- Keywords > compulsory licences
- Keywords > data protection
- Keywords > innovation and intellectual property
- Keywords > Intellectual Property Rights (IPR)
- Keywords > parallel importation
- Keywords > patents
- Keywords > public health
- Keywords > regional frameworks
- Keywords > Trade Related Aspects of the Intellectual Property Rights (TRIPS)
- Keywords > TRIPS flexibilities
(2004; 110 pages) [Spanish]
IV.2.3 Developing Technical and Infrastructural Capabilities for Medicines Regulation
Regulatory approval processes raise a number of issues with respect to availability and improved access to essential medicines. Difficulties and constraints at the national level could be addressed in a regional context through coordination of registration and cross-recognition of registrations in other countries. To be able to establish a coordinated regional system of regulatory approval and/or a system of cross-recognition of registrations, however, several actions will need to be taken by countries. These would include: the coordination of the current lists of drugs registered in each country; the creation of independent and transparent drug regulatory authorities preferably autonomous from the ministries of health; the coordination of national drug policies and guidelines related to rational drug use including the use of national essential medicines lists for drug selection; adherence to interagency guidelines on medicines donations; and the creation of mechanisms to deal with differences in resistance patterns and how to reflect these in drug lists.
Other issues relate to correct labelling, which raises the issue of language; tariffs; inspection procedures; registration of pharmacies and drug vendors and regulation of traditional and herbal medicines. In particular, regulation in advertising through mechanisms that set and enforce guidelines for drug promotion is required to avoid advertisements that may be false, lacking in fair balance, or otherwise misleading. Trademark law could also be used for this purpose. A system could be developed where trademarks that have been abused are nullified. With respect to quality issues a basic requirement, which can be achieved more easily at the regional level, is a well-equipped, well-maintained, well-staffed, quality control laboratory. In this regard, current methods for each country need to be standardized, for example, by following the WHO Good Manufacturing Practices (GMP) criteria. In addition, a coordinated regional warning/drug recalls system could be developed. These steps are also critical in helping to ensure the proper functioning of a regional procurement system as discussed in the next section.
All these steps can be taken through existing regional frameworks and institutions in the South. In Africa, for example, COMESA Member States have committed themselves to cooperate in health matters and on quality assurance through according mutual recognition to drugs registered in the common market. Using the technical committee structure COMESA can, through existing mechanisms, begin to address these issues. SADC has similar aims under its health protocol also and can address the issues of regulation and quality through the health sector coordinating unit, the health sector committee of ministers, the committee of senior official and the subcommittees.91 The EAC Member States have also committed to harmonizing drug registration procedures and national health policies and regulations and are already addressing some of these issues under the Social Sector Committee.
91 See article 4 of the SADC Protocol on Health.
In Latin America and the Caribbean, there are also similar aims and objectives with respect to medicines regulations and quality issues. In MERCOSUR, for example, the Commission on Health which deals with matters related to the production and registration of medicines has established harmonized rules on good practices and quality inspection of medicines; requirements for pharmaceutical products registration; good fabrication practices and control in establishments of pharmaceutical industry; information and documents required for pharmaceutical products registration; validity, renovation, cancellation and modification of pharmaceutical products registers; among others. These provisions constitute a significant step towards MERCOSUR integration in this field, because they allow mutual recognition between governmental agencies which authorize medicines for the domestic markets.92 In CARICOM these matters can be addressed both in the context of the Cooperation in Health Initiative (CCH) and the in the context of the OECS procurement scheme. The CACM also has a commitment towards mutual recognition of medicines and issues related to technical regulations and safety under the Guatemala Protocol.93
92 See Inter-American Development Bank, Serie Red Int. (2000).
93 The concept of the CCH was introduced in 1984 at a meeting of the former CARICOM Conference of Ministers responsible for Health (CMH). The CMH saw this as a mechanism for health development through increasing collaboration and promoting technical cooperation in the Caribbean countries. The initiative, in which seven priority areas were identified, was adopted by the CMH and approved by the Heads of Government in 1986. An evaluation of the Initiative (1992-1994), found that the priorities identified ensured that activities were focused on areas critical to improving health status in the region. Overall it was established that the Initiative was beneficial to Caribbean countries.
In ASEAN, although significant steps have also been taken still more can be done. In the context of the ASEAN Health Declaration and through the ASEAN Ministers of Health technical cooperation plan, significant strides can be made towards achieving the goals of regional cooperation on technical and related matters in medicines regulations.94 The Pharmaceutical Product Working Group is already undertaking activities related to pharmaceutical regulations. The primary objective of the ASEAN Drug Regulatory Harmonisation project is to strengthen national regulatory authorities in order to ensure improved access to safe, effective quality and good quality pharmaceutical products in all the ASEAN countries.
94 More information available at http://www.aseansec.org/8621.htm, last visited on 17 March 2003.
Regional coordination on regulatory issues will offer significant benefits to developing countries and help them overcome current constraints in this area. Existing South-South RECs in Africa, Asia, Latin America and the Caribbean offer ready institutional frameworks for this purpose which should be utilized to address among other things, challenges in drug registration and post-marketing surveillance, development of essential medicines lists, development of medicines policies, and rules on pharmaceutical advertising and labelling. Existing regional efforts on these issues should be studied and lessons on good and bad practices shared.