The UK Government has stressed the importance of medicines safety in a response to the House of Commons Health Select Committee’s inquiry into the influence of the pharmaceutical industry. However, it has also emphasised the esteem in which it holds the pharmaceutical sector to the UK – not only its “outstanding record of innovation for the benefit of patients” but also its contribution to the economy.
In May, the Health Select Committee concluded – amongst other things – that the pharmaceutical industry had been left to its own devices for too long and, as a consequence, "a number of practices have developed, which act against the public interest." The report also claimed that the current regulatory system was "at times frustrating, arguably with excessive attention to unimportant detail... [and] insufficiently effective," and that companies are free to promote "the view that there is a pill for every ill" [[05/04/05a]]. The inquiry was launched amid concerns about striking the right balance between health and commercial objectives [[21/06/04b]].
The Association of the British Pharmaceutical Industry said it too endorses the emphasis given to patient safety: “The safety of medicines is of paramount concern to the pharmaceutical industry, and we welcome the recognition that this is given,” said Dr
Richard Barker, Director General of the ABPI. “It is important that clinical trials are well designed, that their results are transparent and the benefit/risk of new medicines is rigorously monitored once they are in regular use.”
Concern over patient safety led the Select Committee to make various recommendations on the current ‘Yellow Card’ system of reporting adverse drug reactions. These recommendations are accepted by the Government, which has also unveiled a plan to investigate the causes of medication errors and how to reduce them.
On the marketing side, the Government states its intention that promotional material for new products should be pre-vetted by the Medicines and Healthcare products Regulatory Agency – powers it already has. However, the ABPI cautions that this should not delay a medicine’s availability, and raises the flag over plans to reduce allowances for promotion and research under the country’s Pharmaceutical Price Regulation Scheme should a company be found to have breached advertising or research ethics, in stressing that the PPRS is designed as a mechanism for regulating company profitability, not for controlling marketing standards.
Overall, the report calls for greater transparency in all aspects of the Industry’s affairs, which has been progressed through the setting up of voluntary registers for clinical trial data – both positive and negative.
Added Dr Barker: “We recognise that action has to be taken in some areas and endorse the majority of the Government’s proposals, but it is essential that they are implemented in such a way that they do not delay – or, worse still, deny – patients’ access to the benefits of modern, innovative medicines.”