The AU Model Law on Medical Products Regulation and Harmonisation

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

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

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

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

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

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

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

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

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

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

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

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 2013. (Done) Regional consultation meetings with Governments, Legal Experts, NMRAs and Parliamentarians from all AU member states – May to December 2014

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.

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.

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

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

Thank You