The first wave of the UK Government’s no-deal Brexit guidance has more to offer the life sciences sector than most others. Five of the 25 documents focus on medicines, blood products, organs, medical devices and clinical trials.
You may also be interested in other documents in this collection, such as that which considers the EU research funding programme Horizon 2020 and the regulation of GMOs - these are not discussed further in this article.
The guidance issued emphasises that the Government is working hard to reach a deal with the EU, and believes that this is achievable. However, the possibility of a no-deal Brexit stays on the cards until a UK/EU withdrawal agreement is settled and ratified. With that possibility in mind, the Government is offering planning guidance to industry to prepare for the no-deal scenario. This can be contrasted with the guidance published a few weeks ago on preparation for the implementation period and beyond, assuming that an withdrawal agreement is reached.
What does the new guidance cover?
The guidance for a no-deal scenario relating to the life sciences sector covers the following areas:
The papers dealing with organs, tissues and cells, and with blood and blood products outline a fairly limited set of changes that would follow a no-deal Brexit. These areas are harmonised by EU Directives, implemented nationally through UK regulations. These regulations will remain largely unchanged, at least initially, through the operation of the Withdrawal Act 2018. The UK will become a “third country” after 29 March 2019 for the purposes of this area of law, and new arrangements such as written agreements to cover import and export of human tissues and cells will be needed. Affected organisations are encouraged to consult with the relevant regulators for support, and more detailed information will follow.
The papers addressing regulation of medicines, medical devices and clinical trials, submitting regulatory information and batch testing of medicines are more complex. Regulation in these areas is already closely harmonised across the EU, with the involvement of central EU organisations (such as the European Medicines Agency), and are subject to ongoing change. As above, existing EU law will be largely replicated in UK law through the operation of the Withdrawal Act. New EU laws that are agreed but not yet in force (e.g. the new regulations dealing with medical devices and clinical trials) will not, although the UK Government intends to implement their main provisions.
However, some major changes would follow a no-deal Brexit. The UK’s role as a participant in and beneficiary of the central EU systems and structures would fall away entirely in a no-deal scenario. Separate UK approvals and authorisations would be needed for products benefiting from an EU-wide authorisation (such as an EU market authorisations for medicines).
The guidance promises recognition at least in the short term for already-authorised products (recognition of CE-marked medical devices and automatic conversion of market authorisations for Centrally Authorised Products (CAPs), for example) and would accept batch-testing carried out in an EU or EEA country. But businesses would need to deal directly with the MHRA for all UK market issues, and would need to apply to the MHRA for approval of new products intended for the UK market. Market authorisation holders could be EU based until the end of 2020, after which transfer to a UK-established MAH would be required. New generic applications will have to be based on reference products authorised in the UK, as the MHRA would not have access to EU data.
A consultation process is planned for early autumn, to invite views on how these changes will work in detail with a more comprehensive technical notice to follow. Although Government engagement with what are detailed issues is welcome, it is late in the day and leaves little time for planning. We will continue regularly updating this blog as matters continue apace.