Part 5: Regulations under Parts 1, 2, 3 and 4
Section 43: Power to make consequential etc provision
- This section makes further provision about the regulation-making powers in Parts 1, 2, 3 and 4, apart from paragraph 9 of Schedule 2. It provides that regulations made under these powers may make:
- consequential, supplementary, incidental, transitional, transitory or saving provision;
- different provision for different purposes and different areas;
- provision creating exceptions or limited in application to specified cases.
Section 44: Scope of powers of Northern Ireland departments
- This section provides that provision may not be made in regulations under section 2(1) (human medicines) and section 10(1) (veterinary medicines by a Northern Ireland Department (Department of Health in Northern Ireland and the Department of Agriculture, Environment and Rural Affairs in Northern Ireland) acting alone unless the provision, if contained in an Act of the Northern Ireland Assembly, would be within the Assembly’s competence, and would not require consent from the Secretary of State.
- The Northern Ireland Assembly is a devolved legislature and cannot legislate on matters that are outside its legislative competence.
Section 45: Consultation
- This section sets out the consultation requirements that must be met before regulations are made under Parts 1, 2, 3 and 4 of the Act.
- Subsection (1) creates a duty to carry out a public consultation. It provides that before regulations are made under Parts 1, 2, 3 and 4, public consultation must take place. The duty is placed on the "relevant authority" which is defined in subsection (6).
- Subsection (2) creates a duty to consult the Welsh Ministers, the Scottish Ministers, the Department of Health in Northern Ireland, and any other persons as the Secretary of State considers appropriate before making regulations under section 19(1) about the establishment and operation of information systems in relation to medical devices. Section 19(1) provides a power to make UK-wide regulations establishing UK-wide information systems. Given those information systems will use information from healthcare providers throughout the UK for purposes that relate to both devolved and reserved matters, it is appropriate in this particular situation that the Secretary of State consults the devolved administrations when making regulations under this section.
- Subsection (3) provides that a summary of the relevant authority’s assessment of the matters mentioned in sections 2, 11 and 17 must be included in the consultation document ahead of making any regulations under sections 2(1), 11(1) or 17(1). For example, this means that if the Secretary of State proposed policy changes that would require regulations under section 2, the consultation document must include a summary of the Secretary of State’s assessment of the matters in section 2, which includes whether proposed regulatory changes would contribute to the objective of safeguarding public health and if proposed changes may have an impact on the safety of medicines, an initial assessment of whether the benefits of those regulations would outweigh the risks.
- Subsection (4) provides that the consultation duty does not apply in relation to regulations made in reliance on section 7 or section 18 (which can dis-apply provisions relating to human medicines and medical devices respectively where there is a risk of serious harm to health), provided the regulations contain a declaration that they are required urgently due to an imminent risk of serious harm to health.
- Subsection (5) provides that consultation carried out before the Act is passed may satisfy the duty to consult.
- Subsection (6) provides a definition for the term "relevant authority" as used in section 45.
Section 46: Reporting requirements
- Section 46 sets out reporting requirements in relation to the operation of certain regulations made under this Act.
- Subsection (1) requires the relevant authority to lay a report before the appropriate legislature on the operation of any regulations made under sections 2(1), 10(1), 15(1) and 19(1) that were in force during the reporting period. The report must be laid as soon as reasonably practicable after the end of each reporting period. This means that the Northern Ireland department must lay a report before the Northern Ireland Assembly on any regulations they have made (whether alone or jointly with the Secretary of State) under sections 2(1) and 10(1) that were in force at any time during the two-year reporting period. The Secretary of State must lay a report before Parliament on any regulations the Secretary of State has made under sections 2(1) and 10(1) (whether alone or jointly with a Northern Ireland Department) and under sections 15(1) and 19(1) that were in force at any time during the two-year reporting period.
- Subsection (2) provides that when preparing this report, the relevant authority must consult with whomever they consider appropriate.
- Subsection (3) sets out what must be included in the report.
- Subsection (4) provides that the reporting period is two years. This means that a report will be due every two years. The first reporting period start afters on the day the first set of regulations subject to the reporting requirement come into force.
- Subsection (5) sets out definitions of terms "relevant authority" and "appropriate legislature" as used in section 49.
Section 47: Procedure
- This section provides that when the powers to make regulations in Parts 1 to 4 are exercised by the Secretary of State alone or acting jointly with a Northern Ireland department, they are to be exercised by statutory instrument. If exercised by a Northern Ireland department alone, the powers in sections 2 and 10 will be exercisable by statutory rule.
- Subsection (3) refers to a table that sets out the procedure for making regulations under Parts 1 to 4. For the vast majority of regulations made under the Bill the applicable procedure is the draft affirmative procedure. The exceptions to this are Regulations that only contain provision made in reliance on sections 6(1)(a), 12(1)(a), 17(1)(a), or paragraph 9 of Schedule 2; these are subject to the negative procedure. Regulations containing provision made in reliance on sections 7 and 18 are subject to the made affirmative procedure where the regulations contain a declaration that the person making them considers that they need to be made urgently to protect the public from an imminent risk of serious harm to health. Without that declaration, those regulations are subject to the draft affirmative procedure. The table provides that Regulations containing provision made in reliance on any other provision of Parts 1 to 4 are subject to the draft affirmative procedure. This would include for example regulations made under sections 1, 19 and 20, and regulations made under section 2 that rely on sections 3 to 5, 6(1)(b) or (c).
- Subsection (4) provides that provision that may be made in regulations subject to the negative procedure may be included in regulations subject to the draft affirmative procedure. For example, regulatory changes made under section 15 relying on section 17(1)(a) (that on its own would be subject to the negative procedure), may be made in regulations containing provision relying on another section, for example section 16 – in this situation such a set of Regulations are subject to the draft affirmative procedure.
- Subsection (5) sets out the negative procedure.
- Subsection (6) sets out the draft affirmative procedure.
- Subsection (7) sets out the made affirmative procedure.
- Subsections (8) and (9) detail how to calculate the periods of 40 days referred to the made affirmative procedure (in subsection (7)).
- Subsection (10) provides that if as a result of subsection (7) regulations cease to have effect at the end of the period of 40 days, that does not invalidate anything previously done under those regulations and it does not prevent new regulations being made.
