The AU Model Law on Medical
Products Regulation and
Harmonisation
Presentation Outline
1. National Medicines Policy, Legislation and
Regulatory Environment in Africa
2. The need for a Legislative Framework and
Regulatory Reforms
3. The Draft AU Model Law on Medical Product
Regulation and Harmonisation
4. 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
Establishment of a body responsible for medicines regulation
Uganda
Tanzania Zanzibar
Tanzania Main-land
Rwanda
Kenya
Burundi
Key regulatory functions covered by legislation
N
Y
N
Y
Y
Y
Manufacturers
N
Y
N
Y
Y
Y
Importers
Y
Y
Y
Y
Y
Y
Wholesaler/Distributor
Y
Y
Y
Y
Y
Y
Retailers/dispensing outlets
Y
Y
Y
Y
Y
Market Authorization (MA)
N*
Y
N*
Y
Y
Y
Inspection of premises and manufacturing sites
N
Y
N
Y
Y
Y
Establishment of Quality Control Laboratory
N
Y
N
Y
Y
Y
Control of clinical trials
N
N
N
Y
Y
Y
Control of counterfeit medicines
N
Y
N
Y
Y
Y
Control of imports and exports
Y
Y
Y
Y
Y
Y
Safety monitoring of products
N
N
N
Y
N
N
Control of product promotion and advertisement
N
Y
N
Y
Y
Y
Control of other products
N
Y
N
Y
Y
N
Provision for medicines distribution schedules/categories other than controlled drugs
Y
Y
Y
Y
Y
Y
Control of narcotics and psychotropic substances
Y
Y
Y
Y
Y
Y
Administrative and legal sanctions e.g. suspension or revocation of licenses or
fines/imprisonment
Y
Y
Y
Y
Y
Y
Authority to make regulations
N
Y
N
Y
Y
Y
Licensing of
Y
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:
1. Protection of public health
2. Promotion of local production
3. 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 semiautonomous 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