1. Data Disclosure: An Ongoing Progress Towards Transparency Abeer Rabayah B.Sc Pharmacy -MBA /Marketing MeTA National Coordinator

2. Presentation Outline Introduction Survey Background Survey Objective Key Findings Challenges Lessons Learned Recommendations 03/10/2015MeTA2

3. Introduction MeTA a multi-sector approach to improving the quality and transparency of information on the pharmaceutical sector and strengthening accountability for access to medicines

4. Survey Background The main hypothesis of MeTA is: “Transparency (disclosure of robust information) and mutual accountability (stakeholders in the supply chain holding each other to account) results in informed policy change leading to greater efficiency and improved access to medicines.” 03/10/2015MeTA4

5. Pilot MeTA Process New validated data on pharmaceutical sector Disclosure of data and scrutiny by multi- stakeholder group Development of policy options Policy change and implementation Changes in drug prices, availability, quality and/or promotion Improved information for management Improved processes. New validated data on pharmaceutical sector New validated data on pharmaceutical sector Disclosure of data and scrutiny by multi- stakeholder group Development of policy options Policy change and implementation Changes in drug prices, availability, quality and/or promotion Changes in drug prices, availability, quality and/or promotion Improved information for management Improved processes.

6. What kinds of information? Availability – Policy: financing, selection/EML (including who selects), – Data: availability in public/private sectors, length of stock outs - urban/rural, facility level Quality – Policy: regulatory and registration requirements (e.g. GMP), inspection – Data: quality monitoring at port and in supply chain, non-registered drugs Price – Policy: price control, competition, supply chain mark-ups, generics – Data: procurement, prices in supply chain, market structure (competition, volumes) Promotion – Policy: regulations and codes of ethics, direct to consumer advertising, curriculum – Data: brand prescribing where generics exist

7. ‘MeTA’ Tools Baseline: – Disclosure survey/sector scan – Availability (WHO-HAI facility and/or household surveys) – Multi-stakeholder (IDS) MIT supply chain analysis HAI Medicines Promotion Tool NICE – evidence based STGs Harvard Pharmaceutical Policy Flagship Course Multi-stakeholder tool/training Know-how! – Technical assistance – Networking – South-south learning (e.g. Ghana NHIA analysis)

8. Data Disclosure Survey Core Components  Medicines Registration and Quality Assurance  Availability of Medicines  Price of Medicine  Polices and Practices concerning the promotion of medicines 03/10/2015MeTA8

9. Objective The Data Disclosure Survey Tool aims to achieve the following objectives: 1. Assess the current status of data disclosure in the four core MeTA categories 2. Disclose the currently available data in the four MeTA core categories 3. Identify where there are gaps in information 03/10/2015MeTA9

10. 03/10/2015MeTA10 Overview of disclosure process and engagement of stakeholders In Jordan Data Disclosure Survey Tool was sent to all members by mail to have an overview. Start discussing the tool and it’s rational with each committee especially within their areas of expertise and getting feedback on the best way to precede working. The national MeTA Secretariat Organized special MeTA Council Meetings to share and discuss the key disclosed data Collected data was categorized in special tables in order to be verified and accurately referenced based on its official sources. Findings were discussed in a special MeTA council meeting

11. Key Findings under each Key Component 03/10/2015MeTA11

12. Key Findings- Registration and Quality Detailed regulations on process for registration and de-registration is available and disclosed on JFDA website. Registered medicines are disclosed but not in the form of a list. Access is by searching by generic name in English logged in as 'guest' on JFDA website. Successful for some medicines (salbutamol) but unsuccessful for others (metformin, simvastatin, amoxicillin) http://www.jfda.jo/barcode_java/index.jsp?LangID=en http://www.jfda.jo/barcode_java/index.jsp?LangID=en Average length of time to register dataprotected or generic medicines and related fees are disclosed/published. List of GMP compliant Manufacturing plants is available but NOT disclosed. No criteria or list for pre-qualified suppliers in public procurement tenders. Number of samples from market that are sent to quality control laboratories by government inspectors for routine testing in last year are available disclosed/published in the annual report JFDA does not publish a summary of Adverse Event activities regularly. But if any action is taken regarding any medication the results will be published after withdrawal from the market. 03/10/2015MeTA12

13. Key Findings- Availability Public sector budget for medicines disclosed only for MOH There is no national Standard Treatment Guidelines (STG) committee and there are no national STGs- but there are specific STGs at some institutions (like RMS) which are not published/disclosed Essential Drugs lists available at institutional level in public sector. Often not published/disclosed. RDL at JFDA published. Patent law exists. In general 5 year Data Protection regulation followed. List of patented or data protected medicines available (Ministry of Trade) but not published/disclosed as a list. Number of health facilities audited in last year available and published/disclosed Volume and value of medicines supplied in the private sector is not available. Can only be obtained from for a specific fee (e.g from IMS Health) 03/10/2015MeTA13

14. Key Findings- Pricing Laws and regulations governing ex-manufacturing and end user (patient) pricing of medicines in the public (JPD website) and the private sector (JFDA website) are available and disclosed Individual private sector retail medicines prices are disclosed and accessible through JFDA website, but not user friendly http://www.jfda.jo/RDU/ar-JO/HomeSearch.aspx List of ex-manufacture medicine prices in private sector available but not disclosed. Can only be obtained for a fee from JFDA Public sector procurement prices available and published/disclosed on JPD website. Not always user friendly and lack of awareness of data available on website. 03/10/2015MeTA14

15. Key Findings- Promotion List of manufacturers and distributors that subscribe to internationally or nationally recognized codes of conduct is not available List of individuals with their affiliations who are on the national committee to monitor adherence to industry codes of conduct is not available Reports of numbers and types of complaints submitted to the national monitoring committee regarding promotional practices, numbers of violations, and resolution of the complaints is not available 03/10/2015MeTA15

16. Recommendations 03/10/2015MeTA16

17. Recommendations Quality Assurance results available but NOT disclosed. For consideration: publishing available data about GMP compliant manufacturers; list of prequalified suppliers and adverse reactions reports might be beneficial for all stakeholders. Products cannot be registered before passing lab testing, one assumes that all registered products have passed lab testing. For consideration: publish this information at the time of product registration approval. 03/10/2015MeTA17

18. Recommendations No national STGs available. For consideration: Develop national STGs. Where STGs exist, consider publishing/disclosing them (e.g RMS). What are barriers to publishing? Increase awareness of STGs and Essential Drugs List by teaching as official guidelines in medicine/pharmacy/nursing schools Prices of medicines in public (JPD) and private (JFDA) are available on relevant websites, but no user friendly or easy to access. For consideration: improve ease of access to information on relevant websites and raise awareness amongst stakeholders on data available Lists of patented or data protected medicines not disclosed. For consideration: publish these lists to enable easier and faster introduction of generics to market. 03/10/2015MeTA18

19. Recommendations Prices of medicines in public (JPD) and private (JFDA) are available on relevant websites, but no user friendly or easy to access. For consideration: improve ease of access to information on relevant websites and raise awareness amongst stakeholders on data available Promotion guidelines’ procedures are available but currently JFDA has no monitoring plan but would like to develop one. For consideration: set up national committee with the authority to monitor adherence to guidelines and the power to implement appropriate sanctions for non-adherence 03/10/2015MeTA19

20. Recommendations on the level of the disclosure process: National Councils can classify data to A, B and C categories using and then they can start working on transferring data gradually from category C to B and then to A where they reach to a level where most data are available and disclosed. DPL: Disclosure Process Ladder 03/10/2015MeTA20 Not Available Not Publicly Disclosed Available And Publicly Disclosed

21. Recommendations on the level of the disclosure process: This tracking and classification process should be accompanied with an awareness campaigns in collaboration with stakeholders (private, public, CSOs) in order to improve access to available data The data disclosure report highlighted some gaps regarding publicly available data and created a debate for discussion between stakeholders (public, private, CSO). This debate can be considered as an ongoing exercise to assess the pharmaceutical data disclosure status on regular basis in order for MeTA Jordan to track changes, improvements or drawbacks in data disclosure and improve MSP 03/10/2015MeTA21

22. Challenges Key disclosure data on medicines Availability to patients is difficult to obtain (except through Level II Household & Health Facility baseline surveys which are ongoing) Some key data sources not easily accessible (fee needed to obtain data) Official websites sometimes not user friendly or data not frequently updated Private sector is not 'obliged' to provide data Limited contribution from CSO members Data and policies are often complex/technical and not easy to understand by the public 03/10/2015MeTA22

23. Lessons Learned Sharing data among stakeholders is important to raise questions and stimulate discussion Stakeholders exchanged data amongst each other and learned new things Data disclosure meetings were an opportunity for different stakeholder to understand why some data are not disclosed or available Data disclosure meetings uncovered some of the official websites' weaknesses that hinder accessibility to published data Data disclosure meetings raised useful and important COLLECTIVE recommendations Collecting data through focused group and personal interviews helped in understanding a lot of important topics and generated recommendations and key topics for discussion such as topics related to IP and patency. 03/10/2015MeTA23

24. 03/10/2015MeTA24 I would like to thank MeTA Jordan Council Chair, Council Members &National / International MeTA Secretariat who dedicated their time and effort to finalizing the Data Disclosure Survey

25. THANK YOU 03/10/2015MeTA25