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ABPI:1988, amended 1990; NHS Indemnity

Research Involving Patients, Royal College of Physicians of London:
1990;

Guidelines in the Practice of Ethics Committees in Medical Research,
2nd edition; Royal College of Physicians of London: 1990;

Clinical Trial Compensation Guidelines ABPI: 1991

3. The Medicines Act 1968 provides the regulatory framework for clinical studies involving
administration of drugs to patients. Drugs which are used in a sponsored* clinical study in
patients will be the subject of either a product licence (PL), a clinical trial certificate (CTC), or
clinical trial exemption (CTh) which is held by the company as appropriate. A non-sponsored
study conducted independently by a practitioner must be notified to the Licensing Authority
under the Doctors and Dentists Exemption (DDX) scheme. Studies in healthy volunteers are not
subject to regulation under the Medicines Act and do not require a CTC, Cm, or DDX. Further
particulars of these arrangements are provided in Medicines Act leaflet M}U 30: A guide to the
provisions affecting doctors and dentists (DHSS: 1985).

4. Participants in a clinical study may suffer adverse effects due to the drug or clinical procedures.
The appendix to this annex is a model form of agreement between the company sponsoring a
study and the NHS body involved, which indemnifies the authority or trust against claims and
proceedings arising from the study. The model agreement has been drawn up in consultation
with the Association of the British Pharmaceutical Industry
(ABPI).

5. This form of indemnity will not normally apply to clinical studies which are not directly
sponsored by the company providing the product for research, but have been independently
organised by clinicians. In this case, the NHS body will normally carry full legal liability for any
claims in negligence arising from harm to subjects in the study.

6. The NHS body will also carry full legal liability for any claims in negligence (or compensation
under the indemnity will be abated) where there has been significant non-adherence to the agreed
protocol or there has been negligence on the part of an NHS employee, for example, by failing to
deal adequately with an adverse drug reaction.

7. The form of indemnity may not be readily accepted by sponsoring companies outside the UK or
who are not members of the ABPI. NHS bodies should, as part of their risk management,
consider the value of indemnities which are offered and consider whether companies should
have alternative arrangements in place.

*A sponsored study may be defined as one carried out under arrangements made by or on behalf of the company who
manufactured the product, the company responsible for its composition, or the company selling or supplying the product.