Drugs, Drug regulation, Regulatory authorities, test data, WTO Decisions on TRIPS and Public Health, COMESA

1. Drug Regulation 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
I.Introduction
II.Drug regulation in COMESA
III.TRIPS flexibilities for drug regulation
IV.Implementation in COMESA of flexibilities on test data
V.COMESA work on drug regulation
VI.Conclusions: Elements of a sector strategy

3. II. Drug registration in COMESA
Role of drug regulatory authorities in ensuring access to medicines
–Implementation of registration legislation
–Ensure pharmaceutical products are produced according to Good Manufacturing Practice (GMP)

4. Challenges faced by DRA - Resource constraints:
–Trained staff
–Equipment
–Inadequate guidelines
–Lengthy delays in registration
–Ineffective quality testing prior to marketing approval
–Inadequate inspections for GMP
II. Drug registration in COMESA

5. Resource constraints/2:
–Lack of coordination with national health policy
–Local manufacturers may lack capacity to conduct thorough clinical trials
•Risk: failure to comply with GMP
•Cannot export
•No WHO prequalification – cannot produce for donor-funded procurement
–Lack of resources to adequately inspect , investigate and prosecute counterfeits
II. Drug registration in COMESA

6. III. TRIPS flexibilities for drug regulation
Marketing approval is a condition for effective use of patent flexibilities
–Case study: Zambia (Pharco)
–Recognition of drug registration granted in country of export important for importation
–Incentive for COMESA members to file joint notification to have recourse to system under Decision as importing countries

7. III. TRIPS flexibilities for Drug Regulation
Marketing approval (“Bolar”) exception:
–Upset by lengthy delays in granting marketing approval
–Where “Bolar” exception is time limited (Zimbabwe)

8. III. TRIPS flexibilities for drug regulation
Test data protection
–Protection of confidential information
–No current obligation for 8 COMESA member states, WTO members (extended transition period for LDCs)
–No “standstill” commitment
–No obligation at all for 6 of COMESA members states, not WTO Members

9. III. TRIPS flexibilities for Drug regulation
Test data protection/2
–Obligation for the 5 developing country COMESA members also who are Members of WTO
–Subject matter of obligation: “new chemical entities”
–Scope of obligation: “unfair commercial use” and “disclosure”

10. III. TRIPS flexibilities and Drug regulation
BUT no obligation to
–Grant exclusive rights to data
–Grant protection for a minimum of five years

11. IV. Implementation of test data flexibilities in COMESA
Not addressed in most legislation,
Provide for protection in legislation (Egypt, Kenya,* Mauritius) for at least five years
Legislation silent but no protection in practice (Rwanda, Uganda)
Legislation silent but there is protection in practice (Zambia)

12. IV. Implementation of test data flexibilities in COMESA
Cautionary note on Trade and Investment Framework Agreements (TIFAs)
TRIPS-plus

13. V. COMESA work on pharmaceutical registration
Currently no arrangement for mutual recognition of national pharmaceutical registrations
Working at harmonization - There are now Draft Guidelines

14. VI. Conclusions: Elements of a sector strategy
Deny test data exclusivity
DRA recognize a marketing approval granted in a country exporting pharmaceutical products under the importation mechanism or regional trade mechanism and, where none is granted, to request such approval prior to export

15. VI. Conclusions: Elements of a sector strategy
Adopt the COMESA draft technical guidelines on harmonization of pharmaceutical registration procedures
Develop effective systems of pharmaceutical registration and post marketing surveillance
Contact points in administration to coordinate enforcement against trafficking in counterfeit medicines.
Finalize and adopt the COMESA draft Regulations on Non-Tariff Barriers

16. Thank you for your attention
Dr. Susan Isiko Štrba
Susan.isiko.strba@bluewin.ch
www.cardno.com/emergingmarkets
www.enabling-env.com