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Japan's House of Representatives passes brain-death bill
THE LANCET
POLICY AND PEOPLE
Japan’s House of Representatives passes brain-death bill
Philippines gold-rush prompts detox ification programme
E
mergency detoxification is to be carried out on 18 children living near gold-processing sites in the southern Philippines, after studies showed that they had been poisoned by “unacceptable” concentrations of mercury and cyanide. Many live within 500 m of the Mount Diwalwal gold-processing plants in Davao del None, Mindanao. Mercury and potassium cyanide are used in the gold-extraction process. Two studies were done by Nelia Cortes-Maramba, University of the Philippines’ National Poisons Control and Information Service and Cristina Pablo, NonCommunicable Disease Control Service. In 64 children, laboratory tests showed that 12 had mercury levels “above acceptable limits”, with six being recommended for detoxification. A second test, on 50 pupils of the Apokon Elementary School, found that 20 had “elevated levels” of blood cyanide; 12 needed detoxification. Of 39 adult miners, two had inadmissible mercury levels and 10 had dangerous levels of cyanide in their blood. Two were recommended for detoxification.
Claire Wallerstein
1304
expected to be shortened later to ensure surgical safety and to build public trust. Earlier this month, the Japan Society for Transplantation, a strong supporter of the first bill, officially
Science Photo Library
apan’s House of Representatives last week approved a bill that defines brain death as legal death. The move paves the way for heart and liver transplantations, which have been banned for almost three decades. The bill, which has been under discussion for several years, and was spearheaded by members from the leading Liberal Democratic Party, was approved by a vote of 320 to 148. A second bill, which was proposed by the opposition Democratic Party of Japan, was rejected. This alternative bill retained the old definition of death as occurring after the heart stops beating but allowed for organ removal if there was prior consent in writing from the donor and family. The Health Ministry is already drawing up a list of 18 hospitals that would be certified to perform the organ transplantations. This list is
J
A future option in Japan?
endorsed their own guidelines for heart and liver transplantations, that would be directed by the society’s chairman under a nationwide network. Brain death was first defined in Japan in 1988 by the Japan Medical
Association. The five conditions that must be met before someone can be declared legally dead are deep coma, dilatation of pupils, need for assisted respiration, absence of brainstem response, and a confirmation that all of the above conditions are met after a 6-hour waiting period. Transplantation has been banned since the country’s first and only heart-transplant operation in 1968. The bill must now pass the next stage of approval in the Upper House, where opposition is expected to be stronger. Already a third bill, similar to the second one that was rejected, has been proposed by a coalition of non-government parties, and this bill will soon be discussed by a special parliamentary committee. The date for the Upper House vote on the brain-death bills is as yet undetermined. Ed Gutierrez
Canada’s drug industry put under pressure anada’s pharmaceutical firms should be required to open their vaults for university research and training or face a 1% levy on drug sales, a Parliamentary committee has recommended. The committee had done a legislatively required review of a 1992 law that extended patent protection for brand-name drugs. The Commons industry committee on April 24 urged Ottawa to require both the brand-name and generic drug industries to “voluntarily” renew the existing Can$200-million Medical Research Council Pharmaceutical Manufacturers’ Association of Canada health programme when it expires in October, 1998, or begin paying a levy that would be used for research. “The fund would be administered by the MRC through its normal peer review procedures. The fund would support collaboration in health research broadly defined, pharmaceutical research needs that are not being currently met, and projects that strengthen the research base that a self-sustaining biopharmaceutical industry needs.” Although industrial outlays under the existing health programme have lagged behind anticipated levels, the committee did not urge stricter measures to ensure that industrial spending is directed towards basic research
C
rather than clinical trials. Nor did it recommend changes to the law itself, saying that extended patent protection is necessary to ensure the growth of a pharmaceutical industry, even at the expense of higher drug prices. The 1992 law extended patent protection for brand-name drugs to 20 years and eliminated the compulsory licensing system which allowed cheap generic drugs to be copied for a royalty. However, in the face of increasing public concern about rising drug prices, the committee did urge that the mandate of the Patented Medicines Prices Review Board (PMPRB), which fixes a domestic ceiling on new brand-name drug prices, be reviewed and strengthened. The PMPRB has come under considerable criticism of late for using inflated international drug prices as their standard for setting the allowable price of a new drug. Noting “it is imperative that Canadians have trust in the role and methodology” of the PMPRB, the industry committee recommended the Auditor-General of Canada conduct a full audit of the agency’s operations so as to “provide Parliament with information on performance and efficiency”. Wayne Kondro
Vol 349 • May 3, 1997
POLICY AND PEOPLE
Japan’s House of Representatives passes brain-death bill
Philippines gold-rush prompts detox ification programme
E
mergency detoxification is to be carried out on 18 children living near gold-processing sites in the southern Philippines, after studies showed that they had been poisoned by “unacceptable” concentrations of mercury and cyanide. Many live within 500 m of the Mount Diwalwal gold-processing plants in Davao del None, Mindanao. Mercury and potassium cyanide are used in the gold-extraction process. Two studies were done by Nelia Cortes-Maramba, University of the Philippines’ National Poisons Control and Information Service and Cristina Pablo, NonCommunicable Disease Control Service. In 64 children, laboratory tests showed that 12 had mercury levels “above acceptable limits”, with six being recommended for detoxification. A second test, on 50 pupils of the Apokon Elementary School, found that 20 had “elevated levels” of blood cyanide; 12 needed detoxification. Of 39 adult miners, two had inadmissible mercury levels and 10 had dangerous levels of cyanide in their blood. Two were recommended for detoxification.
Claire Wallerstein
1304
expected to be shortened later to ensure surgical safety and to build public trust. Earlier this month, the Japan Society for Transplantation, a strong supporter of the first bill, officially
Science Photo Library
apan’s House of Representatives last week approved a bill that defines brain death as legal death. The move paves the way for heart and liver transplantations, which have been banned for almost three decades. The bill, which has been under discussion for several years, and was spearheaded by members from the leading Liberal Democratic Party, was approved by a vote of 320 to 148. A second bill, which was proposed by the opposition Democratic Party of Japan, was rejected. This alternative bill retained the old definition of death as occurring after the heart stops beating but allowed for organ removal if there was prior consent in writing from the donor and family. The Health Ministry is already drawing up a list of 18 hospitals that would be certified to perform the organ transplantations. This list is
J
A future option in Japan?
endorsed their own guidelines for heart and liver transplantations, that would be directed by the society’s chairman under a nationwide network. Brain death was first defined in Japan in 1988 by the Japan Medical
Association. The five conditions that must be met before someone can be declared legally dead are deep coma, dilatation of pupils, need for assisted respiration, absence of brainstem response, and a confirmation that all of the above conditions are met after a 6-hour waiting period. Transplantation has been banned since the country’s first and only heart-transplant operation in 1968. The bill must now pass the next stage of approval in the Upper House, where opposition is expected to be stronger. Already a third bill, similar to the second one that was rejected, has been proposed by a coalition of non-government parties, and this bill will soon be discussed by a special parliamentary committee. The date for the Upper House vote on the brain-death bills is as yet undetermined. Ed Gutierrez
Canada’s drug industry put under pressure anada’s pharmaceutical firms should be required to open their vaults for university research and training or face a 1% levy on drug sales, a Parliamentary committee has recommended. The committee had done a legislatively required review of a 1992 law that extended patent protection for brand-name drugs. The Commons industry committee on April 24 urged Ottawa to require both the brand-name and generic drug industries to “voluntarily” renew the existing Can$200-million Medical Research Council Pharmaceutical Manufacturers’ Association of Canada health programme when it expires in October, 1998, or begin paying a levy that would be used for research. “The fund would be administered by the MRC through its normal peer review procedures. The fund would support collaboration in health research broadly defined, pharmaceutical research needs that are not being currently met, and projects that strengthen the research base that a self-sustaining biopharmaceutical industry needs.” Although industrial outlays under the existing health programme have lagged behind anticipated levels, the committee did not urge stricter measures to ensure that industrial spending is directed towards basic research
C
rather than clinical trials. Nor did it recommend changes to the law itself, saying that extended patent protection is necessary to ensure the growth of a pharmaceutical industry, even at the expense of higher drug prices. The 1992 law extended patent protection for brand-name drugs to 20 years and eliminated the compulsory licensing system which allowed cheap generic drugs to be copied for a royalty. However, in the face of increasing public concern about rising drug prices, the committee did urge that the mandate of the Patented Medicines Prices Review Board (PMPRB), which fixes a domestic ceiling on new brand-name drug prices, be reviewed and strengthened. The PMPRB has come under considerable criticism of late for using inflated international drug prices as their standard for setting the allowable price of a new drug. Noting “it is imperative that Canadians have trust in the role and methodology” of the PMPRB, the industry committee recommended the Auditor-General of Canada conduct a full audit of the agency’s operations so as to “provide Parliament with information on performance and efficiency”. Wayne Kondro
Vol 349 • May 3, 1997