1. Access to medicines, WTO TRIPS and Seychelles patent law Ellen ‘t Hoen, Medicines Law & Policy Seychelles September 2014

2. What is TRIPS? World Trade Organization Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) Sets out minimum standards for IP protection all WTO members have to comply with Seychelles in accession talks with WTO will have to fully comply with TRIPS and implement IP law.

3. Intellectual Property Law intellectual property law aims at safeguarding creators and other producers of intellectual goods and services by granting them certain time-limited rights to control the use made of those productions.

4. Patent Right to exclude others from making, using, offering for sale, selling, and importing the patented product (or a product made with a patented process) Right granted by a national or regional authority for a certain period of time (minimum 20 years) Patents are national – global patent application procedures exist through the WIPO PCT but a global patent does not exist.

5. Patents and Medicines Patents may be used to delay competition of generic medicines and create market exclusivity/monopoly Without generic competition medicines prices remain high No relation to cost of production and price of patented products For example sofosbuvir: Estimated cost of productionUS$ 68 - 136 Price per treatmentUS$ 84,000

6. Price of imatinib (Gleevec)

7. MedicineSouth Africa –private sectorSouth Africa – public sectorIndia – generic price Imanitib mesylateR863 /400 mgn/aR46.20 /400 mg SorafenibR203.50 /200 mgn/aR8.55 /200 mg BortezomibR11,548.70 per 3.5 mg vialn/aR2,980 per 3.5 mg vial OxaliplatinR2,331.79 per 50mg / 10ml inj. R4,663.53 per 100mg / 20ml inj. R702 for 50 mg injection for infusionR1,405.34 for 100 mg injection for infusion 50 mg price not sourcedR585 per 100 mg vial for injection RituximabR2,789.50 per 10mg / ml infusionR13,947 per 500 mg injection R1,589.99 for 100 mg injection R 7,950.01 for 500mg injection R1,542 per 100 mg vialR6,173 per 500 mg vial TemozolomideR958.73 per 100 mg tabletR903.44 per 100 mg tabletR273.79 /100 mg Cipla announced reduction to R74 per 100 mg tablet) Source: TAC 2012 http://www.fixthepatentlaws.org /?p=510#comment-4425

8. Pre/post TRIPS patenting of HIV medicines 8

9. Flexibilities in TRIPS (non exhaustive) Compulsory licensing and Government Use (Article 31) August 30, 2003 Waiver: CL for export Parallel import Data protection (Article 39.3) Exceptions to patent rights (Article 30) Patentability criteria Transition periods DCs (Article 65) LDCs (Article 66)

10. 2001 Doha Declaration on TRIPS and Public Health Boost to TRIPS flexibility for Public Health 4. We agree that 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. In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.

11. Non-TRIPS measures Voluntary licensing Medicines Patent Pool (MPP) for ARVs Seychelles can benefit from MPP licenses and source medicines for the treatment of HIV and HBV (TDF) from generic producers that have sublicenses from the MPP.

12. Background HCV 185 million people across the world are infected with HCV; 150 million are chronically infected. The HCV pandemic is concentrated in middle-income countries (MICs) 15% of the 150 million people with chronic HCV live in high-income countries (HICs), 73% live in MICs 12% in low-income countries (LICs). It is estimated that HCV-related liver complications kill 350,000 people annually. Until recently treatment was cumbersome and not very effective Seychelles has approx. 440 cases of HCV

13. Direct Acting Antivirals New drug treatments: Direct Acting Antivirals (DAA) came to market in 2013 Simeprevir (formerly TMC435; trade name Olysio) marketed by J&J Sofosbuvir (Sovaldi) marketed by Gilead. Others in the pipeline Oral short course treatments 12- 24 weeks (to be taken together with one or two other products) Highly effective, provides a cure Recent WHO HEPC treatment guidelines recommend the use of DAAs.

14. The case of sofosbuvir Received marketing approval 6 Dec. 2013. Marketed by Gilead. In HICs, sofosbuvir is sold USD1,000 per pill or USD84,000 per person for 12 weeks United States – estimated 5,367,834 persons are infected with HCV. GNI/capita: USD52,340 France, the cost of sofosbuvir is set at US$913 per pill (US$76,720 per person for 12 weeks). GNI/capita: US$41,750 In MICs, Gilead plans to sell sofosbuvir for at least US$2,000 (for a 12-week course).

15. HCV Treatment Cost RegimenCost (US$)Duration (weeks) Olysio+Pegasys+ribavirin106,67348 Incivec+Pegasys+ribavirn106,46848 Victrelis+Peintron+ribavirin95,84548 Sovaldi+Pegasys+ribavirin94,07812 Olysio+Pegasys+ribavirin86,51624 Incivek+Pegasys+ribaviron86,32124 Victrelis+Peintron+ribavirin85,25736 Victrelis+Pegintron+ribavirin64,82528

16. Cost of Production Source: http://cid.oxfordjournals.org/content/early/201 4/01/06/cid.ciu012.full.pdf+html Production cost for 12 week treatment Ribavirin$21 - $63 Daclatasvir (BMS)$10 - $30 Sofosbuvir (Sovaldi -Gilead)$68 - $136 Faldaprevir (BI)$100 - $210 Simeprevir (Olysio-J&J)$130 - $270

17. Gilead Gilead: “We will defend the patents, but at the same time, we are going to be pushing very hard to enable generic production in India with multiple companies.” http://www.thehindubusinessline.com/companies/gilead-local-generic-players-in- talks-to-bring-hepatitis-c-drug-into-india/article5649841.ece http://www.thehindubusinessline.com/companies/gilead-local-generic-players-in- talks-to-bring-hepatitis-c-drug-into-india/article5649841.ece Gilead’s website: “HCV is also a key therapeutic focus area for Gilead, and we are working on programs and partnerships to ensure that, worldwide, those patients for whom treatment with Sovaldi® (sofosbuvir) may be appropriate have access to it.” Yesterday (15 September) announced a voluntary license agreement with 7 Indian generic companies for supply to 91 LMIC countries, including Seychelles.

18. Treatment cost Treatment of 440 PLWHC @ full price– 37 mill $ Treatment of 440 @ 500$ - 220,000 $ Seychelles can benefit from generic production in India because of Gilead’s voluntary license with 9 Indian producers

19. Access Scenarios Originators lower the price to a level Seychelles an afford Originator grants voluntary licenses/ Medicines Patent Pool to generic manufacturers - Seychelles part of territory Patent not granted in India Patent not granted in Seychelles -> import from India Patent granted in Seychelles -> CL/GU -> import from India Patent granted in India -> Section 92(A) Indian Patents Act: CL for export to Seychelles Patent granted in Seychelles -> issue CL/GU SADC regional procurement -> larger orders to benefit from economies of scale – re-exportation from Seychelles to other SADC countries

20. Requirements TRIPS flexibilities included in Seychelles Patent Law. Lawyers group recommendations adopted. Alert: criminalization of patent infringement=problem “Government use” of patents in procurement. Collaboration with other SADC countries to create economies of scale and demand by using the 30 th August 2003 waiver.