Good Governance for Medicines

Good Governance for Medicines A Framework for Good Governance in the Pharmaceutical Sector Good Governance Good Health What is Good Governance? Good governance is an essential factor for sustainable development and economic growth at all levels and within all sectors of society. There are many different definitions of governance and good governance, still 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. The term good governance is increasingly used to emphasize the need for governance to operate with due regard for the rule of law and especially in a manner free of corruption. Good governance is participatory, consensus oriented, accountable, transparent, responsive, effective and efficient, equitable and inclusive, and follows the rule of law. A framework for good governance in the pharmaceutical sector WHO Model Framework Definition of Good Governance in the WHO GGM programme In the WHO Good Governance for Medicines (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, in particular medicine regulatory systems and medicine supply systems, in a manner that is transparent, accountable, follows the rule of law and minimizes corruption. Objectives of the WHO GGM Programme The GGM programme focuses on the fundamental need to have laws, regulations, policies and procedures in place to improve management of pharmaceutical systems and create a corrupt-free environment to promote access to good quality medicines. Its primary emphasis is on prevention of future corruption and on improving systems. This leaflet summarizes a policy document, A framework for good governance in the public pharmaceutical sector. It presents a model to help countries draw up their own national framework for promoting good governance, and relates to Phase II of the three-step GGM programme. > Clearance Ministry of Health PHASE I National transparency assessment > PHASE II Development national GGM framework Figure 1 Phases of the GGM programme > PHASE III Implementation national GGM programme Assessment report GGM officially adopted GGM national strategy

Components of a National Framework for GGM The term framework in this document refers to the basic components needed in the GGM programme to address and prevent corruption in the pharmaceutical sector. The framework proposed here integrates two basic strategies necessary to promote good governance and to reduce corrupt practices: The two basic strategies needed to address corruption Values-based strategy: increasing institutional integrity by promoting moral values and ethical principles as a way of motivating public servants to behave ethically (bottom-up by nature) Discipline-based strategy: establishing laws, regulation and administrative procedures for combating corruption and for the management of the pharmaceutical sector, with appropriate punitive consequences for violations (top-down by nature) Participation of key actors and stakeholders in a consultative process will be vital in the review and analysis of the following 10 components of the proposed GGM framework. 1. Framework of Moral Values and Ethical Principles National integrity is a basic prerequisite for the performance of good governance, ensuring ethical practice in the implementation of policies. The WHO model framework for GGM is based on the following moral values: Justice/Fairness - Justice relates to the exercise of impartial judgement in determining the truth of facts and principles in collective decision-making. Fairness refers to justice and personal moral responsibility for the individual. Truth - This is the basis for trust, integrity and honour - for both the individual and society. Service to the Common Good - A public servant should fulfil the moral imperative to use his/her official position to serve the public interest. Trusteeship - A public institution cannot be effective without an adequate degree of public trust, which is only granted to public servants and organizations that demonstrate trustworthiness. 2. Code of Conduct Studies by Transparency International indicate that countries with an established framework for good governance based on a code of conduct, ethical principles and other key components of an integrity system report the lowest 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, describing the expected behaviour of a public servant. A public servant who adheres to a code of conduct would avoid situations of conflicts of interest or other unethical practices that lead to corruption. 3. The Socialization of Moral Values, Ethical Principles and Code of Conduct This refers to the process where these elements can be learned, internalized, applied and promoted by key actors within the pharmaceutical sector of health ministries, until they become fully integrated into the institutional culture. Some key elements of the socialization process include: 2

Consciousness-raising activities targeting key actors about the importance of the issue of corruption and the need to address it. Activities can include information sharing and facilitation of critical-thinking exercises. Transforming dysfunctional mental models assuming that corruption is inevitable and sustaining patterns of unethical practices and an institutional culture that tolerates corruption. Activities can include raising awareness of specific dysfunctional models and facilitating critical-thinking exercises. Development of intrinsic motivation to apply moral values, ethical principles and to observe a code of conduct. Activities can include conferences, workshops, pamphlets explaining the GGM framework and code of conduct, newspaper articles, institutional bulletins, educational videos and posters. BOTTOM-UP 4. Promotion of moral leadership 5. Enforcement of existing anti-corruption legislation 6. Whistle-blowing mechanisms 7. Sanctions on reprehensible acts 8. Improving pharmaceutical management systems TOP-DOWN # # 1. Framework of moral values & ethical principles Justice/fairness Truth Service to common good Trusteeship 2. Code of conduct 3. Programme for socialization of Valuesbased ethical framework and code of conduct Disciplinebased 9. Collaboration between anti-corruption agencies, CSOs and private sector 10. Management, coordination and evaluation of GGM programme (Steering Committee & Task Force) Figure 2 Components of a national GGM framework 4. Moral Leadership Training Highly committed, moral leadership is essential for the effective functioning of an integrity system and the application of a framework for good governance at every level. In the current anti-corruption discourse the vital importance of leadership in promoting reform is increasingly mentioned, with different terms such as "ethical leadership", "values-based leadership" or "principled-based leadership". The underlying concepts behind these terms have a common ground emphasizing the importance of the moral dimension of leadership which is needed for promoting good governance and for fighting corruption. 5. Enforcement of Existing Anti-Corruption Legislation The GGM Programme draws on existing national anti-corruption legislation for support of the integrity system and the implementation of administrative and technical measures. It makes the best use of anti-corruption legisation for the implementation of the GGM programme. 3

6. Whistle-blowing Mechanisms Most cases of responsible whistle-blowing are courageous acts performed by public servants who place public interest above personal self-interest. A mechanism to protect the whistle-blower from retaliation or victimization is required which would also protect public servants from harmful false allegations. 7. Sanctions on Reprehensible Acts The control of reprehensible acts requires policies and procedures regarding the gradation of measures that will be applied in dealing with acts of corruption. These can be grouped: Internal sanctions implemented by the institution External legal sanctions implemented by the legal system and law enforcement. Decisions regarding the type of sanctions to be applied depend on the nature and gravity of the act. In general, serious acts of corruption should be dealt with using external measures. The various Conventions that support the anti-corruption movement criminalize acts of corruption and propose legal sanctions. Existing legal and administrative sanctions should be reviewed to ensure that they provide adequate deterrence - making corruption a high risk and low profit undertaking. 8. Improving Pharmaceutical Management Systems Phase I of the GGM programme consists of a national assessment measuring the transparency of key functions of national pharmaceutical systems. These assessments in reality identify the loopholes in the country, making the regulation and supply systems vulnerable to corrupt practices. The transparency assessment report is then formally presented to the Ministry of Health for review, creating a positive input for discussion. Administrative and technical recommendations are also presented for assessment, approval and implementation. Internal and external auditing of financial management should be in accordance with standards established by government legislation and good auditing procedures. 9. Inter-institutional Collaboration in Anti-corruption Movement The national GGM programme cannot succeed in achieving its objectives without effective coordination of efforts with other agencies promoting good governance and/ or working on issues of corruption. Civil society organizations, such as Transparency International, Procurement Watch, Oxfam UK and others, have provided valuable institutional moral leadership in the anti-corruption movement. Civil society organizations should be encouraged and supported in all these vital areas. An independent free press and other forms of media will raise public awareness of corruption and inform on progress in enforcing anti-corruption Conventions. 10. Management and Evaluation of the GGM Programme The effective coordination, management, and evaluation of a national GGM programme within a Ministry of Health will require a trained human resources team and adequate logistical support. If a MoH does not have an integrity system in place, then the GGM programme task force should be given the authority and support to carry out those activities that have direct bearing on the GGM programme. Capacity should be developed in response to needs of other MoH departments. 4

Climate of Corruption Corruption is the abuse of entrusted power for private gain. Transparency International Corruption impacts on: Health: Waste of public resources reduces government's capacity to provide good quality essential medicines. Unsafe medical products begin to proliferate on the market. Economy: With pharmaceutical expenditure in low-income countries estimated at 25-65% of total health-care spending, corruption represents a major financial loss. Image/Trust: Inefficiency and lack of transparency reduces credibility in public institutions and erodes the trust of the public and donors. Globally more than US$ 4.1 trillion is spent on health services each year and the value of the international pharmaceutical market is estimated at US$ 600 billion. Such large amounts of money are an attractive target for abuse, corruption and unethical practices. For example, Transparency International estimates that 10 to 25% of all public procurement spending is fraudulently siphoned off, and in some countries up to two-thirds of scarce medicine supplies in hospitals are lost to theft and corruption. Corruption in the pharmaceutical sector can take many forms and can happen at any step of the medicines chain. Conflicts of interest are often the motivating force generating unethical behaviour. When a government official or an expert serving on a government committee has a conflict of interest, s/he may put undue pressure and 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. Or else, government officials may slow down registration procedures in order to pressurize 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, collusion in bid rigging during procurement by providing vendors with confidential and privileged information. Favouritism is also common, with officials favouring recruitment and/or promotion of family members (nepotism) or friends (cronyism) instead of basing their decision on professional merit. Development agencies increasingly recognize corruption as the single greatest obstacle to social and economic development, creating an entrenched vicious cycle: bad governance produces corruption and corruption destroys the basis of good governance. Petty and grand corruption feed on each other and both must be addressed and eliminated Petty corruption refers to small-scale corruption practiced by lower-level public servants who may extort bribes for their services and justify their corrupt behaviour as a survival mechanism to compensate for low salaries. This type of corruption can have an upward spiral effect when supervisors and higher-level officials demand a share of the bribes. Petty corruption has a profound debilitating effect on the integrity system of a nation and its existence is often the sign indicting the existence of grand corruption practices by high-level public servants. Grand corruption is large scale and often involves large international bribes and hidden overseas bank accounts. Exporting nations may knowingly, or unknowingly, offer tax breaks for bribes paid and refuse to regard trans-border corruption of public officials as criminal behaviour. This type of corruption seems to be motivated more by greed then need. 5

Constructing a Frame: objective of GGM programme Phase II Construction of a national framework for Good Governance in the public pharmaceutical sector requires consensus building through a consultation process about which components should be included. It also requires the participation of key actors and stakeholders in the following processes: Review and analysis of the moral values, ethical principles and code of conduct proposed in this document, as a reference point for consideration and consultation; Construction of a national framework designed to improve governance and management in the pharmaceutical sector. Existing legislation and other relevant documents should be considered as reference points in this process; Official adoption and promotion of the national GGM framework by the Ministry of Health. The basic need for consensus building makes it advisable to circulate a copy of the established framework for review and revision periodically. This would assure genuine participation and would motivate renewed commitment to applying the framework in the performance of public duties. Conclusion 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 found throughout the interrelated stages of the medicine chain. The ongoing success of a national GGM programme will depend on the collaboration of the public sector, civil society and the private sector to identify, address and prevent corruption. By promoting a corruption-free environment and access to good quality medicines, the Good Governance for Medicines programme is saving lives and improving global health-care provisions. It is also setting a preventive agenda for the future - a future where corruption has nowhere to hide. Key GGM documents: Measuring Transparency in the Public Pharmaceutical Sector: Assessment Instrument. Geneva, World Health Organization. (Working document). Anello E. A Framework for Good Governance in the Pharmaceutical Sector. Geneva, World Health Organization. (In preparation). Good Governance for Medicines: Curbing Corruption in Medicines Regulation and Supply. Geneva, World Health Organization, 2009. Good Governance for Medicines: Assessment Instrument. Geneva, World Health Organization, 2009. Good Governance for Medicines Programme Progress Report, February 2009. Geneva, World Health Organization, 2009. Additional information and key documents: http://www.who.int/medicines/ggm Or e-mail ggminfo@who.int Department of Essential Medicines and Pharmaceutical Policies, WHO, Geneva All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. This document has been produced with the financial assistance of the European Union. The views expressed herein are those of the authors and can therefore in no way be taken to reflect the official opinion of the European Union. WHO/EMP/MAR/2009.5 6 World Health Organization 2009