1. 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. 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. 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. 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.

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6. 6 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

7. 7 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.

8. 8 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

9. 9 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.

10. 10 Availability of Artemether/lumefantrine 20/120 mg in Kenya Global Fund grant start date (02/2006) Increased financial support and differential pricing can have a dramatic impact on medicine availability

11. 11 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

12. 12 R&D: for real health needs? Trouiller et al., Lancet 2002, 359:2188-94; updated figures: Torreele, Chirac 2005 1999-2004: 163 NCEs, including 3 new medicines for neglected diseases  1975-1999: 1,393 new chemical entities (NCEs) marketed; only 1% of new medicines developed were for neglected diseases

13. 13 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

14. 14 Which society benefits? ‘Patents constitute a temporary monopoly, but in the end society benefits’ Fred Hassan, CEO of Schering-Plough and president of IFPMA 10 Oct 2006

15. 15 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…”

16. 16 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%

17. 17 Effect of Generic Competition Source: http://www.msfaccess.org/fileadmin/user_upload/diseases/hivaids/Untangling_the_Web/Untanglingtheweb_July2008_English.pdf Effect of generic competition www.msfaccess.org

18. 18 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

19. 19 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

20. 20 Sub-standard AMs in Kenya: a sampling of studies StudyResultsComments Bate 2008 35% of the samples failed either or both tests (assay and dissolution)  retail sector  AEI is an American neo-con think tank; pro-big-pharma Atemnkeng 2007 37.5% AMs did not meet Ph. Eur. content requirement of 95 – 105% active ingredient. Kenya and DRC retail sector PPB 2006 16% AMs failed QC testing  unpublished report  all three health sectors surveyed Amin 2005 45% of AMs were sub-standardretail sector

21. 21 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…?!!?!!

22. 22 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…

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24. 24 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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