Samia Saad 1 , Birgit Kerstens 2 , Wilbert Bannenberg 1,2

1. COUNTRY COMPARISON OF META BASELINE DATA DISCLOSURE SURVEYS Samia Saad1, Birgit Kerstens2, Wilbert Bannenberg1,2 1 Medicines Transparency Alliance (MeTA) Pilot, United Kingdom; 2Health Research for Action (HERA), Belgium ABSTRACT 977 Country Comparison of MeTA Baseline Data Disclosure Surveys Saad, Samia (1); Kerstens, Birgit (2); Bannenberg, Wilbert (1,2) samiasaad@gmail.com 1: Medicines Transparency Alliance (MeTA) Pilot, United Kingdom; 2: Health Research for Action (HERA), Belgium Problem Statement: The pharmaceutical sector is complex and information about medicines is often not disclosed or not easily available to stakeholders. Objectives: To improve transparency in the pharmaceutical sector through information disclosure and analysis by a multi-stakeholder group (MSG). The MeTA Data Disclosure Survey (DDS) collates and describes the disclosure status of information on medicines quality, availability, price, and promotion. Design: The DDS tool was designed with support from WHO Harvard Collaborating Center in Pharmaceutical Policy. A list of 37 indicators was developed out of recommended “key types of data to disclose” listed in the tool. Data was then extracted from qualitative information on practices supplied in the MeTA pilot country surveys into a cross-country summary table. Setting: All 7 MeTA pilot countries (low to middle income): Ghana, Jordan, Kyrgyzstan, Peru, Philippines, Uganda, and Zambia. The survey assesses the national situation in both public and private sectors. Study Population: The DDS was conducted with input and validation from a MSG, representing key national institutions from public, private and civil society sectors and academia. Intervention: Surveys were conducted by countries between Aug 2009 and Jan 2010. Duration of data collection was ~2 months. Technical validation by country MSGs took a further 4-6 months. Cross-country summary tables were developed for comparison purposes. Outcome Measure(s): Data covering policies—the laws and regulations that are in place; practices—suggested procedures to follow and actual practices; and results—achievements in the core areas of medicines’ registration and quality, availability, price, and promotion. Practices were extracted into a cross-country table to which a traffic light analysis was then applied. Individual country data disclosure surveys and cross-country analysis have been placed in the public domain. Results: Cross-country analysis of data disclosure on medicines’ price, quality, availability, and promotion highlights similarities and differences in disclosure status across countries, whether disclosure is proactive or reactive, and whether information is out of date, unreliable, or simply unavailable. Conclusions: The DDS enables national stakeholders to prioritize activities, supports progressive disclosure, and creates a baseline against which changes in transparency and disclosure can be measured. It also facilitates multi-stakeholder engagement since it requires that the stakeholders disclose relevant information they and the institutions they represent hold. Cross-country analysis of DDS data is possible and useful. Funding Source: UK Department for International Development (DFID) 6. SELECTED KEY FINDINGS • QUALITY • 1.1 Market registration procedures and registration status of all medicines • Indicator 1. Process for registering and de-registering medicines • AllMeTA pilot countries, except Kyrgyzstan, disclose clear guidelines for registering medicines on their respective regulatory agency websites, underpinned by legislation which is also disclosed. • In Kyrgyzstan, registration requirements are only available to private companies upon request from regulator. • 1.4 Quality assurance data during registration or procurement • Indicators 8. & 9. List of pharmaceutical products that failed quality assurance procedures during REGISTRATION or PROCUREMENT processes • No disclosure of information on quality from inspection results of manufacturers or product testing in registration OR procurement processes. Quality testing information is however available in most countries, but access is restricted to drug regulators. • Exception: Peru's DIGEMID Health Control and Monitoring Division publishes list of products that failed quality control testing on its website. • PRICE • 3.1 Consumer and ex-manufacture prices of medicines in the public, private, and non-profit sectors • Indicator 28. Private sector retail prices for list of key essential medicines • Only Jordan sets medicines retail prices and publishes information though a searchable database. • No information due to lack of systematic price monitoring in Ghana, Kyrgyzstan, Uganda and Zambia. • In Peru and Philippines, partial information is available through recently implemented legislation: Government Maximum Retail Price (Philippines) and the recently launched Price Observatory (Peru). • All seven countries have median price ratios of a basket of 30 essential medicines through WHO/HAI surveys conducted within last seven years. • 3.3 Medicines price components in public, non-profit, & private sectors • Indicator 34. & 35. Data on price components (duties, taxes, mark-ups and other charges) for key essential medicines (domestically manufactured or imported) • Overall data is not available. Only Ghana and Philippines data is disclosed through WHO/HAI surveys, which specifically included price component data. • Apart from Jordan none of the other countries regulate mark ups on medicines prices. Jordan publishes its regulations but not the absolute value of mark ups for individual medicines. • Taxes: Majority of MeTA countries still impose taxes on medicines. Some medicines are tax exempt in Peru; Zambia waives taxes on essential medicines. 2. BACKGROUND • The Medicines Transparency Alliance (MeTA) is a pilot multi-stakeholder alliance (see poster 1025) working to improve access and affordability of medicines for the one-third of the world’s population unable to access essential medicines due to high cost or local unavailability. • A large amount of pharmaceutical information has been collected and collated by the seven MeTA pilot countries (Ghana, Jordan, Kyrgyzstan, Peru, the Philippines, Uganda and Zambia) as part of their baseline country pharmaceutical assessments. • The Data Disclosure Survey representsComponent 1(b) of the MeTA Baseline and provides a standardised tool to assess and describe the current disclosure status of information in the core MeTA areas of: medicines registration and quality assurance;the availability of medicines; the price of medicines the policies and practices concerning the promotion of medicines. • For each core area, disclosed information should cover policies – the laws and regulations that are in place; practices – suggested procedures to follow and actual practices; and results –achievements in the core area. The surveys were conducted between 3. OBJECTIVE • To provide a snapshot of and compare the status of data disclosure of all seven MeTA pilot countriesand highlight common areas of transparency/disclosure, as well as gaps in information. 4. METHODOLOGY • A cross-country comparison table of data disclosure surveys was designed to assemble the available disclosed information in the core MeTA areas. • A list of 37 key indicators was developed out of the recommended 'key types of data to disclose', listed in instructions and guidance for conducting the survey. • Data was extracted from the qualitative information supplied within the individual survey reports prepared by each country. • A traffic light analysis was then applied to the cross-country comparison table, by using - where applicable - green, orange and red colours, which refer respectively to (1) available and disclosed, (2) available but restricted access, and (3) not available at all. The table captures 'practice' on what data is actually disclosed at the time the surveys were conducted. • Text with relevant information is supplied in individual cells of table to supplement traffic light analysis, where helpful in explaining rationale for choice of colour. • PROMOTION • 4.1 Medicines promotion regulations, policies, and industry practices • Indicator 36. List of manufacturers and distributors that subscribe to internationally or nationally recognized codes of conduct • Information is not available in any of the seven MeTA countries. • Indicator 37. Number and type of violations regarding promotional practices and how complaints were resolved • Information is not available in any of the seven MeTA countries, despite the fact that all seven countries have guidelines on medicines promotion and regulation criteria for direct to consumer advertising, which is monitored by the regulator. • Monitoring and disclosing violations to ethical guidelines for promotion of medicines is weak in all MeTA countries. • AVAILABILITY • 2.4 Volume & value of medicines procured in the public and non-profit sectors • Indicator 21. Government budgets for pharmaceuticals for last fiscal year • Overall public sector budget information is difficult to access apart from Jordan and Kyrgyzstan, where budgets are published on MoH and Ministry of Finance websites respectively. • Budget information from Peru, the Philippines and Zambia budget is available but access to it is restricted. • In general there is lack of transparency because budgets for health and pharmaceuticals are distributed across different public sector institutions, and the fact that there are no laws mandating that they disclose budgets. • No data supplied in surveys of Ghana and Uganda. • 5. OUTPUT • A cross-country comparison table of status of disclosure of the large amount of pharmaceutical information that has been collected and collated by the seven MeTA pilot countries was conducted. Extracts of this table are presented in the bottom left hand side of this poster. • The cross country comparison table is accompanied by separate ‘Explanatory Notes’ as well as a ‘Key Findings’ tables. Extracts from the data disclosure cross-country table with traffic light analysis for selected indicators are presented below 7. CONCLUSIONS • Cross-country analysisenables: comparison of level of transparency of pharmaceutical sectors of seven diverse pilot countries, highlights similarities/differences and assesses where there is room for improvement in terms of data disclosure. It also highlights deficiencies in health information management, where data is simply not collected or fragmented. • Gaps - additional ‘key data’ to disclose was recommended in the survey instructions but wasnot included in the cross-country table, as it was not addressed sufficiently well across the individual country surveys. A description of this can be found in the ‘Explanatory Notes’ that accompany table. • Quality:Legislation governing a medicine registration processes is disclosed in all countries except for Kyrgyzstan. Quality testing information is available in most countries, but is restricted to drug regulators and not publicly disclosed. Peru leads by example by making quality failure data public. • Availability: There are no laws that mandate that governments in any of the seven pilot countries disclose their budget for pharmaceutical expenditure. Budget data is non transparent – it is often unavailable or fragmented since separate budgets are held by different public health institutions. • Price: Only Jordan sets and publishes medicines retail prices. No systematic retail price monitoring exists in countries, except recently through two new initiatives in the Philippines and Peru as a result of recommendations by the MeTA Multi-stakeholder Group. No price component data is available except where this is collected ad hoc through HAI/WHO price and availability surveys (Ghana & Philippines). Most countries still impose taxes on medicines except Peru and Zambia, where some essential medicines are exempt. • Promotion: Though ethical promotion guidelines exist in all countries, monitoring is weak and data on violations is not publicly available. 8. FURTHER READING & CONTACTS • Country comparison of MeTA Data Disclosure Survey, individual country Baseline Data Disclosure Survey reports and thetool for the MeTA Baseline Data Disclosure Survey can be found at http://www.medicinestransparency.org/ • See the following linked posters: 1025 for an overview of the MeTA Multi-stakeholder pilot; 1013 for experience and results of the MeTA Baseline Assessments; 967 for cross country comparison of the Baseline Pharmaceutical Sector Scan; 1108 for a cross country comparison of the Multi-Stakeholder Process. • UK DFID has recently approved a continuation of support for MeTA. For more info on the 2nd phase of MeTA contact: • DFID at meta@dfid.gov.uk, Tim Reed (HAI) at tim@haiglobal.org or Gilles Forte (WHO) at forteg@who.int