1. An Enabling Business Environment and A Strategic Collaborative Approach for Sustainable Quality Local Production
Africa Pharma Conference
4-5 June 2019, Johannesburg, South Africa
Jicui DONG (MS, PhD, MBA)
Programme Manager (Local Production & Access to Health Commodities)
Regulatory Systems Strengthening
Regulation of Medicines and Other Health Technologies
Access to Medicines, Vaccines and Pharmaceuticals

2. Local production in the public health context
“The term ‘Local Production’ can be defined in various ways. For the purposes of this statement, ‘local’ refers to the geographical location, i.e. occurring in the country or region, and ‘production’ – in regard to pharmaceuticals for example – refers to all activities along the pharmaceutical manufacturing value chain. Within the context of the public health agenda, promoting local production requires a holistic approach that considers policy coherence, regulatory systems strengthening, access to finance for sustainable production, a careful assessment of the business case, development of skilled human resources, access to technology for production and needs-based innovation, creation of investment incentives and other factors, to enable manufacturers to comply with international quality standards, be competitive and engage in sustainable manufacturing.”
– Extracted from the “Interagency Statement on Promoting Local Production of Medicines and Other Health Technologies”

3. Sustainable Quality Local Production
Promoting sustainable quality local production is a cross-cutting endeavour and needs government commitment and policy coherence
Different sectors need to work in concert to enable the business environment
HEALTH
TRADE
INDUSTRY
Sustainable Quality Local Production …
FINANCE
LABOUR
EDUCATION

4. Other key elements for sustainable quality local production
Regulatory system
Skilled workforce
(HR)
Capital and Financing
Materials & equip
(e.g. API, spare parts)
Infrastructure
(e.g. power, water)
Markets
(e.g. economies of scale)
Market intelligence
Foreign direct investment …

5. Quality assured products are key to achieve public health and economic benefits
PUBLIC HEALTH PERSPECTIVE
BUSINESS PERSPECTIVE
Lack of quality assurance puts health at risk
Ineffective treatments
Drug resistance (e.g. AMR)
Adverse events
Lack of quality assurance puts business viability and sustainability at risk
No access to national and international procurement tenders
Financial loss due to product recall
Less attractive to partners and investors
Loss in confidence and trust

6. NRA and Industry have a concurrent role to ensure quality
NATIONAL REGULATORY AUTHORITY (NRA)
MEDICAL PRODUCT INDUSTRY
Efficient and transparent regulatory system Regional and international quality assurance standards Regulatory convergence and harmonization Strong partnership with the medical product industry
Build quality into the product
Quality-by-design principles
Product selection
Build quality into the system
GMP in the design of the facility
QMS is a leading factor in GMP non- compliance
Strong partnership with the NRA

7. WHO supports Member States in strengthening local production with assured quality, safety and efficacy
Setting strategies
Conducting holistic situational analyses
Support in developing and implementing national strategies and roadmaps
Support in strategic selection of products
Tool for risk-based selection of medicines for local production with assured quality
Technical support and capacity building in collaboration with other WHO technical units and external partners
Holistic training workshop
Compliance with quality assurance standards
Nurturing strategic partnerships

8. Interagency Statement on Promoting Local Production of Medicines and Other Health Technologies
WHA Technical Briefing on Promoting Local Production of Medicines and Other Health Technologies: Official Launch of the Interagency Statement

9. Thank you Jicui DONG (MS, PhD, MBA)
Programme Manager (Local Production & Access to Health Commodities)
Regulatory Systems Strengthening
Regulation of Medicines and Other Health Technologies
Access to Medicines, Vaccines and Pharmaceuticals