On 23 August 2018, the UK Government began publishing technical notes on the effect of a no-deal Brexit. These notes are intended to provide guidance to citizens, businesses, public sector bodies and Non-Governmental Organisations in the United Kingdom on how to prepare for the possibility of the UK leaving the EU next March without concluding a Withdrawal Agreement. SPICe Spotlight is providing analysis and comparative information on a number of the notices. The first blog provided an overview of the UK Government’s Preparations for a no-deal Brexit.
This article covers three of six technical notes relating to health:
- Batch testing medicines if there’s no Brexit deal
- How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal
- Submitting regulatory information on medical products if there’s no Brexit deal
When these notes were first published on 23 August 2018, the UK Government also provided contingency planning guidance for the health and care sector, which mainly concerns the immediate supply of medicines. This blog focuses on the planning for the continuing regulation of medicines and medical devices in the event of a no-deal Brexit.
- Batch testing medicines
Batch testing is the process of confirming that every batch of medicine is consistent and has the correct composition through laboratory testing. The batch is then certified by a ‘Qualified Person’ confirming that the batch meets the requirements set out in the Marketing Authorisation (licence issued by the Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicines Agency (EMA).
Currently, batch testing can be carried out anywhere, including outside of the European Economic Area (EEA), providing that an EU ‘Mutual Recognition Agreement’ is in place. The batch can then be sold anywhere in the EEA. However, medicines manufactured outside the EEA have to be certified after testing by a Qualified Person within the EEA who has to carry out that certification.
In the event of a ‘no deal’ Brexit, the UK would continue to accept medicines into the UK under the same arrangements as currently until change is deemed necessary. The EU European Medicines Agency (EMA) is relocating from the UK to the Netherlands by March 2019. They detail their own preparations for Brexit on their website.
It is not clear what the situation would be in relation to medicines produced in the UK and sold to the EU. However, the EMA will regard the UK as a third country, and will sever the ties with the MHRA, so it is likely that any medicines produced in the UK would have to satisfy EMA regulatory processes.
- Regulation of medicines, medical devices and clinical trials
The UK is integrated into the EU medicines regulatory network. The network works within a legal framework for human medicines which sets standards for safety and efficacy. Regulations set out a regime for how medicines are manufactured, imported distributed, labelled, advertised, monitored, sold and supplied. The MHRA is the UK regulator, but is part of this close-working network. In the event of no deal, then the UK would cease to be part of the network and the MHRA would take on all the EU functions for medicines coming into the UK, which would require a change to statutory regulations
Medical devices used in the UK are subject to EU legislation, and they use CE marking to show compliance. In the event of no deal, the UK will continue to recognise CE marking until new requirements are implemented. The UK will also comply with upcoming EU Regulations related to medical devices and in vitro diagnostics, being applied in May 2020 and 2022 respectively
These are managed nationally, by the MHRA, although some aspects, such as legal representation or sponsorship might be based in the EEA. In the event of no deal, the relevant regulations will remain in force, modified via the EU(Withdrawal) Act. The UK will align itself with new Regulations not yet in force as closely as possible.
Although this sounds relatively straightforward, the note acknowledges that there will be implications, mainly for medicines regulation, which are partly covered in the note. Consultation by the MHRA on the implications with stakeholders has taken place and consideration is underway.
- New medicines come in under a licensing route overseen by the EMA as Centrally Authorised Products (CAPs). All these will be automatically converted into UK ‘Marketing Authorisations’.
- After exit, all new products will need to be licensed by the MHRA, even if they are licensed by the EMA.
- Any in-progress licensing procedures at time of exit would cease if not at the final stage.
- The MHRA will not have access to data on EU approved generic medicines, so new generic applications would need to be based on products already authorised for use in the UK.
- Medicines for children (paediatric medicines) and medicines for rare conditions (‘orphans’) would require a UK system of regulation to ensure incentives remain to encourage them onto the UK market.
- Primary responsibility for the oversight of medicines will move from the EU level to the MHRA. Formal data and information exchange on medicine safety etc would cease.
- Parallel trade of pharmaceuticals and devices, where goods are under copyright, patent or trademark and are imported into a second market, will continue and work is ongoing to ensure that it remains possible into the future.
Submitting regulatory information on medical products
Currently, as part of the EU, the UK has a place on a number of regulatory networks for medicines and devices, with shared processes and systems. After March 2019, with no deal, the UK would no longer be part of these and would have to create their own arrangements. Information from UK stakeholders would cease to go to the EU networks. Companies would have to apply separately to the EU and UK for trials, medicines, devices etc. The UK intend to continue to accept EU forms and EU standards for submissions to ease the process, but as far as the EU are concerned, they could view the UK as a third country from the point of exit, with no automatic recognition of UK processes. The UK Government plan to have the new arrangements in place before the end of March 2019.
As with medicines, there is no guarantee that the EU will allow UK bodies to remain on relevant registers and networks, and might regard the UK as a third country in all matters involving the regulation and supply of medicines, medical devices and clinical trials.
More information on implications on health and social care from Brexit, and the regulation and governance of medical devices can be found on the SPICe Hub, and on the Health and Sport Committee pages. The Committee ran an inquiry on the Impact of the UK leaving the EU on health and social care in Scotland.
Anne Jepson, SPICe Research