Select Committee on Health Written Evidence


APPENDIX 1

Supplementary memorandum by Rethink Severe Mental Illness (PI 2A)

RECOMMENDATIONS TO THE HEALTH SELECT COMMITTEE

  These recommendations follow Rethink's written and oral evidence to the Committee.

PRINCIPLES

  That agreed principles govern the relationship between the pharmaceutical industry, the regulatory bodies, and the voluntary sector. These would include:

    —  transparency;

    —  balance;

    —  regulation;

    —  accessibility; and

    —  realism.

TRANSPARENCY

    —  A regulatory requirement should be introduced to compel the publication of the results from all clinical trials and other evaluations of treatments, including those funded by the government; this requires the establishment of a register of clinical trials and evaluations.

    —  Current regulations governing the declaration of financial interests for those sitting on industry regulatory bodies should be broadened to include all interests relevant to the regulatory process.

    —  Charities and "patient organisations" should make public their funding sources, sponsorship policies, trustee oversight arrangements and methods used to ascertain the views of beneficiaries.

BALANCE

    —  Charities and "patient organisations" should seek a balanced portfolio if funding, as no single source is free from influence and perceptions of influence.

    —  "State" funding should include support for core activities of charities and "patient groups," including ascertaining the views of members and beneficiaries.

    —  "State" funding should be provided to an umbrella body for health charities and "patient groups" (possibly the LMCA) to develop standards and guidelines for transparency in the sector, as outlined above.

REGULATION

    —  Current regulations governing the declaration of financial interests for those sitting on industry regulatory bodies should be broadened to include all relevant interests.

    —  Patient organisations should be required to set out how they ascertained the views of the people they claim to represent in making any submission to official bodies, in line with the standards and guidelines suggested above.

    —  Regulatory bodies for medicines and other treatments should include more lay members and representatives of "patient organisations" which meet the standards developed.

ACCESSIBILITY

    —  Regulatory authorities should have a duty to seek and act upon evidence from charities and "patient groups" of serious adverse effects.

    —  Where there is early suggestion of adverse effects of treatments, "patient groups" should be contracted by regulatory bodies to survey their beneficiaries, to allow a preliminary indication of the severity and frequency of the problem, and to inform decisions on whether to order full scale formal studies.

    —  Regulatory authorities should be enabled to contract "patient groups" to produce user-friendly patient information leaflets and other materials, and to advise on PILs.

REALISM

    —  Government, patient groups and the pharmaceutical industry should co-operate on public education campaigns to achieve a more realistic understanding of the benefits and limitations of medicines.





 
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Prepared 26 April 2005