HC Deb 07 May 1980 vol 984 cc155-9W

1. As announced by the Secretary of State in his speech given at the Jubilee Dinner of the ABPI on 16th April, Ministers propose to revise the arrangements for approval of clinical trials under the Medicines Act. The purpose of this letter is to describe these proposals and to give your organisation an opportunity of submitting comments.

Background

2. For some time now representatives of the industry and of university departments of clinical pharmacology have maintained that existing United Kingdom requirements for certification before clinical trial of a new product begins are so stringent as to have the effect of directing developmental work to other countries which operate different systems of control. Ministers have been advised that this is not only disadvantageous to United Kingdom-based companies but also results in the loss of experience and knowledge which would be valuable to clinical pharmacology departments and the medical profession generally and is thus ultimately to the disadvantage of the community at large. This has led them to review these requirements in consultation with the Medicines Commission, taking account of experience in other developed countries having different forms of control and of the degree of care exercised independently by companies and by doctors at clinical trial stage. They have concluded that changes could reasonably be made to existing methods of scrutiny of applications without endangering the safety of patients. The changes they propose to introduce are outlined below.

Proposals

3. It is proposed to introduce an Order under Section 35(8) of the Medicines Act to give the Licensing Authority discretion to permit exemption from the requirement for a company to obtain a clinical trial certificate. Such a scheme would, very broadly, follow the lines of the exemption scheme which has operated for several years in respect of trials arranged by doctors on their own initiative. Exemption of trials arranged by companies would, however, be subject to certain conditions, chiefly:—

  1. (a) notification of the proposed trial, and application for exemption, in a prescribed form to the Licensing Authority accompanied by summaries of data from the experimental and biological studies and of the chemistry and pharmacy aspects; the application to be signed by a United Kingdom-based medical adviser and the summaries of the data to be certified by the responsible company officials and countersigned by the medical adviser. (In effect, therefore, the medical adviser would be required to take responsibility for the soundness of the application).
  2. (b) absence of a direction within 35 days (extendable in particular cases) from the Licensing Authority that Section 36(3) (i.e. requirement for a clinical trial certificate) shall operate. 35 days would be specified as the normal limit, but it is 157 recognised that there are likely to be cases where further information or discussion with the company will be found necessary, and where it is in the interests of both the company and the Licensing Authority that the time limit should be extended. In such cases, the Licensing Authority would notify the Company of the proposed extension within the initial 35 days.
  3. (c) exemption to be dependent on the approval of the trial by an appropriate ethical committee. It would be for the company to ensure that the clinical trial protocol is considered and approved by the ethical committee i.e. that the committee satisfies itself about the arrangements for the trial, not about the safety of the particular compound. It is thought that such approval would normally follow the provisional granting of an exemption by the Licensing Authority, such exemption to become invalid if the written approval of the ethical committee is not forthcoming. Alternatively, but presumably rarely, clearance by the ethical committee might be sought first.
  4. (d) an undertaking to report to the Licensing Authority any adverse reaction to the compound and any other information coming to the company's attention which casts doubt on its safety or quality. In such circumstances it would be open to the Licensing Authority to withdraw the exemption if it judged this to be necessary on grounds of safety. It would similarly be open to the Licensing Authority to do this if independently it received information of this nature. There would be no obligation to give detailed reason for this action. (See para 6 below on avenues of "appeal").
  5. (e) an undertaking to report to the Licensing Authority any significant change in the arrangements for the trial, e.g. investigator composition or presentation of the compound, criteria for selection of patients, etc.

4. It is envisaged that a separate application for exemption would be required for the investigations carried out by each separate investigator within the trial, although after the granting of the initial exemption any application for inclusion of further investigators or investigations would normally have to be accompanied only by the relevant new information.

5. The order would be prepared so as to provide an administrative framework for the operation of the exemption scheme, within which the data requirements could be varied accordingly to expert advice and developing experience. At least for the time being, companies would still have to generate the same pharmaceutical and pre-clinical data as now before making an application, i.e. the data specified in MAL 4. This will be reviewed when CSM's working party on data requirements for clinical trial certificates has reported.

6. It will be seen that the proposals outlined above would enable the Licensing Authority to make use of the experience and judgment of its professional advisers and to exercise discretion in deciding whether or not to grant an exemption. In cases where an exemption was refused or withdrawn—or, indeed, if the company so wished at the outset—it would remain open to it to apply in the customary way for a clinical trial certificate and, if that was rejected, to exercise its right of making representations to, or having a hearing before, the Committee on Safety of Medicines and the Medicines Commission.

7. The proposed exemption scheme is intended to apply also to products coming within the ambit of the Committee on Dental and Surgical Materials.

8. No fee would be payable for an application for exemption.

Consultation

9. This letter is being sent to the bodies listed in Annex A. It is a statutory consultation for the purposes of section 129 of the Medicines Act. Will you please indicate on the attached pro-forma within a month, whether you intend to comment. Comments should be addressed to Mrs, Harrison in room 1427 at this address, within 2 months of the date of this letter.

The Association of the British Pharmaceutical Industry

The Association of Manufacturers of Medicinal Preparations

The Company Chemist Association Limited

Proprietary Association of Great Britain

British Aerosol Manufacturers Association

British Insulin Manufacturers

The Consumer Association

National Consumer Council

National Federation of Consumer Groups

National Federation of Women's Institutes

The National Union of Townswomens Guilds

The Radiochemical Centre

The Association of Contact Lens Manufacturers Limited

The Association of Dispensing Opticians

Association of Optical Practitioners

The British Contact Lens Association

The British Optical Association

Contact Lens Study Group, The Association of Dispensing Opticians

The European Federation of the Contact Lens Industry Limited

The Joint Committee of Ophthalmic Opticians

The Medical Contact Lens Association

The British Herbal Medicine Association

The British Herbalists Union Limited

The General Council and Register of Consultant Herbalists Limited

Association of Anaesthetists, Great Britain & Ireland

British Medical Association

Faculty of Ophthalmologists, Royal College of Surgeons of England

The Royal College of General Practitioners

Royal College of Pathologists

The Royal College of Physicians

The Royal College of Physicians, Edinburgh

Royal College of Surgeons, Edinburgh

Royal College of Physicians, and Surgeons, Glasgow

British Medical Association (Scottish Branch)

The Faculty of Anaesthetists of the Royal College of Surgeons of England

British Association of Dermatologists

Royal College of Psychiatrists

The Herb Society

National Institute of Medical Herbalists

Anthroposophical Medical Association

The Faculty of Homeopathy, The Royal London Homeopathic Hospital

Homeopathic Association

Homeopathic Joint Committee

The Homeopathic Manufacturers and Importers Association

The Homeopathic Research and Educational Trust

Royal College of Obstetricians & Gynaecologists

Royal College of Radiologists

The British Dental Association

The British Dental Trade Association

General Dental Council

Northern Ireland Committee

British Dental Association (Scottish Branch)

The Medical Research Council

The Pharmaceutical Society of Great Britain

The Pharmaceutical Society for Northern Ireland

The Pharmaceutical Society of Great Britain (Scottish Department)

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