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Stop Stock-outs! Access to Medicines for All! anti-counterfeiting initiatives and

Stop Stock-outs! Access to Medicines for All! anti-counterfeiting initiatives and other access barriers. Christa Cepuch OSI AEM Initiative – CS Role and Response 09 December 2009, Lusaka. Outline. WHO essential medicines concept Medicines access and stock-outs / low availability in Africa

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Stop Stock-outs! Access to Medicines for All! anti-counterfeiting initiatives and

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  1. Stop Stock-outs! Access to Medicines for All! anti-counterfeiting initiatives and other access barriers Christa Cepuch OSI AEM Initiative – CS Role and Response 09 December 2009, Lusaka

  2. Outline • WHO essential medicines concept • Medicines access and stock-outs / low availability in Africa • What are the barriers to access? • The journey of a pill: • R&D • Intellectual Property • Regulation • Generics vs counterfeits vs substandard medicines • Addressing initiatives which may affect stock-outs / low availability… anti-counterfeiting initiatives

  3. What are essential medicines? • satisfy the priority health care needs of the population • selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness • intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford • implementation of the concept of essential medicines is intended to be flexible • exactly which medicines are regarded as essential remains a national responsibility www.who.int/medicines

  4. Availability of essential medicines • Average availability in Africa is only 38% in the public sector and 59% in the private sector. • Public sector availability of medicines is consistently lower than in the private sector.

  5. Barriers to access • Health system capacity • Health budgets • Lack of research and development • Price • Patents • Quality of diagnosis • Accurate prescribing • Selection, distribution, dispensing of medicines • Medicine quality

  6. Price of essential medicines • Lowest-priced generic medicines cost 6.4 and 2.5 times international reference prices(IRPs) in the private and public sectors, respectively. • Add-on costs in the supply chain can more than double medicine prices in the private sector. Public sector mark-ups can also be substantial.

  7. Barriers to access • Health system capacity • Health budgets • Lack of research and development • Price • Patents • Quality of diagnosis • Accurate prescribing • Selection, distribution, dispensing of medicines • Medicine quality

  8. Public expenditure on medicines There is wide variation in national per capita spending on medicines by the public sector, ranging from US $0.04 to $187.30 among developing countries.

  9. Increased financial support and differential pricing can have a dramatic impact on medicine availability Availability of Artemether/lumefantrine 20/120 mg in Kenya Global Fund grant start date (02/2006)

  10. Barriers to access • Health system capacity • Health budgets • Lack of research and development • Price • Patents • Quality of diagnosis • Accurate prescribing • Selection, distribution, dispensing of medicines • Medicine quality

  11. R&D: for real health needs? • 1975-1999: 1,393 new chemical entities (NCEs) marketed; only 1% of new medicines developed were for neglected diseases • 1999-2004: 163 NCEs, including 3 new medicines for neglected diseases Trouiller et al., Lancet 2002, 359:2188-94; updated figures: Torreele, Chirac 2005

  12. Barriers to access • Health system capacity • Health budgets • Lack of research and development • Price • Patents • Quality of diagnosis • Accurate prescribing • Selection, distribution, dispensing of medicines • Medicine quality

  13. ‘Patents constitute a temporary monopoly, but in the end society benefits’ Fred Hassan, CEO of Schering-Plough and president of IFPMA 10 Oct 2006 Which society benefits?

  14. 20 year patent on medicines • 1995: WTO TRIPS Agreement outlines the “minimum standards” for national legislation on IP – concern arose on the effect of TRIPS on access to essential medicines • 2001: WTO Ministerial Doha Declaration on TRIPS and Public Health“… TRIPS …does not and should not prevent… measures to protect public health…”

  15. Generic medicines • Equivalent copy of an originator medicine • Undergoes strict scrutiny before it is licensed and given market approval by the NMRA • In Africa, health systems and budgets depend on generic medicines • PEPFAR’s purchase of generic ARVs resulted in cost-savings up to 90%

  16. Effect of Generic Competition Effect of generic competition Source: http://www.msfaccess.org/fileadmin/user_upload/diseases/hivaids/Untangling_the_Web/Untanglingtheweb_July2008_English.pdf www.msfaccess.org

  17. Barriers to access • Health system capacity • Health budgets • Lack of research and development • Price • Patents • Quality of diagnosis • Accurate prescribing • Selection, distribution, dispensing of medicines • Medicine quality

  18. Substandard medicines • “genuine” medicines which do not meet quality specifications set for them • contamination (impurity) • too much active ingredient (toxicity) or too little active ingredient (ineffective treatment; resistance) • Failure may be due to • poor manufacturing, storage and / or distribution conditions (accidental or lack of resources / expertise) • weak medicines regulatory agencies • lack of information / reporting

  19. Sub-standard AMs in Kenya: a sampling of studies

  20. Anti-counterfeit initiatives: a NEW barrier to access?? • Health system capacity • Health budgets • Lack of research and development • Price • Patents • Quality of diagnosis • Accurate prescribing • Selection, distribution, dispensing of medicines • Medicine quality • Anti-Counterfeit initiatives…?!!?!!

  21. Counterfeit medicines: definitions • WTO TRIPS: trademark infringement • WHO: • deliberately and fraudulently mislabeled with respect to identity and / or source • can apply to both brand and generic medicines • may include medicines with the correct active ingredients, with insufficient active ingredients or with fake packaging • IMPACT… • Country legislations…

  22. Advocating for public-health friendly Anti-Counterfeit initiatives • Kenya ongoing efforts to address the Act’s weaknesses (attempting amendments; supporting the Constitutional Court case; media) • Uganda collaborative efforts to improve the draft Bill • Tanzania identifying issues and finding partners • Zambia CSO meeting 11 Dec • Ghana...? South Africa...? Zimbabwe…? • other countries? • EAC Policy on IPRs and Anti-Counterfeiting

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