Pilot Countries View from the Public Sector

1. Pilot CountriesView from the Public Sector MeTA Ghana MeTA Philippines MeTA Jordan MeTA Uganda MeTA Kyrgyzstan MeTA Zambia MeTA Peru

2. MeTA Ghana Mr. Samuel Boateng Office of Chief Director Ministry of Health (MoH)

3. Summary Analysis at start of MeTA What were the needs and issues in your specific sector at the start of MeTA? Strong existing enabling and legislative environment BUT Benefits of improved procurement not translating into affordability and availability for patients (e.g. 2004 WHO/HAI Medicines Survey); Inconsistency with other sectors (private and mission) in terms of how standards (i.e. quality, availability and pricing) are developed and applied; Low consumer awareness due to very little information on quality, availability and prices of medicines in the public domain, Non-adherence to treatment guidelines by prescribers and irrational use of medicines by providers persists despite improved guidance and education; Supply chain performance problems from CMS downstream leading to high stock-out rate; Vulnerability of NHIS to fraud due to inefficient data analysis and dissemination Public health safety concerns arising from counterfeit and/or substandard products

4. Major milestones What milestones have been achieved during the MeTA pilot phase? • Proactive engagement with private sector, development partners & civil society through multi-stakeholder collaboration in information sharing to build consensus around availability, quality, pricing and rational use to increase access to essential medicines for the poor • Periodic monitoring of medicine prices and availability as well as their rational use using WHO standard indicators-2008 • Key Data on medicines from the NHIA made available for systematic analysis and dissemination to improve transparency, accountability, pricing and quality. • Independent monitoring of medicines quality through sentinel testing using GPHF ‘minilabs’ 2009. • Partnership with CSOs to provide more information to consumers, around quality & rational use in medicines advocacy • Data validation of NHIA data carried out; awaiting dissemination

5. Successes What were the successes for your sector during the MeTA pilot phase? • Provided Ghanaian leadership on medicines transparency and accountability through multi-stakeholder engagement as model in West Africa for both effective governance and market efficiency. • Initiated opportunity for pricing and rational use of medicines monitoring mechanism to inform the NHIS • Reduced and/or eliminating the risk of counterfeit and substandard medication in the supply chain. • Provided mechanism for public sector commitment to fight inefficiency and corruption in the drug supply landscape.

6. Challenges What challenges has your sector endured during the MeTA pilot phase? • Mutual suspicions and mistrust between sectors; • Nervousness of all stakeholders about change; • Need to assume a degree of commitment to transparency by all stakeholders and willingness to be mutually accountable. • Sustaining regular open stakeholder dialogue and commitment of all parties in all sectors. • Right to Information Bill yet to be passed into legislation • Dealing with sensitivities of various interest groups in the sector

7. Lessons Learned What are the lessons that your sector has learned from MeTA? • Multi-stakeholder involvement helping to break barriers • Transparency & Accountability in the engagement process is vital for success of MeTA • The need to accommodate the interests and perceptions of all local stakeholders to reflect the character of the multi-stakeholder is a key ingredient for its efficiency • The essential elements of a strong, vibrant and sustainable MeTA in Ghana are: • Having the right people connected and committed • Willingness of stakeholders to be mutually accountable • Ghanaian ownership driven • Sustainable political commitment

8. Thank you Name of presenter: Mr. Sam Boateng Job Title: Office of Chief Director, MoH; Member, Ghana GC Email: samuel.boateng@moh.gov.gh Mobile number: +233 244 269336 Website: www.moh.gov.gh

9. MeTA Jordan Presenter Name Job Title

10. MeTA Overview of Public Health Sector in Jordan Jordan is characterized by a diverse and fragmented public sector. It consists of: MOH, Royal Medical Services, Jordan University Hospital, King Abdullah the Second University Hospital, King Husain Cancer Center and Prince Hamzeh Hospital The public sector covers about 72% of the population Pharmaceutical expenditure as a percent of total health expenditure is 34.0%, where public accounts for 11.3% Public pharmaceutical expenditure as a percentage of total pharmaceutical expenditure accounts for 33.3%. Pharmaceutical expenditure is growing at 17% per annum compared to GDP growth of 3.3% The public sector is represented at the Jordan MeTA Council by 9 members out of 18 Source: Jordan National Health Accounts (NHA) 2007

11. Comparison of Jordan Public Expenditure on Medicines with other Countries

12. MeTA Level of Public Sector Engagement The Government/ public sector has supported MeTA since the start of MeTA The public sector actively participates in all MeTA activities at the level of the Council, subcommittees and established task forces that work on activities in our national workplan MeTA Council representatives of the Public sector have acted as facilitators for the Baseline Pharmaceutical Assessment Household and Health Facility survey level II, as well as the Pharmaceutical Sector Scan The Public Sector is fully committed and are the main drivers for the MeTA process in Jordan

13. MeTA Level of Public Sector Engagement cont. MeTA is hosted at one of the public health sector institutions/ the High Health Council (HHC) The elected MeTA Chair is the Secretary General of the HHC Representatives from public sector were nominated to participate in the household and health facility survey level II technical committee. Representative pharmacists from public sector institutions participated in facility survey data collection Most of public sector representative at the MeTA Council actively participated in the baseline data disclosure survey

14. Summary Analysis at start of MeTA The needs and issues in the public sector at the start of MeTA focused on three main areas: Improving Availability in the public sector through adapting and using transparent evidence based decision making for the Rational Drug List (RDL) Promoting Rational Drug Use through encouraging best practice and developing STGs The need for reliable Data to be used in forecasting etc. especially with the lack of Health IT within the public sector

15. Major Milestones Developed national Standard Treatment Guidelines (STGs) for essential hypertension for all public primary health care facilities (Expected Output: implementation of pilot STG after discussing implementation strategy with MoH) Reviewed TORs and SOPs of various (therapeutic area-related) committees involved in selection of drugs to be included in Rational Drug List (RDL) (Expected Output: adoption of revised criteria for SOPs and Conflict of Interest declarations and increased accountability) Reviewed criteria for adding and deleting drugs to and from RDL (Expected Output: adoption of revised criteria and increased transparency in medicines selection processes) Reviewed classification of drugs (restricted, unrestricted, authorized and unauthorized) in RDL (Expected Output: adoption of revised classifications using transparent evidence based medicine criteria to inform decisions)

16. Major Milestones cont. For reliable data on medicines availability and use they advised to have the Pharmaceutical Baseline Assessment Survey-Level II and a WHO/HAI surveys to take place and contributed data to them Supported and contributed to a Supply Chain Mapping Assessment Promoted a Rational Drug Use workshop amongst public sector health workers Advised that a series of training sessions on pharmaco-economics take place for health professionals -to date two training sessions have already taken place Promote good practice and work on the development of conflict of interest (COI) declaration and management system for all committees to improve accountability

17. Successes The Government is highly supportive for the MeTA initiative in Jordan as mentioned earlier The public sector is committed to MeTA and they believe in the MeTA main objective and the five core principles The Government has supported MeTA and hosted the initiative at one of the governmental institutions -the HHC. This gave the whole process an official identity and led to the fragmented public sector working together towards improving availability through adapting/using evidence based decision making for the Rational Drug List (RDL) and promoting RDU through encouraging best practice

18. Challenges At the level of the Pharmaceutical Sector: Poor forecasting and estimation of medicines needs which leads to low availability of medicines in public sector High Health expenditure 9.05% of GDP where 34% out of it is spent on medicines with 2/3 expenditure is out of pocket Direct local purchases by institutions (prices of the private sector) instead of sticking to procuring jointly through JPD Irrational Use of Medicines and absence of national STGs in different disease areas Weak role and capacity of pharmaco- vigilance system Lack of private sector transparency

19. Challenges cont. General Challenges: The two year period for MeTA pilot is too short and not long enough to measure outcomes and impact on the availability of medicines in the public sector and on Rational Drug Use Changes in MeTA Council representatives positions/agendas can hinder their participation in effecting medicines policy changes and creates a gap between Council members

20. Lessons Learned 1. The main lesson learned is the importance of partnership AND the multi-stakeholder process: That public sector can be more effective in dealing with issues within the medicine supply chain in terms of availability, distribution, RDU when working with the private sector and civil society organizations (CSO), since the private sector secures the country with medicines and the CSO speak on behalf of patients’ and consumers’ and their needs The MeTA process has opened channels of communication between different stakeholders and between different countries MeTA has acted as a coordinating and facilitating body for the pharmaceutical sector players and stakeholders

21. Lessons Learned cont. 2. We have learned the Importance of Data and Data Disclosure Participated fully in the Pharmaceutical Sector Data Disclosure Survey Contributed fully in the Pharmaceutical Baseline Assessment Survey-Level II: Facility and household and included the Pricing Survey within the baseline assessment facility survey Participated in the Pharmaceutical Sector Scan Survey Agreed to publish all outputs and data on Jordan MeTA Web site and learned that the media should be more involved Identified gaps and formulated recommendations for the Jordan pharmaceutical sector (based on existing pharmaceutical reform sector studies (WB 2004) and publish on the Jordan MeTA Web site

22. Thank you Name of presenter: Job Title: Email: Mobile number: +962 Website: www.meta.jo

23. MeTA KyrgyzstanExpertise of current Legislation Djusupova Djanyl Deputy director of NDRA of KG

24. Summary Analysis at start of MeTA Since gaining independence of KG when the pharmaceutical sector privatized the legal framework corresponding new function requirements in drug provision has been established NDRA KG has been established However, regulatory tools lacked to ensure transparency and accountability in the pharmaceutical sector if basic legislation was available Survey objective: Analysis of legislation, with emphasis on mechanisms of transparency and accountability, including an assessment of the law in practice and existing contradictions

25. Summary Analysis at start of MeTA The new policy reforms aimed at improving the business environment by removing administrative barriers to business and investment has led to: • A reduction of 30% of licenses and permissions for business activities. • Changing the system of control and inspection of business. • Reduction to 30% of the bodies monitoring business. A significant impact on regulation of pharmaceutical sector: According to advisory group of BEI project medicines were considered as an ordinary product without regard to their characteristics. The adoption of some recommendations could lead to deregulation in pharmaceutical sector: • Activities of wholesalers and manufacturers of medicines and pharmacies (except pharmacies produced medicines extempore) is no longer licensed • MoH standards would be voluntary implemented in pharmaceutical sector • the declaration of compliance with medicines is introducing instead of mandatory certification of medicines • Unilateral recognition of medicine registration Pharmaceutical Inspection has no rights to have unexpected visit , even there are public complaints

26. Major milestones • META initiated a dialogue with the USAID BEI project involving private sector, NGOs, government and WHO to prevent an imbalance in the regulation of the pharmaceutical sector under an authoritarian approach and non-transparency of the policy • Expert group on legislation analysis conducted meetings with representatives of different sectors: • - Public sector:MoH, MoF, NDRA • - CSOssector • - Private sector • Identified issues and contraventions in legislation were discussed at the Round Table by all parties participated • E- group involving all stakeholders was created to discuss legislation issues

27. Areas of survey • 1. The main normative documents governing the drug provision in KG: 1.1. Effectiveness of legal documents to ensure transparency of drug provision in KG 1.2. Legal and regulatory shortcomings and contradictions • 2. The patient’s rights on the drug provision and their protection 2.1. Information public support on medicine issues 2.2. Services on the drug provision 2.3. The possibility of appeal by patients of their rights on the drug provision • 3. State regulation 3.1. Regulation of licensing issues concerning the drug provision 3.2. Bodies authorized to control the drug provision 3.3. The system of state control efficiency and drug safety • 4. Responsibility for the public health

28. Challengeswith legislative features 1. Contradictions in certain normative documents including differences in terminology 2. It is necessary to improve the regulatory framework (conflict of interests of NDRA and exclusion of obsolete rules) 3. Medicines included in the scope of the Law "On the basis of technical regulation in the Kyrgyz Republic” 4. New rules of establishment of regulation status may lead to the fact that regulations of the drug provision will cease to be binding 5. Inadequacy of certain legislation (complication of pharmaceutical inspection, law enforcement pressure on pharmacies) 6. The lack of legislative mechanisms to ensure transparency and accountability in the pharmaceutical sector

29. Challengeswith executive features 1. Procurement: • The inaccessibility of information on procurement of medicines, except for procurement announcement • Violation of procurement procedures • 2. Licensing system: • No transparency in issue of licenses • There is no public information on licensed pharmacies • Lack of information management system in the pharmaceutical sector 3. Disciplinary-executive: • - Competence of documentation requirement by certain control agencies (prosecution or other fiscal bodies)

30. Recommendations ofStakeholders (1) • Increasing the responsibility of officials (administrative, criminal, disciplinary) • Obligatory support information of patients including information on ADR • To introduce standards for the number of pharmacies in a particular area To attract the local government to monitor the activities of pharmacies • Promotion of ethic code of pharmacist • To introduce bar code for medicines • To ensure timely review of list of medicines reimbursed

31. Recommendations ofStakeholders (2) Tender: • to implement e-procurement (legalize the flow of documents in electronic format). • to introduce ethic standards for the members of tender commission • to introduce criteria for medicine procurement to procure quality medicines (price should not be sole criterion) • Information: • Increasing public awareness • Information on the DRA website: • Licensed pharmacies , • Certified products, • Registered medicines • To introduce provisional regulations on period of medicine certification

32. Lessons Learned • Working with different sectors revealed a significant lack of information in the pharmaceutical sector (indicated by all parties) • Private sector and NGOs are ready to participate in development and enhancement of legislation through: • Establishing working group involving all sectors to address specific laws • Establishing groups to lobby for promotion of certain laws • The system of regular meetings, newsletters, online forums • Involvement of all stakeholders enhances the process of improving the legislation and its implementation • Activities META promote confidence-building between the sectors

33. Thank you Djusupova Djanyl Deputy director of NDRA of KG Email: ddjanyl@gmail.com Mobile number: +996 770 221 055 Skype: Website: www.pharm.med.kg

34. MeTA Peru Melitón Arce Pedro Yarasca Pedro Tintaya

35. Analytical Summary at the beginning of MeTA What were the needs and problems in this specific sector at the beginning of MeTA Problems: Lax legislation for the Registration and Quality of medicines. Little transparency in the information of prices. Promotion and Publicity of medicines Needs: Transparency in information of prices of Pharmaceutical Products Politics of Generic Medicines Rational use of medicines: Listing of Essential Medicines of the Health Sector Greater availability and affordability of medicines

36. Registered medicines in Peru Total of Medicines with Sanitary Registration in force: 23,022 Fuente: SI-DIGEMID. Abril 2010 01/04/2014 36

37. Main mailstones What milestones have been reached during the MeTA pilot phase? During the period of the MeTA pilot phase, the following milestones have been achieved, favored by MeTA Peru: • Observatoriy of Prices of Pharmaceutical Products: • Regulatory framework for the OPPF • Development of the software for prices reports • Technological support :PCs, Server • Informative campaigns for the dissemination of the OPPF: Informative Modules Aspects that have facilitated to reach this milestones: • New legislation of Pharmaceutical Products, medical devices and sanitary products. • Obligatory nature of prescription in International Common Denomination (DCI)

38. Successes What were the successes of the sector during the MeTA pilot phase? • Elaboration and approval of the normative framework on the Observatory of Prices • Launch of the Observatory of Prices - Currently in Version 2. • Political commitment and support by the Minister of Health • Acceptability of the Observatory of Prices by part of the population

39. Examples Informative campaign on Prices of Medicines 01/04/2014 39

40. Challenges • What challenges have this sector to confront during the MeTA Pilot Phase? • To build a better trust among the associates. • The presence of divergent opinions during the process. • Greater capacity in technological and human resources.

41. Lessons Learned What lessons has this sector learned of MeTA? • Recognition of issues that should be revealed to the population (prices, availability, public purchases, information of medicines). • Allowing space for multisectorial dialogue. • Identification of objectives and common strategies among the associates, always respecting their points of view. • It has permitted to identify prominent tissues for the country in matter of medicines.

42. Thank you Pedro Yarasca e-mail: pyarasca@digemid.minsa.gob.pe Telf.: 0051-1-998704127 www.digemid.minsa.gob.pe

43. MeTA Philippines Usec. Alexander A. Padilla & Robert Louie P. So, MD National Center for Pharmaceutical Access and Management

44. Summary Analysis at start of MeTA Filipinos suffer from lack of Access Sustainable Financing Availability Budget Limited entitlements Transparency/ Accountability Pricing Human resource Issues No outcome indicators for Access to Medicines Information / Addressing Asymmetry Expand understanding of the Philippine Pharmaceutical Situation Engagement with stakeholders for collective strategic efforts to improve sector

45. Major milestones DOH in terms of Public- Private Partnerships • Advisory Council for Price Regulation • DOH- Valsartan Access Program • Insulin Access Program with Eli Lilly and Sanofi- Aventis • Childhood Cancer Medicine Access Program • Pharmacist Services for Botika ng Barangays • Good Governance for Medicines with WHO • Jump Start Medicines Transparency and Alliance Philippines

46. Successes • Institutional Successes • RA 9502 “Universally Accessible and Cheaper Medicines Act of 2008” • Generics promotion • BotikangBarangay • P100 Launching • Price Regulation: Maximum drug Retail Price & Government Mediated Access Program (MDRP & G-MAP) • Good Governance for Medicines • Electronic- Essential Drug Price Monitoring System (E-EDPMS) • Philippine National Drug Formulary System (PNDFS) • DOH support to MeTA • Financial support in early stages • Resource for pharmaceutical scan • Office lodged in DOH compound • Engagements for memberships at the start of MeTA

47. Challenges • Revitalizing the National Medicines Policy in the Philippines in line with significant legislation and inputs from stakeholders • Strengthening government agencies involved in medicines access: FDA and DOH- NCPAM • Improving the general public’s confidence in the use of generic medicines • Strengthening community pharmacies through expanding drug list, disseminating best practices and acquiring pharmacist services • Assessing impact of drug price reduction initiatives • Technical resources are limited • Fiscal resources needs to be improved • Standard guidelines needs to be further developed • MeTA Assistance to Public Sector • Engaging local groups to expand MeTA process. • Rolling out public sector initiatives and raising awareness through MeTA • Role of MeTA as conscience at the grassroots level • MeTA support for consolidating resources in assesing impact/ surveys and technical assistance for capacity building in selling multistakeholder process • Collective support for rolling out good governance initiatives • Other Challenges • MeTA institutionalization and sustainability. • Resolving MeTA personality. • Expanding MeTA acceptance by all sectors

48. Lessons Learned • We were able to share with MeTA the effective mechanisms to engage the different stakeholders in the Philippine pharmaceutical sector in conceptualizing, creation, implementation and evaluation of State initiatives for improving access to medicines are needed. • Advisory Council for Price regulation • Public-Private Partnership • Transparency in pharmaceutical data leads to better and more effective policy making and evaluation • MeTA Philippines is effective as a venue for validation (check and Balance): Act as Social Conscience to guide policies and effective strategies

49. Thank you Alexander A. Padilla Undersecretary in Charge of the National Center for Pharmaceutical Access and Management Robert Louie P. So, MD Project Director of the National Center for Pharmaceutical Access and Management dohncpam@gmail.com Mobile number: +63 917 835 2312

50. MeTA Uganda Presenter: Oteba Olowo Martin Job Title: Assistant Commissioner health Services (pharmacy)