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Trips Agreement Generic Drugs

It is important to note that, in accordance with paragraph 6 of the Doha Declaration, the system will operate in a scenario where there is only one global supplier of patented medicines and therefore there will be no source available for generic drugs. The application of such a system is necessary when the patent holder refuses to supply a patented drug in a country (whose drug manufacturing capacity is insufficient or non-existent) at a price acceptable to the country concerned or under other conditions acceptable to the country concerned. The basic assumption for the application of the system is therefore a situation in which a) a drug is available and could be sold by the patent holder to the country in need, and b) the patent holder opposes it. The TRIPS agreement and the Doha “solution” to increase the availability of essential medicines have two obvious advantages over alternative mechanisms: it is already present in international law and enjoys the political support of the Declaration of Sustainable Development. India has manufacturers capable of producing generic equivalents of sofosbuvir, as does Malaysia. Can countries that do not have production capacity adopt the same strategy? Prior to the Doha Declaration, patent holders would not have been impressed by the threat of a mandatory license from a country without domestic production capacity. Since the statement, such a threat would be credible. Although the Doha Declaration solution has only been used once, it has been sufficient to demonstrate that this is possible as long as countries with production capacity are ready to cooperate. The decision recognizes that the viability of the “solution” depends largely on the existence of economies of scale that justify production. However, in accordance with paragraph 6 of the decision, savings of this magnitude are expected only in cases where the importing country is a party to a regional trade agreement consisting of at least half of its current membership from the least developed countries.

In this case, the obligation to that member, in accordance with Article 31.f of the TRIPS agreement, is removed to the extent necessary for a drug produced or imported in that Member State to be exported to the markets of other contracting parties to the regional development or development trade agreement or from least developed countries that share the health problem in question. Given the demand for participation of the least developed countries, this exemption applies only to certain regional agreements in Africa and not to other regions24, limiting the impact on economies of scale that could have been achieved. By 1995, when the TRIPS AGREEMENT came into force, Brazil and Thailand had already begun producing first-generation generic antiretroviral drugs that were not patent-protected at the time. The TRIPS agreement allowed low- and middle-income countries to wait until 2005 before the agreement was implemented. However, under international pressure, Brazil and Thailand previously offered patent protection and pharmaceutical companies acquired patents on recent antiretroviral drugs7. However, under pressure from industrialized countries, Thailand initially refused, while Brazil faced a request for WTO arbitration from the United States8. to become attractive to potential suppliers … Since eligible import markets will not be large in very small countries, generic drug manufacturers may not be interested in producing these small quantities and waiting for economies of scale. »