Presentation to Civil Society meeting Lusaka 1 October 2013

Patents make medicines unaffordable! Patents create monopolies and dependencies Beneficial for R&D companies (in rich countries) Limited value for Zambia (mainly importing; very few innovations to be patented) May affect access to medicines and pooled procurement Drug companies make money from patents Why did Zambia then sign this agreement? WTO gives other benefits (export to EU etc) Trade stronger in IP policy than Health Strong lobby by rich countries, WIPO etc

Remember the South Africa case? Antiretrovirals were unaffordable $ pp/year due to patents big farma Generics cheaper ($900, then $360 now $62) But generics were not accessible due to patents SA govt made a law to make patented medicines cheaper; Drug companies sued Nelson Mandela’s govt TAC South Africa and MSF won South African case Not with lawyers but with activists testifying in court, press releases,TV interviews, public pressure etc Can Zambia civil society do this too?

Useful but patented medicines 2 nd and 3 rd line ARVs Cancer medicines New antibiotics (resistance to current ones!) Non-communicable diseases Diabetes Cardiovascular diseases High blood pressure Stroke Some are not considered essential as they are so expensive: catch-22 situation Need civil society to demand access to these medicines!

Zambia and patents Zambia may have patents on ARVs, cancer medicines Officially, Zambia Patent Act excludes pharmaceuticals Patents may however have been granted by ARIPO Not easy to find out! Need legal and patent experts! But as an LDC, Zambia can refuse or ignore patents on medicines until 2016 or even 2021 ARVs have been imported as generics from India So why worry about TRIPS?

Why worry about TRIPS? As WTO member it has to respect TRIPS minimum Zambia will have to protect patents in the future Good news: there is a good draft Patent Bill More good news: Zambia (being a Least Developed Country) is exempted from TRIPS until 2021 Bad news: India can no longer make generics for newly patented medicines since 2005 Who will make the generics?? Zambia is discussing new IP Policy and legislation Use the current debate among Trade, Justice & IP to ensure that the maximum of public health flexibilities are built into the new Patents Bill

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!

Relevant WTO decisions Doha Declaration 2001 (TRIPS &Public Health) Para 7: LDCs have no obligation to honour pharmaceutical patents until 2016 (maybe 2021?) TRIPS amendment (art 31.bis) Allows an economic community with a majority of LDCs to circulate products produced in one of its LDC countries (no barrier to export) Importing countries may still need to issue a compulsory or government use license.

SADC Pharmaceutical Business Plan 1. Regional assessment of IP legislation (done) 2. Identify legal resources (done) 3. Database of legal experts (available) 4. Collaborate with partners to enable countries to take full advantage of the flexibilities 5. Avoid TRIPS+ in bilateral trade negotiations

Zambia IP law status Patents Act 1958 obsolete – not TRIPS compliant Zambia developed an IP policy (final draft 2009) New Patents Bill has been drafted Has most of the public health flexibilities Member of ARIPO, so risk of patents being granted unless Zambia actively says “No thank you!” Zambia benefits from the LDC exemption until 2021 Need to discuss in SADC who will make the new generics now India can no longer provide them

Zambia 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 (COMESA is discussing a draft!)

Regional Challenges, Options Patents are granted due to weak assessment capacity ARIPO – LDCs should opt out until 2021 for medicines 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

What can civil society do? Take part in technical working group of Health, IP and Trade officials Review the analysis of Zambia IP laws by IP office, SARPAM and UNDP Ensure rights of patients Assessment whether current patents are posing a problem for Zambia’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 Zambia, SADC and Africa Share information and learn lessons with other SADC CSO

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 for CSO? CSO voices need to be heard!

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 at SADC office, Gaborone Further contact? Wilbert Bannenberg,