% of
Catherine Devine
13
all lung cancer in the UK are linked to smoking”, she
added.
The dangers of tobacco are becoming more known;
hence consumers are trying to quit smoking. However,
many underestimate how difficult it is, with most people
in need of numerous attempts to successfully quit – and
many never managing to do it. Quitting is made diffi-
cult because of the physiological addiction from nico-
tine and the physical, emotional, situational and social
‘addictions’ that comes with giving up smoking. “As it is
most personal, it can feel that smokers are giving up
part of who they are – they are defined by their smok-
ing, and are fearful of what it means if they are not a
‘smoker’ any longer.”
In order to be able to help a quitter to give up smoking,
Nicorette®
built on these consumer insights of the quit-
ting journey and developed an innovative approach in
many senses in relation to communication. From this,
Nicorette®
came up with their slogan: “Do Something
Amazing.”
It speaks to the huge sense of achievement that comes
with finally beating smoking and the opportunities it
can open up. Mrs Devine explained that it is very moti-
vating to speak to smokers like people, not patients,
and applauded those who are brave enough to try and
quit and it focused on the positive end goal, not just
the struggle.
Their latest innovation QuickMist also leverages the key
consumer need around those tough ‘struggle’ mo-
ments. QuickMist provides the fastest craving relief in
the category and is supported by strong claims (150%
more likely to quit, relieves cravings in 60 seconds).
Nicorette’s approach to insight-led innovation has re-
ceived a number of recent recognitions and awards.
“Through insights, Nicorette®
was able to create truly
consumer-led innovation (communication, product, and
channel innovation) to ultimately help consumers break
free from cigarettes and live a longer, happier life,” she
summarised.
On digitalisation, she explained that to stay current in
what was a rapidly changing digital environment, com-
panies could afford to take a “leap into the dark” on
new digital services.” Generally, digital activities were
low cost and so companies could afford to “throw a lot
of things out there.” “If you are not having failures [in
digital], you are not moving fast enough,” she insisted.
She warned delegates of the conference that we need
to “get comfortable with having two-way conversations
with consumers in the digital space or become irrele-
vant.”
Consumer centricity, digital and partner-
ships
Dirk Ossenberg-Engels, AESGP Vice-President and
Head Region Europe South, Central Eastern Europe &
Middle East, Bayer Consumer Care, began by acknowl-
edging that we are in “an exciting and challenging mo-
ment for self-care.” He asked the audience what is the
reason they get up in the morning, “is it to sell boxes”
or to “make an impact on consumers and society”?
He went on to explain his perspectives on how to be
successful in self-care, which in reality features a combi-
nation of consumer centricity, digital and partnerships.
He explained that consumer behaviour is changing
more rapidly and is becoming more diversified. It is
therefore increasingly important to address consumer
needs, “and pick up on nuisances” to find targeted solu-
tions for consumers.
He then gave an example of turning a consumer insight,
driven by a medical need, into a clear tangible benefit
with a line extension. One of Bayer’s franchises, Copper-
tone®
, is based on a consumer insight that the single
biggest barrier to applying sun protection is how the
cream feels on the skin. It also addresses the need to
prevent skin cancer, which is the number one cancer in
the US and is growing. Coppertone®
whipped launched
into 2017 and has been the recipient of a number of
awards.
Conference report
14
“The future is not digital,” he said, keeping the audience
in suspense, “the future is now.” 60-80% of consumers
use smartphone today. It is a reality for our consumers.
$1.9 trillion was the turnover through e-commerce in
2016 and this is expected to increase. Digital can be
used as a platform to provide services, information and
engage with consumers.
Bepanthen®
, he explained, is based on a consumer in-
sight that after pregnancy, the attention shifts from the
mother to the baby. They then developed the 10th
-
month initiative. He then showed a video illustrating the
emotional bond they created with this initiative.
Launched in Turkey, in a few weeks it was seen by 2 mil-
lion people. The website is also now online in nine
countries, six in Europe.
Big data is expected to double every 24 months. He
gave an example of the product Aleve®
in the US which
made use of big data. The company received feedback
from consumers for a non-systemic alternative, and big
data, online threads were used to confirm this gap in
available treatment. They partnered with the TENS
(transcutaneous electrical nerve stimulation) technology
and launched Aleve®
direct therapy in 2015.
“We are getting in better on digital partnerships,” he
said. Ossenberg-Engels then described some non-
commercial partnerships, which he believes companies
should develop. Bayer has partnered with 18 stakehold-
ers – including the White Ribbon Alliance (which advo-
cates for mother and baby’s rights and health), the Unit-
ed Nations where Bayer participated in the ‘Every Wom-
an, Every Child’ Movement and WHO – to launch a poli-
cy position on the role of self-care in maternal, new-
born and child health.
“Success in self-care ultimately provides a unique bene-
fit to consumers, society and health care systems,” he
concluded.
Dirk Ossenberg-Engels
15
The Changing Environment for Health Professions
From left to right: Jacques de Haller, President, Standing Committee of European Doctors (CPME); Briain de Buitleir, CEO, PGT Healthcare; Cristina Cabrita, Senior Project Officer, Deco Proteste, representing the European Consumer Association BEUC; Jurate Svarcaite, Secretary General, Pharmaceutical Group of the European Union (PGEU); Lilian Azzopardi, Presi-dent, European Association of Faculties of Pharmacy (EAFP); Max Wellan, President, Austrian Chamber of Pharmacists
A key prerequisite for a positive development of self-
care remains the attitude and support provided by
health professionals including in particular medical doc-
tors and pharmacists. Leading representatives of the
professions discussed concrete ways forward in times of
growing consumer empowerment and an unprecedent-
ed variety of information. Briain de Buitleir, Chief Exec-
utive Officer, PGT Healthcare, introduced the session by
saying that we are all in the same business, healthcare
professionals, regulators, because “our business” is giv-
ing patients “longer, healthier lives” and in this business
the demand is insatiable. This is creating a crisis for the
pension industry as people live longer lives. He remarks
that we are at an inflexion point because there is the
question now of whether this rate can increase further.
Self-care has an important impact on this rate.
“Looking ahead,” he said, “self-care and the professions
have increasing opportunity to make a positive impact
and better tools and technologies to do it with.”
Of the money spent on helping people live longer, 80%
is spent on chronic disease. However, he believes that
money is better spent on prevention, diagnosis, and
pharmacogenomics. Prevention is accelerating at an
enormous rate, he said, and elaborated on this with an
example of capsules which can be “injected into a per-
son’s hand to read blood and act as a security mecha-
nism.”
CPME supports Self-Care
Jacques de Haller, President, Standing Committee of
European Doctors (CPME), first introduced CPME, which
is the umbrella association for the National Medical As-
sociations of 28 countries in Europe. It represents both
General Practitioners and specialists and, by that, more
than 1.5 million doctors. CPME articulates the medical
profession’s point of view to EU institutions and Europe-
an policy-making through pro-active cooperation on a
wide range of health and healthcare related issues.
The key point of Dr de Haller’s presentation was an ex-
planation of the outcome of the EU-funded pilot project
on the promotion of self-care systems in the European
Union (PiSCE), which has been developing and produc-
Conference report
16
ing communication tools and a series of proposals and
EU policy recommendations and actions on self-care. To
come up with the recommendations, three main meth-
ods were used: review of existing self-care related EU
policies; a survey on the needs of people/patients; and
input of the PiSCE Platform of Experts. This began with
a mapping of existing European self-care initiatives,
which found, for example, that patient safety is at a
more advanced stage of implementation compared to
health literacy.
The main findings of the survey on the self-care needs
of people/patients conducted by the European Con-
sumer Organisation (BEUC) and the European Patient’s
Forum (EPF), identified that the needs of persons ex-
posed to self-management interventions were health
information, access, support from healthcare profes-
sionals, patient groups and families. The main barriers
to self-care were low health literacy, costs of self-care,
difficulty to navigate the healthcare system and lack of
information. The survey also found that vulnerable
groups should be the main target when developing and
implementing self-care policies. 65% of respondents
indicated that they are ready and willing to bear neces-
sary costs of self-care (reflecting an understanding of
the importance of self-care).
Existing self-care related EU policies
Jacques de Haller
17
Themes brought up by the PiSCE Platform of Experts
include empowering patients to be more ‘internet-
savvy’ in terms of judging the quality of information,
empowerment through knowing when to seek profes-
sional advice, good inter-professional cooperation and
the need to educate pharmacists, doctors and patients
to change their behaviours.
The EU Policy Recommendations integrate new tech-
nologies to support people’s self-care (making health
information easily accessible for patients to make in-
formed decisions), embed self-care in health literacy
initiatives (which is still not usual practise), to establish
a framework that will encourage the exchange of best
practices on self-care, to secure an Engagement Plat-
form to support national or regional initiatives on self-
care, and to include self-care in school education and
life-long learning to teach young people how to man-
age their health (which, Dr de Haller remarked, was a
strong proposal of the PiSCE project). The inclusion of
skills to support self-care as part of the curriculum in
education and training of health professionals was also
part of PiSCE project.
He stated that “CPME supports self-care”, commenting
that the association has been fighting prejudice about
this for years. Self-care supports and enhances the dig-
nity of patients. However, he believes that self-care
must not lead to or permit missed or belated diagnosis,
lead to wrong or dangerous use, to the abuse of medi-
cations, or be used as a commercial lever (as patients
aren’t just consumers).
“Self-care will change lots of things over the next 20
years, including the professional identity of doctors,
pharmacists and other healthcare professionals”.
He concluded with the following remark that “self-care
belongs to society as it develops nowadays […] and it is
essential that health professionals be realistic members
of the society.” He also remarked that self- care should
play a greater part in our health systems.
PiSCE Recommendations
Cristina Cabrita, Senior Project Officer, DECO
(Portuguese Consumer Organisation), Proteste, Portu-
gal who works as an expert in the PiSCE project talked
more about the policy recommendations of the PiSCE
project, which covers five minor disease areas, namely
cough, cold, urinary tract infections, heartburn and ath-
lete’s foot. These were selected after a benefit-cost
analysis by the European Commission.
The self-care platform, she explained, consisted of 23
experts on self-care from all over the EU with expertise
in self-care: self-management, patient empowerment,
health literacy, integrated care, health technologies, self
-medication, and expertise related to EU, national and
regional levels. Experts are individuals with affiliations
that represent central actors needed for EU, national,
regional and local levels on self-care: primary care phy-
sicians, pharmacists, nurses, patients, academia, com-
munication specialists, consumers, the self-medication
industry, etc.
Part of the project was the carrying out of a survey to
identify barriers for practising self-care.
Weak health literacy, she explained, leads to less
healthy choices, less therapeutic adherence/
compliance, riskier behaviour, poorer health, less self-
management and more hospitalisation.
“Around 50% of people have difficulties when trying to
use Internet to look for health-related information.”
This was related to not having the skills to evaluate the
health resources found on the Internet and difficulties
to find correct health-related information. Functional
literacy was also assessed and revealed difficulties
when asked to use simple information to manage the
administration of a drug.
Health literacy and self-care in early childhood are criti-
Cristina Cabrita
Conference report
18
cal, she explained, and interacting with parents and
family members through early childhood programs is
important, e.g. through child-to-child programmes.
Children can then teach parents about self-care. It is
therefore important to equip teachers to integrate self-
care in schools and in the curriculum. She then gave
examples of videos, play games which were developed
to test health knowledge, run by the Finnish Medicinal
Products Agency, targeted to each year school. It should
be lifelong learning and be either informal through daily
reading or formally structured.
To include self-care in health professional education,
this requires skills, knowledge and attitudes from
healthcare professionals, to treat the person as an indi-
vidual, to actively listen, communicate and set goals
together.
She concluded by stating that self-care needs to be evi-
dence based, with teachers and parents on board and a
political will behind it.
Community Pharmacists and Self-care
Jurate Svarcaite, Secretary General, Pharmaceutical
Group of the European Union (PGEU), began by noting
that surveys from the European Consumer Organisation
(BEUC) and the European Patient’s Forum (EPF) shows
that patients are more willing to make self-care deci-
sions. “Self-care is not just self-medication but includes
anything patients do to care for themselves.” She ex-
plained that increasingly patients are seeking holistic
care, not just seeking treatment as a condition, “as a
migraine” for example, but to be treated individually to
maintain their health and stay active members of socie-
ty. Healthcare is not just about treating diseases. It is
also good for the economy as people can continue to
live their usual lives. Pharmacists can act as gatekeepers,
to refer/signpost the patient as appropriate, highlight-
ing that inter-disciplinary collaboration is important.
However, she explains that self-medication is a tool to
provide immediate support.
On the PiSCE recommendations, she added that the
greatest strength of the project, for the pharmacists,
was sitting down and discussing the ideas together as a
healthcare team even though the recommendations
could have been a little more challenging.
Reflecting on earlier discussions on digitalisation, she
explained that “the world is changing and healthcare
professionals are also changing.” The pharmacy profes-
sion was one of the early adopters of technology, and
are increasingly writing blogs and interacting with pa-
tients through other channels, for example, pharmacy
Facebook pages.
Alluding again to changing patients, she explained that
“we [healthcare professionals] need to change with
them”.
Barriers to self-care according to PiSCE survey
19
“Access is not just about having a pharmacy around the
corner”, and her vision is for community pharmacy to
be “the smart care around the corner.”
Shifts in pharmacy education
Lilian Azzopardi, President, European Association of
Faculties of Pharmacy (EAFP), began by describing the
challenges for pharmacists in managing complex pa-
tients, handling big data, complex therapies and from
an industrial perspective, how production facilities are
affecting the environment. When EAFP was set up, it ran
a curriculum mapping exercise, which found that chem-
istry subjects dominated the curriculum. In 2006 anoth-
er curriculum exercise was run, which showed a shift in
focus to the medical sciences in pharmacy curricula.
Leufkens, with leaders in clinical pharmacy in the 1990s,
came up with a model that for pharmacists to maintain
their position as healthcare professionals, they need to
put the patient first, be proactive, and partner with the
patient and other healthcare professionals towards im-
proving self-care.
This shift in education was confirmed by a publication
in 2016. The curriculum with the highest mean percent-
age of clinical sciences was the United States at 16.7%
followed by Malta and the Netherlands at 12.3%.
This shift in education goes hand in hand with the need
to maintain knowledge and merge science. Realising
that practice is changing and that patients need to be
supported to navigate health information are important
prerequisites to make change happen.
The future vision is to include clinical pharmacy, and
pharmacy practice as subjects in the EU Directive on
Pharmacy Education, and to support the development
of faculty and opportunities for research in self-care.
At the University of Malta, there is a post-graduate pro-
fessional post doctorate in pharmacy (EU-USA collabo-
Jurate Svarcaite
Conference report
20
rative degree) which focuses on self-care and empower-
ing patients. A third-year student of this programme
completed a research project on Optimising Patient Self
-Medication through the Community Pharmacist which
identified that out of 203 patients reviewed in commu-
nity pharmacy, 38 (19%) had at least one drug-related
issue.
At their recent annual conference in Helsinki, EAFP re-
flected on the challenges and what needs to be done
from an academic perspective. The conclusion was that
there is a need to maintain the science-based aspects of
the curriculum, to have lifelong learners, individual pa-
tient inspiration, interdisciplinarity, and be able to deal
with new therapies, innovations, health systems, and
technology.
“Pharmacy education rather than looking at subjects
should look at the competencies graduates need to
contribute to self-care, to look at what is needed in
pharmacy education and how the future should be
shaped,” she concluded.
Pharmacogenetics and “ApoApp”
Max Wellan, President, Austrian Chamber of Pharma-
cists, began by explaining that patients and people are
mobile. Seven years ago, apps provided on medical/
pharmaceutical information but did not provide trustful
information. Now ApoApp, by the Austrian Chamber of
Pharmacists, is the number one app in healthcare in
Austria for six consecutive years. It provides information
on pharmacy opening hours, contact information and
information about medicines. They also invited the self-
care industry to provide additional tutorials about their
products, so that it can be accessible from the app. It
contributes to health literacy by having all the infor-
mation at hand and also signposts when to seek a phar-
macist’s advice.
“Apoatschool” is an app designed to equip pharmacists
to go into schools and signpost red flags to look out for
(which meets a PiSCE recommendation to include self-
care in school education). He remarks that “patients are
not consumers but are the co-producers of their health,
pharmacists are co-producers, and we are all co-
producers of health.”
The Austrian Chamber of Pharmacists also ran a phar-
macogenetic project in the form of a self-experiment
and invited pharmacists to make their own pharmaco-
genetic profiles. This project would enable pharmacists
to counsel patients on pharmacogenetics and to pro-
vide information to doctors. He remarks that a lot of self
-care products are also connected to pharmacogenetics,
highlighting the need for pharmacogenetic counselling,
as an additional safety step for self-care products.
Lilian Azzopardi Max Wellan
21
Digital Revolution – Self-Care Revolution
Conference report
One of the most exciting trends in healthcare is the
more and more visible impact of digitalisation. The ses-
sion, moderated by Alan Main, Executive Vice-President,
Sanofi Consumer Healthcare, provided an overview of
the challenges for the industry as a whole and the op-
portunities resulting from the developments in the digi-
tal space. An important part of the session was dedicat-
ed to the developments around the use of big data.
Alan Main introduced the session by describing the
positive implications of digitalisation for self-care, also
making reference to the recent ransomware attacks, and
the need for increased vigilance. He explained how digi-
talisation has had the biggest impact on the capability
of systems: Diagnosis (such as advanced MRI scans to
detect prostate cancer), treatment (using nanotechnolo-
gy), monitoring (remote monitoring cardiac devices)
and mobile health apps. “This digitalisation is empower-
ing patients, who now want to play a more active role in
their own health,” he said. He also remarked that digi-
talisation could be used as a mechanism to build trust
with patients.
“Data is often uncensored and unviewed.” Main quoted
that 85% of data was created in the last two years. Re-
ferring to a US survey, Main noted that 80% of people
are willing to share data if they believed it would im-
prove health outcomes for them individually. 60%
would share their data for health research, and 40%
would share information for money. He noted that 85%
of people would be willing to share information with
healthcare professionals, 40% of health insurance com-
panies (for discounts). Interestingly, 16% of people
would be ready to share healthcare information with
industry, 8% with Tech businesses and 8% would share
health information with the government.
He concluded by saying that the data is there, and peo-
ple are willing to share it. “The question is: how are we
going to capture that?”
What do big industry players think?
Brian Ager, Secretary General, European Round Table
of Industrialists (ERT), opened his presentation by ex-
plaining who and what the ERT are. “Members include
55 Chairmen and CEOs of major European multinational
global companies,” he told delegates of the AESGP con-
ference. “These multinationals are primarily cross-
sectorial and cross-country industrials,” he explained.
Since the 1980s, one of its early objectives was to stimu-
late and establish the European Single Market. ERT’s
vision is to “strive for a strong, open and competitive
Europe, with the EU as a driver for inclusive and sustain-
able growth.”
Its priority concerns at the moment are the stabilisation
and promotion of the European Union without the UK,
the impact of globalisation on citizens, and to maintain
and strengthen transatlantic relations and open trade.
Some of it workstreams, each led by a CEO, include en-
ergy and climate change, trade and market access, soci-
etal changes (arguing for the best prospects for youth
employment), gender diversity, encouraging entrepre-
neurship, and digital. Outputs then feed into its contact
programme with political leaders. ERT meets regularly
with political leaders such as Chancellor Merkel or the
European Commission President Juncker.
“Digitisation offers opportunities for all industrial sec-
tors,” he purported. “It is a driver of growth, competi-
tiveness and jobs (for the private, public, and govern-
ment sectors), and to regain its industrial strength, Eu-
rope needs to embrace the new digital society,” he ex-
plained. “It will also demonstrate that the EU can deliv-
er,” he added.
Alan Main
22
He explained that ERT policy priorities on digitalisation
are to deal with the high level of Cybersecurity required,
improving connectivity in Europe by investing in tele-
communications infrastructure to overcome barriers to
the single market fragmentation and harmonisation and
cross-border cooperation. He highlighted the need for
“a real European Digital Single Market” with “all mem-
ber states working together in the same structures.”
On digital data, “free flow of data is vital.” He comment-
ed that the General Data Protection Regulation (GDPR)
is not bad regarding setting out a level playing field for
Europe, but the e-Privacy Regulation “duplicates and
counteracts it.” We are moving fast, and Europe must
optimise its involvement if we are to succeed and move
forward in the coming years.
Customer experiences in the digital world
Max Orgeldinger, Senior Digital Strategist, at Torben,
Lucie und die gelbe Gefahr (TLGG), a digital agency, de-
scribed how digital experiences could affect patient be-
haviour with the example of a Taco Bell’s Snapchat ac-
count. “It is always interesting to see the peculiar expe-
riences that can arise when new technology arises,” he
remarked.
One of the most significant current trends is the dra-
matic increase of smartphone devices over the last few
years.
An example he gave of a company profiting from in-
creased mobile technology was Instagram. Founded in
2010, it was bought by Facebook and is now worth $55
Billion, far above the value it generates.
Smartphones are now surpassing desktop computers
and “the number of microprocessor transistors in a giv-
en space is doubling every 18 to 24 months.”. “This
means smaller, faster, cheaper technology that is ena-
bling all kinds of experiences.” Orgeldinger explained
that these tend to be simple experiences, in areas such
as information sharing, communication, entertainment,
and transactions. But more importantly, it will “reinvent
a given behaviour around the technology that has
emerged.”
Technological progress is creating new possibilities at
exponential growth rates, but not all companies are lev-
eraging this. “CEOs don’t all take these developments
seriously, such as how Netflix was perceived in the be-
ginning,” he noted.
“Technology takes the path of least resistance. It is diffi-
cult to force internet experience on users, and even if it
may currently control customer experience that doesn’t
mean they will continue to follow that experience”, he
explained. Successful companies have become a verb to
own that experience, for example, Twitter’s experience is
“to tweet.” They then get customers used to associate
that experience with their service.
Companies that reinvent experiences around techno-
logical changes often see robust growth, he remarked.
“Convincing customers to adapt new behaviours re-
quires extremely refined experiences and creating these
experiences requires companies to take digital serious-
ly,” he reminded delegates at the AESGP Annual Meet-
ing.
Brian Ager Max Orgeldinger
23
Conference report
Age of disruption and opportunity
John Walsh, Co-founder of Smart Insight Lab, referred
to the Fourth Industrial Revolution and remarked that
there “has never been a more interesting and challeng-
ing time to live in than today in terms of technology
and business.” He emphasised the importance of ethics
and “what do we want as a company/individual to go
forward.” Social Media will help us to move forward, he
explained, and empower people more to decide what
they want. “Digital is the driving force (“oxygen”), with
customers at the heart, and people as the soul in the
company/organisation.”
He reflected on the 2020 healthcare landscape where
informed and demanding patients are now partners in
their healthcare. In the era of digitised medicine – there
would be new business models to drive new ideas.
Wearables would be used to measuring the quality of
life rather than just being clinical indicators. Health data
and big data will be pervasive requiring new tools &
models.
“This business is lagging behind,” he said, as some com-
panies face problems from new competition, emerging
technologies, the explosion of new data and psycholog-
ical/behavioural economics. A Deloitte survey on where
healthcare is going found that “healthcare is a moving
environment which is lagging behind, and needs to be
moving faster and better.”
He remarked that there is minimal data out there on “a
girl’s headache” since there is little open data and
closed data is expensive to access. “More and more
people are going online/on Social Media/Google to see
if there is a knowledge base available to consult before
buying.” Massive time is spent on building a decent
knowledge base, he said.
He reflected on the importance of social engagement
and intimacy involved in selling information about a
product and giving customer “an experience”. We have
been “so focused with disruption we were not looking
at the bigger picture,” he said. In his view, a 2030 strate-
gy needs to be developed to incorporate the 4th indus-
trial revolution scope and digital and data strategies.
“There is a need to focus on corporate digital transfor-
mation programme, the full journey, and to refresh the
existing operational model(s),” he said. Customer and
business adaption to the new GDPR is required. Howev-
er, he warned that if business adaption to GDPR is too
slow, it will lag behind. He also recommended that
pharmacy sites become more integrated, open to en-
gaging the customer. “New business models to engage
customers are also required,” he explained.
As we move from “big data” to “smart data”, as he pre-
fers to call it, his advice to OTC companies was to take a
broader longer-term view. “We are currently focused on
disruption,” he said. “Now is the time to look at the big-
ger picture and develop a robust digital and data strate-
gy.”
24
Smart data helps build wise companies to think ahead.
He explained that machine learning would become big
in the next two to three years (and has already been
introduced with Microsoft Office 365). He also remarked
that at least one in ten big data projects fail to meet
their objectives.
He concluded with some key messages on data privacy
and the new General Data Protection Regulation which
guards private and personal data. “There is an oppor-
tunity to build trust with customers and value-driven
approach and in doing that we should see GDPR as a
value proposition,” he said.
Finally, he raised the question “how can we regain data”
and commented that popular search terms don’t in-
clude “Europe” and recommended a single platform for
online health information.
Thomas Senderovitz, Director General, Danish Medi-
cines Agency, Denmark, explained that nowadays tech-
nology development is exponential. “Patients are be-
coming consumers; the population is ageing and data is
big.”
“Every 24 months the volume of electronic healthcare
data doubles” he explained. There are more than 210
exabytes of available healthcare data today, he stated.
“90% of the world’s data has been created in past two
years.” However, 80% of data is unstructured, so the
challenge is how to make sense of this data.
Another problem is turning big data into knowledge
and knowledge into decisions, regulatory decisions,
pharma decisions, and medical/scientific decisions. He
explained that the work plan of the joint Heads of Med-
icines Agencies (HMA)/European Medicines Agency
(EMA) Task Force on Big Data, of which he is co-chair, is
to characterise relevant sources of big data and define
the format. Sources of big data include genomics and
other “omics”, observational data, clinical trial data, So-
cial Media health, IT/infrastructure and spontaneous
adverse drug reactions (ADRs). Other objectives in the
work plan are to identify areas of usability and applica-
tion of datasets, describe the current status, future
needs and challenges and generate a list of recommen-
dations and a Big Data Roadmap.
Recommendations for how European regulators should
deal with the exponential growth of big data will be
made in just 18 months’ time, he promised. “We cannot
spend the next five years working on a guideline – it
would simply take too long,” he said. “Regulators can-
not ignore the role of real-world data after drugs have
been approved,” he added.
He also highlighted the role of Social Media, wearables
and sensors in generating post-approval data. “We have
to look at data differently, and we have to devise differ-
ent ways of making decisions,” he explained. Drug de-
velopment and approval had been a linear process tra-
ditionally, but the timescales now were such that in fu-
ture some of the regulatory work would have to be car-
ried out in parallel, he believed.
Data quality was an issue for Senderovitz who was dubi-
ous that the algorithms that were being used in health
apps had been properly validated and were making the
right recommendations. “More and more, it’s a black
box,” he said.
He concluded by stating that big data is relevant for
regulators, sponsors, healthcare professionals and citi-
zens/patients and that the HMA/EMA has started to
address the challenges and opportunities that come
with big data.
John Walsh Thomas Senderovitz
25
The session, moderated by Laurent Faracci, Global Cat-
egory Officer and Head of RB’s Category Development
Organisation for infant and child nutrition, discussed
what digitalisation means in concrete terms, what the
role of companies like Google and Facebook could be
and how European consumers see these developments.
Acquiring Mead Johnson “created an inflexion point in
the growth of RB as a business and will have a signifi-
cant impact on RB’s consumer health portfolio,” accord-
ing to Faracci.
“It increases the firm’s consumer healthcare franchise by
90%,” he added. The deal – which is expected to close in
the third quarter of 2017 – would also considerably in-
crease its market presence in Asia.
Introducing the topic of the session, Faracci also made
reference to the increased use of mobile phones and
decrease in time spent watching TV. He also noted that
increasingly voice is beginning to replace typing in
online queries. “20% mobile queries were made via
voice in 2016, and the accuracy is now about 95%” he
explained.
Google’s potential in the healthcare space
Karl Pall, Director Brand Solutions, Google, started off
his presentation by giving background on where Google
sees itself sitting in the health area. “Google’s mission is
to organise the world’s information and make it univer-
sally accessible and useful. So, it should not be a sur-
prise that since the beginning we have always seen our-
selves as an outlet for information about healthcare,” he
said.
“Digitisation has rewritten the rules of the game in
healthcare information. The internet is now the number
one source for healthcare information. Information is
just a fingertip away.” Many people look at their phones
150 times a day.
“The result is that there are now billions of healthcare
queries every day. In Germany alone, there are more
than 6.2 billion per year,” he quoted. One in 20 searches
on Google is health-related. It is one of the most
searched topics on Google, and it is growing, with query
growth rates of around 10%, he explained.
Google is “the world’s largest database of intentions” –
people ask Google everything. Google can, therefore,
offer a broad array of publicly available tools by aggre-
gated search data, and thus can help provide valuable
consumer insights by understanding the patient/
customer journey better and help provide the right in-
formation to consumers/patients.
“Over 85% of people who use the Internet say that
when they have a health concern or question they begin
at a search engine like Google to find information”.
Ehealth Facilitating Self-Care
Conference report
Laurent Faracci Karl Pall
26
“Therefore, Google has taken the responsibility of bring-
ing health information to consumers/patients and have
enhanced their health search functionalities over the
years, most recently with things like the health
knowledge panel which shows up on the right side of
the screen on a desktop or the top of the screen on mo-
bile when a query around a condition is entered.” He
explained that data are vetted by 11 physicians and ap-
proved by Harvard Medical School and the Mayo Clinic.
“Google also sees some health trends.” He explained
that each time someone searches for a health-related
term, a drug name or condition; it provides an insight as
to how consumers are seeking to learn about their
health. “So understanding this data is something that is
very important to Google as we think about what our
next big bets are,” he explained.
Facebook keen to partner with Healthcare
industry
Leigh Thomas, Director of Global Client Partnership,
Facebook, said that Facebook was interested in partner
with consumer healthcare companies for the good of
both the healthcare industry and the over a billion peo-
ple that used the platform.
She began by explaining that healthcare was built on
trusted relationships, and people come to form their
relationships now not just on Facebook, but on mobiles.
She quoted that “1 in 5 hours of people's time on mo-
bile is spent on Facebook and Instagram”, which she
explained is a tremendous opportunity, and “can
change our behaviour.”
Facebook Healthcare groups are one of the fastest
growing. By joining a group, she explained, “you be-
come part of a valuable community, where members
support and encourage each other.” She gave an exam-
ple of at-risk men who joined an HIV prevention group
on Facebook that was eleven times more likely to re-
quest an HIV testing kit.
Doctors also use Facebook personally and professional-
ly, and she highlighted the research on this topic. For
example, when asked, 65% of physicians surveyed indi-
cated interest in engaging with clinical data via social.
“Healthcare is one of the fastest growing verticals in
Facebook at the moment, so the healthcare business is
finding oxygen on the Facebook platform,” she ex-
plained
The opportunity for people based marketing, at scale, is
enormous. Facebook is now home to over 1.95 billion
people. Messenger and WhatsApp now connect over
1.2 billion people around the world, and Instagram rev-
olutionises the way 700 million people capture and
share the world’s moments.
Facebook is also innovating against its mission and
wants to build technology that helps the blind commu-
nity experience Facebook the same way as others do.
Building a digital world consumers can
trust
Ilaria Passarani, Head of the Food and Health Depart-
ment, European Consumer Organisation (BEUC), which
promotes consumer interests, explained that more than
40% of consumers say that information found via Social
Media affects the way they deal with their health.
Consumers continue to have concerns around the secu-
rity of online data, yet, more than ever they are trusting
health information shared on social networks, she ex-
plained. “18 to 24-year-olds are more than twice as like-
ly than 45 to 54-year-olds to use Social Media for health
-related discussions”.
“90% of respondents from 18 to 24 years of age said
they would trust medical information shared by others
on their Social Media networks” she went on to explain.
Leigh Thomas
27
Conference report
She cited some interesting statistics which found that
“19% of smartphone owners have at least one health
app on their phone,” with exercise, diet, and weight
apps being the most popular types. “28% of health-
related conversations on Facebook are supporting
health-related causes, followed by 27% of people com-
menting [on] health experiences or updates,” she ex-
plained.
However, she pointed out that 74% of people world-
wide are worried about how companies use their infor-
mation. Only a third of respondents usually read the
terms and conditions, and two-thirds of respondents are
concerned about not having complete control over the
information they provide online. Nearly two-thirds of
respondents say that they do not trust online businesses
to protect their personal information, with more than a
quarter saying that they do not trust them at all.
Privacy and data protection were the biggest concerns
when it came to using digital in the healthcare sector,
she said, but if these issues were solved, consumers
would benefit considerably.
“Increased access to information in many formats,” she
insisted, “must be exploited for the benefit of public
health.”
Ilaria Passarani
How Regulation Helps Self-Care to Develop
The development of self-care remains strongly influ-
enced by the legal and regulatory framework. An up-
date was provided on the most relevant changes in the
area of food and non-prescription medicines, referenc-
ing AESGP’s priorities.
Christa Wirthumer-Hoche, Chair of Management
Board of the European Medicines Agency (EMA), and
Head of the Austrian Medicines and Medical Devices
Agency (AGES MEA) opened the session by describing
an Austrian national provision which provided for a sim-
plified registration procedure for traditional herbal
medicines. With the European Union (EU) legislation on
traditional herbal medicinal products adopted in 2004,
out of around 300 herbals, only 10% submitted dossiers
according to the new legislation, 20% migrated to the
food sector and some to medical devices and cosmetics.
“The registration for traditional herbal is expensive,
analysis is expensive and there are demanding require-
ments for quality, which encourages a move into the
food supplements sector”, she said.
“Some discussion is ongoing as to whether the scope
for traditional herbal medicines will be enlarged to in-
clude vitamins and minerals”, she added.
Wirthumer-Hoche explained that the availability of non-
prescription medicines is high on the agenda of the EU
Medicines Agencies Network Strategy to 2020, and ap-
preciated that “AESGP stands for the adoption of a bal-Christa Wirthumer-Hoche
28
anced regulatory framework, and that the framework
has to facilitate innovation and rapid market access, in a
harmonised way across Europe.”
Developments in food safety and “REFIT”
Sabine Jülicher, Director of Food and Feed Innovation,
Directorate General Health and Food Safety, European
Commission, gave an outline of developments in the
food legislation, particularly relevant to consumer
healthcare industry.
She began by describing some developments in the
area of food safety and explained that with food crises
which have occurred related to BSE and Dioxin in the
late 1990s, it is very easy for consumers to lose trust.
“Today we have the most stringent system for the man-
agement of food risks in the world”. By that we are bet-
ter placed today to deal with food crisis, but it is still
important to remain alert. The European Commission is
currently conducting a so-called REFIT exercise on the
General Food law to see whether it is still fit for purpose,
and to find out whether there is anything that can and
should be improved. Instead of rushing to add on to the
regulatory framework without evaluating, it will first be
checked if it works and if there is an added value for the
EU.
“People’s expectations have changed. They expect their
food to be not just safe but nutritious and to be pro-
duced in a sustainable manner”. This has called for EU
nutrition polices. In December 2016, the introduction of
mandatory nutrition labelling was finalised. The regula-
tion on nutrition and health claims sets the legal frame-
work for food businesses wishing to highlight beneficial
properties of their products, and to enable customers to
make healthier choices. She explained that a REFIT eval-
uation is currently being undertaken on this regulation,
and is expected to be completed in 2018. The outcome
will help the Commission to take an informed decision
on health claims for botanicals and whether there is a
need to harmonise the use of botanicals in the EU. The
final report of an external study on this is expected end
of September 2017.
She then moved on to talk about reformulation of pro-
cessed foods – a voluntary initiative, to reduce levels of
saturated fat and sugars in the diet. It is an example of
where the European Commission is co-operating with
manufacturers and also member states’ authorities in
terms of monitoring systems. “In health and nutrition,
through voluntary initiatives a lot can be achieved, and
the Commission believes there is room for a dual ap-
proach (regulatory and voluntary)”.
In the current environment, the main challenge, she de-
scribed “is empowering consumers while leaving
enough flexibility to allow for innovation in the food
industry and safeguard the functioning of the internal
market.” The aspiration for a more expansive food poli-
cy is not matched by a public appetite for food related
innovation. “Risk aversion is prevalent in the food sec-
tor, e.g. in relation to Genetically Modified Organisms
(GMOs) and food additives which is getter bigger and
finding its way into public discussion. “There is a reluc-
tance to embrace new approaches which clashes with
the need for food systems to evolve.”
“We need to address the mistrust, hostility, science and
evidence-based decisions” she said which is becoming
increasingly difficult.
Jülicher concluded by saying that the European Com-
mission recognises that consumers increasingly take
responsibility for their own health, and will support con-
sumers in a transparent way, by ensuring that food is
safe and food information is not misleading. This frame-
work contributes to fair competition between food op-
erators, but also ensures that “the limited budget of
consumers goes toward products that work.” She also
added that the objective of the Commission is to take a
forward-looking approach to innovation in food pro-
duction. She reflected on earlier discussions and that
“the Commission must also address the erosion of trust
in a transparent manner.”
Sabine Jülicher
29
Conference report
Hubertus Cranz, Director General of AESGP, gave his
perspective on the discussions from an AESGP point of
view, by explaining that AESGP sees itself as an evidence
based industry. Reflecting on the discussions about
trust, it was pointed out that “the worst thing that can
happen to your business is losing trust. And evidence
base goes hand in hand with trust”. On the right imple-
mentation of rules, he also noted that “self-regulation
matters but needs to be based on a proper legal basis”.
In his view, overall the legal basis is adequate, but suffi-
cient resources are important for the implementation
and supervision process.
On botanical claims, he explained that the process has
been long. He remarked that although “non- action may
seem sometimes like the easiest political solution, it can
have important market implications.”
Challenges in EFSA
Bernhard Url, Executive Director, European Food Safety
Authority (EFSA), described the role of EFSA and chal-
lenges they meet. “Risk management and risk assess-
ment are separated in Europe stringently” he said. The
latter is outsourced to EFSA in Parma while the former is
the responsibility of the European Commission. EFSA is
a small organisation of 450 staff persons, which mobilis-
es 1000-2000 experts on a voluntary basis (but they are
not employed by EFSA) for a three-year mandate to
conduct risk assessments in the food and feed chain.
“There is still a long way to go to achieve globalised risk
assessments in the food and feed chain (although EFSA
is working on this)”, he informed.
On health claims, he acknowledged that the botanical
health claims are still on hold. He also noted that the
EFSA guidance document needs updating to develop
clear criteria on the substantiation of health claims. Two
guidance documents were updated in 2016, and in 2017
guidance on the preparation and presentation of health
claims was published. EFSA has also set up a catalogue
of services to applicants and has introduced an SME
office in a pilot phase to support industry when prepar-
ing and submitting health claims.
Scientific challenges that EFSA faces include endocrine
active substances, antimicrobial resistance and the sur-
vival of beehives. EFSA also faces challenges in sourcing
expertise on issues related to transparency and the in-
dependence of its experts (which he notes is made diffi-
cult as the European research policy, Horizon 2020, forc-
es universities to collaborate with industry).
EFSA has set up a complex system of managing expert
interests to assess conflicts of interest, which can be
burdensome. Finding independent experts, he said, may
be more challenging for EFSA than the EMA. He also
commented that in the food industry there is a high
benchmark for experts as there is a high expectation for
quality in the sector - and EFSA do not pay for experts.
“We need to find new models of reimbursing these ex-
perts/their organisations. EMA has double the staff and
four times the budget”, which EFSA looks on with envy
as it relies on volunteers.
The second challenge is transparency which goes back
to trust. Trust depends on competence (for EFSA scien-
tific competence and opening itself to scrutiny) and
character (being transparent so that its activities could
be replicated). However, industry data cannot be made
public as this would infringe on intellectual property
rights and trade secrets. There is no legal framework in
place to make raw data available to academia for scien-
tific scrutiny. However, he commented that if EFSA
could move in a regulated approach towards this, it
would help regain trust in the industry.
EFSA also faces specific challenges “when science meets
values/policy.” “If EFSA comes out with a scientific opin-
ion that supports the political agenda of a group, EFSA
is praised” he remarked. He gives the example of EF-
SA’s opinion which established the risk of nicotinates to
bees which the European Commission supported, and
was therefore well received.
Bernhard Url
30
He concluded by saying that it is no longer enough to
do good science. “You have to engage with the civil so-
ciety, (and build trust) to come up with a co-evolution of
science which is a challenge for EFSA in the years to
come”.
Hubertus Cranz, Director General of AESGP, gave his
perspective on the discussions from an AESGP point of
view. He expressed his appreciation of EFSA’s efforts in
the improvement of services, such as the help desk. He
also stated AESGP’s belief that a closer interaction be-
tween applicants and scientists (panelists in EFSA’s case)
can improve decision making, and the output of scien-
tific evaluations. “That the pharmacovigilance system is
covered by fees, while nothing is paid into EFSA, is a
discrepancy in the system which is not easy to explain”,
he stated. AESGP disagrees with fees as a pure financing
instrument. However, he acknowledged that fees may
be acceptable if services can be improved by a well-
organised and transparent interaction between appli-
cants and panel members.
Regulatory optimisation and “self-care in a
changing Europe”
Regulators are making efforts to optimise regulatory
operations and ensure greater access to non-
prescription medicines, according to Zaïde Frias, Head
of Human Medicines Evaluation Division, European
Medicines Agency (EMA).
She presented two initiatives, which she said addresses
half of AESGP’s 2020 goals. The first initiative is on the
Regulatory Optimisation Group (ROG), chaired by Stan
Van Belkum from the Dutch Medicines Evaluation Board
and co-chaired by herself, which will formally kick off on
14 June. For the first time, it brings regulators and in-
dustry together to review existing regulatory proce-
dures. The group also brings business and IT together to
leverage the advantage of technology and develop
common ICT platforms. The ultimate goal is to identify
value added data that could be captured in a structured
way to support product life cycle maintenance and deci-
sion making.
She explained that a challenge for the ROG is that it is
“quasi impossible to track the product history over its
entire lifecycle in the European environment”, referring
to pantoprazole, which was switched to non-
prescription status throughout the European Union by a
centralised procedure, but had originally undergone
decentralised authorisations. She also noted that sub-
mission formats have also changed from paper to elec-
tronic documents and will continue to evolve into more
structured data and emerging international regulations/
standards (ISO IDMP).
There is a significant cost linked to send/receive, vali-
date, maintain and distribute Marketing Authorisation
Application data. The idea is to reduce regulatory bur-
den for applicants and regulators, saving administrative
and scientific resources for the more valuable areas of
the regulatory work.
The first target of the ROG would be Type IA variations
and it would be presenting its first business case for
handling such variations to the Heads of Medicines
Agencies (HMA) in September.
She also reminded the audience about the joint multi-
stakeholder initiative of the EMA and the Co-ordination
committee for the Mutual-recognition and Decentral-
ised procedures - human (CMDh) in the area of scientific
advice procedures for OTC medicines – an initiative co-
sponsored by herself and Peter Bachmann as chair of
the CMDh. It targets timely access to non-prescription
medicines and reinforces the regulatory capacity and
capability of the network. Its first stakeholder workshop
would be held in the third quarter of 2017, she said, to
discuss the composition and function of the OTC Expert
Forum that would be led by the CMDh.
Zaïde Frias
31
Conference report
The aim is to build on an early interaction with Appli-
cants/Marketing Authorisation Holders (MAHs) and
stakeholders on relevant aspects of OTC switch for Na-
tional/Mutual Recognition Procedures/ Decentralised
Procedure and Centralised Procedure and create plat-
form for exchange on factors that influence decisions on
switching, beyond the scientific balance of benefits and
risks, and bring relevant stakeholders including experts
from national switching bodies, healthcare professionals
and patients around the table.
“This workshop would be organised, against a backdrop
of every second medicine in the European Union being
non-prescription, yet only four medicines had been
switched through the EU’s centralised procedure in 10
years, and only five medicines were available in every EU
member state.”
She explained that there are two parallel switching
worlds in Europe. At EMA there are first in class switches
of the centralised product or innovative (switch by de-
sign) switches with ultimately a harmonised legal status.
Switches at National/CMDh level which effectively drives
most switches at EU level but do not result in a harmo-
nised legal status in the end. The idea would then be to
bring the “best of both of these worlds” to debate the
full spectrum of switches. It would also provide a forum
to exchange real world experience and the perception
of risks. The aim is to use a well-established EMA scien-
tific advice procedure. A CMDh led expert group would
advise the scientific advice group on whether there is an
interest to invest in the switch. Such a group would also
be able to engage with further stakeholders. It remains
to be decided who these stakeholders might be.
Hubertus Cranz, AESGP Director General commended
on the initiatives from an AESGP perspective. He ex-
plained that it is “fully in line” with the association’s
Agenda 2020, launched at its 52nd Annual Meeting in
Athens a year ago. “We are ambitious but honestly we
didn’t expect such success within the first 12 months
after launch of the agenda”, he remarked.
Putting greater access to non-prescription medicines on
the regulatory agenda, reducing regulatory burden
through the ROG and involving multiple stakeholders in
a non-prescription scientific advice procedure are all top
issues for the self-care industry. AESGP will continue to
contribute to the discussions and looks forward to see-
ing the results.
Hubertus Cranz
32
Challenges Ahead
Medical Devices Regulation – Regulatory
framework and challenges ahead
Gesine Meissner, Member of the European Parliament
(MEP) and Shadow Rapporteur for the new Medical De-
vices Regulation (MDR) and In-Vitro Diagnostics Regu-
lation (IVDR) for her political group and, by that, closely
involved in the negotiation process, began her presen-
tation by giving an overview of the adoption process of
the new regulations. Agreement in the so-called Trilos
was reached on 25 May 2016. The formal adoption by
the European Parliament and Council took place on 5
April 2017. The MDR entered into force on 25 May 2017
and is applicable from 26 May 2020.
As a co-legislator, the European Parliament’s involve-
ment is limited from now on, but the work between the
Member States, the European Commission and the
stakeholders has just begun. In 2020 manufacturers and
notified bodies must be ready to apply the new rules
and the EUDAMED database must be functional. Politi-
cal core issues during the negotiations included the
reprocessing of single use devices, the “scrutiny proce-
dure”, “CMR’s”, Aesthetic Devices, liability, traceability,
the Implant Card, classification rules on nanomaterials
(Rule 19), and substance-based medical devices (Rule
21) and more recently unannounced audits. As a mem-
ber of the Liberal party (Group of the Alliance of Liber-
als and Democrats for Europe), Mrs Meissner was di-
rectly involved in the debate on Rule 21 which was not
previously the focus of discussions in the Parliament.
Gesine Meissner
Transitional provisions under Article 120.4 allowing the devices to stay on the market or under Article 120.3 to be placed on the market after the date of application under certain conditions
33
Conference report
Mrs Meissner updated on the outcome of the debate on
Rule 19 concerning nanomaterials. The Council position
was that the text should read “can be released” vs.
“intended to be released”, the latter being the European
Parliament position. It was finally agreed that for nano-
materials a classification according to the risk of expo-
sure would be defined in the implementing acts. The
European Commission, who is in charge of the imple-
menting acts, should now define based on scientific
knowledge and latest findings, what high, medium or
low risk means. On Rule 21 concerning substance-based
devices, the Parliament managed to move the position
from a complete ban/ complete up classification to all
Class III to an agreement on the classification according
to absorption level and intended purpose.
According to Mrs Meissner, for the implementation
phase of the MDR and, in particular, Rule 21, the con-
cept of a risk-based approach shall be maintained dur-
ing the implementation process. The classification must
always be justified by the intended purpose and the
inherent risk. This is key for a proportionate implemen-
tation approach. “We should define a broad under-
standing of low risk”. In her opinion, substances with a
long history of safe use (e.g. foodstuffs) should be con-
sidered as low risk. She also highlights the need for
clear guidance on what ‘systemic absorption’ is, which
she trusts the European Commission will implement in
consultation with stakeholders to achieve a common
understanding.
She explained that in general, experience from the Hel-
sinki Procedure, has shown that insufficient involvement
of manufacturers and notified bodies result in unsatis-
factory outcomes. It should, therefore, be ensured that
notified bodies and concerned manufacturers are
properly involved and systematically informed at an ear-
ly stage of the procedure.
Stressing the importance of scientific advice, she calls
for a clarification on the consultative role of EMA, EFSA
and ECHA. She also calls for data on a category of prod-
ucts published on the Commission website prior to the
launch of the examination procedure. This would not
only allow a fair and transparent start of the procedure
but also guarantee that the views of all concerned man-
ufacturers and notified bodies are fully taken into con-
sideration by the committee which delivers an opinion
when considering the classification of a specific product
or category of products.
In her view, the principal mode of action of the product
is a key determinant when it comes to differentiating a
medical device from a medicinal product. It is therefore
critical to have proper definitions of pharmacological,
immunological and metabolic means.
She also gave an overview of the transitional arrange-
ments in place. All devices placed on the market pursu-
ant to the Directives can continue to be made available
on the market or put into service until 27 May 2025 if
certain requirements are met. Certificates will become
void on 27 May 2024. However, there are many new
requirements related to an up-classification to Class III
(including new clinical investigations). Accordingly,
manufacturers of substance-based medical devices re-
classified in Class III will face potentially expensive new
requirements.
In light of this, the transitional period in Article 120
should be implemented adequately and uniformly to
provide sufficient time for industry and notified bodies
to ensure availability of substance-based medical devic-
es.
Challenges – the Notified Bodies
Roberta Marcoaldi, Director of Notified Bodies Istituto
Superiore di Sanità (ISS), Italy, gave her perspective on
the implications of the new MDR from a Notified Body
perspective. Since 1996, the Notified Body 0373 works
in the field of medical devices in according to European
Directive 93/42/EEC. The Notified Body 0373 has been
designated for CE Certification for Class III devices. Since
2009, Notified Body 0373 also works in the field of in
vitro diagnostic medical devices in according to Europe-
an Directive 98/79/EC.
Roberta Marcoaldi
34
In the last years, the Istituto Superiore di Sanità has de-
veloped a specific know-how on the evaluation of sub-
stance-based medical devices. In her view, substance-
based medical devices represent a great opportunity for
the healthcare sector.
In the case of substance-based medical devices, the
close correlation between medical devices and medici-
nal products also needs to be considered.
The definitions of medical device and medicinal prod-
ucts are, from her perspective, overlapping. Both can
have same intended use (treatment or prevention of
diseases) but do have different mechanism of action by
which they reach their effect. The terms ‘therapeutic
effect’ and ‘mechanism of action’ are not used consist-
ently, which complicates the situation. A definition of
different mechanisms of action is still lacking.
This is one of the reasons for the increasing number of
products that are on the borderline between medical
devices and medicinal products. However, at the end a
‘case by case’ approach and assessment are necessary.
MDR requirements define also a more stringent ap-
proach to assess such medical devices, which represent
a new challenge for manufacturers and Notified Bodies.
The MDR established the category of substance-based
products and defines a special classification rule: The
Rule 21. As a result, substance-based medical devices
will no longer be classified as Class I. This will mean an
increasing number of medical devices requiring the
evaluation of a Notified Body.
Rule 21 introduced the concept of substance absorp-
tion. It will, therefore, be necessary to define a correct
interpretation of Rule 21 and understand the term
‘absorption’ of substances. The absorption of substanc-
es can determine the different classification of medical
devices. This will determine the kind of documentary
evidence in the product technical dossier with Annex II,
which manufacturers have to provide.
Mrs Marcoaldi expressed the wish that a close collabo-
ration between Notified Bodies and manufacturers is
established during the implementation process of the
new regulation.
Engaging patients / consumers emotionally
to build powerful brand relationships
Ralph Ahrbeck, Founder and CEO, Arqus Advisory,
concluded the session with examples of some success-
ful companies that have leveraged an intimate under-
standing of their consumer to further develop self-care.
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Conference report
“Understanding what consumers think, their attitudes
and values”, he says “is vitally important today”. “Trust in
brands is an intangible asset and is at all time low”.
Trust in a brand increases compliance/product use and
results in better patient outcomes. Trust in OTC brands
reduces visits of General Practitioners for minor ailments
and reduces the burden on the healthcare system. How-
ever, he points out that typically, advertising is all about
preaching product benefits to consumers; what the
problem is and what is the solution. He stresses that we
must speak differently to our consumers. “Today’s em-
powered consumers want us to engage them, under-
stand their needs/wants, go beyond functional and es-
tablish an emotional bond.” A brand is the combination
of tangibles and intangibles – a mix of product, service,
images, associations, people and visual statements that
create a certain perception.
Empowered consumers want companies to take a stand,
have a point-of-view, be modern and relevant.
Ralph Ahrbeck
Invitation to Amsterdam 2018
At the end of the conference, Bernard Mauritz, Executive Director, Neprofarm, invited all participants as well as all
those interested in the latest developments on self-care around the world to the 54th AESGP Annual Meeting, which
will take place in Amsterdam from 5-7 June 2018. The program will be available by the end of this year.
Bernard Mauritz