The National Assembly for Wales has the legislative competence to pass laws (Acts) in relation to health and health services. This legislative competence may be helpfully set out by reference to four strands:
- Strand 1 – Promotion of health. Family planning.
- Strand 2 – Prevention, treatment and alleviation of disease, illness, injury, disability and mental disorder. Control of disease.
- Strand 3 – Provision of health services, including medical, dental, ophthalmic, pharmaceutical and ancillary services and facilities.
- Strand 4 – Clinical governance and standards of health care. Organisation and funding of the National Health Service.
The National Assembly’s legislative competence in this respect is limited by eleven subject specific exceptions (listed below), and by all of the other exceptions which are set out under the different headings in Part 1 of Schedule 7 to the Government of Wales Act 2006. The health subject specific exceptions are:
- Human genetics, human fertilisation, human embryology, surrogacy arrangements.
- Regulation of health professionals (including persons dispensing hearing aids).
- Misuse of and dealing in drugs.
- Human medicines and medicinal products, including authorisations for use and regulation of prices.
- Standards for, and testing of, biological substances (that is, substances the purity or potency of which cannot be adequately tested by chemical means).
- Vaccine damage payments.
- Welfare foods.
- Health and Safety Executive and Employment Medical Advisory Service and provision made by health and safety regulations.
The UK Parliament has retained its power to pass laws for Wales relating to health and health services, and has done so since the National Assembly gained its current legislative competence in May 2011 (see, for example, the Health and Social Care Act 2012).
Measures of the National Assembly
Between 2007 and 2011, the National Assembly could legislate by means of an Assembly Measure on the ‘matters’ listed in Schedule 5 to the Government of Wales Act 2006. A number of Measures relating to health and health services in Wales were made and remain in force. Their legal effect is the same as if they were made by means of an Assembly Act (or Act of Parliament).
Reading pre-2007 legislation
Care should be taken when reading and applying health related statutes enacted prior to May 2007 but which remain in force and apply in relation to Wales.
Generally, references to functions of the ‘Secretary of State’ in pre-1 July 1999 statutes relating to health in Wales are to be read as references to the Welsh Ministers. This is because the National Assembly for Wales (Transfer of Functions) Order 1999 (SI 1999/672) transferred most, but not all, of the Secretary of State’s pre-1999 health functions in relation to Wales to the National Assembly for Wales, and those functions were subsequently further transferred by paragraph 30 of Schedule 11 to the Government of Wales Act 2006 to the Welsh Ministers.
Similarly, references in statutes enacted between July 1999 and May 2007 to functions of the National Assembly for Wales should be read as references to the Welsh Ministers. Again, this is by virtue of the transfer of National Assembly functions to the Welsh Ministers by paragraph 30 of Schedule 11 to the Government of Wales Act 2006.
Most of the key legal provisions relating to health and health services in Wales are to be found in primary legislation (Acts) made by either the UK Parliament or the National Assembly for Wales.
Of those Acts, those marked with an asterisk are Measures and Acts of the National Assembly for Wales and apply only to Wales. The remainder are Acts of the UK Parliament and their provisions may extend to the whole of the UK, to England, Wales and Scotland, to England and Wales, or just to Wales.
The fact that an Act is included in the list of key legislation does not necessarily mean that its subject matter falls within an area which has been devolved to Wales. The purpose of the list is to show where the core elements of the law relating to health in Wales are set out, regardless of whether they relate to subject matter which is devolved to the National Assembly.
These ‘Health and health services’ pages provide further detail on those elements of the law relating to health and health services which are ‘devolved’.
In addition to the primary legislation referred to above, laws on health and health services in Wales are contained in Orders in Council and a large amount of subordinate legislation. The subordinate legislation has been made by the Secretary of State, the National Assembly for Wales or the Welsh Ministers under the primary legislation referred to above and may be in the form of orders, regulations, schemes or codes. This subordinate legislation provides further detail on the regimes, requirements and functions established by the primary legislation.
Before the devolution of power to the National Assembly for Wales in 1999, subordinate legislation made by the UK Government which made provision in relation to health in England and Wales was either made by the Secretary of State for Health acting alone or by the Secretary of State for Health and the Secretary of State for Wales acting jointly. In both cases, the legislation would extend and apply to the whole of England and Wales. Where the subject matter of the subordinate legislation only affected health or health services in Wales, the subordinate legislation would be made by the Secretary of State for Wales acting alone. Some of these pre-devolution instruments – made by the Secretary of State for Health by the Secretary of State for Wales – remain in force.
Most, but not all, of the functions of the Secretary of State in relation to health in Wales were transferred to the National Assembly for Wales in 1999 (by the National Assembly for Wales (Transfer of Functions) Order 1999 (SI 1999/672). A substantial number of the Secretary of State’s powers to make subordinate legislation under the pre-1999 primary legislation relating to health were thus transferred to the National Assembly, although the Secretary of State continued to exercise health functions in relation to Wales in significant areas (e.g. the licensing of medicinal products and the control of their use under the Medicines Act 1968 and the powers under the now-repealed National Health Services Act 1977 in relation to xenotransplantation and human genetics).
The National Assembly exercised the health-related executive powers had been transferred to it until 25 May 2007 when its powers to make secondary legislation were further transferred to the Welsh Ministers on the coming into force of the Government of Wales Act 2006 (GOWA 2006).
Case law and the European Convention on Human Rights (ECHR)
The decisions of domestic courts are an important source of law in relation to the interpretation of numerous health related legislative provisions. There is also a growing body of European Court of Human Rights case law relevant to health and health services, in which the Court has decided, for example, whether particular national provisions on the status of the foetus and abortion were compliant with Article 2 ECHR (‘right to life’), whether national policies on healthcare resource allocation were compliant with Article 2, whether particular national practices in the context of mental health were compliant with Article 5 ECHR (‘right to liberty and security of the person’), and whether specific national laws on reproductive rights were compliant with Article 8 ECHR (‘right to privacy’).
European Union Law
The European Union’s Member States retain responsibility for health policy and the organisation, provision and delivery of healthcare. However, the EU plays a significant part in those areas of health and health services policy where it considers that the Member States cannot act alone effectively and where cooperative action at EU level is considered necessary. These include major health threats and issues with a cross-border or international impact, such as pandemics. EU law provisions on the free movement of goods, services and people are also relevant, and have, for example, required Member States to mutually recognise the qualifications of healthcare professionals (by virtue of EC Directive 2005/36 of 7 September 2005 on the recognition of professional qualifications).
EU law also makes specific provision about health-related matters. For example, there are EU laws and standards for health products and services (e.g. medicines, medical devices) and patients (e.g. safety and cross-border health services), on tobacco products, advertising and sponsorship, and on providing patients with the right to be treated in Member States other than their own.