ABPI responds to UK government

The Association of the British Pharmaceutical Industry (ABPI) has for the most part endorsed the UK government's response to the House of Commons Health Select Committee's (HSC) recommendations following its inquiry into 'the influence of the pharmaceutical industry'.

In particular, the industry has endorsed the emphasis on patient safety and transparency over the publication of clinical trials in both the committee's recommendations and the government's response.

'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 that the benefits and risks of new medicines is rigorously monitored once they are in regular use.

'It is also appropriate that the government, like the HSC, recognises the importance of the pharmaceutical sector to the UK, with particular regard to what it rightly calls the industry's 'outstanding record of innovation for the benefit of patients', as well as its contribution to the economy.'

Concern over patient safety led the HSC to make various recommendations on the current 'Yellow Card' system of reporting adverse drug reactions, which can only operate effectively 'if broad and full use is made of it'. The ABPI has again welcomed the government's plan to investigate medication errors and their causes.

However, in terms of marketing, the government has stated its intention to have all promotional material for new products pre-vetted by the Medicines and Healthcare products Regulatory Agency (MHRA). The ABPI has responded by pointing out that the MHRA already has powers to carry out such pre-vetting, and has raised concerns over such vetting providing further delays to time to market, saying that the government 'must ensure that MHRA staff [have] the right levels of expertise to carry out such pre-vetting without delaying the medicine's availability'.

With regards to companies who breach advertising regulations or published 'misleading findings', the government is considering how their allowances should be reduced under the Pharmaceutical Price Regulation Scheme (PPRS), to which the ABPI responded: 'it is important to remember that the PPRS is designed as a mechanism for regulating company profitability, not for controlling marketing standards'.

The ABPI also claims that the government has 'underestimated the situation with regard to relevant areas of the science base', saying that there is 'a danger of insufficient properly trained scientists in the right disciplines, especially chemistry, coming through the UK university system', and encouraging further action in this area.