1. Implementation of TRIPS Flexibilities In National IP Legislation For Strengthening Access To Medicines In Swaziland Workshop with MOH and stakeholders, Royal Villas, 13 October 2014

2. Obligations of Swaziland to implement the TRIPS agreement Wilbert Bannenberg

3. What is TRIPS? Agreement Trade Related Aspects of Intellectual Property Rights (TRIPS) Administered by the World Trade Organization TRIPS = compulsory (countries cannot opt out) Sets out minimum standards for IP protection all WTO members have to comply with If a country does not adhere, other countries can complain in WTO using “dispute settlement” – WTO can issue trade sanctions, tariff punishments etc

4. TRIPS – some dates 1995 – signed 1996 – developed countries had to comply 2000 – developing countries (e.g. Swaziland) 2005 – developing countries with different patent regimes (e.g. India) 2021 – Least developed countries – 8/15 SADC countries are LDC – Swaziland is not!

5. Patent Right to exclude others from making, using, offering for sale, selling, and importing the patented product Right granted by a national or regional authority for 20 years Patents are national – regional or global patents do not exist

6. Patentability criteria An invention is patentable if: – It is new – Involves an inventive step – Is industrially applicable (Swaziland Patent Law 1997, art 4)

7. Balance of rights between inventor and society Society grants a monopoly to an inventor to reward him for (making public) the invention Inventor has 20 year monopoly – can set prices as they like, and stop import of (more affordable) generics Main business model for big farma Society has access to the invention Science can progress – new inventions follow But society can suspend the patent if the invention is not made available, or at such a price no one can afford For this, TRIPS contains “flexibilities”

8. Swaziland obligations Swaziland as a member of WTO has to be fully compliant with TRIPS since 2000 It has to incorporate the minimum of TRIPS in its Intellectual Property (IP) or Patent law. Countries are allowed to have higher protection, but this is not recommended (“TRIPS+”)

9. Swaziland obligations (2) Domesticate TRIPS Agreement in Patent Law Set up an IP/Patent Office Analyse patent applications, and, if found acceptable: Grant patents for 20 years Partially outsourced to the African Regional IP Office (ARIPO) in Harare At least 20 patents exist for HIV/AIDS medicines

10. Questions? Workshop with MOH and stakeholders, Royal Villas, 13 October 2014