1. Presentation to Civil Society meeting Maseru 12 August 2014

2. No access to medicines? Local (clinic) – ordering, staff, calculations, overuse District – approval, budget?, communications Logistics – winter, mountains, breakdowns NDSO – not enough budget/in time, quantification, ordering, communications, supplier delays, quarantaine (quality checks) National – budget allocation, Essential Medicines selection, bias towards hospitals, QC checking International – batch failure, supplier not paid, delays in transport etc

3. Remember the South Africa case? Antiretrovirals were unaffordable $7000-12000 pp/year due to the patents of big pharma Brazilian/Indian generics cheaper ($900, then $360, now $62) But generics could not be bought due to patents SA govt made a law to make patented medicines cheaper; 39 drug companies vs. Nelson Mandela South Africa eventually won the case in 2001 Not with lawyers! But with activists (TAC) testifying in court, press releases, TV interviews, public pressure (MSF) etc SA govt first did not want to make ARVs available But now has the biggest ARV program in the world

4. Patents make medicines unaffordable! Patents create monopolies and dependencies Beneficial for R&D companies (in rich countries) Limited value for Lesotho (mainly importing; very few innovations have been patented) May affect access to medicines and pooled procurement Drug companies use patents to make money from rich countries Patients in developing world are a problem: Sell the original product to them at same/lower cost? Allow them to use more affordable generics?

5. Lesotho’s epidemics 3 rd highest HIV infection rates! 87,352 people currently on generic ARVs >60,000 still need to go on ARV treatment Many will need 2 nd or 3 rd line ARVs (in future) People on ARVs now survive! So they will get (like other Basotho) the next epidemic: Cancer, diabetes, high blood pressure Miners get (resistent) TB We will all need new medicines in the future

6. Useful but patented medicines 2 nd and 3 rd line anti-retrovirals Cancer medicines Non-communicable diseases: Diabetes, High blood pressure, Stroke Oops – they are expensive! Can the government/patient afford them? Will the Global Fund have enough money? Civil society to demand access to these medicines!

7. A new cure for hepatitis-c Sofosbuvir by Gilead (also makes tenofovir) Need 12 weeks treatment (84 tablets) + 2nd medicine Oops – 1 tablet costs $1000 So a cure (to survive) costs > $84,000 Even in USA/Europe discussions: can we afford? Egypt, Mongolia got 99% discount: $900 per course Still not affordable Production of generic possible for $68 - $136 per course Has ARIPO granted a patent for sofosbuvir in Lesotho?

8. Lesotho and patents Lesotho does have patents on medicines A few granted by the IP Office in 1990’s (now lapsed) Many more have been granted by ARIPO in Harare As a least developed country (LDC), Lesotho can refuse to consider patents on medicines until 2021 So why worry about TRIPS?

9. Why worry about TRIPS? We will need those new medicines Bad news: India can no longer make generics for newly patented medicines since 2005 Who will make the generics?? Lesotho is discussing a new IP Policy Use the current debate among Trade, Law & IP to ensure that the maximum of public health flexibilities are built into the IP/Patents Act Consider local/regional production of new generics!

10. Key TRIPS Flexibilities LDC waiver for TRIPS until 2021 No need to adhere to TRIPS or grant patents Pharmaceutical waiver until 2016 (may be extended?) No need to allow new/2 nd use patents (TRIPS+) Parallel import Compulsory licenses / government use Research exemption Early Working (Bolar clause) No need to provide data protection (TRIPS+) The lawyers will explain in next presentations!

11. Lesotho best uses a strategy to: Fully use the LDC exemption for TRIPS until 2021 Refuse any new pharmaceutical patents Ignore existing patents (using para 7 of Doha Declaration) Buy generics Enter only the minimum required of TRIPS in Patent Law Maximize the permitted public health “flexibilities” Avoid TRIPS+ measures (bilateral trade agreements) Watch out for “anti-counterfeiting” laws making generics illegal

12. Regional Challenges, Options Patents are granted due to weak assessment capacity ARIPO (in Harare) was created to assist countries Database of patented medicines in SADC countries Incorporate and use maximum flexibilities Regional production of new generics in LDC Avoid TRIPS+ Consider Competition Law (SADC policy 2008) Cave anti-counterfeiting laws endangering generics

13. What can civil society do? Take part in technical working group of Health, IP and Trade officials Review the Lesotho IP policy Ensure rights of patients, and access to future generics! Assessment whether current patents are posing a problem for Lesotho’s access to medicines, e.g.: 2 nd and 3 rd line ARVs, cardiovascular, diabetes, cancer Discuss options of future regional production of new generics in Lesotho, SADC and Africa Share information and learn lessons with other SADC CSO

14. Support is available Legal expertise is available to explain/discuss the legal details or Help to fix your national IP and patents legislation. SARPAM support available to SADC Secretariat, member states, private sector and CSO National civil society planning Regional consultation on TRIPS CSO voices need to be heard!

15. Acknowledgements Based on Flexibilities paper by Sisule F. Musungu Concept paper by Wilbert Bannenberg presentation drafted by Elijah Munyuki Comments by Aarti Patel, SARPAM Technical Adviser Further contact? Wilbert Bannenberg, wilbert@sarpam.net