The UK government published its Medicines and Medical Devices Bill (the Bill) on 13 February 2020. The Bill seeks to introduce delegated powers which will allow the Secretary of State to amend or supplement the existing UK regulatory framework for medicines, medical devices, clinical trials and veterinary medicines at the end of the transition period for the UK's departure from the EU (the Transition Period), which is currently scheduled for 31 December 2020. The Bill also consolidates and expands on the existing UK medical devices enforcement powers and provides for an information gateway to permit sharing of information held by the Secretary of State in relation to medical devices.
The regulation of human and veterinary medicines and medical devices in the UK was primarily a matter of EU competence so long as the UK was a member of the EU, with regulatory frameworks established in EU law and implemented in the UK through regulations made through delegated powers under the European Communities Act 1972 (ECA). The European Union (Withdrawal) Act 2018 provides that new pieces of directly applicable EU law, introduced during the Transition Period, will apply in the UK, and also saves and amends the ECA so that it continues to have effect in domestic law, as amended, during the Transition Period.
Once the Transition Period comes to an end, however, delegated powers under the ECA will no longer be available to update legislation concerning human and veterinary medicines, including clinical trials and much of the legislation concerning medical devices. Unless new delegated powers are introduced, primary legislation will need to be passed each time regulations are to be amended (even where those amendments relate to minor details). In the Impact Assessment published by the Department of Health and Social Care in relation to the Bill, it is stated that this would "prevent the maintenance of a dynamic, fit for the future regulatory system capable of adjusting for future innovation".
The Bill, therefore, seeks to introduce targeted delegated powers to allow the regulatory regime to be updated following the end of the Transition Period. For example, the IVD Regulation (EU) 2017/746 will not apply fully in EU Member States until 26 May 2022 (i.e., after the end of the Transition Period). Therefore, the UK will need to make its own decision about the future UK regulation of IVDs using powers proposed in the Bill. Subject to two exceptions—to disapply provisions relating to human medicines or medical devices where there is an actual or imminent risk of serious harm to health—the powers may only be exercised following consultation.
In relation to medical devices, enforcement powers are currently found in several pieces of legislation. In the Explanatory Notes accompanying the Bill, the government states that this structure "does not enable the MHRA to operate efficiently or provide clarity to UK and international manufacturers on the operation of its enforcement regime". The key features of the Bill that seek to remedy this deficiency are:
- Powers to issue enforcement notices will be contained solely within the Bill (meaning that they are specific to medical devices).
- The creation of a bespoke criminal offence, which clarifies which contraventions of the Medical Devices Regulations 2002 could result in prosecutions (this is not intended to criminalise new behaviour but, for the most part, to reflect the existing position under section 12 of the Consumer Protection Act 1987 in a more transparent and focussed way).
- The introduction of 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 and accept an enforcement undertaking.
The Bill also provides the Secretary of State with power to share information with the public in relation to medical devices, regarding safety for example (subject to protection of personal data and commercially sensitive information).
The next step is for MPs to consider the Bill at a second reading in the House of Commons on 2 March 2020. Changes to the current proposed text may be introduced at this or subsequent stages before the Bill is enacted into law.
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