Medicines And Medical Devices Act 2021

Part 2: Human Medicines

Chapter 1: Regulations

Section 2: Power to make regulations about human medicines

37. Section 2(1) confers a delegated power to amend or supplement the law relating to human medicines by regulations.
38. The "law relating to human medicines" is defined (in section 9) to include four pieces of legislation only, namely:
    • the Human Medicines Regulations 2012 which provides the comprehensive regulatory structure under which human medicines are regulated;
    • the Medicines for Human Use (Clinical Trials) Regulations 2004 which regulate trials of human medicines involving humans;
    • the Medicines Act 1968 (specified provisions only) which regulates pharmacies; and
    • the Medicines (Products for Human Use) (Fees) Regulations 2016.

39. Any amendments to this listed legislation will be captured by this definition, meaning this definition will always include the latest version.
40. The power only allows for the existing legislative regime to be amended or supplemented. This means the power will be used to build on what is already there.
41. The power is targeted in its scope because regulations made under it may only contain provision relating to the matters specified on the face of the Act at sections 3 to 7. The lists of matters specified in sections 3, 4, 5, 6 and 7 are exhaustive in each case, meaning that only regulatory changes that fall within these descriptions may be made under this power.
42. Section 2(2) places a duty on the Secretary of State or Northern Ireland department making regulations (or both if acting jointly) to have the overarching objective of safeguarding public health when making regulations using the power under section 2(1).
43. Section 2(3) provides that when considering whether regulations would contribute to the objective set out in section 2(2), the appropriate authority must at least have regard to the three factors set out at (a) to (c). These are the safety and availability of human medicines, and the likelihood of a relevant part of the UK (England, Scotland, Wales, or Northern Ireland) as being seen as a favourable place in which to carry out research relating to human medicines, to conduct clinical trials, and to manufacture or supply human medicines. Other factors may of course be relevant to any decision to exercise the delegated power.
44. Section 2(4) provides that the appropriate authority may make regulations under section 2(1) that may have an impact on the safety of human medicines only if the authority considers that the benefits of doing so outweigh the risks.
45. The delegated power is conferred on the "appropriate authority". In relation to England, Scotland and Wales, the "appropriate authority" is the Secretary of State. "Secretary of State" is defined in the Interpretation Act 1978 (c.30) to mean any Secretary of State but in practice it would be the Secretary of State for Health and Social Care exercising this power. 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.

Section 3: Manufacture, marketing and supply

46. Section 3(1) lists matters relating to the manufacture, marketing and supply of human medicines that regulations made under section 2(1) can address. The list is exhaustive.
47. Subsection (1)(a) allows provision to be made in relation to manufacturing authorisations. As a general rule, a manufacturing authorisation is required by any person manufacturing human medicine in the UK as set out in regulation 17 (manufacturing of medicinal products) of the Human Medicines Regulations 2012 (HMRs). Regulations made under section 2(1) and relying on section 3(1)(a) could, for example, amend the application process for applying for such an authorisation, add to the requirements that must be met by the holder of a manufacturing authorisation or amend the exceptions to the requirement for a manufacturing authorisation.
48. Subsection (1)(b) allows provision to be made in relation to authorisations to import human medicines. In general, regulatory rules are in place to secure supply chains for medicines entering the UK. A manufacturer’s licence is required in order to import medicines into the UK from outside the EEA, as set out in regulation 17 of the HMRs. A wholesale dealer’s licence is required in order to import unlicensed medicines from within the EEA, as set out in regulation 167(7) of the HMRs. Regulations made under section 2(1) and relying on section 3(1)(b) could, for example, amend the requirements relating to importation that must be met by the holders of such authorisations.
49. Subsection (1)(c) allows provision to be made in relation to wholesale dealing authorisations. Generally, a wholesale dealing authorisation is required by any person supplying medicines by way of wholesale dealing in the UK. This is governed by regulation 18 (wholesale dealing in medicinal products) of the HMRs. Wholesale dealers are the middle-persons in the supply chain moving products from manufacturers to the persons who will actually supply the product to its end user. Usually wholesale dealers are distribution companies but not necessarily – if a hospital supplies a medicine to another hospital then that is also an example of wholesale dealing and will need an authorisation unless an exception applies. Regulations made under section 2(1) and relying on section 3(1)(c) provision could, for example, amend the application process for applying for such an authorisation, add to the requirements that must be met by the holder of a wholesale dealing authorisation or amend the exceptions to the requirement for a wholesale dealing authorisation.
50. Subsection (1)(d) allows provision to be made in relation to marketing authorisations. As a general rule, a marketing authorisation is required by any person who wishes to place a medicine on the UK market. This is governed by Part 4 (requirement for authorisation) of the HMRs. Regulations made under this provision could, for example, amend the application process for applying for such an authorisation, add to the requirements that must be met by the holder of the authorisation or amend the exceptions to the requirement for a marketing authorisation.
51. Subsection (1)(e) allows provision to be made in relation to the importation, distribution and manufacture of active pharmaceutical substances. These are the raw ingredients used to make finished medicines and give a medicine its therapeutic effect. Chapter 4 of Part 3 of the HMRs requires any person who imports, manufactures, or distributes an active substance to register with the MHRA. The MHRA has produced a flowchart that provides further information on the stages of the registration process.
52. Subsection (1)(f) allows provision to be made in relation to the brokering of medicines. Brokering of medicinal products consists of negotiating independently and on behalf of another legal or natural person in relation to the sale or purchase of medicinal products. Under Chapter 3 of Part 3 of the HMRs, brokers have to register with the MHRA. As part of this they must have a permanent address in the UK and comply with the guidelines on good distribution practice (GDP), insofar as those guidelines apply to brokers.
53. Subsection (1)(g) provides that regulatory provisions may be made in relation to the registration of the premises of a pharmacy business. "Pharmacy business" is defined at section 9.
54. Subsection (1)(h) allows provision to be made in relation to the recording of information about the supply of human medicines. Regulation 253 of the HMRs currently require, with some exceptions, a pharmacy to keep records in respect of the sale or supply of prescription only medicines (POMs). Regulations made under section 2(1) and relying on section 3(1)(h) provision could, for example, amend these requirements.
55. Subsection (1)(i) allows provision to be made in relation to notifying and reporting requirements. This would include requirements relating to the reporting of adverse reactions to medicines which are used to ensure that emerging risks in connection with a medicine are identified and acted upon as early as possible.
56. Subsection (1)(j) allows provision to be made in relation to the labelling and packaging of human medicines as well as the patient information leaflets (PILs) that accompany them. Existing requirements are found in Part 13 (packaging and leaflets) of the HMRs. Regulations made under section 2(1) and relying on this provision could update the existing requirements to allow further for the provision of information online and/or through other emerging media platforms or they could be used to create new requirements to address gaps identified in the provision of information, for example to require that patient information leaflets are included in both boxes where a pharmacist splits a product between two patients.

    Example (1): Labelling and Leafletting The labelling and leafletting of medicines in the UK are currently regulated by Part 13 (Packaging and Leaflets) of the HMRs. MHRA approves all packaging and labelling information for medicines sold in the UK including the information that must be provided. Medicines must include a patient information leaflet (PIL) if the label does not contain all the necessary information. It is essential for certain medicines that they are dispensed together with a PIL and other risk minimisation materials. An example of how this power may be used could be to make provision imposing an obligation on the holders of marketing authorisations for medicinal products, to make available the information which must be included in the package leaflet associated with such product, at all times in electronic format.

57. Subsection (1)(k) allows provision to be made in relation to the advertising of human medicines. Existing requirements are found at Part 14 (advertising) of the HMRs. Regulations made under section 2(1) and relying on the provision could, for example, allow some of the information that must appear in adverts to healthcare professionals to be provided via a web link rather than included in the advert’s small print.
58. Subsection (1)(l) provides that regulations made under section 2(1) may make provision relating to the registration of persons who sell human medicines over the internet. Currently Part 12A (sale of medicines to the public at a distance) of the HMRs requires persons who sell medicinal products to the public over the internet to notify the licensing authority and comply with certain requirements. This power could, for example, be used to introduce a national scheme to replace the EU scheme.
59. Subsection (1)(m) provides that regulatory provision may be made in relation to the requirements that need to be met for a prescription to be valid. Current requirements are found in regulations 217 to 219A in Part 12 (Dealing with Medicinal Products) of the HMRs. Regulations made relying on subsection (1)(m) could, for example, amend the particulars that must be included in a prescription or the types of prescriptions that can be sent electronically.
60. Subsection (1)(n) provides that amendments may be made to provisions in the general rules on who can supply human medicines and from where they can be supplied. The rules are set out in subsection (2) and include regulations 214 (sale or supply of prescription only medicines), 215 (prescribing and administration by supplementary prescribers), 220 (sale or supply of medicinal products not subject for general sale), 221 (sale or supply of medicinal products subject for general sale) and 249 (restrictions on persons to be supplied with medical products) of the HMRs. These provide that prescription only medicines (POMs) can only be supplied in accordance with a prescription and set out who can issue prescriptions. They also set out that medicinal products that are not subject to general sale (POMs and pharmacy medicines) must be supplied from a registered pharmacy, while general sale medicines need to be supplied from premises that can be closed off to exclude the public. Finally, they restrict who can be supplied with medicinal products by way of wholesale dealing. There are multiple exemptions from these rules set out in Chapter 3, Part 12 of the HMRs and the associated Schedules. An example of an existing exemption is one that enables Royal National Lifeboat Institution (RNLI) first aiders to supply prescription only medicines in the course of their work for the RNLI when needed to treat the injured. Another exemption allows schools to obtain asthma inhalers and to supply them in an emergency to pupils who are known to suffer from asthma. Regulations made under section 2(1) and relying on section 3(1)(n) could, for example, be used to allow additional healthcare professionals to be given appropriately restricted prescribing rights or to amend the exemptions to the requirement for a prescription.

    Example (2): Prescribing Policy Some medicines are available to patients where they are given a prescription by an appropriate practitioner. An appropriate practitioner can either be an independent prescriber (someone able to prescribe medicines under their own initiative), or a supplementary prescriber (someone able to prescribe medicines in accordance with a pre-agreed care plan that has been drawn up between a doctor and their patient). Part 12, Chapter 2 of the HMRs sets out which groups of healthcare professionals are regarded as having the appropriate qualifications to make prescribing decisions and such groups are granted the responsibility to prescribe, either generally or in a defined set of circumstances. Over time the roles of staff within the health service will evolve and using this proposed power, certain professionals will be added to this list by amending the HMRs.

61. Subsection (1)(o) provides that regulations can be made about the use of human tissues or cells in relation to human medicines. Human tissues or cells are defined by regulation 5(1) of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (SI 2007/1523).

Section 4: Falsified medicines

62. Section 4 sets out two matters that regulations made under section 2(1) may be used to address. The first provides that regulatory provisions may be made about the prevention of the supply of falsified medicines. The second, provides that provisions can be made about the use, retention and disclosure of information held within a possible future falsified medicine prevent system for any additional purpose to do with human medicines.
63. Falsified human medicines are defined in section 9, by reference to regulation 8 of the HMRs, as human medicines that represent falsely their identity (including packaging, naming or composition), source or provenance.
64. Subsection (2) sets out a framework for preventative measures that regulations made under subsection (1)(a) may include. Subsection (2)(a) provides what regulation made under section 2(1) and relying on clause 4(1)(a)) may include, i.e. rules around the inclusion of unique identifiers and anti-tamper devices on packs of authorised human medicines in order to allow the identity and authenticity of individual packs to be verified.
65. Subsection (2)(b) allows provision to be made for checks to be carried out relating to these packs and ensuring all medicines in scope include a unique identifier and anti-tamper device.
66. Subsection (2)(c) provides that provision can be made in relation to the infrastructure, systems and processes around these checks, including who should set up, pay for and maintain any necessary systems.
67. Subsection (3) sets out a duty to have regard to the importance of ensuring that information that is collected for the purpose of the prevention of the supply of falsified medicines is retained securely. This duty applies to provisions made in reliance of clause 4(1)(a) and (b).

Section 5: Clinical trials

68. Section 5(1) lists matters relating to clinical trials that provisions made under section 2(1) may address.
69. Subsection (1)(a) provides that provision may be made which is corresponding or similar to the EU Clinical Trial Regulation.
70. Subsection (1)(b) provides that provision may be made about the authorisation and ethical approval of clinical trials. This is governed by Part 3 (authorisation for clinical trials and ethics committee opinion) of the Medicines for Human Use (Clinical Trials) Regulations 2004. Regulations made under this provision could, for example, amend the application process for applying for such an authorisation.
71. Subsection (1)(c) allows provision to be made about the notification and reporting requirements that apply to clinical trials. Parts 4 (conduct of clinical trials) and 5 (pharmacovigilance) of the Medicines for Human Use (Clinical Trials) Regulations 2004 impose various obligations on trial sponsors and investigators responsible for the conduct of the trial to notify adverse events and safety measures to the UK licensing authority. Regulations made under section 2(1) and relying on this provision could, for example, update the existing requirements in order to make them more proportionate for trials that are considered to carry low levels of risk.
72. Subsection (1)(d) allows amendments to be made to the requirements that must be satisfied before a trial is started. This could include either amending or removing existing requirements for some or all trials to ensure they remain proportionate or adding new requirements to ensure that trials continue to be conducted to high standards that maximise participant safety.
73. Subsection 1(e) allows provision to be made about the conduct of clinical trials. Part 4 (good clinical practice and the conduct of clinical trials) of the Medicines for Human Use (Clinical Trials) Regulations 2004 requires, amongst other things, that clinical trials in the UK must be conducted in accordance with the conditions and principles of good clinical practice set out in Schedule 1 of those Regulations. Regulations made relying on this provision could amend and update these standards that clinical trials must comply with.

Section 6: Fees, offences, powers of inspectors

74. Section 6(1) lists other matters which regulations made under section 2(1) may provide for.
75. Subsection (1)(a) allows regulations made under section 2(1) to introduce charges where they relate to functions conferred by regulations made under section 1(1), the HMRs or the Medicines for Human Use (Clinical Trials) Regulations 2004.
76. Subsection (1)(b) allows regulations made under section 2(1) to make the breach of requirements or prohibitions introduced by the regulations a criminal offence. These criminal offences may carry a maximum of two years imprisonment.
77. Subsection (1)(c) allows regulations made under section 2(1) to apply the existing powers of entry and inspection in human medicines legislation to new prohibitions and requirements introduced by the regulations. The powers of entry and inspection may be applied with modifications. The existing powers in human medicines legislation are at Part 8 (Miscellaneous and Supplementary Provisions) of the Medicines Act 1968, Part 16 (Enforcement) of the HMRs, and the Medicines for Human Use (Clinical Trials) Regulations 2004.
78. Subsection (2) provides that regulations made under section 2(1) cannot provide for any offence, whether new or existing, to be punishable with a sentence of imprisonment of more than two years.

Section 7: Emergencies

79. Section 7 allows amending and supplementary regulations to be made under section 2(1) about the relaxation of regulatory requirements relating to medicines in circumstances where there is a need to alleviate a threat of serious harm to the health of the general public or a section of the public. The Covid-19 pandemic would be an example of such circumstances.
80. By way of example, the provisions could be made to facilitate stocks of medicines to be shared between persons who do not hold wholesale dealer’s authorisations, such as doctors’ surgeries, for quicker distribution within the community. Or it could allow for larger packs of pills to be split into smaller packs where necessary in an emergency by persons who do not hold the correct authorisation to do so and who are not otherwise exempt from the requirement to hold such an authorisation before doing so.
81. Subsections (2) and (3) provide that the relaxing of a regulatory requirements can be made subject to conditions. Conditions may be found in regulations or a time-limited protocol that is published by the Secretary of State and the Department of Health in Northern Ireland. For example, the regulations could allow for the supply of medicines without a prescription, or otherwise than from a registered pharmacy, in circumstances that pose a serious risk to human health provided the supply is in accordance with a protocol that sets out specific conditions, such as the medicinal products which may be supplied or the criteria under which a person is to be eligible for treatment. Conditions can be important safeguards and may need to be bespoke. The use of protocols may be the most effective means to communicate the applicable conditions to healthcare and other professions accustomed to operating within the comprehensive regulatory regime governing medicines.

Chapter 2: International Agreements: Disclosure of Information

Section 8: Disclosure of information in accordance with international agreements

82. Section 8 confers a power on the Secretary of State and the Department of Health in Northern Ireland to disclose information they hold relating to human medicines.
83. Section (2) provides that information may be disclosed to a relevant person outside the UK where it is required in order to give effect to international agreements and arrangements concerning the regulation of human medicines and the relevant authority considers that the disclosure is in the public interest.
84. Subsection (3) provides that the relevant authority may not disclose commercially sensitive information under this section unless the relevant authority considers the disclosure to be necessary and proportionate.
85. Subsection (4) sets out that, except as provided by subsections (5) and (6), any disclosure of information in accordance with this section does not breach the restrictions on disclosure at (a) and (b).
86. Subsection (5) provides a restriction requiring that identifiable patient information is only shared with the patient's consent.
87. Subsection (6) provides that nothing in this section allows disclosures of information that breach data protection legislation or are prohibited by Parts 1 to 7 or Chapter 1 of Part 9 of the Investigatory Powers Act 2016 .
88. Subsection (7) makes it clear that this section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law (for example under common law powers).
89. Subsection (8) provides definitions for terms used in section 8.

Chapter 3: Interpretation

Section 9: Interpretation of Part 2

90. This section provides definitions for certain terms used in Part 2.