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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
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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
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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
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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 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
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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.
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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
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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.
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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
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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
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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
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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
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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
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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…”
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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%
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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
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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
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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
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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
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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…?!!?!!
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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 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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