EU-ASEAN Workshop on Data Protection (Pharmaceuticals), 29-30 April 2004, Bangkok

The forum provided a unique opportunity for representatives of ASEAN national health authorities, European and local pharmaceutical industry, the generic drug sector, academics and NGOs to elaborate their positions regarding data protection under Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) of the WTO. Presiding over the opening of the workshop were Ambassador Klauspeter Schmallenbach, Head of the EC Delegation to Thailand; Mr. Suraphol Jaovisidha, Deputy Director-General of the Department of Intellectual Property and ECAP II Director Valentin Mir.  In his opening remarks, Ambassador Schmallenbach stressed the importance of intellectual property rights protection.  “Data protection is an independent IP right, crucial for protecting such innovation. This is true in particular of pharmaceutical products that are costly to develop. At the same time, data protection, as stipulated in TRIPs, must not obstruct access to medicines. The issue of data protection is especially relevant for off-patent products and for products that are difficult to patent, such as biotech products. Hence, data protection rules are of particular importance to many developing countries and in particular pharmaceuticals.”

In recent years, European and international research-based pharmaceutical companies have increased their investments in ASEAN countries. In doing so, they committed themselves to bringing innovative medicines to these markets, while contributing to the development of local pharmaceutical sector, since many of these investments activities are done in partnership with local companies. The protection of IP rights in line with international standards, along with a stable and predictable business environment, will ensure continuity of such investments into the region. On the other hand, generic manufacturers are seen as vital guarantee for the availability of life-saving medicines at affordable prices. By bringing together cross sections of stake holders in this issue, this particular activity was meant as a dialogue in contribution to the search for a balanced solution for conflicting interests.

"The workshop helped to educate and create understanding among all parties concerned. Each of the different groups and sectors has their own reasoning and policy-makers ought to take into account views of all sides, "said Dr. Jakkrit Kuanpoth of Sukhothai Thammathirat Open University, one of the speakers at the event.   Assoc. Prof. Jakkrit is a well-known IP academic and a member of the committee appointed by the Ministry of Public Health to study implementation of Article 39.3.  

“We are going to draft the regulations in order to implement Article 39.3. Therefore attending this workshop is very useful to my task,” Vietnamese delegate Nguyen Van Bay from the Legislation and Management Division of the National Office of Intellectual Property Office commented about the event.

Mr. V.A. Binus Manik, Chief of Legal Services Division, Bureau of Law and Organization, Indonesia’s Ministry of Health said the workshop contributed to broadening his perspectives for his future work of processing recommendation on marketing approval for pharmaceutical products.

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Presentation materials are available for downloading:

• Opening Speech by Mr Suraphol Jaovividha, Director General, Department of Intellectual Property, Ministry of Commerce
• Opening Statement by Mr Klauspeter Schmallenback, Ambassador - Head of the Delegation of the European Commission to Thailand
• Creation and Development of A Medicinal Product by Mr Lars Walan, Vice President, Global Drug Development Emerging Markets, Astra Zeneca
• Experiences of the Pharmaceutical Industry in Europe on Approval Procedures and Data Protection by Mr Lars Walan
• Procedures and Requirements for Approval of Medicinal Products in Europe by Dr Heike Wohling, Managing Director, DABIO Gesellschaft fur Auftragforschung mbH
• Experiences of the Pharmaceutical Industry in Europe on Approval Procedures and Data Protection  (Document/Powerpoint)by Mr Manuel Campolini, Representative INTERPAT
• Current Registration System in ASEAN countries, the  ASEAN Common Technical Dossier (ATCD) and ASEAN common Technical Requirements
  *  Brunei (Document/Powerpoint)
  *  Cambodia (Powerpoint)
  *  Indonesia (Powerpoint)
  *  Laos (Document/Powerpoint)
  *  Singapore (Powerpoint)
  *  Vietnam (Document)
• Data Protection as a Distinctive Right by Mr Christophe de Vroey, Directorate-General Trade of the European Commission
• Conduct of Clinical Trials by a thrid-party prior to Patent Expiry - a Comparative Approach by Mr Duncan Matthews, Queen Mary Intellectual Property Research Institute
• Law and Practice on Data Protection in Asia by Dr Jakkrit Kuanpoth, Associate Professor, Sukhothai Thammathirat Open University
• Role of Generic Drugs for the ASEAN countries by Dr Howard Rosenberg, Director, IP & API Strategy, Merck Generics