Transcript Model Law on Medical Products Regulation

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