The UK government has published several guidance documents on how to prepare for Brexit in the event of a "no deal" scenario (i.e. if the UK and EU do not agree a future trade deal and the proposed post-Brexit implementation/transition period does not go ahead).
Several of the documents are relevant to pharmaceutical and medical device companies, including:
- Medicines supply contingency planning programme
- 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
- Batch testing medicines if there's no Brexit deal
- Ensuring blood and blood products are safe if there’s no Brexit deal
- Quality and safety of organs, tissues and cells if there’s no Brexit deal
While much of the information contained in the guidance simply confirms the known or expected position, the documents do contain new information on a number of points, such as how the UK would handle issuing UK marketing authorisations (MAs) for medicines authorised at an EU level via the centralised procedure, and timelines for moving MA holders and QPPVs for UK MAs that are currently based in the EU to the UK.
The key points in the guidance documents include that in the event of a "no deal" scenario:
- The Department of Health and Social Care (DHSC) is working with relevant MA holders that supply medicines to the NHS from or via the EU/EEA to ensure they have a minimum of 6 weeks' additional supply of medicines for the UK over and above their usual operational buffer stocks, to help mitigate any resulting supply disruptions. For products with a short shelf life that cannot be stockpiled and are currently imported to the UK from the EU/EEA via road, sea and/or rail, suppliers should have plans in place to air freight those products if necessary.
- The UK would no longer be part of the EU regulatory network, systems or data exchanges. The MHRA would take on the functions currently undertaken by the EMA for medicines on the UK market. All regulatory information relating to medicines and devices on the UK market would need to be submitted directly to the MHRA via a new national portal. The MHRA would continue to accept applications using the current EU forms and the eCTD.
- MAs for centrally authorised products would be automatically converted into a UK MA on Exit day (29 March 2019). The MHRA would write to those MA holders in advance giving them the opportunity to opt out of receiving an automatic UK MA.
- The UK would no longer be part of the EU centralised, mutual recognition or decentralised procedures for authorising medicines. Existing medicines that received a marketing authorisation for the UK via the mutual recognition or decentralised routes prior to 29 March 2019 will be unaffected as they already hold a national UK MA.
- For new applications via the centralised procedure, a separate UK MA application would be required for the UK market. This application process would be "streamlined" with the aim of issuing the UK MA at the same time as the EU MA.
- For applications via the centralised procedure in progress on Exit day, the EMA application would need to be resubmitted to the MHRA, which would take into account the EU decision on the application when assessing the UK application. For mutual recognition or decentralised procedures in progress at time of EU Exit it is proposed that a transitional provision will be made for mutual recognition or decentralised procedures in progress immediately before Exit day. These procedures currently already result in a national MA.
- Data and marketing exclusivity for MAs would not change and would still be calculated based on the date of authorisation of the product in the EU or UK, whichever is earlier.
- The MHRA would no longer have access to the data for EU approved products so new generic applications for the UK market would need to be based on a UK authorised reference product. Existing MAs for generic products based on a reference product authorised in an EU country would remain valid.
- For UK MAs held by a company in an EU/EEA country, this would need to be moved to an entity located in the UK by the end of 2020.
- Where the QPPV for a product is currently based in an EU/EEA country, a QPPV in the UK would be needed by the end of 2020 (but the MHRA would need to be able to access relevant safety data from the EU QPPV from Exit day).
- The UK would continue to accept batch testing of medicines and investigational medicinal products carried out in countries named on a list to be created by the MHRA, which would include EU and EEA countries, as well as third countries with which the EU has a mutual recognition agreement. The UK would also continue to recognise certification, release and assurance of compliance with the marketing authorisation and GMP conducted by a QP based in a country on that list.
- The UK would continue to accept packaging and leaflets for UK products that also include information for other countries.
- The UK would no longer be part of the EU system for sharing pharmacovigilance information. The MHRA would take on primary responsibility for overseeing pharmacovigilance activities relating to UK MAs and UK MA holders would need to submit pharmacovigilance data directly to the MHRA.
- The UK would continue using EU GMP and GDP guidelines.
- The current clinical trials requirements in the UK would remain the same. The new EU Clinical Trials Regulation would not be automatically incorporated into UK law on Exit day but the UK would align with the requirements of the CTR as far as possible "without delay". The MHRA is currently piloting a streamlined process involving a single application and single decision for authorising UK trials by both the MHRA and relevant ethics committee.
- Sponsors or legal representatives could continue to be based in the EU/EEA but there would need to be an individual based in the UK with responsibility for the trial who could be contacted in the event of an issue relating to the trial.
- The UK would continue current incentives for paediatric and orphan medicines, and would consult on future arrangements for such products.
- The UK would unilaterally align to the EU/EEA exhaustion regime for parallel imports and convert all currently approval parallel distribution authorisations for centrally authorised medicines into parallel import licences.
- Online sellers of medicines in the UK would no longer be able to register for and display the EU common logo for online sellers, but the UK would likely require a new UK logo to be used from 2021.
The guidance provided in the notes in relation to medical devices is notably much more limited than for medicines:
- The UK would continue to recognise medical devices that are CE marked and placed on the EU market for "a time-limited period", including where the device has been certified by a Notified Body in the EU. Any future change to this position would be subject to consultation.
- UK Notified Bodies would no longer be able to assess the conformity of devices for the EU market. This means that they will no longer be able to issue CE Certificates of Conformity.
- The UK would align with the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR) as far as possible.
- The MHRA would continue to carry out national post-market surveillance on devices on the UK market. The Agency would also take national decisions concerning the marketing of a device in the UK, regardless of the position of the European regulatory network, or any decision of the CJEU.
- The UK would no longer be formally involved with any EU committees relating to medical devices.
A number of the other guidance notes issued by the government on the same day also contain points that are relevant to life sciences companies, including "Horizon 2020 funding if there's no Brexit deal" (the Government would ensure that recipient of Horizon 2020 funding continue to receive funding, subject to certain conditions) and "Trading with the EU if there's no Brexit deal" (customs declarations would be needed to import/export goods with the EU).
The guidance documents stress that the UK government is working to agree a trade deal with the EU and that position set out in the guidance notes only applies in the event that such a deal is not reached. The information provided in the guidance documents is helpful in informing companies' "worst case scenario" planning and provides answers to at least some of the questions that life sciences companies are currently considering as they prepare for Brexit.