Page 16 - Pharmacy Appeals 1/4/04 to 31/3/05

then, under the terms of the Consumer Protection Act 1987, it is no defence for the
producer to show that he exercised reasonable care. Under normal circumstances,
therefore, NHS indemnity would not apply unless there was a question whether the
health care professional either knew or should reasonably have known that the
drug/equipment was faulty but continued to use it. Strict liability could apply if the
drug/equipment had been manufactured by an NHS body itself, for example a prototype
as part of a research programme.

15. Are Local Research Ethics Committees (LRECs) covered?
Under the Department’s guidelines an LREC is appointed by the Health
Authority to provide independent advice to NHS bodies within its area on the ethics of
research proposals. The Health Authority should take financial responsibility for
members’ acts and omissions in the course of performance of their duties as LREC
members.

16. Is there liability for non-negligent harm?
Apart from liability for defective products, legal liability does not arise where a person is
harmed but no one has acted negligently. An example of this would be unexpected
side-effects of drugs during clinical trials. In exceptional circumstances (and within the
delegated limit of £50,000) NHS bodies may consider whether an ex-gratia payment
could be offered. NHS bodies may not offer advance indemnities or take out commercial
insurance for non-negligent harm.

17. What arrangements can non-MIS bodies make for non-negligent harm?
Arrangements will depend on the status of the non-NHS body. Arrangements for clinical
trials sponsored by the pharmaceutical industry are set out in Annex B. Other
independent sector sponsors of clinical research involving NHS patients (eg universities
and medical research charities) may also make arrangements to indemnify research
subjects for non-negligent harm. Public sector research funding bodies such as the
Medical Research Council (MRC) may not offer advance indemnities nor take out
commercial insurance for non-negligent harm. The MRC offers the assurance that it will
give sympathetic consideration to claims in respect of non-negligent harm arising from
an MRC funded trial. NHS bodies should not make ex-gratia payments for non-negligent
harm where research is sponsored by a non-NHS body.

18 Would health care professionals be covered If they were working other than In
accordance with the duties of their post?
Health care professionals would be covered by NHS Indemnity for actions in the course
of NHS employment, and this should be interpreted liberally. For work not covered in
this way health care professionals may have a civil, or even, in extreme circumstances,
criminal liability for their actions.

19. Are health care professionals attending accident victims (“Good NHS Indemnity
Samaritan” acts) covered?