Technological and regulatory environment challenges in the - - PowerPoint PPT Presentation

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Technological and regulatory environment challenges in the - - PowerPoint PPT Presentation

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Technological and regulatory environment challenges in the development of local production in developing countries WHO-UNCTAD-I CTSD AFRICAN WORKSHOP ON TECHNOLOGY TRANSFER FOR LOCAL MANUFACTURING CAPACITY ON DRUGS AND VACCINES Organised with

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Technological and regulatory environment challenges in the development of local production in developing countries

WHO-UNCTAD-I CTSD AFRICAN WORKSHOP ON TECHNOLOGY

TRANSFER FOR LOCAL MANUFACTURING CAPACITY ON DRUGS AND VACCINES

Organised with the support of the European Commission 10-11 December 2009, Cape Town, South Africa

Christoph Spennemann, Legal Expert IP Unit, Division on Investment & Enterprise UNCTAD

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Overview of Presentation

  • Challenges related to technology

acquisition, learning & development

  • Challenges related to the regulatory

environment

  • Other challenges
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Challenges related to technology acquisition & development

  • What technology?
  • Production of drugs for diseases mainly affecting

developing countries (type 2 & 3)

  • HIV/AIDS
  • Malaria
  • Basis: UNCTAD case studies in Ethiopia &

Uganda (November 2009)

  • Similar technology challenges typical for

many LDCs and poor DCs

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Level of technology used in production

  • General lack of capacity to undertake

pharmaceutical R&D

  • Some firms specialize in production of

excipients, capsules, or any non-R&D-based

  • utput (e.g. oral rehydration salts)
  • Others limit activities to formulation
  • Importation not only of APIs, but of all materials,

including binders

  • Effect on price
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Main technology challenge

  • Larger firms (200/300 staff): foreign technology

partners (China, India, etc)

  • Foreigners attracted by government support
  • Main challenge: how to absorb & use foreign technology
  • SMEs (e.g. 60 staff): difficult to find partners to

acquire new technologies

  • Often lack of government support
  • Main challenge: access to technology
  • Common denominator: lack of technological expertise

in local firms

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Development of domestic technological capacities (1)

  • Universities provide theory, but no capacity in

R&D commercialization

  • Missing link between universities and industry
  • R&D institutes and ministries lack

coordination & strategic vision on use of technology for development

  • Need for Science, Technology & Innovation

(STI) Policy

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Development of domestic technological capacities (2)

  • Key players do not always see importance of

STI Policy in local production context

  • Universities: ivory tower mentality; no effective IP

& innovation policies

  • Industry: quick benefits more attractive than long-

term building of capacities

  • Government: local production as issue of

investment & public health, more than tech transfer opportunity

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Development of domestic technological capacities (3)

  • Role of IP: main objective seems

implementation of TRIPS, rather than use of IP as a tool to foster long-term technological development & growth

  • Part of STI Policy
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The regulatory environment (1)

  • Local producers need efficient drug regulatory

authority (DRA)

  • DRAs often underfunded & understaffed
  • Delay in marketing approvals
  • Limited capacity to undertake quality control
  • WHO pre-qualification considered major

hurdle

  • Need for GMP & quality training
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The regulatory environment (2)

  • Need to ensure drugs quality has triggered

anti-counterfeit legislation in some countries

  • Risk to confuse counterfeits with generic

medicines

  • Definitions of « counterfeits » built on IP holder’s

authorization

  • Disincentive for local producers
  • Need for awareness building among policy makers

and producers

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Other challenges

  • Level playing field/foreign competition
  • Indian export subsidies
  • Need to import all ingredients
  • Tariffs on imported raw materials
  • IP on imported raw materials
  • Irregular procurement by government
  • Access to capital
  • Poor credit rating need for intermediaries to

purchase ingredients

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Contact

Christoph Spennemann Legal Expert Intellectual Property Unit 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 97 http://www.unctad.org/tot-ip