WTO's new rules allow poorest to import drugs
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《加拿大医疗协会学报》
The World Trade Organization is planning to put into law a waiver originally drafted in 2003 that allows least-developed countries to import generic drugs in public health emergencies, such as the HIV/AIDS epidemic.
The waiver pertains to Article 31 of the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which requires that drugs manufactured under compulsory licensing be sold predominantly in the domestic market of the countries that produce them. If it stood, that provision would restrict the ability of countries lacking production capacity to import cheaper generic copies of patented drugs.
The amendment to Article 31 will come into force after ratification by two-thirds of WTO member countries — likely by December 2007. A statement attached to the agreement says that members will use the provision in "good faith" to deal with public health problems, not to meet industrial or commercial policy objectives.
The amendment "confirms once again that members are determined to ensure that WTO's trading system contributes to humanitarian and development goals," WTO Director-General Pascal Lamy stated in a news release.
But Médecins Sans Frontières says the 2003 waiver is cumbersome and inefficient: it requires each country to notify the WTO and to license the manufacture of generic drugs on a case-by-case basis. Once a generic manufacturer obtains a licence, it can produce only enough medication to supply a single country. There is no provision in the agreement that would allow international tendering to procure the medicines, "which is the most common and efficient way of purchasing drugs," says Carol Devine, acting program director for MSF.
So far, not one patient has benefited from the waiver, says Devine, who considers it "premature" to give it the force of law.
MSF intends to test the Canadian law by ordering drugs to treat patients in a country that should qualify under the definitions of the WTO agreement. But Devine fears there is so much red tape involved that getting a licence for a generic version, producing it and then having it approved by Health Canada will take years.
The International Federation of Pharmaceutical Manufacturers & Associations supports the amendment, saying it meets the needs of least-developed countries while preserving the agreement itself.(Laura Eggertson)
The waiver pertains to Article 31 of the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which requires that drugs manufactured under compulsory licensing be sold predominantly in the domestic market of the countries that produce them. If it stood, that provision would restrict the ability of countries lacking production capacity to import cheaper generic copies of patented drugs.
The amendment to Article 31 will come into force after ratification by two-thirds of WTO member countries — likely by December 2007. A statement attached to the agreement says that members will use the provision in "good faith" to deal with public health problems, not to meet industrial or commercial policy objectives.
The amendment "confirms once again that members are determined to ensure that WTO's trading system contributes to humanitarian and development goals," WTO Director-General Pascal Lamy stated in a news release.
But Médecins Sans Frontières says the 2003 waiver is cumbersome and inefficient: it requires each country to notify the WTO and to license the manufacture of generic drugs on a case-by-case basis. Once a generic manufacturer obtains a licence, it can produce only enough medication to supply a single country. There is no provision in the agreement that would allow international tendering to procure the medicines, "which is the most common and efficient way of purchasing drugs," says Carol Devine, acting program director for MSF.
So far, not one patient has benefited from the waiver, says Devine, who considers it "premature" to give it the force of law.
MSF intends to test the Canadian law by ordering drugs to treat patients in a country that should qualify under the definitions of the WTO agreement. But Devine fears there is so much red tape involved that getting a licence for a generic version, producing it and then having it approved by Health Canada will take years.
The International Federation of Pharmaceutical Manufacturers & Associations supports the amendment, saying it meets the needs of least-developed countries while preserving the agreement itself.(Laura Eggertson)