white paper on public procurement of biological medicines...value-based evaluation p. 15 p. 16...
TRANSCRIPT
WHITE PAPER ON
Public Procurement of Biological Medicines
JUNE 2015
3
Table of contents
Executive summary
Introduction
EU policy framework
Procurement of biological medicines: current practice
p. 6
p. 8
p. 9
p. 11
Single winner-takes-all v. multiple
winners, multiple choices
Price-based evaluation v.
value-based evaluation
p. 15
p. 16
Introduction
Assessment criteria used in the
EuropaBio review
Types of public procurement of
biological medicines
p. 11
p. 13
p. 14
Combination of types of
public procurement –
some illustrative examples p. 18
Cross-border joint procurement
Key EuropaBio recommendations
Annexes
p. 20
p. 23
p. 26
Case studies
Template Research
Questionnaire
p. 28
p. 37
References
1.
2.
3.
4.
5.
6.
7.
4.1.
4.2.
4.3.
4.3.1
4.3.2
4.4
7.1.
7.2.
8. p. 38
6
Executive summary
1.
In February 2014 the EU adopted a new
legislative package on public procurement.
Member States are expected to transpose the
EU Directives by 18 April 2016. The transposition
of these new rules in national law offers a
timely opportunity to address issues related
to the application of the public procurement
rules for the purchase of complex medicinal
products, namely biological medicines,
including vaccines.
This White Paper aims at presenting the
key findings of research conducted by
EuropaBio between September and November
2014 on national practices for procuring
biological medicines across the European
Union (EU). This research is based on the direct
feedback of EuropaBio member companies
participating in public tenders in 14 countries
in the European Economic Area (EEA) and on a
review of the existing literature on public
procurement rules. The input of EuropaBio
member companies on national procurement
was collected based on a detailed
questionnaire (see Annex I and II) and analysed
by a group of EuropaBio experts.
The internal EuropaBio research reveals
that in recent years national public
authorities are increasingly using public
procurement to purchase medicinal products.
Tendering practices differ considerably across
national jurisdictions in Europe. To assess such
a complex and fragmented landscape,
EuropaBio developed a specific analytical
framework based on a number of assessment
criteria. Although the overarching parameter
to assess procurement practices across Europe
is “access to treatments for patients”, a number
of additional specific criteria were identified
by EuropaBio experts, as follows: competition;
access to multiple therapeutic solutions;
change of therapy for treated patients;
interchangeability/assessment of therapeutic
equivalence; award criteria; transparency.
Our research has led us to the definition of
three recurring types of public procurement:
1. Single “winner-takes-all” v. multiple
winners, multiple choices;
2. Price-based evaluation v. value-based
evaluation;
3. Cross-border joint procurement.
Building on its own analysis, EuropaBio was
able to draw some key recommendations to
guide the future procurement of biological
medicines (see box on next page). EuropaBio is
ready to contribute to any stakeholder dialogue
that the European Commission and any other
institutions would put in place, including any
other rules falling under the competence of the
EU such as the cross-border joint procurement
rules under Decision 1082/2013/EU
7
on serious cross-border threats to health.
EuropaBio is committed to making sure that
public procurement rules are appropriately
implemented and used to provide European
patients with the best available therapies on
the market.
EuropaBio public procurement recommendations
1. Reflect patients’ needs and allow freedom
of choice for doctors/patients, by ensuring
that treatment options are not limited and
decisions can always be made by a physician
in consultation with patients;
2. Respect physicians’ prescribing authority as
regards decisions to keep treated patient
with their current treatments;
3. Take into account the complexity of
manufacturing practices for biological
medicines, and thus allow for sufficient
lead times;
4. Be awarded based on careful consideration
of additional criteria besides price;
5. Foster fair market competition and
innovation.
Public tenders for biological medicines, including vaccines, should:
8
Introduction
2.
The adoption of the new European legislative
package for public procurement in February
20141 sets a more efficient and flexible
framework for the public procurement of
goods, works and services across the Union.
While the competent authorities are
working towards the transposition of these
rules into national law by April 2016, there
is a need to consider how these will apply
to the procurement of complex products
such as biological medicines and to explore
whether the development of sector-specific
recommendations for transposition is needed.
These recommendations could guide the
relevant national competent authorities in the
effective application of the new rules.
The report starts with a summary of the new
legislative package for public procurement,
with a focus on its relevance for biological
medicines, and previous EuropaBio positions
on the matter. The following section introduces
an analytical framework to describe national
practices for the procurement of biological
medicines across Europe and then provides
concrete examples drawn from the experience
of EuropaBio members. The final section
describes in more detail the key EuropaBio
recommendations for the procurement of
biological medicines, including vaccines.
9
EU policy framework
3.
In February 2014, the EU adopted the legislative
package on public procurement which
aimed at an in-depth modernisation of public
procurement in the EU. The objectives behind
this package of legislations were two-fold:
1) an increase in the efficiency of public
spending; and 2) supporting common
societal goals through a better use of public
procurement. Member States are expected
to transpose the Directives by 18 April 2016.
The new package, which applies to the
procurement of goods, works and services,
modernises and adds flexibility to previous
rules dating back to 2004. It also allows for
the inclusion of common societal goals in the
procurement process, such as environmental
protection, social responsibility, innovation,
combating climate change, employment,
public health and other social and
environmental considerations.
EuropaBio assessment
EuropaBio members welcome the new
directives on public procurement as they
promise to simplify and modernise the existing
rules. In particular, EuropaBio welcomes the
following provisions of relevance for the public
procurement of biological medicines:
· Simplification of procedures:
The new Directive introduces a number of
simplified rules and procedures, including
an Innovation Partnership – to fill innovation
gaps in the market – and a negotiated
procedure without prior publication2.
The latter applies in case products are,
for example, only supplied by one economic
operator in order to ensure the protection
of exclusive rights such as intellectual
property rights.
· Updated award criteria:
By clearly recommending the “Most
Economically Advantageous Tender” (MEAT)
criterion3, public authorities are requested
to place more emphasis on quality,
environmental considerations and social
aspects or innovation, in particular taking
into account the price and life-cycle cost of
what is procured. While until now the focus
was placed on the “lowest price” criteria, with
the reinforcement of the MEAT criteria in the
new Directive the best value for money can
be achieved by taking into account common
societal goals.
10
· Benefits for Small and Medium
Size Enterprises:
The revised rules facilitate the access of
SMEs to public procurement, for instance by
dividing contracts into lots and by reducing
requirements for participation.
· Sound procedures and governance:
Member States are asked to ensure
that the procurement procedures are
transparent and properly monitored, with an
implementation report transmitted to the
European Commission every three years.
11
About biological medicines
About biosimilars
Procurement of biological medicines: current practice
4.
4.1. Introduction
A biological medicine is a product whose active
ingredient is a biological substance. The latter is
material that is produced by or extracted from a
biological source and that needs a combination
of physico-chemical- and biological testing for its
characterisation, quality determination, production
process and production control. As biotechnology-
derived medicines comprise proteins that would be
digested and would never reach the site of action
when taken orally, biological medicines are typically
administered by injection or infusion.
Biological medicines include products developed by
DNA recombinant technology or antibody methods,
vaccines and products derived from human blood and
human plasma4. Being produced by living systems,
biotechnology-derived medicines are highly sensitive
to minor changes in their physiological environment,
thus meaning that their physicochemical and
biological attributes are more variable than traditional
small-molecule pharmaceuticals. This makes them
more difficult to characterise and replicate. In turn,
this also has implications in the way these products
are procured, stored and dispensed to patients. One of
the most common examples of biological medicines
is vaccines. Vaccines are used to produce or improve
immunity against a particular disease by inoculating
killed or weakened disease-causing micro-organisms
in the human body: in this way the production of
antibodies is stimulated. Because of their nature,
vaccines, as other biological products, require specific
and careful handling at all stages.
Three decades on after the first biological medicines
were launched, exclusivity rights on the early biological
medicines have begun to expire, paving the way for
the introduction on the global market of off-patent
versions of biologic medicines, i.e. biosimilars. The
latter are developed to be similar to an existing
biological medicine (the “reference medicine”) and
are marketed once the exclusive rights have expired5.
Biosimilars assessed by the EMA are approved if they
have demonstrated similar quality, safety and efficacy
as the reference medicine6. However, their approval
does not include any recommendation regarding
their interchangeability or substitutability with
the originator product they reference. Decisions of
interchangeability and/or substitution rely on national
competent authorities.
Public procurement has been defined as
“buying pharmaceuticals by purchasers like
public hospital associations on the basis
of a – often strictly defined – tendering
procedure with granting of the contract to
the pharmaceutical company/importer who
offered the best bid.7” For the purpose of this
White Paper, we will follow this definition.
12
Within Europe, many countries use public
procurement for the provision of medicinal
products and particularly in hospital settings.
These procurement practices include both
small chemical molecules and biological
medicines8. Because the organisation of
national healthcare systems varies greatly
across Member States, the practice of public
procurement for medicines also differs
considerably across national jurisdictions.
Such practices range from largely public to
largely private funding, with the UK National
Health Service having the highest percentage
of government funding, to countries such as
Cyprus and Italy where many hospitals are
receiving more substantial funding from the
private sector.
13
To evaluate the public procurement situation
in Europe more easily, it is important to
highlight some underlying trends. Based on
its own research and analysis, EuropaBio has
elaborated the following six assessment criteria:
4.2. Assessment criteria used in the EuropaBio review
EuropaBio Assessment Criteria
Available Attributes & Attributes’ Weight
Best Practice Attributes
Competition: sets out the degree to which the tender
provided a single winner or multiple winners
Single winner = 0
Multiple winners = 1
Multiple winners
Access to multiple therapeutic solutions: determines whether, after the public procurement
process is completed, patients have (or continue to
have) access to multiple therapeutic choices or if
(as a consequence of the award decision) they are
restricted to the treatment offered by the winner of
the tender
Restricted = 0
Allowed = 1
Allowed
Change of therapy for treated patients: reflects
whether the affected patients already undergoing
the treatment have it substituted after the public
procurement process is completed or if they have the
option of keeping with the same therapeutic plan
Limited doctors’
discretion = 0
At doctors’ discretion = 1
At doctors’ discretion
Interchangeability / assessment of therapeutic equivalence: assesses whether the procurement rules
are based on interchangeability9 or not, i.e. assesses
if tenders acknowledge inherent differences among
biological medicines or if they are arbitrarily grouped
together regardless of whether an assessment of
therapeutic equivalence exists
Not mentioned = 0
Mentioned = 1
Mentioned
14
EuropaBio Assessment Criteria
Available Attributes & Attributes’ Weight
Best Practice Attributes
Award criteria: takes into account the criteria used
by the purchasing agency in evaluating and awarding
the tender, including whether there was a narrow
focus on best price/lowest costs or whether the
procurement procedure takes into account multiple
factors, including quality, capacity, credibility, etc.
Price only = 0
Qualitative criteria
and price = 1
Qualitative criteria and price
Transparency: evaluates whether the process by
which the public procurement was conducted was
perceived as transparent
Low = 0
Up to Standard = 1
Up to Standard
The EuropaBio evaluation of the case studies
included in Annex was conducted by applying
the 6 criteria above. Case studies scoring 5/6 or
above in the grid above were deemed well-
designed/well-implemented tenders and
therefore labelled “best practices”.
Case studies scoring between 4/6 and 5/6 were
deemed “good, but improvable’, therefore
labelled “good practices”. Case studies below
4/6 were deemed not well-designed/well-
implemented tenders and therefore labelled
“bad practices”.
Based on examples collected among EuropaBio
and the assessment criteria identified above,
three types of public procurement of biological
medicines in Europe were identified:
1. Single “winner-takes-all” v. multiple winners,
multiple choices;
2. Price-based evaluation v. value-based
evaluation;
3. Cross-border joint procurement.
Examples of countries are included at the end
of each section. It should be noted that one
country can fall within different types of public
procurement. This complexity is illustrated in the
section 4.4 related to Combination of types of
public procurement.
4.3. Types of public procurement of biological medicines
15
The single winner-takes-all
· This represents the cases where
the tenders result in a single winner and
which consequently lead to a limited
(single) treatment choice as well as
treatment substitution of patients already
on other therapies.
· There are circumstances where “single
winner” leads to single choice of therapy
for new patients but not to treatment
substitution for existing patients.
This is the case in Italy, where the country’s
law requires (for public health reasons)
that treated patients are not switched to
another therapy, thus ensuring continuity
of treatment.
· An important consideration within this type
is that the interchangeability of biological
medicines is often not taken into account
in the procurement. In one case of winner-
takes-all such as in Hungary there is a clear
consideration of the interchangeability of
the biological medicines whereas in many
recorded cases, the interchangeability
(or lack thereof) was clearly neglected.
· The winner-takes-all type restricts choice
and can lead to automatic substitution of
therapies without consent from a physician.
This practice has potential negative
consequences for patient safety as it can
lead to switching of medicines without a
clear medical reason. It is inappropriate
for biological medicines and may lead to
potential negative health outcomes, or even
adverse reactions, for patients. Ultimately,
the public procurement of biological
medicines should always foster physicians’
freedom of prescription choice by ensuring
that a number of therapeutic options are
available to appropriately treat patients.
· In this type of procurement, procurers
become dependent on the single winner
(and supplier); hence, vulnerable to
potential shortages in medicines in
case the single supplier experiences
unexpected circumstances.
· The winner-takes-all type of tender can have
direct impact on the market. By limiting
the number of providers, it can impact
competition and distort market efficiency.
In addition, a single market provider increases
the risk of shortages given the difficulty to
manufacture biological medicines.
· The impact on market competition with this
procurement type is particularly acute when
it is coupled with so-called “decentralised”
forms of tender organisation. In this sub-type,
procurement practices may take the shape
of (individual) negotiations between suppliers
and local purchasing groups/hospitals, rather
than competitive tenders. Arguably, in these
(decentralised winner-takes-all) procurement
sub-types the level of market competition is
4.3.1. Single winner-takes-all v. multiple winners, multiple choices
16
significantly lower than in more centralised
(competitive) winner-takes-all tenders. In
cases of perceivably biased negotiations, this
may even lead to potential suppliers pulling
out of the competition. Ultimately, designing
and organising tenders that enable free
competition is crucial in order to maintain
full participation of market players and
therefore delivering the best available
products to the patients.
· The European countries that broadly fall under
this type are: Cyprus, Germany, Hungary,
Netherlands, Poland, Spain and the UK.
Multiple winners, multiple choices
· This type is defined by tenders that lead to
multiple winners and thus offer patients and
their physician’s therapeutic choices.
· In a few cases, where multiple winners each
dominate a certain portion of the market
(when a tender is divided in lots), some
patients are forced to switch treatment
without prior decision from a physician.
This is the case in some examples from
Poland and the UK where each winner gains
its own lot, leading to a re-shuffle in the
number of patients per treatment in order
to fulfil the quantity requirements.
· There is no clear pattern identifiable that
interchangeability of biological medicines
(or lack thereof) is taken into consideration
within these types of tenders.
· The European countries that broadly fall
under this type are: Croatia, Italy, Norway,
Portugal, Slovenia and Spain.
Price-based evaluation
· Price based evaluations are procurements
that are evaluated and awarded on the
sole criterion of the cheapest price.
This type of tender is primarily used as
a cost-containment tool and aimed at
reducing the costs of a product. It does not
take into account other potential evaluation
factors such as quality or the reliability
of supply.
· Price-based evaluation is more prevalent
in single-winner-takes-all situations than
in multiple-winners/multiple-choices
situations. This is an understandable
correlation considering that the procurer
in this type aims to select the single
cheapest provider.
· Only if two or more providers offer almost
identical low prices, in some instances, the
purchasing authority may consider other
award criteria such as quality.
4.3.2. Price-based evaluation v. value-based evaluation
17
· The price-based evaluation has a strong
drawback: medication or vaccination is not
selected based on patient’s needs of various
therapeutic options, quality of supplier
and predictability of supply or its clinical
attributes, but on its price tag. In addition,
lowest price does not automatically imply
best value for public money.
· The European countries that broadly fall
under this type are: Cyprus, Denmark
(to some extent), Germany, Hungary, Italy,
Norway, Poland, Portugal, Slovenia
and the UK.
Value-based evaluation
· This type reflects procurements that are
evaluated and awarded based on multiple
criteria – in addition to price. These criteria
include quality, capacity, assurance,
credibility of the supplier, and suitability
of the product for the treatments,
among others.
· This type of evaluation is preferred for
biologics in particular over the simple
price/cost-based evaluation for a number
of reasons. Firstly there is a higher regard
for the inherent complexities of biological
medicines, including suitability of the
medicine for the patient; secondly there is
a stronger adherence to product labels
and to clinical practice guidelines.
Thirdly, while considering (life-cycle)
costs instead of price it provides a more
comprehensive cost-effectiveness analysis
and allows for better estimation of the
budget impact and therefore is more
valuable for the procurer. The only caveat
is when a value-based evaluation eventually
leads to a single-winner-takes-all scenario,
as this could restrict the options for
the patient.
· In some cases, such as Denmark, while
value-based evaluations are undertaken,
price often remains the main final criteria for
awarding a tender.
· The European countries that broadly fall
under this type are: Denmark (to some
extent), Ireland, Italy (to some extent),
Spain and the UK.
18
4.4. Combinations of types of public procurement – some illustrative examples
To illustrate the types described above,
two relevant examples will be presented in
this section, integrating each of the main
types. Detailed characteristics about the
examples below are available in the annex of
this report:
A. Slovenia (centralised procurement,
winner-takes-all, price/cost-evaluation)
In 2014, the Slovenian Ministry of Health set
out a public procurement for the supply of
erythropoietin (a hormone that controls red
blood cell production). The reasoning behind
the tender was a reduction in costs of medicine
spending as well as a reorganisation of
procurements of medicines used in hospitals.
The tender was centrally organised, designed,
and evaluated by the scientific committee of the
Ministry of Health. The evaluation criterion for the
tender was price/cost. In this instance, both the
reference product and its biosimilars compete
for the same patients with the bidders bidding
for predefined lots. With the best price winning
the lot, the winner is granted the entire market
and patients as well as physicians are confined
to a single treatment choice. Existing patients’
treatments are changed in favour of the medicine
of the winner of the tender. As such, any issues
related to the possible lack of interchangeability
were ignored. As the tenders of these lots take
place every six months, it creates complex
situations on treatment continuance and product
traceability. The proceedings were deemed
non-transparent due to their complexities and
disregard for the different types of medicines.
19
This practice does not appear to take
innovation into account, which is a
fundamental issue for the biopharmaceutical
sector, where certainty about the reward of
innovation is a key element, particularly for
the survival of SMEs. This practice does not
appropriately account for patient’s needs either.
Potentially, this practice may lead to
situations where patients under successful
treatment are substituted at pharmacy level.
B. Ireland (decentralised, multiple winners &
multiple choices, value-based evaluation)
In 2013, Ireland conducted a local procurement
for the Supply of Filgrastim 30MU and 48MU
solution or concentrate for injection. The reason
for the tender was to reduce the spending on
medicines by a hospital pharmacy.
The evaluation of the proposals of the bidders
was value-based, with a weighted assessment
“palette” including a 40% weight on price,
30% on product quality, and 30% on product
suitability to meet the needs identifed by
the purchasing authority. The decentralised
procurement featured a tender designed and
awarded by the local hospital via its internal
pharmacist (looking after tender design only)
and the Haematologist and Pharmacy Business
Manager (making final decision). The tender led
to multiple winners, with the award distributed
70%, 20%, and 10% among the various winners.
As such, patients had multiple choices to
choose from for their treatment. Moreover,
this ensured that patients were not forced to
substitute their current treatment. Admittedly,
the procurement was technically facilitated
by the fact that the tender was for filgrastim
molecules only, therefore the available
suppliers licensed on the Irish market were
also limited. However, this does necessarily
imply that multiple-winners tenders cannot
be successfully organised for other or broader
therapeutic classes.
20
At a general level, cross-border joint procurement
is the purchase of a good by two or more public
purchasing authorities from different Member
States through a joint call for tender. While today
there is no experience with cross-border joint
procurement in the EU, it may be possible that
some Member States start using this instrument
in the future.
Medicines can be jointly purchased cross-border
via two different legal mechanisms:
· Article 5 of the decision on cross-border
health threats: originally, the mechanism was
designed to address urgent needs associated
with an emergency pandemic context (e.g.
H1N1) where fast access and global availability
to a specific medicinal product were critical
constraints. The current Joint Procurement
Agreement (JPA) allows for the tendering of
countermeasures for communicable diseases10.
With regard to medicines, it is arguably limited
to communicable diseases only; and
· EU (general or internal market) procurement
rules: this mechanism already existed under
the old public procurement rules, but has
been simplified under the new rules to ensure
that Member States can easily bundle tenders
of simple products which do not require very
technical specifications. As stated in recital 2 of
Directive 2014/24/EU on public procurement,
the new EU procurement rules were revised
also in order to support the achievement of
smart, sustainable and inclusive growth while
ensuring the most efficient use of
public funds.
In general, principles applying to national public
procurement of biological medicines should
also apply to cross-border joint procurement
but considering the multi-national aspect of this
instrument, the following additional principles
should be considered:
· The practice of “forum shopping” between
jurisdictions should be regulated so as to
respect national health policy objectives
and to avoid detrimental effects on patient
access and clinical outcomes. In cross-border
procurement agreements under the EU
general procurement rules, it is foreseeable
that contracting authorities select the national
jurisdiction that has the most favourable rules
and procedures to achieve their objectives.
Given that European healthcare systems are
different in terms of health policy objectives
and patient care delivery mechanisms,
it is important that joint cross-border
public procurement agreements take into
consideration such diversity and lay ground
rules on both the procurement objectives and
the best applicable jurisdiction.
Cross-border joint procurement
5.
21
· In circumstances where the EU plays a role
in joint cross-border procurement,
the principles regulating the competence
area of Member States should be respected:
subsidiarity and proportionality are
fundamental principles which guarantee
that action at EU level is justified in light of
the national situations11 and limited to what
is necessary to achieve the objectives of the
Treaties12. It is important, for instance, that,
when a JPA mechanism is used,
Member States carefully assess whether this
new purchasing practice distorts competition
compared to existing practices and
alternative purchasing mechanisms available
in the country. If Member States have not
experienced any difficulties in procuring
medical countermeasures, the use of the JPA
may in fact undermine otherwise functioning
competition in the domestic market.
· In the context of the Decision on serious
cross-border threats to health,
serious public health issues should be
addressed in a holistic way: joint
cross-border public procurement
alone cannot address public health issues
and should be accompanied by other public
health measures, such as prevention and
health promotion programmes. In the case of
vaccines, the lack of coordination of national
immunisation programmes between
countries and the lack of coverage within
countries should be addressed first, to reduce
inequalities of access to vaccination.
· Joint cross-border public procurement
should not create a situation of European
monopoly, and should create a level playing
field for all potential providers. The experience
with the joint purchase of vaccines13 shows
that market specificities (for example, small
number of suppliers with limited volume
and a high fixed cost of production) can
lead to suppliers being pushed out of the
market. Joint procurement should allow
for multiple/“split winners” to ensure fair
competition and avoid negative impact on
market structure.
· Access to joint cross-border public
procurement should also be encouraged
for innovative small and medium sized
enterprises (SMEs) by, for example, avoiding
the creation of unnecessary administrative
requirements.
22
· Regardless of the procedure, ultimately,
it is of paramount importance that no
cross-border joint procurement mechanism
creates additional delays in the process of
getting innovative treatments to patients.
In case JPAs are initiated, it is crucial that
the additional JPA procedures are integrated
into the overall timelines for pricing and
reimbursement of medicinal products,
as mandated by EU and national laws,
and do not unduly extend the amount of
time patients have to wait before accessing
medical treatment.
23
Based on both the examples collected by
EuropaBio member companies in several
countries from the European Economic Area
(EEA) and the types defined in the previous
chapter, some key recommendations for
the appropriate procurement of biological
medicines can be drawn for the benefit of
future procurers and regulators. They are
summarised below:
Recommendation 1:
Tenders should reflect patients’
needs and allow freedom of choice
for doctors/patients, by ensuring
that treatment options are not
limited and decisions can always be
made by a physician in consultation
with patients.
· Public procurement used for the purchase
of biological medicines should provide for
a sufficiently broad choice of medicinal
products: ideally a variety of medicines
should be available for physicians
and patients instead of a single medicine.
Public procurement should foster this diversity
of suppliers by ensuring the final allocation of
contract is not limiting doctors/patients to one
treatment choice.
· Two biological medicines are not identical:
public procurement should take into
consideration the diversity of therapeutic
needs of patients. In order to ensure that
procured medicines meet the needs of
patients, any grouping of medicines in a
potential tender lot, even more so when
these are biological medicines,
should only include products that are
therapeutically equivalent.
· Physicians’ freedom of choice and accurate
patient information should be promoted
by tenders: The relationship between
patient and healthcare professional is
crucial for ensuring the best treatment/care
decisions and health outcomes for each
patient. All available therapeutic options
should be discussed thoroughly and
healthcare professionals should ensure that
patients understand the options, relative
benefits and risks.
Key EuropaBio recommendations
6.
24
Recommendation 2:
Tenders should respect physicians’
prescribing authority as regards
decisions to keep treated patients
on current treatments
· The fact that biological medicines cannot be
simply interchanged needs to be reflected
in the design of public procurements.
Ultimately, the public procurement of
biological medicines should always foster
physicians’ freedom of prescription choice.
· Treated patients should not be switched:
it is important that public procurement does
not lead to the unintended switch of a treated
patient to another biological medicine during
the course of his/her treatment. As such,
winner-takes-all tenders should be avoided,
so that treatment options are not limited and
decisions can always be made by a physician
in consultation with patients.
Recommendation 3:
The complexity of manufacturing
biological medicines should
be considered in procurement
processes and sufficient lead times
should be granted
· Public procurement should take into
account the complexity of biological
manufacturing and allow for sufficient
stability and predictability:
Biological processes are highly specialised
and time-consuming. For example,
in the case of vaccines and other biological
medicines, time between reception of raw
materials to final packaging and shipment
can take from 3 months (e.g. protein-
replacement therapies) to 26 months
(e.g. complex vaccines) depending on the
complexity of the product. It is therefore
paramount that tender contracts are
sufficiently stable and accurately predict
demand over a sufficiently long period of time
in order to guarantee stable supply.
Recommendation 4:
Price should not be the only
decision-making criterion
· Public procurement decisions should be
based on a variety of criteria:
the allocation of final contracts should not
be based only on price or cost, but should
take into account the overall value, such as
the reliability of supply, characteristics of the
products (for example the ease of route
of administration or the value for patients and
healthcare systems). The introduction of the
concept of Most Economically Advantageous
Tender (MEAT) criteria with best price/
quality ratio in the revised EU general public
procurement rules is a first step toward the
full inclusion of quality criteria in public
procurement. Criteria such as environmental
impact, social aspects, quality or technical
merit among others should generally be
considered when procuring biologics.
25
Recommendation 5:
Public procurement should
foster fair market competition
and innovation
· Growth, competitiveness and innovation
should be key political drivers underpinning
public procurement practices: all national
public procurement practices should support
the long-term EU policy objective to foster
innovation, growth and competitiveness
(Europe 2020) by ensuring that innovation is
valued and appropriately rewarded.
· Public procurement applied to biological
medicines should be considered as a tool
for fair competition to foster incentives
for innovation and ensure sustainable
market conditions: There needs to be a
balance between short-term cost savings
and longer-term incentives for innovation.
In this context, the bundling of on- and off-
patent biological medicines in a single tender
should be avoided. Procurement of on-patent
(or innovator) biological medicines should
generally be made by way of the
negotiated procedures.
· Fair and transparent competition between
potential providers should be encouraged:
calls for tender should be designed in such
a way that they guarantee fair competition
between all potential suppliers. Transparency,
including of the definition of eligibility criteria
and the decision-making process leading to
the award decision, should be a critical feature
of every tendering process.
· Preliminary discussions with the
different bidders help ensure that the
needs of purchasing authorities are met:
purchasing authorities should engage with
bidders in preliminary market discussions
to better evaluate the potential offers.
An early dialogue would also ensure that
the purchasing authorities may access
at the right time and place any potential
commercially confidential information
which they may later need to assess while
reviewing the different offers. Finally, such a
dialogue may help to assess the constraints
on manufacturing and supply capacity for
a tender – this is especially true in the field
of vaccination where the manufacturing
process (and therefore lead times) can be
particularly complex.
· Volume commitments from purchasing
authority: purchasing authorities
should provide guidance on the volume
commitment as part of the tender
announcement so that the manufacturer
has a good understanding of what volumes
are being asked by the purchasing authority
over the tender duration.
26
Annexes
7.
Source: examples reported by EuropaBio
members companies based on their
experiences as bidders
(anonymised as per EuropaBio antitrust rules
and to respect commercial confidentiality).
Country where tender took place
Tender Date Tender Scope EuropaBio Evaluation
1. Croatia 2014 Regional Best
2. Cyprus 2014 National Good
3. Denmark 2013 National Good
4. Germany 2014 National Bad
5. Hungary 2014 National Bad
6. Ireland 2013 Local/Hospital Best
7. Italy 2014 Regional Best
8. Netherlands 2014 National Bad
9 Norway 2014 National Bad
10. Poland 2014 Local/Hospital level Bad
11. Portugal 2012 National Bad
12. Slovenia 2014 National Bad
13. Spain 2013 / 2014 National and regional Bad
14. & 15. UK 2008 / 2009 Regional Bad
Table of contents
27
Case Study Number
Country Year National / Regional procurement
Description Short description of some specific features of the tender at hand.
EuropaBio assessment EuropaBio Assessment Criteria Available Attributes & Attributes’ Weight
Competition: sets out the degree to which the tender provided a single winner or multiple winners
Single winner = 0Multiple winners = 1
Access to multiple therapeutic solutions: determines whether, after the public procurement process is completed, patients have (or continue to have) access to multiple therapeutic choices or if (as a consequence of the award decision) they are restricted to the treatment offered by the winner of the tender
Restricted = 0Allowed = 1
Change of therapy for treated patients: reflects whether the affected patients already undergoing the treatment have it substituted after the public procurement process is completed or if they have the option of keeping with the same therapeutic plan
Limited doctors’ discretion = 0At doctors’ discretion = 1
Interchangeability/assessment of therapeutic equivalence: assesses whether the procurement rules are based on interchangeability9 or not, i.e. assesses if tenders acknowledge inherent differences among medicines – small molecules or biological medicines – or if they are arbitrarily grouped together regardless of whether an assessment of therapeutic equivalence exists
Not mentioned = 0Mentioned = 1
Legend
Award criteria: takes into account the criteria used by the purchasing agency in evaluating and awarding the tender, including whether there was a narrow focus on best price/lowest costs or whether the procurement procedure takes into account multiple factors, including quality, capacity, credibility, etc.
Price only = 0 (or also “price mainly”)Qualitative criteria and price = 1
Transparency: evaluates whether the process by which the public procurement was conducted was perceived as transparent
Low = 0Up to Standard = 1
EuropaBio evaluation Best practice ≥ 5/6
Good practice 4/6
Bad practice < 4/6
28
7.1. Case studies
Case Study 1 Croatia 2014 Regional procurement
Description This tender aimed at selecting a supplier for a variety of products, divided into different lots. As required by law, the procurement of biological medicines in Croatia is carried through an annual routine hospital tender. Led by a hospital tender commission, this regional procurement is split into different lots comprising different medicines. Generally, lots are specified by Anatomical Therapeutic Chemical (ATC) Classification System14 and/or International Non-Proprietary Names (INN). In the case of originator biological medicines and their follow-on biosimilars, both products were separated into two lots specifying quantities for the originator medicines and for quantities for any new patients. For each lot, the winners are selected on the basis of a best price selection criterion.
EuropaBio assessment EuropaBio Assessment Criteria
Available Attributes & Attributes’ Weight
Competition Multiple winners = 1
Access to multiple therapeutic solutions Allowed = 1
Change of therapy for treated patients At doctors’ discretion = 1
Interchangeability/assessment of therapeutic equivalence
Not mentioned = 0
Award criteria Qualitative criteria and price = 1
Transparency Up to Standard = 1
EuropaBio evaluation Best practice 5/6
29
Case Study 2 Cyprus 2014 National procurement
Description This tender aimed at selecting a supplier for biological medicines in the therapeutic areas of rheumatology, gastroenterology & dermatology for new patients. A second tender was issued for existing patients treated with biological medicines indicated for the same therapeutic areas. It was designed and run by the Pharmaceutical Services Unit and the Tender Committee of the Ministry of Health.
EuropaBio assessment EuropaBio Assessment Criteria
Available Attributes & Attributes’ Weight
Competition Single winner = 0
Access to multiple therapeutic solutions Allowed = 1
Change of therapy for treated patients At doctors’ discretion = 1
Interchangeability/assessment of therapeutic equivalence
Mentioned = 1
Award criteria Price only = 0
Transparency Up to Standard = 1
EuropaBio evaluation Good practice 4/6
Case Study 3 Denmark 2013 National procurement
Description This tender aimed at selecting a supplier of healthcare products addressing anaemia. The tender was organised by AMGROS, the pharmaceutical procurement service for the five regional authorities in Denmark. The tender was primarily based on price, although other criteria (inherent quality, shelf-life, etc.) were also marginally considered.
EuropaBio assessment EuropaBio Assessment Criteria
Available Attributes & Attributes’ Weight
Competition Multiple winners = 1
Access to multiple therapeutic solutions Allowed = 1
Change of therapy for treated patients At doctors’ discretion = 1
Interchangeability/assessment of therapeutic equivalence
N/A
Award criteria Price only = 0
Transparency Up to Standard = 1
EuropaBio evaluation Good practice 4/6
30
Case Study 4 Germany 2014 National procurement
Description This tender aimed at selecting a supplier for some retail anti-inflammatory products. It was organised by Retail Sick Funds. Although sometimes framed as most economically advantageous tenders, the contracts were awarded just on price (even where factors such as supply reliability were used as entering criteria).
Prescriptions are made by INN and the pharmacists provide the product provided by the tender winner, leading to potential treatment substitutions.
EuropaBio assessment EuropaBio Assessment Criteria
Available Attributes & Attributes’ Weight
Competition Single winner = 0
Access to multiple therapeutic solutions Restricted = 0
Change of therapy for treated patients Limited doctors’ discretion = 0
Interchangeability/assessment of therapeutic equivalence
N/A
Award criteria Price only = 0
Transparency Up to Standard = 1
EuropaBio evaluation Bad practice 1/6
Case Study 5 Hungary 2014 National procurement
Description This tender aimed at selecting a supplier for TNF inhibitor treatments. It was organised by the National Sick Fund in collaboration with the Ministry of Health and the Ministry of Finance. All products could compete but the single winner determined the medicine for new patients (or treatment substitution to those who did not receive the therapy in the past 12 months). Previously used treatments would therefore be scaled back. Switch was not allowed for this tender.
EuropaBio assessment EuropaBio Assessment Criteria
Available Attributes & Attributes’ Weight
Competition Single winner = 0
Access to multiple therapeutic solutions Restricted = 0
Change of therapy for treated patients Limited doctors’ discretion = 0
Interchangeability/assessment of therapeutic equivalence
Mentioned = 1
Award criteria Price only = 0
Transparency Up to Standard = 1
EuropaBio evaluation Bad practice 2/6
31
Case Study 6 Ireland 2013 Regional procurement
Description This tender aimed at selecting a supplier for a biological molecule called a granulocyte colony-stimulating factor (G-CSF) and in various dosage. It was organised by the hospital pharmacy, in particular by the local Pharmacy Business Manager and the Haematologist.
It was limited to G-CSF molecules at the time authorised only on the Irish market. The tender criteria were based on price, product quality, and product suitability. Furthermore, the tender was awarded to different bidders, based on splitting the business on a respective 70, 20, and 10 percent basis. There was no forced treatment substitution.
EuropaBio assessment EuropaBio Assessment Criteria
Available Attributes & Attributes’ Weight
Competition Multiple winners = 1
Access to multiple therapeutic solutions Allowed = 1
Change of therapy for treated patients At doctors’ discretion = 1
Interchangeability/assessment of therapeutic equivalence
N/A
Award criteria Qualitative criteria and price = 1
Transparency Up to Standard = 1
EuropaBio evaluation Best practice ≥ 5/6
Case Study 7 Italy 2014 Regional procurement
Description This tender aimed at selecting a supplier for a biological molecule called Erythropoietin (EPO). It was organised by a combination of regional payers, hospital pharmacists, and an appointed administrative director. It was split in two lots based on the status of the target population for the supplied product, i.e. on treated and off-treatment patients prior to the tender.
In this tender, treated patients were allowed to stay with previous treatment.
EuropaBio assessment EuropaBio Assessment Criteria
Available Attributes & Attributes’ Weight
Competition Multiple winners = 1
Access to multiple therapeutic solutions Allowed = 1
Change of therapy for treated patients At doctors’ discretion = 1
Interchangeability/assessment of therapeutic equivalence
Mentioned = 1
Award criteria Qualitative criteria and price = 1
Transparency Up to Standard = 1
EuropaBio evaluation Best practice 6/6
32
Case Study 8 Netherlands 2014 National procurement
Description This tender aimed at selecting a supplier for some respiratory medicines with inhaler device. It was set up by the healthcare insurers (HCIs) and open to multiple potential suppliers. The focus of the tender was lowering prices and led to a situation of “winner takes all”, which led to treatment substitution.
As doctors and pharmacists were strongly guided by the HCIs to prescribe the preferred medicine, chronic COPD/Asthma patients were switched to another device by doctors’ prescription or by pharmacist dispensing behaviour while co-payment increased for patients seeking alternative treatments.
EuropaBio assessment EuropaBio Assessment Criteria
Available Attributes & Attributes’ Weight
Competition Single winner = 0
Access to multiple therapeutic solutions Restricted = 0
Change of therapy for treated patients Limited doctors’ discretion = 0
Interchangeability/assessment of therapeutic equivalence
Not mentioned = 0
Award criteria Price only = 0
Transparency Up to Standard = 1
EuropaBio evaluation Bad practice 1/6
Case Study 9 Norway 2014 National procurement
Description This tender aimed at selecting a supplier for a range of medical products. It was organised by Norway’s national tender organisation (LIS) in cooperation with regional health authorities.
It sought to reduce prices on every tendered product – except anti-inflammatory, multiple sclerosis and some cancer therapies. Although it did not recommend automatic substitution, in practice doctors are encouraged to follow the recommendations from the national authorities.
EuropaBio assessment EuropaBio Assessment Criteria
Available Attributes & Attributes’ Weight
Competition Multiple winners = 1
Access to multiple therapeutic solutions N/A
Change of therapy for treated patients Limited doctors’ discretion = 0
Interchangeability/assessment of therapeutic equivalence
Not mentioned = 0
Award criteria Price only = 0
Transparency Up to Standard = 1
EuropaBio evaluation Bad practice 2/6
33
Case Study 10 Poland 2014 National procurement
Description This tender aimed at selecting a single supplier of biological medicines treating rheumatoid arthritis and other inflammatory diseases. The tender originated from a specific request by the Ministry of Health to the Public Procurement Office.
In general, in Poland public procurement is not centralised and each hospital sets out its own public tenders. The tender is evaluated on a price-criterion, leading to situation where a single winner takes all the market based on price. Regarding these particular biological medicines, the tenders are organised according to the Ministry of Health guidelines – hospitals have to buy the less costly version of the medicine, leading to non-medical switching of treatment.
EuropaBio assessment EuropaBio Assessment Criteria
Available Attributes & Attributes’ Weight
Competition Single winner = 0
Access to multiple therapeutic solutions Allowed = 1
Change of therapy for treated patients Limited doctors’ discretion = 0
Interchangeability/assessment of therapeutic equivalence
Not mentioned = 0
Award criteria Price only = 0
Transparency Up to Standard = 1
EuropaBio evaluation Bad practice 2/6
Case Study 11 Portugal 2012 National procurement
Description This tender aimed at selecting a supplier for erythropoiesis-stimulating agents (ESAs). It was organised by the National Authority of Medicines and Health Products – INFARMED – and the centralised purchasing agency (SPMS). The tender grouped together the different ESAs into lots of medicines at ATC level 4 or higher. The three offers with the lowest prices were considered by the SPMS.
The tender inappropriately grouped together different biologics into the same group, thereby ignoring product differences. There was potential for treatment substitution as hospital administrations mainly aim to buy what is included in national catalogue, which can change after tenders. It focused only on the price criterion rather than on the most economically advantageous criteria.
EuropaBio assessment EuropaBio Assessment Criteria
Available Attributes & Attributes’ Weight
Competition Multiple winners = 1
Access to multiple therapeutic solutions Restricted = 0
Change of therapy for treated patients Limited doctors’ discretion = 0
Interchangeability/assessment of therapeutic equivalence
Not mentioned = 0
Award criteria Price only = 0
Transparency Up to Standard = 1
EuropaBio evaluation Bad practice 2/6
34
Case Study 12 Slovenia 2012 National procurement
Description This tender aimed at selecting a supplier for erythropoietin (EPO). It was organised by the Ministry of Health based on a 2 years framework agreement and organised into lots defined by ATC5 code and INN (in this case there were no separate lots for reference biological medicines and biosimilars). For each lot, the winners were selected on the basis of price. Tender is run every 6 months (winning product could change every 6 months, increased complexity for hospital pharmacies and physicians). There is treatment substitution as the winner takes the whole market each time, leading to forced changes in therapy for patients.
This tender did not take into consideration the product differences. Furthermore, it increased complexity as hospitals needed to procure additional quantities of the specific products for their existing patients. Ultimately, it focuses only on a price criterion rather than on the most economically advantageous criteria.
EuropaBio assessment EuropaBio Assessment Criteria
Available Attributes & Attributes’ Weight
Competition Single winner = 0
Access to multiple therapeutic solutions Restricted = 0
Change of therapy for treated patients At doctors’ discretion = 1
Interchangeability/assessment of therapeutic equivalence
Not mentioned = 0
Award criteria Price only = 0
Transparency Up to Standard = 1
EuropaBio evaluation Bad practice 1/6
35
Case Study 13 Spain 2013 / 2014 National & regional procurement
Description This tender aimed at selecting a supplier for flu vaccines. It was organised by the central Ministry of Health and the regional Public Health Departments. The tender was split between the national level and the regional level. The focus for both was on price. There was a first phase with a pool of suppliers and a second phase that implies a reduction in the number of local suppliers. There was no legal limitation at regional level to have one single supplier, although this is most commonly the case in reality in Spanish autonomous communities.
The tender was conducted in two phases: the national tender shortlisted a pool of suppliers; subsequently the regional tender chose a single local supplier. The criteria differed per phase: the first phase evaluated bidders on lowest price, the second (regional) phase evaluated both on lowest price and other qualitative elements.
Segmentation of the national patient population by regions (with a potentially different winner in each) might lead to non-uniformity of flu vaccines used within the country. This could cause complex scenarios and inconveniences to patients moving across regions.
EuropaBio assessment EuropaBio Assessment Criteria
Available Attributes & Attributes’ Weight
Competition Single winner = 0
Access to multiple therapeutic solutions Restricted = 0
Change of therapy for treated patients Limited doctors’ discretion = 0
Interchangeability/assessment of therapeutic equivalence
Not mentioned = 0
Award criteria Qualitative criteria and price = 1
Transparency Up to Standard = 1
EuropaBio evaluation Bad practice 2/6
36
Case Study 14 UK 2008 / 2009 Regional procurement
Description This tender aimed at selecting a supplier for biological medicines (with the option of a Homecare Delivery Service) in Northern Ireland. It was organised by the Pharmaceutical Clinical Evaluation and by the Head of Pharmacy for the Northern Health and Social Care Trust.
In the first phase, the tender’s evaluation was based on the most economically advantageous offer, using numerous qualitative factors both for homecare delivery service indicators and the product itself. These factors included supplier credibility and quality assurance as well as clinical efficacy, safety and dosage. After this phase, the evaluation subsequently focused on lowest price and therapeutic rationalisation.
The winning bid was officially based on qualitative evaluation but ended up using the lowest price criterion, with a view to unbundle homecare services. The tender was abandoned in 2011.
EuropaBio assessment EuropaBio Assessment Criteria
Available Attributes & Attributes’ Weight
Competition N/A
Access to multiple therapeutic solutions Restricted = 0
Change of therapy for treated patients N/A
Interchangeability/assessment of therapeutic equivalence
Mentioned = 1
Award criteria Price only = 0
Transparency Up to Standard = 1
EuropaBio evaluation Bad practice 2/6
Case Study 15 UK 2008 / 2009 National procurement
Description This tender aimed at selecting a supplier for erythropoiesis-stimulating agents (ESAs). It was centrally organised by the NHS England. All available ESAs were included in a single group in order to reduce medicine spending on this product class.
This tender neglected the non-interchangeability of biologic medicines. The criteria for the contract were based on two elements: most economically advantageous tender and the lowest price – as set out in the UK Public Contracts Regulations 2006. The tender included value-based criteria.
EuropaBio assessment EuropaBio Assessment Criteria
Available Attributes & Attributes’ Weight
Competition Single winner = 0
Access to multiple therapeutic solutions Restricted = 0
Change of therapy for treated patients Limited doctors’ discretion = 0
Interchangeability/assessment of therapeutic equivalence
Not mentioned = 0
Award criteria Qualitative criteria and price = 1
Transparency Low = 0
EuropaBio evaluation Bad practice 1/6
37
Country
Year
Geographical scope of the example (remove non-applicable reference) Close ended question
Local procurement / National procurement / Regional procurement
Objective of tender (i.e. supply of which biological medicine)
Indicate any motivation behind the organisation of this tender (e.g. reduction of medicine spending, restructuring of healthcare system, etc.)
Who is involved in the tender design? Who is involved in the final decision-making about the winner?
Does the tender lead to substitution of patients on treatment?
Briefly describe the specific procurement / tender selection criteriaBriefly describe the process of this tender
Explain why these criteria were appropriate / inappropriate for the procurement of biological medicines
If the criteria were inappropriate, explain how they could have been improved
Indicate whether the tendering process is complete and the potential implications/results
In your opinion, overall this example is (remove non-applicable reference) Close ended question
A good practice of public procurement of biological medicines / A bad practice of public procurement of biological medicines
Briefly explain your answer to the above
Briefly explain what the ideal tender for biologics should look like
Any other comments
7.2. Template Research Questionnaire
38
References
1 Directive 2014/24/EU on public procurement and repealing
Directive 2004/18/EC; Directive 2014/25/EU on procurement by
entities operating in the water, energy, transport and postal services
sectors and repealing Directive 2004/17/EC; Directive 2014/23/EU on
the award of concession contracts
2 In a negotiated procedure, the contracting authority consults
the economic operators of its choice and negotiates the terms of
the contract with them. In this situation the contract notice is not
published for a number of specific reasons which are described in
Article 32 (Use of the negotiated procedure without prior publication)
of Directive 2014/24/EU on public procurement.
3 Article 67.1 of Directive 2014/24/EU
4 Refer to the annex to Directive 2001/88, as amended
5 See EMA (2014), Questions and answers on biosimilar medicines
(similar biological medicinal products)
6 EC Consensus Information Paper, What you need to know about
Biosimilar Medicinal Products, April 2013. Available at: http://
ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_
report_en.pdf EMA, Q&A on biosimilar medicines, EMA/837805/2011
Available at: http://www.ema.europa.eu/docs/en_GB/document_
library/Medicine_QA/2009/12/WC500020062.pdf
7 C. Leopold, C. Habl, S. Vogler & L. Favry; Tendering of
Pharmaceuticals in EU Member States and EEA countries:
Results from the country survey; 2008; ÖBIG Forschungs- und
Planungsgesellschaft mbH
8 P. Kanavos, L. Seeley & S. Vandoros;
Tender systems for outpatient pharmaceuticals in the European Union:
Evidence from the Netherlands, Germany and Belgium; 2009; LSE
Health; London School of Economics
9 Interchangeability: The medical practice of changing one medicine
for another that is expected to achieve the same clinical effect in a
given clinical setting and in any patient on the initiative, or with the
agreement of the prescriber.
Substitution: Practice of dispensing one medicine instead of another
equivalent and interchangeable medicine at the pharmacy level
without consulting the prescriber.
Switching: Decision by the treating physician to exchange one
medicine for another medicine with the same therapeutic intent in
patients who are undergoing treatment.
See: EC Consensus Information Paper, What you need to know
about Biosimilar Medicinal Products, April 2013. Available at: http://
ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_
report_en.pdf
10 European Commission; Joint Procurement Agreement to
Procure Medical Countermeasures; 2014. Available at: http://
ec.europa.eu/health/preparedness_response/docs/jpa_agreement_
medicalcountermeasures_en.pdf
11 European Commission, European Glossary, definition of
Subsidiarity. Available at: http://europa.eu/legislation_summaries/
glossary/subsidiarity_en.htm
12 European Commission, European Glossary, definition of
Proportionality. Available at: http://europa.eu/legislation_summaries/
glossary/proportionality_en.htm
13 The World Bank and GAVI alliance;
The vaccine market pooled procurement; 2010. Available at: http://
www.who.int/immunization/programmes_systems/financing/
analyses/Brief_12_Pooled_Procurement.pdf
14 The Anatomical Therapeutic Chemical (ATC) Classification System
is used for the classification of active ingredients of drugs according
to the organ or system on which they act and their therapeutic,
pharmacological and chemical properties. It is controlled by the
World Health Organization Collaborating Centre for Drug Statistics
Methodology (WHOCC), and was first published in 1976. One drug
can have more than one ATC code, but on the other hand several
different brands share the same code if they have the same active
substance and indications.
8.
EuropaBio is the European Association
of BioIndustries. EuropaBio’s mission is
to promote an innovative and dynamic
biotechnology base in Europe.
Members are involved in research,
development, testing, manufacturing
and commercialisation of biotechnology
products and processes.
Our membership is composed
of corporate, associate members
and bio-regions, as well as 16 national
biotechnology associations,
who in turn represent more than 1800
small and medium sized biotech
companies in Europe. EuropaBio’s
Healthcare Council represents both
large biopharmaceutical companies and
biotech SMEs developing medicines,
vaccines and diagnostic tools
using biotechnology in their development
or manufacturing processes.
About EuropaBio
www.europabio.org | @EuropaBio