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Just a few days ago, the WTO agreed to make permanent a temporary waiver that allows a country to produce drugs for export to the world’s least developed country, even when these drugs are still subject to patent laws.
Pascal Lamy, the Director-General of the WTO, said that the move "confirms once again that members are determined to ensure the WTO's trading system contributes to humanitarian and development goals."
But the medical aid agency Medecins Sans Frontieres (MSF) says that the decision to make permanent the 'August 30 decision' is a mistake.
"The waiver has not delivered any drugs," said Ellen ‘t Hoen, Director of Policy Advocacy for MSF’s Campaign for Access to Essential Medicines.
The August 30 decision was a 2003 amendment to the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement. Under TRIPS, a government could issue a compulsory license which would allow the generic manufacture of a patented drug. The majority of that drug should be for the domestic market and the patent holder must be compensated, though the rules for compensation are vague.
However, the countries that need access to the cheaper generic drugs are often those that do not have the means of production, and those that have the means of production often have no need to issue a compulsory license. The August 30 decision allows the exportation of more than half of the medicines produced under a compulsory license.
‘t Hoen said that the WTO should learn from the August 30 decision and make improvements before finalizing the amendment to TRIPS. She said that the decision is too complex to provide adequate economic incentive to make generic drugs.
Also in the last week, China has changed its patent laws, in accordance with the August 30 decision, to allow the production of generic drugs predominantly for export. Such production will legally take place only when a compulsory license is issued.
China has the capacity to make generic anti-retro viral drugs (ARVs), which are used to combat HIV. It is the largest producer of the raw materials in the world for ARVs, though currently produces just a few of the drugs in small quantities. If a compulsory order is issued, China may produce a wider variety of ARVS. The economy of scale allowed by the production of generic drugs largely for export may encourage manufacturers to produce the drugs where a smaller scale might make it unfavorable to do so. This will benefit Chinese HIV/AIDS patients.
However, Suerie Moon, the China Campaigner for the Campaign for Access to Essential Medicines, said it was yet to be seen whether compulsory licenses would be issued. There were political issues that would have to be considered by China.
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These agreements are the result of trade negotiators protecting their country’s industrial interests, ‘t Hoen said. "If these [negotiators] were ministers of health, you would have a different dynamic."
‘t Hoen said that the WTO’s intellectual property laws were not the result of member nations thinking that the laws were the best way to control the trade of medicine. She noted 1995 comments of Ed Pratt, the CEO of the pharmaceutical company Pfizer, about the inclusion of medication in international intellectual property laws: "The current GATT victory, which establishes provisions for intellectual property protection, resulted in part from the hard-fought efforts of the U.S. government and U.S. businesses, including Pfizer, over the past three decades."
While emphasising that MSF is not anti-patent, ‘t Hoen said that the development of medicine should not be supported by charging high prices for drugs that would be consumed only by a minority. "What sort of innovation is that?"
‘t Hoen explained that fixed dose combination ARVs, which combine various medications into a small number of pills, were developed in India and available only in countries where the drugs were under compulsory licenses. Fixed dose combination pills make taking a course of medication far simpler as fewer pills have to be taken, increasing the number of people correctly taking the medication. However, in places that do not have compulsory licenses for these drugs, including the US and Europe, patent laws do not allow the drugs, which are under separate patents, to be combined in one pill. Fixed dose combination ARVs are not available in these countries.
Pascal Lamy, the Director-General of the WTO, said that the move "confirms once again that members are determined to ensure the WTO's trading system contributes to humanitarian and development goals."
But the medical aid agency Medecins Sans Frontieres (MSF) says that the decision to make permanent the 'August 30 decision' is a mistake.
"The waiver has not delivered any drugs," said Ellen ‘t Hoen, Director of Policy Advocacy for MSF’s Campaign for Access to Essential Medicines.
The August 30 decision was a 2003 amendment to the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement. Under TRIPS, a government could issue a compulsory license which would allow the generic manufacture of a patented drug. The majority of that drug should be for the domestic market and the patent holder must be compensated, though the rules for compensation are vague.
However, the countries that need access to the cheaper generic drugs are often those that do not have the means of production, and those that have the means of production often have no need to issue a compulsory license. The August 30 decision allows the exportation of more than half of the medicines produced under a compulsory license.
‘t Hoen said that the WTO should learn from the August 30 decision and make improvements before finalizing the amendment to TRIPS. She said that the decision is too complex to provide adequate economic incentive to make generic drugs.
Also in the last week, China has changed its patent laws, in accordance with the August 30 decision, to allow the production of generic drugs predominantly for export. Such production will legally take place only when a compulsory license is issued.
China has the capacity to make generic anti-retro viral drugs (ARVs), which are used to combat HIV. It is the largest producer of the raw materials in the world for ARVs, though currently produces just a few of the drugs in small quantities. If a compulsory order is issued, China may produce a wider variety of ARVS. The economy of scale allowed by the production of generic drugs largely for export may encourage manufacturers to produce the drugs where a smaller scale might make it unfavorable to do so. This will benefit Chinese HIV/AIDS patients.
However, Suerie Moon, the China Campaigner for the Campaign for Access to Essential Medicines, said it was yet to be seen whether compulsory licenses would be issued. There were political issues that would have to be considered by China.
These agreements are the result of trade negotiators protecting their country’s industrial interests, ‘t Hoen said. "If these [negotiators] were ministers of health, you would have a different dynamic."
‘t Hoen said that the WTO’s intellectual property laws were not the result of member nations thinking that the laws were the best way to control the trade of medicine. She noted 1995 comments of Ed Pratt, the CEO of the pharmaceutical company Pfizer, about the inclusion of medication in international intellectual property laws: "The current GATT victory, which establishes provisions for intellectual property protection, resulted in part from the hard-fought efforts of the U.S. government and U.S. businesses, including Pfizer, over the past three decades."
While emphasising that MSF is not anti-patent, ‘t Hoen said that the development of medicine should not be supported by charging high prices for drugs that would be consumed only by a minority. "What sort of innovation is that?"
‘t Hoen explained that fixed dose combination ARVs, which combine various medications into a small number of pills, were developed in India and available only in countries where the drugs were under compulsory licenses. Fixed dose combination pills make taking a course of medication far simpler as fewer pills have to be taken, increasing the number of people correctly taking the medication. However, in places that do not have compulsory licenses for these drugs, including the US and Europe, patent laws do not allow the drugs, which are under separate patents, to be combined in one pill. Fixed dose combination ARVs are not available in these countries.
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