Page 20 - Pharmacy Appeals 1/4/04 to 31/3/05

Annex B

Indemnity for Clinical Studies

Sponsored by Pharmaceutical companies

Section One

1. Clinical research involving the administration of drugs to patients or non-patient human
volunteers is frequently undertaken under the auspices of
Health Authorities or NHS Trusts.

2. When the study is sponsored by a pharmaceutical company, issues of liability and
indemnity may arise in case of injury associated with administration of
the drug or other aspects of the conduct of the trial.

3. When the study is not sponsored by a company but has been independently organised by
clinicians, the NHS body will carry full legal liability for claims
in negligence arising from harm to subjects in the study.

4. The guidance in Section 2 and the Appendix has three purposes:

• to ensure that NHS bodies enter into appropriate agreements which will provide
indemnity against claims and proceedings arising from
company-sponsored clinical studies;

• to ensure that NHS bodies, where appropriate, use a standard form of agreement
(Appendix) which has been drawn up in consultation with
the Association of the British Pharmaceutical Industry (ABPI);
• to advise Local Research Ethics Committees (LRECs) of the standard form of
agreement.

Section Two

1. A wide variety of clinical studies involving experimental or investigational use of drugs
is carried out within NHS bodies. This includes studies in patients (clinical trials) and
studies in healthy human volunteers. They may involve administration of a totally new
(unlicensed) drug (active substance or ~NAS’) or the administration of an established
(licensed) drug by a novel route, for a new therapeutic indication, or in a novel
formulation or combination.

2. Detailed guidance on the design, conduct, and ethical implications of clinical studies is
given in:

HSG(91)5: Local Research Ethics Committees (with accompanying booklet).
NHS Executive: 1991;

Guidelines for Medical Experiments in non-Patient Human Volunteers