After the Parliamentary vote on the Brexit deal in January 2019, Pharma giant Novartis issued a statement that the risk of a No-Deal Brexit will be “hugely impactful for patients, particularly around the supply and safety of medicines.” Moreover, divergence from the EU regulatory and legal systems would have “far-reaching implications for the way the life sciences sector operates and its ability to develop and deliver medicines for UK patients.”
The Medicines and Healthcare products Regulatory Agency (MHRA) has now issued further guidance documents which can be found in its Brexit collection regarding the regulation of medicines, medical devices and clinical trials in the UK in the event of a No-Deal Brexit. In order to aid the transitional process, this Guidance outlines the MHRA’s broadened scope of powers in a No-Deal situation.
The Department for Business, Energy & Industrial Strategy has also issued guidance for the sector which covers regulation and standards, importing and exporting, employees and data protection.
Contingency legislation is required for the MHRA to take over the regulatory processes for human medicines and devices that are currently undertaken by the European Medicines Agency. Three pieces of draft legislation have been submitted to Parliament for approval,which will come into force on exit day, in order to establish the MHRA as the sole regulator outside of the EU framework and to allow for the continued sale of, and access to, medicines, medical devices and clinical trials:
- The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019: These Regulations will amend the Human Medicines Regulations 2012 by enabling the MHRA to operate as a standalone regulator and for the UK to continue to recognise prescriptions from the EU/EEA. This provision was a direct response to Government concerns that UK patients might not be able to access forthcoming treatments that are currently being assessed by the EMA.
- The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 – These Regulations will amend the Medical Devices Regulations 2002, including to ensure that the UK will have a regulatory system in place on 30th March mirroring (as far as it is possible) the EU medical devices Regulations (and in line with the transitional timetable for the application of those Regulations).
- The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019– in the event of a No-Deal Brexit, the UK’s current participation in the European regulatory network for clinical trials would cease. The MHRA will take on the regulatory responsibilities that are currently undertaken through the EU system. The UK’s current regulatory framework for all clinical trials will remain in force but modified as appropriate. Additionally, the new EU Clinical Trials Regulation (CTR) will not be in force by 29 March 2019 and so cannot be incorporated into UK law on exit day. Accordingly, the government has committed to align, wherever possible, with the CTR when it comes into force within the EU – subject to Parliamentary approval.
All of these Regulations seek to ensure that the existing legislation remains up-to-date and to minimise any disparities between the EU and UK rules; maintaining the equivalent effect of EU legislation within the UK and ensuring that the contingency plans and preparations allow for the continuity of supply and access. The government has also reiterated its priority to ensure UK patients can access all the medicines and products available. The Department of Health and Social Care has released an update on medicines and medical products supply which states that “detailed plans” are being made to ensure continued supply of medicines, incorporating a multi-layered approach to circumvent any supply disruptions or risks (such as reducing the traffic flow between Calais and Dover and building up buffer stocks and stockpiling medicines).
In addition to the three Exit Regulations, The Human Medicines (Amendment) Regulations 2019 came into force on 9 February 2019. Whilst the Explanatory Memorandum confirms that these Regulations are intended to implement certain aspects of the Falsified Medicines Directive (albeit this will need to be revised post-exit, with an evaluation of a UK falsified medicines framework), Regulation 9 also introduces a “serious shortage protocol” which will allow pharmacists to dispense an alternative drug if the one prescribed to a given patient is in short supply. The Explanatory Memorandum states that this provision was not specific to Brexit, but also highlights that “if withdrawal from the [EU] becomes a contributing factor to a serious shortage of prescription only medicines, a serious shortage protocol could be used in such circumstances.”
Concerns have been raised that the proposal was rushed and did not adequately consult with patient and clinical groups. A judicial review challenge has been issued against the Regulations.
EMA Relocation and Practical Guidance 2019
Meanwhile, the EMA’s business continuity plan entered its fourth phase on 1 January 2019. This plan aims to ensure that EMA can continue its core activities whilst physically relocating to its temporary premises (the Spark building in the Sloterdijk area of Amsterdam) and to cope with the anticipated loss of 25% of its total workforce. The move to permanent headquarters, a new building in the Zuidas business district of Amsterdam, is planned for November 2019. The UK Court meanwhile has decided that the EMA is unable to rely upon the law of frustration as a result of Brexit in order to break its lease on its Canary Wharf headquarters (which is not due to expire until 2039, and has no break clause), as discussed in our recent bulletin.
The EMA published an updated Practical Guidance Plan on 4 March 2019 (the Notice to Stakeholders and Q&A document have also been updated) regarding procedural changes post-Brexit for medicinal products for human and veterinary use within the EU framework. The EMA Guidance complements the MHRA Guidance Documents by ensuring that certain changes are made by the withdrawal date. Meanwhile, the EMA is encouraging European MAHs to file any Type 1 Brexit-related variations as soon as possible. It has also issued a letter to Members States’ Heads of the Medicines Agencies, announcing that a closely monitored limited in time exemption will exist to allow MAHs to continue to rely on batch testing conducted in the UK, before it is imported into the EU.