1. The AU Model Law on Medical Products Regulation and Harmonisation

2. Presentation Outline
National Medicines Policy, Legislation and Regulatory Environment in Africa
The need for a Legislative Framework and Regulatory Reforms
The Draft AU Model Law on Medical Product Regulation and Harmonisation
Way forward

3. Medical Products regulation
The essence of control and regulation means:
Protecting public health by ensuring that only quality regulated products that are safe, efficacious and wholesome reach the public
Impacts directly on the consuming public ultimately
Public need to have confidence in their regulatory system:
Laws
Institutions
Policies

4. Medical Products regulation (2)
By nature medicines regulation requires sound legal and policy environment
So many actors with differing objectives
Effective medicines regulation demands the application of:
Sound medical, scientific and technical knowledge and skills
Operates within a legal framework (WHO 2003)
Effective regulation requires strong enforcing power

5. The NEPAD agency situation analysis (2)
Comprehensiveness varies from one country to the other.
The existing policies and legislations are territorial i.e. they do not enable NMRAs to:
legally recognize decisions made by other NRAs,
mutually recognize or accept joint regulatory decisions

6. Implication of the prevailing Situation
Countries are not obliged to use any decision or procedures that it has made though it participated in the processes.
The question we can ask ourselves is how then can countries harmonise in such a situation?
If the expectation is that countries would become more efficient and effective through work sharing, information sharing and collective effort on medicines regulation, then legislative reforms are inevitable

7. Key regulatory functions covered by legislation
Burundi
Kenya
Rwanda
Tanzania Main-land
Tanzania Zanzibar
Uganda
Establishment of a body responsible for medicines regulation N Y
Licensing of
Manufacturers
Importers
Wholesaler/Distributor
Retailers/dispensing outlets
Market Authorization (MA) N*
Inspection of premises and manufacturing sites
Establishment of Quality Control Laboratory
Control of clinical trials
Control of counterfeit medicines
Control of imports and exports
Safety monitoring of products
Control of product promotion and advertisement
Control of other products
Provision for medicines distribution schedules/categories other than controlled drugs
Control of narcotics and psychotropic substances
Administrative and legal sanctions e.g. suspension or revocation of licenses or fines/imprisonment
Authority to make regulations

8. What is it that we want to change?
To achieve the level of required efficiency and effectiveness in medicines regulations there is need to focus on legislation that:
Provides the mandate to NMRAs to regulate medicines.
Facilitates country participation in the regional harmonization process.
Supports the NMRA to determine what can and cannot be done

9. Pan African Parliament Committee on Health Labour and Social Affairs (CHLSA) recommendation
July 2011: PAP – CHLSA recommended that a model law for Medical Product Regulation and Harmonization should be drafted to:
To ensure a systematic approach for development of legislation on medical products in African countries that have outdated laws on medicines regulation or that lack them altogether

10. Purpose of the model law
To provide a comprehensive medical products regulation law
To serve as a guide member states and RECs in their endeavour to harmonise medicines regulation
To provide an enabling regulatory environment for the growth of local manufacturing
To ensure access to quality, safe and efficacious medical products medical and technologies to the African population

11. Parts of the Model Law Part I: Preliminary Provisions
Part II: Administration, General Provisions and Governance
Part III: National Regulatory System
Part IV: Regulatory Inspection and Enforcement
Part V: Other Regulated Products

12. Parts of the Model Law (2)
Part VI: Offences and Legal Proceeding
Part VII: Administrative Appeals Procedures
Part VIII: Harmonization of Regulation of Medical Products and International Cooperation
Part IX: Monitoring and Evaluation
Part X: Regulations
Part XI: Statutory and Transitional Arrangements

13. AU Model Law Process
Validation of the Draft Model law by experts on Medicines Policies and Regulatory Reforms before consultations (Done)
Presentation of the Draft Model Law to the Pan African Parliamentary (PAP) Committee on health, labour and Social Affairs in August (Done)
Regional consultation meetings with Governments, Legal Experts, NMRAs and Parliamentarians from all AU member states – May to December 2014

14. AU Model Law Process (2)
Presentation of the Final Draft Model Law to the AU STC – April to October 2015
Submission of the Final Draft Model Law on medical products regulation and harmonization for consideration by AU structures – November to December 2015.
Tabling of the Model Law on Medical Products Regulation and Harmonization – January 2016
Domestication of the Model law by Member States – From January 2016.

15. Targets on the Model Law
Domestication of the Model law by at least 20 Member States by 2020
At least 5 Regional Economic Communities have adopted regionally harmonized policies and legislative frameworks by 2018.
At least 2 regional medicines agencies established by 2018.

16. Conclusion Three Key Objectives that the Model Law will deliver on:
Protection of public health
Promotion of local production
Facilitation of intra and inter-regional trade

17. Key Recommendations and Way Forward
Advocacy for the adoption of Model Law and implementation in the RECs and Member States.
Advocacy for the establishment of semi-autonomous NMRAs that are able to effectively carry out their regulatory functions.
Monitoring and evaluation of
Functioning of the regulatory agency
The participation in regional harmonization efforts for building effective regulatory systems

18. Thank You