UK government fails to tackle weaknesses in drug industry
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《英国医生杂志》
The UK government has failed to tackle the weaknesses in the pharmaceutical industry in its response to a report published earlier this year on the industry抯 role and influence, says a leading critic.
Ike Iheanacho, editor of the Drug and Therapeutics Bulletin, a publication from the consumer body Which?, told the BMJ that healthcare staff needed to know if they had been misled by drug advertisements. The government抯 response has not acted on many of the recommendations made in a highly critical report on the influence of the pharmaceutical industry on drug regulation, healthcare professionals, and the NHS, he said.
The highly critical report, published by the House of Commons?health select committee on 5 April, dealt with the growing influence of the industry on prescribing and the lack of transparency in the drug regulatory system (BMJ 2005;330:805).
"The pharmaceutical industry is entering a new era of openness. It is important that all parties work together so that the concerns about the industry expressed by the select committee are dispelled," said Health Minister Jane Kennedy in a press statement launching the government抯 response, which was posted on the Department of Health抯 website, without a press conference. She stressed the "enormous importance" of the industry to the UK economy, and was "mindful" not to impose regulatory burdens on the sector in the government抯 response.
In response to many of the committee抯 recommendations, the Department of Health said that current guidelines or measures would deal with many of the concerns raised.
There were also outright rejections, such as the committee抯 recommendation that the government should consider making the postmarketing surveillance of medicines independent of the drug regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA). Public inquiries into the withdrawal of certain drugs were also rejected.
The department also did not strongly back the proposal that the MHRA should be subject to an independent review, which would have considered its ties to the industry. Instead the department recommended a review "perhaps on a four yearly cycle" but said that the terms of reference and timing would need to be further considered.
The government also disagreed with the committee that there was a lack of independent advice to prescribers on medicines and that the MHRA should publish early data from drug firms from their applications. "It is imperative that the licensing authority has reached a final decision before data is put into the public domain."
The government did act in relation to drug marketing, however. It agreed that all company promotional material for new products should be vetted by the MHRA before publication. The industry has also been asked to consider introducing limits on the amount of promotional material for new products.
But the department did not back the committee抯 recommendation that corrective statements be issued each time a company was found to breach the advertising regulations. Requiring them on every occasion would run the risk of trivialising their impact, the department argued.
Furthermore, the committee抯 recommendation that the responsibility for the industry should be transferred from the Department of Health to the Department of Trade and Industry was not backed by the government.
Although the Association of the British Pharmaceutical Industry welcomed the government抯 overall response, it was concerned with the proposal to reduce companies?promotion and research allowances under the government抯 Pharmaceutical Price Regulation Scheme if they were found to breach the advertising regulations. The Association of the British Pharmaceutical Industry said that the scheme is for regulating "company profitability, not for controlling marketing standards."
The Government Response to the Health Committee's Report on the Influence of the Pharmaceutical Industry is available at www.dh.gov.uk(Liza Gibson)
Ike Iheanacho, editor of the Drug and Therapeutics Bulletin, a publication from the consumer body Which?, told the BMJ that healthcare staff needed to know if they had been misled by drug advertisements. The government抯 response has not acted on many of the recommendations made in a highly critical report on the influence of the pharmaceutical industry on drug regulation, healthcare professionals, and the NHS, he said.
The highly critical report, published by the House of Commons?health select committee on 5 April, dealt with the growing influence of the industry on prescribing and the lack of transparency in the drug regulatory system (BMJ 2005;330:805).
"The pharmaceutical industry is entering a new era of openness. It is important that all parties work together so that the concerns about the industry expressed by the select committee are dispelled," said Health Minister Jane Kennedy in a press statement launching the government抯 response, which was posted on the Department of Health抯 website, without a press conference. She stressed the "enormous importance" of the industry to the UK economy, and was "mindful" not to impose regulatory burdens on the sector in the government抯 response.
In response to many of the committee抯 recommendations, the Department of Health said that current guidelines or measures would deal with many of the concerns raised.
There were also outright rejections, such as the committee抯 recommendation that the government should consider making the postmarketing surveillance of medicines independent of the drug regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA). Public inquiries into the withdrawal of certain drugs were also rejected.
The department also did not strongly back the proposal that the MHRA should be subject to an independent review, which would have considered its ties to the industry. Instead the department recommended a review "perhaps on a four yearly cycle" but said that the terms of reference and timing would need to be further considered.
The government also disagreed with the committee that there was a lack of independent advice to prescribers on medicines and that the MHRA should publish early data from drug firms from their applications. "It is imperative that the licensing authority has reached a final decision before data is put into the public domain."
The government did act in relation to drug marketing, however. It agreed that all company promotional material for new products should be vetted by the MHRA before publication. The industry has also been asked to consider introducing limits on the amount of promotional material for new products.
But the department did not back the committee抯 recommendation that corrective statements be issued each time a company was found to breach the advertising regulations. Requiring them on every occasion would run the risk of trivialising their impact, the department argued.
Furthermore, the committee抯 recommendation that the responsibility for the industry should be transferred from the Department of Health to the Department of Trade and Industry was not backed by the government.
Although the Association of the British Pharmaceutical Industry welcomed the government抯 overall response, it was concerned with the proposal to reduce companies?promotion and research allowances under the government抯 Pharmaceutical Price Regulation Scheme if they were found to breach the advertising regulations. The Association of the British Pharmaceutical Industry said that the scheme is for regulating "company profitability, not for controlling marketing standards."
The Government Response to the Health Committee's Report on the Influence of the Pharmaceutical Industry is available at www.dh.gov.uk(Liza Gibson)