1 / 12

Christoph Spennemann, Legal Expert, IP Team Division on Investment and Enterprise UNCTAD

Local Production of Pharmaceuticals in Developing Countries Taking advantage of TRIPS flexibilities Study Tour University of West Indies Geneva, 13 May 2009. Christoph Spennemann, Legal Expert, IP Team Division on Investment and Enterprise UNCTAD. Overview of Presentation.

liona
Download Presentation

Christoph Spennemann, Legal Expert, IP Team Division on Investment and Enterprise UNCTAD

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Local Production of Pharmaceuticals in Developing Countries Taking advantage of TRIPS flexibilities Study Tour University of West Indies Geneva, 13 May 2009 Christoph Spennemann, Legal Expert, IP Team Division on Investment and Enterprise UNCTAD

  2. Overview of Presentation • Intellectual Property Rights (IPRs) and Access to Medicines (ATM) • The Example of Uganda • The Local Production Initiative

  3. IPRs and ATM (1)Historical facts • Concerns about access & price  OECD governments refused patents on pharmaceutical products • France until 1960 • Germany until 1968 • Japan until 1976 • Switzerland until 1977 • Italy & Sweden until 1978 • Spain until 1992

  4. IPRs and ATM (2)General issue • Drug development by industry is costly & risky  incentives needed to encourage R&D investment  TRIPS obligation to make patents available for drugs • Exclusive rights contribute to higher drug prices • OECD countries: safeguards (insurance schemes; competition law & policy to address IP abuses) • DCs: no or only few safeguards  access problem (IP as one among many factors)

  5. Factors inhibiting ATM in DCs (Example: Uganda) • Poor health care infrastructure • Corruption in the management of public funds • Weak drug regulatory/quality control systems • High prices of procured pharmaceutical products and diagnostic kits • Lack of vaccines/cures for HIV/AIDS & tropical diseases

  6. Striking a balance: IPRs and ATM • Important incentives for pharmaceutical R&D • Impact on prices • WTO Doha Declaration on TRIPS & Public Health • India as source of affordable generics • Industry engagement on tiered pricing (e.g. Gilead, 2008) and non-enforcement of IP (Roche) • Impact on pharmaceutical innovation • Tropical diseases: alternative incentives? (WHO Global Strategy & Plan of Action) • Innovation through competition: generic fixed dose combination HIV/AIDS drugs (e.g. Cipla’s Triomune)

  7. Maximal innovation level Optimal protection level P Striking a balance: Patents as a Policy MeasureProtection (P) vs.Innovation (I) Source: Swiss Federal Institute of Intellectual Property, October 2006 I Minimal protection level

  8. TRIPS Agreement: tools for balance • In order to become operational on national level, most TRIPS provisions need further elaboration by domestic law makers • This leeway in implementation is referred to as « TRIPS flexibilities » • UNCTAD assists DCs and LDCs in the implementation of flexibilities • Examples: East African Community (EAC) Secretariat, Kenya, Rwanda, Uganda, Tanzania

  9. The Local Production Initiative • Rationale: production of affordable drugs • BMZ/Germany: Overall coordination • UNCTAD: Legal advice facility • InWEnt: training courses on TRIPS flexibilities • UNIDO: Economic feasibility studies, promotion of business partnerships, plant-level advice (quality issues) • GTZ: Production-related assistance & equipment • action medeor: training of pharmacists • Bank for Reconstruction (KfW): funding of SMEs

  10. A beneficiary: Pharmakina/DRC • Located in Bukavu/DR Congo • Independent business since 1999 • Technical & financial support from GTZ & action medeor • World’s leading producer of quinine (for anti-malarials) • Since 2005: production of ARV «Afri-Vir» • Combination therapy: 3 ingredients in one pill (stavudine, lamivudine, nevirapine) • Costs per patient: 15 Euros per month • At present: therapy for 200 locals • Envisaged: WHO prequalification (for international procurement) • Capacity to produce 180,000 tablets per day

  11. Local production in Uganda • Joint venture: Quality Chemicals – Cipla • Production of ARVs since February 2009 • Envisaged $9 per month per patient • Envisaged two million tablets per day • Incentives to attract Indian producer • Government provides land & funds infrastructure • Government pledges to procure ARVs worth of $45 million per year for seven years • Government implements TRIPS transition period on pharma patents until 2016 (as opposed to India) • « This plant exists largely thanks to TRIPS », Quality Chem. Finance Director • Cipla provides training & technology transfer

  12. Contact Christoph Spennemann Legal Expert Intellectual Property Team Division on Investment and Enterprise (DIAE) UNCTAD E-mail: Christoph.Spennemann@unctad.org Tel: ++41 (0) 22 917 59 99 Fax: ++41 (0) 22 917 01 94 http://www.unctad.org/tot-ip

More Related