Birgit Kerstens 1, Samia Saad 2, Wilbert Bannenberg 1,2 1 Health Research for Action (HERA), Belgium; 2 Medicines Transparency Alliance (MeTA) Pilot, United Kingdom Country comparison of MeTA baseline pharmaceutical sector scan data November 2011MeTA

Objective To provide a cross-country comparative snapshot analysis of the baseline information about the pharmaceutical sector in each of the seven MeTA pilot countries November 2011

Design (1)  The MeTA pilot countries collected and reported pharmaceutical sector data for more than 250 indicators  Criteria for selecting the most "representative" indicators per form were: – which indicator reflects the form topic the best ? – which indicator is the most relevant for transparency purposes? – which indicator is the easiest to collect for comparison purposes? November 2011

Design (2)  Cross-country analysis: 45 core (  ) and secondary indicators relating to  Medicine prices (1 + consumer & procurement prices)  Quality (13)  Availability (8)  Promotion (4)  Transparency and accountability (18) November 2011

Design (3)  A traffic light analysis was added to the multi-country comparative table to show the degree of availability and disclosure of the data:  Available and disclosed  Available but not disclosed  Not available at all November 2011

Cross-country tables (1) November 2011

Cross-country tables (2) November 2011

Key findings on indicators (1) November 2011 QUALITY:  Ind : List of registered products is publicly available, identifying originator brands, branded generics and generics

Key findings on indicators (2) November 2011 AVAILABILITY:  Ind. 23.7: Availability of basket of key medicines in health care facilities:

Key findings on indicators (3) November 2011 PROMOTION:  Ind. 18.3: Pharmaceutical companies are required to report promotion and advertising budget in taxes disclosures:

Key findings on indicators (4) November 2011 TRANSPARENCY AND ACCOUNTABILITY:  Ind. 25.1: Legal provisions exist to govern the licensing and prescribing practice of prescribers and health facilities:

Key findings on indicators (5) November 2011 PRICES:  Ind. 14.4: Regulations exist mandating that retail medicine price information should be publicly accessible:

Key findings on indicators (6) November 2011 CONSUMER PRICESLow price generics Atenolol 50mg Cap/tabGhanaJordanKyrgyzstanPeruPhilippinesUganda Public sector110,2819,5921,300,0020,300,86 Private sector110,28450,5524,9842,2327,884,32 Salbutamol 0.1mg/dose inhalerGhanaJordanKyrgyzstanPeruPhilippinesUganda Public sector328,01103,00239,46113,13-1,26 Private sector445,16221,62241,19935,476,041,51  Ind : Consumer prices:

Key findings on indicators (7) November 2011 PROCUREMENT PRICESPublic sector Atenolol 50mg Cap/tabGhanaJordanKyrgyzstanPeruPhilippinesUganda Low price generics2,320,480,800,002,501,02 Originator medicines 5,30 Salbutamol 0.1mg/dose inhalerGhanaJordanKyrgyzstanPeruPhilippinesUganda Low price generics0,831,511,172,582,801,07 Originator medicines 1,96 3,20  Ind : Procurement prices:

Challenges & recommendations  Information gap: ensure that key pharmaceutical information is widely available and disseminated in the public domain November 2011

Challenges & recommendations  Information gap: ensure that key pharmaceutical information is widely available and disseminated in the public domain  Comparison gap: ensure that data collection is compliant with instructions (e.g. consumer and procurement prices) November 2011

Challenges & recommendations  Information gap: ensure that key pharmaceutical information is widely available and disseminated in the public domain  Comparison gap: ensure that data collection is compliant with instructions (e.g. consumer and procurement prices)  Disclosure gap: ensure that public data, regulations, lists are disclosed in a transparent and accessible way (through websites and other publishing platforms) November 2011

Dissemination Individual country pharmaceutical sector scans and the cross-country analysis have been placed in the public domain: medicinestransparency.org/ ICIUM abstract: 967 November 2011

Samia Saad 1, Birgit Kerstens 2, Wilbert Bannenberg 1,2 1 Medicines Transparency Alliance (MeTA) Pilot, United Kingdom; 2 HERA, Belgium COUNTRY COMPARISON OF META BASELINE DATA DISCLOSURE SURVEYS November 2011MeTA

Objective Provide snapshot and compare status of data disclosure of all seven MeTA pilot countries Highlight common areas of transparency/disclosure and gaps in information. November 2011

Methodology/Design Cross country comparison of available disclosed information in core MeTA areas of quality, availability, price and promotion of medicines List of 37 core indicators developed out of recommended 'key types of data to disclose', listed in instructions and guidance for conducting survey Data extracted from qualitative information supplied within individual country survey reports into cross country table (EXCEL) Traffic light analysis applied to cross-country table using where applicable Green = available and disclosed Orange = available but restricted access Red = not available at all November 2011

Output Cross Country Comparison Table that captures practice on what data is actually disclosed at time surveys were conducted in a ‘Selected Indicators’ table Accompanying ‘Explanatory Notes’ table and a ‘Key Findings’ table November 2011

Cross-country Tables (1) - Sample of Key Indicators November 2011

Cross-country Tables (2) – Sample of Traffic Light Analysis November 2011

Key Findings (1) QUALITY 1.1 Market registration procedures and registration status of all medicines Indicator 1. Process for registering and de-registering medicines – Pilot countries disclose clear guidelines for registering medicines on respective regulatory agency websites, underpinned by legislation disclosed. – Exception: Kyrgyzstan - registration requirements only available to private companies upon request from regulator. 1.4 Quality Assurance data during registration or procurement Indicators 8. & 9. – Quality testing information available in most countries, but access restricted to drug regulators. No disclosure. – Exception: Peru's DIGEMID Health Control and Monitoring Division publishes list of products that failed quality control testing on its website. November 2011

Key Findings (2) November 2011 AVAILABILITY 2.4Volume & value of medicines procured in the public and non- profit sectors Indicator 21. Government budgets for pharmaceuticals for last fiscal year Public sector budget information difficult to access. Exception: Jordan and Kyrgyzstan – budgets published on MoH and Ministry of Finance websites respectively. Budget information from Peru, the Philippines and Zambia available but access restricted. Lack of transparency because no laws mandating disclosure of budgets for health and pharmaceuticals – budgets distributed across different public sector institutions. No data supplied in surveys of Ghana and Uganda.

Key Findings (3) 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 searchable database (but not user friendly). No information due to lack of systematic price monitoring in Ghana, Kyrgyzstan, Uganda and Zambia. In Peru and Philippines, partial information available through recently implemented new legislation: Government Maximum Retail Price (Philippines) and 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. November 2011

Key Findings (3) PRICE 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 not available. Only Ghana and Philippines data disclosed through WHO/HAI surveys (specifically included price component data). Apart from Jordan, countries don’t regulate mark ups on medicines prices. Jordan publishes its regulations but not 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. November 2011

Key Findings (4) 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 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 not available in any MeTA pilot countries, although 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 weak in all MeTA countries. November 2011

Conclusions - Cross country Comparison DISCLOSURE enables comparison of level of transparency of pharmaceutical sectors of seven diverse pilot countries highlights similarities/difference s and assesses where there is room for improvement of data disclosure. GAPS Information not available (deficiency in health information management system) Other key data not included in comparison - not addressed well in individual surveys (Explanatory Notes). November 2011 Non Disclosure

Dissemination All the MeTA Baseline tools are available as part of the ‘Core Tools’ in the MeTA Toolkit at Individual Country Baseline Data Disclosure Survey Reports can be found and downloaded at countries/ countries/ Country Comparison of MeTA Data Disclosure Survey can be found at countries/country-comparison/ November 2011