Consent guidance: Legal Annex - Legislation

Making decisions when patients lack capacity

England and Wales

Mental Capacity Act 2005

This Act provides a legal framework for making decisions in relation to people who lack capacity. It clarifies:

  • who can make decisions, including decisions about medical care and treatment, for people who are unable to decide for themselves
  • how those decisions should be made.

Section 1 of the Act sets out five statutory principles that apply to any action taken and decisions made under the Act. These are:

  • a person must be assumed to have capacity unless it is established that they lack capacity
  • a person is not to be treated as unable to make a decision unless all practicable steps to help him do so have been taken without success
  • a person is not to be treated as unable to make a decision merely because he makes an unwise decision
  • an act done, or decision made, under the Act for or on behalf of a person who lacks capacity must be done, or made, in his best interests
  • before the act is done, or the decision is made, regard must be had to whether the purpose for which it is needed can be as effectively achieved in a way that is less restrictive of the person’s rights and freedom of action.

In this Act, people lack capacity in relation to a particular matter if, at the material time, they are unable to make a decision for themselves in relation to the matter because of an impairment of, or a disturbance in the functioning of, the mind or brain (section 2(1)).

Doctors and other healthcare professionals must have regard to the supporting Code of Practice, which explains how the Act should work on a day to day basis and sets out the steps that those using and interpreting it should follow when:

  • assessing a person’s capacity, or
  • reaching a decision in the best interests of a person who does not have capacity.

Mental Capacity Act 2005 (opens in a new window)

Mental Capacity Act Code of Practice (opens in a new window)


Adults with Incapacity (Scotland) Act 2000

This Act provides ways to help safeguard the welfare of people aged 16 and over who lack the capacity to take some or all decisions for themselves, because of a mental disorder or inability to communicate. It also allows other people to make decisions on their behalf. The Act provides various methods of intervening (that is, taking decisions or action) on behalf of an adult who lacks capacity, including in relation to healthcare. The Act sets out the principles that must be followed when deciding whether to intervene.

Any intervention must be:

  • necessary and must benefit the person
  • the minimum necessary to achieve the purpose.

Those making decisions must:

  • take account of the person’s present and past wishes and feelings, and must try every possible means of communicating with the person to find out what these are
  • take into account the views of the person’s nearest relative and primary carer, and of any other person with powers to intervene in the person’s affairs or personal welfare, or with an interest in the person, so far as it is reasonable and practical to do so
  • encourage the person to use any skills they have to make decisions
  • consider whether it would be possible to intervene without using the Act.

In this Act, incapacity means being incapable of acting on, making, communicating, understanding, or remembering decisions by reason of mental disorder or inability to communicate due to physical disorder.

The Act is supported by Codes of Practice setting out guidance for those acting under the legislation, including doctors and other healthcare professionals who are treating adults with incapacity. Part 5 of the Code of Practice covers decisions about medical treatment and research.

Adults with Incapacity (Scotland) Act 2000 (opens in a new window)

Scottish Executive site for the Act (opens in a new window)

Northern Ireland

There is currently no primary legislation on capacity covering Northern Ireland. Decisions about medical treatment and care when people lack capacity must be made in accordance with the common law, which requires decisions to be made in a person’s best interests.

The Bamford Review recently produced a final report to conclude a four-year independent review of the effectiveness of current policy and service provision relating to mental health and learning disability, and of the Mental Health (Northern Ireland) Order 1986. The report recommends that there should be
a single comprehensive legislative framework for the reform of mental health legislation and for the introduction of capacity legislation in Northern Ireland.

The Bamford Review of Mental Health & Learning Disability (N. Ireland) (opens in a new window)

Treatment for mental disorder without consent

England and Wales

Mental Health Act 1983 (as amended by the Mental Health Act 2007)

The Mental Health Act provides a statutory framework, which sets out when patients can be compulsorily treated for a mental disorder without consent, to protect them or others from harm. It also sets out the rights of patients to challenge the use of compulsory powers through the Mental Health Tribunal.

Mental Health Act 2007 (opens in a new window)


Mental Health (Care and Treatment) (Scotland) Act 2003

This Act sets out the circumstances in which people with mental disorders can be compulsorily treated without their consent, for their mental disorder. As well as establishing compulsory powers, the Act sets up rights and safeguards for patients (including the Mental Health Tribunal and a right of access to independent advocacy services). One of the conditions for the use of compulsory powers under the Act is that the person’s ability to make decisions about treatment for their mental disorder must be ‘seriously impaired’.

Mental Health (Care and Treatment) (Scotland) Act 2003 (opens in a new window)

Scottish Government page for the Act (opens in a new window)

Northern Ireland

Mental Health (NI) Order 1986

Article 69 of this Order in Council provides for treatment for mental disorder to be given to patients in certain circumstances without their consent.

Mental Health (NI) Order 1986 (opens in a new window)

Use of human tissue

England, Wales and Northern Ireland

Human Tissue Act 2004

The Act requires that consent is obtained before:

  • a person’s organs and tissue can be stored or used for purposes such as research, post-mortem examination, and transplantation
  • a deceased person’s organs and tissue can be removed for these purposes.22

The Act specifies whose consent is needed and in what circumstances. The Human Tissue Authority (HTA) publishes a Code of Practice which gives detailed advice on how consent should be obtained and recorded.

Human Tissue Act 2004 (opens in a new window)

Human Tissue Authority website - Codes of Practice (opens in a new window)


Human Tissue (Scotland) Act 2006

The Act requires that authorisation is obtained before a deceased person’s organs and tissue can be stored or used for purposes such as research, post-mortem examination, and transplantation. It does not cover the use and storage of tissue from living people, other than organ donation for transplantation.

Human Tissue (Scotland) Act 2006 (opens in a new window)

Fertility Treatments

Human Fertilisation and Embryology Act 1990

This Act provides a legal framework across the UK for all those involved in fertility treatments. It defines the rights of donors, patients and the children who may result from the treatment, restricts research on human embryos to specified purposes and places time limits on the storage of embryos, eggs, and sperm. The Human Fertilisation and Embryology Authority (HFEA) was created under the Act to oversee the licensing and compliance of treatment clinics and research centres and to keep new developments under review. At the time of publication, Parliament was considering a number of amendments to the Act.

Human Fertilisation and Embryology Act 1990 (as amended) (opens in a new window)

Human Fertilisation and Embryology Act 2008 (opens in a new window)

Human Fertilisation and Embryology Authority website (opens in a new window)

Human Rights

The Human Rights Act 1998

The preamble to the Human Rights Act 1998 (HRA) describes it as ‘an Act to give greater effect to rights and freedoms guaranteed under the European Convention on Human Rights’ (the Convention). The HRA only incorporates the rights in Articles 2 to 12 and in Article 14 of the Convention, plus those in the First and Sixth Protocols. The incorporated rights are set out in the First Schedule to the HRA and are referred to as ‘Convention rights’.

As far as it is possible to do so, primary legislation and subordinate legislation must be read and given effect in a way that is compatible with these Convention rights.

The HRA requires that all public bodies must ensure that everything they do is compatible with the Convention rights unless an Act of Parliament makes that impossible. They must provide a way for people to challenge a public body if they believe it has acted, or proposes to act, in a way that is unlawful under the HRA.

The Convention Articles most likely to be relevant to decisions about medical investigations and treatment are:

  • Article 2 (the right to life)
  • Article 3 (the right to be free from inhuman or degrading treatment)
  • Article 8 (the right to respect for privacy and family life)
  • Article 10 (the right to freedom of expression, which includes the right to hold opinions and to receive information)
  • Article 14 (the right to be free from discriminatory practice in respect of these rights).

Ministry of Justice Human Rights pages (opens in a new window)