Local Production of Pharmaceuticals and Related Technology Transfer Dr. Padmashree Gehl Sampath Division for Technology and Logistics UNCTAD UNCTAD/CD-TFT 1 1 Background Case studies part of the EU funded project titled Improving Access to Medicines through Local Production and Related Technology Transfer of Medical Products Project under the GSPA, Element 4 that urges Member States to promote technology transfer for local production of medical products in developing countries 13 Outputs of the first phase of the project: 8 case studies, 2 global reports on trends of local production and technology transfer apart from some work on vaccines and diagnostics. UNCTAD/CD-TFT 2 2 UN Copyright 2003 1
Selection of firms was based on four models of ToT 1. South-South Transfer of Technology Related to Local Production of Pharmaceuticals (Bangladesh, Ethiopia and Uganda) 2. North-South Transfer of Technology Related to Local Production of Pharmaceuticals (Colombia and Indonesia) 3. State-Supported Creation of Domestic Technological Capacities Related to Production of Pharmaceuticals (Thailand) 4. Creation by Local Private Sector of Domestic Technological Capacities Related to Production of Pharmaceuticals (Argentina and Jordan) UNCTAD/CD-TFT 3 3 Methodology and Purpose A case study approach was used to understand the firm level and country level circumstances that impacted upon actors ability to engage and benefit from technology transfer initiatives for local production. Country level factors were analyzed from the perspective of the individual firm (micro level). Focus was on three main aspects: What factors triggered off the transfer of technology in the pharmaceutical firms in question? How did this lead to building capacity? What system-specific, country specific aspects played a key role in this endeavor? To what extent can the experience of the firm be generalized at the sectoral level? 4 4 UN Copyright 2003 2
1. General Findings: issues of definition 1. What is local production Is it only (geographical, only indigenous firms or including MNC subsidiaries)? Is it production that entails technological learning of some sort, if so how much learning is good? How can different forms of learning (finished formulation and APIs be accommodated)? Is it for simple therapeutic products or for more complex drugs that cater to PH needs? 2. What is access to medicines in the context of LP? UNCTAD/CD-TFT 5 5 UNCTAD/CD-TFT 6 UN Copyright 2003 3
2. Specific Findings Local production is feasible and ongoing in developing and least developed countries Technology transfer has been an important factor in making production feasible and competitive in three important ways: Expanding export markets and product portfolios Meeting quality standards required for exports and safe domestic use Technology transfer for API production helps to increase the competitiveness of local production UNCTAD/CD-TFT 7 7 2. Specific Findings Local Production Promotes Access to Medicines in four ways: offers price-based competition in the market, ensuring cheaper prices of drugs and greater affordability. caters to specific health needs of developing by promoting incremental innovations that produce generics of existing drugs. produce new products (in segments that are not catered to by the global pharma) that meet local needs. Promote rural access UNCTAD/CD-TFT 8 8 UN Copyright 2003 4
3. Specific Findings for Africa: Competitiveness, Economics and Finance Much technology transfer is for HIV/AIDS, Malaria. ToT in other pharma areas needs to be introduced (e.g. Type I, II and III diseases, medical devices, vaccines, etc.). More ToT is needed for APIs. Vaccine production should be given priority (capital intensive during start up but low operating cost). Building on existing relationships to form a base for ToT (e.g. Ethiopia, Uganda) Producing already abundant medicines is not the way forward (e.g. paracetamol). Creating specialization building on comparative advantage is necessary by identifying undersupplied markets where demand exists (to benefit from economies of scale). 9 9 UNCTAD/CD-TFT 9 3. Specific Findings: Know-how, technology and innovation The importance of a coordinated government approach to science technology and innovation policy that also promotes investment strategically. Industry needs Government to take a leadership role in promoting a conducive and coherent environment. Level of development of a country will determine the amount of support for the private sector. Importance of partnerships and regional collaboration between national R&D facilities and between private sector and universities. UNCTAD/CD-TFT 10 10 UN Copyright 2003 5
3. Specific Findings: Good Manufacturing Practices, Regulation, Standards Quality Control Regulatory requirements are needed to ensure the quality, safety, and efficacy of products. There are barriers in meeting these requirements: There is a lack of financing to meet GMP and licensing requirements. There is lack of human resource capacity of regulatory authorities, including skills, personnel, as well as funding. This contributes to longer timeframes for marketing approval of local products. There is limited local capacity to undertake safety and efficacy/bioequivalence studies, clinical trials and other studies required for product registration.. UNCTAD/CD-TFT 11 11 THANK YOU Padmashree.gehl.sampath@unctad.org UNCTAD/CD-TFT 12 12 UN Copyright 2003 6
1. General Findings: issues of definition 3. What is innovation and technology transfer for LP? Innovation as any new products, processes and organisational changes that are new to the enterprise, context and country in question, although not necessarily to the world at large. Technology transfer was defined as all components of technology, both codified (in terms of blue prints, hardware, machine parts and plant technologies) and tacit (know-how and skills) that are essential to enhance the capacity of the organizations in the recipient country to produce pharmaceutical products. 13 13 UNCTAD/CD-TFT 13 UN Copyright 2003 7