1.  Maximising the use of TRIPS flexibilities to meet the challenge of access to affordable medicines in Africa. Professor Yousuf A Vawda University of KwaZulu-Natal AU Roundtable, 25 March 2014 AU Roundtable

2.   Full use of all flexibilities under TRIPS.  Reform of national IP laws to give effect.  LDCs use exemption from granting patents on drugs.  International exhaustion allowing parallel imports.  Simple & operational compulsory licence procedures.  Take advantage of WTO Aug 30 2003 decision.  Not agree to bilateral trade agreements with TRIPS+.  Information-sharing on pricing & procurement.  Encourage national generic industry. First Global Parliamentary Meeting, Manila 2007

3.   Inventor is given a long monopoly, in exchange for  Disclosure, commercialisation and access to the invention, for the benefit of the public  Quid pro quo Theory of IP Rights

4.   Although TRIPS attempts to ‘harmonise’ IP law globally, countries have a relative freedom to fashion their IP regimes to suit local conditions  This relative freedom is contained in various provisions of the TRIPS Agreement, and in the Doha Declaration. What is a Flexibility?

5.   Art. 1:  Implementation and enforcement of IPRs can be determined within own legal system  Art. 8.1:  Countries may adopt measure necessary to protect public health and nutrition and to promote the public interest provided they are TRIPS-compliant.  Art. 7:  TRIPS should contribute to technology transfer, mutual advantage of producers and users, social and economic welfare, and a balance of rights and obligations Important interpretive principles in TRIPS

6.   “ 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 in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.” Doha Declaration on TRIPS & Public Health

7.   Right to use flexibilities:  Grant compulsory licences & freedom to choose grounds for them.  Define national emergency / circumstances of extreme urgency.  Freedom to decide exhaustion regime.  Expeditious solution to problem of members with insufficient or no manufacturing capacity.  Developed countries to promote and encourage technology transfer.  Pharmaceutical exemption for LDCs. Specifically …

8.   Patent: A private right, granted to an inventor, to exclude others from making etc the invention for a time-limited period.  Compulsory licence: A government-granted authority to a 3 rd party to make etc the invention without the consent of the patent holder (negotiate first, pay royalties).  Government use: Government grants to itself or sub- contractor right to use patent without consent (no negotiations only inform; pay royalties)  Parallel importation: The ability of a supplier to comparison-shop abroad for cheaper versions of the same patented product than available locally. Some Definitions

9.   Patent standards: The degree of novelty, inventiveness or industrial applicability or utility required for a patent to be granted.  Data exclusivity: Disallowing a regulator from relying on originator’s clinical trial test data, (proving safety & efficacy) to approve a generic.  Exceptions: acts which can legitimately be undertaken without infringing a patent (eg bolar/early working, research exceptions).  Exclusions: certain subject matter can be excluded from patent protection. Definitions (contd)

10.   TRIPS requires: novelty, inventive step, industrial applicability.  Perfectly acceptable to define as including:  Full disclosure (best mode; prior art)  Only new chemical entity for pharmaceuticals  No new forms or new uses of existing patents on medicines, unless enhanced efficacy (eg India)  Disclosure of INN for medicines Patent standards

11.   Permitted by TRIPS (Article 31(b)).  Ideal provision for public health emergencies (though not limited to them).  The use order can be for government of a 3 rd party contracted to use the patented product or process.  No need for prior negotiations, only to notify patent holder; need to pay royalties.  Used successfully in Thailand recently for ARVs and cancer drugs. Government use

12.   Allowed by TRIPS (Art 31):  Does not spell out the grounds.  Certain procedures & limits (prior negotiations, scope & duration limited, royalties payable, judicial review).  Can be on number of grounds:  Address public health crisis / emergency etc.  Remedy anti-competitive practices (excessive pricing).  Any other ground (public demand not met; patented product not affordable; non-working locally eg India)  Para 6 solution – not ideal.  Requires streamlined administrative procedures. Compulsory Licences

13.   Allowed by TRIPS (Art 6).  Exhaustion can be national, regional, international.  International exhaustion best option – allows one to parallel import from anywhere in the world.  Usually meant to apply to patented products.  Kenya allows parallel importation of generic medicines for public health emergencies (clause 37 of Kenyan Industrial Property Regulations, 2002). Parallel importation

14.   Allowed by TRIPS, subject to judicial review (Art 32).  Usually patents may be revoked on any of a number of grounds of fraud.  Also available in instances where:  Grant of compulsory licence didn’t prevent abuse.  Necessary to protect human, animal, plant life.  Necessary to respond to public health emergency. Revocation

15.   No specific mention in TRIPS, but domestic practice.  Provision for both pre- and post-grant opposition, with following provisions:  Flexible locus standi ( standing) requirements.  Patents applications must be published & public comment invited.  Administrative tribunal to hear evidence & legal argument in simplified procedure.  Rules of natural justice apply ( audi alterem partem). Opposition procedures

16.   Not all countries examine applications; many eg South Africa use a registration system – grant of patent is a formality.  Application of high patent standards frustrated if no examination on substantive merits.  Non-examination system resulted in perversities:  Grant of thousands of ‘weak’ patents  Ease of applications proven to benefit foreign rather than local innovators Patent examination

17.   Establishment of examination system not easy task (financial & human resources required).  But only way to ensure that inventions that are not genuine do not get 20 year monopoly.  Requires infrastructure to be set up, training of examiners etc.  Response to critics:  Training available (developed countries, WTO/WIPO, UN agencies & NGOs.  Costs offset by user fees eg Indian Patent Office. Patent examination system

18.   Allowed by TRIPS, subject to provisos (Art 30).  Early working (bolar) exception.  Use of invention for purposes of bona fide research, educational and scientific activities.  Other (pharmacy etc). Exceptions

19.   Allowed by TRIPS (Art 27.3).  May exclude:  Diagnostic, therapeutic, surgical treatment methods.  Plants & animals.  Essentially biological processes for production of plants & animals. Exclusions

20.   Allowed by TRIPS (Art 39).  Requires protection of clinical trial data from ‘unfair commercial use’  Is use of the originator data by a regulator to approve a follow-on generic prohibited?  Not unfair commercial use as it is a legitimate governmental function.  Data exclusivity in not required by Art 39. Data Protection

21.   The protection afforded to an innovator’s data from unfair commercial use shall not preclude a drug regulatory authority from approving equivalent generic substitutes by reliance on the originator data, in the interests of public health. Sample Data Provision

22.   When deliberating on an application for a pharmaceutical or other patent, which has the potential to have an impact on the public health, the CIPC or other administrative or judicial authority shall consider the representations of the relevant health authorities as to the public health implications of the grant of such patent. (Suggested formulation for South Africa) ANVISA option

23.   Everything, depending on:  Political will  Technical capacity  Already efforts in several countries:  South Africa  Uganda  Swaziland  Other  Co-ordinate with other regional & continental initiatives - AU-NEPAD Draft Model Law on Medicines Regulation. What is Possible?

24.   Attempt to overhaul IP policy across disciplines (copyright, patents, trademarks etc)  Good intentions & pro-public health provisions:  Patent examination  Compulsory licences  Parallel importation  Pre- & post-grant opposition  Significant gaps:  Lacks details on patent standards, opposition, simplified CL procedures, etc. SA Draft IP Policy

25.   In response to draft, several submissions from industry, academics, civil society.  Pro-industry views uniformly critical of policy.  January 2014 – PAE document leaked:  US-groups backed strategy to oppose  Using local front organisations  Delay & filibuster  Minister of Health offensive, joined by civil society  Industry on back foot. Backlash - Pharmagate

26.   AU Summit Decision, 28 January 2013: The Heads of State also decided to create the Pan- African Intellectual Property Organization (PAIPO). They requested the Commission to convene a meeting of all stakeholders dealing with intellectual property in the implementation of the Decision by May 2013 Summit. PAIPO

27.   Balancing rights of holders & users?  Protection of health, social and public interests?  Use of flexibilities for benefit of African countries?  External pressures to adopt TRIPS+ measures?  Costly border, criminal and civil enforcement obligations on Africans?  Development agendas and efforts for Africa? More question than answers

28.   Adopt all TRIPS/Doha flexibilities to enhance access to medicines.  Avoid TRIPS+ provisions in trade deals.  Strengthen medicines regulatory systems to weed our substandard & falsified medicines.  Avoid anti-counterfeit legislation which wrongly defines generic medicines as ‘counterfeit’  Explore development of local manufacturing and regional collaboration.  Initiatives such as PAIPO should open up policy choices for countries, and not shackle them. Watchwords/ Issues

29.  FlexibilityPresentPartiallyAbsent Government use Compulsory Licensing Patentability standards Disclosure Opposition procedures Examination Parallel importation Revocation Early working Research exceptions Acquisition by state Data exclusivity ANVISA option Competition licences Flexibility scorecard

30.  Thank you!