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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
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
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)
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
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
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
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)
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
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”
III. TRIPS flexibilities and Drug
regulation
BUT no obligation to
– Grant exclusive rights to data
– Grant protection for a minimum of five years
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)
IV. Implementation of test data flexibilities in COMESA
Cautionary note on Trade and Investment
Framework Agreements (TIFAs)
TRIPS-plus
V. COMESA work on
pharmaceutical registration
Currently no arrangement for mutual
recognition of national pharmaceutical
registrations
Working at harmonization - There are now
Draft Guidelines
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
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
Thank you for your attention
Dr. Susan Isiko Štrba
www.cardno.com/emergingmarkets
www.enabling-env.com
