Exiting the EU
2 On 1 January 1973 the UK joined the European Economic Community, which has since evolved to become today’s EU. As a condition of EU membership, the UK was required to give effect to EU law in the UK. This was achieved through the European Communities Act 1972 (ECA) which provided for EU Regulations to take direct effect in UK law and conferred a delegated power (section 2(2) ECA) by which EU Directives and other pieces of EU legislation could be transposed into UK law through domestic regulations.
3 On 17 December 2015 the European Union Referendum Act 2015 received Royal Assent. The Act made provision for holding a referendum in the UK and Gibraltar on whether the UK should remain a member of the EU.
4 The referendum was held on 23 June 2016 and a majority voted to leave the EU. The European Union (Notification of Withdrawal) Act 2017 received Royal Assent on 16 March 2017. On 29 March 2017, the Prime Minister gave notification of the withdrawal of the UK from the EU under article 50(2) of the Treaty on the European Union.
5 On 26 June 2018 the European Union (Withdrawal) Act 2018 received Royal Assent. Via operation of section 1 of that Act section 2(2) ECA will be repealed.
6 On 19 December 2019, the European Union (Withdrawal Agreement) Bill was introduced to Parliament. It received Royal Assent on 24 January 2020. The Act implements the Withdrawal Agreement, as agreed between the United Kingdom and the EU. The Act provides that new pieces of directly applicable EU law that are introduced during the transition period will continue to apply automatically within the UK, in line with Part 4 of the Withdrawal Agreement. It also inserted section 1A into the European Union (Withdrawal) Act 2018 to save and amend the ECA so that it continues to have effect in domestic law, as amended, during the transition period.
Existing regulatory framework overview and delegated powers
7 The regulation of human medicines (including clinical trials of human medicines), veterinary medicines and medical devices falls within EU competence. The EU has legislated in each of these fields (taking clinical trials separately from the other regulatory aspects of human medicines) and created comprehensive regulatory frameworks in each case. The comprehensive frameworks, informed through the negotiation process by the UK Government, are established in EU legislation and have primarily been implemented in the UK by the following legislation:
● The Human Medicines Regulations 2012 1
● The Medicines for Human Use (Clinical Trials) Regulations 2004 2
● The Veterinary Medicines Regulations 2013 3
● The Medical Devices Regulations 2002 4
8 Each of the above sets of Regulations were made using the delegated power at section 2(2) ECA. The same delegated power has been used on a regular basis to update each set of regulations, for example, the Human Medicines Regulations 2012 have been updated 11 times using section 2(2) ECA since their inception. Updates have taken place across these Regulations to reflect changes in EU Directives and updates to the EU regulatory frameworks.
9 After the end of the transition period, section 2(2) ECA will no longer be available to update the regulatory schemes for human medicines, clinical trials of human medicines, or veterinary medicines through secondary legislation. In the absence of section 2(2) ECA, it will not be possible to update the schemes except through primary legislation, even where those changes relate to minor details in the existing regulatory frameworks.
10 The effect of the repeal of section 2(2) ECA on medical devices is slightly different. This is because medical devices legislation in the UK is made jointly under section 2(2) ECA and section 11 of the Consumer Protection Act 1987 (CPA). Whilst section 11 CPA is not being repealed (though it is being dis-applied with respect to medical devices – see below) it cannot be relied on exclusively to update the regulatory framework for medical devices. This is because it only allows for provision to be made for the purpose of securing that devices are "safe", that is, that they do not create a risk of death or personal injury. This means that many aspects of the regulatory scheme cannot be updated using section 11 CPA, such as most technical requirements (particularly for lower risk devices), and obligations on manufacturers and others in the supply chain. This means that it will not be possible after the end of the transition period to update much of the regulatory framework for medical devices without primary legislation.
11 Parts 1 to 3 of the Bill therefore create critical, but targeted delegated powers which enable specific features of the regulatory regimes for human medicines, clinical trials of human medicines, veterinary medicines and medical devices to be updated. The delegated powers may only be exercised in relation to a finite list of matters specified on the face of the Bill and only after consideration has been given to the safety and the availability of human or veterinary medicines or devices (as the case may be) and the attractiveness of the UK as a place to develop and supply these products. Subject to two discrete exceptions, the powers may also only be exercised following consultation.
Human Medicines - Existing regulatory framework
12 The regulatory framework for human medicines in the UK is based on the EU Human Medicines Directive 5 and is set out in the Human Medicine Regulations 2012 (HMRs). The framework provides a comprehensive scheme for regulating human medicines that covers their licencing, manufacture, importing, brokering, labelling, distribution, advertising and pharmacovigilance (safety monitoring), amongst other things. The scheme is overseen by the UK licensing authority which consists of the Secretary of State (for Health and Social Care) and the Minister of Health in Northern Ireland. In practice, the scheme is overseen by the Medicines and Healthcare products Regulatory Agency (MHRA) acting on behalf of the Secretary of State.
13 The MHRA is an executive agency of the Department of Health and Social Care. It operates as a trading fund which means that it has a degree of financial autonomy but it does not have a separate legal personality from the Department.
14 As well as transposing the EU Medicines Directive into UK law, the HMRs contain some provisions on matters that relate to human medicines, but which fall outside EU competence and hence are a matter of national policy. In particular the HMRs create a framework around the supply of human medicines to the patient, for example who may prescribe prescription-only medicines, who may supply them and the circumstances in which non-prescription medicines may be supplied, including in all cases multiple exceptions.
15 The Medicines Act 1968 (c.67) also contains some national provision that relates to human medicines. It contains the provisions that regulate pharmacies and pharmacists in relation to supplying human medicines which is also a matter that falls outside EU competence.
Clinical Trials of human medicines - Existing regulatory framework
16 The regulatory framework for clinical trials in the UK is based on the EU Clinical Trials Directive 6 and is set out in the Medicines for Human Use (Clinical Trials) Regulations 2004 (CTRs). The framework provides a scheme for regulating clinical trials of medicines involving humans that covers the authorisation of clinical trials, their ethical approval, the conduct of the trial including adherence to good clinical practice, the reporting of adverse events and breaches of the authorisation, the manufacture and importation of the medicinal products involved in the trial and their labelling. The regulatory system is again overseen by the UK licensing authority operating through the MHRA (as described in paragraphs 11 and 12).
17 The EU legislation on which the CTRs are based is due to be repealed and replaced by a new EU Regulation 7 . Whilst this EU Regulation is in force, it is not expected to apply in the EU until after the end of the transition period meaning it will not form part of retained EU law 8 .
Veterinary Medicines - Existing regulatory framework
18 Veterinary medicines are currently regulated by the Veterinary Medicines Regulations 2013 (SI 2013/2033) which implement various pieces of EU legislation. These regulations help ensure animal welfare, and protect the safety of treated animals, people handling the medicines, consumers of produce from treated animals, and the environment. They do this by regulating the authorisation, manufacture, classification, distribution and administration of veterinary medicinal products.
Medical Devices - Existing regulatory framework
19 A medical device is an instrument, apparatus, appliance, software, material or other article that is used in the prevention, diagnosis or treatment of illness or disease, the alleviation of / compensation for a handicap or injury or the replacement of a physiological process or the control of conception. Some types of medical device, known as in-vitro diagnostic medical devices (IVDs) are also used to conduct in-vitro diagnostic tests. These are tests done on samples such as blood or tissue that have been taken from the human body. In-vitro diagnostics can detect diseases or other conditions and be used to monitor a person’s overall health. With limited exceptions devices placed on the EU market must bear a CE mark - a mark to prove that a product has been assessed and meets required performance, safety, health and environmental protection standards.
20 The MHRA, acting on behalf of the Secretary of State (as described in paragraphs 11 and 12) is the designated competent authority that regulates compliance with and enforces the law on medical devices in the UK. It has a range of investigatory and enforcement powers to ensure device safety, quality and performance. It is also responsible for the post market surveillance and vigilance of medical devices on the UK market, working with Competent Authorities across the EU on safety considerations including where the device has not been certified by a UK Notified Body.
21 Medical devices are regulated in the UK by the Medical Devices Regulations 2002 (SI 2002/618). These regulations provide definitions for medical devices (including IVDs), and place obligations on manufacturers to ensure that medical devices are safe and fit for their intended purpose. Some aspects of the General Product Safety Regulations 2005 9 apply to devices that are also consumer products.
22 The new EU Regulation on Medical Devices (Regulation (EU) 2017/745) which covers all general medical devices (including active implantable devices) will apply across the EU and in the UK from the 26 May 2020 following a three year transition period. The new EU Regulations on In Vitro Medical Devices (IVDR) (Regulation (EU) 2017/746) has a transition period of five years and will fully apply in EU member states from 26 May 2022. The aim of both of the new EU Regulations is to address inherent weaknesses in the existing Directives as well as drive increased patient safety and confidence in the system of conformity assessment. As the UK will not be a Member State of the EU it will need to make its own decisions about the future regulation of IVDs using the powers proposed in this Bill.
Consolidating and expanding medical devices enforcement provisions
23 Chapter 2 of Part 3 of the Bill seeks to consolidate the enforcement regime for medical devices and provides the Secretary of State with the ability (see Schedule 1) to impose civil sanctions as an alternative to criminal prosecution. Chapter 3 provides the Secretary of State with a new information sharing gateway.
24 Currently, the Secretary of State’s powers to enforce compliance with medical device regulation can be found in numerous pieces of legislation, including the Medical Devices Regulations 2002 (SI 2002/618), the Consumer Protection Act 1987 (c. 43), the Consumer Rights Act 2015 (c. 15) and the General Product Safety Regulations 2005 (SI 2005/1803).
25 The structure of these legislative powers does not enable the MHRA to operate efficiently or provide clarity to UK and international manufacturers on the operation of its enforcement regime. For instance, currently, the Secretary of State has enforcement powers to restrict the supply of devices in both the Medical Devices Regulations 2002 and the CPA (see regulation 63 (restriction notices) of the Medical Devices Regulations 2002 and sections 13 (Prohibition notices and notices to warn) and 14 (suspension notices) of the CPA), and it is not clear in what circumstances each power should be used.
26 The link to the CPA also means that the sanction for failing to comply with medical device regulations is the general offence of breaching safety regulations contained in section 12 (Offences against the safety regulations) of the CPA. This offence contains four "limbs" and determining whether or not a failure to comply with a provision of the Medical Devices Regulations 2002 is an offence involves an analysis of whether the provision fits within any of the "limbs". This creates uncertainty for both the Secretary of State and industry.
27 The Bill seeks to remedy this uncertainty by creating a clearer consolidated enforcement regime. The key features of this new regime are:
a. the disapplication of the CPA, and amendments to the Medical Devices Regulations 2002, so that powers to issue enforcement notices are contained solely in this Bill (meaning that they are more specific to medical devices); and
b. the creation of a bespoke criminal offence, which clarifies which contraventions of the Medical Devices Regulations 2002 could result in prosecutions (note: this does not criminalise new behaviour but for the most part reflects the existing position under section 12 of the CPA in a more transparent and focussed manner). This offence will retain the existing maximum penalties under section 12 of the CPA.
28 The Bill also introduces new powers to impose civil sanctions on those who have breached the Medical Devices Regulations 2002, as an alternative to criminal prosecution. In particular, the Bill provides the Secretary of State with powers to impose a monetary penalty on a person (where the Secretary of State is satisfied beyond a reasonable doubt that the person has committed an offence) and accept an enforcement undertaking (where the Secretary of State has reasonable grounds to suspect a person has committed an offence and that person offers the undertaking).
29 The Bill also provides the Secretary of State with new powers to share information it holds about medical devices in limited circumstances. These include a power to share medical device information with the public where necessitated by safety concerns and a power to share information with persons providing services or exercising functions in relation to medical devices. Such powers are subject to data protection legislation, and also to provisions which place restrictions on the disclosure of commercially sensitive
1 S.I 2012 No. 1916
2 S.I 2004 No. 1031
3 S.I 2013 No. 2033
4 S.I 2002 No. 618
5 Directive 2001/83/EC on the Community Code relating to medicinal products for human use
6 Directive 2001/20/EC
7 EU No. 536/2014
8 It will apply 6 months after publication of a notice by the European Commission in the Official Journal of the European Union.
9 SI 2005 No 1803