Health And Care Act 2022

Part 6: Miscellaneous

Pharmaceutical services

Section 161: Pharmaceutical services: remuneration in respect of vaccines etc

1117. Subsections (1) and (2) amend Section 164 of the NHS Act 2006 and Section 88 of the National Health Service (Wales) Act 2006 respectively to amend the powers that enable regulations to be made to establish different payment arrangements for special medicinal products (compared to other medicinal products) to include vaccines and immunisations, medicines or drugs used for preventing or treating pandemic or potential pandemic diseases, and associated products. The regulations could include, for example, calculation of remuneration by means of obtaining quotes, but most significantly, in practice, they could provide for circumstances where remuneration would not be provided, in particular where products were centrally procured.
1118. Subsection (1)(a) substitutes for "special medicinal products", previously the only type of product for which regulations could provide for different payment arrangements, a list comprising the following:
      • Drugs or medicines that can be used for the purposes of vaccination or immunisation of people against disease; and any products that may be used in connection with the supply or administration of such drugs or medicines.
      • Other drugs or medicines that may be used for preventing or treating a disease which at the time regulations are made the Secretary of State considers to be either a pandemic disease or at risk of becoming a pandemic disease; and anything used in connection with the supply or administration of such drugs or medicines.
      • A special medicinal product, which is an unlicensed medicinal product supplied as outlined in regulation 167 of the Human Medicines Regulations 2012.

1119. Subsection (1)(b) makes amendments consequential to the new list outlined in subsection (1)(a).
1120. Subsection (1)(c) removes the definition of special medicinal product from subsection (8E) of section 164 as this is now included in the list at new subsection (8A)(e).
1121. For England, subsection (1)(d) specifies that where regulations are made with respect to medicines or drugs that are used for preventing or treating a disease which the Secretary of State considers to be either a pandemic disease or at risk of becoming a pandemic disease the Secretary of State must revoke the regulations within such a period as the Secretary of State considers reasonable, once the disease to which the measures relate is no longer pandemic or at risk of becoming pandemic.
1122. Subsection (2) replicates subsection (1) provisions regarding England for Wales, by amendment of section 88 of the National Health Service (Wales) Act 2006. Explanations for subsections (2)(a)-(2)(c) are consistent with those for subsections (1)(a)-(1)(c) outlined above. The only exception is regarding (2)(d) where Welsh Ministers, rather than the Secretary of State, are responsible for deciding that what they consider a pandemic disease or a disease at risk of becoming a pandemic disease is no longer in this category, at which point measures relating to medicines or drugs used for preventing or treating the disease must be revoked within such period as the Welsh Ministers consider reasonable.

International Healthcare

Section 162: International Healthcare arrangements

1123. This section amends the Healthcare (European Economic Area and Switzerland Arrangements) Act 2019 ("HEEASAA") to enable the Government and the Devolved Authorities to implement comprehensive reciprocal healthcare agreements with countries outside the EEA and Switzerland.
1124. Subsections (1) and (7) change the title of the Healthcare (European Economic Area and Switzerland Arrangements) Act 2019 to the Healthcare (International Arrangements) Act 2019 (HIAA)so it is clear that the legal framework for implementing comprehensive healthcare arrangements in the Act is no longer restricted to arrangements with the EEA and Switzerland.
1125. Subsections (3) and (4) remove the wide power to make healthcare payments in section 1 HEEASAA and the power to make regulations in relation to healthcare and healthcare agreements in section 2 HEEASAA and replace them with a healthcare agreements and payments discretionary regulation-making power. The previous powers were created to support people to access healthcare in the EEA and Switzerland in the event of leaving the EU without an agreement. As the UK Government has now agreed social security coordination provisions covering healthcare in the EU in the Withdrawal Agreement and the Trade and Cooperation Agreement, these measures are no longer needed. The UK Government has also reached an agreement with Switzerland to continue reciprocal healthcare provisions.
1126. The amendments provide the Secretary of State (new section 2(1) HIAA) and the devolved authorities (new section 2A(1) HIAA) with a power to make regulations (subject to draft affirmative procedure) that make provision for the purpose of giving effect to a healthcare agreement, including provision about payments.
1127. The Secretary of State will also be able to make regulations for the payment of healthcare provided in another country where the healthcare is outside the scope of a healthcare agreement but only if the Secretary of State thinks the payment is justified by exceptional circumstances and the healthcare is provided in a country with which the UK has a healthcare agreement (new section 2(2) HIAA). This discretionary power, could, for example, be exercised to pay for a specific, urgent treatment which falls marginally outside the scope of an agreed healthcare agreement.
1128. New sections 2(4) and 2(5) HIAA set out certain provision that may be under the regulations. Section 2(4) states that regulations made under section 2 may include provision about administrative arrangements (including evidential requirements). Section 2(5) states that regulations made under new section 2 HIAA are capable of being used to confer or delegate functions to a "relevant public authority" (which is defined at new section 2(7) HIAA) and Scottish and Welsh health boards.
1129. New section 2A(2) and (4) HIAA describe the circumstances in which a devolved authority (defined in new section 2A(3) HIAA as the Scottish Ministers, Welsh Ministers and a Northern Ireland department) can use the power in section 2A(1) HIAA to make regulations. New section 2A(2) HIAA provides that a devolved authority may not make provision under section 2A(1) unless the provision is within the devolved authority’s competence. Devolved competence is defined at new section 2A(4) HIAA.
1130. Among other things, regulations made under new section 2A HIAA are capable of being used to confer or delegate functions to a "public authority" (section 2A(6) HIAA) which is defined at new section 2A(8) HIAA.
1131. New section 2B HIAA sets out that consent of a Minister of the Crown is required if a Devolved Authority is making a provision using the power in new section .2A HIAA and the provision, if contained in primary legislation made by the devolved legislatures, would require the consent of a Minister of the Crown. That could be where the relevant devolved legislature’s legislative powers were subject to a consent requirement, or where the devolved authority would normally require consent to make such a provision via secondary legislation. This requirement for consent will not apply if the devolved authority already has power to make such provision using secondary legislation without needing the consent of the Minister of the Crown.
1132. Subsection (5) amends the definition of "healthcare agreement" in section 3 of HIAA so that it is clear it includes any agreement regarding healthcare provided in another country or territory outside of the UK, whether payments are included in the agreement or not.
1133. Subsection (6) amends the regulations and directions section of HIAA (section 7) to reflect the existence of the new regulation-making powers and ensure that they are subject to the draft affirmative procedure.
1134. The territorial extent and application of this section is England and Wales, Scotland and Northern Ireland.

Social Care: Regulation and Financial Assistance

Section 163: Regulation of local authority functions relating to adult social care

1135. This section amends Chapter 3 of Part 1 of the Health and Social Care Act 2008. Subsection (3) inserts section 46A to the Health and Social Care Act 2008 to introduce a new duty for the CQC to review and make an assessment of the performance of English local authorities in their delivery of their adult social care functions under Part 1 of the Care Act 2014.
1136. Section 46A(1) will require the CQC to review local authorities’ undertaking of "regulated care functions" (prescribed adult social care functions under Part 1 of the Care Act 2014), assess their performance following such a review and then publish a report of its assessment.
1137. Section 46A(2) and (3) provide that the "regulated care functions" to be reviewed are to be set out in secondary legislation and may include all or an aspect of a function.
1138. The reviews undertaken by the CQC under new section 46A will be by reference to objectives and priorities set for the CQC by the Secretary of State under section 46A(4). Review by the CQC will be by reference to a set of quality indicators determined by the CQC and subject to the subsequent approval of the Secretary of State (section 46A(5)). Under section 46A(8) the CQC must devise a methodology for assessing and evaluating local authorities’ performance , and the frequency by which it will undertake its performance reviews, which it must then set out in a statement to be approved by the Secretary of State. The methodology can be varied according to the circumstances of the review.
1139. Upon approval by the Secretary of State, in accordance with section 46A(11) the CQC must then publish this statement. The CQC must also publish the objectives and priorities against which it is undertaking its reviews as set by the Secretary of State, and the quality indicators against which performance is to be assessed.
1140. The new review and performance assessment duty of the CQC will apply to "relevant English local authorities" who have duties and responsibilities to undertake adult social care functions, namely: county councils, district councils where there is no county council, London borough councils or the Common Council of the City of London. For the purposes of this section it is also specified in new section 46A(12) that the Council of the Isles of Scilly is included in this definition of "English local authority" only so far as references to local authority in Part 1 of the Care Act 2014 include references to the Council of the Isles of Scilly.
1141. Subsection (4) amends section 48 so that reviews under 46A are excluded from constituting a special review under that section.
1142. Subsection (5) amends section 50 of the Health and Social Care Act 2008, such that following a review of a local authority under Section 46A, there will be certain steps that the CQC may or must take when a local authority is considered by the CQC to be failing in the discharge of its adult social services functions. In accordance with the provisions in section 50, these steps are determined by whether the CQC considers the local authority is failing to discharge any of its adult social services functions to an acceptable standard.
1143. Subsection (6) amends section 60 of the Health and Social Care Act 2008, so that the CQC may carry out inspections of relevant English local authorities in relation to the exercise of their regulatory functions.

Section 164: Default powers of Secretary of State in relation to adult social care

1144. Subsection (1) amends Section 7D of the Local Authority Social Services Act 1970.
1145. Under section 7D of the Local Authority Social Services Act 1970, where the Secretary of State is satisfied that any local authority has failed – without a reasonable excuse – to comply with any of their duties that are social service functions (other than certain specified functions), the Secretary of State may make an order containing directions to the local authority for the purpose of ensuring the duty is complied with. Subsection (1) takes duties imposed by or under Part 1 of the Care Act 2014 out of scope of the powers conferred by section 7D.
1146. Subsection (2) makes provision to amend the Care Act 2014. Subsection (3) inserts sections 72A and 72B into the Care Act 2014.
1147. Under section 72A(1), where the Secretary of State considers that a local authority is failing, or has failed, to discharge its duties under Part 1 of the Care Act 2014 to an acceptable standard, the Secretary of State may issue directions to the local authority for the purpose of addressing the failure.
1148. Under section 72A(2), directions may:
      1. require the local authority to co-operate with advice given by the Secretary of State or their nominee;
      2. require the local authority to collaborate with the Secretary of State or their nominee in taking steps specified in the directions; or
      3. require the local authority to provide information required either by the Secretary of State or their nominee.
1149. Under section 72A(3), where necessary for addressing the failure, directions may provide for specified adult social care functions of the local authority to be carried out by the Secretary of State or their nominee.
1150. Under section 72A(7) the local authority may be required by the directions to financially remunerate the Secretary of State or their nominee for costs they have incurred as a consequence of the directions.
1151. In accordance with section 72A(4), where the Secretary of State or their nominee have taken over the running of adult social care functions under subsection (3), where appropriate a reference to a local authority in legislation or other documents is to be read as a reference to the Secretary of State or their nominee.
1152. In accordance with section 72A(5), where directions given under section 72A(3) expire or are revoked and not replaced, a reference in any instruments or other documents to the Secretary of State or their nominee is to be read as a reference to the local authority to whom the directions were issued.
1153. Under section 72A(6), where the Secretary of State has taken over the running of any adult social services following directions made under subsection (3), they may by regulations disapply or modify legislation which gives the Secretary of State a function in relation to a function of a local authority. For example, under section 40 of the Care Act 2014 the Secretary of State is responsible for resolving ordinary residence disputes. It may not be appropriate for the Secretary of State to perform this role if the Secretary of State is also exercising adult social care functions of one of the LAs involved.
1154. Section 72B makes supplementary provisions in relation to directions made under section 72A.
      1. The Secretary of State must give the local authority an opportunity to make representations on draft directions, except where the Secretary of State considers that for reasons of urgency it is not practical to do so (section 72B(1)).
      2. The Secretary of State may change or revoke the directions by issuing further directions (section 72B(2)). Where the Secretary of State considers variations not to be significant, the duty in subsection (1) to allow local authorities to make representations does not apply (section 72B(3)).
      3. The Secretary of State must issue directions to the local authority in writing (section 72B(4)). The Secretary of State must publish their directions, and the reasons for issuing them (72B(5)).
      4. The Secretary of State can seek to enforce directions by applying for a court order (section 72B(6)).
1155. Subsection (4) amends section 125(4) of the Care Act 2014 to provide for the procedure by which regulations made under section 72A(6) are made (draft affirmative).

Section 165: Care Quality Commission’s powers in relation to local authority failings

1156. This section amends section 50 of the Health and Social Care Act 2008 to provide that:
      1. The CQC is required to notify the Secretary of State wherever it identifies that a local authority is failing to discharge its duties to an acceptable standard, and to recommend next steps it considers the Secretary of State should take (subsection (2)).
      2. The CQC’s power to give a notice to a local authority where it considers the failure is not substantial is removed.
1157. This section also clarifies that CQC may specify failures and provide recommendations to the local authority in its reports (new subsection (3A) of section 50, as inserted by subsection (3)(b)).

Section 166: Cap on care costs for charging purposes

1158. Subsection (1) sets out that the Care Act 2014 is to be amended.
1159. Subsection (2) makes amendments to section 15 of the 2014 Act meaning the costs that accrue towards the cap on care costs are the costs the adult is required to pay (at the local authority rate) rather than the combined costs incurred by both the adult and the local authority.
1160. Section 15(2) and (3) of the 2014 Act is substituted by a new subsections (2) to (3B) to specify what costs incurred in meeting eligible care and support needs can count towards the cap on care costs:

• Where a local authority is meeting eligible needs, the amount the adult was required to pay accrues towards the cap, at a local authority determined rate, which is set out in a personal budget.
• Where a local authority is not meeting eligible needs, the rate of spend that accrues towards the cap will be set out in either an adult’s personal budget (section 26(2A)(a) of the 2014 Act) or an independent personal budget.

1161. The new subsection (3) confirms any reference to "eligible needs" does not include any eligible needs prior to when a Personal Budget or Independent Personal Budget is in place, other than the period of time between the individual making the request for the Personal Budget or Independent Personal Budget, or while it is being prepared, and it being put in place.
1162. The new subsection (3A) includes a new definition of the term "eligible needs" in section 15 of the 2014 Act and the new subsection (3B) is a new definition of "responsible local authority". Both of these definitions apply across Part 1 of the 2014 Act.
1163. Subsection (3) amends section 24 of the 2014 Act (the steps for the local authority to take) by substituting subsection (3) of that section, which sets out the steps to be taken by a local authority where none of an adult’s eligible care needs are being met by a local authority. This provides a duty for the responsible local authority to prepare an Independent Personal Budget, which is used to determine the rate the adult will accrues towards the cap.
1164. Subsection (4) amends section 26 (personal budget) of the 2014 Act to require specific information on the needs a local authority is meeting and how costs are apportioned and then charged to an adult, to be set out in a personal budget. If eligible needs are being met by a local authority, there is also a requirement for the personal budget to include the cost of meeting those needs at the local authority rate, how much the adult must pay towards that cost and any daily living costs, if appropriate. In addition, if the adult has other eligible needs which are not being met by a local authority, the local authority must include in the personal budget what the cost of meeting those needs would be at the responsible local authority’s rate and any daily living costs, if appropriate.
1165. Subsection (5) amends section 28 of the 2014 Act (independent personal budget) to provide that an independent personal budget specifies what the cost of meeting an adult’s eligible needs during a relevant period at the responsible local authority determined rate would be.
1166. Subsection (6) amends section 29 (care account) to prevent duplication and refer to the new definition of "responsible local authority", as inserted by subsection (2) of this section.
1167. Subsections (7) and (8) amend Section 31 (adults with capacity to request direct payments) and 32 (adults without capacity to request direct payments) of the 2014 Act respectively, to clarify that, where the personal budget includes both eligible needs to be met by the local authority and eligible needs that the local authority is not meeting (as provided for in the amendments to section 26 of the 2014 Act set out in subsection (4)), the request for a direct payment can only apply to those needs the local authority must or chooses to meet under section 24(1) of the 2014 Act.
1168. Subsection (9) amends section 37(15)(a) of the 2014 Act (notification, assessment etc.) to omit a definition of "eligible needs" as a new definition of "eligible needs" has been inserted for the purposes of Part 1 of the 2014 Act into section 15 of the 2014 Act by subsection (2) of this section.
1169. Subsection (10) inserts new locations of definitions for "eligible needs" and "the responsible local authority" into section 80 of the 2014 Act to aid interpretation of that Act.

Section 167: Provision of social care services: financial assistance

1170. This Section amends sections 149 to 153 of the Health and Social Care Act 2008 ("the 2008 Act").
1171. This section inserts new subsections (1A) and (1B) to section 149. These provisions set out a new power for the Secretary of State to provide financial assistance to any bodies engaged in the provision of social care services, or the provision of services connected with those social care services, if those social care services are provided in England.
1172. The section replaces section 153 of the 2008 Act, enabling the Secretary of State to direct certain bodies to exercise their functions to provide financial assistance to bodies engaged in providing social care and health services (or providing services connected with the provision of those services) under section 149(1) and new section 149(1A).
1173. The new section 153(3) also allows the Secretary of State to direct either a National Health Service trust or a Special Health Authority to exercise the power in section 149(2) to establish a qualifying body.
1174. Section 153(5) also allows the Secretary of State to issue directions to those using the power on his behalf about how exactly to conduct their exercise of these functions.
1175. The section also adds the new subsection (1A) to section 154. This allows the Secretary of State to make an arrangement with any third party other than a Special Health Authority for the powers under new section 149(1A) to be exercised on their behalf.

Professional Regulation

Section 168: Regulation of health care and associated professions

1176. This section amends sections 60 and 62 of and Schedule 3 to the Health Act 1999 and enables further changes to be made through secondary legislation to the professional regulation system.
1177. Subsection (2)(a) and (b) of this section amends section 60 by inserting new subsection (1)(bza) and (be) and permits a profession currently regulated to be removed from statutory regulation when the profession no longer requires regulation for the purpose of the protection of the public. This power extends to the regulation of social care workers in England, for whom the power to regulate in legislation is not currently enacted. Subsection (2)(c) substitutes a new subsection (2) into section 60 which provides an updated list of the legislation that regulates the professions and subsection (2)(d) inserts a new subsection (2ZZA) which clarifies that a healthcare profession within the scope of section 60 includes any group of workers, whether or not they are generally regarded as a profession, which may include senior managers and leaders. Subsection (2)(e) amends subsection (2ZB) of section 60 to make clear the new power to take professions out of regulation includes the currently un-enacted provisions concerning social care workers in England.
1178. Subsection (3) amends section 62 of the Health Act 1999 to require the consent of the Welsh Ministers to any provision in an Order in Council made by virtue of section 60(2ZZA) that is within the legislative competence of Senedd Cymru, and is not merely incidental to, or consequential on provision that would be outside of that competence.
1179. Subsection (4)(a) and (b) amends Schedule 3 to the Health Act 1999 (by inserting a new paragraph 1C and removing sub-paragraphs (1) and (1A) of paragraph 7) to permit the abolition of an individual health and care professional regulatory body, where the professions it regulates will continue to be regulated by another regulatory body or where the professions have been deregulated. This power includes the regulation of social care workers in England for which the power to regulate in legislation is not currently enacted.
1180. Previous restrictions on the power for health and care regulatory bodies to delegate their functions in Schedule 3, paragraph 8, through legislation are amended by subsection (4)(c) to enable the delegation of certain functions to another regulatory body. These functions are the keeping of a register; determining standards of education and training for admission to practice and providing advice about standards of conduct and performance; and carrying out the fitness to practise function. This will also apply to the regulation of social care workers in England, if the provisions concerning them are enacted. The intention is that the delegating regulator will retain responsibility for the delegated function in relation to the professions it continues to regulate.

Medical Examiners

Section 169: Medical Examiners

1181. This section makes a number of amendments to Part 1, Chapter 2 of the Coroners and Justice Act 2009 (Notification, certification, and registration of deaths) and an amendment to both the Births and Deaths Registration Act 1953 and the 2012 Act.
1182. Subsection (1) inserts sections 18A (Medical examiners: England) and 18B (Medical Examiners: Wales) into the Coroners and Justice Act 2009.
1183. Section 18A contains four subsections, 18A(1) to 18A(4).
1184. Section 18A(1) introduces a power for English NHS bodies to appoint medical examiners.
1185. Section 18A(2) introduces a duty on the Secretary of State to ensure that enough medical examiners are appointed in the healthcare system in England, that enough funds and resources are made available to medical examiners to enable them to carry out their functions of scrutiny to identify and deter poor practice, and to ensure that their performance is monitored.
1186. Section 18A(3) introduces a power for the Secretary of State to give a direction to an English NHS body in order to: require the body to appoint one or more medical examiners; set out the funds or resources that should be made available to such employed medical examiner; set out the means and methods that may be employed to monitor performance of medical examiners.
1187. Section 18A(4) defines English NHS body for the purposes of section 18A as:
      1. NHS England;
      2. an integrated care board;
      3. a NHS Trust;
      4. a Special Health Authority; or
      5. a NHS Foundation Trust.
1188. Section 18B contains three subsections, 18B(1) to 18B(3).
1189. Section 18B(1) introduces a power for Welsh NHS bodies to appoint medical examiners.
1190. Section 18B(2) introduces a duty on Welsh Ministers to ensure that enough medical examiners are appointed in the healthcare system in Wales, that enough funds and resources are made available to medical examiners to enable them to carry out their functions of scrutiny to identify and deter poor practice, and to ensure that their performance is monitored.
1191. Section 18B(3) defines a Welsh NHS body for the purposes of section 18B as:
      1. a Local Health Board;
      2. a NHS Trust; or
      3. a Special Health Authority.
1192. Subsection (2)(a) amends the heading of section 19 of the Coroners and Justice Act 2009 to "Medical Examiners: supplementary".
1193. Subsection (2)(b) removes subsections 19(1) and (2) of the Coroners and Justice Act 2009, which previously made provision for local authorities in England, and Local Health Boards in Wales, to appoint persons as medical examiners.
1194. Subsection (2)(c) amends section 19(5) of the Coroners and Justice Act 2009 to provide that nothing in sections 18A, 18B or 19 of that Act provides English or Welsh NHS bodies any role in relation to the way in which medical examiners exercise their professional judgment as medical practitioners.
1195. Subsection (3) amends section 20(5) of the Coroners and Justice Act 2009 (Medical certificate cause of death), which provides a power to make regulations requiring a fee to be payable in respect of the medical examiner’s confirmation of cause of death. The amendment will require any such fee to be payable to an English or Welsh NHS body.
1196. Subsection (4) amends Section 48(1) of the Coroners and Justice Act 2009 (Interpretation: general) to provide that the definition of a medical examiner is a person appointed under Section 18A or 18B.
1197. Subsection (5) amends section 41(1) of the Births and Deaths Registration Act 1953 to provide that the definition of medical examiner in that Act has the same meaning as section 48(1) of the Coroners and Justice Act 2009.
1198. Subsection (6) amends the 2012 Act removing the provision which inserted references to English local authorities initially into the Coroners and Justice Act 2009.

Organ trafficking

Section 170: Commercial dealings in organs for transplantation: extra-territorial offences

1199. This section inserts new section 32A into the Human Tissue Act 2004 and new section 20A into the Human Tissue (Scotland) Act 2006, to extend the prohibition of commercial dealings in human material for transplantation to acts done outside of the UK when the material concerned is a human organ and when the act is committed by a person who is habitually resident in England, Wales or Scotland or is a UK national who is not habitually resident in Northern Ireland.
1200. The section makes it an offence to pay for the supply of an organ, pay for an offer to supply an organ, or seek somebody willing to supply an organ for payment anywhere in the world. It would also make it an offence to supply, or offer to supply, an organ for payment anywhere in the world. This includes initiating or negotiating any arrangement involving the giving of a reward for the supply of, or for an offer to supply, an organ, and taking part in the management of a body that does so.

Human Fertilisation and Embryology

Section 171: Storage of gametes and embryos

1201. This section introduces a Schedule relating to the storage of gametes and embryos. New section 171 introduces Schedule 17. Part 1 of Schedule 17 amends section 14, section 17, and section 47 of, and Schedule 3 to, the Human Fertilisation and Embryology Act 1990 (the "1990 Act").

Schedule 17: Storage of gametes and embryos

1202. Paragraph 2(3) of Schedule 17 substitutes section 14, subsections (3) to (5), of the 1990 Act to clarify the new maximum statutory storage period for gametes and embryos.
1203. New subsection (3)(a) and 3(b) of section 14 of the 1990 Act state that the maximum statutory storage period is 55 years for gametes and embryos to be used in fertility treatment.
1204. New subsection (3)(c) sets out that embryos that are to be used in research or for training purposes but not for treatment purposes can only be kept in storage for a maximum of 10 years. The 10-year period will start on the day that the embryo was first placed into storage for research or training purposes, or on the day that consent was provided specifically for storage for research or training purposes, if the materials have been in storage for alternative purposes (such as treatment) previously.
1205. New subsection (3)(d) states that the maximum storage limit of 10 years will also apply to human admixed embryos. Admixed embryos are embryos which contain both human and animal DNA. The creation of admixed embryos has been allowed since the 2008 Act; however, their use is restricted to research only. Admixed embryos are only allowed to be kept for up to 14 days from the day on which the process of creating the human admixed embryo began or until the appearance of the primitive streak, whichever comes first. This is consistent with the time limits for keeping human embryos in vitro for research purposes. The research use of admixed embryos to date has been limited and it was determined that there is no reason to change the maximum storage limit for admixed embryos.
1206. The substitution made by paragraph 2(3) of Schedule 17 to section 14(3) to (5) of the 1990 Act also removes the regulation making power previously set out in section 14(5) of the 1990 Act, so that the Secretary of State is no longer able to change gamete and embryo storage limits by way of regulations. This means that the Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) Regulations 2009 (the "2009 Regulations") and the Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) (Coronavirus) Regulations 2020 (the "2020 Regulations"), no longer apply following commencement of these provisions on 1 July 2022. Consent provided for the storage of material under these two sets of Regulations before they are revoked will remain effective. The 2009 Regulations allowed those who were classed as "prematurely infertile" to extend the storage limit for ten-year periods up to a maximum of 55 years. The 2020 Regulations allowed an additional two-year storage on top of the maximum base limit of ten years for those with material in storage on 1 July 2020. This was introduced as a response to the COVID-19 pandemic, which resulted in the closure to fertility clinics and ongoing delays to fertility treatments.
1207. The new subsection (5) inserted into section 14 of the 1990 Act sets out the definitions of "treatment purposes", "training purpose", and "research purpose" for the purposes of that section.

Disposal of material

1208. Paragraph 5 inserts a new paragraph (ca) following section 14(1)(c) of the 1990 Act to make clear that storage facilities must dispose of gametes and embryos when storage is no longer lawful. This insertion also modernises the language of the 1990 Act. A similar update was made to section 17(1)(c) by Paragraph 6.

Consent to storage

1209. Paragraph 7(1), (2), and (3) of Schedule 17 amends Schedule 3, paragraph 1 of the 1990 Act so that where consent to 10 year’s storage is renewed, that renewal must be in writing and must be signed by the person giving consent, unless there are specific exemptions in place.

Renewal of consent to storage of gametes

1210. Paragraph 7(4) inserts new paragraphs 11A to 11D into Schedule 3 to the 1990 Act. The new paragraphs 11A and 11B specify the requirement for 10-year review periods and consent renewals as a condition to continue the storage of gametes up to the maximum of 55 years. These new requirements will need to be complied with as a condition of any storage licence granted under the 1990 Act by facilities storing gametes.
1211. Paragraph 11A applies the renewal requirements to people who are storing their gametes for the purposes of their treatment alone or with a partner, including for the purposes of surrogacy arrangements. The facility storing the gametes must attempt to contact the person storing their gametes 1 year in advance of expiry of any 10-year storage period and request that consent for ongoing storage is renewed. If the person whose gametes are in storage does not renew their consent, then their consent may be taken as withdrawn after certain requirements have been met. The facility must then attempt to contact the person storing their gametes on or around the date of expiry to tell them that their storage period has come to an end. If the gamete provider does not provide renewed consent, the facility must dispose of the gametes 6 months following the expiry of consent to store. This is effectively a "cooling off" period to allow for disposal.
1212. Paragraph 11A(9) provides for a 10-year grace period for storage, if a person storing their gametes dies. This provision will only apply if consent to posthumous storage and use is in place prior to the individual’s death, in which the person storing their gametes specifies that their partner can use their gametes in treatment posthumously. The surviving partner will need to provide a death certificate to validate the storage extension and enable use of the gametes in their treatment. This will be a one-off extension of 10-years calculated from the date of death of the gamete provider. If at the end of the 10-year grace period the deceased person’s gametes are still in storage, the storage facility must dispose of them.
1213. Paragraph 11A(10) to (12) provides for a 10-year grace period, if a person storing their gametes becomes incapacitated. This provision will only apply if consent is in place prior to the incapacitation in which the person storing their gametes specifies that their partner can use their gametes in treatment in the event the person loses capacity. For the 10-year period to apply, a registered medical practitioner must certify that the person does not have capacity and that they are unlikely to regain it. The 10-year grace period would apply from the date of the medical professional’s certification. If the person storing their gametes regains capacity within the 10-year grace period, then they will be able to renew their consent and continue storage as before. If at the end of the 10-year grace period the incapacitated person’s gametes are still in storage, and they have not regained capacity or not informed the storage facility that they had, then the storage facility must dispose of the gametes.
1214. The renewal of consent requirements set out in paragraph 11A do not apply to donated gametes stored for the treatment of others.
1215. Paragraph 11B sets out the definitions for terms used in paragraph 11A including of a "consent period", the "relevant day", the "renewal period", and what is meant by persons "lacking capacity" respectively. Paragraph 11B(8) allows provisions relating to capacity to be interpreted in line with the Scottish definition of incapacity, where persons are undergoing treatment in Scotland.

Renewal of consent to storage of embryos

1216. Paragraph 11C (Renewal of consent to storage of embryos) applies to people who are storing their embryos, created in vitro, for the purposes of their treatment or that of a partner, including for the purposes of surrogacy arrangements. This paragraph applies in the same way as paragraph 11A, subject to the exception that both gamete providers must provide consent to storage, and the facility storing the material must contact both persons whose gametes have been used to produce the embryo, in order to renew consent, unless one set of gametes is provided by a third-party donor. If either of the gamete providers fail to renew their consent before the 6 months after the consent expires, subject to certain requirements, consent for storage will be taken as withdrawn and the facility must dispose of the embryo(s) following another 6 months cooling off period.
1217. The renewal of consent requirements set out in paragraph 11C do not apply to donated embryos stored for the treatment of others.
1218. Paragraph 11C(9) provides for a 10-year grace period, if a person storing their embryos dies, to the same effect as paragraph 11A(9).
1219. Paragraph 11C(10) to 11C(12) provides for a 10-year grace period, if a person storing their embryos becomes incapacitated, to the same effect as paragraph 11A(10) to 11A(12).
1220. Paragraph 11D contains relevant definitions and interpretations rules, similar to paragraph 11B.

Part 2 of Schedule 17

1221. Part 2 of new Schedule 17 contains paragraphs 8 to 18 of which set out the transitional provisions. Paragraph 8 sets out the definitions for terms used in this Part of this Schedule, including "the commencement day" and the "transitional period".

Application of Part 1 to material already in storage

1222. Paragraphs 9 and 10 stipulate that the new provisions will apply to pre-commencement licences if the gametes or embryos are still stored at commencement. The new requirement for 10-year renewal periods will apply to gametes and embryos that were stored pre-commencement.
1223. As set out in Paragraph 9(2) the new provision will not however apply to embryos already in storage on the commencement day (1 July 2022), which are stored for the purposes of research or training only, and not for treatment purposes. These embryos will continue to be stored lawfully until the end of their statutory storage period as set out in the 1990 Act.

Date of first storage

1224. Paragraph 11 applies to rare cases, where the gametes or embryos are stored under a pre-commencement licence and where, at the end of the transitional period, the storage facility has taken all "reasonable steps" to establish the date on which the material first went into storage but was unable to establish that exact date. In these instances, the storage facility can provide the gamete or embryo provider(s) with a new date from which the statutory storage period will continue to be calculated from.

Storage periods specified in pre-commencement storage licences

1225. Paragraph 12 provides that for any gametes and embryos in storage under pre-commencement licence under the 1990 Act, the period of 55 years began on the day on which the gametes or embryos were first entered into storage. For example, if a person stored their gametes for the first time on the 5 July 2014 then their maximum statutory storage period of 55 years would be calculated from that date. They would then be able to lawfully store their gametes, containing the 10-year renewal periods, until the 4 July 2069. These provisions do not apply to embryos in storage for the purposes of research or training only.

Storage after expiry of pre-commencement consent

1226. Paragraph 13 sets out that if gametes or embryos are in storage on pre-commencement licences, under the 1990 Act, and the consent expires during the transitional period, then they will not be automatically treated as being stored unlawfully. This will allow clinics time to implement the new system and contact patients regarding future consent during the transitional period without risk of unlawful storage.

Storage with no effective consent prior to commencement

1227. Paragraph 14 applies to gametes and embryos in storage under pre-commencement licences, where immediately before the commencement day (1 July 2022), there is no effective consent in place. In these cases, the storage facility must request the person whose gametes or embryos are in storage to provide consent. The request must be given in writing by the 1 July 2023, a year from the commencement date. The gamete provider will have the remainder of the transition period, until the 1 July 2024, to provide their consent for ongoing storage. During this period, the gametes or embryos in storage will not be treated as being stored unlawfully.

Time for first renewal of consent

1228. Paragraphs 15 and 16 apply to gametes and embryos in storage either under the 2009 Regulations or the 2020 Regulations. These paragraphs specify that the 10-year consent renewal date will be 10-years following the beginning of the relevant statutory storage period. The consent renewal date is calculated from whenever the old statutory storage period was due to expire. For example, for gametes stored under the 2009 Regulations, a medical professional’s opinion would have been required every 10-years for the gametes to continue to be stored lawfully. Therefore, a new 10-year consent period would start following the date of expiry of the most recent 10-year period, as certified by a medical professional. For gametes or embryos stored under the 2020 Regulations, consent would have to be renewed following expiry of consent given under the 2020 Regulations.

Renewals falling due in the transitional period

1229. Paragraphs 17 and 18 apply to gametes or embryos stored under Schedule 3 of the 1990 Act for which the first 10-year renewal period ends within the transitional period. For these cases, the facility storing the gametes or embryos must contact the person storing their gametes or embryos before 1 July 2023 and consent must be secured in writing before 1 July 2024. If consent is not renewed by this time, then the gametes or embryos must be removed from storage and disposed of.

Food and Drink

Section 172: Advertising of less healthy food and drink

• This section inserts Schedule 18, which amends the Communications Act 2003 to restrict the advertising of certain food and drink products. This schedule is divided into three main paragraphs:
  • Paragraph 1: the watershed prohibition as it applies to Television
  • Paragraph 2: the watershed prohibition as it applies to ODPS under UK jurisdiction
  • Paragraph 3: the paid-for prohibition as it applies online
  • Paragraphs 4 to 6 then make consequential amendments needed to the Communications Act 2003

Schedule 18: Advertising of less healthy food and drink

Part 1: Programme services: Watershed

Paragraph 1: Television programme services

1230. Paragraph 1 of Schedule 18 inserts new section 321A into the Communications Act 2003.
1231. Subsection (1) of the new section 321A requires OFCOM to set standards to prohibit the advertising of identifiable less healthy food and drink products on television programmes between 5.30 a.m. and 9 p.m., and subsection (2) confirms this must take effect from the beginning of 1 January 2023. Subsection (6) gives the Secretary of State the power to amend the date in subsection (2) to a later date.
1232. Subsection (3) sets out that the prohibition must not apply to advertisements by food or drink small and medium sized enterprises ("SMEs"); and any advertisements exempted in any regulations made by the Secretary of State.
1233. Subsection (4)(a) confirms that "advertisements" include those under sponsorship agreement and, for the purpose of these restrictions, sponsorship credits around television programmes. Products are "identifiable" if a person could reasonably be expected to identify the advertisements as being for that product (subsection (4)(b)). Products are determined to be "less healthy" via a two stage approach (subsection (4)(c)). They first need to be included in one of the product categories that will be set out in regulations, then the "relevant guidance"- the "Nutrient Profiling Technical Guidance1" will need to be applied. Subsection (7) confirms that the Secretary of State may amend the definition of "relevant guidance" through regulations. Subsection (4)(e) also defines "food or drink SME" as meaning a small or medium enterprise as defined in regulations and subsection (5) allows that definition to include staff of another person.
1234. Subsection (8) states that before the Secretary of State can make any regulations for additional exemptions under subsection (3)(b) or amend the relevant guidance under subsection (7) they are under a duty to consult. Subsection (9) confirms that any changes made to the definition of "relevant guidance" in regulations must be subject to the draft affirmative procedure.

Paragraph 2: On-demand programme services

1235. Paragraph 2 inserts a new section 368FA in the Communications Act 2003.
1236. Subsection (1) of new section 368FA, from the beginning of 1 January 2023, introduces a restriction on the advertising of less healthy food and drink on on-demand programme services between 5.30 a.m. and 9 p.m. Subsection (6) gives the Secretary of State the power to amend the date in subsection (1) to a later date.
1237. Subsection (2) states that the prohibition will not apply to advertisements by food or drink SMEs.
1238. Subsection (3) provides that further exemptions to the prohibition may be made by regulations by the Secretary of State.
1239. Subsection (4) confirms that "advertisements" include those under sponsorship agreement and, for the purpose of these restrictions, sponsorship announcements. Products are "identifiable" if a person could reasonably be expected to identify the advertisements as being for that product. Products are determined to be "less healthy" via a two stage approach. They first need to be included in one of the product categories that will be set out in regulations, then the "relevant guidance", the "Nutrient Profiling Technical Guidance2", will need to be applied. Subsection (7) states that the Secretary of State may amend the definition of "relevant guidance" through regulations. Subsection (4)(e) also defines "food or drink SME" as meaning a small or medium enterprise as defined in regulations and subsection (5) allows that definition to include staff of another person.
1240. Subsection (8) states that before the Secretary of State can make any regulations for additional exemptions under subsection (3) or amend the meaning of "relevant guidance" under subsection (7), they are under a duty to consult. Subsection (8) confirms that any changes made to the definition of "relevant guidance" in regulations must be subject to the draft affirmative procedure.

Part 2: Online Services: Prohibition

1241. Paragraph 3 inserts Part 4C Online advertising of less healthy food and drink into the Communications Act 2003, after Part 4B. Part 4C comprises Sections 368Z14 through to 368Z21.

368Z14 Prohibition of paid-for advertising of less healthy food and drink

1242. Subsection (1) prohibits paid-for advertising of identifiable less healthy food and drink online from 1 January 2023.
1243. Subsection (2) confirms that the prohibition does not apply to advertisements by food or drink SMEs. Subsection (3) confirms that the prohibition does not apply to business-to-business advertisements. This subsection also exempts: advertisements that are included in UK regulated on-demand programme services as these fall into the watershed prohibition, advertisements in regulated radio services, and advertisements that are not intended to be accessed principally by a UK audience.
1244. Subsection (4) provides that further exemptions to the prohibition may be made by regulations by the Secretary of State in order to keep up with developments in technology and changes in the industry to this policy as it develops.
1245. Subsection (5) confirms that "payment" includes monetary or non-monetary exchange when in reference to placing advertisements on the internet. "Placed" includes continued to be placed. "Advertisements" include those under sponsorship agreement. Products are "identifiable" if a person in the UK could reasonably be expected to identify the advertisements as being for that product. Products are determined to be "less healthy" via a two-stage approach. They first need to be included in one of the product categories that will be set out in regulations, then the "relevant guidance"- the "Nutrient Profiling Technical Guidance3" will need to be applied. Subsection (8) confirms that the Secretary of State may amend the definition of "relevant guidance". Subsection (5) also defines "food or drink SME" as meaning a small or medium enterprise as defined in regulations and subsection (6) allows that definition to include staff of another person. Likewise, subsection (5) states that regulated radio services will be given meaning by regulations. Subsection (7) gives the Secretary of State the power to amend the date in subsection (1) to a later date and to make corresponding amendments to subsections (11) and (12).
1246. Subsection (9) confirms that before the Secretary of State can make any regulations for additional exemptions under subsection (4) or amend the definition of relevant guidance under subsection (8) they are under a duty to consult. Subsection (10) confirms that changes to made to the definition of relevant guidance through regulations made under subsection (8) must be subject to the draft affirmative procedure.
1247. Subsection (11) confirms that from 1 August 2021 any paid online advertising of less healthy food or drink to be placed online on or after 1 January 2023 amounts to a breach of the prohibition. Subsection (12) confirms that subsection (11) does not apply if arrangements are put in place and reasonable action is taken to remove the advert before 1 January 2023.

368Z15 Enforcement

1248. Subsection (1) details that when the appropriate regulatory authority considers a person is contravening or has contravened the prohibition of paid-for advertising on the internet (section 368Z14), they may give the person an enforcement notification and/or impose a financial penalty on them in accordance with the financial penalties detailed in section 368Z16.
1249. Subsection (2) confirms that action outlined in subsection (1) cannot occur unless there are reasonable grounds for believing that a breach of the prohibition is occurring or has occurred and that the appropriate regulatory authority has allowed the person considered in breach an opportunity to make representations.
1250. Subsection (3) confirms that enforcement notifications should specify how a person has breached the prohibition, impose requirements on the person to take steps to remedy the breach, provide a reasonable amount of time for a person to remedy and set out the reasons for the appropriate regulatory authority’s decision to issue the enforcement notification.
1251. Subsection (4) confirms that remedial actions dictated by the appropriate regulatory authority may include instructing or requesting that specified persons remove advertisements from the internet and/or arranging for advertisements to be modified in specific ways.
1252. Subsection (5) states that a person in receipt of an enforcement notification must comply with it. Subsection (6) outlines that the duty under subsection (5) is enforceable in civil proceedings (i.e. through the civil court) by the appropriate regulatory authority. Subsection (7) confirms that in circumstances of non-compliance with enforcement notifications, the appropriate regulatory authority can impose financial penalties as detailed in section 368Z16.

368Z16 Financial penalties

1253. Subsection (1) outlines the financial penalty imposed on a person is as the appropriate regulatory authority determines to be appropriate and proportionate to the scale of the breach. The maximum penalty on a relevant business is such amount not exceeding the greater of 5% of the turnover of the relevant business for the relevant period or £250,000. In any other case it is £250,000.
1254. Subsection (3) confirms that a person’s "relevant business" is any business carried on by the person which involves or is associated with the manufacture or sale of less healthy food or drink. "Relevant period", means the period of one year ending the 31 March before the time at which the penalty is imposed. However in the case that the person has been carrying on that business for less than a year the relevant period is the time during which the business has been carried on, and if a business has ceased to operate when the penalty is imposed, then the relevant period is one year ending with the time the business ceased to operate. This subsection also outlines that the turnover of a relevant business should be calculated in accordance with UK accounting practices. If the relevant business consists of two or more undertakings, then the turnover for each is combined.
1255. Subsection (4) confirms that to determine the applicable financial penalty under subsection (1) the appropriate regulatory authority must have regard to statements published by OFCOM under section 392 of the Communications Act 2003 (the guidelines to be followed in determining the amount of penalties).
1256. Subsection (5) outlines that the financial penalty imposed under this section, if not paid within the relevant period, can be recoverable by the appropriate regulatory authority as a debt from the person obliged to pay it. Subsection (6) details that if a financial penalty is imposed under this section that has a connection with Northern Ireland and no connection with the rest of the United Kingdom, the penalty must be paid into the Consolidated Fund of Northern Ireland, but in any other case, a financial penalty imposed under this section is to be paid into the Consolidated Fund of the United Kingdom as described in subsection (7).

368Z17 Power to demand information

1257. Subsection (1) allows the appropriate regulatory authority to give a person a notice demanding information, for the purpose of carrying out their functions under this new Part 4C. Subsection (2) confirms that they may demand any information that the person appears to have or be able to generate. Under subsection (3) notices must describe the required information, fix a reasonable period for the information to be provided and set out the appropriate regulatory authority’s reasons for requiring it. Subsection (4) details that a notice under this section may specify the manner in which the information is to be provided.
1258. Subsection (5) states that the appropriate regulatory authority may not request information under this section unless they have given the person from whom it is required an opportunity to challenge the grounds for the request. Subsection (6) outlines that the enforcement mechanisms outlined in Section 368Z15 apply in relation to a failure to comply with a demand for information. Subsection (7) confirms that "information" includes copies of advertisements.

368Z18 Guidance

1259. Subsection (1) confirms that the appropriate regulatory authority must draw up and, from time to time, review and revise, guidance relating to the online advertising prohibition. Subsection (2) places a requirement for them to consult the Secretary of State before drawing up or revising the guidance, and in subsection (3) they must ensure any guidance is brought to the attention of those who will be affected by it.

368Z19 The Appropriate Regulatory Authority

1260. Subsection (1) allows OFCOM to designate their function as the appropriate regulatory authority to a body for the purposes of any provision in respect of the online advertising prohibition. "Designation" means the act of specifying an appropriate regulatory authority (subsection (12)). Subsection (9) outlines the requirements for a body to be designated.
1261. Subsection (2) confirms that if OFCOM do not designate, that they (OFCOM) will be the appropriate regulatory authority. If a body is designated then subsection (3) allows OFCOM to act as the appropriate regulatory authority for that purpose concurrently with or in place of that body. Subsection (4) allows OFCOM to provide a designated body with assistance (including financial assistance) in connection with any of the functions of the body under this Part.
1262. Subsections (5) and (6) outline the designation framework to appoint a body as the appropriate regulatory authority. Subsection (7) states that a designation is effective for a period specified by OFCOM and may be revoked by OFCOM at any time. Subsection (8) says OFCOM must publish any designation so that it is brought to the attention of people who are likely to be affected by it. Subsection (10) allows OFCOM to provide and share information to a designated body if it relates to their functions as the appropriate regulatory authority and vice versa. Subsection (11) allows the appropriate regulatory body to carry out, commission or support (financially or otherwise) research where related to their functions.

368Z20 Power to amend this Part to extend prohibition

1263. Subsection (1) gives the Secretary of State the power to amend the new Part 4C for the purpose of broadening the scope of restrictions to prohibiting persons from placing on the internet advertisements for an identifiable less healthy food or drink product and/or making arrangements for advertisements for an identifiable less healthy food or drink product to be placed on the internet. Subsection (2) defines "placing" as including leaving in place and "placed" as including continuing to be placed.
1264. Subsection (3) allows the power detailed in subsection (1) to repeal, revoke or amend a provision made by or under any of the following whenever passed or made-
      • an Act;
      • an Act of the Scottish Parliament;
      • a Measure or Act of Senedd Cymru;
      • Northern Ireland legislation.

1265. Subsection (4) sets a requirement to consult before making regulations under subsection (1) and subsection (5) sets a requirement for a statutory instrument containing regulations under subsection (1) to be subject to the draft affirmative procedure.

368Z21 Interpretation

1266. This Part outlines that the "appropriate regulatory authority" is to be construed in accordance with section 368Z19; and that "less healthy", in relation to a food or drink product, has the meaning given by section 368Z14(5)(e). Products are determined to be "less healthy" via a two stage approach. They first need to be included in one of the product categories that will be set out in regulations, then if they meet the description set out in regulations the "relevant guidance", the "Nutrient Profiling Technical Guidance4", will need to be applied.

Part 3: Consequential Amendments

1267. These paragraphs make amendments to the Communications Act 2003 to ensure that the new parts detailed in this Act are in line with the rest of the 2003 Act.
1268. It requires section 368C of the Communications Act 2003 to be updated to include a requirement on the appropriate regulatory authority to draw up, review and revise guidance on section 368FA (the restriction for On-demand programme services) and for there to be a requirement to consult the Secretary of State before drawing up this guidance.

Section 173: Hospital Food Standards

1269. Section 20 of the Health and Social Care Act 2008 provides the Secretary of State with a general power to make regulations imposing any requirements to be met by providers and managers of regulated activities that he sees fit in relation to regulated activities. The regulations made may, in particular, include provision intended to safeguard the health, safety and welfare of people who receive regulated health care, and to ensure that those services are of the necessary quality.
1270. This section introduces new section 20(3)(da) to the Health and Social Care Act 2008 and allows the Secretary of State to make regulations as he sees appropriate to impose requirements in connection with food or drink provided or made available to any person on hospital premises in England that are used in connection with the carrying on of a regulated activity. Such requirements include the power to specify nutritional standards, or other nutritional requirements, such as to specify descriptions of food or drink that are not to be provided or made available.
1271. Paragraph (a) amends subsection (3) of section 20 of the Health and Social Care Act 2008 to introduce a new paragraph (da) which gives the Secretary of State a power to impose requirements in relation to food or drink provided or made available to any person on hospital premises in England that are used in connection with carrying on a regulated activity.
1272. Paragraph (b) inserts a new subsection (4A) into section 20 of the Health and Social Care Act 2008 to specify that regulations made in relation to food and drink under the new subsection (3)(da) may be in relation to specific nutritional standards or other nutritional requirements, and may require that specified descriptions of food or drink are not to be provided or made available .
1273. Paragraph (c) sets out that the definition of hospital for the purposes of this section is defined in section 275 of the NHS Act 2006 which states:
      • "hospital" means:
      • any institution for the reception and treatment of persons suffering from illness,
      • any maternity home, and
      • any institution for the reception and treatment of persons during convalescence or persons requiring medical rehabilitation,
      • and includes clinics, dispensaries and out-patient departments maintained in connection with any such home or institution, and "hospital accommodation" must be construed accordingly.

1274. The Secretary of State is obliged to consult on any regulations made or any significant changes to existing regulations as required under subsection (8) of section 20.
1275. Section 162 of the Health and Social Care Act 2008 sets out the parliamentary scrutiny for regulations made under section 20. Any regulations made under subsection (3)(da) of section 20 will be subject to those requirements.

Section 174: Food information for consumers: power to amend retained EU law

1276. This section introduces new section 16(3A) and (3B) to the Food Safety Act 1990 and allows the Secretary of State (in relation to England) and Ministers in Scotland (in relation to Scotland) and Ministers in Wales (in relation to Wales) to amend by regulations pursuant to section 16(1)(e) requirements set out in retained direct principal EU legislation, Regulation (EU) No. 1169/2011 relating to food information and labelling. Section 16(1)(e) outlines which matters the regulations made under the power in this subsection may concern. For example, regulating, labelling, marking, presenting or advertising of food, and the descriptions which may be applied to food.
1277. Subsection (2) of the section amends section 48 of the Food Safety Act 1990 and relates to Parliamentary scrutiny for regulations made under section 16(1)(e) and 16(3A) of the Food Safety Act 1990. Subsection 48 is amended to state that any regulations made in reliance of section 16(3A) will be subject to the affirmative procedure.

Fluoridation of Water Supplies

Section 175: Fluoridation of water supplies

1278. This section amends certain provisions of the Water Industry Act 1991 to remove the power of local authorities to initiate new water fluoridation schemes or make variations or to terminate to existing schemes in England, and to confer that power instead on the Secretary of State.
1279. Subsection (2) amends section 87 of the Water Industry Act 1991. It inserts a new enabling power (section 87(6A)) allowing the Secretary of State to disapply, through regulations, the existing provisions in section 87(6) which require the Secretary of State to reimburse water undertakers for capital and operating costs for operating fluoridation schemes. As provided by the new section 87(12), the affirmative resolution procedure must be used to make such regulations. New section 87(6B) enables the Secretary of State to make regulations (subject to the negative procedure) requiring public sector bodies to make payments to the Secretary of State to meet water fluoridation costs. New section 87(7G) imposes on the Secretary of State a duty to consult before making regulations under either new section 87(6A) or section 87(6B).
1280. Subsection (2) also amends section 87(11) of the Water Industry Act 1991 so as to require the Secretary of State to consult water undertakers (water companies who provide water and sewerage services for general domestic use to UK homes) on whether any fluoridation scheme, or variation or termination to an existing scheme is operable and efficient, prior to undertaking any consultation required by section 89 of the Act.
1281. Subsections (3) and (4) make the necessary amendments to remove the local authorities’ power to initiate, vary or terminate schemes in England, with subsections (6) and (8) making amendments consequential upon those changes.
1282. Subsection (5) makes changes to section 89 of the Water Industry Act 1991 so that it applies to both England and Wales (rather than just Wales, as currently). The effect of these amendments is to require the Secretary of State to consult on any proposals for new fluoridation schemes or proposals to vary/terminate existing schemes. There is an existing regulation making power in section 89 which, as applied to England, will enable the Secretary of State to make regulations to provide further detail on the process and requirements of any consultation (including circumstances where consultation is not required).
1283. Subsections (7) and (9) deal with the regulation making powers under the amended provisions, subsection (7) providing that regulations under the new section 87(6A) will be subject to the affirmative resolution procedure, and subsection (9) providing that the first exercise of the power to make regulations under section 89 (as amended) will be subject to the affirmative resolution procedure.

Section 176: Fluoridation of water supplies: transitional provision

1284. This section inserts new transitional provisions into the Water Industry Act 1991 in relation to England. They provide to the Secretary of State for Health and Social care the power to require water undertakers to enter into updated water fluoridation arrangements where the Secretary of State considers it necessary to render the arrangements fit for purpose. This section also amends section 91 of the Water Industry Act 1991 so that it applies only to Wales, maintaining the current position for transitional provisions in relation to Wales and any Welsh fluoridation arrangements.

Section 177: review into disputes relating to treatment of critically ill children

1285. This section requires the Secretary of State to commission a review of the causes of disputes relating to the care of critically ill children between the providers of care and persons with parental responsibility, how these disagreements can be avoided and how we can sensitively handle their resolution. This will provide evidence-based recommendations to support the creation of healthcare environments that foster good, collaborative relationships between parents and healthcare staff.
1286. The Secretary of State must publish and lay before Parliament a report on the outcome of the review within one year.

Section 178: Early medical termination of pregnancy

1287. Section 178 amends section 1 of the Abortion Act 1967 to make provision for early medical termination of pregnancy to add to the places where treatment for the termination of pregnancy may be provided.
1288. Section 178 inserts new subsections (3B) to (3C) into section 1 of the Abortion Act 1967. Subsection (3B) sets out the circumstances in which subsections (3C) and (3D) apply. The treatment for the termination of pregnancy must be the prescription and administration of medicine, and the registered medical practitioner "RMP" terminating the pregnancy must be of the opinion, formed in good faith, that the pregnancy will not exceed ten weeks at the time when the medicine is administered. If the medicines known as Mifepristone and Misoprostol are prescribed, the pregnancy should not exceed ten weeks when the Mifepristone is administered in accordance with the instructions of the RMP.
1289. In these circumstances, new subsection (3C) provides that an RMP whose usual place of residence is in England or Wales may prescribe the medicine or medicines from their home.
1290. New subsection (3D) provides that a pregnant woman whose usual place of residence is in England or Wales, having had a consultation with an RMP, registered nurse or registered midwife about the termination of the pregnancy, may self-administer the medicine or medicines at home.

Child Safeguarding: Information Sharing

Section 179: Child Safeguarding: Information Sharing

1291. This section requires the Secretary of State to publish and lay before Parliament, within one year of commencement of the section, a report describing the government’s policy in relation to information-sharing by or with public authorities in the exercise of children’s health and social care functions in England, for purposes relating to children’s health or social care or the safeguarding or promotion of the welfare of children. The section will commence three months after Royal Assent. Subsections (3) and (4) set out certain matters which must be covered in the report.

Section 180: Licensing of cosmetic procedures

1292. The current legal framework relating to non-surgical cosmetic procedures is found in various existing legislation. The Local Government (Miscellaneous Provisions) Act 1982 allows local authorities to make provision for the registration of certain cosmetic treatments, including cosmetic piercing, electrolysis, tattooing, semi-permanent make up and acupuncture. However, registration is a very simple process, there is no requirement for the provision of proof of qualifications, and local authorities have few powers to refuse registration.
1293. Some local authorities have made byelaws to regulate non-surgical cosmetic procedures but the content of these is restricted, for example to the cleanliness of premises. In addition, a small number of local authorities in England have introduced local licensing schemes. These include Essex (under the Essex Act 1987), Nottingham (under the Nottinghamshire County Council Act 1985) and London (under the London Local Authorities Act 1991).
1294. The subsection (3)(b) therefore grants the power to repeal local Acts such as these in order to ensure that the licensing scheme is applied uniformly across England so that the same national minimum standards of safety and training qualifications are upheld.

Disability and autism training

Section 181: Mandatory training on learning disability and autism

1295. This section amends the Health and Social Care Act 2008 (the "HSCA 2008)").
1296. Subsection (2) inserts a new subsection (5ZA) into section 20 (regulation of regulated activities) of the HSCA 2008. New subsection (5ZA) places a duty on the Secretary of State to make regulations to require service providers to ensure that persons by working for them for the purpose of regulated activities receive training specifically on learning disability and autism appropriate to the person’s role. This introduces a specific requirement to provide learning disability and autism training within the existing CQC regulated framework.
1297. Subsection (3) inserts a new subsection (5D) into section 20 of the HSCA 2008 which defines the terms "learning disability" and "service provider" both of which appear in new subsection (5ZA.).
1298. Subsection (4) inserts a new section 21A (Learning disability and autism training: Code of Practice) into Chapter 2 of the HSCA 2008. The new section imposes a duty on the Secretary of State to issue a Code of Practice (CoP) about compliance with requirements set out in regulations relating to training on learning disability and autism.
1299. Section Subsection (2) of new section 21A sets what the CoP must include.
1300. Section Subsection (3) of new section 21A gives the CoP some flexibility to make different provisions for different cases or circumstances.
1301. Section Subsection (4) of new section 21A imposes a duty on the Secretary of State to review the CoP at least every five years and to lay before Parliament a report with the findings of that review.
1302. Subsection (5) makes several amendments to section 22 (consultation in relation to Code of Practice under section 21) of the HSCA 2008.
1303. Subsection (5) (a) changes the heading of section 22 to reflect the scope of section 22. It now covers the CoP in new section 21A as well as the pre-existing CoP in section 21 on health care associated infections.
1304. Subsections (5) (b) and (5) (c) add references to the new section 21A into subsections (1) and (2) of section 22. The references function to ensure that the duties for the Secretary of State to prepare a draft and consult on COP under section 21are also applied to the new CoP for learning disability and autism training.
1305. Subsection (5)(d) makes subsection (3) of section 22 apply only to a draft or revised CoP made under section 21 (health care associated infections). Subsection (3) relates to when a CoP under the HSCA 2008 comes into force. By doing so it means that subsection (3) does not apply to the CoP made under new section 21A.
1306. Subsection (5)(e) inserts new subsections (5A) to (5D) into section 22 of the HSCA 2008. Subsection (5A) places a duty on the Secretary of State to lay a copy of the draft CoP before Parliament following a consultation. Subsections (5B) sets out that if either House of Parliament resolves not to approve it within a 40-day period following laying, the Secretary of State cannot issue the CoP. Subsections (5C) and (5D) provide clarification on how the 40-day period is calculated.
1307. Subsection (6) adds references to new section 21A into section 25 of the HSCA 2008. This ensures that the CoP may be taken into account in the making of certain decisions or in certain proceedings under the HSCA 2008 and makes the CoP admissible as evidence in other criminal or civil proceedings. Subsection (7) sets out that until the first regulations made using powers in new subsection (5ZA) come into force, the HSCA 2008 and the 2014 Regulations, should be read as if regulation 18 of the 2014 regulations already contain the requirements set out in subsection (5ZA) for learning disability and autism training. In practice this means that from commencement of these provisions in the Health and Care Act, the 2014 Regulations and HSCA 2008 are to be read as including a requirement for all health and social care providers who carry out regulated activities to ensure that their staff receive specific training on learning disabilities and autism appropriate to their role.