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Select Committee on Science and Technology Appendices to the Minutes of Evidence


Memorandum submitted by the Association of the British Pharmaceutical Industry (ABPI)


  Since providing our written evidence to the original inquiry in March 2000 there have been a number of important developments outlined in the detailed comments in our response. These include:

    —  Industry representation on the newly formed National Cancer Research Institute

    —  New processes for speedier approval of clinical trials as set out in the conclusions of the Pharmaceutical Industry Competitiveness Task Force Report published in March 2001

    —  The publication of the EU Clinical Trials Directive in May 2001 with implementation due by May 2004 and providing for a maximum 60 day timeline for regulatory authorities and ethics committees to consider clinical trial protocols

    —  The development of Cancer Research Networks

    —  A number of positive appraisals of cancer medicines by NICE

  However there are some potential negatives and they include:

    —  A potential threat to cancer registries through the Data Protection provisions

    —  Failure of local hospital trusts and primary care trusts to adequately implement NICE guidance

  A number of the new developments including the NCRI, Cancer Research Networks and the rules for ethics committees are in their infancy and the ABPI believes that it is too soon to judge what effect they will have on cancer management in the UK. Therefore we believe that this review by the Select Committee should be the first of a series and that regular reviews of cancer management in the UK should be undertaken. The ABPI would be delighted to continue to provide evidence both written and oral to the Committee.

  Our detailed comments are as follows:


  In our evidence to the Select Committee Inquiry into Cancer Research, we highlighted the problems in the UK of getting clinical trials started. As a result of the agreements within the Clinical Research Workstream of the Pharmaceutical Industry Competitiveness Task Force (PICTF) set up by the Government in April 2000, we are pleased to report that systems are in place to considerably reduce the timelines in getting clinical trials started. However as the new systems are currently being instituted, it is too early to comment on whether they have been successful. This process will also potentially be helped by the introduction of the EU Directive on Clinical Trials which essentially requires a decision to be made on whether a trial can start by the regulatory authority and the relevant ethics committees within 60 days. The Directive will be implemented in the UK by May 2004. The Medicines Control Agency (MCA) have indicated that they wish the regulatory process to remain as efficient as it currently is and therefore this should benefit sponsored clinical research in the UK.

  With regard to the NHS Cancer Plan, we believe that it is too early to come to any concrete conclusions on whether it is delivering it targets. We believe that the awaited report from the Commission for Health Improvement (CHI) on the NHS uptake of the Calman-Hine report will provide evidence as to whether Health Authorities and Trusts are taking the management of cancer seriously enough. However there can be no doubt that the appointment of a "Cancer Czar" has had a beneficial effect on cancer services and it was clear from Dr Richards' presentation at the All Party Cancer Group Conference on 31 October that over the next year or so, there should be considerable developments in the management of cancer in the UK.


  The ABPI welcomes the fact that the newly instituted National Cancer Research Institute (NCRI) has an industry member in the person of Dr John Patterson of AstraZeneca. As we indicated in our oral evidence to the Select Committee, it was a considerable disappointment that the industry had not been invited to take part in the Cancer Research Funder's Forum. The ABPI has formed a Cancer Working Group to support Dr Patterson and it met with Dr Liam O'Toole, the manager of the NCRI recently. As yet it is too early to comment on whether the NCRI will transform cancer research in the UK or just be a talking shop, although we recognise that it is Dr O'Toole's intention that it will be much more positive than a talking shop.

  The ABPI fully supports the development of a National Tissue Bank to be used by researchers involved in cancer research and involving all the safeguards laid down in the report of the Alder Hey Inquiry.


  The UK is one of the leading countries in the world in the field of cancer epidemiology. There are two major reasons for this, firstly we have a National Health Service which enables data to be collected fairly easily on patients with cancer and for their disease path to be followed and secondly our strong tradition in evidence-based medicine. It is of vital importance that the cancer registries are not lost but improved and increased. Of course it is also vital that individual patient data be protected as much as possible but particularly in the field of cancer, the ABPI believes that societal requirements must outweigh individual requirements. We believe that judicious use of Clause 60 of the Health and Social Care Act will enable cancer registries to develop whilst at the same time protecting individual patient data as much as possible. Researchers in the cancer field will need access to these registries but they will not require identifiable patient data. However there must be some mechanism for the keyholder of anonymised information to obtain further information in an anonymised form where required. We believe that this will be an important role for the Patient Information Advisory Group (PIAG), which has been set up under Clause 61 of the Health and Social Care Act. The ABPI is disappointed that none of its four nominees to PIAG have been appointed and we hope that its membership will include some researchers who will understand the need for access to suitably anonymised individual patient data in diseases like cancer.


  Experience with the new cancer research networks has so far been positive. Both the national lead, Professor Peter Selby, and some of the regional leads are happy to work and collaborate with industry and we view this as a positive step. The networks are in their infancy and more time is required before we will be able to judge just how effective they are but the signs are good.


  The ABPI recognises that the Health Select Committee will be holding a short inquiry into the National Institute for Clinical Excellence (NICE) early in 2002, but we believe it is appropriate to comment on the implementation of NICE decisions on cancer therapies. Although there have been a number of positive appraisals on cancer medicines made by NICE the only one that has so far led to a significant increase in prescribing was the appraisal of taxanes for ovarian and breast cancer and even this increase is £14 million short of the predicted £25 million from Government. The ABPI is concerned that the results of the recently published survey from CancerBACUP (, which shows that "fewer than half the health authorities in England and Wales have a policy for monitoring local compliance with NICE guidance". Also we are concerned that "guidance on a wide range of treatments for other types of cancer is not being followed in all parts of the country eg only 15 per cent of respondents to the survey said that specific funds are available to implement NICE guidance on lung cancer". This means that there are too many patients not receiving medicines given a positive appraisal by NICE who might well benefit.

  However with all the above comments in mind, the ABPI welcomes Lord Hunt's statement at the Annual NICE Conference on 5 December. He announced that the Government will meet its commitment to ensure that patients receive drugs and treatment recommended by NICE if deemed appropriate by their clinician. There will be statutory obligations on Health Authorities and Primary Care Trusts to provide appropriate funding for recommended treatments, although we have difficulty in assessing from where the extra funding will come. This announcement will undoubtedly benefit cancer patients in England and we hope that similar announcements will be forthcoming from the Welsh Assembly and Scottish Parliament. For instance we do understand that in Dundee funding for lung cancer therapy recommended by NICE is unavailable.

  If the uptake of cancer medicines increases as a result of the Government announcement then this should increase the UK oncology market and may lead to an increase in sponsored clinical research in new cancer medicines in the UK.

6 December 2001

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