Health and Care Act 2022 in Scotland

The Secretary of State may by regulations require manufacturers or commercial suppliers of health care products, or connected persons, to—

The regulations may make further provision about when and how the information is to be published or provided.

The information may, in particular, include information about—

The regulations may make provision permitting or requiring the further sharing, publication or use of the information.

The regulations may impose requirements on manufacturers or commercial suppliers of health care products, or connected persons, about the retention of information relating to payments or other benefits provided by them to relevant persons.

The regulations may—

The regulations may impose requirements on a person mentioned in subsection (6)(c)(i) about the retention of information mentioned there.

The provision for exceptions that may be made by the regulations includes provision authorising the Secretary of State to grant an exception from a requirement imposed by the regulations in a particular case, on grounds specified in the regulations.

The regulations may provide that the disclosure of information under the regulations does not breach—

Provision made by the regulations may, in particular, be framed by reference to manufacturers or commercial suppliers with a specified connection to the United Kingdom or a part of it.

In this section—

In this section—

• “commercial supplier”, in relation to a health care product, means a person who supplies the product otherwise than in the course of providing health care;

• “data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018;

• “health care” means all forms of health care provided for individuals, whether relating to physical or mental health;

• “health care product” means a medicine, medical device or other product which is supplied or prescribed in the course of the provision of health care;

• “manufacturer”, in relation to a health care product, means a person who manufactures or assembles the product;

• “payments or other benefits” includes any payment or other benefit—

  1. (a)

     wherever it is provided,

  2. (b)

     whether or not it is of a financial nature,

  3. (c)

     whether it is provided under a contract or otherwise, and

  4. (d)

     whether it is provided directly or through a third party.

Regulations under section 92(1) may make provision for the enforcement of requirements imposed by the regulations, including provision conferring on the Secretary of State the power to impose a financial penalty on a person who, without reasonable excuse—

The amount of the financial penalty is to be specified in, or determined in accordance with, the regulations.

Regulations by virtue of subsection (1) must include provision—

The provision that may be made by the regulations by virtue of subsection (1) includes provision—

Before making regulations under section 92, the Secretary of State must—

Consent is not required under subsection (1)(c) in relation to any provision if—

The Secretary of State may by regulations transfer a function of a relevant body to another relevant body.

Regulations under this section may be made only if the Secretary of State considers that they serve the purpose of improving the exercise of public functions, having regard to—

Regulations under this section may not transfer a function of NHS England if the Secretary of State considers that to do so would make NHS England redundant.

The provision which may be made by regulations under this section by virtue of section 183(1)(a) includes provision—

Where—

the Secretary of State must make provision by virtue of section 183(1)(a) modifying the constitutional arrangements of the body referred to in paragraph (a) so that they contain corresponding provision as to membership.

In this section, “Minister” means a Minister of the Crown (as defined by section 8 of the Ministers of the Crown Act 1975).

The Secretary of State may by regulations provide for a relevant body to exercise specified functions of the Secretary of State on behalf of the Secretary of State.

The functions that may be specified are —

The provision which may be made by regulations under this section by virtue of section 183(1)(a) includes provision—

Where—

the Secretary of State must make provision by virtue of section 183(1)(a) modifying the relevant body’s constitutional arrangements so that they contain corresponding provision as to membership.

Regulations under this section may make provision for determining whether and in what circumstances the Secretary of State or a relevant body is liable for the exercise of the specified functions by the relevant body.

The specification of a function in regulations under this section does not preclude the Secretary of State from exercising the function.

In this section “the health service” has the same meaning as in the National Health Service Act 2006 (see section 275(1) of that Act).

In sections 103 and 104, references to modifying the functions of a body include—

In sections 103 and 104, references to the constitutional arrangements of a body include matters relating to—

In sections 103 and 104, references to modifying the funding arrangements of a body include—

Regulations under section 103 or 104 may repeal and re-enact (but may not create)—

The provision which may be made by regulations under section 103 or 104 may be made by repealing, revoking or amending provision made by or under an Act, whenever passed or made.

The provision which may be made by regulations under section 103 or 104 by virtue of section 183(1)(a) includes provision repealing, revoking or amending provision made by or under any of the following, whenever passed or made—

In this section, “Minister” means a Minister of the Crown (as defined by section 8 of the Ministers of the Crown Act 1975).

The Secretary of State may, in connection with regulations under section 103 or 104, make one or more schemes for the transfer of property, rights and liabilities (“transfer schemes”).

A transfer scheme in connection with regulations under section 103 may provide for the transfer of property, rights or liabilities to any appropriate person from the relevant body from which functions are transferred by the regulations.

A transfer scheme in connection with regulations under section 104 may provide for the transfer of property, rights or liabilities to any appropriate person from—

The things that may be transferred under a transfer scheme include—

A transfer scheme may—

A transfer scheme may provide—

In subsection (5)(f), “the TUPE regulations” means the Transfer of Undertakings (Protection of Employment) Regulations 2006 (S.I. 2006/246).

For the purposes of this section—

For the purposes of subsection (8)(a)—

In this section “appropriate person” means—

The Treasury may by regulations make provision varying the way in which a relevant tax has effect in relation to—

The provision which may be made under subsection (1)(a) includes in particular provision for—

The provision which may be made under subsection (1)(b) includes in particular provision for—

Regulations under this section are subject to annulment in pursuance of a resolution of the House of Commons.

In this section references to the transfer of property include the grant of a lease.

In this section—

• “relevant tax” means income tax, corporation tax, capital gains tax, value added tax, stamp duty or stamp duty reserve tax;

• “tax provision” means a provision of an enactment about a relevant tax.

Before making regulations under section 103 or 104, the Secretary of State must—

Consent is not required under subsection (1)(c)(i) in relation to any provision if—

Before making regulations under section 103 or 104, the Secretary of State must consult the following about a draft of the regulations—

If, as a result of consultation under this section, it appears to the Secretary of State appropriate to change the draft regulations, the Secretary of State must carry out such further consultation with respect to the changes as the Secretary of State considers appropriate.

It is immaterial for the purposes of this section whether consent is obtained or consultation is carried out before or after the commencement of this section.

A power under any enactment (whenever passed or made) other than this Part to require the disclosure of, or to seize, any information, document, equipment or other item may not be used—

Subsection (1) applies to a power to require disclosure, or to seize, however it is expressed (and, for example, it applies if the power is to require a person to give, supply, furnish or produce any information, document, equipment or other item).

Subsection (1) does not apply to a power to the extent that the provision conferring it is within the legislative competence of a devolved legislature.

A provision is within the legislative competence of a devolved legislature if—

In this section “enactment” includes an enactment comprised in subordinate legislation within the meaning of the Interpretation Act 1978.

References to the HSSIB in subsection (1) include—

It is an offence under the law of Scotland for a person to carry out virginity testing.

“Virginity testing” means the examination of female genitalia, with or without consent, for the purpose (or purported purpose) of determining virginity.

An offence is committed under subsection (1) only if the person—

“United Kingdom national” means an individual who is—

In subsection (2), “female genitalia” means a vagina or vulva.

It is an offence under the law of Scotland—

Virginity testing has a sufficient jurisdictional connection for the purposes of subsection (1)(a) if it is carried out in relation to a person who is—

In this section—

• “United Kingdom national” has the meaning given by section 140(4);

• “virginity testing” has the meaning given by section 140(2).

It is an offence under the law of Scotland for a person who is in Scotland, or for a person who is outside Scotland but who is a United Kingdom national or habitually resident in Scotland, to aid, abet, counsel, procure or incite the carrying out of virginity testing that has a sufficient jurisdictional connection.

Virginity testing has a sufficient jurisdictional connection for the purposes of subsection (1) if it is carried out in relation to a person who is—

This section does not affect the application to an offence under section 140 of any rule of law relating to aiding, abetting, counselling, procuring or inciting.

In this section—

• “United Kingdom national” has the meaning given by section 140(4);

• “virginity testing” has the meaning given by section 140(2).

A person who commits an offence under section 140, 141 or 142 is liable—

Where a person outside Scotland commits an offence under section 140, 142 or 143 the person may be prosecuted, tried and punished for the offence—

as if the offence had been committed in that district.

Where subsection (2) applies, the offence is, for all purposes incidental to or consequential on the trial and punishment, deemed to have been committed in that district.

In this section “sheriff court district” is to be construed in accordance with section 307(1) of the Criminal Procedure (Scotland) Act 1995 (interpretation).

It is an offence under the law of Scotland for a person to carry out hymenoplasty.

“Hymenoplasty” means the reconstruction of the hymen (with or without consent).

An offence is committed under subsection (1) only if the person—

“United Kingdom national” means an individual who is—

It is an offence under the law of Scotland—

Hymenoplasty has a sufficient jurisdictional connection for the purposes of subsection (1)(a) if it is carried out in relation to a person who is—

In this section—

• “United Kingdom national” has the meaning given by section 152(4);

• “hymenoplasty” has the meaning given by section 152(2).

It is an offence under the law of Scotland for a person who is in Scotland, or for a person who is outside Scotland but who is a United Kingdom national or habitually resident in Scotland, to aid, abet, counsel, procure or incite the carrying out of hymenoplasty that has a sufficient jurisdictional connection.

Hymenoplasty has a sufficient jurisdictional connection for the purposes of subsection (1) if it is carried out in relation to a person who is—

This section does not affect the application to an offence under section 152 of any rule of law relating to aiding, abetting, counselling, procuring or inciting.

In this section—

• “United Kingdom national” has the meaning given by section 152(4);

• “hymenoplasty” has the meaning given by section 152(2).

A person who commits an offence under section 152, 153 or 154 is liable—

Where a person outside Scotland commits an offence under section 152, 153 or 154 the person may be prosecuted, tried and punished for the offence—

as if the offence had been committed in that district.

Where subsection (2) applies, the offence is, for all purposes incidental to or consequential on the trial and punishment, deemed to have been committed in that district.

In this section “sheriff court district” is to be construed in accordance with section 307(1) of the Criminal Procedure (Scotland) Act 1995 (interpretation).

contains amendments to the Human Fertilisation and Embryology Act 1990 which make provision relating to the storage of gametes and embryos, and

makes transitional provision in relation to those amendments.

The Secretary of State may by regulations make provision that is consequential on this Act.

Regulations under this section may amend, repeal or revoke provision made by this Act or any provision made by or under primary legislation passed—

In this section “primary legislation” means—

A power to make regulations under any provision of this Act includes power to make—

A power to make regulations under section 92, 103 or 104 includes power to make different provision for England, Wales, Scotland or Northern Ireland.

Regulations under this Act are to be made by statutory instrument.

A statutory instrument containing any of the following (whether alone or with other provision) may not be made unless a draft of the instrument has been laid before and approved by a resolution of each House of Parliament—

Any other statutory instrument containing regulations under section 182 is subject to annulment in pursuance of a resolution of either House of Parliament.

This section does not apply to regulations under section 186.

any expenditure incurred by the Secretary of State under or by virtue of this Act, and

any increase attributable to this Act in the sums payable under any other Act out of money so provided.

This Act extends to England and Wales only, subject to subsections (2) to (5).

The following extend to England and Wales, Scotland and Northern Ireland—

The following extend to Scotland only—

The following extend to Northern Ireland only—

An amendment, repeal or revocation made by this Act has the same extent as the provision amended, repealed or revoked.

This Part comes into force on the day on which this Act is passed.

Section 161(2) comes into force on such day as the Welsh Ministers may by regulations appoint.

Section 171 and Schedule 17 (storage of gametes and embryos) come into force on 1 July 2022.

Section 172 and Schedule 18 (advertising of less healthy food and drink) come into force at the end of the period of two months beginning with the day on which this Act is passed.

Section 179 comes into force at the end of the period of three months beginning with the day on which this Act is passed.

Except as mentioned in subsections (1) to (5), this Act comes into force on such day as the Secretary of State may by regulations appoint.

Different days may be appointed under subsection (2) or (6) for different purposes.

In relation to section 166, different days may be appointed under subsection (6) for different areas.

The Secretary of State may by regulations make transitional or saving provision in connection with the coming into force of any provision of this Act.

The Welsh Ministers may by regulations make transitional or saving provision in connection with the coming into force of section 161(2).

The power to make regulations under subsection (9) or (10) includes power to make different provision for different purposes.

Regulations under this section are to be made by statutory instrument.

The enactments listed in sub-paragraph (2) are amended in accordance with the table.

The enactments are—

• the Reserve and Auxiliary Forces (Protection of Civil Interests) Act 1951, Schedule 2;

• the Public Records Act 1958, Part 1 of the Table at the end of paragraph 3 of Schedule 1;

• the Public Bodies (Admission to Meetings) Act 1960, the Schedule;

• the Leasehold Reform Act 1967, section 28;

• the Parliamentary Commissioner Act 1967, Schedule 3;

• the Health Services and Public Health Act 1968, sections 63(1) and (2) and 64;

• the Employers’ Liability (Compulsory Insurance) Act 1969, section 3;

• the Local Authority Social Services Act 1970, Schedule 1;

• the Local Government Act 1972, section 113;

• the Health and Safety at Work etc. Act 1974, section 60;

• the National Health Service (Scotland) Act 1978, section 17A;

• the Acquisition of Land Act 1981, sections 16 and 17;

• the Mental Health Act 1983, sections 12ZB, 12ZC, 39, 117, 134 and 139;

• the Disabled Persons (Services, Consultation and Representation) Act 1986, sections 2 and 7;

• the Copyright, Designs and Patents Act 1988, section 48;

• the Children Act 1989, sections 21, 24, 24C, 27, 29, 47, 80, 85 and 105;

• the London Local Authorities Act 1991 (c xiii), section 4;

• the Health Service Commissioners Act 1993, sections 2 and 2A;

• the Value Added Tax Act 1994, section 41 and Schedule 8;

• the Education Act 1996, section 322;

• the Employment Rights Act 1996, sections 43K, 49B, 50 and 218;

• the Housing Grants, Construction and Regeneration Act 1996, section 3;

• the Crime and Disorder Act 1998, section 115;

• the Greater London Authority Act 1999, section 309E;

• the Health Act 1999, section 61;

• the Freedom of Information Act 2000, Schedule 1;

• the Local Government Act 2000, section 9FF;

• the Adoption and Children Act 2002, section 8;

• the International Development Act 2002, Schedule 1;

• the Nationality, Immigration and Asylum Act 2002, section 133;

• the Criminal Justice Act 2003, section 325;

• the Finance Act 2003, section 67A;

• the Health and Social Care (Community Health and Standards) Act 2003, sections 148 and 165;

• the Children Act 2004, sections 10 and 11;

• the Civil Contingencies Act 2004, Schedule 1;

• the Domestic Violence, Crime and Victims Act 2004, section 9;

• the Armed Forces Act 2006, section 343AA (as inserted by section 8(3) of the Armed Forces Act 2021);

• the Childcare Act 2006, section 4;

• the Emergency Workers (Obstruction) Act 2006, section 1;

• the National Health Service Act 2006, except section 275;

• the National Health Service (Wales) Act 2006, sections 7, 13, 17, 26, 28, 34, 106, 115, 162, 197, 206 and Schedule 5;

• the NHS Redress Act 2006, section 1;

• the Safeguarding Vulnerable Groups Act 2006, section 6;

• the Corporate Manslaughter and Corporate Homicide Act 2007, section 6;

• the Local Government and Public Involvement in Health Act 2007, sections 104, 116, 222, 224 and 227;

• the Statistics and Registration Service Act 2007, section 42(4A);

• the Health and Social Care Act 2008, sections 20A, 30, 39, 45A, 48, 54, 59, 64, 80, 81 and 97;

• the Autism Act 2009, section 4;

• the Health Act 2009, sections 2, 8 and 36;

• the Charities Act 2011, section 149;

• the Health and Social Care Act 2012, sections 83, 84, 102, 130, 197, 234, 236, 237, 239, 241, 249, 250(4) and (7), 253, 254, 255, 260, 263, 265, 268, 274, 295, 296, 298 and Schedule 12;

• the Care Act 2014, sections 6, 22 and 101 and Schedule 1;

• the Children and Families Act 2014, sections 26, 28, 31, 53, 56, 57 and 77;

• the Immigration Act 2014, Schedule 3;

• the Local Audit and Accountability Act 2014, section 13 and Schedules 7 and 11;

• the Cities and Local Government Devolution Act 2016, section 18;

• the Data Protection Act 2018, Schedule 3;

• the Mental Health Units (Use of Force) Act 2018, section 9.

In any other enactment (apart from this Act) passed before the day on which section 1 comes into force, and in any instrument or other document made before that day, any reference to the National Health Service Commissioning Board is to be read, in relation to any time on or after that day, as a reference to NHS England.

In this paragraph “enactment” includes an enactment comprised in, or in an instrument made under, an Act of the Scottish Parliament.

Section 136 of the Enterprise Act 2002 (investigations and reports on market investigation references) is amended as follows.

In subsection (7), omit paragraph (i).

In subsection (8), omit “, Monitor”.

In this Part of this Schedule—

• “the commencement day” means 1 July 2022;

• “the transitional period” means the period beginning with the commencement day and ending with 30 June 2024.

In this Part of this Schedule—

• “the 1990 Act” means the Human Fertilisation and Embryology Act 1990;

• “the 2009 Regulations” means the Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) Regulations 2009 (S.I. 2009/1582);

• “the 2020 Regulations” means the Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) (Coronavirus) Regulations 2020 (S.I. 2020/566).

In this Part of this Schedule—

• “gamete storage licence” means a licence under Schedule 2 to the 1990 Act that authorises the storage of gametes;

• “embryo storage licence” means a licence under Schedule 2 to the 1990 Act that authorises the storage of embryos;

• “storage licence” means a licence under Schedule 2 to the 1990 Act that authorises the storage of gametes, embryos or human admixed embryos;

• “pre-commencement”, in relation to a storage licence, or a storage licence of any description, means granted before the commencement day and “post-commencement” means granted on or after that day.

In this Part of this Schedule—

• “statutory storage period” has the same meaning as in the 1990 Act immediately before the commencement day;

• references to gametes, embryos and human admixed embryos have the same meaning as in that Act;

• “the training purpose”, “the research purpose” and “treatment purposes” have the same meanings as in section 14(3)(c) of that Act.

The amendments in paragraphs 2 to 6 of this Schedule have effect in relation to pre-commencement storage licences under which gametes, embryos or human admixed embryos are kept in storage on or after the commencement day (as well as having effect in relation to post-commencement storage licences).

This is subject to sub-paragraphs (2) and (3).

In the case of a pre-commencement embryo storage licence, the condition imposed by section 14(3)(c) of the 1990 Act (as substituted by paragraph 2 of this Schedule) does not apply in relation to an embryo which, on the commencement day, is kept in storage for the training or research purpose but not for treatment purposes.

In the case of any pre-commencement storage licence, the condition imposed by section 14(1)(ca) of the 1990 Act (as substituted by paragraph 5 of this Schedule) applies only in relation to times on or after the commencement day.

This paragraph applies if the person storing gametes or an embyro under a pre-commencement gamete or embryo storage licence—

The person may give a notice to each person whose consent to the storage is required under Schedule 3 to the 1990 Act specifying a date on which the gametes are or embryo is to be regarded as having been first placed in storage.

Where notice is given under sub-paragraph (2), the gametes are or embryo is to be regarded, for all purposes of the 1990 Act and this Part of this Schedule, as having been first placed in storage on the date specified in the notice.

For the purposes of section 14(3)(a) of the 1990 Act (as substituted by paragraph 2 of this Schedule), a pre-commencement gamete storage licence under which, on and after the commencement day, gametes are kept in storage is to be regarded as specifying the period of 55 years beginning with the day on which the gametes were first placed in storage.

For the purposes of section 14(3)(b) of the 1990 Act (as substituted by paragraph 2 of this Schedule), a pre-commencement embryo storage licence under which, on and after the commencement day, an embryo is kept in storage for treatment purposes is to be regarded as specifying for those purposes the period of 55 years beginning with the day on which the embryo was first so kept.

If a pre-commencement consent to the storage of gametes or an embryo expires at any time in the transitional period, the storage of the gametes or embryo for the remainder of that period is not unlawful merely because of that fact.

In sub-paragraph (1)—

This paragraph applies in relation to the storage of gametes or an embryo under a pre-commencement gamete or embryo storage licence where, immediately before the commencement day, there is no effective consent to the storage by a relevant person.

The person keeping the gametes or embryo in storage must request the relevant person to give consent to the storage under Schedule 3 to the 1990 Act.

A request under sub-paragraph (2) must be given before 1 July 2023 in writing.

The storage of the gametes or embryo at any time before the end of the transitional period is not unlawful merely because there is no effective consent to the storage by the relevant person.

In this paragraph—

• “effective consent” means consent under Schedule 3 to the 1990 Act which has not been withdrawn;

• “relevant person” means a person whose consent is required under Schedule 3 to the 1990 Act to storage of the gametes or embryo.

This paragraph applies in relation to the storage of gametes under a pre-commencement gamete storage licence where the statutory storage period applicable immediately before the commencement day was provided for by—

For the purposes of paragraph 11A of Schedule 3 to the 1990 Act (as inserted by paragraph 7 of this Schedule), paragraph 11B(1)(a) of that Schedule has effect as if the reference to the period of 10 years beginning with the relevant day were a reference to the period which—

This paragraph applies in relation to the storage of an embryo under a pre-commencement embryo storage licence where the statutory storage period applicable immediately before the commencement day was provided for by—

For the purposes of paragraph 11C of Schedule 3 to the 1990 Act (as inserted by paragraph 7 of this Schedule), paragraph 11D(1)(a) of that Schedule has effect as if the reference to the period of 10 years beginning with the day on which the embryo was first placed in storage were a reference to the period which—

This paragraph applies in relation to the storage of gametes under a pre-commencement gamete storage licence in a case where—

Where this paragraph applies, paragraph 11A of Schedule 3 to the 1990 Act has effect in relation to that first consent period as if—

This paragraph applies in relation to the storage of an embryo under a pre-commencement embryo storage licence in a case where—

Where this paragraph applies, paragraph 11C of Schedule 3 to the 1990 Act has effect in relation to that first consent period as if—