The UK Government issued the first batch of its Brexit “No Deal” Technical Notes on 23 August 2018. These are designed to provide guidance to businesses and other interested parties on how to deal with the problems that a “no deal” scenario will throw up i.e. if the UK exits the EU at the end of March 2019 with no transitional arrangements in place.
There were 25 notes released in this initial batch (see Herbert Smith Freehills’ general commentary here). Over 50 further technical notes are expected to be published before the end of September.
Of the first notes issues, those that will be of particular interest to life sciences businesses include:
More detail on each of these is provided below.
- Regulation of medicines, medical devices and clinical trials
- The UK Government’s July 2018 White Paper set out the Government’s proposal to explore the terms on which the UK could remain part of the European Medicines Agency (EMA). However, UK participation in the EMA will cease at Brexit if there is “no deal” and in that scenario the MHRA would take on the functions currently performed by the EMA in relation to medicines on the UK market (there will be a consultation on necessary changes to the law to allow this, in early Autumn 2018).
- New medicines which are already centrally authorized in the EU will automatically get a UK MA on 29 March 2019, unless the MA holder opts out.
- Unless and until the UK rejoins the EMA system, an MA application will have to be submitted to the MHRA for national assessment in order to market a new medicinal product in the UK after the UK leaves the EU.
- MA applications which are pending in the EU system on 29 March 2019 will have to be restarted by way of a separate application to the MHRA for UK marketing authorisation.
- As the MHRA will not have access to data provided by MA holders in support of EU approved products, the note indicates that new generic applications after Brexit will have to be based on reference products that have been authorized in the UK.
- Medical devices
- The UK will recognize EU-approved devices in the first instance, with a consultation on longer term arrangements to follow.
- The UK will comply with “all key elements” of the EU Medical Devices Regulation and In Vitro Diagnostic Regulations when they come into force.
- Clinical trials
- The note indicates that the UK will seek to “align where possible” with the EU Clinical Trials Regulation when it comes into force.
- The general message is that arrangements will be made with the aim of minimising the disruption to clinical trials.
- This is just a brief summary of the guidance provided in the note, which goes into much more specific detail which will need to be considered carefully by any company wishing to sell medicines or medical devices in the UK, or run clinical trials, after the UK leaves the EU.
- On the same day that the guidance notes were published, the Secretary of State for Health and Social Care (Matt Hancock MP) wrote to pharmaceutical companies asking them to ensure that by 29 March 2019 they had stockpiled supplies in the UK for an extra six weeks over their usual stock levels. The Government has asked pharmaceutical companies to confirm their plans on a product-by-product basis and to draw up additional contingency plans for medicines meeting certain requirements. A similar letter was also sent to suppliers of medical devices and clinical consumables, and the Government published more detailed guidance for MA holders to consult regarding contingency planning.
- Batch testing medicines The UK Government has indicated that it hopes to ensure that products only need undergo one approval process for their sale in the EU and the UK after Brexit however, as discussed above, if there is no deal then the UK would not be part of the EMA. In this note the UK Government has said that in the event of ‘no deal’ it would continue to accept batch testing of human medicines carried out in certain countries (yet to be named by the MHRA but to include at least initially EU and EEA countries and third countries with which the EU has a mutual recognition agreement). The UK will also continue to accept batch testing of substances in medical trials (IMPs) manufactured in the EU and EEA states. For human medicines and IMPs, those manufactured in the UK (or a third country and imported direct into the UK) would still require a UK-based qualified person (QP) to certify batches and ensure compliance with marketing authorisations (MA) and good manufacturing practice (GMP) guidance. Where manufacture occurs in a third country, but importation is from certain countries (yet to be identified by the MHRA, but to include initially EU and EEA countries), certification, release and assurance of compliance with MA and GMP guidelines will be recognised, if conducted by a QP based in that listed country, without the need for further certification. There would be at least 2 years notice for any changes to this arrangement.
- Submitting regulatory information on medicinal products If there is no deal then the UK will cease to be part of the EU medicines and medical devices regulatory networks. Sharing of common systems and the data associated with them would end. New IT systems are being developed for March 2019 to allow the UK to manage regulatory activities around human medicines and devices. Under this system regulatory information would have to be submitted directly to the MHRA which would set up a new national portal for this purpose. The aim is to minimise the impact on stakeholders eg by accepting EU application forms and standards and following existing processes. The new systems will be put out for testing before March 2019 and training will be provided if necessary.
- Horizon 2020 funding
- If there is ‘no deal’, the Government says it has taken steps to provide continued support for research and innovation currently being funded through this EU project fund. The Government will guarantee funding in most cases relating to successful bids submitted by UK participants before the UK exits the EU, for the full duration of the project. Funding will only be for UK participants however. Where UK participants are leading consortia of non-UK parties and would normally be distributing the Horizon 2020 funds, the Government will seek to discuss with the EU Commission how best to address this. Also for discussion is the impact of any change in status of the UK from a member state to a third country on compliance issues with Horizon 2020 rules. The UK Government’s guarantee additionally covers funding for successful bids, where UK organisations are able to participate as a third country in competitive EU grant programmes. This extension runs from exit day until the end of 2020. nb: Third country participation does not extend to some Horizon 2020 calls, including European Research Council (ERC) grants, some Marie Sklodowska-Curie Actions and the SME instrument.
- The Government is considering what other measures may be necessary to support UK research and innovation in the event that the guarantee and the extension are required. Looking beyond 2020, the UK remains committed to ongoing collaboration in research and innovation and wants to work with the EU on a mutually beneficial outcome. The Government’s plan for the future relationship between the UK and the EU was set out in its White Paper, mentioned above, including the proposal to form a cooperative accord with the EU on science and innovation.
- Actions for businesses and other stakeholders: UK Research & Innovation will be developing systems to ensure payments to beneficiaries of Horizon 2020 funding can continue. Current UK recipients of Horizon 2020 funding will soon be invited to provide initial data about project(s) on a portal hosted on GOV.UK. The guidance states that the portal will remain open after the UK leaves the EU, so that UK applicants can continue to register, as and when, they are informed that their bid has been successful. More information on the portal is available on the UKRI webpage.
What now? As the clock ticks down to 29 March 2019, the UK and the EU are stepping up their preparations for the possibility of a “no-deal” outcome. From a corporate governance and risk management perspective, businesses that have not done so already, should carry out a Brexit assurance process in order to identify all Brexit-related risks and, to the extent practicable, take appropriate and timely steps to respond to them. This article summarises at a high level the kinds of issues more generally that we are coming across in helping clients plan for a ‘no-deal’ Brexit. It supplements our pamphlet, Delivering Brexit: Putting Plans into Practice.