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Sustainable development in healthcare, through improving the availability, accessibility, quality and proper usage of prescription medications.
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Drug trade between developed and developing countries :
efficacy of regulation systems, problems and perspectives P. Naboulet, B Van der Heide, C. Bruneton This study describes the current state and efficacy of the regulations concerning the export of drugs in 17 European countries. It also deals with the regulatory aspects of the pharmaceutical market in 17 developing countries in order to help the drug regulatory authorities, the centers of information on drugs, the supply agencies and the consumer organizations in the developing countries to be more critical about the drugs they import. It is also a tool intended for the health workers and the consumers and aiming at exerting some pressure on the pharmaceutical policies in the developing as well as developed countries.
The analysis of the situation in these 17 European countries, based on questionnaires sent to resource-persons in the north and south, has highlighted at least 10 loopholes existing in the European export legislation. Stressing these loopholes the authors aim at facilitating the development of some consciousness regarding the need for new measures to improve the quality of information on European producers.
In the examined developing countries the situation of drug regulations tends to improve. Except for one, all the countries have implemented legislation tools and structures aiming at controlling the pharmaceutical market. All the drugs, whether produced locally or imported, have to be registered by the relevant authorities in many countries, notably apart from drugs coming from international donations.
The Certification Scheme of WHO remains insufficiently or incorrectly used except for some international tenders. It is a proof of registration in the country of origin which is required. This study mentions the large variety of certificates not always corresponding to those issued by the exporting countries, or to those recommended by the WHO.
The authors request from the European Union to implement the conditions allowing export of only safe and efficient drugs from the member states. They stress the importance of a strict and full implementation of the Certification Scheme of WHO. Download the report  |
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Updated : 01/05/10
