Summary of the Zim NMP - Trade, TRIPS and Access to Medicines

OVERVIEW OF THE
ZIMBABWE NATIONAL
MEDICINES POLICY
Dr C E Ndhlovu, M Med Sci, FRCP
Chairperson, NMTPAC
Deputy Dean, UZCHS
National workshop, Jan 22-23, 2014
Outline of presentation
• Discuss the specific objectives of the ZNMP
• Discuss achievements and highlight challenges
1. Availability
• Aim to have 100% availability of the V items
• At primary care level throughout the nation
• VEN classification to prioritize procurement of medicines
• CBAS classification
• Level of use of medicines
• C medicines - primary health care (clinic) level and should be available at all levels of
care.
• B medicines - district hospital level or secondary and higher levels of care.
• A medicines are prescribed at provincial or central hospital levels.
• S medicines -specialist only medicines can be used by specialist physicians only in
settings adequate diagnostic and laboratory monitoring facilities.
2. Legislation and Regulation of
Medicines and Medical Supplies
• Through MCAZ, DPS, NMTPAC & relevant stakeholders
• Use of registered or authorized medicines only
• “SAFEQUAR”
• Regular reviews and updates of policies/guidelines
• TRIPS compliance(2003)
• Parallel importation allowed
• Compulsory licensing to promote local production
• “Bolar provisions” in place
3. Medicine Selection
• Adoption of the “essential medicines concept”
• Adoption of primary health approach since 1980
• Use of standard treatment guidelines
• PEDLIZ (1980)
• Now at EDLIZ (6th edition/2011)
• ART guidelines
Principles of the Essential Medicines
Concept
• Majority of health
problems
• treated with a small
number of medicines
• Health professionals in
practice use few
medicines
• fewer medicines can be
used more rationally
• Procurement &
distribution
• more efficient with fewer
medicines
• Patients can be better
informed when fewer
medicines are used
4. Generic Medicines
• Register, procure, prescribe and dispense “generics”
• Promote local production of generic medicines
5. Assuring quality , safety and efficacy of
medicines
• Mainly MCAZ functions:
• Medicines must be “registered” or “authorized”
• Review and maintain the register
• E.g. remove “unsafe” medicines
• Monitor adverse medicines events via Pharmacovigilance and
Clinical Trials(PVCT) Committee
6. Production of Medicines within
Zimbabwe
• Promote production of essential medicines
• Promote production of cost-effective medicines
• Using current Good Manufacturing Practice(GMP)
7. Information, Advertising and Promotion
• Provide accurate, unbiased, evidence based medicine
information
• For healthcare workers and the general public
• Watch out for “unethical” medicine promotion
8. Rational use of medicines
• Promotion of rational or appropriate prescribing,
dispensing and use of medicines
• For both public and private sectors
• Promote training in RUM at pre-service and in-service
levels
• Monitor RUM through data collection/ regular surveys
9. Medicines Supply- procurement, distribution
and storage
• Medicine Management cycle
What is NatPharm’s role?
“ the government will support the status
and viability of the procurement agency
and will provide sufficient financial basis
for its operations”
10. Other Objectives
• 10. Economic Strategies
• 11. Organization, management and coordination of the
ZNMP
• 12. Development of Human Resources
• 13. Operational and Technical research
• 14. The National Medicine and Therapeutics Policy
Advisory Committee (NMTPAC)
• Setting up of HMTC
• 15. National, Regional and International Collaboration
Final objective
• 16. Trade and Public Health
• Need to balance IPR and the public health good
• to ensure/enhance access to essential medicines
• for public health purposes
• Allow parallel importation
• Compulsory licensing
• Allow exploitation of the “Bolar provisions”
Has Zimbabwe addressed equity?
• Equity issues arise at least 3 levels
• international level
• Zim became TRIPS compliant in 2003:
• compulsory licensing through the Ministry of Health
• parallel importation of patented products
• Bolar provisions
• national level
• registration of all medicines insisting on generic labelling of medicines
• adoption of essential medicines concept
• training in AMU at pre-graduate and post-graduate levels
• and community level??
• Use of medicines appropriately
ConclusionsNice to look at ! But how useful are they to us?