Jordan Framework For Good Governance in the Pharmaceutical Sector

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2 Jordan Framework For Good Governance in the Pharmaceutical Sector 1

3 Acknowledgement The Steering Committee and Task Force members of the Good Governance in Medicine Programme in Jordan would like to acknowledge the effort, support and guidance provided by WHO HQ and EMRO /EMP, and WHO Jordan, Dr Guitelle Baghdadi (technical Officer), Dr Zafar Mirza (Regional Advisor), Dr Mohamed Ramzi (TO), and Dr Fatima Serhan (TO). Also special thanks to the team behind management, facilitation, and production of this document Dr Sana Naffa (HSS Officer) WHO Jordan, RDU-JFDA staff Dr Adi Nuseirat, and Dr Lubna Qusous. Special appreciation to our missed leader Dr Eloy Anello, who set the stage for and developed the tools and resource documents necessary for successful implementation of the GGM program in many countries, including Jordan. Special thanks to the leaders Dr Mohamed Rawashdeh JFDA DG and Dr Hashim Elzein WR Jordan, who pushed this work forward in Jordan, making it the first country in the region to implement the programme. 2

4 Preface In December 2007, Jordan officially launched the good governance for medicines programme, Supported by the World Health Organization. Jordanian national assessors examined the pharmaceutical sector and identified areas where the system lacks transparency and is most vulnerable to unethical practices. These areas have been seriously considered by the Ministry of Health and the Jordan Food and Drug Administration and have been the subject of extensive debate. The debate 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. Several important developments have been taken place after the assessment as a result of its findings. Conflict of interest forms have been developed and are now required from members of several important committees in the pharmaceutical sector. Standard operating procedures have been created in several functions to further increase transparency of decision making processes. Other developments are taking place as part of the Jordan Food and Drug Administration s continuous strive to maximize outputs and outcomes of their work. Two important committees have been formed by Ministerial decrees and support the work in this area. The GGM steering committee includes a broad range of high level policy makers and is responsible for the overall management, adoption, and evaluation of the national GGM programme. The second is the GGM Task Force which includes mid-level professionals working in pharmaceuticals and other sectors. Its main tasks includes managing the national consultations process necessary to share the results of the national assessments of transparency and vulnerability to corruption in the pharmaceutical sector and develop and implement the national GGM framework for approval by the steering committee. In the realm of transparency, Jordan pharmaceutical sector has participated in two important initiatives, the WHO Good Governance for Medicines Programme and the Medicines Transparency Alliance. These two complimentary initiatives have provided opportunities for interaction with global experiences and credible experts from around the world. They have also provided a platform for the local interaction of a broad range of stakeholders in the health field. Sustaining this interaction is a challenge but one we are willing to address. Improving the health of Jordanian citizens is the interest of all parties and the efforts to do so should involve as many actors as feasible and required. To ensure the best health services and quality of life to the citizens of Jordan, by increasing access to safe effective medication of high quality and at affordable price. in accordance with His Majesty King Abdullah vision improve the quality of life of the citizen requires attention to health care, and the right of every citizen, Man sound reassuring about his health and the health of his children and his family is the human being capable of work and production. On behalf of the Ministry of Health, it is my pleasure to endorse this document and express my government s commitment and enthusiasm to address the gaps identified in the assessment. The Jordan good Governance for Medicines Framework is considered a road map which will help us over the coming years to systematically increase the transparency of our system and decrease it s vulnerability to corrupt or unethical practices. In addition, express our commitment and enthusiasm to move forward to achieve prosperity and a better life for the citizens of Jordan. Minister of Health Dr.Nayef AL-Fayez 3

5 Forward WHO launched the Good Governance for Medicines programme to assist member states in improving the situation of medicines regulation and supply. The programme raises awareness of potential abuse in the pharmaceutical sector and promotes good governance practices with the aim of ensuring better access to essential medicines and less loss through corrupt or unethical practices. The Good Governance for Medicines programme offers a three step technical support package which involves: national transparency assessment; development of a national framework on good governance for medicines; and implementation of a national program me. Twenty six countries globally and 5 countries in the Eastern Mediterranean Region have joined this programme. Jordan has taken a proactive role in the work and is among the first countries to complete and publish its national good governance for medicines framework. This speaks of the political and operational supports which have been pervasive during this phase of national consultations and stakeholder involvement. This document represents a construction of rules, actions and structures which Jordanian stakeholders have committed to maintain and pursue in their efforts to improve access to pharmaceuticals. It is an explicit political and operational agenda which will guide a comprehensive socialization plan and capacity building package aiming at enhancing the integrity of the system and the ethical conduct of the public officials involved in this field. The GGM Framework was developed based on the findings of an assessment of transparency and vulnerability to corruption which Jordanian national assessors published in early The report is available at Areas of vulnerability identified in the assessment have been addressed and methods of improving them are outlined in this framework. The technical cooperation between WHO and the Ministry of Health in Jordan is a longstanding relationship. Since the creation of the Jordan Food and Drug Administration, it has been a leader in improving the situation of pharmaceuticals in Jordan. Many achievements have been made and much work is ahead of us. On behalf of the World Health Organization I would like to state my appreciation of the efforts of the Jordanian Government in continually addressing the health needs of the population and express our organizational commitment to provide the technical support needed for such endeavors. WHO Representative Jordan & Head of Mission Dr Hashim Elzein Elmoussad 4

6 Members of the GGM Steering Committee t Dr. Mohammad Rawashdeh / Director General of Jordan Food and Drug Administration (JFDA) t Major General Dr. Abdel- Latif Woreikat / Director General of Royal Medical Services (RMS) t Dr. Abdul Karim Al-Qudah / Director General of Jordan University Hospital (JUH) t Ph. Maisa Al-Saket / Director General of Joint Procurement Department (JPD) t Dr. Taher Abu El-Samen / Secretary General of the High Health Council (HCC) t Eng. Manal Annani / Director of Administrative Affairs in Ministry Of Health (MOH) t Dr. Mohammad Obeidat / President of Jordan Consumer Protection Society (JCPS) t Ms. Subhiay Maani / President of Drug Stores Owners Association t Ph. Hanan Sboul / Secretary General of Jordanian Association of Pharmaceutical Manufacturers (JAPM) t Ph. Taher Shakhsheer / President of Jordan Pharmacy Association (JPA) t Ph. Laila Jarrar / Director of Drug Directorate (JFDA) t Dr. Hashim Elzein Elmoussad / WHO Representative Jordan & Head of Mission Members of the GGM Task Force t Ph. Adi Nuseirat / JFDA t Ph. Lubna Qusous / JFDA t Ph. Tahseen Abbadi / JFDA t Ph. Lina Bajjali / JFDA t Ph. Nancy Ghabboun / MOH t Ph. Waleed Marahleh / MOH t Eng. Monther Bataineh / MOPSD t Mr. Ahmad Salah / Anti- Corruption Agency t Ph. Wafa Ghanem / JPD t Ph. Khawla Abu Hamoor / JUH t Ph. Samar Khudairi / RMS t Dr. Sana Naffa / WHO 5

7 Content Executive summary Good governance in the pharmaceutical sector The problem of corruption International initiatives to combat corruption Anti-corruption in Jordan The pharmaceutical sector Types of unethical behaviour Impact on the health system and health status Trends of strengthening management and organization of the chain of medicine National integrity system Integrity system in the pharmaceutical sector A Framework for good governance in the pharmaceutical sector Moral values and ethical principles Justice/fairness Truth Service to the common good Trusteeship A Code of Conduct The socialization of an ethical framework and code of conduct Moral leadership Enforcement of existing anti-corruption legislation Whistle-blowing Sanctions on reprehensible acts Improving management system Inter-institutional collaboration in anti-corruption movement Management and evaluation of the GGM programme Role of civil society organizations and the media Role of the private sector institutions Political will Conclusion Annexes Annex A: Terms of reference (TOR) for a GGM Committees Annex B: Ethical principles of justice/fairness Annex C: Ethical principles of truth Annex D: Ethical principles of service to the common good Annex E: Ethical principles of trusteeship Annex F: Capabilities for moral leadership Annex G: Related links

8 Executive summary Globally more than 4.4 Trillions US$ is spent on health services each year. Such large amounts of money are an attractive target for abuse, corruption and unethical practices. In fact, experts estimate that up to quarter of procurement spending on medicine is lost because of corruption and bad governance, and millions of people living in the poorest countries will suffer; as resources that could be used to buy medicines or recruit much needed health professionals are wasted as a result of corruption, which reduces the availability of essential medicines and can cause prolonged illness and even deaths. In 2004, WHO established the Good Governance for medicines (GGM) programme. The programme s goal is to reduce corruption in pharmaceutical systems through the application of transparent accountable administrative procedures and the promotion of ethical practices. The GGM is implemented in a 3-steps approach: Phase I, Measuring transparency in the public pharmaceutical sector provides us with a comprehensive picture of the level of transparency and the vulnerability to corruption in key functions of the pharmaceutical sector. The 2 nd phase includes the development of this document Jordan Framework for Good Governance in the Pharmaceutical Sector after wide consultation with key stakeholders. The 3rd phase is the phase of implementation the national program of good governance and institutionalizing it in the pharmaceutical sector. This framework includes methodological goals, and expected outputs of the program, in which good governance, its requirements and characteristics are defined. In addition, it includes international anticorruption initiatives and conventions as well as procedures and initiatives carried out in Jordan. The results of the transparency assessment were completed in 2007 and have been discussed as well as the functions that can be vulnerable to corruption. Based on this, a work plan has been prepared to guarantee the application of recommendations in the assessment phase. Based on WHO model framework document (reference) and its contextualization to Jordan context, this document defines the elements that need to be in place at country level including; moral values and ethical principles necessary for the building of good governance in the pharmaceutical sector. In addition, the document includes the code of conduct in order to establish ethical standards, norms and basic principles of public service ethics, values and high professional culture of public servants, and to enhance adherence to these standards and norms, values and consolidate the foundations of good practices and good governance. The national team who prepared this document discovered the importance of highly committed leadership for the effective functioning of an integrity system, and the enforcement of existing anti-corruption legislation including effective whistle-blowing mechanisms and sanctions on reprehensible acts, in addition to the importance of working together, coordination among stakeholders and involvement of civil society organizations to raise awareness and enhance ethical principles. The national team is proud of preparing this document where a number of ministries, institutions and Jordanian organizations worked together, in cooperation with the WHO, to issue this document of reference on good governance in the pharmaceutical sector. It is intended that the document shall be integrated and institutionalized into the pharmaceutical sector. This shall be achieved by providing the necessary support to the national team for good governance of medicine, in order to carry out these activities and measure the level of effectiveness of the program in its three phases. Dr Sana Naffa, MD, MScPH 7

9 1. Good governance in the pharmaceutical sector Good governance is an essential factor for economic growth and sustainable development at all levels and within all sectors of society. The social and economic chaos, corruption and violence that proliferate in failed states clearly demonstrate the results that ensure when bad governance prevails. There are many different definitions of governance and good governance in the literature. Although the definitions do not always use the same terminology, 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. There is growing consensus on the major characteristics of Good Governance. Good Governance is participatory, consensus oriented, accountable, transparent, responsive, effective, efficient, equitable and inclusive and follows the rule of law. The establishment of a national integrity system is a basic prerequisite for the performance of good governance. Good policies can be subverted by corrupt practices. Thus, there is need for an effective integrity system to ensure ethical practice in the implementation of policies. An integrity system is based upon a set of elements that ensure that governance reflect the characteristics of good governance and comply with established moral values and ethical principles in formulating and implementing policies and enforcing laws. Concretely, governance is about decision-making processes related to policy formulation and the way policies are implemented to assure effective and ethical management. If decisions are made with respect for the major characteristics of Good Governance and in reference to an established ethical framework, then the implementation of policies in the various sectors (education, health, agriculture, etc.) will lead to social well being and economic progress. In an attempt to curb corruption in pharmaceutical systems, WHO established the Good Governance for Medicines (GGM) programme. The programme s goal is to curb corruption in pharmaceutical systems through the application of transparent accountable administrative procedures and the promotion of ethical practices. The GGM is implemented in a 3-steps approach: WHO has developed a technical package to help countries establish such programmes at the national level. For Phase I, an assessment instrument Measuring transparency in the public pharmaceutical sector provides a methodology to measure the level of transparency and the vulnerability to corruption in key functions of the pharmaceutical systems. For the 2nd phase, a national GGM framework is developed after wide consultation with key stakeholders. In the third phase, good governance of medicine shall be formally adopted in order to apply and follow it up. In the GGM programme, the focus is on the fundamental need to have good laws, regulations, policies and procedures in place to improve the management of the medicine chain and a corrupt-free environment to promote access to good quality medicines. The GGM Programme s primary emphasis is on prevention of future corruption and on improving systems rather than hunt down culprits. 8

10 2. The problem of corruption Corruption is a global scourge not confined to a certain culture or country and is the biggest single obstacle in the way of economic and social development. Corruption has serious economic and political impact reflecting on the status of development, stability and security of the country, especially in light of globalization growth, and rapid technological development. Corruption eats up the nations wealth, impedes investment and reduces quality of basic services received by citizens, such as health and education; it runs counter to democratic values, disrupts the rule of law, and threatens stability and security of societies. Excessive corruption gives a clear indication about the extent of exacerbation of moral crisis that States progress suffers from. In addition, corruption causes deterioration of confidence and general attitudes, and it strongly undermines capacity of community institutions which has been respected with the passage of time while managing human affairs for the good of the public. Corruption takes many forms: it has a supply side (private bribes) and a demand side (public officials). There is grand corruption, involving high-level officials with discretionary authority over government policy, and petty corruption, involving lower-level officials who control the accessibility of public services, such as education and electricity. Ultimately, addressing all aspects of the issue is vital because they feed into one another. Transparency International defines corruption as: the abuse of entrusted power for private gain. Efforts to address the issue of corruption in the public sector have focused on the application of two basic strategies. One strategy has been a legislative reform approach, which establishes laws against corruption with appropriate punitive consequences for violations. This approach is often referred to as the discipline based approach, which attempts to deter corrupt practices through the fear of punishment. The second strategy, often termed the values based approach, attempts to increase institutional integrity by promoting moral values and ethical principles as a way of motivating public servants to behave ethically. Experience with these two strategies has shown that neither is sufficient if used alone and coordinated use of both is required to have a significant impact on establishing ethical practices within an institution. This reflection document focuses on both approaches. It fully recognizes the need to coordinate and integrate such endeavours with existing legislative efforts to establish a legal framework and ethical framework that adequately address the problem of corruption within the context of each country. The assessment instrument for measuring transparency used during phase I and which has been carried out in Jordan by the end of 2007, focuses mainly upon the components related to the disciplinary approach to existing laws, regulations, policies and relevant administrative procedures. The recommendations arising from the transparency assessment should become an integral part of activities planned under phases II and III. The complementary nature and mutual dependence of these two approaches must be taken into account in developing an effective integrity system. 2.1 International initiatives to combat corruption In response to the international consensus on the need to intensify efforts to promote transparency and accountability in the governmental sector, several international organizations have launched various initiatives to promote these concepts. The United Nations is also working to form an international consensus and implement various activities focusing on transparency and accountability of the government sector. Many documents ranging from the United Nations Millennium Declaration to the Charter of the United Nations against corruption have been issued. Theses documents stipulate certain conditions to enhance transparency and accountability of the governmental sector. The following are some of the main documents that have been selected since 2000 as shown below: 2000 / United Nations Millennium Declaration (A/RES/55/2) / Report of the International Conference on Financing Development (A/CONF.198/11) / Report of the World Summit on Financing Development (A/CONF.19/20) / Charter of the United Nations against Corruption (A/58/422). 9

11 1999/2000: comparative political study on the ethics of public service in Africa. 2001: the meeting of a team of experts in financial management, accountability and transparency in Rome. 2002: The issuance of a Manual on the promotion of procedures for civil applications. 2003: The issuance of a training manual on professional ethics of government service in Africa. UNDP has developed Transparency and Accountability Program (PACT) since This program represents a global initiative to support some selected countries through providing technical assistance to improve systems of accountability and financial management. Since 2001 the transparency and accountability program (PACT) has developed the so-called State evaluation in terms of transparency and accountability (CONTACT). It aims to assist governments to conduct self-evaluation of its financial management and work in the fight against corruption. This instrument has been developed jointly by the Department of Economic and Social Affairs of the United Nations (UN DESA) and the World Bank. In addition, the United Nations Development Program (UNDP) has established a special fund for the democratic governance through which the UNDP supports the technical cooperation to achieve accountability, transparency and integrity. At the regional level, the Regional Bureau for Arab States (RBAS) has published two reports about Arab Human Development in 2002 and Arab States also have enthusiastically joined the international effort, and this has been obvious through their participation in many special activities. Including the following: A. Transparency and accountability Project in the public sector in the Arab region. It is a comparative technical study of policies aims to diagnose good practices and gaps in policies and programs, and is a prerequisite for the improvement of transparency and accountability in the public sector. The study was conducted by the Department of Economic and Social Affairs of the United Nations in 2002 and 2003, in cooperation with the United Nations Development Program (UNDP), the Regional Bureau for Arab States (RBAS) and through participation of eleven Arab countries including Jordan. B. Good governance initiative of development service in the Arab countries, stages I and II, Good governance initiative of development service in the Arab countries was launched in February, 2005 at the Dead Sea, Jordan under the patronage of His Majesty King Abdullah II, and presence of 18 Arab countries at the prime minister and ministers level and supported by the Governance Program of the United Nations Development Program, and the Organization of Economic Development and Cooperation (OECD), which was a major turning point towards a comprehensive Arab effort in the fight against corruption, and laid foundations for good governance based on transparency, justice and accountability. C. The Project for the support of the implementation of the United Nations Convention against Corruption in the Arab countries where the Arab will for fighting corruption has been emphasized through the activities of the regional conference held at the Dead Sea (Jordan) from January 2008, which was launched in the presence of the Minister of Justice, government officials, and high-rank representatives from the judiciary authority and the concerned parties regarding the fight against corruption from 19 Arab countries, as well as representatives of civil society, the media, the private sector, and regional and international experts. This conference has been devoted to the commitment of Arab countries to activate their efforts to fight corruption by building their capacity to implement the United Nations Convention against Corruption. D. The initiative of the World Economic Forum of partnership for the fight against corruption, which was officially, launched in January, 2004 by senior executives in engineering, construction, energy, minerals and mining industries. Some of the International Agreements for Anti- Corruption: A. Inter-American Convention against Corruption (ASOC) in B. The United Nations Anti- Corruption Convention which was adopted in the United Nations General Assembly on October 31, 2003, which has been made effective on December 14, It came to express international consensus and effort, and form a collective framework through which an international unified and comprehensive system can be developed in order to confront corruption and build appropriate strategies to prevent and fight its various forms. 10

12 Basically, the conventions against corruption are based on an international consensus and unanimity on views concerning laws and mechanisms that should be established and applied at the national and international levels to fight corruption 2.2 Anti-corruption in Jordan Jordan is one of the leading countries that has been continuously working to provide and develop legislative and institutional framework for fighting corruption through several efforts since the early establishment of the country, which are represented by the following: A. Jordan Constitution of 1952 formed the basis for the major efforts undertaken by the Kingdom to fight corruption. Article (55) gives the Parliament the authority to prosecute government ministers and establishes the Supreme Council that can prosecute ministers for committing bad conduct in duty. The law of prosecution of Ministers No. (35) Of 1952 has been promulgated. The Council has been given authority to prosecute Ministers accused of high treason, abuse of authority (bribery, theft, conflict of interest, exploitation and abuse of authority). B. Law of litigation (No. 16) of Article (3) of this law specifies crimes against the state administration, including those relating to bribery, embezzlement and conflict of interest, in addition to abuse of authority and misuse of duties. C. Inspection and Control Bureau. The bureau was established in 1992 to review administrative procedures of institutions, so as to improve the level of their performance and productivity and to monitor the application of the effective laws and the internal regulations. The bureau has the authority to evaluate plans and programs to ensure that internal monitoring units in various institutions perform their duties in line with government rules and regulations. D. Economic Crimes law. No. (11) Of Article (3) of this law states that the misuse of government funds are crimes that harm the economic situation of the Kingdom, or result in detraction of confidence in its economy. E. Administration of Fighting Corruption. This administration was founded in mid-1996 by a Royal Decree and was assigned to the Department of General Intelligence. It aimed to prevent acts of corruption and take appropriate remedial actions. F. The High Commission for transparency and accountability. This Commission was founded in 2002 and chaired by the Deputy Prime Minister. Then, it was reformed in October 2003 to look at cases of corruption at the highest levels of society and refer them to specialized institutions to deal with them and take corrective actions. G. The National Commission against Corruption and Nepotism. This commission was formed in light of the Royal guidance, and its members were appointed by the prime minister. It was founded in order to carry out guidelines and recommendations stipulated in the document Jordan First in order to contribute to the development process and address the challenges faced by Jordan. H. Anti-corruption Bureau. This Bureau has been established in accordance with a Royal message to the government in 2005, stating that an independent institution be established ; it shall coordinate with the relevant agencies to develop and apply an overall strategy that prevents corruption and protect the society from it in an institutionalized way, to be able to detect corruption in all its forms, including the financial and administrative corruption, to investigate people committing corruption and referring them to the judicial concerned authorities to sentence them to just punishment they deserve, to dry up corruption places, and to make citizens aware of corruption and its serious effects on the development of political, economic and social plans. In the light of this, the Bureau Act No. (62) of 2006 was passed in 2006; The law stipulates the establishment of this Bureau as an independent body, and stipulates all authorities and capacities necessary for its success in order to achieve the desired objectives. 11

13 I. Bureau of the Ombudsman. The bureau was established under a special law in 2008; Article 12 of the law stipulates tasks and authorities of the bureau which are the following: 1) To address complaints concerning any decisions, procedures or practices or refrain from any of these acts made by the government administration or its employees. 2) To recommend administrative procedures to enable citizens benefit from the services provided by the government administration effectively and in a simple manner, by submitting the complaints to the bureau. J. National Center for Human Rights. The most important objectives of this establishment are stipulated in Article (4) of this Act of this center stipulates the following: 1. Enhancement of human rights principles in the Kingdom, and contribution to consolidation of these principles in terms of thought and practice. 2. Enhancement of the democratic process in the Kingdom so as to form an integrated and balanced model based on spreading freedom. 3. Ensuring political pluralism, respect of the rule of law, ensuring the right in economic social and cultural development, which is one of the bases of its establishment. K. The Audit Bureau Act No. (28) Of 1952 was issued in accordance with the provisions of Article (119) of the Jordanian Constitution. The article states The Audit Bureau shall be formed in a law to control the state revenues, and expenditure and disbursement methods. The bureau seeks to achieve the following objectives: 1. To preserve public funds and ensure that it is used in the right way legally and effectively. 2. To develop the management of public resources and verify the authenticity of spending in accordance with the effective laws and regulations. 3. To draw attention to deficiencies of effective financial or administrative legislation, and propose remedies. 4. To cooperate with local, regional and global institutions to improve control actions. 5. To ensure the right application of effective environmental legislation. 6. To ensure that declarations and administrative procedures are done in accordance with the effective legislation. 3. The pharmaceutical sector Globally more than US$ 4.4 trillion is spent on health services each year. The value of the global pharmaceutical market is estimated at over US$ 600 billion. Such large amounts of money are an attractive target for abuse, making the pharmaceutical sector highly vulnerable to corruption and unethical practices. Global estimates conducted recently show that about 10-25% of the medicine being procured could be lost as a result of fraud, bribery and other corrupt practices. This is partly due to high market value of pharmaceutical products, and lack of organization in the pharmaceutical sector in terms of poor specification, documentation of operations, and absence of controls, in addition to lack of transparency that increases corruption liability. It is worth mentioning that drugs move through complex series of production and distribution before they reach needy patients. This increases opportunities of corruption and opens the door wide for the flow of counterfeit products of low quality, thus exposing communities to greater danger. The data obtained from the Jordanian Ministry of Health shows that the total annual national expenditure on the health sector is about 10% of the gross domestic production (GDP), a third of which is spent in medicine. So, these large amounts of money are attractive targets of abuse, thus making the pharmaceutical sector vulnerable to corruption and unethical practices. 12

14 3.1 Types of unethical behaviour The pharmaceutical sector is wide and complex sector - also referred to as the medicine chain - includes many different steps, starting with the research and development of new medicines or chemical entities, and ending with the consumption of medicines by the patient and pharmacovigilance. Each step involves different expertise and each step is vulnerable to corruption. The expertise involved includes the medical profession (e.g. nurses, pharmacists, and physicians), economists, lawyers, and researchers. Those can serve in governments, private pharmaceutical companies, the academia or civil society organizations. The medicine chain includes the following steps: - Research and development of new medicines or chemical entities - Conducting clinical trials - Manufacturing - Registration and Pricing - Licensing of professionals and establishments - Selection of essential medicines - Procurement - Distribution - Inspection of establishments - Prescription - Dispensing - Pharmacovigilance - Control of medicines promotion. Management of conflicts of interest Conflicts of interest are often the motivating force generating unethical behaviour. Three types are frequently encountered in public institutions that tolerate corrupt behaviour, namely when a public servant: Has vested personal interests in a particular company Practices nepotism or cronyism when hiring personnel Receives post-employment benefits from a contracted company. When a government official or an expert serving on a government committee, for example for the registration of medicines, or the selection of essential medicines or tender committee, has a conflict of interest, he/she may put undue pressure and influence on the final decision of that committee to favour a particular company, instead of basing the decision of scientific evidence. Such practices include: * Providing incentives to individuals, such as bribes and gifts in order to speed up services and access to them. *Falsification of safety data and effectiveness resulting from clinical experiments. * Collusion in procurement and pricing. Public institutions often limit their concern about unethical practices to these three forms of corrupt behaviour, by establishing policies and procedures that attempt to prevent these types of conflict of interest. Unfortunately other forms of corrupt practices exist that are sometimes ignored by public institutions, and which becomes part of the unofficial institutional culture. Accepting or extorting bribes, kickbacks and/or gifts: Bribery and gift giving are probably the most common forms of corruption in any sector and the pharmaceutical sector is no exception. They can be proactively offered to or extorted by public servants, for speeding up services or simply making some services happen. For closing an eye on some information or on missing important information, or also to falsify data. Bribes or gifts can be offered at any step of the medicines chain, for example: 13

15 Registration: * By suppliers to government officials to register medicines even though the required information has not been provided * By suppliers to government officials to speed up the process of drug registration * Government officials will slow down registration procedures in order to pressurize suppliers into paying a bribe Selection of essential medicines * By suppliers to selection committee members to include the medicines they manufacture or import on the national essential medicines list. Testing and inspection: * non-inclusion of laboratory testing within reports on the quality of medicine. * Non-inclusion of inspection reports within observations not bound by the adopted manufacturing standards. Control of medicines promotion: * Offering of bribes by suppliers to government officials to approve, for example, an unethical promotion campaign or materials * Offering of bribes by companies to government officials to gain authorization for pseudo clinical trials that are a cover for marketing. Procurement: * To provide bribe to government officials by suppliers to obtain a competitive position in the stages of bidding, study and referring of bids or contracts. * Collusion in the preparation of bids in the process of procurement by providing some suppliers with special and confidential information regarding prices, for example. Distribution * Theft of drugs, whether for personal use or for re-sale in the private sector. * Receiving money in exchange of medicine supposed to be distributed free of charge. The existence of these patterns of corrupt behavior is natural, and this is not limited to the pharmaceutical sector. Unfortunately, all sectors of society are, to some extent, subject to such non-ethical practices. The development of ethical framework for good governance, and the organization of medicine sectors could be beneficial for other sectors. This is similar to the impact of learnt experience from other sectors in terms of confronting ethical issues which might be beneficial for the medicine field. 3.2 Impact on the health system and health status Corruption and unethical practices in the pharmaceutical sector could have a significant impact on health system and the health status of population; some of these are the following: a health impact as the waste of public resources reduces the government s capacity to provide good quality essential medicines, and unsafe medical products proliferate on the market; it also leads to an increase in the irrational use of medicines; an economic impact 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, representing potentially major financial loss; an image and trust impact as inefficiency and lack of transparency reduce public institutions erode the trust of the public and donors, and lower investments in countries. 14

16 3.3 Trends of strengthening management and organization of the chain of medicine To stimulate legislative reforms so as to pass laws against corruption and compromise between the enforcement of procedures and procedures of penalty and strengthening of the discipline approach to deter corrupt practices through the fear of punishment. To encourage the development of standard systems to reduce or prevent violations through the dissemination of standards and special procedures regarding the selection of medical products and staff involvement in the organization and purchase of medicines. Encourage ethical practices through activities aiming to change behavior and train staff by focusing on the value approach. 4. National integrity system The concept of national integrity system as promoted by Transparency International is a holistic approach that draws together various strands and actors that collectively comprise the nation s integrity system and is based on partnerships and coalition-building to contain corruption. No country or society can enhance its ability to reduce corruption to manageable levels and in a sustainable way without the will of the political leadership, the high level of public awareness, support, and the stimulation of the private sector. In many countries, the difficult part of the equation is the development of the will of civil society, overcoming its reluctance, and the promotion of its attempts to play a meaningful role in the formation of the positive environment to activate the integrity system. Therefore, the national integrity system should include the following components: Leadership Public programmes Government reorganization Law enforcement Public awareness The creation of institutions to prevent corruption. 4.1 Integrity system in the pharmaceutical sector The term system integrity, as used in this document, refers to the basic components required by good governance of medicine so as to address the problem of corruption in pharmaceutical sector, which should follow two approaches, Disciplinary approach (top to bottom) and the Values approach (bottom to top) in order to promote good governance and reduction unethical practices. The World Health Organization and other organizations have prepared technical references and manuals, proposing practical measures to improve efficiency and effectiveness of management in the pharmaceutical sector, as well as proposing policies aiming to prevent unethical practices and corruption in all stages when dealing with medicine. However, they did not work effectively within the framework of a clear ethical values and rules of conduct that encourage ethical practices so as to prevent corruption and fighting it. Therefore, the main objective of the program of good governance of medicine is to focus on the prevention of corruption in the future and improve health systems, rather than to track down the culprits. This is done through the formulation and application of appropriate policies and procedures that ensure effective, efficient and ethical management systems of medicine in a transparent and accountable manner that achieve the rule of law, reduce corruption, and enhance access to medicines of good quality for all members of society, thus improving the health and well-being of society. Therefore, all phases of dealing with the drug need to be protected from unethical practices, not only to ensure access to medicines for the patient, but also to ensure that the patient has access to of high-quality and affordable medicines. 15

17 5. A Framework for good governance in the pharmaceutical sector Construction of a national framework for Good Governance in the pharmaceutical sector requires consensus building through the discipline approach (top to bottom) which is based on the development and review anti-corruption laws, policies and administrative procedures, and attempts to impose compliance with them through legal sanctions, values approach (from bottom to top) which starts inside institutions based on consensus building on shared moral values and ethical principles. Participation of public servants in the process of consensus building generates a sense of ownership and personal identification with the moral and ethical framework, which is essential for creating the intrinsic motivation necessary for self-imposed adherence to the norms promoted by the framework. Formulating a national ethical framework requires: 1. Participation of key actors and stakeholders in the review and analysis of the ethical framework and code of conduct proposed in this document, as a reference point for consideration and consultation. 2. Participation of key actors and stakeholders in the construction of a national ethical framework and code of conduct designed to improve governance and management in the pharmaceutical sector. Existing legislation and relevant work done by other agencies should be considered as reference points in this process. 3. Official adoption and promotion by the ministry of health of a national ethical framework and code of conduct for the pharmaceutical sector. This is to ensure genuine participation, stimulate and renew commitment to this framework regarding the performance of public duties, and to ensure its sustainability. So, it is necessary to circulate a copy of the framework set out for search and periodic review, thus promoting accurate understanding of meaning of moral values and rules of conduct and support the issue of fighting corruption. The basic components of an effective integrity system for the GGM Programme are: A. Values approach: 1. A framework of moral values and ethical principles 2. A code of conduct 3. A programme for the socialization of an ethical framework and code of conduct 4. Promotion of moral leadership B. Disciplinary approach 1. Established anti-corruption legislation 2. Mechanisms for whistle-blowing 3. Sanctions on reprehensible acts based on anticorruption legislation 4. Established management procedures, including internal and external financial audits 5. Collaboration between anti-corruption agencies, CSOs and private sector. 6. Management, coordination and evaluation of the integrity system. The first four components on the list are based on the values approach and the remaining six on the disciplinary approach. To be effective in addressing the problem of corruption, an integrity system must integrate both approaches in a coherent and balanced system. The first component on the list is an ethical framework is the heart of the proposed integrity system. 16

18 5.1 Moral values and ethical principles Moral values have to do with what is believed to be good and of primary importance to human civilization, and are often articulated as ideals. Moral values inform judgment by defining right from wrong and good behaviour from bad. Ethical principles are the operational expression of moral values and provide guidance to decision-making and action. Ethical principles are guides to action; they operationalize values and cue behaviour befitting public service. The framework proposed in this document is based on four moral values that are believed to be essential for good governance: justice, truth, service to the common good and responsible trusteeship. These four values were selected because they were identified as core values that directly address prevailing moral weaknesses that create vulnerability to corruption. Under each moral value, basic ethical principles and precepts that are derived from them are listed. Some ethical principles are clearly derived from a specific moral value, while others may have their roots in more than one. The goal of clarifying the ethical reference of principles of conduct is to create self-motivation to ensure sustainability of application, and to enable the government official resist temptations and sliding into triviality of corruption Justice/fairness Justice relates to the exercise of impartial judgment in determining the truth of facts and principles in making decisions that guide action. Justice is based on the two pillars of reward and punishment and is concerned with giving each his or her fair due of reward and/or punishment. The institutions of society should govern by principles of justice. Fairness is the operational expression of justice at the individual level. The institutions of society administer justice on a collective level. The ethical principles of justice/fairness (See annex B) include the following elements: Rule of law. Accountability for the proper exercise of authority and use of public resources. Equity in administering rewards and punishments. Equality of rights and opportunities. Participation in the consultative process for collective decision-making. Merit system in contracting personnel Truth The government official has moral responsibility in the search for truth, and to be aware of and adhere to all matters. Fidelity to the truth is the basis for entitlement to obtain trust of the community, whereas the basis of justice is integrity and honesty for both the individual and society. The ethical principles of truth (See annex C) include the following elements: Truthfulness in reporting the facts. Honesty in managing resources. Evidence-based decision-making. Transparency of decision-making and resource management for public scrutiny. Safeguards for whistle-blowers Service to the common good Society should expect a public servant to fulfil the moral imperative to use his/her official position to serve the public interest. The honour and distinction of a public servant is based on having rendered outstanding and valuable services to the common good. This precept applies equally to public institutions and to the individual. Personal and institutional commitment to the core moral value of serving the common good is a source of intrinsic motivation, which is capable of sustaining the efforts and perseverance often required to promote social transformation and development. When a public servant uses his/her public position to serve personal self-interests, this behaviour tends to destroy the basis of public trust, which is 17