1. Regulation of Medical Products & Patient Safety- A Narrative Review
Charles Ouma
Management Sciences for Health
Kenya

2. Background
Substandard, spurious, falsely labelled, falsified & counterfeit medicals product (SSFFCs)- significant risk to public health
Harm patients &undermine confidence in medical products, healthcare professions & health systems
Adverse drug event (ADEs) from poor product quality a growing problem- increased morbidity & mortality
Authenticated products pose additional risks- ADRs with considerable economic & clinical costs

3. Why Regulation?
Effective regulation intended to mitigate this harm, promote & protect public health and contribute to better health outcomes
Should target to ensure the quality, safety & efficacy of medicines or performance of devices to safeguard health of citizens
Improve overall access to medical products and technologies
Effective regulatory systems an essential component of health systems strengthening

4. Regulation & Dimensions of Access to Medicines
This figure highlights that ACCESS to medicines involved more than just geographic accessibility (as is sometimes thought).

5. Scope of Regulatory Functions
Licensing of products, manufacturers & distributors
Inspection of manufacturing sites and distribution facilities
Laboratory testing/Quality validation
Control of clinical trials
Control of advertising and promotions
Post Marketing surveillance of quality and safety
Consumer education

6. Drug regulation is a multi- faceted activity at the centre of complex interactions
Government
Experts
Manufacturers
Regulatory authority
Prescribers
Products
Medicines
Patients/Consumers
Importers/Wholesalers/Retailers

7. Methodology
Narrative review of published literature on regulation & patient safety in SSA
Qualitatively describe the status of medicines regulation in the region
Determine impact on public health
Synthesize recommendations to address identified gaps
Literature reviewed included online databases, libraries, journals , authoritative publications and texts

8. Results NMRAs exist in almost all SSA countries
Legal framework for operation is fragmented and sometimes not well articulated
Capacity is highly variable, some with no capacity at all
Funding/resource constraints limit the capacity of these NMRAs to fulfil their mandate

9. Differences in regulatory capacity in WHO African Region
Medicines Regulatory capacity in 46 WHO AFRO
Member States
Due to chronic shortages of human, technical, financial and other resources many National Medicines Regulatory Authorities (NMRAs) in Africa don't have the full capacity to perform most core regulatory functions
Source: WHO/AFRO/EDP/04.5: Availability of Drug Regulatory and Quality Assurance Elements in Member States of the WHO African Region, 2004, Brazzaville.

10. Impact/Outcomes
Inadequate capacity & resources for PV and post-market surveillance for quality & safety – significant impact on patient safety
Access to required essential medicines limited by insufficient regulatory capacity
Poor uptake of new and existing health solutions costs millions of lives in many of these countries

11. What is the situation in Kenya?
NMRA- legal framework, capacity, funding?
Most important question- So what?
Are our patients protected from SSFFCs & the resultant problems?
Have all the dimensions of access been adequately addressed in country? What gaps exist & how can they be addressed?
What is the contribution of NMRA activities to public health & patient safety?
What is the status of pharmacy practice in the country?

12. Conclusion/Recommendations
Regulatory activities have a direct and significant impact on patient safety & public health
Globalization has resulted in the need for strengthened & more stringent regulation
Regulation can no longer be implemented as a fragmented single country activity
Need for fast-tracking efforts to harmonize and integrate regulatory activities across countries for standardization & improved efficiency

13. Thank you