1. Intellectual Property Rights and Access to Medicines: an Overview and Introduction to the TRIPS flexibilities Workshop on the Utilization of the TRIPS flexibilities in Botswana 26-27 March 2013, Gaborone, Botswana Katie Kirk HIV, Health and Development Practice, UNDP

2. Overview What is a patent? What are the threats to treatment? What is TRIPS and what does it mean for access? What options are available? – The TRIPS flexibilities and the Doha Declaration – The flexibilities, unpacked The policy making process Conclusions

3. Patent characteristics A patent is a social contract between the inventor and society: temporary monopoly in exchange for disclosure of how to make invention to the exclusion of others A patent gives the inventor the temporary exclusive right to make, use, import, export, sell or market an invention in the country where the invention is patented Patent rights are territorial rights International treaties particularly the TRIPS Agreement set minimum requirements that national laws should contain There have been exceptions to patent rights, common exceptions have been national interest and public order

4. Patent system must weigh: 1) Right of inventor to benefit, and 2) Right of society to benefit

5. How do patents affect access? 2 ways: – 1 st is by creating protections on existing drugs, which give patent holders exclusive control to licence, manufacture and distribute their product. – 2 nd is by influencing the kind of innovation which is undertaken in the first place.

7. Non patent factors Critics often argue that patents not the main barrier to better access to medicines in poor regions of the world. We recognise, and would not seek to underplay other factors, like: – slow registration of medicines – inefficiencies in procurement and budgeting; – the presence or absence of a viable generics industry; – human resources constraints; – and wider health system distribution and capacity.

8. But…. World Health Organisation (WHO) adviser, Dr Zafar Mirza – "We recognize that they [the TRIPS flexibilities] are not the simplest mechanisms to use...but it's a tool that we can use and should use to improve access to treatment as much as we can.“

9. What are the threats to treatment? Combination of factors affecting countries abilities to sustain or scale up access: Increased demand from changing treatment guidelines, leading to more people on treatment (CD4 threshold from 250-350) Anticipated increases in resistance High costs of second and third generation treatments Insecure funding from external funding sources Increasing health burdens from co-infections and non- communicable diseases

11. What is TRIPS? Long title: Agreement on Trade-Related Aspects of Intellectual Property Rights – agreed 1994, entry into force 1995. – A WTO agreement setting minimum standards of IP protection for countries to follow.

12. How did TRIPS change things? Before the TRIPS Agreement, up to 50 countries did not grant patents for pharmaceutical products Brazil & India changed colonial laws to exclude pharmaceutical products from being patented, stimulating innovation Many developed countries only granted pharmaceutical patents after their industries developed e.g. Switzerland 1977, Italy 1978 TRIPS prescribes minimum standards for IP protection & enforcement Article 33 requires WTO Members to provide a 20 year minimum period of patent protection

13. Public Health TRIPS Flexibilities at a Glance

14. Doha Declaration Long title: Declaration on the TRIPS Agreement and Public Health (the ‘Doha Declaration’) in 2001. – “the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all”.

15. Preventive – Article 27 – Patentability flexibilities Article 27.2 and 27: Freedom to exclude new use and substances, methods and processes Article 27(1) Patents shall be available for any inventions whether processes or products in all fields of technology provided that they are: a)New b)Involve an inventive step c)Capable of industrial application Countries have flexibility to determine what constitutes novelty, inventive step and industrial application Strict patentability criteria can limit ‘ever-greening’, increase quality of patents. Successfully used in India with section 3(d)

16. Patent oppositions Preventive (pre-grant) Introducing opportunities for pre-grant opposition will improve the quality of patents granted, – as more evidence is brought to the attention of examiners by third parties during the decision-making process. Remedial (post grant) Post grant opposition opportunities would act as a safeguard if earlier Chapter 2 suggested measures do not result in a correct determination as to patentability

17. Remedial – Compulsory licensing Article 31 of the TRIPS Agreement provides that a government, or third party authorised by the government, may use the subject matter of a patent without the authorisation of the right holder, where: “the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use.‟

18. Thailand compulsory licenses 2006-2008 Since 2003 government has a policy of universal access to antiretroviral drugs From 2001 to 2007 Thailand increased spending ten-fold on ARVs 2006 World Bank Report on Thailand documented the failure of price negotiations November 2006, Thailand issued government use order for effavirenz (1 st generation ARV), January 2007, Government issued Government use order for (2 nd generation ARV combination of lopinavir+ritonavir) and clopidogrel (for heart disease) Thailand faced rigorous protest by pharma and by developed Countries Use of TRIPS flexibilities was welcomed by Treatment activists and some UN bodies January 2008, Government issued government use order for Letrozole, Docetaxel, Erlotinib and Imatinib (all medicines for treatment of cancer) Threatened with loss of market access, Government conducted cost/benefit analysis

19. Cost savings of medicines in Thailand in 2007-2012 (Source: Ministry of Public Health and the National Health Security Office 2007) http://www.hitap.net/backoffice/project/pdf_projects/2009-05-20_Final%20report%20-06-301-2551.pdf http://www.hitap.net/backoffice/project/pdf_projects/2009-05-20_Final%20report%20-06-301-2551.pdf DrugUses Patent holder in Thailand Estimated # of patients requiring Treatment (per year 2007 Estimate) Cost Savings through government use licenses (million USD) 2007-2012 Efavirenz First-line ARV (alternative to nevirapine-based regimens) Merck Sharp and Dohme 200,000113.4 Lopinavir + Ritonavir Second-line treatment for HIV/AIDS Abbott Laboratories Limited 50,00076.8 Clopidogrel Prophylaxis of coronary artery obstruction Sanofi-Aventis Limited 300,00021.5 Docetaxel Treatment of breast, lung, prostate and stomach (GIST) cancers Sanofi-Aventis Limited 1,500-2,00047.6 Letrozole Treatment of breast cancer Novartis4,90091.8 ErlotinibTreatment of lung cancerRoche4,6006.7

20. TRIPS Agreement and impact on IP enforcement Key elements of IP enforcement in TRIPS Article 41: – There should be provisions in domestic law to take action against IP infringement – Enforcement procedures must not create barriers to legitimate trade – Enforcement procedures must be fair and not unnecessarily complicated or likely to lead to delays – Must be some form of review of first decisions made by administrative or judicial bodies – Members are not obliged to establish a separate judicial system to enforce IPRs TRIPS Article 61 Criminal procedures and penalties are only required where there is willful trademark counterfeiting or copyright piracy on a commercial scale TRIPS Article 46 The measure imposed should be proportional to the seriousness of the infringement

21. A public health sensitive IP policy Contributing voices to the development of IP law and policy must come from a wide range of stakeholders – Including (but not limited to): elected and public officials, civil society, industry, academia, patient and professional groups from a variety of sectors, including the public health, science, education, economic, industrial and innovation policy and practice sectors.

22. Conclusions TRIPS Agreement has minimum obligations for developing countries but also contains many flexibilities Incorporation of flexibilities into domestic legislation should be guided by strategic domestic objectives – In line with international commitments Using flexibilities can keep national treatment programs affordable Countries should be mindful of public health implications in committing to TRIPS plus commitments e.g. anti-counterfeiting legislation Policy coherence is essential. IP cuts across trade/commerce, health, agriculture, education, science and technology legislation.