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Model Framework - World Health Organization
Good Governance for Medicines
Model Framework
Updated version 2014
Good Governance for Medicines:
Model Framework
Updated version 2014
WHO Library Cataloguing-in-Publication Data
Good governance for medicines: model framework, updated version 2014.
1.Drugs, Essential – standards. 2.Pharmaceutical Preparations – standards. 3.Drug Industry –
ethics. 4.National Health Programs. 5.Conflict Interest. I.World Health Organization.
ISBN 978 92 4 150751 6
(NLM classification: QV 736)
© World Health Organization 2014
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Chapter 1. Introduction to the Good Governance for Medicines programme
The problem of corruption
Poor governance and corruption
Types and causes of corruption
Corruption in health
Corruption in the pharmaceutical sector
Background of anti-corruption initiatives
Overview and progress of the Good Governance for Medicines programme worldwide
Chapter 2. Basic components of the model framework
Values-based strategy
1. Key ethical principles
2. Code of conduct
3. Socialization of key ethical principles
4. Promoting ethical leadership
Discipline-based strategy
5. Enforcement of existing anti-corruption legislation
6. Mechanisms for whistleblowing
7. Sanctions on reprehensible acts
8. Transparent and accountable regulations and administrative procedures
9. Collaboration among anti-corruption and transparency initiatives:
strengthening linkages
10. Management, coordination and evaluation
Chapter 3. Process for developing national good governance for medicines framework
Step I. GGM Information meeting and presentation of the national transparency
assessment results
Step II. First national GGM workshop to initiate the country GGM framework
Step III. Second national GGM workshop
Step IV. Third national GGM workshop
Step V. GGM framework training workshop
Step VI. Institutionalizing the national GGM framework and programme
Good Governance for Medicines: Model Framework
Chapter 4. Challenges and successes in developing a national good governance
for medicines framework
Common challenges
Common successes
Chapter 5. Conclusions
Annex 1
Annex 2
Annex 3
Table 1. Types of corruption
Table 2. Example of an action plan (1)
Table 3. Example of an action plan (2)
Figure 1. Examples of unethical practices that can happen throughout the medicines chain 5
Figure 2. WHO model process to implement the Good Governance for Medicines
Figure 3. Complementary GGM strategies
Figure 4. Six steps to achieve good governance for medicines
Boxes of country examples
Box 1. Legal incorporation of the Code of Conduct and declaration of Conflict
of Interests in Mongolia
Box 2. Legislation regarding whistleblowing in Malaysia
Box 3. Sanctions for corruption in the pharmaceutical field: Syrian Republic
Box 4. The Lebanese Regulations on Inspection and Drug Control Box 5. Political will in Jordan
Box 6. Management and coordination of funding the GGM programme in
the Philippines
Box 7. Example of GGM Step I: Jordan
Box 8. Example of GGM Step I: Bolivia
Box 9. Example of GGM Step II/III: Lebanon
Box 10. Example of GGM Step II/III: Philippines
Box 11. Example of GGM Step II/III: Thailand
Box 12. Example of GGM Step IV: Jordan
Box 13. Example of GGM Step V: Malaysia
Box 14. Example of GGM Step V: Mongolia
Box 15. Example of GGM Step VI: Philippines
Box 16. Example of GGM Step VI: Malaysia
Special thanks are extended to Dr Guitelle Baghdadi-Sabeti for her global programme leadership
and valuable contributions in implementing the WHO Good Governance for Medicines (GGM) programme worldwide from 2004–2010, helping to increase transparency in the pharmaceutical sector.
The efforts of the following staff and collaborators are also gratefully acknowledged: Dr Gilles
Bernard Forte, Coordinator of the WHO Medicines Programme and Dr Cécile Macé, Technical
Officer, for providing the current global leadership for the GGM programme; and Dr Mohamed
Ramzy Ismail, Technical Officer, WHO Regional Office for the Eastern Mediterranean, who gave
support to the GGM programme at global level in 2011. All contributed to the finalization of this
Appreciation in memoriam: Dr Eloy Anello was the author of the first draft of this framework in
2007 and made inestimable contributions to the Good Governance for Medicines work. Some elements of his first draft have been included in this current model framework. Dr Anello passed away
in October 2009.
Thanks and acknowledgements go to Dr Didar Ouladi, the author of this document, for continuing the work of Dr Anello and for her valuable contributions to the programme as part of the global
GGM technical team.
Furthermore the following experts and country representatives are hereby recognized for their
contribution to the development of this model framework by giving their valuable insights and feedback on the draft versions and/or sharing the GGM experiences and successful examples in their
Good Governance for Medicines Advisory Group, Global Technical Team
and external reviewers (in alphabetical order)
Dr Dato’Eisah Abdul Rahman, Senior Director of Pharmaceutical Services, Ministry of Health,
Kuala Lumpur, Malaysia (Technical Team)
Dr Mohamed Abdelhakim, Technical Assistant, Essential Medicines and Pharmaceutical Policies,
WHO Regional Office for the Eastern Mediterranean, Alexandria, Egypt (Technical Team)
Ms Dardane Arifaj, former Senior Technical Officer, Pharmaceuticals Essential Medicines and
Technologies Unit, WHO Regional Office for the Western Pacific, Manila, Philippines (Technical
Ms Carole Belisario, Executive Director, Procurement Watch Inc., Manila, Philippines (Technical
Dr Maryam Bigdeli, Programme Officer, WHO Alliance for Health Policy and Systems Research,
Geneva, Switzerland (Technical Team)
Dr Moses Chisale, Regional Adviser, Essential Medicines Program/Division of Health Systems and
Services Development, WHO Regional Office for Africa, Libreville, Gabon (Technical Team)
Dr Kees de Joncheere, Director, WHO Department of Essential Medicines and Health Products,
Geneva, Switzerland
Good Governance for Medicines: Model Framework
Dr Adi Fawzi Nuseirat, Head of Rational Drug Use Department, Jordan Food and Drug
Administration, Amman, Jordan (Technical Team)
Ms Fiona Fleck, News Editor, WHO Department of Knowledge Management and Sharing
(External Reviewer)
Dr Kerstin Leitner, Germany (Former Global Chair, GGM Advisory Group)
Ms Loraine Hawkins, Consultant, Department for International Development, London, United
Kingdom (External Reviewer)
Dr Rasha Hamra, Director Health Education Department, Ministry of Health, Beirut, Lebanon
(Technical Team)
Dr Andreas Seiter, Senior Health Specialist–Pharmaceuticals, World Bank, Washington DC, USA
(External Reviewer)
Dr Chanvit Tharathep, Deputy Permanent Secretary, Office of Permanent Secretary, Ministry of
Public Health, Nonthaburi, Thailand (Technical Team)
Dr Mirza Zafar Ullah, Coordinator, WHO Department of Public Health, Innovation, Intellectual
Property and Trade, Geneva, Switzerland (GGM Advisory Group)
WHO Team and Good Governance for Medicines Phase II and III country
representatives (in alphabetical order)
Dr. Habib Abboud, Director of National Drug Quality Control and Research Laboratories, Ministry
of Health, Damascus, Syrian Arab Republic
Dr Dalia Badawi, Director of Healthcare Planning and Development, Dasman Diabetes Institute,
Dasman, Kuwait
Dr Salmah Bahri, Director of Pharmacy Practice and Development, Ministry of Health, Putrajaya,
Mr Mohamed Bin Shahna, Regional Adviser, Essential Medicines and Pharmaceutical Policies,
WHO Regional Office for the Eastern Mediterranean, Alexandria, Egypt
Ms Munkhdelger Chimedtseren, Head, Division of Pharmaceuticals and Medical Devices,
Ministry of Health, Ulaanbaatur, Mongolia
Ms Valentina Ciumeica, Drug Information Centre, Medicines Agency, Chisinau, Republic of
Dr Victoria De Urioste, Sub Regional Adviser, Biological Medicines, WHO Country Office, La Paz,
Dr Maisaa Fahed Nasr, Drug Inspection Directorate, Ministry of Health, Damascus, Syrian Arab
Dr Melissa Guerrero, Program Director, National Center for Pharmaceutical Access and
Management, Department of Health, Manila, Philippines
Dr Ileana Herrera G., Health Regulation, Ministry of Health, San José, Costa Rica
Dr Niyada Kiatying-Angsulee, Director, Social Research Institute, DSMDP, Chulalongkorn
University, Thailand
Dr Arta Kuli, National Professional Officer, WHO Country Office, Skopje, The former Yugoslav
Republic of Macedonia
Professor Frederic Loko, Directeur des Pharmacies, Ministry of Health, Cotonou, Benin
Dr Alfred Dansou, Assistant Head Manager, CAME, Cotonou, Benin
Dr Nelly Marin, Regional Adviser, Essential Medicines, WHO Regional Office for the Americas,
Washington D.C., United States of America
Dr Sana Naffa, Heath System Strengthening Officer, WHO Country Office, Amman, Jordan
Ms Jesselle Anne M. Navarro, National Center for Pharmaceutical Access and Management,
Department of Health, Philippines
Ms Rosminah binti Mohd Din, Deputy Chief Pharmacist, Kuala Lumpur Hospital, Kuala Lumpur,
Dr Clive Ondari, Coordinator, Medicines Access and Rational Use, WHO Department of Essential
Medicines and Health Products, Geneva, Switzerland
Ms Agnetta Peralta, Director, Bureau of Health Devices and Technology, Department of Health,
Manila, Philippines
Dr Alissar Rady National Professional Officer, WHO Country Office, Beirut, Lebanon
Dr Lembit Rago, Coordinator, Quality and Safety of Medicines, WHO Department of Essential
Medicines and Health Products, Geneva, Switzerland
Professor Renata Slaveska Raichki, Faculty of Pharmacy, Vodnjanska, Former Yugoslav Republic of
Ms Grace Regina, GGM Project Assistant, National Center for Pharmaceutical Access and
Management, Department of Health, Manila, Philippines
Professor Tsetsegmaa Sanjjav, Dean, School of Pharmacy, Health Sciences University, Ulaanbaatur,
Dr Robert Louie So, Medical Officer VII/ Program Manager, National Center for Pharmaceutical
Access and Management, Department of Health, Manila, Philippines
Ms Wilma Teran, Medicines Unit, Ministry of Health, La Paz, Bolivia
Ms Catherina Maria E. Timmermans, Senior Technical Officer, Pharmaceuticals Essential
Medicines and Technologies Unit, WHO Regional Office for the Western Pacific, Manila,
Dr Zahira Tinoco, Chief of the Drug and Clinical Therapeutic Department, Social Security, San
José, Costa Rica
Ms Lucia Turcan, Health Department, Medicines Agency, Chisinau, Republic of Moldova
Dr Gerson Uzquiano, Coordinator/Liaison SEDES Santa Cruz- WHO Office, Santa Cruz de la
Sierra, Bolivia
WHO is grateful to the Australian Agency for International Development, the Federal Ministry for
Economic Cooperation and Development in Germany, the Government of Kuwait, the United Kingdom Department for International Development and the European Community, without whose
generous support the achievements of the Good Governance for Medicine programme described in
this report would not have been possible.
Good Governance for Medicines: Model Framework
Business Environmental Risk Intelligence
Conflict of interest
Corruption Perceptions Index
CSO Civil society organizations
EU European Union
GDP Gross Domestic Product
Good Governance for Medicines programme
International Country Risk Guide
Ministry of Health
MDGs Millennium Development Goals
Organization of American States
OECD Organisation for Economic Co-operation and Development
Partnering Against Corruption Initiative
UNCAC United Nations Convention Against Corruption
WHO World Health Organization
Introduction to the Good Governance
for Medicines programme
The problem of corruption
Corruption has long plagued organized societies. From ancient China
“Corruption is the
to modern-day Europe and North America, governments and socieabuse of entrusted
ties have struggled to contain this cancer. Thousands of years of litpower for private gain.”
erature document the presence of corruption (1). It is found in rich
Definition of corruption
endorsed by Transparency
and poor, developing and developed countries alike, albeit in different
International (2)
forms and magnitude. The corruption that prevails is a clear indicator
of the profound moral crisis that many societies are experiencing. The
social injustices and the poverty that more than half of humanity endures, together with the deterioration of public trust gen“It is the bane of society… an
erated and perpetuated by corruption, have greatly diminished
incurable cancer… a social
the capacity of society’s time-honoured institutions to govern
evil that impedes economic
growth, induces inequality,
human affairs for the common good.
deepens poverty and results in
In essence, corruption is an act by individuals who unlawfully
the exploitation of the poor.”
wrongly use their official position to benefit themselves or
Druk Phuensum Tshogpa Manifesto
2008–2013 (3)
someone related or close to them at the cost of others (4).
Corruption fosters an anti-democratic environment characterized by uncertainty, unpredictability, declining moral values
and disrespect for constitutional institutions and authority. It
reflects a democracy, human rights and governance deficit that
“Corruption can kill – for
negatively impacts on poverty and human security. High levexample, when corrupt
officials allow medicines to
els of corruption can lower the level of human development by
be tampered with, or when
reducing economic growth, increasing poverty and inequality,
they accept bribes that
raising the costs and reducing the quality of services such as
enable terrorist acts to take
place… it is a major obstacle
health and education (5,6).
to achieving our Millennium
Corruption has been a matter of increasing concern for the
Development Goals.”
international development agenda and is recognized as one of
Ban Ki-moon, United Nations
Secretary-General, at the launch of the
the biggest impediments to the world’s efforts to reach the MilStolen Asset Recovery Initiative, 2007
lennium Development Goals (MDGs) (7).
Poor governance and corruption
Empirical research over the past decade has shown convincingly that poor governance, typically
manifested by different forms of corruption, is a major deterrent to investment and economic growth
and has had a disproportionate impact on the poor. In-depth case studies have given form and life
to these quantitative findings and have brought home the reality that corruption is indeed harmful
to the individual, family, community, and society as a whole. Globally, public awareness of the detrimental impact and severity of the problem has increased markedly, as the media, policy institutes,
and nongovernmental organizations worldwide have raised concerns to unprecedented levels.
Good Governance for Medicines: Model Framework
By the late 1990s, the World Bank Institute had developed a comprehensive data set covering
broader governance concerns. This data set covers six dimensions of governance: control of corruption; rule of law; government effectiveness; regulatory quality, voice and accountability; political
stability; and the absence of violence. They provide a picture of the overall state of governance in
a country, and are derived from “several hundred individual variables measuring perceptions of
governance, drawn from 37 separate data sources constructed by 31 different organizations” (8).
Through aggregation of the numerous individual variables, the six indicators tend to have significantly smaller margins of error than any individual measure.
Macro-level econometric-based studies have established a strong causal link between corruption
and, more broadly, poor governance on the one hand and weak private investment and growth on
the other. A number of comparative country studies have also been conducted on combating corruption. While not all are statistically based, they nonetheless provide empirical analyses of reforms and
strategies (9–16). As Mauro (1995) estimates, a one standard deviation increase (improvement) in
the corruption index is associated with an increase in the investment rate by 2.9% of Gross Domestic
Product (GDP) (17). Empirical studies by institutions like the World Bank, the International Monetary Fund and the Asian Development Bank reveal that corruption reduces economic growth in a
country by 0.5-1% a year (18–20).
Types and causes of corruption
The types and causes of corruption are diverse – socially, culturally, economically and politically.
Scholarly research into the causes and consequences of corruption goes back several decades (21).
Although there are many types of corruption, they can be grouped into two broad areas, often
referred to as “petty” and “grand”.
Petty corruption is small-scale corruption practised by lower-level public servants who extort
bribes for their services and who often perceive and justify their corrupt behaviour as a survival
mechanism to compensate for low salaries. Petty corruption can have a profound debilitating effect
on the integrity of a nation and its existence often indicates the practice of grand corruption by
high-level public servants.
Grand corruption is large scale and often involves significant, international bribes and hidden
overseas accounts. It is frequently fostered by exporters from countries (particularly industrialized
countries) who may (knowingly or unknowingly) offer tax breaks for the bribes paid and refuse to
regard the trans-border corruption of public officials as criminal behaviour. This type of corruption
seems to be motivated more by greed than by need. Each broad area incites the other.
Within these two general levels, a variety of types of corruption can fall in either petty or grand
corruption or both. These types of corruption have different causes and risk areas as was established
from the findings of the Corruption Perception Survey 2007, the Corruption Perception Index1 and
strengthened by the enquiry/survey conducted by the Centre for Bhutan Studies, 2009 (22). Some
of the most common of these are shown in the table below.
Corruption in health
Much of the corruption found in the health sector is a reflection of general problems of governance
and public sector accountability (23,24). Corruption reduces the resources effectively available for
health, lowers the quality, equity and effectiveness of health-care services, and decreases the volume
and increases the cost of provided services. A study carried out by the International Monetary Fund
Transparency International has published the Corruption Perceptions Index (CPI) annually since 1995, providing ample
data for those researching corruption. The 2004 update is distinguished by expansion of the index to 146 countries from
133 the previous year. The index is a composite measure of 17 data sources, each comparing overall corruption levels
among countries, from 13 organizations.
Chapter 1. Introduction to the Good Governance for Medicines programme
TABLE 1. Types of corruption
Abuse of power
Weak recruitment system
for leaders, accountability,
mechanisms for detection and
punishment, oversight, as well
as discretionary powers, general
failure in the implementation of
the Code of Conduct and Ethics,
weak media and a tolerant
All levels
All institutions
Uncontrolled discriminatory
power, non-uniform application
of laws, rules and norms, unclear
and lengthy procedures, lack of
information and transparency,
failure to implement Code of
Conduct and Ethics, inefficient
service delivery, social demands
and obligations, systemic flaws.
Services delivery
promotions, transfer
and training
Adjudication of cases
Central agencies
Autonomous agencies
Projects Judiciary
Unlimited desires, lengthy
procedures, unclear rules,
weak supervision, and lack of
checks and balances; general
administration weakness and
poor moral values.
Academic transcripts,
bank guarantees
Bills and other
Government departments
School admissions
Construction and mining
Collusion between
public and private
Non-application of the rule of
rotation, lack of transparency
and accountability, discretionary
powers, weak oversight body,
failure to implement Code of
Conduct and Ethics, inefficient
service delivery, poor moral
values and social ties.
procurement system
Foreign investments
Processing of mining
leases and rights
Hiring of machinery
and vehicles
Procurement section
Licensing divisions
Trade division
Natural resources
regulatory agencies
using data from 71 countries, shows that countries with high indices of corruption systematically
have higher rates of infant mortality (25).
Corruption also affects the availability of funds from health budgets to pay salaries, fund operations and maintenance, leading to lower quality of care and reduced service availability (26). A study
carried out in 2005 in one European country revealed that up to 9.5% of national expenditures on
health care are estimated to be lost due to corruption. Not only does corruption affect health service
delivery but it also has a detrimental impact on population health as shown by increased infant and
child mortality indicators, even after adjusting for income, female education, health spending, and
level of urbanization (27).
Globally, the World Bank (2004) estimates that more than US$ 1 trillion is paid in bribes each
year. The Asian Development Bank found that corruption adds 20–100% to the cost of procuring
government goods and services in several Asian countries. There is evidence that reducing corruption can improve health outcomes by increasing the effectiveness of public expenditures (28).
Research also reveals that the countries that tackle corruption and improve their rule of law can
increase their national incomes by as much as four times in the long run and child mortality can fall
by as much as 75% (22).
Good Governance for Medicines: Model Framework
Corruption in the pharmaceutical sector
Medicines represent one of the largest components of health expenditure. The value of the global
pharmaceutical market has increased steeply over time, at a faster rate than the total health expenditure and even more than the growth of GDP worldwide (29). In 2009, the total value of the pharmaceutical market was estimated at US$ 837 billion (30). Such large amounts of money are an attractive
target for abuse, corruption and unethical practices, and the pharmaceutical sector is particularly
vulnerable to such practices. Resources that could otherwise be used to buy medicines or recruit
much-needed health professionals are wasted as a result of corruption, which can result in prolonged illness and even deaths.
In developing countries, pharmaceutical expenditures and drug procurements account for 20–50%
of public health budgets (23,24). Making essential medicines available for everyone at affordable
prices is a key condition for improving national health indicators. Inadequate provision of medicine
and medical supplies has a direct bearing on the performance of the health system. Corruption in
procurement/distribution of pharmaceutical and medical supplies reduces access to essential medicines, particularly for the most vulnerable groups. WHO estimates (2004) indicate that approximately 2 billion people lack regular access to medicines and that improving access to medicines
could potentially save the lives of 10 million people every year (31).
Corrupt and unethical practices in the pharmaceutical sector can have a significant impact on:
• Health: as the waste of public resources reduces the government’s capacity to provide qualityassured essential medicines, and unsafe medical products proliferate on the market; it also
leads to an increase in the irrational use of medicines;
• Economy: when large amounts of public funds are wasted: it is estimated that pharmaceutical
expenditure in low-income countries amounts to 25–65% of total health-care expenditures.
These significant amounts of money provide potential room for major financial loss;
• Image and trust: as inefficiency and lack of transparency reduce public institutions’ credibility,
erode the trust of the public and donors, and lower investments in countries.
The pharmaceutical sector is wide and complex. Also referred to as the “medicines chain”, it includes
many different steps, beginning with the research and development of new medicines or chemical
entities and ending with the consumption of medicines by the patient and pharmacovigilance. As
shown in the figure below, each step is vulnerable to corruption and unethical practices. The pharmaceutical sector involves professionals from fields such as law enforcement authorities, regulators, physicians, nurses, pharmacists, economists, lawyers and researchers. These can serve in governments,
private pharmaceutical companies, health-care facilities, academia or civil society organizations.
Poorly defined and documented processes, lack of checks and balances, unclear roles and responsibilities, as well as lack of transparency and accountability in any part of the medicines chain will
increase vulnerability to corruption (32). For example: Transparency International estimates that
10–25% of all public procurement spending is fraudulent. Equally, if institutional checks are too
cumbersome and slow down processes, clients may be tempted to offer bribes or gifts “to get things
done”. There are numerous unethical practices that increase the vulnerability of the pharmaceutical
sector to corruption and thus the risks to the health of the population. Among these are:
• Information imbalance between various players such as manufacturers, regulators, healthcare providers and consumers. Information is not shared equally and not all players have the
necessary information to make informed judgments and independent assessments of the quality, safety and efficacy of medicines.
• Counterfeit and unregulated medicines that are of sub-therapeutic value can contribute to
the development of drug resistant organisms, increase the threat of pandemic disease spread,
Chapter 1. Introduction to the Good Governance for Medicines programme
FIGURE 1.Examples of unethical practices that can happen throughout the medicines chain
R&D clinical trials
of interest
Tax evasion
Procurement & import
Falsification of
Source: Baghdadi-Sabeti, G. and Serhan, F. (30).
and severely damage patient health, as they might have the wrong ingredients or include no
active ingredients at all and undermine public trust in important medicines (32,33).
• Unethical drug promotion and conflict of interest among physicians can have negative
effects on health outcomes. Promotional activities and other interactions between pharmaceutical companies and physicians, if not tightly regulated, can influence physicians to engage in
unethical practices (34). Studies have shown that these interactions can lead to non-rational
prescribing (35) and increased costs with little or no additional health benefits. Patients’ health
can be endangered as some doctors enrol patients in trials even though they do not meet the
trial inclusion criteria, or prescribe unnecessary or potentially harmful treatments, in order
to maximize profit (36). Conflicts of interest are also a motivating force generating unethical
behaviour in many other steps of the medicines’ chain. A government official or expert serving on a government committee may put undue pressure or influence on the final decision to
favour a particular company, instead of basing the decision on scientific evidence.
• Bribery and gift giving can be proactively offered or extorted by public servants. For example, suppliers can offer government officials a bribe to register medicines without the required
information or to leave out findings on medicines quality in inspection reports, thus falsifying
evidence. Or government officials may slow down registration procedures in order to put pressure on suppliers into paying a bribe. Other forms of corruption or unethical practices include
theft in the distribution chain for personal use or diversion for private sector resale, or collusion in bid rigging during procurement by providing vendors with confidential and privileged
Development agencies increasingly recognize corruption as the single greatest obstacle to social
and economic development, creating a vicious cycle: bad governance produces corruption and cor-
Good Governance for Medicines: Model Framework
ruption destroys the basis of good governance. Corruption in the public pharmaceutical sector is
endangering the health of millions of people worldwide. There is no easy and quick solution, with
entrenched unethical practices throughout the interrelated stages of the medicines’ chain.
Background of anti-corruption initiatives
Since the mid-1990s, corruption and governance have become legitimate subjects of international
interest and concern. Empirical research has raised public awareness worldwide of the detrimental
impact of corruption on socioeconomic development and its threat to human development (1). Much
of the effort put into public sector reforms during the past 15 years has been aimed in part at reducing corruption. Cross country, perception-based assessments and public opinion research show that
corruption and governance are among the top concerns of people and leaders around the world, and
it is now part of all national and international development dialogues and agendas (37–40).1
Many national, regional, multinational and international organizations have worked very hard
and for many years individually or together on valuable initiatives to establish frameworks, policies,
instruments and other necessary standards to eradicate corruption. These initiatives, which form the
basis for much of the anti-corruption work that is being done today, are supported by a number of
international and multinational agreements and conventions including:
• The Inter-American Convention Against Corruption approved by 34 members of the Organization of American States (OAS) in 1996;
• The Organisation for Economic Co-operation and Development (OECD) Convention on Combating Bribery of Foreign Public Officials in International Business Transactions signed by the
29 members of the OECD, along with five non-members in 1999;
• The African Union Convention adopted an Anti-Corruption covenant signed in March 2003;
• The World Economic Forum Partnering Against Corruption Initiative (PACI) formally launched
by Chief Executive Officers from the Engineering and Construction, Energy and Metals and
Mining Industries in January 2004; and
• The United Nations Convention against Corruption (UNCAC) adopted by the United Nations
General Assembly Resolution 58/4 of 31 October 2003, published in September 2004.
These anti-corruption conventions and agreements are based on international consensus regarding the laws and mechanisms that must be established and implemented at national and international levels to combat corruption. The OECD and OAS Conventions are regional in scope, while
UNCAC is global in reach. The OAS Convention is the first international agreement to
“The adoption of the United Nations Convention
against Corruption will send a clear message
address corruption on all scales, and as such is
that the international community is determined
more ambitious and broader in scope than the
to prevent and control corruption. It will warn
OECD Convention, which focuses primarily
the corrupt that betrayal of the public trust will
on legal measures to address the corrupt busino longer be tolerated. And it will reaffirm the
importance of core values such as honesty, respect
ness practice of bribing foreign public officials.
for the rule of law, accountability and transparency
The OAS Convention directs signatory States
in promoting development and making the world a
to develop and strengthen legal mechanisms
better place for all.”
to “prevent, detect, punish and eradicate” offiKofi Annan, former UN Secretary General. UNCAC foreword,
September 2004 (41)
cial corruption. It differs from the OECD and
The International Country Risk Guide (ICRG), whose data have been used extensively in quantitative research, began
its surveys in 1980. The Business Environmental Risk Intelligence (BERI) began to provide governance-related, survey-based indexes in the early 1980s. The Economist Intelligence Unit began providing related data around this time as
well. For more recent additional sources, see Political Risk Consulting (http://www.asiarisk.com) and the World Economic Forum (http://www.weforum.com).
Chapter 1. Introduction to the Good Governance for Medicines programme
the United Nations anti-corruption conventions because it is “not grounded principally on trade or
economic concerns, but on morality and the need to protect democratic institutions”.
The process of enforcing UNCAC began in December 2005. Over 140 signatory States participated in the UNCAC conferences held in Indonesia in January 2008 and in Qatar in November 2009.
One of the key issues addressed was the need to establish adequate mechanisms to monitor the
enforcement of the Convention, a need shared by the OAS and OECD, although valuable experience
has been gained and is being shared between regions. Systematic monitoring and reporting by civil
society organizations (CSOs) and by the press are essential to promote awareness of corruption
issues and to mobilize the public support and political will necessary for the successful enforcement
of these conventions. Governments must demonstrate to the public the measures and mechanisms
that are being applied to enforce the conventions, to prevent corruption, and to ensure legal cooperation among states.
It is within the context of this movement and its spirit of reform that the Good Governance for
Medicines (GGM) programme draws great support for its activities in promoting good governance
in the pharmaceutical sector, and builds upon the legal framework and mechanisms of enforcement
established by the anti-corruption conventions ratified by the signatory States.
Overview and progress of the Good Governance for Medicines programme
In an attempt to curb corruption in the pharmaceutical systems, the World Health Organization
(WHO) established the Good Governance for Medicines programme (42). The GGM programme
focuses on the fundamental need to have in place laws, regulations, policies and procedures based on
ethical principles to improve the management of pharmaceutical systems and create a corrupt-free
environment to promote access to quality-assured medicines. Its primary emphasis is on prevention
of corruption and on improving systems.
Good governance is an essential factor for sustainable development and economic growth at all
levels and within all sectors of society. There are many definitions of governance and good governance. Yet, there is an emerging general consensus that governance is about managing the resources
and affairs of society to promote the well-being of its members.
In the WHO GGM programme, good governance refers to the formulation and implementation
of appropriate policies and procedures that ensure the effective, efficient and ethical management of
pharmaceutical systems, especially in medicine regulatory and supply systems, in a manner that is
transparent and accountable, and follows the rule of law and minimizes corruption.
General objective
The general objective of the GGM is to contribute to health systems strengthening and prevent corruption by promoting good governance in the pharmaceutical sector.
Specific objectives
i) To raise awareness of the impact of corruption in the pharmaceutical sector and use this awareness to inform the national health policy agenda;
ii) To increase transparency and accountability in medicine regulatory and supply management
iii) To promote individual and institutional integrity in the pharmaceutical sector; and
iv) To institutionalize good governance in pharmaceutical systems by building national capacity
and leadership.
The GGM programme is implemented in a 3-step strategy to institutionalize good governance in
ministries of health, as shown in Figure 2 below:
Good Governance for Medicines: Model Framework
FIGURE 2.WHO model process to implement the Good Governance for Medicines programme
Development of
national GGM
of national GGM
in MOH
Following the launch of the GGM programme in 2004 as a pilot project in four countries, the
programme has been very successful and currently comprises 36 countries. A detailed description of
the GGM process is provided below.
Phase I
For Phase I, a standardized assessment instrument entitled Measuring Transparency in the Public
Pharmaceutical sector provides the methodology to measure the level of transparency and vulnerability to corruption in key functions of the pharmaceutical system (43). Independent national assessors
evaluate the country’s vulnerability to corruption using the WHO standardized assessment instrument, which focuses on-key functions of the pharmaceutical sector. On completion of the assessment, a report with the findings and recommendations for action is produced, providing a baseline
to monitor the country’s progress over time. The assessment has been conducted in 26 countries and
to date WHO has published the results for 14 countries (44). The country studies as well as transparency monitoring carried out in 15 countries in 2010 have produced valuable data enabling ministries
of health and medicines regulatory authorities to identify gaps in the system and develop strategies
to close them (30). For a comparative analysis of transparency assessment reports, please consult
the GGM chapter of the 2011 World Medicines Situation (31) or the individual country assessment
reports available on the GGM website (44).
Phases II
For Phase II, this model framework serves as a guideline for countries to develop their own national
GGM framework, after analysis of the results for the Phase I assessment, based on a nationwide
consultation with key stakeholders and contextualization to national situations. It integrates the
top-down and bottom-up approaches necessary to promote good governance and to reduce corrupt practices. This document, once adapted to the national context, should be officially adopted
to guarantee institutionalization within the legal, ethical and political structure of the ministry of
health (MOH). To date 11 countries have developed their national frameworks: 8 have been officially
adopted (Benin, Bolivia (Plurinational State of), Jordan, Lao People’s Democratic Republic, Lebanon, Malaysia, Thailand and The Former Yugoslav Republic of Macedonia) and 5 have been drafted
(Malawi, Mongolia, Philippines, Republic of Moldova, and Syrian Arab Republic).
Chapter 1. Introduction to the Good Governance for Medicines programme
Phase III
This Phase involves implementation of the national programme and focuses on translating the
guidelines of the Model Framework for GGM into action, institutionalizing the programme and
ensuring that it is fully integrated within the MOH of each country. To date, seven countries are in
phase III of the implementation of GGM (30).
Worldwide, the programme is being increasingly adopted based on an apparent great need in the
subject area. Its preventive and constructive approach is appealing as well as its focus on processes
and systems. The progress of each country from one phase to the next depends on “champions”
that are dedicated to the success of the programme and that have strong ethical leadership and
governance, an active and dedicated GGM team, high political will and support, GGM integrated in
other structures, collaboration with key stakeholders and anti-corruption movements. Challenges
experienced are a passive attitude towards corruption, resistance to change, political instability,
bureaucracy, high rotation of staff, and other priorities.
GGM is also contributing to WHO’s current health systems strengthening by promoting
transparency and leadership, thus preventing corruption in the medicines sector and maximizing
the use of limited resources. GGM is the first global initiative in this field. Countries` interest in
implementing GGM is much higher than anticipated 36 countries currently applying the programme).
The GGM programme focuses on strengthening knowledge, values, attitudes and ethical behaviours
that help each individual raise his/her level of consciousness in order to prevent corruption. It also
helps create legal and social mechanisms that enhance these ethical behaviours. The increase in the
level of consciousness and ethical leadership will help promote higher standards of transparency in
areas such as governance, medicines and technology, information management and recruitment of
human resources. This, in turn, will have an impact on financing and service delivery.
GGM has developed a technical package of tools, guidelines and training materials that provide
universal and internationally recognized standards for governments to adapt and use depending on
their local context. The GGM promotes transparency and leadership in the key medicine areas of
development of national medicines policy, access, quality assurance and rational use of medicines.
This document was prepared for the use of health professionals, decision-makers, managers,
policy-makers and MOH personnel involved in GGM in their countries. It can be used as a guide or
model for their country GGM frameworks and programmes. The successful examples included in
this document are from countries in phases II and III of the programme and are only a few of many
to inspire and help the GGM teams worldwide in their anti-corruption efforts.
Good Governance for Medicines: Model Framework
Basic components of the model framework
The model framework for good governance for medicines is intended to be a guideline and can be
adapted by each country according to their needs. It includes the basic components required by
the GGM programme and steps necessary to achieve these. The basic components of the GGM
framework are divided in two strategies that are complementary:
• Values-based strategy: this strategy attempts to increase institutional integrity by promoting
key ethical principles and moral values as a way of motivating key actors to behave ethically.
It is a bottom-up approach within institutions, based on consensus-building of shared ethical
principles. Participation of key actors in the process of consensus-building generates a sense of
ownership and personal identification.
• Discipline-based strategy: this is essentially a top-down legislative process that establishes
anti-corruption laws, policies and administrative procedures, and attempts to impose compliance
with them through legal sanctions.
Experience with these two strategies has shown that a complementary use of both is required in
order to have a significant impact on establishing ethical practices within institutions and governments. There are 10 basic components of the model framework, each of which belongs to one of the
strategies listed below.
Values-based strategy
Key ethical principles
Code of conduct
Socialization of key ethical principles
Promoting ethical leadership
Discipline-based strategy
Enforcement of existing anti-corruption legislation
Mechanisms for whistleblowing
Sanctions on reprehensible acts based on anti-corruption legislation
Transparent and accountable regulations and administrative procedures
There are also two cross cutting components that need to be integrated within both strategies:
9. Collaboration among anti-corruption agencies, civil society organizations and the private sector
10. Management, coordination and evaluation.
These 10 components are further explained below.
Chapter 2. Basic components of the model framework
FIGURE 3.Complementary GGM strategies
Proposed components for National GGM Frameworks
Values-based approach
Key ethical principles
 Investigation of the truth
 Establishment of justice
 Service to the common good
 Accountable trusteeship
 Unity in diversity
Code of conduct
Socialization programme
Promotion of ethical leadership
Discipline-based approach
5. Enforcement of established anti corruption legislation
6. Whistle-blowing mechanism
7. Sanctions on reprehensible acts
8. Transparent and accountable
regulations and administrative
9. Collaboration with other GG and AC initiatives
10. Management, coordination and evaluation of GGM programme (Steering Committe
and Task Force)
Values-based strategy
1. Key ethical principles
Cultural diversity tends to generate different nuances of understanding about the meaning of ethical
principles and moral values. Nonetheless, there are relatively high degrees of consensus on their relevance and importance in addressing the issue of corruption. This consensus is the basis of the key
ethical principles of the GGM programme. Each key ethical principle has a set of moral values that
are seen more clearly when practising the capabilities of ethical leadership. Five key ethical principles
were selected through consultation and consensus as those that would help address the prevailing
weaknesses that create vulnerability to corruption, i.e.:
• Investigation of the truth: Independent investigation of the truth, based on facts and evidence, requires detachment from all previously acquired knowledge, concepts, ideas or prejudices. Individuals must be able to strive to see with their own eyes and to know from their own
knowledge, analysing and evaluating information that is presented. Then, whether the new
information, concepts, or principles are accepted, partially accepted, with reserved judgment
or rejected, they will be able to give a coherent explanation supporting their action. This is
the basis for trust, integrity and honour – for both the individual and society. Additionally, it
requires consistence between words and actions.
• Establishment of justice: Justice relates to the exercise of impartial judgment in determining
the truth of facts and principles in collective decision-making. Fairness refers to justice and
personal moral responsibility for the individual. It requires the application of the two pillars of
reward and punishment.
• Service to the common good: Any person in power should fulfil the ethical imperative to
use his/her official position to serve the public good. True service is characterized by wisdom
and does not create dependency, but rather frees people from it. It does not seek to bind, but to
Good Governance for Medicines: Model Framework
emancipate. It respects the dignity of each person, and its purpose is to empower those who
are served. Therefore, it is not concerned solely with satisfying the immediate needs of the
members of the organization or community, but rather with assisting each member to develop
the capabilities needed in order to contribute to personal material, intellectual and spiritual
well-being and that of the family, the organization, and the community. Selfless leadership
implies detachment from the expectation of recognition from others as a reward for services
offered and resisting the temptation of magnifying the contributions given. Invisible leadership implies giving ample credit to those who share in the work, or the group as a whole.
• Accountable trusteeship: An institution cannot be effective without an adequate degree of
public trust, which is only granted to people and organizations that demonstrate trustworthiness through transparency and responsible management of what is entrusted to them. Public
servants are trustees of public resources and are accountable to the society they serve.
• Unity in diversity: Though actors and stakeholders might be diverse in their backgrounds,
cultures and languages, they need to be united in a shared belief and vision that corruption
is detrimental not only for the individual or for a specific programme but for the society as
a whole. Key actors need to act together to eradicate corruption and use their differences to
enrich the anti-corruption work they are engaged in. Unity in diversity requires a fundamental
capability, which is consultation.
Each of these key ethical principles has a set of values and capabilities that requires ample training in
their proper use. It also requires reflection and change in terms of the mental models or mind frames
that might hinder or enhance their implementation. The GGM programme is elaborating a training
manual that includes various areas that could be used for this purpose.
2. Code of conduct
Some governments have established codes of conduct based on moral values and ethical principles
as a measure to prevent unethical behaviour by public servants in the performance of their duties.
Studies by Transparency International indicate that governments that have established a framework
for good governance based on a code of conduct, ethical principles and other key components of
an integrity system are listed among the 10 countries with very low levels of corruption. There is a
logical and consistent link between values, principles and a code of conduct. The code of conduct
attempts to articulate in concrete terms the application of ethical principles.
3. Socialization of key ethical principles
In the context of this document the term “socialization” refers to the process by which moral values,
ethical principles and a code of conduct can be learnt, internalized, applied and promoted by a group
of key actors until they become fully integrated into the institutional culture. This requires constant
communication strategies and training. For more detail on this, see GGM training materials.
4. Promoting ethical leadership
In the current anti-corruption discourse, increasing mention is made of the importance of leadership
and good governance in promoting reform. It has been aptly stated that the current global leadership crisis is not due to a lack of people wanting to lead, but rather to the lack of people willing to
exercise ethical leadership. It must be emphasized that ethical leadership is not limited to individuals
in positions of authority within an organization, but rather a concept based on the notion of shared
leadership that encourages and enables every individual of an organization and community to exercise this leadership within their sphere of responsibility and influence at whatever level that may be.
Chapter 2. Basic components of the model framework
Discipline-based strategy
5. Enforcement of existing anti-corruption legislation
The GGM programme draws on existing anti-corruption legislation in each county to support the
integrity system and implementation of administrative and technical measures. Thanks to the
activities of the anti-corruption movement and international anti-corruption conventions, there is
an emerging spirit in many countries of reform and a growing receptivity to address the problem
of corruption (Box 1). The objectives of the GGM programme aim to promote the enforcement of
existing legislation, to protect whistleblowers and to sanction those who commit corrupt acts.
An important example is to have an established form that covers different types of conflict of
interest (COI) and to enforce a legal requirement on declaration of interests including sanctions in
case of non-declaration or falsified or incomplete declaration as explained in Annex 1. An example
of a COI Form can be seen in Annex 2.
The Declaration of Conflict of Interests form for external experts of drug registration in the
Health Department is being implemented since 2009. The amendment to the Drug Law
was approved by Parliament in 2010 and incorporated the Conflict of Interest declaration
forms for members of the Drug Committees. The Code of Conduct for Inspectors was
approved by the General Agency for Specialized Inspections director order N370, 2006. The
Code of Conduct for pharmacists was adopted during the first Assembly of the Mongolian
pharmacists in 2006. Registration for a special permission to conduct professional activities
in the medical field and the licensing to import medical equipment and pharmaceuticals can
be completed by using the Licemed website since 2008. The Government has approved the
law for tenders, and all hospitals and other institutions procuring medicines must follow the
specific tender documents.
6. Mechanisms for whistleblowing
A whistleblower is someone who sheds light on something that is hidden. This “hidden” thing is usually a corrupt, fraudulent or illegal act. It has different meanings in different contexts. For GGM, the
concept of whistleblowing is to bring forth that hidden act without being punished or reprimanded.
A dialogue usually follows once a complaint is filed against somebody within an institution to further investigate the allegation. Once the allegation is proven to have merit, the matter is handled
through the courts or through the ombuds system. Most cases of responsible whistleblowing are
courageous acts performed by public servants who place the public interest above personal self-interest and so assume the risks of retaliation in various forms. These risks require that a mechanism
for whistleblowing be set up in order to protect the whistleblower from victimization and retaliation
by those who perform corrupt practices. There mechanisms comprise:
• Internal disclosure within the organization, anonymously, confidentially or openly, by a peer
• External disclosure through a complaint by someone outside the institution. This may be a
supplier/contractor, the private sector, or other stakeholders such as CSOs or academia privy
to the details of the corrupt act. The disclosure can be made openly, confidentially or anonymously. This mechanism requires adherence to a proper procedure in filing a complaint, failing
which it may not be acted upon promptly by the proper officials.
Good Governance for Medicines: Model Framework
• Public disclosure during which the disclosure is acted upon in a forum such as a public hearing.
Usually the media covers such events and, in some cases, also affect the outcome or increase
public interest in the complaint.
The challenge is to choose the mechanism that is right and comfortable for the whistleblower, while
at the same time protect public servants from irresponsible and unethical whistleblowing that could
damage their reputation and career due to false allegations. For this reason there should be rigorous
prerequisite conditions for acceptable whistleblowing. For example, they should only be considered
when they:
deal with serious problems
are supported by unequivocal evidence
have exhausted internal channels
are likely to obtain satisfactory results.
Under the Government Transformation Programme, various initiatives were put in place to
ensure that the fight against corruption was effective. Strategies were formulated on three
focused areas most prone to corruption, namely the regulatory and enforcement agencies,
government procurement and “grand or political corruption”. Whistleblower legislation
passed in 2010, and improved transparency in government contracts, were key components
of this effort. The government is also working to pass legislation to require those suspected
of corruption to be brought to trial within one year. Performance will be assessed using
Transparency International’s Corruption Perception Index.
7. Sanctions on reprehensible acts
The control of reprehensible acts requires the establishment of policies and procedures regarding
the gradation of measures that will be applied in dealing with acts of corruption. The measures are
usually grouped in two basic categories:
a) Internal sanctions implemented by the institution;
b) External legal sanctions implemented by the legal system and law enforcement.
In April 2010, the Government of Syria issued Presidential Decree 24 for the year 2010
on regulation of production and supply of medicines, replacing decree 40 of 1949 and
law 67 of 2001. This new Decree, which now has the power of law, addresses several
recommendations reported in the 2009 assessment of transparency and vulnerability
to corruption in the Syrian pharmaceutical sector. The Decree also includes measures to
control counterfeit pharmaceutical products and sanctions on violators. Sanctions include
5–10 years of hard labour, imprisonment and a minimum fine of 5 million Syrian liras (over
US$ 100 000). If medicinal products have led to death or permanent disability, punishment is
increased to 20 years and a minimum fine of 10 million Syrian liras. The Decree provides the
legal background for MOH inspectors to access pharmaceutical establishments and grants
them judiciary authority in enforcing the related laws.
Chapter 2. Basic components of the model framework
Decisions regarding the type of sanctions to be applied depend on the nature and gravity of the act
of corruption. In general, serious acts of corruption should be dealt with using external measures
implemented by the judicial system and law enforcement. Conventions related to the anti-corruption movement criminalize acts of corruption and propose legal sanctions for such acts. The existing
legal and administrative sanctions in each country should be studied to make sure that they provide adequate deterrence, thus making corruption a “high-risk” and “low-profit” undertaking (i.e.
increasing both the risk of being detected and the likelihood of appropriate punishment thereafter).
8.Transparent and accountable regulations and administrative internal and
external financial audits
Governments have a responsibility to create sound institutional structures, processes, and policies
to reinforce outcomes that promote public welfare. As part of this effort, anti-corruption measures
that include transparent and accountable regulations/procedures, if implemented successfully,
can improve access to medicines, saving public money and the credibility of governments or other
organizations. Governments have two core responsibilities in the pharmaceutical system.
First, they are responsible for regulating the manufacture, distribution, sale, and use of pharmaceutical products, which includes regulating all actors involved in the pharmaceutical sector.
Second, where governments provide drug coverage, public purchasers are responsible for the
selection, purchase, and logistical management of medicines for use through the public health-care
Both roles are of equal importance for good governance in the pharmaceutical system and to
ensure access to essential medicines for the population. Specific regulations and procedures need
to be created or enforced for each vulnerable area. Internal and external periodic auditing of the
financial management of the pharmaceutical sector must also be implemented as a mechanism to
diminish corruption.
Drug control: Strengthening pharmaceutical inspection capabilities centrally and regionally
include: contracting with 18 new pharmacist inspectors; training pharmacist inspectors
locally and abroad; close cooperation with the Division of Research for smuggling at the
Lebanese Customs and the Criminal Investigation Department in the Internal Security Forces;
preventing the retail of smuggled pharmaceutical products or counterfeits; withdrawing
these from the market; informing the relevant authorities (particularly WHO) and publishing
related decisions. Also, pharmaceutical regulations include contributing to an awareness
campaign on smuggled and counterfeit medicines; publishing the cost of medicines on the
web site for pharmacists and citizens; and monitoring compliance with the official price.
As an additional mark approved by its members, the insertion of Lebanese Pharmaceutical
Importers Associations hologram was instituted to ensure an uninterrupted chain of
responsibilities from the producer to the citizen.
Disciplinary audit bureau (financial audit): This administrative court manages the finances
to ensure the safety of public funds and those deposited in the Treasury.
9. Collaboration among anti-corruption and transparency initiatives: strengthening linkages
The GGM programme cannot achieve its objectives without effective collaboration and coordination
of efforts. It is important that the MOH is proactive – from the beginning and at every stage of the
programme – in establishing alliances and strengthening linkages with other agencies that promote
good governance and/or work on the problem of corruption at the local, national and international
Good Governance for Medicines: Model Framework
levels (see Annex 3 for list of possible stakeholders). Clearly the public and private sectors and civil
society must join forces to solve the problem of corruption, thus showing unity in diversity. WHO is a
global public institution that has the mandate to serve its Member States and their MOH throughout
the world. Thus, the GGM programme focuses primarily on the role of the MOH in taking measures
within the public pharmaceutical sector to establish good governance and to prevent corruption.
Collaborative agreements should be established that clearly define roles and responsibilities for
each partner, mechanisms of communication and coordination, and protocols for information and
resource sharing. These agreements can assist in avoiding overlap and the duplication of efforts, and
allow the GGM programme to benefit from advances made by other agencies. Entering into collaborative agreements will require political will and leadership from the MOH and other agencies.
Political will: Obviously, the GGM programme contributes to the objectives of the anti-corruption
movement and at the same time draws valuable support and leverage from its agencies and activities
and from the enforcement of its conventions. The minimum political support required for the success
of the GGM programme consists of official approval of the MOH for the implementation of the
programme in the pharmaceutical sector and of allocation of funds in the MOH annual operating
budget for the sustained operation of the programme.
The MOH and the Jordan Food and Drug Administration has demonstrated commitment and
political will from the beginning of the GGM programme by involving not only the health
sector but several other ministries, senior officials from public and private pharmaceutical
organizations, representatives from consumer groups, local agencies concerned with good
governance and others. It has also worked closely with other good-governance initiatives
in the medicines sector, such as the Medicines Transparency Alliance programme, financing
entities and other global stakeholders to increase good governance.
10. Management, coordination and evaluation
Management, coordination and evaluation of the GGM programme needs to be carried out from
the beginning and during the whole process. It includes improving the management system, fund­
raising and resource mobilization, as well as constant monitoring and evaluation.
a) Improving the management system: The GGM programme initiates a transparency assessment to identify points in the management system of the medicines chain that are vulnerable
to corruption, among other things. The transparency assessment report is formally presented
to the MOH for review and discussion. It provides excellent input for building awareness in the
MOH on the problem of corruption and the measures that can be taken to reduce and to prevent
it in the future. As the focus of the assessment is systems improvement for good governance,
rather than the identification of criminals, the assessment report provides a positive entry point
to address the difficult issue of corruption in a non-threatening manner.
b) Monitoring and evaluation of the GGM programme: The effective coordination, management, monitoring and evaluation of a GGM programme requires a team of trained human
resources and adequate logistical support. If a MOH does not have a system that promotes
transparency and good governance practices, the GGM programme Task Force team should
be given the authority and support necessary to carry out activities pertaining to such a system
that has direct bearing on the GGM programme. In any event, the GGM programme must be
able to respond to the needs of other departments within the MOH, which requires additional
personnel and logistical support. The responsibilities and activities of the Task Force during the
Chapter 2. Basic components of the model framework
first three stages of the GGM programme require a team composed of two types of professionals: one that has expertise in evaluating and managing the medicines chain and another that
has expertise in facilitating the process of socializing key ethical principles and leadership, and
designing and implementing training programmes for personnel in management and leadership positions. Terms of reference should be prepared for this Task Force and ongoing monitoring and evaluation carried out to ensure improvements in addressing the problems.
c) Fundraising and resource mobilization: Initially, it is important for each country to map its
current and future possible donors. Sustainability of the GGM programme requires a thorough
analysis of cost-effectiveness and minimum financial resources. Inclusion of the GGM programme in an annual national budget clearly indicates strong government commitment and
ensures the future institutionalization and sustainability of the programme.
Implementation of the GGM programme in the Philippines is funded both by WHO and the
government budget. Major events such as the GGM awards and the development of the
GGM manuals are at this time funded by WHO, while other activities that are part of good
governance reforms and integrity development initiatives are funded by the Government.
Improvements in procurement and drug management, rational use and access are funded
separately by the Government with support from development partners such as the World
Bank and the European Commission. At this stage of implementation, and the establishment
of the National Center for Pharmaceutical Access and Management – which is taking on the
technical secretariat work for the programme – the majority of the funding will be given by
this office with the support of major initiatives such as the GGM programme from WHO and
Good Governance for Medicines: Model Framework
Process for developing national good governance
for medicines framework
The construction of a framework for Good Governance in the pharmaceutical sector requires
consensus-building through a national consultation process involving all relevant stakeholders.
It also requires adequate training to be able to critically analyse and reflect on all the necessary
elements that should be incorporated in the framework. With the experience of countries that are
currently implementing the GGM programme, this revised and updated process in the development
of a national GGM framework will serve as a guideline for the phases required, especially phases
II and III. It is important to note that the steps can be carried on in a parallel or circular way. Also,
the experience gained by applying the framework will add new elements that each country can
incorporate in updated versions of their framework.
The Model Framework for Good Governance in Medicines has been used by countries that have
initiated Phase II of the GGM programme. Examples of successful development of a national
framework for each country coming from GGM country case studies are summarized in this chapter.
To date eight countries have officially adopted national GGM frameworks, each of which has had its
challenges in its development and implementation. Despite these obstacles, most have persevered
and found creative ways of overcoming barriers.
Figure 4 outlines the steps necessary for developing a national GGM framework.
FIGURE 4.Six steps to achieve good governance for medicines
GGM information meeting and
presentation of the national transparency
assessment results
First national GGM workshop to initiate
country GGM framework
Second national GGM workshop
Third national GGM workshop
GGM framework training workshop
Institutionalizing national GGM framework
and programme
Chapter 3. Process for developing national good governance for medicines framework
Step I: GGM Information meeting and presentation of the national
transparency assessment results
The objective of this step is to give information and share the GGM programme and its three phases
with key stakeholders. In this meeting the results of the Transparency Assessment for Phase I are
presented, reviewed and validated. In this first stage, it is also important to officially nominate both
the Task Force and the Steering Committee.
• Task Force: Members may include as many different key stakeholders as possible at the local,
regional and national levels to ensure that all sides of the issue are taken into account.
• Steering Committee: Members include as many decision-makers at the highest levels as possible, including the Minister of Health.
A date is set for the first national GGM workshop. The Task Force and Steering Committee will
organize and make the necessary arrangements, invitations and agenda for this workshop.
In November 2008 the results of the transparency assessment were presented to key
stakeholders, the MOH and the Jordan Food and Drug Administration. The debate that
resulted extended beyond the health sector to involve others from government, civil society
bodies, and all interested in fighting corruption and ensuring better health for Jordanian
citizens. Thus, the Minister of Health in Jordan officially appointed the following two
1. The Steering Committee of good governance for medicines, which was headed by the
Jordan Food and Drug Administration Director General, officials from the public and
private pharmaceutical sectors holding vital positions in the medicine sector, high-level
policy-makers, and a representative of the consumers group. These were responsible
for the overall establishment, adoption and management of policies and procedures
for the control of reprehensible acts, whistleblowing mechanisms, implementation and
evaluation of the national GGM programme.
2. A Task Force was made up of mid-level professionals from key government
representatives of the pharmaceutical sector, civil society and local agencies concerned
with good governance. Its main tasks included: a) managing the national consultation
process to share results of the national assessment of transparency and vulnerability to
corruption in the public pharmaceutical sector; b) following up recommendations made
in the national assessment reports and by the Steering Committee; and c) coordinating
the development, adoption, and socializing the national ethical framework and code of
In 2007 a national workshop presented the transparency assessment and recommendations
with the participation of key MOH and Ministry of Transparency and Anti-corruption
dignitaries, representatives from the MOH Pharmaceutical Health Unit, national and
local health authorities, public and private pharmaceutical senior officials, academic field
representatives and other key stakeholders. The MOH nominated a Task Force to coordinate
the programme and implement the necessary recommendations.
Good Governance for Medicines: Model Framework
Step II: First national GGM workshop to initiate the country GGM framework
The WHO model GGM framework is presented and studied, followed by training for a Steering
Committee, Task Force and other key stakeholders on the values- and discipline-based strategies
(with their 10 components), on how to integrate these components to address gaps in the system and
on searching the best ways of collaboration. This training is divided in two parts and should include:
Part 1
a) Raising consciousness about the importance of key ethical principles, values and capabilities,
and understanding mind frames or mental models that hinder or enhance these principles.
Failing the necessary time for training, an extra training session should be programmed as soon
as possible before the second national workshop.
b) Discipline-based strategy and its components.
c) Understanding how these strategies together can address vulnerability to corruption in the
medicines chain.
Part 2
a) Forming subcommittees with key collaborators and stakeholders to apply the two strategies to
address vulnerability to corruption found in the national transparency assessment. Each subcommittee should have a Task Force member to ensure proper follow up; a Secretary and Chairperson should also be appointed.
b) Analysis by each subcommittee of a medicines chain area most vulnerable to corruption together
with specific recommendations made by the national transparency assessment in order to develop an action plan to strengthen the area and make it less vulnerable to corruption. Subcommittees will thus need to research existing laws, regulations and legislation for current needs.
c) Identification by subcommittees of key ethical principles and functional mental models that
require reinforcement in order to reduce vulnerability to corruption in their corresponding area.
d) Listing key stakeholders with whom collaboration will lead to the necessary changes.
e) Analysis and inclusion of all activities required to complete this task and describe their description in the corresponding section of the Action Plan together with the responsible institutions or
persons, and the timelines for finishing these activities.
f) Mention of the monitoring and evaluation process or instrument that will be used to follow up
the implementation of this specific task and its frequency (monthly, annually, etc.).
g) Presentation of work done by subcommittees and feedback from the larger group. The secretary
of each subcommittee will take notes on the feedback given by the group at large.
The following tables are examples of how an action plan can incorporate the above tasks for part 2
of Step II.
Chapter 3. Process for developing national good governance for medicines framework
TABLE 2. Example of an action plan (1)
Registration Transparent
Law or Decree
for registration
and import of
Fines or
medicines not
Key ethical
Establishment of
Justice (laws with
sanctions: punishment and rewards)
Key stakeholders
in export/
import of
(transparency by
registering all
medicines available
and making list
available to all)
Public and
private phar- Consensusmaceutical
building with
key stakeholders to draft law
and sanctions
Workshops to
reinforce and
integrate key
principles and
mental models
GGM Task
3 months Evaluate
with GGM
and evaluation
Law in
mental models:
Service to the
common good
Socializing and
promoting law
with all
TABLE 3. Example of an action plan (2)
and market
centrally and
Fines or closure
of establishments that do
not comply
Key ethical
Investigation of the
truth (inspecting
with the purpose of
discovering the
Establishment of
Justice (laws with
sanctions: rewards
and punishments)
(transparency by
inspection results
and list of
medicines, prices
and others)
Functional mental
Service to the
common good
Public and
police force
and other
agencies to
prevent entry
of counterfeit
and substandard medicines
General public
and health
illegal or
Training in
ethical leadership and
smuggled and
4 months Annual
of GGM
and evaluation
alert systems
available list
of approved
facilities and
medicines for
procurers and
Media and
Investigation of the
Good Governance for Medicines: Model Framework
Step III: Second national GGM workshop to socialize the work that began during the first
national workshop by the subcommittees formed, and continued after, to incorporate feedback
given by the group and further research done by each. Additional training can be given in this
workshop, if necessary. At this point, the first draft of the national GGM framework is initiated.
Work is continued by subcommittees after the workshop and shared with the group at large and the
Steering Committee so that they can all give feedback (via e-mail or other means as convenient).
Once all feedback is sent, the Task Force consolidates it into a final document and resends this to all
for final approval.
The working teams in the national workshops studied the model framework carefully and
divided the work among the members. Each was asked to do a literature review to search
what was available in general or specifically in the Lebanese law and policies of the Ministry,
related to a specific area missing in the Transparency Assessment. The focus of the work was
integral, both on the discipline-based strategy (regulations and administrative procedures)
and the values-based strategy. The framework components were rearranged according to
priority. The final framework included all legislations, laws and administrative procedures
related to good governance, sanctions, and mechanisms to promote transparency and the
code of conduct. Moreover, the document covered mechanisms for reporting breaches,
suggested cooperation with other initiatives of good governance, and encouraged
collaboration with institutions that fight corruption via administrative, judicial, social, and
media means.
A national workshop undertaken to develop the GGM framework included the disciplineand values-based strategies by building “accountable systems” through which “accountable
individuals” can work. A personnel order named members of the ethical framework
(equivalent to Task Force) to develop the advocacy mechanism and training programme to
socialize the framework. An agreement was also reached on key principles and core values,
similar to those listed in the model framework. Most components of the framework are also
part of the 22 ‘doables’ of the Integrity Development Plan mandated by the Presidential
Anti-Graft Commission such as the norms of behaviour (code of conduct), whistleblowing
mechanism, gift policy, and public disclosure. These may be customized for medicine
registration, selection and procurement if necessary.
The Thai GGM framework draws from the WHO model framework and integrates a
top-down and bottom-up approach. A national workshop was organized to prepare the
framework. The values-based strategy included the moral values and ethical principles, a
code of conduct, and promotion of moral leadership, while the discipline-based strategy
incorporated a system of whistleblowing, transparent and accountable regulations
and administrative procedures, management, coordination and evaluation of the good
governance programme.
Chapter 3. Process for developing national good governance for medicines framework
Step IV: Third national GGM workshop: This step socializes the final national GGM framework
document with all key stakeholders and receives final approval from the Steering Committee for its
In April 2010, Jordan completed and published its national GGM framework. The document
included methodological goals, expected outputs of the programme, and defined good
governance, its requirements and characteristics. It also included the elements that need
to be in place at the country level such as moral values and ethical principles necessary for
building good governance in the pharmaceutical sector. In addition, it includes international
anti-corruption initiatives and conventions as well as procedures and initiatives carried
out in Jordan. Based on the result of transparency assessment, a work plan was prepared
to guarantee the application of recommendations in phase III. This framework has been
socialized in various encounters.
Step V: GGM framework training workshop: This involves sharing the final published
document with all stakeholders at the local, regional and national levels, accompanied by training
on all components of the framework and how best to use the document for phase III of the GGM
programme in their country.
In November 2009, the Malaysian GGM framework was published, the key components
of which were moral values, ethical principles and the do’s and don’ts for the five areas
in the pharmaceutical sector, namely registration, selection, procurement, inspection
and promotion. Also, various seminars, training workshops and awareness campaigns on
integrity and good governance were carried out throughout the country by hospitals and
institutions alone or in collaboration with other agencies. The Public Service Department
issued brochures entitled ‘My Integrity’ to all public servants. An audit value management
system had been implemented to evaluate the effectiveness of the various programmes
introduced to instil ideal values to the public personnel.
In January 2010, a seminar on “Enhancing the participation of private organizations in the
promotion of the GGM programme and transparency in the health sector” was organized
with the participation of many key stakeholders from different sectors. The seminar’s
purpose was to enhance knowledge and awareness about the GGM programme among
private pharmaceutical organizations; to improve their participation and collaboration
towards GGM; to identify barriers of complying with regulations and rules; and to discuss
challenges and identify further actions for improvement. Also included was training in
ethical leadership capabilities among directors, managers and executives of pharmaceutical
Good Governance for Medicines: Model Framework
Step VI: Institutionalizing the national GGM framework and programme by including
it in the existing MOH guidelines and in the national annual planning and budget, to ensure its
Currently, the National Center for Pharmaceutical Access and Management, which is funded
by the MOH, assumes the technical secretariat work for the GGM programme. The awards
programme is another initiative that institutionalizes transparency and good governance
in regard to the regulation, supply and overall management of medicines in the public and
private sectors. It encourages local government units, national health facilities and the
private sector to develop innovative initiatives that provide models of good governance.
The development of the GGM framework in line with the National Integrity Plan – a
countrywide plan to reduce corruption and increase ethical practices – is among the key
steps taken towards institutionalizing GGM. Successes in this area have been achieved
through a combination of various programmes put in place by the Government, in addition
to the GGM programme, including the Government Transformation Programme and the
national mission for achieving vision 2020 – designed to help Malaysia become a fully
developed nation. Most of the funding is also from government sources.
Chapter 4. Challenges and successes in developing a national Good Governance for Medicines framework
Challenges and successes in developing a national
Good Governance for Medicines framework
The development of the GGM national framework in various countries has experienced common
challenges and successes, some of which are mentioned below.
Common challenges
Political instability and changes in government
Poor understanding of the culture of transparency and good governance
Resistance to change
Access to legislation documents
Maintaining motivation of Task Force experts
Low priority of the Good Governance for Medicines programme for ministries of health
Lack of adequate monitoring and evaluation tools for follow-up
Integrating this programme within existing efforts in the same area given different players and
priorities (for some countries)
Common successes
• Involvement of many different key stakeholders and their commitment from the beginning of
the programme (national and local authorities, public and private institutions, academia, civil
servants, nongovernmental organizations, consumers and others)
• GGM perceived as a catalyst for change
• Increase in level of public awareness about ethical leadership and good governance
• Increase in transparency and ethics of procedures, legislation and practices, thus addressing
gaps encountered in transparency assessment
• Ethical leadership applied and more visibly seen
• Successful collaboration and partnerships
• Information made accessible and available
• Standard operating procedures created in several functions to increase transparency of decision-making processes
Good Governance for Medicines: Model Framework
Corruption in any one of the critical decision points in the pharmaceutical system can be harmful
to a country’s ability to improve the health of its population as it limits access to quality-assured
medicines and reduces the gains associated with their proper use. While corruption affects the entire
population, it is typically the poor who are most susceptible when officials hoard medicines, or waste
resources on the wrong kind of medicines. Good governance is therefore a sine qua non for ensuring
better access to essential medicines. Greater transparency and accountability in the pharmaceutical
system will help to improve access to medicines. Honest assessment of the institutional robustness
at all core decision points in the pharmaceutical system is an initial necessity. Governments need to
know what areas of the system are less than optimal and vulnerable to corruption.
The first step towards stopping corruption in the pharmaceutical sector is to understand its structure, actors, and motivations, and to identify the key points where corruption can occur. Based on
this, priority measures to stop corruption at these points should be identified for the short, medium,
and long-term. Priorities should be based on the extent to which the identified corruption is a threat
to safety and health in the first instance, and secondly, its economic implications. Irrespective of
what priorities are made, transparency and accountability mechanisms are critical at every point in
the pharmaceutical system to encourage movement towards stopping corruption sooner rather than
The development and management of the GGM programme within the pharmaceutical sector
of the Ministry of Health of each country requires ethical leadership for its sustained and effective
operation. There is no easy and quick solution to the problem of corruption in the pharmaceutical
sector. Establishing ethical leadership and good governance throughout the discipline-based components in this sector requires analysis, reflection and systematic work, such as that mentioned in
this framework. It will require investment of public resources for the development and socialization of its components, and the provision of an adequate operational budget for its implementation.
Political will is vital if the required investment is to occur.
A public servant’s faithful application of a model framework and sustained compliance to a code
of conduct requires the development of intrinsic motivation based on a personal commitment to the
underlying ethical principles. This type of commitment empowers and motivates a public servant to
“walk the talk” and to “become the change he seeks to create”.1 Such an approach will require moral
courage to take bold initiatives and to persevere throughout the process of change and to assume the
risks that are required in establishing good governance in the pharmaceutical sector.
Saying attributed to Mahatma Ghandi.
Good Governance for Medicines: Model Framework
Conflict of interest
The reality of human diversity is such that conflicts of interest may exist in any human interaction,
whether at individual, family, organization or national level. An individual may be confronted with
potential, apparent or real conflict of interest in the exercise of his/her professional responsibilities.
There is nothing fundamentally unethical in finding oneself facing a potential conflict of interest.
The manner in which individuals manage the perceived conflict of interest will determine whether
they have been ethical in their decisions and action.
There is an inherent tension between altruism and self-interest. This type of tension can exist in
the interactions between individuals and in some cases between organizations interacting in society. Thus, when a public organization such as a ministry of health (MOH) – whose altruistic mission
is to serve the common good in terms of public health – interacts with a commercial enterprise,
whose mission is to maximize profits for its owner(s), a tension emerges due to the potential conflict
of interest between two types of organizations motivated by very distinct goals. This does not mean
that a commercial enterprise is incapable of expressing altruism and philanthropy, in complement
with a MOH’s mission, but that a conflict of interest could emerge, especially if the means used by
the enterprise to generate profit has proven to be harmful to the common good.
Some social analysts take the position that public service organizations must maintain a distance
from private interests “because an organization like the United Nations is driven, to some extent, by
a set of ethical principles while a business is largely driven by the profit motive and the interests of
shareholders. Tensions and conflicts of interest, therefore, are likely to arise when private interests
exert undue influence over the decision-making processes of a public-interest organization and
engage in what has been called ‘institutional capture” (45).
It is generally assumed that the fulfilment of the profit motive is the primary purpose for the
existence of commercial enterprises. The fundamental question is: can a non-profit public service
institution (such as a MOH) interact with a commercial enterprise in a collaborative relationship
by means of which both entities can fulfil their missions without any apparent or real conflicts of
interest that could be detrimental to either or both entities? If the answer is no, then there would be
no point in developing guidelines for working with the private sector. If the answer is yes, then there
must be ways of structuring the relationship and designing projects with commercial enterprises
that will not jeopardize the interests of a MOH. The next question is how to do it? The capability of
negotiating, structuring and designing conflict of interest-free agreements and interactions needs to
be developed in MOH staff.
Definition of conflict of interest
It is often unclear what is referred to by the term ‘conflict of interest’. More serious than a mere
conflict of views and opinions, it is a situation that can lead to a penal fault such as corrupt practice, misappropriation of corporate funds, ‘insider dealings’; thus it is important to understand the
meaning of the term and its relevance to a MOH’s collaborative interactions with governments and
commercial enterprises.
Good Governance for Medicines: Model Framework
There are two categories of conflict of interest pertinent to a MOH that require definition: individual and organizational.
Individual (or personal): consists of the types of conflict of interest that arise when a MOH staff
member, in his/her relations and interactions with a commercial enterprise or other private entity,
uses his/her professional position to influence MOH decisions and activities in ways that could lead
directly or indirectly to financial gain and/or other benefits for the staff member or his/her family to
the detriment of the MOH’s interests.
This category has to do with the “abdication of professional duty by an individual staff member
in pursuit of personal gain” (46). If the employee chooses to abdicate official responsibility to take
advantage of the situation for personal gain this would be a clear conflict of interest, which could
lead to a penal fault. The responsibility for the types of conflict of interest in this category falls primarily on the shoulders of the MOH employee. However, if the employee does not take advantage
of the situation, this does not mean the issue of conflict of interest is eliminated. In this case, the
MOH is responsible as an institution (legal entity) to establish and implement principles, guidelines
and procedures that effectively manage and eliminate potential situations of conflict of interest from
its internal organizational environment and from its collaborative interactions with other entities.
Institutional (or organizational): consists of the types of conflict of interest that arise when a MOH
staff member through his/her actions creates a situation in which a MOH enters into a collaborative
interaction with a commercial enterprise or other private entity in a manner that puts the interests
of the outside organization above a MOH’s public health mission and objectives, although the staff
member as such would not gain any personal benefit.
This type of conflict of interest is not necessarily the result of a conscious and deliberate intention
on behalf of the staff member, but rather the result of the staff member’s inexperience and/or naiveté
in dealing with commercial enterprises and other private entities and in negotiating agreements.
A MOH, as a legal institution, is responsible for these types of conflict of interest if it allows such
situations to arise by failing to provide adequate procedures, guidelines, orientation and training
to employees; such guidance would enable them to negotiate more effectively with private entities
through well designed collaborative interactions that would protect and promote the interests and
objectives of a MOH.
This is why institutional policies related to the management of conflict of interest are necessary.
Guidelines, a declaration of interest form, organizational screening procedures, etc. are necessary
means for managing conflict of interest. This Annex 1 for Managing Conflict of Interest facilitates
the orientation and training of MOH employees.
Individual level
The individual types of conflict of interest are more conventional, and those that first come to mind
when considering the issue. The following examples reflect a conscious and deliberate “abdication
of professional duty by an individual in pursuit of personal gain” (2) to the detriment of a MOH´s
Accepting benefits
Influencing peddling
Using MOH resources for private advantage
Seeking and/or accepting post-employment.
Annex 1. Conflict of interest
Institutional level
Some MOH staff members provided the following examples that form the institutional type of conflict of interest. The examples are presented in a generic form without specific details to avoid sensitivities.
• Procurement of products
• In-kind donations
• Donation of funds
• Formulation of treatment guidelines
• Misuse of MOH emblem and programmed logos
• Co-sponsoring of meetings, seminars or conferences
• Attendance of industry personnel in MOH meetings
• Divulging confidential information.
• Endangering public health policy.
Prevention of conflict of interest
The application of the principles, guidelines and approval procedures delineated in this Reference
Manual is the best measure to prevent and manage conflict of interest when interacting with
commercial enterprises. The best means of protection against unwarranted external influences
upon a MOH are the institutional measures established to protect its integrity and independence,
coupled with the ethical and competent management by MOH staff of the various forms of conflict
of interest.
Ultimately, the most effective safeguards against conflict of interest are the MOH staff members
themselves working in an organizational environment and culture that fosters commitment to the
institution and that does not tolerate the ethical laxity that gives rise to conflict of interest. Of course
this implies a continuous process of institutional learning and the development of personnel in key
positions who are willing to exercise ethical leadership in protecting and promoting the best interests of their MOH in its service to the public good.
In public institutions where corruption has become a serious problem, one of the key obstacles
in addressing the issue of conflict of interest is often referred to as a ‘culture of tolerance’. This term
refers to an institutional culture that tolerates the existence of apparent and/or real conflict of interest as a normal state of affairs, in which staff members are not inclined nor encouraged to assume
the moral responsibility to ‘blow the whistle’ when ethical principles are violated. Staff members are
often unaware that their passive tolerance is a form of irresponsibility towards and complicity with
the corrupt practices based on conflict of interest. They fail to recognize that their personal integrity
is at risk, as well as the institutional integrity of the MOH.
In such cases a training programme for staff is necessary to develop awareness and understanding regarding the issue and the capabilities necessary to manage situations of conflict of interest
effectively. The development of the capability to apply ethical principles in the management of collaborative interactions with external agencies is of high priority.
Principles for managing interactions
The following principles provide a framework for managing interactions with commercial enterprises
in a manner that prevents conflict of interest:
• Mission congruence principle: Interactions with a commercial enterprise should lead to public health gains in accordance with the mission and objectives of a MOH, and the gains should
be worthy of and commensurate to the effort involved in establishing and maintaining the
Good Governance for Medicines: Model Framework
• Selective association principle: A MOH should avoid association with onerous and disreputable commercial enterprises. Only those and other private agencies approved by the Office of
Resource Mobilization are acceptable for interaction. The mission of a collaborating commercial enterprise should not be contrary to the public health mission of a MOH, such as those of
the tobacco and the armament industry.
• Non-exploitation principle: A MOH’s name and logo, and/or any other institutional patrimony or asset, should not be subject to exploitation by a commercial enterprise.
• Safeguarding the MOH´s normative functions principle: The integrity and independence
of the normative functions of a MOH must be vigilantly and rigorously protected from any
unwarranted and unethical influence by a commercial enterprise.
• Non-privileged advantage principle: A MOH’s interactions with a commercial enterprise
should not provide the enterprise with a privileged competitive advantage or monopoly. Private sector entities should not be privy to information that is considered by MOH as confidential and/or classified.
• Intellectual property rights principle: Legal arrangements for intellectual property rights
regarding the products of an interaction should be agreed upon and formalized prior to
engaging in a proposed interaction.
• Transparency principle: All interactions and agreements between a MOH and a commercial
enterprise should be transparent and open for disclosure and public scrutiny. The periodic
monitoring of interactions and audit of conflict of interest should be performed to secure and
maintain transparency.
• Conflict of interest disclosure principle: MOH personnel who have a direct role in making
institutional decisions on equipment or drug procurement must disclose to the purchasing
unit, prior to making any such decision, any financial interest they or their immediate family
have in companies that might substantially benefit from the decision. Such financial interests
could include equity ownership, compensated positions on advisory boards, a paid consultancy, or other forms of compensated relationship. The purchasing unit will decide whether the
individual must recuse him/herself from the purchasing decision. All members of the procurement unit and committees should be required to disclose all personal and professional
relationships with industry prior to joining and annually thereafter.
• Accountability principle: MOH personnel with responsibility for decision-making and
actions related to interactions with a commercial enterprise will be held accountable for compliance to the principles, policies, guidelines and procedures, as delineated by the MOH, and
non-compliance should be sanctioned.
These principles should be presented to the proposed collaborator as a MOH’s ground rules of interaction. It should be made clear to the collaborating agency that all interactions with the MOH must
comply with these principles and that they are non-negotiable.
Annex 1. Conflict of interest
Declaration of Interests for WHO Experts
WHO's work on global health issues requires the assistance of external experts who may have interests related to
their expertise. To ensure the highest integrity and public confidence in its activities, WHO requires that experts serving in an
advisory role disclose any circumstances that could give rise to a potential conflict of interest related to the subject of the
activity in which they will be involved.
All experts serving in an advisory role must disclose any circumstances that could represent a potential conflict of
interest (i.e., any interest that may affect, or may reasonably be perceived to affect, the expert's objectivity and independence).
You must disclose on this Declaration of Interest (DOI) form any financial, professional or other interest relevant to the subject
of the work or meeting in which you have been asked to participate in or contribute towards and any interest that could be
affected by the outcome of the meeting or work. You must also declare relevant interests of your immediate family members
(see definition below) and, if you are aware of it, relevant interests of other parties with whom you have substantial common
interests and which may be perceived as unduly influencing your judgement (e.g. employer, close professional associates,
administrative unit or department).
Please complete this form and submit it to WHO Secretariat if possible at least 4 weeks but no later than 2 weeks
before the meeting or work. You must also promptly inform the Secretariat if there is any change in this information prior to,
or during the course of, the meeting or work. All experts must complete this form before participation in a WHO activity can
be confirmed.
Answering "Yes" to a question on this form does not automatically disqualify you or limit your participation in a
WHO activity. Your answers will be reviewed by the Secretariat to determine whether you have a conflict of interest relevant
to the subject at hand. One of the outcomes listed in the next paragraph can occur depending on the circumstances (e.g, nature
and magnitude of the interest, timeframe and duration of the interest).
The Secretariat may conclude that no potential conflict exists or that the interest is irrelevant or insignificant. If,
however, a declared interest is determined to be potentially or clearly significant, one or more of the following three measures
for managing the conflict of interest may be applied. The Secretariat (i) allows full participation, with public disclosure of your
interest; (ii) mandates partial exclusion (i.e., you will be excluded from that portion of the meeting or work related to the
declared interest and from the corresponding decision making process); or (iii) mandates total exclusion (i.e., you will not be
able to participate in any part of the meeting or work).
All potentially significant interests will be disclosed to the other participants at the start of the activity and you will be
asked if there have been any changes. A summary of all declarations and actions taken to manage any declared interests will
be published in resulting reports and work products. Furthermore, if the objectivity of the work or meeting in which you are
involved is subsequently questioned, the contents of your DOI form may be made available by the Secretariat to persons
outside WHO if the Director-General considers such disclosure to be in the best interest of the Organization, after consulting
with you. Completing this DOI form means that you agree to these conditions.
If you are unable or unwilling to disclose the details of an interest that may pose a real or perceived conflict, you must
disclose that a conflict of interest may exist and the Secretariat may decide that you be totally recused from the meeting or
work concerned, after consulting with you.
Date and title of meeting or work, including description of subject matter to be considered (if a number of
substances or processes are to be evaluated, a list should be attached by the organizer of the activity):
Please answer each of the questions below. If the answer to any of the questions is "yes", briefly describe
the circumstances on the last page of the form.
The term "you" refers to yourself and your immediate family members (i.e., spouse (or partner with whom
you have a similar close personal relationship) and your children). "Commercial entity" includes any commercial
business, an industry association, research institution or other enterprise whose funding is significantly derived
from commercial sources with an interest related to the subject of the meeting or work. "Organization" includes a
governmental, international or non-profit organization. "Meeting" includes a series or cycle of meetings.
Within the past 4 years, have you received remuneration from a commercial entity or
other organization with an interest related to the subject of the meeting or work?
1a Employment
1b Consulting, including service as a technical or other advisor
3a Stocks, bonds, stock options, other securities (e.g., short sales)
3b Commercial business interests (e.g., proprietorships, partnerships, joint ventures, board
memberships, controlling interest in a company)
4a Patents, trademarks, or copyrights (including pending applications)
4b Proprietary know-how in a substance, technology or process
5b Have you held an office or other position, paid or unpaid, where you represented interests
or defended a position related to the subject of the meeting or work?
Within the past 4 years, have you or has your research unit received support from a
commercial entity or other organization with an interest related to the subject of the
meeting or work?
2a Research support, including grants, collaborations, sponsorships, and other funding
2b Non-monetary support valued at more than US $1000 overall (include equipment,
facilities, research assistants, paid travel to meetings, etc.)
Support (including honoraria) for being on a speakers bureau, giving speeches or training
for a commercial entity or other organization with an interest related to the subject of the
meeting or work?
Do you have current investments (valued at more than US $10 000 overall) in a
commercial entity with an interest related to the subject of the meeting or work? Please
also include indirect investments such as a trust or holding company. You may
exclude mutual funds, pension funds or similar investments that are broadly diversified
and on which you exercise no control.
Do you have any intellectual property rights that might be enhanced or diminished by
the outcome of the meeting or work?
PUBLIC STATEMENTS AND POSITIONS (during the past 3 years)
5a As part of a regulatory, legislative or judicial process, have you provided an expert
opinion or testimony, related to the subject of the meeting or work,
for a commercial entity or other organization?
6a If not already disclosed above, have you worked for the competitor of a product that is
the subject of the meeting or work, or will your participation in the meeting or work
enable you to obtain access to a competitor's confidential proprietary information, or
create for you a personal, professional, financial or business competitive advantage?
6b To your knowledge, would the outcome of the meeting or work benefit or adversely
affect interests of others with whom you have substantial common personal, professional,
financial or business interests (such as your adult children or siblings, close professional
colleagues, administrative unit or department)?
6c Excluding WHO, has any person or entity paid or contributed towards your travel costs in
connection with this WHO meeting or work?
6d Have your received any payments (other than for travel costs) or honoraria for speaking
publicly on the subject of this WHO meeting or work?
6e Is there any other aspect of your background or present circumstances not addressed
above that might be perceived as affecting your objectivity or independence?
7. TOBACCO OR TOBACCO PRODUCTS (answer without regard to relevance to the
subject of the meeting or work)
Within the past 4 years, have you had employment or received research support or other
funding from, or had any other professional relationship with, an entity directly involved
in the production, manufacture, distribution or sale of tobacco or tobacco products or
representing the interests of any such entity?
EXPLANATION OF "YES" RESPONSES: If the answer to any of the above questions is "yes", check
above and briefly describe the circumstances on this page. If you do not describe the nature of an interest or
if you do not provide the amount or value involved where relevant, the conflict will be assumed to be
Nos. 1 - 4:
Type of interest, question
number and category (e.g.,
Intellectual Property 4.a
copyrights) and basic
descriptive details.
Name of
organization, or
Belongs to you, a
family member,
employer, research
unit or other?
Amount of income
or value of interest
(if not disclosed, is
assumed to be
interest (or
year ceased)
Nos. 5-6: Describe the subject, specific circumstances, parties involved, time frame and other relevant details
CONSENT TO DISCLOSURE. By completing and signing this form, you consent to the disclosure of any
relevant conflicts to other meeting participants and in the resulting report or work product.
DECLARATION. I hereby declare on my honour that the disclosed information is true and
complete to the best of my knowledge.
Should there be any change to the above information, I will promptly notify the responsible staff of
WHO and complete a new declaration of interest form that describes the changes. This includes any change
that occurs before or during the meeting or work itself and through the period up to the publication of the
final results or completion of the activity concerned.
Date: ________________
WHO 850 E LEG (16/06/2010)
Good Governance for Medicines: Model Framework
List of key stakeholders in the pharmaceutical
• Ministry of Health (e.g. health service department, pharmaceutical units, national programmes
for disease control, medical stores, procurement division);
• Medicine Regulatory Authority (registration, inspection, control of promotion, licensing and
clinical trial units/departments, etc.);
• Procurement agencies, importers and distributors both from the private and the public sector
(including tertiary-care hospitals, primary‐care facilities, pharmaceutical brokers and consolidators, hospital pharmacists);
• Members of committees, such as tender committees, therapeutics committees, selection of essential medicines committees, at national and local level;
• Ministries of finance, industry and commerce, customs and importation;
• Local anti-corruption organizations/commission;
• National quality control laboratories;
• Audit departments (internal, external, and state auditors);
• Pharmaceutical industry (multinational and national) and associations;
• Nongovernmental organizations, such as those engaged in health service activities, patient advocacy groups, “watch‐dog” organizations;
• International donor organizations, such as the World Health Organization, the United Nations
Children’s Fund, the United Nations Development Programme, the World Bank and the Global
• Academic institutions (national colleges, state universities and research institutes);
• Professional associations (medical, pharmacy, biochemist associations, etc.);
• Media (if knowledgeable about the pharmaceutical sector);
• Ethics committees, institutional review boards;
• Health insurance funds.
Other important stakeholders
Civil society and the media: Civil society organizations (CSOs), such as Transparency International, Procurement Watch and Oxfam GB, have provided valuable institutional moral leadership in
the anti-corruption movement. They have raised their voices as whistleblowers when necessary and
have played important roles as independent monitors and assessors of the enforcement process of
anti-corruption conventions. CSOs are important in the promotion of values in society related to
human rights, the environment and social well-being, good governance and others. In one sense,
CSOs fulfil the role of moral conscience in society and safeguard society from the abuses of government and the private sector.
Also important is an independent free press and other forms of media such as radio and television that work with the key ethical principle of investigation of the truth. They will help raise public awareness about the gravity of the problem of corruption and keep the public truthfully informed
about the progress or lack of progress in enforcing anti-corruption laws and conventions. They will
Annex 3. List of key stakeholders in the parmaceutical sector
also help advocate for the good governance for medicines programme and other anti-corruption
movements. Informed public opinion can be a powerful force in mobilizing political will for change.
Transnational corporations: By definition, acts of corruption involve two actors: a corruptor and
a corruptee. Both parties are responsible for a corrupt act that they jointly commit. In the bribery of
foreign public officials, the corruptor is generally a transnational corporation and the corruptee is a
public official with discretionary decision-making powers. The initiator of the corrupt action could
be either the representative of a corporation who offers a bribe or a public official who demands the
payment of a bribe. In general the anti-corruption movement addresses both sides of the corruption equation. The Organisation for Economic Co-operation and Development (OECD) Convention
focuses on the criminalization of bribery of foreign officials by European corporations as a deterrent
to this corrupt practice. During the last 10 years, over 150 cases have been investigated under the
OECD Convention and a few have resulted in convictions. Although these numbers may not be
impressive, they do communicate a clear message to the corporate world that the increasing enforcement of the Convention is a reality that will shape the future of international business practices with
which it will have to conform. As anti-corruption conventions have clearly rejected the rule of geographical morality and cultural relativism as justifications for corruption, transnational corporations
can no longer use them to try to rationalize the bribing of foreign officials. Some corporations have
actively joined in the promotion of the OECD Convention and many have developed codes of ethics
and internal mechanisms to monitor and sanction corrupt behaviour by their employees. These
measures represent the beginning of a positive trend that hopefully will gain momentum, although
some critics suspect that these anti-corruption measures taken by transnational corporations are
symbolic and only elements of a marketing strategy to improve corporate image.
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