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WHO/EMP/PAU/2014.2
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GOOD GOVERNANCE IN THE
PHARMACEUTICAL SECTOR
Report of a World Health Organization Technical Working Group Meeting
Tunis
17−−−−21 March 2014
This publication contains the report of the Technical Working Group on Good Governance in the
Pharmaceutical Sector and does not necessarily represent the decisions or policies of the World Health
Organization
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AKNOWLEDGEMENTS
We are grateful to all of the contributors to the technical working group meeting for their valuable
insights and contributions. Special thanks are extended to Anne Paschke, who also prepared the final
report.
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ACRONYMS
CoC Code of Conduct
CoI Conflict of Interest
CSO Civil Society Organization
EMP WHO Essential Medicines and Health Products Department
EMRO WHO East Mediterranean Regional Office
GGM Good Governance for Medicines Program
GRECO Council of Europe Group of States against Corruption
KI Key Informant
MeTA Medicines Transparency Alliance
MoH Ministry of Health
MSH Management Sciences for Health
SIAPS Systems for Improved Access to Pharmaceuticals and Services Program
SmOC Summary of Product Characteristics
SOP Standard Operating Procedure
TGW Technical Working Group
ToR Terms of Reference
UNDP United Nations Development Program
WHO World Health Organization
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1. BACKGROUND
WHO has been leading the Good Governance for Medicines (GGM) Programme since 2004 with support
from various donors including the governments of Germany, Australia and Kuwait. The goal of the
programme is to contribute to health systems strengthening and to prevent vulnerability to corruption
by promoting good governance in the pharmaceutical sector. The programme focuses on the
formulation and implementation of appropriate policies and procedures that ensure the effective,
efficient, ethical, transparent and accountable management of pharmaceutical systems.
The programme is implemented following a three-phase model process: national transparency
assessment (Phase I); development of a National GGM Framework (Phase II); and implementation of a
National GGM Programme (Phase III). In addition, the programme advocates the coordinated application
of two basic strategies for improving governance: the discipline-based (top-down) and the values-based
(bottom-up) approaches. To date, 37 countries have completed various phases of GGM implementation
in the six WHO Regions: 17 in Phase I, 10 in Phase II and another 10 in Phase III.
A technical Working Group for GGM was first established in 2008 to support WHO in the development of
strategies and tools for good governance. It was mandated to review and improve GGM instruments
and to help plan activities in WHO regions. The technical working group comprises individuals who have
been directly involved in the implementation of GGM activities including experts from ministries of
health, national regulatory authorities, academia, Civil Society Organizations (CSO) and international
organizations.
In October 2012, WHO held a global meeting with participating countries. At this meeting a number of
recommendations were made to improve the GGM technical package and provide support to
countries. In addition, a recent evaluation that was carried out on the programme confirmed the need
for additional training and tools in order to strengthen governance in the pharmaceutical sector. WHO
thus reconvened the network of GGM experts to support the GGM programme in its next phase.
2. OBJECTIVES AND EXPECTED OUTCOMES
The proposed objectives of this meeting were to:
• Identify and elaborate guidance documents for specific components of the model framework
such as conflict of interest and code of conduct
• Discuss and define indicators and methodologies for good governance monitoring and evaluation
• Review and validate WHO training materials
• Review the WHO transparency assessment instrument
• Agree on priorities and timelines for future work
3. MEETING PROCEEDINGS
The meeting commenced with welcome remarks by Nicole Krueger from the WHO Tunis Center. These
were followed by an introductory round during which participants introduced each other through
partner interviews.
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FIRST DAY: MONDAY, 17 MARCH 2014 │ GGM UPDATE ON ACHIEVEMENTS, PROGRESS
AND WAY FORWARD; COUNTRY PERSPECTIVES AND PARTICIPANT PRESENTATIONS
Deirdre Dimancesco gave a GGM UPDATE ON ACHIEVEMENTS, PROGRESS AND WAY FORWARD and
reported the progress that has been made since the last global meeting as well as on the results of the
GGM programme evaluation that was completed in 2013 (see table 1). She briefly introduced the
Medicines Transparency Alliance (MeTA) initiative and its synergies with GGM. Pending issues since the
last global meeting include the validation and publication of the training package, and the development
of guidance on Code of Conduct and Conflict of Interest. Road maps for countries have been received
and require a review of support needs. A new version of the model framework has been available for
public comment and will be put forward for finalization.
Table 1
GGM Program evaluation results
Aspects evaluated GGM Programme Evaluation
ACHIEVEMENTS
• Improved medicines procurement practices
• Revised pharmaceutical laws and regulations
• Increased transparency in registration and licensing
• Improved management of conflict of interest
• More public information on medicines policy and governance
• Increased commitment to create and sustain transparency in key stages of the
medicines chain
WEAKNESSES AND
VULNERABILITIES
• Most frequently identified area most vulnerable to corruption: Promotion
• Widespread lack of access to information
• Lack of formal criteria to guide selection of members of key committees
• Registration committees have a weak policy base and lack adequate
operational procedures
• Conflict of interest policies lacking or poorly implemented; rare or no sanctions
at all for violation
FACILITATING
FACTORS FOR
IMPLEMENTATION
• High national priority to tackling corruption including tangible support at
highest political levels
• Engagement of other ministries i.e. ministry of finance
• Dedicated GGM management group comprising senior stakeholder
representatives
• WHO technical support, benchmarking progress and sharing lessons
STILL PENDING
• Agreement to validate the training package and make publicly available
• Decision to develop guidelines and manuals to assist countries to develop
national GGM Frameworks: COI, Code of Conduct, Code of Ethics, monitoring
and evaluation frameworks
• Road maps for further GGM Phase II and III implementation
Mohamed Ramzy presented the PROGRESS of GGM COUNTRIES in the EMRO REGION. In total 16
countries from EMRO are involved in GGM (7 in phase I, 6 in phase II, 3 in Phase III). The diversity of the
region and political instability of many EMRO countries pose particular challenges. An analysis of all
country assessments revealed that promotion was the function most vulnerable to corruption. Mr.
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Ramzy identified political commitment to increase access to medicines and medicine laws in all countries
as a common strength. The absence of policies and standard operating procedures for COI as well as a
lack of implementation and collective adoption of codes of conduct were reported as common gaps in
governance across the region. Mr. Ramzy highlighted the national champions and capable national
assessors as success factors for GGM as well as high-level political support leading to institutionalization
of GGM in the ministry of health. He closed on the note that there was more interest in the subject area
than anticipated.
The rest of the day was devoted to presentations by participants (see table 2 for summaries of
presentations) and plenary discussions.
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Table 2: Summaries of presentations by participants
Title&Presenter Presentation summary
Measuring transparency
related to promotion in the
public pharmaceutical sector
in Tunisia
Lassaad Msahli
• Some of the problems related to promotion in Tunisia are: Loopholes in legislation; off-label prescribing; conversion of
patients to loyal customers by focusing on selling strategies rather than providing pharmaceutical counseling; disease
mongering; misinformation (and retention of information); and manipulation of clinical trials.
• Potential solutions to address these problems could be a watch list of offenders (i.e. companies that practice unethical
promotion by exploiting legislative loopholes), the establishment of aggressive and dissuasive taxes and penalties for
inappropriate promotion.
Conflict of interest
management and code of
conduct in Jordan
Adi Nuseirat
• Jordan introduced a conflict of interest management system for the pharmaceutical sector as well as a national code of
conduct for pharmacists.
• The guiding principles for managing COI are: serving public interest; supporting transparency; and promoting individual
responsibility.
Training of Trainers for the
Good Governance in
Medicines Program in
Malaysia
Salmah Bint Bahri
• Training of trainer workshops and training workshops were held on: (1) GGM concept in the pharmaceutical sector; (2)
areas of vulnerability to corruption; (3) proposed counter-measures and way forward; (4) techniques and skills to build
culture of good governance.
• Remaining objectives include collaboration with other ministries (Finance, Education, Anti-Corruption Commission, etc.)
and private pharmacies.
Good procurement practices
for medicines in Macedonia
Renata Raichki
• The national “framework for public medicinal procurement in an electronic era” was introduced, including five
components: (1) Legislation; (2) Institutional and administrative infrastructure; (3) Review and remedies system; (4)
Independent internal control systems; (5) External audit and oversight.
• The guideline for public procurement in the health sector encompass open procedures, limited procurement, competitive
dialogue, procedure with negotiation and procedure with a request for bids gathering.
• It was stressed that policy measures are not enough but that political will and government stewardship are necessary for
a successful procurement system.
GGM: Sensitizing District
Health Officers in Malawi
Moses Chisale
• Malawi presented GGM achievements at WHA side event 2013. District health officers were briefed on the programme.
They were surprised to have no knowledge of such a programme and showed overwhelming enthusiasm to be associated
with the programme together with their staff. They asked to receive more detailed briefing of GGM and extend the
programme to other staff in their respective functions.
• Various procurement activities including those related to GGM chave contributed to stock-outs dropping from 95% in
January 2013 to about 50% in February 2014
GGM- An integration of all
components: Thailand’s
Experience
Somkiat
Wattanasirichaigoon
• GGM in Thailand is currently in the implementation phase which has produced valuable lessons on what worked,
including:
o Group purchasing as a good tool to control drug prices;
o Information systems (databases, websites) as successful tools to increase transparency in the health sector;
o Group decision making in committees to foster good governance.
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Presenter Presentation summary
Minimum Standards for Selection,
Procurement and Distribution in
the Philippines
Caroline Belisario
• Significant accomplishments, included the launch of price referencing data and the Cheaper Medicines Act;
• The need for monitoring was stressed as a means to measure tangible outcomes, identify gaps and improve processes,
including the monitoring of CSO initiatives for governance;
o
Making Pharmaceutical Systems
Healthy through Good
Governance
Dinsie Williams
• The concept of good governance was introduced as encompassing more elements than transparency, such as
accountability, efficiency, rule of law, and participation;
• Several projects related to good governance undertaken at the University of Toronto were presented including
“Institutional Transparency in Pharmaceutical Governance” which examines the relationship between policy makers
and the pharmaceutical industry;
Another project assesses the “Governance in medical equipment donations”; about 70% of medical equipment remains
unused in some countries in sub-Saharan Africa due to lack of trained operators and inadequate infrastructure.
Measuring data disclosure
Catherine Vialle Valentin
• The data disclosure survey is a qualitative instrument that was developed to initiate and structure stakeholder
discussions about transparency in the pharmaceutical sector in MeTA countries;
• The results of the data disclosure survey with regards to promotion were similar to the results of the GGM assessment
which showed a high risk of vulnerability for corruption in the pharmaceutical sector;
• Large variations in other areas such as procurement and selection were found across MeTA countries.
Good Governance in Medicine
Registration in Low and Middle
Income Countries - SIAPS
Activities
Helena Walkowiak
• The Systems for Improved Access to Pharmaceuticals and Services (SIAPS) program is funded by the US Agency of
International Development
• The program has developed the Regulatory Systems Assessment Tool which includes governance indicators drawn from
the GGM assessment tool;
• SIAPS approach to strengthening governance in pharmaceutical systems is based on UNDP model of good governance,
encompassing elements such as participation, transparency, rule of law, equity and accountability. The approach
focuses on establishing policies and legislation supported by rule of law; organizational structures able to exercise
appropriate decision making, authority, and oversight; transparent, ethical, and accountable systems and processes
grounded in well-formed policies and legislation; and human resource management systems that promote effective
performance and ethical practices
• Activities include strengthening medicines registration committees and developing policies, legislation and guidelines
for medicines registration, and strengthening transparency and accountability;
• A web-based integrated regulatory information management system “PharmaDex” has been developed and
implemented in selected countries to register pharmaceutical products. More info: http://siapsprogram.org/tools-
and-guidance/pharmadex.
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Title& Presenter Presentation summary
Civil society monitoring
of political and petty
corruption: Ukraine and
India
Taryn Vian
• A CSO called the Anti-Corruption Centre (AntAC) in Ukraine works through partnerships with parliament and investigative
journalists to trace money. The campaign “Who makes money on epidemics of HIV/AIDS and Tuberculosis in Ukraine”
revealed various corruption pathways in procurement such as companies with same ownership “competing” with each other
and direct cartel agreements prior to bids; it was suggested that one approach for GGM could be to build capacity of CSOs to
conduct analysis of tenders and corporate ownership .
• Another online civic innovation against corruption introduced was the crowdsourcing model “Ipaidabribe.com”, where
corruption reports can be submitted; the website turns the topic into something constructive and reveals (e.g. regional)
corruption patterns.
Research at the WHO CC
for Pharmaceutical policy
and regulation: selection
of medicines as an
example
Aukje Mantel-Teeuwisse
• The research on selection of medicines was presented as an example of the work that is carried out at Utrecht University.
Highlighted conclusions from the research included:
• Selection process improved and treatment often possible with selected medicines
• Factors that play a role in medicines selection include region, income level, year of NEML update, disease burden
• Availability of medicines is low, even if selection seems adequate
Good Governance for
Medicines Model
Framework
Didar Ouladi
• The 2007 GGM Model framework was revised and to provide a practical and simple tool that would serve the needs of the
countries implementing the GGM programme. The revisions took into account feedback from the GGM Global Advisory
Group, GGM Global Technical Team, WHO Regional and country teams, 31 GGM country teams and external reviewers.
• Elements of the framework were strengthened and clear steps/ processes were added to guide countries in preparing their
own country frameworks for Phase 2 of the GGM programme. Successful country examples were also included so that new
countries could see the practical application of discipline-based and values-based approaches, as well as the successful
implementation of the steps/processes leading to their own model frameworks. The revised is available on
http://www.who.int/medicines/areas/governance
• 4 Successful country case studies were also prepared separately so that new countries could benefit from lessons learnt.
Additional case studies need to be prepared and published.
Training of Leaders for
Good Governance in
Medicines Program at
Nur University, Bolivia
Didar Ouladi
• One of the formal postgraduate degree programs offered at the Public Health Department of Nur University in Bolivia
• For health care professionals working in the field who want to become leaders (or are leaders) in the area; participants are
usually from Ministry of Health, regional health authorities, hospitals, urban/rural health care facilities, NGO´s and private
institutions
• Duration of 4-6 months, 600 hours that are theoretical-practical; classes are a weekend a month with preparation before and
practical application after class on learning outcomes, measured by results of implementation of GGM in their institutions
Key ethical issues in
health systems
Andreas Reis
• Ethics was defined as an analysis of what is good, right, and fair, and as a decision making process to seek agreement when
principles / values are in conflict (dilemma).
• Ethical aspects of the universal health coverage concept were outlined, namely equity of access, access according to need and
financial risk protection.
• It was stressed that there is sometimes always an equity-efficiency tradeoff in allocating resources for health.
• Four conditions for a fair process were addressed: (1) publicity / transparency, (2) relevance, (3) appeals mechanism, (4)
enforcement / regulation.
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The discussions after and between presentations throughout the day evolved around the following issues:
• Meaning of scores of the transparency assessment tool?
The assessment revealed promotion to be the function most vulnerable to corruption (See Lessons
Learnt, 2004-2012) - but is it also the most important pharmaceutical function? In contrast procurement
was deemed to be less vulnerable by the transparency assessment. With regard to this the question was
raised whether the tool is sensitive enough to detect all relevant areas with respect to transparency that
are potentially prone to corruption. A general issue related to the transparency assessment was that,
because the assessment tool is complex, sometimes by the time it been completed, it is already obsolete
due to changes in environment. Since the transparency assessment study serves as a baseline each
country should measure the progress in the implementation of the recommendations made in the study.
A key question is: Is transparency the main measure of vulnerability to corruption? These issues were
discussed in depth on Day 3.
• How can Civil Society be more actively involved in GGM?
The GGM programme could do more to engage credible civil society organizations (CSOs) and improve
capacity. One suggestion was to build an online platform with all disclosed information (that is otherwise
often hidden on e.g. regulatory websites that are unknown by CSOs) and best practices/suggestions on
how to use this information to build pressure and campaigns for access to medicines. Another suggestion
was to connect CSOs that are new to the field with more experienced ones. It was stressed that CSO
should not be used as a buzzword but that a meaningful involvement of NGOs and patients will be
crucial, e.g. by actively participating in or observing making decisions and representation in committees.
Another issue raised was regarding different types of media that would need to be used to reach people
in remote areas without internet access (e.g. through radio). Guidance for CSOs in countries is needed on
the potential role of CSO in improving governance and how to get involved, which could be provided
through GGM.
• Could aspects of GGM be applied to the medical device sector?
While some commonalities with medicines were acknowledged (CoI, SOPs, etc.), it was agreed that it
was probably too early to expand the GGM programme to the medical devices sector.
SUMMARY OF ACTION POINTS DAY 1
� Review potential for GGM to support CSO role in improving governance.
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SECOND DAY: TUESDAY, 18 MARCH 2014 │ CODE OF CONDUCT
Introduction
After a summary of issues discussed during the first day and two more presentations by participants (see table
2), the second day was devoted to in-depth discussions and knowledge sharing on Code of Conduct. The
workshop was facilitated by Roth Judd and alternated between explanations by the facilitator, panel
discussions and group work. The objective was to identify specific needs for guidance on a code of conduct in
the pharmaceutical sector.
Code of Conduct
The focus was on codes of conduct in the civil service, however the need for code of conduct in the private
sector and for the pharmaceutical industry was also discussed. The main topics for discussion included:
(1) to whom should the code apply?
(2) elements of the code
(3) implementation of the code.
The discussion around these issues is summarized in the following section.
FOR GOOD GOVERNANCE FOR MEDICINES, TO WHOM SHOULD A CODE OF CONDUCT APPLY?
• In many countries numerous codes exist, for example: for parliament members, civil servants,
professional pharmacists associations, professional physicians associations, for specialized professional
activity, e.g. inspectors, a tender committee member etc.
• A first step in understanding a country situation would be to map out the different codes and their
commonalities and to identify gaps.
• It is acceptable to have more than one code applicable to a single position. For example a physician
may have a civil servant code, a code from the physicians
association and a code from the institution where he/she
works for example.
• Pharmaceutical industry can also have a code of ethics or a
code of conduct that depends on private initiative not rule of
law.
• Although a sector wide code could be applied, different areas
of the pharmaceutical sector may have specific requirements in the code. A guidance document should
present a model that identifies the key elements that should be applied across the sector and specific
considerations should be identified for regulators, inspectors, procurement officials, etc.
• The scope could be expanded to address not only a government official’s or employee’s use of office or
position to obtain an advantage for self but also to obtain an advantages for family members.
ELEMENTS OF A CODE OF CONDUCT
The facilitator presented the following as key elements of a code of conduct for the pharmaceutical sector
(Table 3). Plenary discussion points are displayed in the call out boxes to the right. A more detailed example of
a CoC for the pharmaceutical sector can be found in ANNEX I.
It will be important to map
the different codes that
exist in country as a first
step in defining gaps
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Table 3:
Key elements of an exemplary
code
Throughout the discussions on a code of conduct, definitions were of concern. These are some of the
definitions that were put forward.
Key elements of a code presented
1. No government official may use his position for
financial gain
2. No government official may use his position to affect a
matter that is not in the public interest
3. A government official may not solicit or accept a
payment or gift that could affect the official’s action
4. A public official may not use public information that
may result in the official’s receipt of something of
value
5. A government official may not have a private interest
in a government or public contract
6. A public official may not represent a private interest
before a government office
7. Former government officials may not accept
employment for a certain number of months from any
business from which he/she had authority
8. A government official may not use his position to
obtain an unlawful benefit
Element Definition
"Anything of value" means any money or property, favor, service, payment, advance,
forbearance, loan, or promise of future employment.
but perhaps excluding
• compensation and expenses paid by the government and
• fees and expenses expressly permitted by law and publicly reported
and accounting for political campaign contributions and normal,
everyday, common hospitality extended for a purpose unrelated to a
person’s government position or to government business
“Gift” means the payment or receipt of anything of value
"Lobbying" means the practice of attempting to influence legislative or governmental
action by oral or written communication with a governmental official or
employee.
• Needs to include services, favours,
anything of value, and/or personal
relations that affect business
decisions
• Gifts need to be defined
• Need for specification how far gifts
that include career improvement or
have a public benefit are
acceptable; must certainly be
disclosed
• This could be difficult in countries
with limited expertise. Time period is
important to prevent influence from
occurring. What is the correct time -
2,4,6 years?
• Important to specify how COI
should be declared and managed
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“The biggest issue is not the
existence of the code, but the
implementation of it.”
Specific elements and questions to be considered for a code of conduct
• Gift giving should be considered as part of a code, in addition to gift receiving
• Should the onus be on the individual, managers or on the institution that is giving the gift? Or on
both?
• Can an institution be corrupt or only an individual?
How to address each?
• Information on lobbying should be included in any
CoC, particularly the following issues:
• A public official should not engage in
lobbying for the private benefit of the
official, for the official’s family, or for a
business or other organization with which
the official is associated.
• Lobbyists should be allowed to express ideas
as long as they clearly identify who is paying
them to lobby and they do provide a
government official with a gift or anything of
value.
• While private companies and interests can
lobby, CSO may not have the resources to mobilize to effectively lobby. How can this be
addressed?
IMPLEMENTATION OF A CODE OF CONDUCT
Who would initiate/enforce a code of conduct?
• Potential initiators and enforcement bodies include:
o the department of justice
o civil service bureau
o the Ministry of Health
o ombudsman
o Anticorruption Agency
o State commission for preventing corruption
o anti-Corruption commission or office with responsibility
o CSOs
o Professional organizations and Chambers
• While it was stressed that this was certainly country specific depending on the context and there is not
one solution for all, there was the view that the Ministry of Health should have a key role as it is the
body most concerned with the issue.
• Where a CoC does not currently exist, one approach would be to include it in a 5 year strategic plan for
the health sector or the national anti-corruption plan.
• When introducing a code it is important to consider groups of people who can either move or block the
process.
• Buy-in at highest level (e.g. cabinet) was considered important.
• A combination of regulatory bodies could be an alternative to one body that enforces a code of
conduct including: anti-corruption initiative / ministry; CSO; different ministries; chamber of
Lobby control: Example from the US
In the state of Wisconsin, USA, paid lobbyists must
register with the government. A business or
organization that pays a person to lobby must
register and report about the matters it is trying to
influence before its lobbyist communicates with a
government official. This information is published
daily online and searchable by issue, bill, and
organization. The online report displays every
organization trying to influence a matter as well as
how much time and money the organization spends
on its lobbying effort.
www.opensecrets.org publishes all lobby payments
(including by the pharmaceutical industry) to
legislators.
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There was a general view that any
new body should be institutionalized
within existing frameworks.
commerce; better business bureau; MoH; social media; individual champions; office of the auditor
general; and/or the justice department. But this approach runs a risk of creating uncertainty and
impediments to enforcement because of overlapping jurisdiction and conflicting standards and
interpretations.
Table 4:
Examples of CoCs for the pharmaceutical sector in countries
Country Type of CoC Specifics
Macedonia CoEthics for public procurement
CoEthics for Civil servants
CoEthics for Pharmacists
Code was issued by the public procurement
bureau in the Ministry of Economy
Code was issued by Ministry of Information
Society and Administration
Code was issued by the Chamber of
Pharmacists
Tunisia CoC for the pharmaceutical sector Code is administered by independent anti-
corruption commission
Thailand Ethical code of conduct based on anti-
corruption legislation (Anti-corruption
act and Royal Decree On Good
Governance)
Ministry of public health covers the code for
selection and procurement. The code includes
a whistle blowing mechanism.
Administrative body
When establishing an administrative body for the CoC, decisions need to be made on whether (i) to include one
or more representatives of the pharmaceutical sector, (iii) to rely on a non-partisan independent citizen body,
(iii) to involve an office of the ombudsman, or (iV) to rely on a MoH, Ministry of Justice, or other government
body. The following considerations for choosing whom to put on the administrative body were discussed:
o Board of 6-8 members is favorable to preserve institutional memory and to avoid reliance on only one
person
o Reputation, integrity and public trust in individuals is crucial
o How can the members be protected? (in some cases people can be threatened, whistle blowers or
decision makers can be prosecuted)
o Individuals must be free of external influence
o When including factions (political, ethnic, business
groups, consumer advocates) interests are
represented which can create possibility of split
vote, e.g. industry vs. government
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Table 5:
Examples of administrative bodies
Implementation process
Should implementation be phased in?
If so, with senior official first before employees; or by agency? Or should it be applied to everyone at the same
time?
− Apply at once: Approval from all stakeholders would be needed. If this is not possible, a phased
approach would be required.
− Phased approach: Difficult to start, would need change management to overcome resistance. It was
stressed that senior officials need to adopt first to practice what they preach (e.g. integrity). On the
other hand applying it to ground level first could be beneficial as seniors will be more pressured to
accept for themselves if lower employees take it up.
− Mixed: Phased approach for awareness and training and one date for implementation.
• It was suggested to start with MoH and agencies most influenced by the pharmaceutical industry.
• Implementation should best be accompanied by a learning program on (a) what the code means; (b) how
to use CoC forms; (c) what will happen when code is violated.
• After implementation, reminders were considered important as people might forget about the code
otherwise (e.g. MSH passes CoC certification for procurement every year).
• Every code should be regularly reviewed (e.g. every 4 years).
• SOPs can help with implementation.
• Sensitization of people to what is right and wrong is important in addition to enforcement.
• Should be included in university curricula of professions to which code applies
• Should be established in the culture of target audiences
Full-time ethics Commission (very rare)
In this model members are full-time and well-paid. They meet regularly to oversee a
commission’s day-to-day activity. An advantage can be that they develop a very broad and deep
understanding of the commission’s work. A disadvantage can be that their jobs and income
depend upon retaining their positions as commissioners and this may cause them to make
decisions in favor of the person or position that appoints them instead of making hard decisions
against superiors.
Part-time citizen board or commission (more feasible)
An example of a part-time citizen board or commission might be a 6 member body with members
appointed for 6 year staggered terms. They are not paid. To avoid a close decision, four votes
needed to take a decision. In the case of the former Wisconsin, USA Ethics Board only 2 decisions in
20 years were not unanimous. Members could not be members of a political party or have state
employment. The board members hired a lawyer as its director. The director was then responsible
for hiring additional employees and overseeing the agency’s day-to-day operation. Appointed by
governor with consent of the legislature. Reward is respect and sense of "doing good".
Accountability comes from citizens as all meetings were public and everything transparent.
Members publicly exposed which is a risk in some countries. Needs source of financing.
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Mongolia
Professional societies working on CoC and MoH have been invited to
be part of process
Jordan GGM framework was impetus for development of CoC, involved all
stakeholders, based on model framework of CoC
Philippines Integrity committee helps to establish cultural change
Macedonia
Transparency International for the State Commission for Prevention of
Corruption and for the OSCE mission to Skopje promoted
transparency and accountability in public institutions
Thailand Thailand CoC – was integrated into undergraduate curricula
Prevention
The following means of prevention of violations of code of conduct were discussed:
• Standard operating procedures (SOPs) as a means to avoid corruption in the first place.
• Using e-processes which can reduce personal contact and risk of corruption.
• Desired behavior can be encouraged by tying incentives to performance.
• Providing advice on potentially problematic situations before they become a problem. For example,
people can write to the ethics commission and ask for an opinion on a concrete problem to clarify
whether a particular action is acceptable or not. If the committee approves of the action, it can be
carried out without fear of sanctions. Any responses on such requests could be published anonymously
on a website as other people might encounter the same problem.
• FAQs can be very useful to guide behavior and clarify questions about the code of conduct.
Participants considered the following FAQs important:
FAQs on CoC considered important for professionals in the pharmaceutical sector
• Why does code of conduct matter and what are the benefits of a code?
• What is an unacceptable gift, offer of service or invitation?
• What to do when offered a gift, service or invitation
o How to declare?
o How to refuse?
o How to report?
• What are the consequences of violation of the code?
• How to recognize relationships that could affect decision making?
• Are donations to the institute acceptable?
• What body manages code of conduct i.e. ombudsman, ethics committee etc.?
• How should industry representatives be managed?
• What to do about free samples of medicines?
• What to do when a violation is suspected or observed? Where and how to report violations?
• Where to obtain information on violations that have been reported ?
Table 6:
Examples of implementation processes from
countries
WHO/EMP/PAU/2014.2
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Violations and Sanctions
Any violation of code of conduct and consequent penalty in case of non-adherence should be supported by
law. Penalties, if too light or too severe, become ineffectual. An administrator needs a range of penalties to suit
the crime, e.g. a warning; monetary fine; time in jail; return of value of goods; or return of e.g. 3 times the
value. It is important to get the balance right between level of severity of violation and enforcement, sanctions
should be proportional.
Violations that require sanctions should be turned over to a court and investigated appropriately. The body
responsible for investigation of possible violations of a CoC should have authority to investigate a matter
whenever circumstances warrant, even if a complaint has not been filed. An example of central vigilance
committees in India was alluded to, where people can raise concerns informally. In order to bring it forward it
then needs to be brought to a formal complaint.
It was further noted that unfounded or frivolous complaints could also be subject to reprimand or sanction to
punish and to deter them. Procedural fairness means that most often only the outcomes of investigations
should be made public. Otherwise the reputations of individuals could be adversely affected when no
conviction is made or penalty applied. In case media reports about purported violations surface without any
formal accusation, an official, to try to clear his or her good name, should be able to ask the administrator of
the CoC to investigate.
The implementation of any CoC needs to encompass the establishment of mechanisms for reporting violations.
SUMMARY OF KEY CONSIDERATIONS FOR DEVELOPMENT OF A GUIDANCE DOCUMENT ON CODE OF
CONDUCT FOR THE PHARMACEUTICAL SECTOR
� How a code is implemented and enforced is context specific.
� There are many different ways to set up supportive structures depending on the country
context and already existing structures.
� There was agreement that any new code should build on existing structures.
� A mapping exercise of existing CoCs in countries was considered essential as a first step.
� A global guidance document on CoC for good governance for medicines could serve as a
strong advocacy tool for countries.
� The document should also address how such a code should / could be financed, including its
implementation and supporting structures.
WHO/EMP/PAU/2014.2
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THIRD DAY: WEDNESDAY, 19 MARCH 2014 │ MONITORING & INDICATORS
Introduction │ Revision of the WHO Assessment Instrument: Measuring Transparency in the Public
Pharmaceutical Sector
Jane Robertson introduced the objectives of the day which were to review:
• Usefulness of the current transparency assessment tool
• Proposed revisions to the current tool
• Indicators for monitoring and evaluation
Mohamed Ramzy introduced the structure and purpose of the transparency assessment tool, which covers
eight functions of the pharmaceutical sector. An underlying assumption with the use of the current tool is that
the presence and awareness of documentation is an indication of transparency.
Anne Paschke presented results of a survey that had been sent to National Assessors prior to the meeting in
order to obtain feedback on the practicability and usefulness of the current assessment tool. The feedback was
presented as a starting point for discussions about the revision of the tool. The following key points were
made:
• All respondents thought that the tool had been very useful to initiate discussions and develop
measures for GGM.
• The assessment helped to identify weakness in the pharmaceutical sector and point to the lack of
transparency in the sector.
• Some respondents suggested changes to the scoring system.
• An extension of the tool for application in the private sector and separate analysis of the private and
public sector was suggested.
• Some reorganization of the tool was proposed.
The subsequent plenary discussion captured the perspectives of participants on what should be kept and what
should be changed during the revision process. The discussion evolved around the following themes:
What do we (want to) measure?
• While the title is “Transparency Assessment Tool” it measures more than that; it should be identified
which other aspects of governance are covered and which elements -additional to transparency - should
be included, such as participation, accountability, ethics, efficiency, rule of law, etc.
• There was a strong view expressed of the need to separate the measurement for (1) existence and (2)
knowledge of documents / policies; deciding on what elements should be measured (Existence of
documents/policies? Knowledge of the existence of documents? How much knowledge (level of detail) is
expected?) Would also depend on target audience.
• The question was raised whether the tool does really measure vulnerability to corruption and if so, how
this was related to transparency.
• One suggestion was to use “super scoring” by picking 10 key documents that people should be aware of,
then measure what percentage of people are aware of it / have it.
Scoring
• Considerable doubt was expressed whether all indicators and sub-questions were equally relevant and
should be equally rated/scored
• It was suggested that two different scores were needed for (1) existence and (2) knowledge/awareness
of documents/policies.
WHO/EMP/PAU/2014.2
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• It would be more meaningful if the scores detailing awareness were expressed as “X percentage knows
about it”.
• The fact that two training sessions were needed to explain the scoring indicates that a simplification of
the scoring system would be helpful.
• Explain more clearly that an indicator should be excluded from scoring when more than 50% of
respondents answer ‘do not know’.
Methodology and structure of tool
• It was stressed that the difference between M1 and M2 type questions should be clarified.
• It was suggested that there was a need to clarify terminology since the quantitative questions cannot be
considered indicators.
• Potentially missing functions were stated as: pricing (how are they set?); prescribing and dispensing;
inspection of manufacturers vs. pharmacy etc. Inclusion of further aspects will depend on agreement on
the purpose and scope of the assessment.
• Tunisia reported that they had rearranged all indicators by function first and governance elements
second (e.g. legislation, equity, transparency, unethical behavior) which was perceived as making
questions and results more meaningful.
• It was suggested to provide more space for comments/suggestions under each question.
• A suggestion was made to include an independent 3rd party (i.e. neutral or external person) as a national
assessor; however it was then reported that the Global Advisory Group had already discussed this once
but it was ruled out because externals would have a bigger learning curve and there was a need to keep
cost down and time to complete the survey reasonable to keep methodological rigor for reliable and
valid data.
Key Informants
• It was stressed that the choice of key informants was important as this will always have an influence on
the results.
• Several participants encouraged interviewing both public and private sector key informants; different
sets of questions might need to be considered for public and private key informants
Results
• There is a need to express results by percent and provide easily understandable summaries for public
officials; the issue is that the current scoring system is not meaningful enough to public officials and it is
important to convey messages clearly and unambiguously.
• The assessment tool produces a wealth of data, useful for different audiences. People can read the
report and go into more detail in specific areas as needed. However maximum impact will come from
clear summary statements/data that are easily understood by audiences.
Group work session on tool revision
The panel discussion was followed by a group work session. Each of the four groups worked on the indicators
of one function of the tool. Three of the selected functions were shortly introduced in five minute
presentations:
• Registration/inspection │Adi Nuseirat
• Procurement │Taryn Vian
• Promotion │Mohamed Ramzy
WHO/EMP/PAU/2014.2
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Every group received a copy of the questions from the assessment tool on the respective functions. They were
asked to review the questions, suggest changes and discuss general issues regarding the revision of the tool.
Table 7 shows the results of the Group discussions.
General aspects discussed Suggested considerations for a revision
REGISTRATION& INSPECTION
• What are best practices in governance in registration and
how does actual practice compare?
• Should quality and safety be considered?
• Cover various elements of good governance:
transparency, participation (multi-stakeholder
involvement in committees for guidelines, i.e.
registration committee), fairness, procedures, legal
provisions, regulations, appeals (participation); rule of
law/sanctions; ethics (COC); and responsiveness.
• Assess decision as key point (reasons for acceptance and
rejection).
• Key informants should include: regulatory officials
(registration officials, inspectors, ethics, appeals
committee), manufacturers/wholesalers/private
pharmacies, pharmaceutical industry associations, others
who are impacted by the decision such as suppliers,
purchasers
• Existence of list of registered medicines and re-
registration.
• Procedures for application (checklists,
timelines, forms);
• Assessment committees (criteria, process and
results of decision making; member terms
(rotations etc.);
• Provisional registrations (exceptions)
• Process for withdrawal from the market;
efficacy; investigation procedures.
• Existence of appropriate legislation and
implementation.
SELECTION
• What is the tool addressing?
���� Transparency can be measured quantitatively
���� Effectiveness of transparency is qualitative
• There should be separate questions on governance elements
(e.g. transparency, effectiveness measures)
• Criteria for selection should distinguish
between “must have” and “good to have”.
• ToRs for committee.
• Are stakeholders consulted?
• Are relevant documents/data in the public
domain?
• What are the SOPs?
PROCUREMENT
• Audience for report: Head of procurement, legislature, health
facilities concerned with stockouts; What they want to know:
− about governance in general, not just transparency
− Which documents should be made more available?
− Disclosed decisions
− Do people understand the process?
− How are people on the tender committee selected?
− Is there bench marking against international prices?
− Reports on how conflict of interest are managed
− Policy on recusal from committee decision making • Instead of scoring use traffic light system as this is easier to read
and interpret
• VII3: Not enough to have quantification. Can it
be made available including assumptions?
• Are audit reports made public? Were the
findings acted on?
• Does a formal appeals process exist? Is there a
fixed time period in which an appeal should be
decided?
• Select indicators derived from computer
(procurement) software that help to detect
weaknesses, e.g. measure percent of suppliers
delivering late
PROMOTION
• Is pre-approval officially required? Suggest modifications to
include comparison of product characteristics.
• Formal complaints process: questions should also address
objectivity.
• Is there a committee responsible for monitoring?
• IV3: should be linked to SOP characteristics; Is
pre-approval officially required?
• IV4: assess if key informant is aware of
sanctions.
• IV5: consider sub-questions addressing
Table 7
Results of group work on revision of tool
WHO/EMP/PAU/2014.2
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• Ask more questions about CSOs
• Information should not only be collected from professionals
but also from patients, health workers, and or CSOs for
relevant questions
• Analysis could group responses according to elements of
governance.
• Some M1 could be converted to M2 questions.
objectivity and anonymity of the complaints
system and existence of a mechanism for
whistleblowing
• IV6: With respect to monitoring, involvement
of CSO may improve transparency.
SUMMARY OF KEY RECOMMENDATIONS FOR REVISION
OF THE TRANSPARENCY ASSESSMENT TOOL
� The range of comments suggested multiple areas of review are required
� Technical detail required in document depends on clear articulation of the purpose and scope of
assessment
� Emphasis on defensible scoring system or move away from numeric scores to traffic light summary
� Decisions and consequences should be measured in addition to structures and processes.
� Extend tool from transparency to (elements of) Good Governance (e.g. Participation,
Accountability, Ethics, Efficiency, Rule of Law, etc.)
� Include a wider range of key informants (e.g. private sector, CSOs, etc.)
Introduction │Monitoring and Indicators
The need for indicators that allow measurement of progress of GGM activities in countries has continuously
been expressed over the past years. This session set out to capture the views of national and global experts on
which indicators would be useful and feasible for GGM. Jane Robertson gave a short introduction with regard
to the purpose, characteristics and pitfalls of indicators.
This information together with an initial plenary discussion set the scene for the subsequent group work (same
groups as during tool session in the morning) with the following objective and aspects given for consideration:
to review the nominated section of the transparency assessment and generate a list of candidate indicators
that can be used in a future expert review process.
1. Consider what indicators might be useful to assess improvements or progress in good governance for
the topic area.
2. Rank the indicators according to the usefulness you think they have.
3. Consider the relative value of structure, process and outcome indicators.
4. Discuss whether there is also a need for overall governance indicators as well as
indicators related to specific topics in the assessment instrument.
The results of the group work are summarized in Table 8.
WHO/EMP/PAU/2014.2
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FUNCTION STRUCTURE PROCESS OUTCOME
PROCUREMENT
1. There are explicit procedures for
procurement of pharmaceutical products
2. These explicit procedures are publicly
available
3. There is a tender committee with functions
that are clearly separated from those of the
procurement office.
4. Documented procedures and process for
managing COI exists
5. Documented procedure and process for
appealing decision of tender committee to
an independent body
1. Proportion of individuals involved in
procurement for whom a Conflict of
Interest Declaration is available
2. Proportion of tender committee minutes
where individual members’ conflicts of
interest were discussed and management
actions taken
3. The results of the last procurement office
audit are no older than 12 months and
publicly available (what kind of audit?—
compliance/performance/value for
money?)
4. Percentage of all procurements that were
emergency procurements
5. Meeting held or report submitted to
evaluate poor performing suppliers from
previous procurement cycle.
1. Percentage of medicine
procurements implemented
through a competitive process.
2. List of procurements done without
competitive bidding and rationale
for alternative mechanisms
3. Public sector procurement prices
for a list of key essential medicines
4. Percent of average price of a set of
indicator medicines procured
relative to an established
international benchmark price
SELECTION
1. There is a functioning, publicly available
website publishing the results of decisions about
selection of medicines for the EML or medicines
reimbursement lists. (Comment: If hits measured,
how to set up a reasonable threshold of website
functionality (timeliness of information)? indicator
should reflect if process exists to update the website
every time a decision is made. Having a website may
not correspond to best practice in very poor countries
where access to relevant key information through
mobile phones or professional associations may be
more cost-effective.)
2. There are published criteria for assessing
medicines being considered for the EML or
medicines reimbursement lists.
3. Is selection linked to STG /Are there criteria of
cost-effectiveness, clinical evidence (safety,
efficacy) used to select medicines on the EML?
4. Indicator needed addressing selection
committee (questions VI-5, VI-9)
1. An updated EML or medicines
reimbursement list has been published in
the last 12 months
2. Proportion of EML committee members for
whom conflict of interest declarations have
been completed and submitted to a
register
3. Proportion of EML committee members for
whom conflict of interest declarations have
been completed and submitted to a
register.
4. A list of the members of the national EML
committee that fulfill the ToR
5. Do SOP exist for selecting medicines on the
EML?
1. % of EML medicines on the
hospital formulary
2. Volume and value of medicines
which are on either the EML or the
reimbursement list
3. Number and % of medicines
added/removed from EML or
reimbursement list every year.
4. Consumption of medicines
indicated for the top 10 most
prevalent diseases in the country
5. Consumption of medicines that
represent 80% of value in the
country
6. Cost-effectiveness of medicines on
the list (problem of high cost
medicines)
Table 8
Results of group work – proposed structure, process and outcome
indicators for monitoring governance
WHO/EMP/PAU/2014.2
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FUNCTION STRUCTURE PROCESS OUTCOME
PROMOTION 1. There is a committee or institution (with
clear terms of reference) responsible for
monitoring and enforcing the provisions
on medicines promotion
2. There is an obligation for committee
members to fill in CoI and submit it to a
register
3. The CoI forms have been validated / A
report on CoI analysis is publicly
available
1. Proportion of pharmaceutical
advertisements that did not comply with
regulations in the last 12 months
2. Number (/proportion?) of valid public
complaints received in relation to
unethical promotional practices in the
last 12 months
3. Length of time for processing complaints
4. Proportions of violations investigated
that resulted in sanctions
5. Ratio of validated complaints / received
complaints
REGISTRATION
• Web site with list, decisions with rationale, procedures, criteria, easily accessible
• Register of CoI (should not make this public); how recent, has it changed? How managed?
o List of registered medicines /also applies for re-registration + information about each medicine
o Procedures for application (fairness and procedures) – Checklists, Timelines, Forms
o Committees for assessing applications - Does it exist? ; Qualifications; ToRs; SOPs; Criteria for decision; process for decision
making; the decision itself; Terms (rotations etc.); Provisional registrations (exceptions)
• Process for withdrawal – Pharmacovigilance, Efficacy, Investigation procedures
• Appropriate legislation and implementation exists
• Alignment with policy link- i.e. generics
• Transparency – all information publicly available (/public access to information)
• Legislation - availability not good indicator=> degree to which legislation is implemented and how the process is played out in practice
• Participation - is CSO involved?
• Accountability - sanctions for violations of law procedures etc.
• Ethics- CoI available and degree to which it is implemented (how many breaches noted)
• Efficiency- What proportion of applications processed within the time frame?
• Country specific indicators
WHO/EMP/PAU/2014.2
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The Plenary discussion identified some important issues that need to be considered when developing
indicators for good governance in the pharmaceutical sector:
• While the assessment identifies weaknesses, there was a considerable need for tracking of
progress over time, e.g. stock out rates going down.
• The question was raised on how to translate the assessment tool to a smaller set of indicators
for reviewing progress.
• Discussion also evolved around the meaning attached to indicators. For example, the indicator
for the number of complaints could mean that a sector is well governed because there are
complaints (complaint system works �participation and awareness are present) - or that the
complaints are an indication that the system is poorly governed.
• It was mentioned that GRECO (Council of Europe Group of States against Corruption) uses a peer
review system where countries review other countries.
• It was discussed whether and how institutional corruption (i.e. when the system creates the
opportunity for the individual) could be measured and addressed.
• It was highlighted that performance can only be measured in relation to what is set as a standard
in the country. For example, registration within three months is good in one country but not
another. As standards are usually set at a national level this would mean that country specific
targets should be measured.
• A case was made to include broader, non-function specific indicators as well such as engagement
of CSO in access to medicines campaigns
• There was a concern about the procurement indicator and the need to measure not only
tendering based on price but also the number of bidders to take into account products without
competition. Indicators are needed related to whether the system is detecting collusion, i.e. is
there a process for ex-post analysis of procurements to identify possible collusion. This might not
be part of normal audit procedure.
• The discussion also evolved around the changing role of the essential medicines lists as more and
more procured medicines are not on the essential medicine list.
SUMMARY OF KEY RECOMMENDATIONS FOR INDICATORS FOR MONITORING AND EVALUATION
� There is a constant and strong need and request for indicators to measure progress of GGM
work.
� The group sessions revealed that finding indicators which are both relatively easy to measure
yet are meaningful remains a challenge.
� Each group generated new ideas on what might be good indications of governance in the
pharmaceutical sector.
� The discussion points and list of indicators from each group are valuable contributions to the
process of developing governance indicators for the pharmaceutical sector and will be
considered for future steps.
WHO/EMP/PAU/2014.2
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FOURTH DAY: THURSDAY, 20 MARCH 2014 │ CONFLICT OF INTEREST, TRAINING, CASE
STUDIES
Several group sessions were held to further define training gaps and needs, provide input to the
guidance document on conflict of interest and to develop illustrative case studies.
Exercise 1: Governance in the pharmaceutical sector training gaps and needs
There was agreement that there was a need for training on CoI at different points (e.g. new employees,
senior employees) and for different target audiences (e.g. CSOs, policy makers, board members). A broad
range of training needs was identified including: strategic planning, leadership, boards, anti-corruption,
citizen engagement and participation, ethics and conflict of interest. Wherever possible, training sessions
should be integrated into already existing training programmes. Participants felt strongly about using
appropriate methods for each audience (e.g. e-learning, face-to-face, role plays). Trained CSOs could
support raising awareness on CoI for example, amongst the general population. It was suggested that
WHO support mapping out of needs.
Exercise 2: Input for the guidance document on conflict of interest
Lisa Bero joined the technical working group via Skype and introduced a draft guidance document on
Conflict of Interest that had previously been handed out. She explained the structure and content of the
document to prepare participants for the session on CoI. Three key issues were reviewed in the group
sessions which should inform further revisions to the guidance document.
1. What exists and what is needed
Most countries reported having declaration of interests forms as the basis for assessing potential for
conflict of interests, however the process for managing the conflicts was often noted as insufficient. Thus
the first exercise was to outline what is already existing in countries and what is needed with regards to
the management of conflict of interest.
WHAT EXISTS IN COUNTRY WHAT IS NEEDED
• Declaration form
• Integrity Committee
• Legislation and guidelines to prevent CoI
• Action plan
• Anticorruption commission
• Website
• Requests to declare CoI and for whistle
blowing
• Better enforcement
• Multi-stakeholder committee
• Assessment of areas with high risk for conflict of
interest
• Raising awareness on CoI
• Guidelines to achieve a document at state level
with specifics for health sector
• Special unit to work on CoI
Table 9
What exists & what is needed?
WHO/EMP/PAU/2014.2
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2. What should by disclosed, by whom and how often
The second issue discussed was what should be disclosed, by whom and how often. Two groups
discussed this question in general while the other two debated what the pharmaceutical industry should
disclose and how this could be implemented. The summary of discussion points is presented in Tables 10
and 11. In addition to the question proposed for discussion, some participants pointed out that the
reason for declaring and the benefits of declaring should be more prominently addressed.
Who should disclose? What should be disclosed? When and how often?
Group
1
• Public sector employees
• Consultants
• Members of the committees
and any person involved in
making decisions.
• Any money received related
to employment,
consultation, research.
• Any gift or rewards received.
• Investments
• Potential conflicts
concerning relatives
• Declaration should
occur at the start of
appointment and every
year thereafter.
Group
2
• Advisors, Experts, Professionals
• Committee Members,
Investigators, Inspectors
• Observers/ representatives of
the consumer groups, civil
society, pharmaceutical
industry
• Members of Secretariat.
• Members of scientific reviews &
editors of scientific journals
• Any direct Interest in the
pharmaceutical industry-
e.g. employment,
consultancy, advisory role,
financial, ownership of
patent.
• Indirect Interest in the
pharmaceutical industry-
e.g. principal Investigator,
investigator, individual’s
department or institution
receiving grants or funding
• Declaration should
occur at the start of
appointment.
• Annually or when
changes happen within
the declaration period
What should be disclosed? What is needed to implement this?
Group 3
• Donations
• Gifts
• Training
• Continuing education
• Events and hospitality
• Member of director’s board
• Open discussion with public, private and CSO to
explore possibility of entering into a social contract
to uphold transparency through the declaration of
COI.
• Link up and partner with national anti-corruption
commission/office.
• How much industry paid to public • As industry should disclose mostly for the purpose
Table 11:
What should the pharmaceutical industry disclose and how?
Table 10:
Who should disclose, what, when?
WHO/EMP/PAU/2014.2
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3. High medium and low risk conflicts and strategies to deal with them
The third issue was to categorize potentially, conflicting interests according to influence (e.g. on the
decision or action) and potential strategies to deal with the risk according to the level. The notion of risk
being the potential to affect the decision or action of the individual .
Level of risk Example of conflict Example of strategy to manage
risk
High Member of selection committee is a
consultant to the pharmaceutical
industry.
Remove from selection committee
Medium Member of selection committee has
a cousin who is an employee of the
pharmaceutical industry.
Include in discussion but exclude
from vote
Low Member of selection committee
benefited from one training course
several years previous, sponsored by
the pharmaceutical industry.
None required
Participants noted that the categorization of level of risk was helpful in defining a management strategy.
Exercise 3: Case Studies
During the last working group session every group was asked to think of case studies that describe
conflict of interest situations and how they have been handled. Case studies were collected and will be
written up in a format that can be used in future GGM publications to make COI more tangible.
Group 4
officials/politicians
• How much public officials (+
families) received from the pharma-
industry
• How much industry paid to public
health professionals
• How much health professionals (+
families) received from the pharma-
industry
of cross-checking –> if possible use auditing
information for cross-checks
• Legislation on obliging disclosure of everything
mentioned above (see Table 10, what should be
disclosed)
• Legislation to forbid payments and gifts from
pharmaceutical industry
Table 12:
Examples of categorizing levels of risk to define the management strategy
WHO/EMP/PAU/2014.2
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WAY FORWARD AND CLOSURE OF MEETING
At the end of day four, Deirdre Dimancesco recapped the most important outcomes of the meeting and
summarized next steps:
� Networks
o Draft meeting notes and share with Technical Working Group (TGW) / share presentations
o Keep up momentum on TWG (how to communicate?)
o Improve reach through WHO collaborating centers
� Guidance
o Publish Model Framework
o Finalize 1st draft guidance on Code of Conduct and Conflict of Interest
o Continue to build consensus on revisions to the Transparency Assessment Tool
o Advance work on indicators for monitoring and evaluation building on 15 country study
� Sharing of stories (e.g. of conflict of interest)
o Finalize pending country GGM case studies
� Funds
o Raise funds for 2015 and beyond
� Country GGM roadmaps
o Move forward with implementation support
ACTION POINTS
� Review notes of the meeting
� Share relevant links, reports, etc.
� Support development of new case studies, illustrative examples
� Code of conduct
� Conflict of interest
� Identify opportunities for tangible collaborations with relevant partners
� In countries: continue to advocate for, develop and implement national GGM programmes
� Continue to provide us with your views, support and experience to help us support global
GGM work
The meeting was closed by Dr. Gilles Forte who joined the end of the meeting via skype and thanked
participants for their valuable contributions.
WHO/EMP/PAU/2014.2
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LIST OF PARTICIPANTS
International Consultants
1. Dr. Moses G.P. Chisale
Director Pharmaceutical Operations
Central Medical Stores Trust
Mzimba Street
Private Bag 55
Lilongwe, Malawi
Tel: +265 1753910/912 Fax: +265 1751326
Cell: +265 888841967 E-mail: [email protected] , [email protected]
2. Dr Roth Judd
Independent Advisor on creation, administration, and enforcement of codes of conduct
and conflict of interests laws and disclosure
Madison Wisconsin
3. Dr Didar Ouladi
Coordinator, Public Health Department
Universidad Nur. Casilla 3273 Santa Cruz Bolivia
Tel: +591 3 336 3939 // Mobile: +591 716 65691 Email:
4. Ms Anne Paschke
Consultant
University of Hamburg
5. Taryn Vian, SM, PhD
Associate Professor of International Health
Faculty Director, Global Management MBA-MPH Degree Program
Boston University School of Public Health
801 Massachusetts Avenue, Crosstown, 3rd fl.
Boston, MA 02118
Tel. office 617-414-1447 or cell 857-636-9859
6. Dr Helena Walkowiak,
Principal Technical Advisor
Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program
Management Sciences for Health
+1-703-840-3808
7. Dinsie Williams
Graduate Student w/ Jillian Kohler
Leslie Dan Faculty of Pharmacy &
Munk School of Global Affairs
University of Toronto Toronto Canada
8. Dr Catherine Vialle Valentin
Harvard University Boston Massachusettes
WHO/EMP/PAU/2014.2
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9. Aukje Mantel-Teeuwisse, PhD
Managing director WHO Collaborating Centre for Pharmaceutical Policy and Regulation
Tel: +31 6 22736017 or +31 30 253 7324 (secretariat)
Utrecht University, Faculty of Science
Utrecht Institute for Pharmaceutical Sciences (UIPS) Division of Pharmacoepidemiology and
Clinical Pharmacology PO Box 80 082, 3508 TB Utrecht, The Netherlands
Experts from participating GGM countries
EMRO
10. Adi Nuseirat
JordanFood and DrugAdministration
11. Dr LassaadMsahli
Pharmacist
Member of « Instance Nationale de Lutte Contre la Corruption (INLUCC) »
Economy PHD Student Paris 13 University Cité – La Sorbonne
Tunisia
Tel: 00216 98 324 074
Email: [email protected]
12. Dr Nedia Ben Hamdane
Pharmacy Inspector
Ministry of Health
Tunisia
Tel: 00216 99 323 550
Email: [email protected]
13. Ms Sonia Elkara
Pharmacist
Tunisia
Mob: + 216 25 263 739; + 216 98 658 713
EURO
14. Dr Renata Raichki
Faculty of Pharmacy
University Ss Cyril and Methodius. Vodjnjanska 17
Macedonia
Tel: +3892126032: ext. 122
WPRO
15. Ms Carole BELISARIO Philippinnes
Executive Director, Diaspora for Good Governance (D4G2)
Chairperson, Philippine Procurement Network Philippines
Tel: +632 687 4251 // Tel (dir): +632 706 5819 // Mobile: +63 922 801 4404
16. Dr.Salmah BintiBahri
Director of Pharmacy Practice and Development Division Ministry of Health Malaysia
WHO/EMP/PAU/2014.2
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17. Dr Purevsuren Sodnomtseren
Fourth Health Sector Development Project, National consultant on Drug Safety Governance
Olympic street 2 Government Building 8 Annex behind MOH, room#1Ulaanbaatar-48 Mongolia
Office tel: +976-11314147, Mobile: +976-99107298, 88007805, E-mail: [email protected],
SEARO
18. Somkiat Wattanasirichaigoon
Director
Health Systems Research Institute (HSRI)
4th Floor, National Health Building
88/39 Tiwanon 14 Rd., Muang Nonthaburi, Thailand
Tel: 662 832 9233 Mobile: 668 1648 4135
Fax: 662 832 9201
www.hsri.or.th
WHO
WHO HQ
19. Mrs Deirdre Dimancesco, EMP/PAU
20. Andreas Reis, KER/GHE
21. Dr Jane Robertson, EMP/PAU
EMRO
22. Dr Mohamed Ramzy
EURO
WHO/EMP/PAU/2014.2
32
ANNEX I: Example of Code of Conduct for the pharmaceutical sector
A governmental official or employee whose responsibilities or actions, whether or not explicitly
authorized, relates to more than an insignificant degree to the manufacture, import, registration,
licensing, approval, sale, distribution, promotion, export, or regulation of medicine or a product
purported to be or promoted as a medicine: should not:
1. Use his or her governmental position to obtain financial gain for the official, the official’s family, or
the official’s business.
2. Use his or her governmental position to affect a matter in which the official or the official’s business
or family is financially interested. For example, using position to obtain government approval of a
business permit or an import license for a family business.
3. Solicit or accept a payment, gift, service or other thing of value that could reasonably be expected to
influence the official’s vote, official actions or judgment, or could reasonably be considered as a
reward for the official ’s previous action or inaction.
4. Use nonpublic information in any way that could result in the receipt of anything of value for the
official, for his or her immediate family, or for any other person, if the information has not been
communicated to the public or is not public information.
5. Private interest in public contract.
b. In private capacity enter into a contract which the official is authorized to take some official
action.
c. In public capacity, participate in a contract in which the official has a private interest. i. [a.In the officer's or employee's private capacity, negotiate or bid for or enter into a contract in which the
officer or employee has a private pecuniary interest, direct or indirect, if at the same time the officer or
employee is authorized or required by law to participate in the officer's or employee's capacity as such
officer or employee in the making of that contract or to perform in regard to that contract some official
function requiring the exercise of discretion on the officer's or employee's part; or
ii. b.In the officer's or employee's capacity as such officer or employee, participate, in the making of a
contract in which the officer or employee has a private pecuniary interest, direct or indirect, or performs in
regard to that contract some function requiring the exercise of discretion on the officer's or employee's
part.]
6. Represent or advocate a private interest of the official, the official’s family, official’s business, or for
which the official is paid before a governmental office or entity or before any official or employee
thereof if the interest relates to more than an insignificant degree to the manufacture, import,
registration, licensing, approval, sale, cost, price, distribution, promotion, export, or regulation of
medicine or a product purported to be or promoted as a medicine. Example: A government official meets with an official of another agency in an attempt to influence a decision
or action that will affect a pharmaceutical interest.
7. Limitations on former officials and employees. No former official or employee may for __ [example
24] months accept employment with or compensation from any business or organization for which
the former official held some discretionary authority. Why:
a. So that official will not use position to try to obtain job.
b. So that business will not be able to reward official for an action.
WHO/EMP/PAU/2014.2
33
8. Use of position to obtain unlawful benefit or advantage. Use or attempt to use his or her public
position to influence or gain unlawful benefits, advantages or privileges personally or for others. Example. An official uses his public position to help a pharmaceutical firm illegally avoid taxes or illegally
distribute medicines.
iii. The benefit was already illegal but what is important in this context is that the official used his public position.
iv. Even if the official’s action were already illegal this provision makes the act illegal also under a Code of
Conduct for Good Medicines and consequently a matter for the Code’s administrator.