In particular, the industry endorses the emphasis given to patient safety in both the select 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 the benefit/risk of new medicines is rigorously monitored once they are in regular use.
“It is also appropriate that the Government’s response – like the Select Committee’s report – 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 Select Committee to make various recommendations on the current ‘Yellow Card’ system of reporting adverse drug reactions. These recommendations are accepted by the Government, and the ABPI also endorses them. The Yellow Card system is an essential mechanism for reporting side effects of new medicines, but can only operate effectively if broad and full use is made of it. The Government’s plan to investigate medication errors, what is causing them and how to reduce them is also warmly welcomed. There are many possible causes of such errors, including systems deficiencies and incomplete staff training for hospital pharmacists and medical staff. Specific research to examine the causes of such errors will enable the NHS and the industry to take appropriate action.
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 (MHRA). The ABPI notes that the MHRA already has powers to carry out such pre-vetting.
However, it is important that this action does not further delay innovative, new medicines from reaching patients. The Government must ensure that the MHRA has the appropriate staff with the right levels of expertise to carry out such pre-vetting without delaying the medicine’s availability.
On the rare occasions when companies are found to have breached advertising regulations, or published misleading findings from research, the Government appears to be considering whether and in what way the allowances for promotion and research, respectively, should be reduced under the Pharmaceutical Price Regulation Scheme (PPRS). The ABPI will discuss this with Government at the appropriate time. However, it is important to remember that the PPRS is designed as a mechanism for regulating company profitability, not for controlling marketing standards.
The ABPI believes the Government has underestimated the situation with regard to relevant areas of the science base. There is a danger of insufficient properly trained scientists in the right disciplines, especially chemistry, coming through the UK university system, and the industry is increasingly having to recruit from abroad. Further action in this area would be welcomed.
The Government has recognised the concerns that lay behind the Select Committee’s recommendations on patient groups and how they receive and acknowledge funding from other sources, including the pharmaceutical industry, and emphasised the importance of self-regulation. The ABPI endorses both these points.
There is a broad movement towards greater transparency in all aspects of the industry’s affairs, which is supported by the ABPI. The need for greater transparency over the publication of clinical trial results was also recognised in the Government’s response.
At the beginning of the year, the worldwide industry announced the establishment of registers of clinical trials that are underway and results of trials that have taken place, whether positive or negative. The Government’s response welcomes the global pharmaceutical industry’s initiative in establishing these voluntary registers. The industry’s commitment has since been underlined by creating a portal via which all such information can be accessed, in advance of that eventually to be established by the World Health Organisation.
“The welfare of patients has to be at the centre of actions of both Government and industry with regard to the Select Committee’s recommendations,” said 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.”
For further information, please contact: ABPI Press Office 020 7747 1410