Good Governance for Medicines in Jordan Presented by: Dr Sana Naffa November 14-18 Turkey Antalya

1. Good Governance for Medicines in Jordan Presented by: Dr Sana Naffa November 14-18 Turkey Antalya Prepared by :Adi Nuseirat & Sana Naffa 1

2. JORDAN • Jordan is a low– middle income country • Population in millions: 6,058,491 • 10% of the Jordanian GDP is spent on health with one third of this spent on medicinal drugs. • Government annual expenditure on health as percent of total expenditure on health is 43%. • Medicines expenditure growth 17% per annum compared to GDP growth of 2.3%. 2 MeTA 08/12/2011 2

3. Assessment of transparency in Jordan PHASE I PHASE II PHASE III • Assessment was conducted in Oct-Nov 2007; • Transparency Assessment report submitted to WHO in Dec. 2007 • Assessment reportwas published and disseminated in January 2009- • The results of the assessment and recommendations disseminated to all stakeholders in February 2008 3

4. Recommendations from the workshop • Revise laws, administrative structures and procedures based on the finding of the assessment. • Develop a national ethical framework for promoting good governance in medicines regulation and procurement through a consultation process. • Socialize the national ethical framework and the code of conduct by training government officials to generate civil servant's sense of ownership and personal identification within an ethical framework. • Nomination a working group responsible for coordinating. managing the implementation of GGM Programme, and following up the steering committee resolutions. 4

5. Interventions • Two committees have been formed by ministerial decree, a Task force to follow up on study findings and recommendations, to develop a framework for implementing and socializing the framework, and a steering committee to approve and set policies for reform in the pharmaceutical sector. • The Code of Ethics and conduct was enforced in the civil servants practice. • Conflict of Interest consent form was enforced in all committees working at JFDA. • Guidelines regarding drug promotion control have been issued. 5

6. GGM framework • GGM Steering Committee, and Task Force Committee nominated in sep. 2008. • Jordan GGM Framework Partnership: MOH, MPSD, JFDA, ACC, RMS, HHC, JPD, JUH, WHO. • National GGM framework officially adopted by SC in April 2009. PHASE I PHASE II PHASE III 6

7. Post- intervention (Transparency Monitoring Study 2010) 7

8. Post- intervention (Transparency Monitoring Study 2010) 8

9. Implementation of National GGM Programme • Action plan was adopted in July 2010. • Action Plan involves the following: • Adoption of a code of conduct in the pharmaceutical sector. • Development of a COI guidelines. • Develop clear whistle blowing mechanism & safeguard document for protection of whistle blowers. • Prepare document that compiles anticorruption legislation & relevant institutional policies that clearly present laws & sanctions related to corruption. 9

10. Lessons Learned • Level of commitment and enthusiasm played a major role in implementation; • There are bits and pieces of regulations but a system for governance would activate it; 10

11. Code of Conduct in the Pharmaceutical Sector A. General duties and responsibilities of public servant: The code asserts that the public servant should perform all his duties actively seeking accuracy, integrity, impartiality, professionalism, and objectivity, using the most possible potentialities to achieve the public interest and not any other things, and to make sure that he possesses knowledge about laws and regulations in force and apply them without any abuse, malfeasance or negligence. B. Relations with others: The public servant should respect the rights and interests of others without exception, and deal with the public with respect, without discrimination on the basis of race, gender, religious beliefs, political or social status, age, physical status or any forms of discrimination, and deal with his superiors, colleagues and subordinates With respect, good humor, sincerity, and disclose corruption and unethical practices to authorized parties. 11

12. Code of Conduct in the Pharmaceutical Sector C. Maintaining confidentiality and mechanisms of the disclosure of information: This asserts that official information, and documents obtained by public servants in the course of performing his duties be not disclosed to others if instructions, resolutions or special legislation have been issued concerning its confidentiality. On the other hand, official information that should be fully and accurately disclosed shall be released by the public servant by virtue of office. D. Acceptance or requesting gifts, privileges and other benefits: the public servants should not accept or request any form of gifts or hospitality or other benefits of any kind, whether directly or through a mediator , which might have a direct or indirect impact on objectivity of the public servant regarding the carrying out tasks of his job which might affect his decisions. 12

13. Code of Conduct in the Pharmaceutical Sector E. Conflict of interest: The employee shall: 1. Refrain from conducting an activity which may lead or seems to lead to a conflict between his own interests on one side and his official responsibilities and functions on the other. 2. Avoid using or trying to use his job, directly or indirectly, for reaping benefits, in cash or in kind, for him or his family or for an establishment related to him or his family. 3. Declare his /her assets and financial obligations and that of his immediate family, in accordance with the valid rules and regulations. 5. Avoid establishing close relations with individuals or institutions whose interests depend basically on his decisions and those of his administration. 6. Refuse within one years from leaving his work to accept a job with an establishment which used to have significant dealing with his administration. 13

14. Management of Conflict of Interest for Advisors in the Pharmaceutical Sector • TF Almost finished a document (draft) for managing COI for advisors who are involved in the technical committees that deals with drug registration, pricing, procurement, …etc. • The documents consist of the following: • Definition of COI, Types, Categories, disclosure form, principal guidance…etc. • Establishing a committee for assessment of COI. This committee will have a clear TOR. • Disclosure requirements. Details advisor disclosure obligations before, during and after engagement. 14

15. Management of Conflict of Interest for Advisors in the Pharmaceutical Sector • Details the criteria for assessing information provided to determine whether a COI exists and whether further risk assessment should be undertaken • Outlines the criteria for assessing the COI to determine if the risk profile is manageable • Details strategies to manage COI • Implementation and governance: outlines each party’s key roles and responsibilities in implementing COI processes.

16. Compilation of anticorruption legislation and policies • Anti-Corruption Commission Act No. 62 of 2006. • Jordan Food and Drug Administration Act No. 41 of 2008. • Public Health Act No. 47 of 2008. • Medicine and pharmacy Act No. 80 of 2001. Where penalties are stipulated in articles 90 to 99. • Penal Act No. 16 of 1960. • Act of Profession Pharmacy Practice, No. 43 of 1972 • Accounting Office Act No. 28 of 1952. • H. Monitoring and Administrative inspection Bureau Act of 1992. • Ombudsman Bureau Act No. 11 of 2008. 16

17. Compilation of anticorruption legislation and policies • System of general supplies Act No. 32 of 1993 & its amendments. • Civil Service Regulation No. 30 of 2007. • Unified procurement system of medicines and medical supplies No. 91 for the year 2002. TF Prepared document that complies anticorruption legislation & relevant institutional policies that clearly present laws & sanctions related to corruption and unethical practices 17

18. Whistle-blowing • TF almost finished a document that deals with Whistle-blowing mechanism • Definition of whistle-blowing • Types of misconduct whistle blowers can report • Mechanisms for reporting and exchange of information • Adoption of procedures to protect whistle-blowers on corruption • Increase awareness of the actions of the staff of the public sector. 18

19. Next Activities for Phase III 1. Promoting awareness: • Development of training materials about moral values and ethical principles. • Integrate GGM framework & code of ethics in universities curricula. 2. Control of drug promotion (assessment & control of drug promotion and advertising to ensure accuracy of data, and review the regulations). • Assign a team to Review & set the procedure for implementation of the drug promotion regulation & to establish formal complaints procedure to report unethical promotional practices • Publish the formal complaints procedure • National workshop with participants from all involved sectors to disseminate ,adopt and promote the code of ethics in marketing and the impact of unethical medicine promotion. 19

20. Next Activities for Phase III 3. Improve quality of services to achieve the transparency & accountability of performance • Publish all regulation requirements, procedures, guidance and criteria for decision-making • Issuing customer manual contains all regulations & guidance. • Establish on line database for updated, complete and accurate drug information (package leaflet) to make easily accessible to consumers, & healthcare professionals. • Establishing periodical (every 6 months) information bulletin on the drug situation, contains all activities (newly registered drug, withdrawals, and actions taken by Pharmacovigilance unit…) 20

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