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Healthcare Industries

Platform on Access to medicines in developing countries with a focus on Africa

The Platform on Access to Medicines in Developing Countries with a Focus on Africa was one of the three work areas of the Process on Corporate Responsibility in the field of Pharmaceuticals. The goal of the Africa-Platform was to reflect on the contributions the stakeholders can make by pooling and coordinating their resources and capabilities in this continent and more specifically in the sub-Saharan region.

Scope of the initiative

Following a first informal workshop held in March 2011 with international experts and stakeholders based on the workshop's outcome, two working groups were launched, in close co-operation with other Commission services on :

  • patent information
  • local capacity building

Membership

The Platform was chaired by the Directorate General for Enterprise and Industry of the European Commission.

The EU Member States and EFTA countries (European Free Trade Association) were approached to nominate representatives and the European Commission also invited the African Union Commission to contribute.

The following stakeholders’ organisations were invited to participate :

  • European Patent Office
  • World Health Organization
  • United Nations Industrial Development Organization
  • United Nations Conference on Trade and Development
  • World Intellectual Property Organization
  • International Patient Alliance (Reginal group Africa)
  • Medicines Patent Pool
  • Médecins Sans Frontières
  • Global Fund
  • International Federation of Pharmaceutical Manufacturers & Associations Germany
  • European Federation of Pharmaceutical Industries & Associations
  • European Generic medicines Association
  • European Association for Bioindustries
  • European Association of Full-Line Wholesalers
  • SME Pharmaceutical Entrepreneurs Association
  • East African Pharmaceutical Manufacturers
  • Southern African Generics Association
  • South African Generics Medicines Organization
  • African business associations

Steering Group

The work under the Africa-Platform was steered by the Steering Group.

Projects

The members of the platform were invited to contribute to two projects. While each project has a balanced representation of relevant stakeholders, the composition differs between projects, reflecting their distinctive nature and the different issues they address.

Working Group "Patent Information System"

Regarding public patent information (such as identification of patent holders and patent families in different countries), transparent and accessible data is needed as it has implications for research, development and procurement of the medicines. The objective of the Working Group was to improve the availability and access to patent information through expert search and analysis of augmented patent data. The Working Group decided to carry out a pilot project with one compound (GS7977, a Hepatitis C pipeline drug).

The establishment of a database of expert reviewed, indexed and classified patent information related to certain medical products for relevant diseases addressing the public health needs in Sub-Saharan Africa was also considered as reflected in the final report.

Terms of reference pdf - 22 KB [22 KB]

The final deliverable is a report presenting the results of the pilot project and final recommendations on how such a system could be set-up. The paper is assessing issues with regard to feasibility, actual user requirements, resources required both, initially and for maintenance, etc.

Final report + EPO results

Working Group "Local Capacity Building"

The aim of the Working Group was to explore the possibilities to support the building of capacities relevant to medicines, i.e. distribution channels, local production, clinical trials etc. It was our intention to foster a comprehensive approach, i.e. to go beyond manufacturing since capacity building is not confined to pure manufacturing capacity but does also cover related topics like the quality of products leaving these plants and the required tests.

As identified in intensive contacts with all relevant parties, the following areas were identified as worth further exploring:

  • Good manufacturing practices / good clinical practices / good laboratory practices
  • Pharmacovigilance
  • Distributing / dispensing of medicinal products
  • Regulatory environment including its enforcement
  • General lack of relevant skills

As the main outcome the European Commission organised in close co-operation with European industry stakeholders an EU-Africa Pharma Business to Business Forum: An exchange of views between regulators and business community from Europe and Africa which took place on 16 September 2013 in Brussels.

Agenda B2B Forum pdf - 21 KB [21 KB]

Presentations

The Forum's main objective was to give an overview of obstacles related to responsible business relations and reach a consensus on how European stakeholders could best share their technical knowledge with their African counterparts. The report on the event with a list of recommendations on business-to-business relations and collaboration aiming at delivering safe quality medicines to patients was drawn up.

Report

The work of the Africa-Platform was completed end 2013.

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