Module 5 Presentations

19/07/2024

No fault compensation arrangements

• ABPI Phase II, III and IV Clinical Trial Compensation Guidelines (2014) • Compensation to be paid without proof of fault for injuries resulting from the trial • Proof of causation on the balance of probabilities • No compensation for injury caused by licensed comparators • No compensation should be paid (or it should be abated) where injury arisen (a) through a departure from the protocol (b) through the negligence of a third party or (c) through contributory negligence by the patient • Amount of compensation consistent with damages awarded by English court where liability admitted • Compensation abated/excluded in light of (a) seriousness of disease treated and warnings given and (b) risks and benefits of established treatment • In case of dispute, opinion of expert to be given weight

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No fault compensation arrangements

• ABPI Phase I Clinical Trial Compensation Guidelines (2014) – Applicable to Phase I studies that offer no prospect of direct therapeutic benefit to the research subject – Contractual obligation – Without requirement to establish negligence or that IMP was “defective” – Compensation to be paid where “health or wellbeing of the trial subject deteriorates significantly as a result of taking part in the trial” – Quantum consistent with damages awarded by English court where liability admitted – Quantum reduced where subject partly responsible for injury – Disputes to be referred to arbitrator

The Organisation for Professionals in Regulatory Affairs

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