Section 22: Strict liability of sponsor

22. Strict liability of sponsor (1) A sponsor shall be strictly liable for any damage or injury suffered by a subject as a direct or indirect result of a clinical trial. (2) Any provision of a contract between a sponsor and a subject purporting to limit the sponsor’s liability under subsection (1) shall be null and void. (3) Before commencing a clinical trial, a sponsor shall enter into an insurance contract which covers the liability under subsection (1). (4) A sponsor shall be responsible for the costs of treatment of a subject for any damage or injury suffered by the subject as a result of a clinical trial. [Issue 3] C25A – 16 Revised Laws of Mauritius (5) Where the treatment under subsection (4) is not available in Mauritius, the sponsor shall, subject to the approval of the Council, make such treatment available in another country.