Commentary on Sections Schedule 7 – Part 1: amendments of other enactments Section 57 - Functions in relation to biological substances
622.This section confers on the Secretary of State new UK-wide functions in relation to biological substances (see subsection (8) for the definition of ‘biological substances’). These are functions previously carried out by the HPA. Functions relating to biological substances include standardising and controlling biological medicines like vaccines or blood products to ensure their safety and effectiveness.
623.Subsection (1) imposes a number of specific duties on the Secretary of State and the Department of Health, Social Services and Public Safety in Northern Ireland (DHSSPS) acting alone or both of them acting jointly in relation to biological substances. Subsection (7) provides the definition of ‘appropriate authority’.
624.Subsection (2) provides the Secretary of State and the DHSSPS with general powers by which their functions in relation to biological substances may be discharged.
625.Subsections (3) to (5) provide for a reciprocal duty of co-operation between the Secretary of State and DHSSPS on the one hand and any person or body exercising biological substances functions similar to those of the Secretary of State and the DHSSPS on the other. The duty of co-operation applies irrespective of whether those functions are exercised in relation to the UK or overseas.
626.Subsection (6) empowers the Secretary of State and the DHSSPS to charge for their activities in relation to biological substances, including on a commercial basis.