Part 2: Health and Adult Social Care Information Section 101: Medicine Information Systems
Subsection (1) provides that the following provisions amend the Medicines and Medical Devices Act 2021.
	Subsection (2) substitutes "Regulations: general" for the heading of Chapter 1 of Part 2.
	Subsection (3) inserts a new Chapter 1A (Regulations: Information Systems) after Chapter 1 of Part 2 of the Medicines and Medical Devices Act 2021, which consists of a section 7A and 7B. The new section 7A confers a power on the appropriate authority to make regulations providing for a system of information in relation to medicines to be established and operated by the Health and Social Care Information Centre ("the Information Centre"), and specifies the type of provision which can be included in the regulations. In relation to England, Scotland and Wales, the "appropriate authority" is the Secretary of State. In relation to Northern Ireland, the "appropriate authority" is the Department of Health in Northern Ireland acting alone, or the Secretary of State and the Department of Health in Northern Ireland acting jointly. "Appropriate authority" is defined in section 2 (Power to make regulations about human medicines) of the Medicines and Medical Devices Act 2021. The definition reflects the position whereby key functions under the Human Medicines Regulations 2012 (S.I. 2012/1916) are carried out by the Licensing Authority, which consists of both Secretary of State and Northern Ireland Minister.
	New section 7A(1) provides that regulations may be made about the establishment and operation, by the Information Centre, of one or more information systems. The power is restricted to purposes relating to the safety of human medicines, including the safety of clinical decisions relating to human medicines, and the quality and efficacy of human medicines. Such purposes may include the generation of high-quality evidence regarding the use, benefits and risks of these medicines to inform regulatory decision making, supporting local clinical practice and providing patients and prescribers with the evidence they need to make better informed decisions.
	Subsection (1)(a) and (c) of section 19 of the Medicines and Medical Devices Act 2021 makes specific provision relating to devices that are placed on the market, and about the improvement of medical device safety and performance through advances in technology. It was necessary for these subsections to be worded in this way to distinguish between devices on the market and those that are not, and to make specific provision about technological developments in relation to the latter. However, when it comes to subsection 7A(1), this wording was not necessary given the differences in the regulation of medicines and medical devices.
	Section 7A(2) describes the type of provision that the regulations may make. This is a non-exhaustive list. Provision may be about the type of information that could be gathered, for example this may be information relating to a particular medicine, patients who are prescribed the medicine or prescriber information. Regulations may also impose requirements to provide that information to the Information Centre and make provision about the use or disclosure of that information and requirements that may be placed on the Information Centre in exercising its functions under the regulations. These provisions ensure that the Information Centre is able to mandate the provision of specific information to be included in the information system and that the Information Centre is able to use and disclose such information.
	Section 7A(3) sets out additional information about the kind of provision which may be made pursuant to section 7A(2)(a) and (b). It provides that regulations concerning the information which is to be collected and entered into any medicines information system may relate to information for specified purposes, information that the Information Centre considers necessary or expedient to carry out its functions under the regulations, information which is of a specified description that may relate to individuals and information described in a written direction given by the appropriate authority, which may also relate to individuals. Relying on these powers, regulations can specify the type of information required so that for example, details of patients, and their prescribers can be recorded and monitored to improve pharmacovigilance. It also ensures that the appropriate authority can set out in a direction the details of what information must be collected. Directions may be used as a means to enable the appropriate authority to specify what information needs to be collected by the Information Centre for each registry. This will enable the appropriate authority to promptly amend what information is collected by the Information Centre, as public health needs change or develop, and the need for new or different information emerges. It also ensures that the appropriate authority can set out in a direction the details of what information must be collected.
	Section 7A(4) goes on to specify the kind of provision which can be included in the regulations pursuant to section 7A(2)(b).
	Section 7A(4)(a) provides that the regulations may specify the persons, or categories of persons who may be required to provide information to the Information Centre. Those persons or categories must fall within section 7A(5). For example, the regulations would be able to set out the types of healthcare providers who are required to submit information to the Information Centre, including private providers and providers in devolved administrations. This would enable the collection of comprehensive, UK-wide information.
	Section 7A(4)(b) provides that regulations may specify the time and manner in which the information required must be provided or for those matters to be determined by the Information Centre. This provision can be used to ensure the Information Centre receives the information in a way that can be easily analysed by requiring providers to send information by a specific time and in a specific format.
	Section 7A(4)(c) provides that regulations may describe any procedural steps the Information Centre must follow when requiring a person to provide information. This ensures secondary legislation can set out the way in which the Information Centre would need to request information from providers, for example taking into account that the process for collecting information may vary in devolved territories.
	Section 7A(4)(d) provides that regulations may specify that required information is recorded or retained. Regulations can for example set out what information must be recorded and stored and the duration of storage of such information.
	Section 7A(4)(e) provides that regulations may include provision about the enforcement of requirements imposed by regulations made under section 7A(1). This provides a mechanism to set out in secondary legislation how the collection of information would be enforced.
	Section 7A(5) sets out who may be required to store information and/or provide it to the Information Centre. This is limited to any person who provides services, or exercises any powers or duties, relating to human medicines, health or education. This means that information can be collected from providers such as healthcare providers, private providers and providers of education services. For example, data relating to education and child development may be required in a registry to understand the potential for neurodevelopment disorders in those exposed to medicines in utero or transgenerational effects on the children of people who were exposed to the medicine.
	Section 7A(6) provides a non-exhaustive list of provisions that may be included in the regulations on the use and disclosure of information held within the information system (section 7A(2)(c)). These include the analysis of that information (whether alone or linked with other information), the publication of that information (or of information that has been analysed in combination with it), the disclosure of that information to specified persons or descriptions of persons or for specified purposes, and the use or further disclosure of that information by any person to whom information has been disclosed under the regulations. This means that the Information Centre would be able to link non-information system data such as data already collected by the Information Centre, with information system data and share this with, for example, the MHRA for the purpose of establishing registries.
	Section 7A(7) provides that where regulations confer a power on the appropriate authority to give a direction under section 7A(3)(d), they must provide that the power includes a power to vary or revoke the directions by a subsequent direction. This means previous directions can be changed or replaced if there are circumstances where a new direction was needed. For example, if further information was required to be collected for an existing medicines registry. This section also provides that where regulations confer a power on the appropriate authority to give a direction under section 7A(3)(d), the appropriate authority must consult with Scottish or Welsh Ministers before giving a direction that relates to Scotland or Wales respectively.
	Section 7A(8) and (10) provides that where the Information Centre will require information from healthcare providers in Scotland and/or Wales, the regulations must allow for Scottish and or Welsh Ministers (as applicable), or a person designated by them, to collect the required data. Regulations will also be able to set out exceptions to this whereby, under certain circumstances, the Information Centre can collect the data directly. For these purposes, section 7A(9) and (11) enables regulations to confer powers or duties on Scottish or Welsh Ministers, or a person designated by them so that they have all of the powers or duties that they need to make this arrangement work.
	Section 7A(12) enables regulations made pursuant to section 7A(1) to provide that disclosure of information for the purposes of medicines information systems does not contravene an obligation of confidence owed by the person making the disclosure or any other restriction on the disclosure of information, other than a restriction imposed by data protection legislation. These provisions will allow regulations to include provision setting aside duties of confidence as well as other restrictions on disclosure of information. No disclosure would be able to contravene data protection legislation. This provision would ensure that the Information Centre can disclose information, including information that has been lawfully linked under this section, onwards, for example to the MHRA for the purposes of establishing a registry.
	Section 7A(13) defines terms used in section 7A.
	Section 7B creates a new offence related to information disclosure.
	Section 7B(1) provides that a person commits an offence if they receive information under regulations made under section 7A(1) and then use or disclose that information in contravention of those regulations. This is to ensure information included in the information system is used and disclosed appropriately and is consistent with the provision made for disclosure of information contained in medical devices information systems.
	Section 7B(2) outlines the maximum penalties for these offences. These are:
As a result of a summary conviction in England and Wales, which is an offence that is triable in a magistrates’ court, a person can be imprisoned for up to 51 weeks, receive a fine, or both.
As a result of a summary conviction in Scotland or Northern Ireland, a person can be imprisoned for up to 6 months, or receive a fine not exceeding level 5 on the standard scale, or both. A level 5 on the standard scale references the scale of fines for summary offences as outlined in the Criminal Justice Act 1982.
	Section 7B(3) outlines that the maximum 51 weeks imprisonment outlined in section 7B(2)(a) is to be read as 6 months if the offence is committed before section 281(5) of the Criminal Justice Act 2003 is commenced.
	Subsection (4) amends section 19 (medical devices: information systems) of the Medicines and Medical Devices Act 2021 as described below.
	Subsection (4)(a) amends subsection (6) of section 19 to provide for publication and other disclosure of information that has been analysed in combination with information contained in a medical device information system.
	Subsection (4)(b) inserts a new subsection (7A) after section 19(7) that inserts the same provision as section 7A(12) into section 19, so allowing regulations to provide that a disclosure of information for the purposes of medical devices information systems does not contravene an obligation of confidence owed by the person making the disclosure or any other restriction on the disclosure of information, other than a restriction imposed by data protection legislation.
	Subsection (5) amends section 43 (power to make consequential etc provision) of the Medicines and Medical Devices Act 2021. Where regulations made under sections 7A or 19 make consequential provision by virtue of section 43(2)(a), the new section 43(3) to will ensure that those regulations may change the territorial extent of provisions of Chapter 2 of Part 9 of the 2012 Act (constitution and functions etc of the Health and Social Care Information Centre), or otherwise amend that Chapter. In establishing and operating the medicines and medical devices information systems the Information Centre will have more substantial functions in relation to Scotland and Northern Ireland than it had prior to the Medicines and Medical Devices Act 2021 as amended by this Act. To ensure effective functioning and operation of the information systems it is therefore appropriate to ensure that certain provisions of the 2012 Act which relate to NHS Digital’s functions under the Medicines and Medical Devices Act, could form part of the law of the whole of the UK, rather than just England and Wales, if deemed necessary.
	Subsection (6) amends section 44 (scope of Northern Ireland departments) of the Medicines and Medical Devices Act 2021 to require that regulations under section 7A(1) cannot be made by a Northern Ireland Department acting alone unless the provision would fall within the legislative competence of the Northern Ireland Assembly and would not require the consent of the Secretary of State.
	Subsection (7) amends section 45 (consultation) to include 7A(1) in the list of sections in subsection (6)(a). This provides that consultation on regulations made pursuant to section 7A(1) is to be carried out by the appropriate authority. Subsection (7)(a) also provides a requirement for the appropriate authority to specifically consult Welsh and Scottish Ministers (as appropriate) on regulations under section 7A(1) if regulations concern Scotland or Wales.
	Subsection (8) amends section 46 (reporting requirements) so that regulations made under section 7A(1) are subject to the same reporting requirements as medicines regulations made under section 2.
	Subsection (9) amends section 47 (procedure for regulations) to ensure the procedure for making regulations under section 7A(1) is the same as that for medicines regulations made under section 2 of the Medicines and Medical Devices Act 2021 (the draft affirmative procedure).
	Subsection (10) amends section 253 of the 2012 Act (general duties of Information Centre), to provide that subsections (1) and (2) of that section do not apply in relation to the functions of the Information Centre by virtue of the Medicines and Medical Devices Act 2021. This is because the duties in section 253 are England-specific and therefore not appropriate to the UK-wide functions conferred on the Information Centre by the Medicines and Medical Devices Act 2021.