This piece was originally posted on the Birmingham Law School news page.
The committee stage of the Medicines and Medical Devices Bill 2019-20 resumed this week. The government has brought forward this new legislation to regulate medicines and medical devices following Brexit. Progress on the Bill paused in March 2020 due to the Covid-19 crisis, but its recommencement has come suddenly and with tight scrutiny timeframes.
As it currently stands, the Bill places emphasis on the attractiveness of the UK for medicine and medical device related activities (such as conducting clinical trials of medicines and developing medical devices). Patient safety, however, must be prioritised above market attractiveness in any new legislation.
Medicines and medical devices are highly innovative and fast-developing areas. Medical devices alone now encompass health and medical apps and the complex area of integrated medical implants reliant on software, as well as those potentially utilising AI and online connectivity. As such, it is important that this new legislation provides for high standards of safety and is forward-looking in its aims.
In some respects, the Bill achieves these aims. Its purpose is to enable the existing regulatory framework (including the continued application of existing EU regulations) to be updated and to grant powers to make new provisions regarding medicines and medical devices. The Bill is drafted in a way that acknowledges the need to be responsive and flexible with regards regulation, a need that Covid-19 has underscored. Importantly, it also introduces new, and much needed, enforcement provisions – both criminal and civil – for breach of obligations with regards medical devices. Although we note that these provisions were questioned by Dr Phillipa Whitford MP in the second reading of the Bill, and highlighted by the Law Society of Scotland, as being incompatible with the sentencing powers in the summary complaints procedure in Scotland in regards to these breaches. Amendments have been proposed which would rectify this if taken on board.
Other aspects of the Bill are less positive and could see the current regulatory framework become even more complex, unwieldly, and difficult to navigate. With regards to medical devices, the most recent secondary legislation, adopted in December 2019, ensured the continued implementation of the new EU Medical Devices Regulation 2017. However, in doing so this added even more amendments and complexity to the existing UK regulations. The Bill confers the Secretary of State with an extensive range of delegated powers to make new provisions regarding medicines and medical devices, and so risks simply continuing and adding to the current complexity. The Bill is an opportunity to ensure future streamlining of the regulatory framework; something which would be advantageous.
User safety is a key issue with regards medicines and medical devices. Scandals such as the DePuy metal-on-metal hips, PIP breast implants, and most recently the vaginal mesh crisis – currently the subject of the Cumberlege Review (findings still pending) – make the case for strong regulatory oversight. Patients are very vulnerable when medicines or medical devices fail. The Bill does require the Secretary of State having regard to safety, does not establish a hierarchy in relation to other considerations such as the attractiveness of the UK as a place to conduct clinical trials or develop and supply medicines and medical devices. Jo Churchill, Parliamentary Under-Secretary of State for Health, stressed that safety and market attractiveness are not mutually exclusive during Committee proceedings. However, lack of clarity in the wording of the Bill raises questions about assurances that the NHS is not for sale and the government must be clear that safety comes first.
The timing of the Bill raises some questions. In the lead up to October 2019 necessary provisions regarding both medicines and medical devices were introduced via secondary legislation, there was at that time no perceived need to introduce primary legislation to deal with a “No Deal Brexit”. Granting extensive delegated powers indefinitely, as this Bill would, risks inadequate scrutiny and oversight of major regulatory changes. It is something which the Lords Select Committee on the Constitution recently cautioned against. It recommended the use of delegated powers be limited to ‘make provision for minor and technical matters.’
Other issues with the Bill relate to devolution and the future of regulatory unity across the UK. Medicines form part of Northern Ireland’s devolved competences; although they intersect with reserved matters such as consumer safety. In the Bill the Department of Health for Northern Ireland shares delegated powers with the Secretary of State on these matters. These were identified in the UK Government’s list of EU law intersecting with devolved powers. They were also highlighted as areas that required common rules across the UK to be implemented by non-legislative agreement and ones where “consistent fixes to retained EU law (made using secondary legislation) will create a unified body of UK law alongside the non-legislative framework agreement”. It is not clear from this statement, how this will work out in practice. Although the “fix” to existing EU law seems to be accomplished by this Bill, it still leaves open the potential for regulatory divergence.
Clarity on these issues, and a commitment to patient safety could assuage some of the concerns related to this Bill. Amendments tabled by individual MPs that would set a timetable for the introduction of new primary legislation and remove the attractiveness consideration were withdrawn during the Committee proceedings with the caveat that they would be returned to later. These important issues must not be allowed to slip from the agenda.
Prof Muireann Quigley, Professor of Law, Medicine, and Technology, University of Birmingham
Prof Jean McHale, Professor of Healthcare Law, University of Birmingham
Dr Rachael Dickson, Research Fellow, University of Birmingham
Dr Laura Downey, Research Assistant, University of Birmingham