UK government tightens rules for drug regulators
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《英国医生杂志》
Drug regulators will be barred from having any links to the pharmaceutical industry under new measures announced last week. The proposals are designed to increase public confidence in the monitoring of the safety of medicines and to encourage drug companies to be more open.
Norman Warner, health minister for England, said that the government was aware of the criticism of the Medicines and Healthcare Products Regulatory Agency which suggested that the agency was "in the pockets of the industry."
Although refuting this position, Mr Warner said that, as the advisory committee structure for medicines regulation has remained unchanged since 1968, it was time for change.
A new commission will be formed to advise ministers on the safety and effectiveness of medicines combining the responsibilities of the Medicines Commission and the Committee on Safety of Medicines.
The 18 member strong commission will include two lay representatives and no industry member. Expert advisory groups will also include patient representation.
Mr Warner said, "We want to give patients and the public a greater role in advising on safety of medicines by including strong lay and patient representatives."
Members of the commission, likely to be named the Commission on the Safety and Efficacy of Medicines, and of the advisory groups, will have to prove impartiality. Mr Warner said, "It is time to respond to concerns that the arrangements concerning declaration of interests are not as wide ranging as they could be."
Members will have to prove that they have neither a direct nor an indirect financial interest in the pharmaceutical industry as well as declaring any other interests, including those of their immediate family.(Kathryn Godfrey)
Norman Warner, health minister for England, said that the government was aware of the criticism of the Medicines and Healthcare Products Regulatory Agency which suggested that the agency was "in the pockets of the industry."
Although refuting this position, Mr Warner said that, as the advisory committee structure for medicines regulation has remained unchanged since 1968, it was time for change.
A new commission will be formed to advise ministers on the safety and effectiveness of medicines combining the responsibilities of the Medicines Commission and the Committee on Safety of Medicines.
The 18 member strong commission will include two lay representatives and no industry member. Expert advisory groups will also include patient representation.
Mr Warner said, "We want to give patients and the public a greater role in advising on safety of medicines by including strong lay and patient representatives."
Members of the commission, likely to be named the Commission on the Safety and Efficacy of Medicines, and of the advisory groups, will have to prove impartiality. Mr Warner said, "It is time to respond to concerns that the arrangements concerning declaration of interests are not as wide ranging as they could be."
Members will have to prove that they have neither a direct nor an indirect financial interest in the pharmaceutical industry as well as declaring any other interests, including those of their immediate family.(Kathryn Godfrey)