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

Conclusions-Nice to look at ! But how useful are they to us?