The document reviews the implementation of TRIPS flexibilities regarding patents in COMESA countries. It finds that while many countries have incorporated flexibilities into their laws, there is a lack of uniformity and the laws are not always followed in practice. It recommends that COMESA countries further promote access to medicines by extending transitional periods for pharmaceutical patents, implementing guidelines on compulsory licensing processes, allowing parallel imports, and enabling regional trade of generics between members. Adopting these measures could help COMESA countries better utilize TRIPS flexibilities to address health issues.

1. REVIEW OF IMPLEMENTATION OF TRIPS FLEXIBILITIES ON PATENTS IN COMESA
Dr. Susan Isiko Štrba
Workshop on the Implementation of WTO Decisions on TRIPS and Public Health in COMESA, 1-5 March, 2011, Kampala

2. Structure
•Introduction
•Implementation in COMESA of TRIPS Patent flexibilities
•Promotion of systems for grant of regional patents
•Patent coverage of some essential medicines
•Conclusions

3. Implementation in COMESA of TRIPS flexibilities

4. Implementation of TRIPS flexibilities (1)
•Extended transition period for LDCs
–Patent protection for pharmaceuticals
•Expressly exclude protection (Burundi, Madagascar,* Rwanda, Uganda)
•Do not exclude protection (Djibouti, DRC, Malawi, Zambia)
•Case study of Malawi – need to amend legislation

5. Implementation of TRIPS flexibilities (2)
–Use of “mailbox”
•Case study of Quality Chemicals – role of patent policy in attracting investment
•Case study of India – encouraging investment while keeping “mailbox”

6. Implementation of TRIPS flexibilities (3)
•Availability of patents for “New Uses”
–Most legislation is silent
–Exclude but allow process patents (Rwanda)
–Available but with exceptions (Kenya)
–Available (Uganda)
–Exclude all (Zambia)

7. Implementation of TRIPS flexibilities (4)
•Compulsory licensing and government use
–Grounds for compulsory licensing
•Several grounds but lack uniformity
•Most commonly available grounds
– failure to exploit
–Government use
–anti-competitive conduct

8. Implementation of TRIPS flexibilities (5)
•Compulsory licensing - Grounds
•Case study of Zimbabwe (Varichem) – national emergency
•Case study of South Africa (Aspen) – using competition rules

9. Implementation of TRIPS flexibilities (6)
–Conditions for use of compulsory licensing
•Prior Negotiations with brand holder
–Case study of Brazil: compulsory licensing following failed negotiations
–Case study of Rwanda/Apotex – using the importation mechanism under the Decision

10. Implementation of TRIPS flexibilities (7)
–Conditions for use of CL (2)
•Time frames for negotiation voluntary licence
–no clear guidelines in national legislation
–Not uniform within COMESA
–Uncertainty for potential generic manufacture
–Need standard time limits for sake of harmonization (e.g. Tanzania)

11. Implementation of TRIPS flexibilities (8)
•Conditions for CL (3)
–Remuneration
•Avoid double compensation under the Decision (Burundi, Djibouti)
•Amount not specified
•But can be determined at time of granting CL in case of CL for Government use (Zambia)

12. Implementation of TRIPS flexibilities (9)
•Conditions for grant of CL (4)
–Remuneration (2)
•Generally, amount can be appealed before judicial body (eg Ethiopia)

13. Implementation of TRIPS Flexibilities (10)
•Conditions for CL (5)
–Remuneration: solutions
•Devise alternative means to judicial review
•clear guidelines on compensation to harness economies of scale
•Common procedures and body to determine remuneration
•Royalty rates which are clear to generic manufacturers

14. Implementation of TRIPS flexibilities (11)
•Use of compulsory licensing for export and regional trade
–CL predominantly for supply of domestic market (Kenya, Egypt* Rwanda)
–Case study of Zambia: need to amend domestic legislation
–CL for export (Djibouti,* Burundi, Uganda, Zambia)

15. Implementation of TRIPS flexibilities (12)
•CL for export and regional trade (2)
–Re-export to regional market (Uganda)
•Acceptance of the Protocol
–Only 4 COMESA members (Mauritius, Egypt, Zambia and Uganda)
•Exhaustion of rights /parallel importation
–National exhaustion in a strict sense (Ethiopia, Madagascar, Sudan)

16. Implementation of TRIPS flexibilities (13)
•Exhaustion of rights /parallel importation (2)
–National exhaustion but with exceptions (Rwanda)
–International exhaustion (Burundi, Djibouti, Egypt, Kenya, Mauritius, Uganda, Zambia, Zimbabwe*)
–Products put on the market by the patent owner (Burundi, Djibouti, Egypt, Uganda)

17. Implementation of TRIPS flexibilities (14)
–Products put on the market through lawful means
•compulsory licensing (Kenya, Mauritius, Zambia, Zimbabwe)

18. Implementation of TRIPS flexibilities (15)
•Early working (“Bolar”) exception
–In a number of national laws
–Use in course of pre-clinical trial phase (Rwanda, Uganda)
–Use for marketing approvals worldwide (Burundi, Rwanda, Uganda)
–Choices: allow use in pre-clinical research

19. Implementation of TRIPS flexibilities (16)
•Scientific research exception
–In a number of national laws
–Allow to experiment to gain new knowledge
–Allow to use invention as a research tool to develop products

20. Promotion of systems for the grant of regional patents

21. Promotion of systems for the grant of regional patents
•African Regional Intellectual Property Organization (ARIPO)
–Seven of COMESA members also members of ARIPO (Kenya, Malawi, Sudan, Swaziland, Uganda, Zambia, Zimbabwe)
–Provide for regional compulsory licensing
•Andean Community system
–Provide for international exhaustion

22. Promotion of a system for grant of regional patents (2)
•Contours of a system for grant of regional patents
–Aim to promote implementation of regional trade mechanism
–predictable

23. Patent coverage of some essential drugs

24. Patent coverage of some essential drugs
•Some facts about selected drugs
–Most essential medicines are not patented
–Patents on some important medicines have recently expired
–24 pharmaceutical patents in ARIPO as of June 2010
•Lessons for use of TRIPS flexibilities to promote access to medicines in COMESA

25. Conclusions
•Challenges
•Old legislation vs current draft laws
•Evidence of effort to include flexibilities in legislation, but
•Lack of uniformity /harmonization
•Legislation not always followed by practice

26. Elements of a sector strategy (3)
•LDCs not to make available pharmaceutical patents until end of transition period.
•Request TRIPS Council to grant further extension of transitional period until 2021
•Guidelines on time-limits for negotiating a voluntary license where required, and on royalty rates for CL, including a zero rate where remuneration has been paid under CL in exporting country

27. Elements of a sector strategy (4)
•Implement international exhaustion of patents, including through legislation if necessary, to allow parallel imports
•Implement the marketing approval (“Bolar”) exception
•Amend patent laws to allow unlimited export to other COMESA members that share the health problem in question.

28. Elements of a sector strategy (5)
•Consider amendment of the COMESA Competition Regulations to allow the COMESA to allow Competition Commission to restrict direct enjoyment of privileges and protection conferred in cases of abuse of dominant position
•Members that have not already done so to deposit instruments of acceptance of the Protocol to place the importation mechanism and regional trade mechanism on a permanent basis

29. Thank you for your attention
Dr. Susan Isiko Štrba
Susan.isiko.strba@bluewin.ch