(2004; 110 pages)
I.2 The Study Process and Methodology
This study was undertaken through a consultative process that spanned over a year. The research was undertaken by a Task Force (TF) consisting of three developing country experts with experience on international law, international intellectual property law and policy, and public health and regional cooperation. The TF also drew on the expertise of medical and health professionals, partner intergovernmental organizations and civil society groups. The TF was assisted in an advisory role by an Expert Consultative Group (ECG) made up of international experts in international law, international intellectual property and technology law and policy, economics and public health.
The first part of the process involved the South Centre identifying the core research team in February 2003. The idea was to identify developing country experts with a demonstrated experience at country, regional and international level on issues of patents and public health. An effort was also made to ensure that the members of the TF included experts based in the regions. After establishing the TF, the second task was to identify the members of the ECG. Here the premise was to identify international experts on the subject and to include both nationals of developing countries and some experts from the North. An effort was made to ensure that there was expertise in the ECG not only on patent issues, but also on medicines and public health issues as well as on economic issues to ensure a multidisciplinary approach to the analysis. After establishing the TF and the ECG, the initial research and determination of the scope of the study began. This initial phase culminated in the first meeting of the TF in April 2003. This first meeting provided an opportunity for the TF to discuss and finalize the outline of the study and to share the results of their initial research.
Following the first meeting of the TF, work on the first draft began. In addition to the research and writing during this phase, the lead author travelled to Africa to meet representatives of RECs in June 2003. These meetings were aimed at enabling the lead author to have an initial exchange of views and ideas on the study with the REC secretariats. In this regard, the lead author had meetings with the representatives of the Common Market for Eastern and Southern Africa (COMESA), the Southern Africa Development Community (SADC) and the East African Community (EAC). After these meetings, there followed a period of research and writing which resulted in completion of the first draft of the study in July 2003. The draft was then presented and reviewed by an expert group at a meeting in New York on 22 July 2003. The expert review meeting was cosponsored by the Department of Essential Drugs and Medicines Policy (EDM) of WHO and the Health Equity Department of the Rockefeller Foundation.
On the basis of the first draft and the results of the New York expert review, a working meeting was held in August 2003 of the TF and the ECG in Geneva to discuss the draft and the outcomes of the expert review. This meeting provided an opportunity for the TF and the ECG to engage in an in-depth discussion of the various components of the study and share information and insights. This meeting was followed by a consultative workshop on 12 August 2003 also in Geneva. The consultative workshop provided a forum for discussions and consultations on the first draft of the study with a wider group of stakeholders and experts. The workshop brought together the TF, the ECG, and international experts on intellectual property, public health, pharmaceutical markets and procurement, representatives of a significant number of the permanent missions of developing countries in Geneva and representatives of various RECs from the South including SADC, COMESA, EAC and the Andean Community. Participants also included representatives of international Organizations such as the United Nations Conference on Trade and Development (UNCTAD), the World Health Organization (WHO), the UN Special Programme on AIDS (UNAIDS) and The Global Fund as well as civil society organizations.
Following the consultative workshop, the TF again met to review the outcomes of the workshop and plan for the final phase of research and writing. This final phase was undertaken between September and November 2003 at which time the initial final draft of the study was produced. This draft was circulated among the ECG and selected experts for further review in December 2003 and, on the basis of their comments, observations and suggestions the final draft was prepared in March 2004. This was followed by a period of editing, formatting and revisions culminating in the publication of the study in April 2004. The conclusions and recommendations in the study have therefore been arrived at through research and a series of meetings and consultations with various stakeholders. In terms of the sources of information and data, the study relies predominantly on secondary sources except in a few cases where questionnaires were used.