Me Ta Private Sector Meeting 23 June 2009

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Collection of presentations given at the MeTA Consultative meeting with the phamaceutical industry in London, 23 June 2009.

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  • Title of presentation 23/06/09 MeTA
  • Support to countries through the MeTA International Secretariat, funds from DFID to support country work, and, upon request, technical assistance. Title of presentation 23/06/09 MeTA
  • This scenario would provide the basis for fair and open competition among ethical pharmaceutical companies and other private sector groups involved in the supply of pharmaceuticals. Increasing access to medicines implies increasing market size with higher volume sales and profits for manufacturers, distributors and retailers Access to accurate market information will enable companies to develop cohesive marketing and sales strategies and plans, and to identify opportunities and openings in the market. Title of presentation 23/06/09 MeTA
  • MeTA is committed to the creation of this level playing field in 7 pilot countries, - Jordan, Ghana, Peru, Kyrgyzstan, Zambia, The Philippines and Uganda Later in further countries should the process be deemed to be successful in an evaluation of in these pilots which will take place in the first quarter of next year Title of presentation 23/06/09 MeTA
  • MeTA has been in existence for one year MeTA process is now in full operation all 7 pilot countries Further countries have expressed interest in the MeTA concept Title of presentation 23/06/09 MeTA
  • Title of presentation 23/06/09 MeTA MeTA developing these tools with Harvard, WB, WHO and others
  • Country contexts are varied. varied and sometimes conflicting interests – need to be worked thorugh Title of presentation 23/06/09 MeTA
  • Title of presentation 23/06/09 MeTA For more information, visit the website, engage in the international discussion forum
  • Following the MeTA forum in January, 25 CSOs grouped together and nominated one person to represent them in the MeTA council
  • While MeTA conducted meetings among various sectors before the IRR was published, there was no more engagement of MeTA after that.
  • Title of presentation 23/06/09 MeTA
  • Title of presentation 23/06/09 MeTA
  • Title of presentation 23/06/09 MeTA
  • Title of presentation 23/06/09 MeTA
  • Title of presentation 23/06/09 MeTA
  • Title of presentation 23/06/09 MeTA
  • Title of presentation 23/06/09 MeTA
  • Title of presentation 23/06/09 MeTA
  • Title of presentation 23/06/09 MeTA
  • Title of presentation 23/06/09 MeTA
  • Title of presentation 23/06/09 MeTA
  • Title of presentation 23/06/09 MeTA
  • Title of presentation 23/06/09 MeTA
  • Title of presentation 23/06/09 MeTA
  • Me Ta Private Sector Meeting 23 June 2009

    1. 1. MeTA Consultative Meeting with Pharmaceutical Industry A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES 23 June 2009 23/06/09
    2. 2. Financial Times Welcome and Introduction Andrew Jack 23/06/09
    3. 3. A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES 23 June 2009 23/06/09
    4. 4. Growth and Investment Group, DFID Opening remarks Calum Miller 23/06/09
    5. 5. A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES 23 June 2009 23/06/09
    6. 6. International MeTA Secretariat Brian Elliott 23/06/09
    7. 7. Brian Elliott, Executive Director, International MeTA Secretariat CONSULTATIVE MEETING WITH THE PHARMACEUTICAL INDUSTRY 23 June 2009, London Medicines Transparency Alliance(MeTA) Creating a level playing field in emerging markets
    8. 8. Meeting objectives <ul><li>To inform , consult , engage with and receive feedback from the pharmaceutical industry on MeTA’s concepts , principles and operations </li></ul><ul><ul><li>especially MeTA’s aspirations </li></ul></ul><ul><ul><ul><li>to promote and encourage ethical business practices and fair competition in developing country pharmaceutical markets through transparency </li></ul></ul></ul><ul><ul><ul><li>that this process will lead to increasing access to essential medicines in these markets </li></ul></ul></ul>
    9. 9. What is MeTA? <ul><li>International multi-stakeholder alliance to promote dialogue and encourage and support change . </li></ul><ul><li>Country support through the MeTA International Secretariat, funds from DFID, and technical assistance from partners. </li></ul><ul><li>Multi-stakeholder alliances in seven pilot countries to focus on what can be done to: </li></ul><ul><ul><li>increase access to quality medicines </li></ul></ul><ul><ul><li>improve information and increase transparency: on price, quality, availability and promotion </li></ul></ul><ul><ul><li>support stronger governance and more accountability </li></ul></ul>
    10. 10. MeTA Core Principles <ul><li>Governments are responsible for providing access to health care, including access to essential medicines </li></ul><ul><li>Stronger and more transparent systems and improved supply chain management will increase access </li></ul><ul><li>increasing equitable access to medicines improves health and enables other human development objectives to be achieved </li></ul><ul><li>Improved information about medicines can inform public debate, and provide a basis for better policy </li></ul><ul><li>A multi-stakeholder approach that involves all sectors – private, public and civil society - will lead to greater accountability </li></ul>
    11. 11. MeTA’s goal <ul><li>MeTA’s overall goal is to increase access to essential medicines for the poorest of the poor in developing countries </li></ul><ul><li>MeTA proposes that a fundamental and key condition for this goal to be achieved is the creation of a level playing field for ethical pharmaceutical companies, research based and generics, locally and internationally based. </li></ul>
    12. 12. The level playing field <ul><li>Poor patients could afford essential medicines </li></ul><ul><li>Fake and sub standard drugs eliminated </li></ul><ul><li>Stockouts and theft in the public sector and leakages from the public to the private sector controlled </li></ul><ul><li>High government taxation reduced or eliminated </li></ul><ul><li>importers, distributors, wholesaler and retailers margins curtailed </li></ul><ul><li>Registration and regulatory procedures streamlined </li></ul><ul><li>Medicines rationally prescribed </li></ul><ul><li>Ethical codes and promotion standards observed </li></ul><ul><li>IP rights protected as described under TRIPS - country's legitimate need for processes to obtain fair access to essential medicines recognised </li></ul>
    13. 13. The benefits of a level playing field <ul><li>Fair competition </li></ul><ul><li>Higher volume sales </li></ul><ul><li>Accurate market information </li></ul>
    14. 14. Not just another ATM initiative <ul><li>Not reinventing the wheel </li></ul><ul><li>A dding value to existing country ATM efforts through transparency and multi-stakeholder working </li></ul><ul><li>Testing the approach in different country settings , </li></ul><ul><li>Actively engaging stakeholders at country and international levels </li></ul><ul><li>Pr oviding a validated model for further countries. </li></ul>
    15. 15. Not just another attack on pharma prices <ul><li>MeTA’S multi-stakeholder process calls for </li></ul><ul><li>Transparency and progressive disclosure of data and information on quality, price, availability and promotion into the public domain </li></ul><ul><li>Full transparency around all of the barriers to access in the 7 pilot countries </li></ul><ul><li>Discussion, assessment, evaluation and analysis of these data and information by three stakeholder groups in a structured and collaborative setting in each country. </li></ul>
    16. 16. The scope of MeTA <ul><li>Currently 7 pilot countries </li></ul><ul><li>Possibility of expansion to others after evaluation of pilot </li></ul>
    17. 17. MeTa Country commitments <ul><li>Establish an effective multi-stakeholder forum and strengthen stakeholder capacity to engage </li></ul><ul><li>Progressive disclosure of data in four areas </li></ul><ul><li>Quality Availability Price Promotion </li></ul><ul><li>Private Sector Consultation identifying the key private sector stakeholder groups and suggesting private sector priorities to inform an overall strategic direction for MeTA </li></ul>
    18. 18. MeTA 23/06/09
    19. 19. Key implementation challenges <ul><li>Stakeholder engagement and maintaining interest </li></ul><ul><li>Insufficient legislation/regulation and excessive bureaucracy </li></ul><ul><li>Difficulties in extracting and accessing information </li></ul><ul><li>Lack of tools for analysing and assessing information </li></ul>23/06/2009 MeTA
    20. 20. Lessons learned in countries <ul><li>Needs to be country-led </li></ul><ul><li>Time to get the right people at the table and develop relationships between stakeholders </li></ul><ul><li>Consensus builds with exchange of views </li></ul><ul><li>Stakeholder commitment is key </li></ul><ul><li>Building trust is an essential part of the initiative. </li></ul><ul><li>Some problems need tough political action ; starting with less controversial issues is key. </li></ul><ul><li>Systems and structures for disclosing data often do not exist and may have to be created . </li></ul>
    21. 21. Key priorities for MeTA <ul><li>Progressive disclosure of data about medicines </li></ul><ul><li>Developing and testing a new multi-stakeholder approach including identifying and trying to fill gaps in the MeTA Councils; preparing stakeholders for meaningful engagement </li></ul><ul><li>Ensuring the strong engagement of the private sector at country and international level </li></ul><ul><li>Increasing the voice of patients and consumers which involves strengthening capacity and opportunity for their engagement </li></ul><ul><li>Documenting innovation, change and good practice across the programme. </li></ul>
    22. 22. MeTA – after the pilot phase <ul><li>After a successful evaluation in mid 2010, MeTA may include more countries </li></ul><ul><li>This means that building fair competition on level playing fields will be in progress in a significant number of countries </li></ul><ul><li>Expanded MeTA will require further funding and technical partners </li></ul>
    23. 23. MeTA asks the Pharma industry <ul><li>To support the MeTA principles of transparency and multi stakeholder dialogue at international level </li></ul><ul><li>To engage with MeTA at country level : </li></ul><ul><ul><li>Begin the process of progressive disclosure of data and information concerning price, quality, availability and promotion </li></ul></ul><ul><ul><li>Engage with the other stakeholders through the MeTA Councils in the dialogue arising from these disclosures aimed at eliminating barriers to access to essential medicines </li></ul></ul>
    24. 24. <ul><li>International Secretariat, [email_address] </li></ul><ul><li>www.MedicinesTransparency.org </li></ul>23/06/09 MeTA
    25. 25. A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES 23 June 2009 23/06/09
    26. 26. In Country MeTA – How MeTA works in four pilot countries 23/06/09
    27. 27. Pharmaceutical and Healthcare Association of the Philippines Reiner W. Gloor MeTA 23/06/09
    28. 28. MeTA Philippine Projects <ul><li>Strengthened the secretariat; Project Coordinator and Website Master now on board </li></ul><ul><li>Developed the MeTA Philippine website ( www.metaphilippines.org.ph) </li></ul><ul><li>Organized the Civil Society Group (CSO) and established systems for their inclusion in the MeTA council. CSOs have established CHAT (Coalition for Health and Transparency) </li></ul>
    29. 29. MeTA Philippine Projects <ul><li>Regular council meetings to discuss critical </li></ul><ul><li>issues on: </li></ul><ul><li> ~ Cheap Medicine Bill ~ Marketing Practices ~ BFAD Strengthening Bill ~ Final list of work plans </li></ul>
    30. 30. Level of Engagement of Stakeholders <ul><li>CSOs have a non-technical perspective of the issues </li></ul><ul><li>MeTA has a responsibility to educate CSOs on the technical and legal aspects of the pharmaceutical business. </li></ul><ul><li>(Funding from MeTA for CSO still pending) </li></ul>
    31. 31. Role of Pharma Sector In MeTA Key Issues <ul><li>Get involved in the core processes of MeTA and providing them representation in the Council </li></ul><ul><li>Cooperate with and support MeTA in its initiative to extract pharmaceutical information to achieve utmost transparency throughout the supply chain </li></ul><ul><li>Besides PHAP, PCIP (Philippine Chamber of Pharmaceutical Industry) is now also a member </li></ul>
    32. 32. Opportunities for the Pharma Sector <ul><li>MeTA is key to leveling the playing field among pharma companies </li></ul><ul><li>Develop a strong culture of ethical marketing </li></ul><ul><li>in both the private and public sectors </li></ul><ul><li>(e.g. gov’t procurement) </li></ul>
    33. 33. Opportunities for the Pharma Sector <ul><li>Support of MeTA objective of transparency and access to medicines will reduce the need for government intervention </li></ul><ul><li>MeTA can map out internationally acceptable marketing practices </li></ul>
    34. 34. MeTA & the Pharma Industry - Future Strategy <ul><li>Call for approval of country work plans </li></ul><ul><li>and awarding </li></ul>
    35. 35. Key Questions for Breakout Groups <ul><li>Should a Maximum Retail Price be imposed at all? </li></ul><ul><li>Supreme Court Ruling (exempting registration with BFAD of imported medicines) </li></ul>
    36. 36. A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES 23 June 2009 23/06/09
    37. 37. Pharmaceutical Manufacturers Association of Ghana (PMAG) Paul Lartey MeTA 23/06/09
    38. 38. MeTA – Ghana Formal Launch Establishment of Secretariat 12 th Nov. 2008 10 th Sept. 2008 Jan 2009 - June <ul><li>Multi-stakeholder group assembled </li></ul><ul><li>Formally inaugurated by Dep. Min of Health </li></ul><ul><li>Launch by Deputy Minister of health </li></ul><ul><li>Excellent media coverage </li></ul><ul><li>Secretariat staffed </li></ul><ul><li>CSO/Media training on 23 rd April, 2009 </li></ul><ul><li>Work plan under development </li></ul><ul><li>Website launched </li></ul><ul><li>www.metaghana.org </li></ul>Inauguration of Governing Council
    39. 39. MeTA – Ghana: Milestones <ul><li>Operating secretariat </li></ul><ul><li>Standardized data collection tools developed and operating </li></ul><ul><li>Coordinated data collection/collation system established </li></ul><ul><ul><li>Pricing </li></ul></ul><ul><ul><li>Quality </li></ul></ul><ul><ul><li>Availability </li></ul></ul><ul><ul><li>Rational use </li></ul></ul><ul><li>Mechanisms established </li></ul><ul><ul><li>Managing and analyzing </li></ul></ul><ul><ul><li>Quarterly dissemination </li></ul></ul><ul><li>Facilitation of peer oversight across healthcare professions </li></ul><ul><li>Annual multi-stakeholder open forum </li></ul>
    40. 40. Stakeholders <ul><li>Public Sector </li></ul><ul><li>Policy </li></ul><ul><li>Regulation </li></ul><ul><li>Healthcare delivery </li></ul><ul><li>Private Sector </li></ul><ul><li>- Manufacturing </li></ul><ul><li>Distribution </li></ul><ul><li>Retail </li></ul><ul><li>Other healthcare </li></ul><ul><li>Mission hospitals </li></ul><ul><li>Private hospitals/clinics </li></ul><ul><li>Advocacy Groups </li></ul><ul><li>Civil Society </li></ul><ul><li>Organizations </li></ul><ul><li>Media </li></ul>
    41. 41. <ul><li>Government (Policy) 4 </li></ul><ul><ul><li>Health </li></ul></ul><ul><ul><li>Trade </li></ul></ul><ul><ul><li>Finance </li></ul></ul><ul><ul><li>Attorney General </li></ul></ul><ul><li>Government drug programs 2 </li></ul><ul><ul><li>GNDP </li></ul></ul><ul><ul><li>National Drug Inf. Resource Center </li></ul></ul><ul><li>Health Care Providers 3 </li></ul><ul><ul><li>Ghana Health Service </li></ul></ul><ul><ul><li>Christian Health Assoc. of Ghana </li></ul></ul><ul><ul><li>Association of Private Medical and dental Practitioners </li></ul></ul><ul><li>National Hlth. Ins. Authority 1 </li></ul><ul><li>Professional Associations 3 </li></ul><ul><ul><li>Pharmaceutical Society of Ghana </li></ul></ul><ul><ul><li>Ghana medical Association </li></ul></ul><ul><ul><li>Nurses and midwives Council </li></ul></ul>Governing Council <ul><li>International Agencies 2 </li></ul><ul><ul><li>WHO </li></ul></ul><ul><ul><li>DFID </li></ul></ul><ul><li>Ghana Food and Drugs Board 1 </li></ul><ul><li>Private Sector 4 </li></ul><ul><ul><li>Pharmaceutical Manufacturers Association of Ghana </li></ul></ul><ul><ul><li>Wholesalers Group PSGh </li></ul></ul><ul><ul><li>Retail Group PSGh </li></ul></ul><ul><ul><li>Association of Licensed Chemical Sellers </li></ul></ul><ul><li>Civil Society Organizations 2 </li></ul><ul><ul><li>Health Access Network </li></ul></ul><ul><li>Media 1 </li></ul><ul><li>Academic Institutions 2 </li></ul>25 Member Council
    42. 42. Level of Engagement <ul><li>3 Governing Council meetings to date – fully attended </li></ul><ul><ul><li>>5 Absentees </li></ul></ul><ul><ul><li>Apologies sent </li></ul></ul><ul><li>Establishment of sub-committees: </li></ul><ul><ul><li>Administration and management </li></ul></ul><ul><ul><li>Technical </li></ul></ul><ul><ul><li>Advocacy </li></ul></ul><ul><li>Obtaining commitment of new Minister of Health </li></ul><ul><li>Resolution to register as Not-for-Profit </li></ul><ul><li>Draft Constitution under review </li></ul>
    43. 43. Missing Links? <ul><li>Adequacy of media involvement </li></ul><ul><ul><li>Representatives from Ghana Journalists Association </li></ul></ul><ul><li>Representation from major pharmaceutical manufacturers </li></ul><ul><ul><li>70% of medicines are imported </li></ul></ul><ul><ul><li>Need to include Reps of Ethical Pharmaceutical Manufacturers Association? </li></ul></ul><ul><li>Ghana Statistical Services </li></ul><ul><ul><li>Observer on the Council recruited </li></ul></ul><ul><li>Traditional healers Association </li></ul><ul><ul><li>To be part of annual open forum </li></ul></ul>
    44. 44. Ghana MeTA secretariat <ul><li>Staffed and in operation </li></ul><ul><ul><li>Located in the premises of the GNDP </li></ul></ul><ul><ul><li>Staffing: </li></ul></ul><ul><ul><ul><ul><li>Snr. Technical Advisor </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Technical Coordinator </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Office Manager </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Accountant </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Data Analyst </li></ul></ul></ul></ul><ul><li>Decision to relocate from MOH </li></ul><ul><ul><li>Space constraints </li></ul></ul><ul><ul><li>Quest for independence </li></ul></ul>
    45. 45. Pharmaceutical Sector in Ghana <ul><li>Majority of medicines in the country are imported </li></ul><ul><ul><li>~30% Locally manufactured </li></ul></ul><ul><ul><li>~60% Imported from Asia </li></ul></ul><ul><ul><li>~10% US/EU </li></ul></ul><ul><li>Significant problem with fake and substandard drugs </li></ul><ul><ul><li>10 – 30% </li></ul></ul>
    46. 46. Local Pharmaceutical Industry <ul><li>Industry started in Ghana in 1957 </li></ul><ul><li>35 Companies registered with PMAG </li></ul><ul><li>Currently supply <30% of the country’s needs </li></ul><ul><li>Narrow portfolio of medicines </li></ul><ul><ul><li>Analgesics </li></ul></ul><ul><ul><li>Haematinics </li></ul></ul><ul><ul><li>Antimalarials </li></ul></ul><ul><ul><li>1 ARV manufacturer </li></ul></ul><ul><ul><li>3 Antimalarial manufacturers </li></ul></ul>
    47. 47. Challenges to the Local Industry <ul><li>Key essential drugs (HIV/Malaria) purchased entirely through donor funds </li></ul><ul><ul><li>Requirement for WHO prequalification </li></ul></ul><ul><ul><li>No local producer is WHO prequalified </li></ul></ul><ul><li>High local cost of production </li></ul><ul><ul><li>Access to affordable financing </li></ul></ul><ul><ul><li>Cost of utilities </li></ul></ul><ul><ul><li>Needed economies of scale </li></ul></ul><ul><li>Cheap/fake imports </li></ul><ul><ul><li>Copies of innovators </li></ul></ul><ul><ul><li>Dumping </li></ul></ul><ul><ul><li>Trojan horse gifts </li></ul></ul><ul><ul><li>Sub standard drugs </li></ul></ul><ul><li>Perception of inferior quality </li></ul>
    48. 48. Opportunities <ul><li>Survey by ECOWAS and GTZ shows the Ghana industry to be strongest </li></ul><ul><ul><li>Relatively more stringent regulator FDB </li></ul></ul><ul><ul><li>Quality – GMP compliance </li></ul></ul><ul><ul><li>Capacity (<40% utilization) </li></ul></ul><ul><li>3 Companies working toward WHO prequalification </li></ul><ul><li>Technologically more advanced </li></ul><ul><ul><li>First API manufacturing capacity in West Africa </li></ul></ul><ul><ul><li>Equipment and facilities upgrading toward compliance </li></ul></ul>
    49. 49. Possible Role of MeTA <ul><li>Transparency around quality of locally manufactured vs. imported drugs </li></ul><ul><ul><li>Collection and dissemination of available data </li></ul></ul><ul><ul><ul><ul><li>Fake’ drugs </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Substandard drugs </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Adulterated drugs </li></ul></ul></ul></ul><ul><li>Encouragement of partnering between local and major pharmaceutical manufacturers </li></ul><ul><ul><li>Capacity building as contribution </li></ul></ul><ul><ul><li>Capacity utilization of local industry </li></ul></ul><ul><ul><ul><ul><li>Lower cost of local labor for local supply </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Capacity utilization for economies of scale </li></ul></ul></ul></ul>
    50. 50. Key Question <ul><li>What are the barriers, pros and cons to collaboration between major pharmaceutical manufacturers and the local industry? </li></ul>?
    51. 51. A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES 23 June 2009 23/06/09
    52. 52. Uganda Pharmaceutical Manufacturers Association Nazeem Mohamed MeTA 23/06/09
    53. 53. Uganda Pharmaceutical Market: Dynamics <ul><li>90% of medicines imported and subsidized (India/China) </li></ul><ul><li>Only 6 local manufacturers, working at around 50% capacity </li></ul><ul><li>Educated workforce but with low skill base </li></ul><ul><li>Manufacturers unable to access donor funds </li></ul><ul><li>High cost of operations (finance, utilities, etc) </li></ul><ul><li>Good regulatory authority but lacking resources </li></ul>
    54. 54. Challenges for the Private Sector - Pharmaceuticals <ul><li>Lack of Data </li></ul><ul><li>Insufficient Skills/technology </li></ul><ul><li>Poor patient information </li></ul><ul><li>Poor distribution/access </li></ul><ul><li>Unfair Competition </li></ul><ul><li>Insufficient Government Support </li></ul>
    55. 55. Issue: Lack of Data <ul><li>No data available on; </li></ul><ul><ul><li>Product sales, usage, dosage, etc </li></ul></ul><ul><ul><li>Therapy area trends, e.g. CVD </li></ul></ul><ul><ul><li>Pricing of products at different levels of supply chain </li></ul></ul><ul><ul><li>Appropriate use/mis-use of products by consumers </li></ul></ul>Difficult to attract investors due to lack of transparency of market
    56. 56. Issue: Insufficient Skills/Technology <ul><li>Science teaching very academic with little industrial experience </li></ul><ul><li>Formulation and new product development skills limited </li></ul><ul><li>Maintenance of equipment (e.g. HPLC, HVAC) difficult </li></ul><ul><li>Regulatory environment getting more stringent! </li></ul>Need for facilitating technology transfer from MNC’s and others
    57. 57. Issue: Poor Medicines Distribution <ul><li>5% of population live in cities with 95% of pharmacies!! </li></ul><ul><li>Access to a pharmacy or licensed drug store difficult in rural areas </li></ul><ul><li>Few pharmacists - most outlets run by traders with no training!! </li></ul><ul><li>Medicines for “Public use” diverted to “Private market” (Corruption!!) </li></ul>
    58. 58. Barriers for local Manufacturers <ul><li>Exclusion from Donor funded procurement (WHO pre-qualification?) </li></ul><ul><li>Cheap imports subsidized by source countries </li></ul><ul><li>Access to technology/skills is limited </li></ul><ul><li>Variations in Quality of raw material </li></ul><ul><li>Power shortage/high energy costs, poor infrastructure ------ high cost of Production! </li></ul><ul><li>Regulatory authority increasingly stringent </li></ul>
    59. 59. Recommendations <ul><li>Assistance in Technology and Skill transfer to aid local manufacturers </li></ul><ul><li>Find ways to use Global Fund to procure from local manufacturers (non-tariff barrier) </li></ul><ul><li>Consider centralized raw material sourcing </li></ul><ul><li>Consumer education/information on correct use of medicines </li></ul><ul><li>Transparency of Market data to allow growth of local industry </li></ul>
    60. 60. MeTA Uganda: Structure <ul><li>Council </li></ul><ul><ul><li>Civil Society </li></ul></ul><ul><ul><li>Private sector </li></ul></ul><ul><ul><li>Government </li></ul></ul><ul><ul><li>Rotating Chair </li></ul></ul><ul><li>Secretariat </li></ul><ul><ul><li>Member from each stakeholder </li></ul></ul><ul><ul><li>Coordinator </li></ul></ul><ul><li>Meetings </li></ul><ul><ul><li>Council, secretariat and stakeholders mtgs </li></ul></ul>
    61. 61. MeTA Uganda: Projects <ul><li>Medicines Price Survey </li></ul><ul><li>On line access to drug information held by National Drug Authority </li></ul><ul><li>Create public awareness to control self medication </li></ul><ul><li>Promote transparency in planning, provision and accountability of medicines by Govt </li></ul>
    62. 62. Medicines Price Survey <ul><li>Objective </li></ul><ul><li>Provide an accurate and regular survey of prices and availability of medicines along the supply chain </li></ul><ul><li>Deliverables </li></ul><ul><li>Quarterly pricing/availability surveys </li></ul><ul><li>Highlight shortages/stock outs </li></ul><ul><li>Highlight margins at different levels, e.g. manufacturer, wholesaler, retailer </li></ul><ul><li>Recommend pricing policy to Govt </li></ul>
    63. 63. On line access to drug information <ul><li>Objective </li></ul><ul><li>Disseminate accurate information on registration data base and usage of medicines in the country </li></ul><ul><li>Deliverables </li></ul><ul><li>Electronic on line register of medicines at NDA </li></ul><ul><li>Capture all imports/exports of medicines </li></ul><ul><li>Clinical and Pharmacovigilance data </li></ul>
    64. 64. Create public awareness to control self medication <ul><li>Objective </li></ul><ul><li>Empower communities to reduce “abuse” of medicines </li></ul><ul><li>Deliverables </li></ul><ul><li>Awareness campaigns on specific groups of medicines, e.g. anti-malarials </li></ul><ul><li>Training for community medicine handlers </li></ul><ul><li>Media campaigns (radio, street theatre, etc) </li></ul>
    65. 65. Promote transparency in procurement of medicines <ul><li>Objective </li></ul><ul><li>Funds for public procurement of medicines are used correctly </li></ul><ul><li>Deliverables </li></ul><ul><li>Evaluate the implementation of the Health Sector Plan (Global Fund, etc) </li></ul><ul><li>Recommendations for improvement </li></ul>
    66. 66. Private Sector & MeTA Private Sector Needs MeTA Projects Lack of Data Addressing (pricing/NDA) Insufficient Skills Not addressed Poor Patient Information Addressing (HEPS/PSU) Poor Distribution Partly addressed (MoH) Unfair Competition Not addressed
    67. 67. MeTA /Private Sector Future Considerations?? <ul><li>Facilitate access to “experts” willing to help with skill transfer </li></ul><ul><li>Create a buddy system with MNC’s to ease transfer of technology </li></ul><ul><li>Enable used but valuable equipment to be donated to private sector </li></ul><ul><li>Align goals of academia with the private sector (industrial experience!!) </li></ul>
    68. 68. A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES 23 June 2009 23/06/09
    69. 69. Jordanian Association of Manufacturers of Pharmaceuticals and Medical Appliances Hanan Sboul MeTA 23/06/09
    70. 70. OUTLINE <ul><li>Brief on Jordanian pharmaceutical industry  </li></ul><ul><li>Brief on MeTA project in Jordan </li></ul><ul><li>Structure of MeTA in Jordan, who is at the table, and who is not but should be </li></ul><ul><li>key priorities for MeTA Jordan, workplan </li></ul><ul><li>Role of pharmaceutical sector in MeTA Key issues, and how MeTA will benefit the sector </li></ul><ul><li>Challenges </li></ul>
    71. 71. Jordanian Pharmaceutical Industry <ul><li>Started in 1962 </li></ul><ul><li>16 companies, 17 branches outside Jordan </li></ul><ul><li>Export oriented; to 66 export markets. Major export markets are Saudi Arabia & Algeria </li></ul><ul><li>Local market share; 50% in volume & 28% in value </li></ul><ul><li>Essential for Jordan economy; employment & export </li></ul><ul><li>Strategic alliances with international firms </li></ul>
    72. 72. Among the Jordanian industry’s objectives <ul><li>Making medicines available and affordable </li></ul><ul><li>Addressing fundamental inefficiencies in the pharmaceutical market </li></ul><ul><li>Increasing transparency and accountability in medicines supply chains </li></ul><ul><li>Leveling the playing field & achieving transparency in medicines </li></ul>
    73. 73. <ul><li>MeTA initiative: DFID/ UK in collaboration with WHO & WB </li></ul><ul><li>Consultations in Jordan in 2007 resulted in design & plan for a country- led MeTA. MeTA council in Jordan started in May 2008 and held official launch in May 2009. </li></ul>
    74. 74. Stakeholders in MeTA Council WHO DFID WB
    75. 75. Jordan MeTA Secretariat <ul><li>Location- hosted by the High Health Council </li></ul><ul><li>Staffing: pharmacist, administrative officer and accountant </li></ul><ul><li>Website: national website under construction </li></ul><ul><li>http://www.medicinestransparency.org/meta-countries/jordan/ </li></ul>
    76. 76. National Priorities & Workplan for MeTA - Jordan <ul><ul><li>MeTA Council developed a workplan within a framework with integration / collaboration of all the players in the Jordan pharmaceutical sector </li></ul></ul><ul><ul><li>The framework is based on the structure of the National Drug Policy ( NDP ) 2002 document </li></ul></ul><ul><ul><li>Workplan consists of following elements: </li></ul></ul><ul><ul><ul><li>A: Baseline data </li></ul></ul></ul><ul><ul><ul><li>B: Three working groups </li></ul></ul></ul>
    77. 77. A: Baseline Data <ul><li>Activities to generate baseline data within MeTA workplan to be shared amongst MeTA stakeholders: </li></ul><ul><li>Private Sector Mapping (conducted March 2009) </li></ul><ul><li>Supply Chain Mapping (conducted April 2009) </li></ul><ul><li>WHO Level II Pharmaceutical Sector Assessment - includes household and health facility surveys on price and availability (ongoing) </li></ul><ul><li>Drug Utilization database - CSO Alliance (planned July-Dec 2009) </li></ul><ul><li>Data/findings will be disclosed on Jordan MeTA website & discussed in Public Forum October 2009 </li></ul>
    78. 78. <ul><li>B: Three Working Committees: </li></ul>
    79. 79. Committee I
    80. 80. Committee II
    81. 81. Committee III
    82. 82. Role of Pharmaceutical Sector in MeTA Key Issues How will MeTA benefit the Sector? <ul><li>Be active in the transparency process, active representation </li></ul><ul><li>Learn how to benefit from the transparency, requires capacity building for the sector </li></ul><ul><li>Do studies on impact of transparency related measures on accessibility and affordability of medicines, may include: outcomes in public procurement, monitoring of promotional activities </li></ul>
    83. 83. Challenges <ul><li>Willingness of the private sector to share information, such as information related to prices, promotional activities and quality </li></ul><ul><li>Building capacity of private sector to actively get engaged in the process </li></ul>
    84. 84. Thank You for your attention <ul><li>Questions to: </li></ul><ul><li>[email_address] </li></ul><ul><li>www.japm.com </li></ul>
    85. 85. A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES 23 June 2009 23/06/09
    86. 86. Epirus Oriol Ramis MeTA 23/06/09
    87. 87. GROUP WORK <ul><li>Predefined small group discussion. </li></ul><ul><li>Increases the chances of contrasting views. </li></ul><ul><li>Facilitates dialogue </li></ul>
    88. 88. Method: <ul><li>Small groups directed to look for answers to one question: </li></ul><ul><ul><li>select some one to report back. Flip charts are encouraged </li></ul></ul><ul><ul><li>allow 1-2 minutes for personal thinking before engaging in group work. </li></ul></ul><ul><ul><li>arguments forbidden </li></ul></ul><ul><ul><li>everyone is free to share what he/she wants & everyone is responsible for it. </li></ul></ul><ul><ul><li>allow time for each participant to talk (45 minutes/9= 5 minutes) </li></ul></ul><ul><li>Facilitation to help the group to do the task </li></ul><ul><li>Temporary organisation likely to experience some of the MeTA tensions and hence becoming material to be explored. </li></ul>
    89. 89. Q1: Pricing <ul><li>Do you see a role for MeTA in the clarification (through data disclosure) of the supply chain in countries as a way to ensure a more rational and sustainable pricing systems? What would you be expecting, as a private sector actor, from MeTA? </li></ul><ul><li>How do you think the manufacturing industry could help MeTA? </li></ul>
    90. 90. Q2: Quality <ul><li>MeTA is concerned in setting up local interventions to support the eradication of fake and substandard drugs in these markets through more transparency and improved national regulation and other interventions. </li></ul><ul><li>To what extent do you think that can be effective? What meaningful actions do you suggest? </li></ul>
    91. 91. Q3: Availability <ul><li>Drugs availability is often described as a/the major problem in most countries. </li></ul><ul><li>Supply chains and local manufacturing are weak. What would you expect for an initiative as MeTA to contribute? And, how do you think the private sector could also contribute? </li></ul>
    92. 92. Q4: Ethical Practices <ul><li>Unethical practices prevent both a good functioning market and an efficient and equitable supply chain. </li></ul><ul><li>Do you see opportunities for MeTA to contribute effectively to the eradication of these practices in developing economies and to the chronic disruptions (including leakages) of public and private supply chains? </li></ul>
    93. 93. Rooms <ul><li>Room 1: Council Chamber </li></ul><ul><li>Room 2: Censor Room </li></ul><ul><li>Room 3: Linacre 1 room </li></ul><ul><li>Room 4: Linacre 2 room </li></ul>
    94. 94. A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES 23 June 2009 23/06/09
    95. 95. Plenary group feedback discussions MeTA 23/06/09
    96. 96. A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES 23 June 2009 23/06/09
    97. 97. Peter Stephens, IMS HEALTH Wilbert Bannenberg, Technical Director, MeTA Transparency, data and information to be disclosed in MeTA pilot countries MeTA 23/06/2009
    98. 98. MeTA’s Focus <ul><li>MeTA’s focus will be on strengthening developing country capacity to collect, analyse, disseminate and use data on medicine quality, availability, pricing and promotion . </li></ul><ul><li>We work in a multi-stakeholder approach </li></ul><ul><li>This will help improve transparency and accountability around the way medicines are selected, regulated, procured, distributed, supplied and then prescribed to and used by patients. </li></ul>MeTA
    99. 99. What is IMS HEALTH? <ul><li>Trusted source of pharmaceutical intelligence </li></ul><ul><li>104 countries, 130,000 suppliers, 730,000 outlets </li></ul><ul><li>Billions of transactions, >60 million anonymised longitudinal patient records, 260 million consultations world-wide per annum </li></ul><ul><li>Used by supply chain, manufacturers and regulators </li></ul>
    100. 100. Why does IMS want to help MeTA? <ul><li>Corporate strategy Corporate responsibility </li></ul>Transparency Coverage History
    101. 101. How has or can IMS help MeTA? <ul><li>Data </li></ul><ul><ul><li>Peru </li></ul></ul><ul><li>Capacity strengthening on a not-for-profit basis </li></ul><ul><ul><li>Sub-Saharan Africa </li></ul></ul><ul><li>Trusted Third Party </li></ul><ul><ul><li>To minimise business risk and open up opportunities for all stakeholders, including IMS </li></ul></ul>
    102. 102. What will help tip the balance in favour of disclosure? <ul><li>Active encouragement by principals of importers to share data </li></ul><ul><li>Dissemination and analysis of import data </li></ul><ul><li>Opportunities versus risk modelling for public & private supply chains </li></ul><ul><ul><li>Based on understanding real market conditions; analysis outside Gov’t </li></ul></ul><ul><li>Validation of outlet survey data using actual sales data </li></ul><ul><ul><li>Needs only partial disclosure; policy based on real information </li></ul></ul>
    103. 103. Transparency? <ul><li>Improving information access, scrutiny and use, in order to support the development of viable, efficient medicines markets and supply systems that benefit all developing country consumers </li></ul><ul><ul><li>Transparency = not only disclosure of the price, quality, use, availability of medicines; but also: </li></ul></ul><ul><ul><li>how to use the information to identify barriers, and to agree on solutions </li></ul></ul>23/06/2009 MeTA
    104. 104. Key data collected in MeTA <ul><li>[Mainly through disclosures by stakeholders] </li></ul><ul><li>Price data of medicines </li></ul><ul><ul><li>Procurement prices (~ MSH Intl price indicator) </li></ul></ul><ul><ul><li>Retail prices private, public sector (~WHO/HAI methodology) </li></ul></ul><ul><ul><li>Components (tax, VAT, margins, profit etc) </li></ul></ul><ul><li>Quality and registration status </li></ul><ul><ul><li>Medicines, GMP plants, GDP wholesalers, Licensed outlets </li></ul></ul><ul><li>Availability (basket) </li></ul><ul><li>Promotion (being developed) </li></ul>23/06/2009 MeTA <ul><li>… for each area: </li></ul><ul><li>Policy </li></ul><ul><li>Practices </li></ul><ul><li>Outcomes? </li></ul>
    105. 105. Contextual information collected <ul><li>[From surveys rather than from disclosures] </li></ul><ul><li>Supply chain operations </li></ul><ul><ul><li>Supply chain mapping data </li></ul></ul><ul><li>Affordability </li></ul><ul><ul><li>Generic utilization data, cost of treatment (related to salary) </li></ul></ul><ul><li>Equitable access </li></ul><ul><ul><li>Data on health and medicines expenditure by income group, and experiences of treating key illnesses by income group. </li></ul></ul><ul><li>Rational use </li></ul><ul><ul><li>Household survey data, prescribing data in health facilities </li></ul></ul>23/06/2009 MeTA
    106. 106. Who should disclose what? <ul><li>Government : VAT, taxes, budget, selection, quantification, </li></ul><ul><li>Procurement agency : purchase & selling prices </li></ul><ul><li>DRA : quality and registration data, inspection, QC lab results </li></ul><ul><li>Private sector : prices, margins, availability, promotion codes of conduct </li></ul><ul><li>Civil society / academics : Availability (equity), Affordability, Rational use </li></ul>23/06/2009 MeTA
    107. 107. What should this lead to? <ul><li>Better information to the sector & general public </li></ul><ul><li>More engagement in MeTA Councils </li></ul><ul><li>All stakeholders better informed </li></ul><ul><li>More trust and collaboration between stakeholders </li></ul><ul><li>Seeking improved, joint solutions </li></ul><ul><li>Better access to medicines </li></ul><ul><ul><li>Key hypothesis to be proven! </li></ul></ul>23/06/2009 MeTA
    108. 108. Thank you! <ul><li>Wilbert Bannenberg </li></ul><ul><li>Email: wilbert@metasecretariat.org </li></ul><ul><li>Mobile: +31-6-20873123 </li></ul><ul><li>MeTA website: www.MedicinesTransparency.org </li></ul><ul><li>Peter Stephens </li></ul><ul><li>Email: pstephens@uk.imshealth.com </li></ul><ul><li>Mob: +44-7711-148653 </li></ul><ul><li>IMS website: www.imshealth.com </li></ul>MeTA
    109. 109. A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES 23 June 2009 23/06/09
    110. 110. International MeTA Secretariat Andrew Chetley MeTA 23/06/09
    111. 111. Andrew Chetley Communication and Capacity Strengthening Director International MeTA Secretariat 23 June 2009, Consultative meeting with the pharmaceutical industry, London Medicines Transparency Alliance (MeTA): The core principles MeTA 16/09/2008
    112. 112. 5 key principles <ul><li>Responsibility for access </li></ul><ul><li>Role of transparency </li></ul><ul><li>Importance of equity </li></ul><ul><li>Importance of evidence-based policy </li></ul><ul><li>Mutual accountability through multi-stakeholder action </li></ul>16/09/2008 2
    113. 113. 1. Responsibility for access <ul><li>Governments are responsible for providing access to health care, including access to essential medicines </li></ul>23 June 2009 3
    114. 114. 2. Role of transparency <ul><li>Stronger and more transparent systems and improved supply chain management will increase access </li></ul>16/09/2008 3
    115. 115. 3. Equity <ul><li>Increasing equitable access to medicines improves health and enables other human development objectives to be achieved </li></ul>16/09/2008 4
    116. 116. 4. Evidence-based policy <ul><li>Improved information about medicines can inform public debate, and provide a basis for better policy </li></ul>23 June 2009 6 2. Affordable prices ACCESS 1. Rational selection 4. Reliable health and supply systems 3. Sustainable financing
    117. 117. 5. Mutual accountability through mutli-stakeholder action <ul><li>A multi-stakeholder approach that involves all sectors – private, public and civil society - will lead to greater accountability </li></ul>23 June 2009 7
    118. 118. What’s new about MeTA? <ul><li>“ Learning to engage in dialogue means to move from hearing to listening.” </li></ul>16/09/2008 MeTA
    119. 119. Will poor people in these countries have greater access to medicines? 16/09/2008 MeTA
    120. 120. <ul><li>[email_address] </li></ul><ul><li>www.MedicinesTransparency.org </li></ul>16/09/2008 MeTA
    121. 121. A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES 23 June 2009 23/06/09
    122. 122. Indian Pharmaceutical Alliance Dilip Shah MeTA 23/06/09
    123. 123. London 23 June 2009 By D G Shah Secretary General Indian Pharmaceutical Alliance Industry Engaging with the MeTA Concept and Principles
    124. 124. Outline of Presentation <ul><li>Global Experience </li></ul><ul><li>Pro–Competitive Policy Framework </li></ul><ul><li>Balanced Policy Approach </li></ul><ul><li>Indian Experience </li></ul>IPA: 06/09
    125. 125. Global Experience IPA: 06/09 Prices of ARV Triple Combination : 2000-2003 Source: Sources and Prices of Medicines June 2003, A Joint Unicef, UNAIDS, WHO, MSF Project Prices Per Patent Per Year Originator $ $727 Originator $ 10439 Brazil $2767 Hetero $347 Ranbaxy $295 Aurobindo $209 Hetero $201 Cipla $350 Originator $ $ 931
    126. 126. Global Experience <ul><li>Lesson from Prices of ARV Triple Combination </li></ul><ul><ul><ul><ul><li>Predictability of Demand </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Sustainability of Funding </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Economy of Scale </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Single Regulatory Approval </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Transparency in Procurement </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Multi-Sources of Supply </li></ul></ul></ul></ul>IPA: 06/09
    127. 127. Pro-Competitive Policy Framework <ul><li>Creating Conditions for Affordable Medicines </li></ul><ul><ul><ul><li>Augmenting Supply </li></ul></ul></ul><ul><ul><ul><li>Encouraging New Entrants </li></ul></ul></ul><ul><ul><ul><li>Reducing Risks – Stability of Policy </li></ul></ul></ul><ul><ul><ul><li>Rewarding Enterprise </li></ul></ul></ul><ul><ul><ul><li>Weighing Cost v/s Benefits </li></ul></ul></ul>IPA: 06/09
    128. 128. Pro-Competitive Policy Framework <ul><li>Barriers to Affordable Medicines </li></ul><ul><ul><ul><li>Multiple Regulatory Approvals </li></ul></ul></ul><ul><ul><ul><li>Fragmented Capacities </li></ul></ul></ul><ul><ul><ul><li>High-Risk Business </li></ul></ul></ul><ul><ul><ul><li>Over Regulation of Industry </li></ul></ul></ul><ul><ul><ul><li>Single Source of Supply </li></ul></ul></ul>IPA: 06/09
    129. 129. Balanced Policy Approach <ul><li>Policy Framework </li></ul><ul><li>Short Term & Long Term </li></ul><ul><li>Cost v/s Quality, Safety, Efficacy </li></ul><ul><li>Current Needs & Future Growth </li></ul><ul><li>Access & Innovation </li></ul>IPA: 06/09
    130. 130. Indian Experience <ul><li>Lessons from Drugs (Prices Control) Order, 1979 </li></ul><ul><ul><ul><ul><li>Shortages/ Black Marketing of Medicines </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Emergence of Spurious & Counterfeits </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Slowdown of Investment </li></ul></ul></ul></ul>Statement from 1986 Drug Policy “ Creating an environment conducive to new investment into the Pharmaceuticals industry, to encouraging cost-effective production with economic sizes and to introducing new technologies and new drugs”. IPA: 06/09
    131. 131. Indian Experience <ul><li>Lessons from Drugs (Prices Control) Order, 1995 </li></ul><ul><li>Abundance of Medicines Except Price Controlled Products </li></ul><ul><li>Intensely Competitive Market </li></ul><ul><li>Robust Growth </li></ul><ul><li>Innovations in Delivery Mechanism </li></ul><ul><li>Quality & GMP – Differentiator from Others </li></ul>IPA: 06/09
    132. 132. THANK YOU [email_address] IPA: 06/09
    133. 133. A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES 23 June 2009 23/06/09
    134. 134. Panel discussion and industry feedback MeTA 23/06/09
    135. 135. Andrew Jack – Financial Times Chair MeTA 23/06/09
    136. 136. Panel MeTA 23/06/09
    137. 137. MeTA International Advisory Group Sophia Tickell MeTA 23/06/09
    138. 138. Indian Pharmaceutical Alliance Dilip Shah MeTA 23/06/09
    139. 139. American Pharmaceutical Group Workstream Chris Mockler MeTA 23/06/09
    140. 140. European Generics Medicines Association Rory O’Riordan MeTA 23/06/09
    141. 141. A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES 23 June 2009 23/06/09
    142. 142. Andrew Jack Summary and Conclusions MeTA 23/06/09
    143. 143. Thank You ! 23/06/09

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