Select Committee on Health Fourth Report

3  Difficulties facing the pharmaceutical industry

36. As PICTF indicated, the UK-based pharmaceutical industry is faced with a number of difficulties in conducting research and operating successfully. The cost of conducting medical research in the UK is second only to the US.[29] Extra security is needed because of threats from animal rights protesters, for instance. Novartis UK has spent an extra £1 million on security measures at its UK sites in the last two years alone.[30] The cost of research programmes run within NHS hospitals are elevated because of 'overheads', which vary from 30% to 100% extra, depending on the hospital.[31] According to the Department of Health, it has "paid close attention to creating a safe and positive environment for both publicly funded medical research and commercial contract research", and "it is Government policy that Industry must meet the full costs of work that the NHS undertakes for industry under contract".[32]

37. Authorisation to conduct early stage trials in animals has to be obtained from the Animals Procedures Committee of the Home Office and it is more difficult to obtain permission to conduct animal experimentation in the UK than in any other comparator country.[33] This may place an additional constraint on the conduct of research. Cancer Research UK stated:

An example of such constraint is the requirement for primate research for certain types of pre-clinical assessment. If the costs and barriers for drug development continue to increase, fewer new drugs will comes to market, thus stifling innovation and, more importantly, potential patient benefit.[34]

38. The "fragmented and customer un-friendly nature of academic units and clinical services" was highlighted by the Royal College of General Practitioners (RCGP). The College also mentioned the "multiple layers of Research Ethics approval" that may be required and a "disparate, and sometimes competing, collection of clinical and academic teams" that may need to be brought together to achieve sufficient mass for large-scale research.[35]

39. Many large-scale Phase II and III trials are currently being carried out in Eastern Europe and elsewhere as a result of high costs imposed here.[36] Dr Malcolm Boyce, who runs a London-based Contract Research Organisation (CRO), stressed:

A strong pound sterling makes matters worse for overseas companies. For those reasons, companies are increasingly placing their Phase II and III trials outside the UK, in low cost areas such as Eastern Europe, Russia and India.[37]

40. There are not enough trained medical researchers in the UK.[38] This means there are too few individuals who can organise clinical trials or take part in a reviewing or implementation capacity. Prof Patrick Vallance, from University College London (UCL), told us:

There is a shortage of appropriately trained clinical investigators in the UK, and this reflects lack of investment in clinical research and problems with clinical training pathways.[39]

41. Specialist facilities are also lacking. There are very few centres in which paediatric clinical trials may be effectively conducted, for example. This will become more relevant following the introduction of a new European Regulation on Paediatric Medicines in 2006, which will require more medicines to be licensed for use in children.[40]

42. Witnesses pointed out that the NHS does not have a coherent approach to industry-sponsored clinical trials and lacks the staff and specialist facilities in which to conduct them. This partly explains why a very low percentage of patients are enrolled in clinical trials in the UK; experience shows that recruitment can be increased substantially provided suitable policies and other measures are in place.[41] For example, the National Cancer Research Network (NCRN) provides the NHS with the 'infrastructure' to support cancer clinical trials in England. It was established by the Department of Health in April 2001. Since that date the number of patients taking part in cancer clinical trials in the UK has doubled. All results from NCRN trials are scrutinised by an Independent Data Monitoring Committee, which is the only body to see unblinded data. All results emerging from trials approved by the Clinical Trials Awards and Advisory Committee are published.

43. A flourishing UK pharmaceutical industry is of great importance for healthcare as well as having economic benefits. To achieve this, it is most important for the industry to be able to undertake research effectively. The success of the NCRN shows that it is possible to provide the infrastructure within the NHS that the industry requires. Similar systems need to be put in place throughout the NHS as a matter of urgency. The industry's ability to compete internationally requires a legislative and organisational framework for research that protects the interests of all stakeholders - patients, researchers and pharmaceutical companies.

29   PI 28 Back

30   PI 29 Back

31   PI 20 Back

32   PI 01 Back

33   PI 51 Back

34   PI 59 Back

35   PI 19 Back

36   PI 19, 107 Back

37   PI 107 Back

38   PI 33 Back

39   PI 106 Back

40   PI 35 Back

41   PI 106 Back

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© Parliamentary copyright 2005
Prepared 5 April 2005