Section 25: Validity and applicability of advance decisions

86.     This introduces the two important safeguards of validity and applicability in relation to advance decisions to refuse treatment.

87.     To be valid the advance decision must not have been withdrawn or overridden by a subsequent LPA giving a donee the authority to consent or refuse consent to the treatment (other LPAs will not override - see subsection ((7)). Also, if the person has acted in a way that is clearly inconsistent with the advance decision remaining his fixed decision, then the advance decision is invalid. An example of an inconsistent action might be a former Jehovah's Witness converting to Islam and marrying a Muslim man. Even if she had forgotten to destroy a written advance decision refusing blood transfusion, her actions could be taken into account in determining whether that earlier refusal remained her fixed decision.

88.     An advance decision will not be applicable if the person actually has capacity to make the decision when the treatment concerned is proposed. It will also not be applicable to treatments, or in circumstances, not specified in the decision. Furthermore the decision will not be applicable if there are reasonable grounds for believing that the current circumstances were not anticipated by the person and, if they had been anticipated by him, would have affected his decision. For example, there may be new medications available that radically change the outlook for a particular condition and make treatment much less burdensome than was previously the case.

89.     Subsection (5) introduces further rules about the applicability of advance decisions to refuse treatment that is necessary to sustain life. An advance decision will not apply to life-sustaining treatment unless it is verified by a statement confirming that the decision is to apply to that treatment even if life is at risk. The reference to "life" includes the life of an unborn child. Both the decision and the statement verifying it must be in writing and be signed and the signature must be witnessed. It is important to note that a person does not physically need to write his advance decision himself. This means that advance decisions recorded in medical notes are considered to be in writing. Writing can also include electronic records.

90.     If the maker of the advance decision cannot sign then another person can sign for him at his direction and in his presence (section 25(6)(b)). As with a signature by the person himself, the witness must be present when the third party signs.

Section 26: Effect of advance decisions

91.     This deals with the legal effect of a qualifying advance decision. If it is both valid and applicable it has the same effect as a contemporaneous refusal of treatment by a person with capacity. That is, the treatment cannot lawfully be given. If given, the person refusing would be able to claim damages for the tort of battery and the treatment-provider might face criminal liability for assault. Subsections (2) and (3) clarify the rules about liability. A treatment-provider may safely treat unless satisfied that there is a valid and applicable qualifying advance refusal; and a treatment-provider may safely withhold or withdraw treatment as long as he has reasonable grounds for believing that there is a valid and applicable qualifying advance decision.

92.     If there is doubt or a dispute about the existence, validity or applicability of an advance decision then the Court of Protection can determine the issue. There is an important proviso to the general rule that an advance refusal is legally effective. There may be a doubt or dispute about whether a particular refusal is in fact one which meets all the tests (existence, validity and applicability). As with decisions by donees or deputies in section 6(7), action may be taken to prevent the death of the person concerned, or a serious deterioration in his condition, whilst any such doubt or dispute is referred to the court.

Excluded decisions

Section 27: Family relationships etc.

93.     This lists certain decisions that can never be made under the Act on behalf of a person who lacks capacity. For example, in relation to adoption, if a birth parent lacks capacity to consent to an adoption order the rules as to dispensing with consent in the adoption legislation will apply. There will be no question of an attorney consenting or of the Court of Protection making an order or appointing a deputy to provide the requisite consent.

Section 28: Mental Health Act matters

94.     This deals with the question of people who are detained for psychiatric treatment pursuant to the Mental Health Act 1983. The section ensures that the Mental Capacity Act does not apply to any treatment for mental disorder which is being given in accordance with the rules about compulsory treatment set out in Part 4 of the 1983 Act. The specific statutory safeguards which the 1983 Act gives in relation to compulsory psychiatric treatment must always be afforded to those patients to whom that Act applies.

Section 29: Voting rights

95.     This provides that the Act does not apply to decisions on voting.

Research

Section 30: Research

96.     This section and sections 31 to 33 allow intrusive research to be lawfully carried out on, or in relation to, a person who lacks capacity, where the research is part of a research project approved by an appropriate body and it is carried out in accordance with the conditions set out in sections 32 and 33. The provisions are based on long-standing international standards, for example, those laid down by the World Medical Association and the Council of Europe Convention on Human Rights and Biomedicine.

97.     This section relates to intrusive research, which means research that would normally need consent if it involved an adult with capacity. Clinical trials that are currently regulated under the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031) (or regulations succeeding or amending them) are excluded from the Act because those Regulations already make provision for trials involving participants who lack capacity. Research on anonymised medical data or tissue is also not included, but may be subject to controls under the Data Protection Act 1998 or the Human Tissue Act 2004.

98.     The appropriate authority (the Secretary of State in relation to research in England and the National Assembly for Wales in relation to research in Wales) must specify an appropriate body for approving research projects, such as a Research Ethics Committee (REC).

Section 31: Requirements for approval

99.     This section sets out the matters of which the appropriate body - such as an REC— must satisfy itself before approving a research project involving a person who lacks capacity.

100.     Subsection (2) requires that the research must be connected with an impairing condition that affects the person participating in the research or with the treatment of the condition. Impairing condition means one that is, or may be, attributable to or causes or contributes to the impairment of or disturbance in the functioning of the person's mind or brain. This limits the sort of research projects that the person may be involved in but will include research into the effects of the impairment on his health and day-to-day life as well as into the causes or possible causes of the impairment and its treatment. Subsection (4) requires that there are reasonable grounds for believing that there is no alternative to the involvement of the person in the research, that is, it cannot be carried out as effectively if it only involves people who have capacity.

101.     Subsections (5) and (6) deal with the anticipated benefits and risks of the research. There are two alternatives: either the research has the potential to benefit the person without imposing a burden disproportionate to that benefit (this type of research is sometimes called "therapeutic research"); or the research is to provide knowledge of the causes of the person's condition, its treatment or the care of people who have the same or similar condition now or who may develop it in the future. In relation to this latter category, there must be reasonable grounds for believing that the risk to the person is negligible and the research must not interfere with the person's freedom of action or privacy in a significant way or be unduly invasive or restrictive. This latter category of research might include indirect research on medical notes or on tissue already taken for other purposes. It may also include interviews or questionnaires with carers about health or social-care services received by the person or limited observation of the person. And it could include taking samples from the person, e.g. blood samples, specifically for the research project.

Section 32: Consulting carers etc

102.     Before any decision is taken to involve a particular person in approved research, the researcher must take reasonable steps to identify a person close to the person (this could include an attorney or deputy but not someone acting in a professional capacity or for payment, such as a paid carer) who is prepared to be consulted about the person's involvement in the research (subsection (2)). If there is no such person, then the researcher must nominate a person independent of the research in accordance with guidance issued by the appropriate authority (see paragraph 99).

103.     Subsection (4) requires the researcher to give the consultee information about the research and to ask him or her for advice as to whether the person should take part in the research and what, in his opinion, the consultee's wishes and feelings would be about taking part in the research. If at any time the person consulted advises the researcher that in his opinion the person's wishes and feelings would be likely to lead him to decline to take part in the project then the researcher must ensure that the person does not take part in the project, or if it is already underway must ensure that the person is withdrawn from it. But the person may still receive treatment he was receiving during the research if withdrawal would create a significant risk to his health (subsection (6)).

104.     Subsections (8) and (9) allow for action to be taken in relation to the research where treatment is to be provided to the person urgently and there is insufficient opportunity to consult. The researcher may proceed if he has the agreement of a doctor who is not connected to the project or in accordance with a procedure agreed by the appropriate body at the time of approval. However subsection (10) makes it clear that the researcher may only rely on subsection (9) while there is an urgent need to treat. Examples of this type of research may involve action by a paramedic or doctor to make measurements in the first few minutes following a serious head injury or stroke. These arrangements are similar to those provided for in the Clinical Trials Regulations.

Section 33: Additional safeguards

105.     The purpose of section 33 is to provide additional safeguards for the person participating in the research once the research has begun. It requires the researcher to respect any signs of resistance from the person (except where this would conflict with procedures designed to protect him from harm or injury), and not to involve the person in research that would be contrary to an advance decision or any other form of statement. The person's interests must be assumed to outweigh those of science and society (subsection (3)).

106.     The person must be withdrawn from the project without delay if he indicates that he wishes to be withdrawn from it or if the researcher has reasonable grounds for believing that any of the requirements for approval of the project as set out at in section 31(2) to (7) are no longer met. As in section 32, the person may still receive treatment he was receiving during the research if withdrawal would create a significant risk to his health (subsection (6)).

Section 34: Loss of capacity during research project

107.     This section provides for a transitional regulation-making power to cover research started before section 30 comes into force and which involves people who had capacity when enrolled but who lose capacity before the end of the project. The regulations will lay down the conditions on which such research may continue; the research must meet prescribed requirements, the information or material used in the research must have been obtained before the loss of capacity and certain steps must be taken to protect the person participating (subsection (2)).

108.     The regulations will set out these requirements and steps and may include safeguards similar to those provided for in sections 31 to 33 but with any necessary alterations to the requirements for approval by an appropriate body, consultation with carers or the additional safeguards (subsection (3)). Regulations made by the Secretary of State will be subject to the affirmative procedure in Parliament (see section 65).

Independent mental capacity advocate service

Section 35: Appointment of independent mental capacity advocates

109.     Sections 35 to 41 create a new scheme designed to provide the input of an independent mental capacity advocate ("IMCA") where certain decisions need to be taken for particularly vulnerable people who lack capacity. This may include older people with dementia who have lost contact with all friends and family, or people with severe learning disabilities or long term mental health problems who have been in residential institutions for long periods and lack outside contacts. Such people will be represented and provided with support when decisions are to be made about serious medical treatment or significant changes of residence provided by public bodies.

110.     Subsection (1) places a duty on the appropriate authority to make arrangements for the provision of a new independent mental capacity advocacy service. The appropriate authority is, in relation to England, the Secretary of State and, in relation to Wales, the National Assembly for Wales.

111.     Subsection (2) allows the appropriate authority to make regulations setting out how the IMCA will be appointed. This will ensure that an individual will need to meet common standards in order to be approved as an IMCA. Subsection (4) provides that, as far as practicable, the IMCA should be independent of the person who is making the decision concerned. Subsection (5) provides that the arrangements may include provision for payments to be made to, or in relation to, the IMCA. Subsection (6) stipulates that an IMCA must be able to meet the person concerned in private and see relevant health, social services and care home records. This is to enable the IMCA to be able to perform properly his function of representing and supporting the person who lacks capacity.

Section 36: Functions of independent mental capacity advocates

112.     This section allows the appropriate authority to make regulations setting out the functions of IMCAs. Subsection (2) provides that those regulations may set out the steps which an IMCA needs to take in fulfilling those functions. These steps should ensure that the IMCA supports the person to participate as fully as possible in the decision; obtains and evaluates relevant information; ascertains and represents the person's wishes, feelings, beliefs and values; finds out about all the available options; and seeks a second medical opinion if necessary. Subsection (3) provides that the regulations may also set out the circumstances in which the IMCA may challenge the decision-maker on behalf of the person, if appropriate.

Section 37: Provision of serious medical treatment by NHS body

113.     This section applies where "serious medical treatment" is to be provided or arranged by the NHS for a person who lacks capacity, and there is no one for the treatment-provider to discuss it with. If there is neither a person from the list in section 40 (such as an attorney under an LPA or deputy) nor a non-professional carer or friend whom it is appropriate to consult, then an IMCA is to be instructed.

114.     The role of the IMCA will be both to represent and to support the person in accordance with the regulations made under section 36. The information and submissions provided by the IMCA must be taken into account by the decision-maker.

115.     Subsection (2) provides that where the person's treatment is regulated under Part 4 of the Mental Health Act 1983, the IMCA does not need to be instructed under section 37(3). That Act already contains its own safeguards.

116.     Subsection (4) makes provision in relation to urgent treatment. Subsection (6) provides that the types of "serious medical treatment" to be covered will be set out in regulations. Subsection (7) provides that regulations will also define the particular NHS bodies who will become subject to the duties. The intention is that this will cover the bodies responsible for direct provision or funding of treatment as appropriate.

Section 38: Provision of accommodation by NHS body

117.     This section applies to long-stay accommodation in a hospital or a care home, or a move between such accommodation, where this accommodation is provided or arranged by the NHS. Subsection (9) clarifies that this section only applies when the accommodation is to be provided for more than 28 days in relation to accommodation in hospital or more than 8 weeks in relation to accommodation in a care home. The IMCA is to be instructed where such accommodation is being proposed and a person lacks capacity to agree to the arrangements and there is no other person to discuss it with. Again the role of the IMCA is both to support and to represent the person concerned. Any information or submissions from the IMCA must be taken into account by the NHS body.

118.     Subsection (2) provides that where the person concerned is to be detained in hospital or otherwise required to live in the accommodation in question under the Mental Health Act 1983, the IMCA does not need to be consulted, as that Act already contains its own safeguards. Subsection (3) makes provision in relation to urgent placements.

119.     Subsection (4) is intended to ensure that an IMCA is involved in relation to people whose residence is initially intended to be less than 28 days/8 weeks (see paragraph 118) if the period is later extended beyond the applicable period.

120.     Subsections (6) and (7) define the types of care homes and hospitals which are covered under by this section. Subsection (8) provides that regulations will also define the particular NHS bodies who will become subject to the duties.

Section 39: Provision of accommodation by local authority

121.     This section applies to long-stay accommodation (8 weeks or more) arranged by a local authority or a change in such accommodation. It applies to residential accommodation provided in accordance with section 21 or 29 of the National Assistance Act 1948. This may be accommodation in a care home, nursing home, ordinary and sheltered housing, housing association or other registered social housing, or in private sector housing provided by a local authority or in hostel accommodation. The IMCA safeguard will also apply to people accommodated following discharge under section 117 of the Mental Health Act 1983.

122.     The IMCA is to be instructed where a person lacks capacity to agree to the arrangements and there is no other person to discuss it with. Again the role of the IMCA is both to support and to represent the person concerned. Any information or submissions from the IMCA must be taken into account by the local authority.

123.     Subsection (3) provides that the IMCA does not need to be instructed where the person is to be required under the Mental Health Act 1983 to live in the accommodation in question (for example, as a requirement of conditional discharge). Subsection (4) makes provision in relation to urgent placements.

124.     Subsection (5) is intended to ensure that an IMCA is involved in relation to people whose residence is initially intended to be less than 8 weeks if the period is later extended.

Section 40: Exceptions

125.     This section provides that the independent mental capacity advocacy service does not have a role when the person concerned already has somebody who can speak with the provider of treatment or accommodation (e.g. a person chosen in advance, an attorney under an EPA or LPA, or a deputy). This overrides sections 37(3), 38(3) and (4) and 39(4) and (5), which generally trigger the involvement of an IMCA when there is no one appropriate to consult about the person's interests, other than a paid or professional carer.

Section 41: Power to adjust role of independent mental capacity advocate

126.     This section provides that the scope of the independent mental capacity advocacy service can be extended, by regulations made for England by the Secretary of State or for Wales by the National Assembly for Wales, to other sets of circumstances. Such regulations would follow consultation about where the involvement of an IMCA might prove useful. Regulations made by the Secretary of State will be subject to the affirmative procedure in Parliament (see section 65).

Miscellaneous and supplementary

Section 42: Codes of practice

127.     This section provides for the Lord Chancellor to make and revise a code or codes of practice to supplement the Act. Attorneys, deputies, professionals, paid workers, researchers and IMCAs acting on behalf of adults who lack capacity will be under an obligation to have regard to any relevant code. Any codes of practice issued will be allowed to be used as evidence in court or tribunal proceedings.

Section 43: Codes of practice: procedure

128.     This section sets out the procedure for issuing and revising any codes of practice. The Lord Chancellor will have to consult the National Assembly for Wales and other appropriate persons before preparing or revising a code. Draft codes will have to be laid before both Houses of Parliament for 40 days. They may then be issued, provided that neither House has resolved to reject the draft. The Lord Chancellor must arrange for the code to be brought to the attention of people who may need to know about it.

Section 44: Ill-treatment or neglect

129.     This section creates an offence of ill-treatment or wilful neglect of a person lacking capacity by anyone responsible for that person's care, donees of LPAs or EPAs, or deputies appointed by the court.

PART 2: THE COURT OF PROTECTION AND THE PUBLIC GUARDIAN

The Court of Protection

Section 45: The Court of Protection

130.     This section establishes a superior court of record, called the Court of Protection, which will be able to sit anywhere in England and Wales. Welfare matters previously referred to the High Court may be referred to this court. It is intended that the Court of Protection will have a regional presence but will have a central office and registry as designated by the Lord Chancellor. Additional registries (being High Court district registries or county courts) may also be designated. Subsection (6) provides that the former office of the Supreme Court known as the Court of Protection will cease to exist.

Section 46: The judges of the Court of Protection

131.     The Lord Chancellor or an appropriate person acting on his behalf will nominate judges to exercise the jurisdiction of the Court of Protection. Subsection (2) sets out which judges may be nominated. Subsection (3) gives the Lord Chancellor the power to appoint one of the senior nominated judges to be designated President of the Court of Protection and another to be Vice-President of the Court of Protection. Subsection (4) gives the Lord Chancellor the power to appoint a judge to be Senior Judge of the Court of Protection, with various administrative functions.

Supplementary powers

Section 47: General powers and effect of orders etc.

132.     Subsection (1) gives the Court of Protection the same powers as the High Court, for example in relation to witnesses, contempt and enforcement.

Section 48: Interim orders and directions

133.     This section allows the court to make interim orders even if evidence as to lack of capacity is not yet available, where there is reason for the court to believe that the person lacks capacity in respect of a particular matter and it is in his best interests for the court to act without delay.

Section 49: Power to call for reports

134.     This section makes provision for reports to assist the court in determining a case. Such reports can be commissioned from the Public Guardian, local authorities, NHS bodies or Court of Protection Visitors. The Public Guardian is a new statutory official (see section 57) and the Court of Protection Visitors replace current "Lord Chancellor's Visitors" (see section 102 of the Mental Health Act 1983 and section 61). Local authority staff or NHS staff may already be providing services to the person concerned and be able to report to the court on the basis of their existing involvement.

135.     Subsections (7) to (9) allow the Public Guardian or Court of Protection Visitor who is reporting to the court to have access to health, social services or care records relating to the person and interview him in private. Where a Court of Protection Visitor is a Special Visitor (e.g. a registered medical practitioner or someone with other suitable qualifications or training) he may, on the directions of the court, carry out medical, psychiatric or psychological examinations.