NHS criticised for lax control over drugs industry
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《英国医生杂志》
Links between the pharmaceutical industry and the UK Department of Health have become so intertwined that the public's health is being put at risk, says a highly critical report from a cross party group of MPs, published this week. The much anticipated report cites multiple failings at the United Kingdom's drug regulatory body for not scrutinising thoroughly enough data from companies seeking licences for new drugs and for not monitoring side effects adequately.
It also blames lax controls at the Department of Health for allowing pharmaceutical companies to have expanded influence over the public and the medical profession, which has led to overprescribing by doctors and an unhealthy reliance on medicines by the public.
The report, from the House of Commons health select committee, recommends a raft of changes throughout the Department of Health. It is especially critical of the Medicines and Healthcare Products Regulatory Agency (MHRA), which it says should be the subject of an independent review. Stricter controls on promotional materials from pharmaceutical companies, particularly in the first six months after a drug is launched, are needed. Also, the activities of a company should be restricted if it breaches regulations or publishes misleading research, says the report.
The MHRA should also be given greater powers to guide what research drug companies do and to randomly audit their data and to publish the results. More staff are also needed to monitor drugs more closely after they are launched and to consider whether drugs should have their licences renewed after five years.
The Department of Health should also be relieved of its responsibility to oversee the pharmaceutical industry, recommends the report: "The secretary of state for health cannot serve two masters. The department seems unable to prioritise the interests of patients and public health over the interests of the pharmaceutical industry. We therefore recommend that sponsorship of the industry pass from the Department of Health to the Department of Trade and Industry."
MPs recommend changes throughout the Department of Health including relief of its responsibility to oversee the pharmaceutical industry
Credit: WILL & DENI MCINTYRE/SPL
The Association of the British Pharmaceutical Industry has welcomed some aspects of the report but taken issue with others. Richard Barker, director general of the association, said: "The committee's report puts forward a number of constructive proposals to increase public accountability and transparency among all those involved in decisions about health care."
But the association questioned recommendations that intend to restrict doctors' freedom to prescribe and companies' ability to provide information to the medical profession. Claims in the report that "consumption of drugs is vast and increasing" and that prescribing soars in the months after a drug is launched were misguided, it said. According to the association, the UK spends the least on medicines per head in Europe and has among the lowest use of new medicines during their first five years on the market.
Which?, a UK consumer association, also welcomed the report. But Ike Iheanacho, editor of the Drug and Therapeutics Bulletin, which it publishes, saw the lack of guidance on reclassifying drugs as over the counter products as a major flaw.
"The absence of any recommendations on reclassification is an important and obvious omission. This is particularly worrying in the light of evidence produced by this week on the MHRA's failure to accurately report the consultation which preceded becoming available over the counter," he said.
"If the government is truly concerned with public health, it must move away from a blind desire to simply reclassify drugs and ensure that only those proved to be safe and effective for the target group are made available over the counter."(Zosia Kmietowicz)
It also blames lax controls at the Department of Health for allowing pharmaceutical companies to have expanded influence over the public and the medical profession, which has led to overprescribing by doctors and an unhealthy reliance on medicines by the public.
The report, from the House of Commons health select committee, recommends a raft of changes throughout the Department of Health. It is especially critical of the Medicines and Healthcare Products Regulatory Agency (MHRA), which it says should be the subject of an independent review. Stricter controls on promotional materials from pharmaceutical companies, particularly in the first six months after a drug is launched, are needed. Also, the activities of a company should be restricted if it breaches regulations or publishes misleading research, says the report.
The MHRA should also be given greater powers to guide what research drug companies do and to randomly audit their data and to publish the results. More staff are also needed to monitor drugs more closely after they are launched and to consider whether drugs should have their licences renewed after five years.
The Department of Health should also be relieved of its responsibility to oversee the pharmaceutical industry, recommends the report: "The secretary of state for health cannot serve two masters. The department seems unable to prioritise the interests of patients and public health over the interests of the pharmaceutical industry. We therefore recommend that sponsorship of the industry pass from the Department of Health to the Department of Trade and Industry."
MPs recommend changes throughout the Department of Health including relief of its responsibility to oversee the pharmaceutical industry
Credit: WILL & DENI MCINTYRE/SPL
The Association of the British Pharmaceutical Industry has welcomed some aspects of the report but taken issue with others. Richard Barker, director general of the association, said: "The committee's report puts forward a number of constructive proposals to increase public accountability and transparency among all those involved in decisions about health care."
But the association questioned recommendations that intend to restrict doctors' freedom to prescribe and companies' ability to provide information to the medical profession. Claims in the report that "consumption of drugs is vast and increasing" and that prescribing soars in the months after a drug is launched were misguided, it said. According to the association, the UK spends the least on medicines per head in Europe and has among the lowest use of new medicines during their first five years on the market.
Which?, a UK consumer association, also welcomed the report. But Ike Iheanacho, editor of the Drug and Therapeutics Bulletin, which it publishes, saw the lack of guidance on reclassifying drugs as over the counter products as a major flaw.
"The absence of any recommendations on reclassification is an important and obvious omission. This is particularly worrying in the light of evidence produced by this week on the MHRA's failure to accurately report the consultation which preceded becoming available over the counter," he said.
"If the government is truly concerned with public health, it must move away from a blind desire to simply reclassify drugs and ensure that only those proved to be safe and effective for the target group are made available over the counter."(Zosia Kmietowicz)