The recent news that a clinical trial for a heart drug was halted due to Brexit concerns have put in sharp focus the significant uncertainty for the industry as a result of a potential no deal. We last reported on Brexit developments in the August edition when we reported on the MHRA's various statements seeking to allay industry fears. The MHRA has now issued a consultation on the future regulatory framework in a 'no deal' scenario, and the government has issued a number of important notices, alongside letters to medicines and medical devices companies to reiterate the contingency planning needed. The EMA also continues to put pressure on the industry to ensure it is ready for 'no deal'. Of course, industry remains hopeful that a deal will be done, including an implementation period until end 2020.
On 4 October, the MHRA issued a consultation on no deal contingency legislation for the regulation of medicines and medical devices, which closed within a tight timeframe, on 1 November 2018. The overall approach is, that in the 'unlikely event' of a no deal, the MHRA will be a stand-alone medicines and medical devices regulator, taking over the decisions and functions currently carried out at EU level, but also looking at new innovative licensing routes, new global partnerships and a competitive fee structure. The consultation is accompanied by draft legal text for 'no deal' statutory instruments, an impact assessment and a document explaining the approach taken to amending legislation.
'No Deal Notices'
The MHRA consultation builds on the government's series of No Deal Notices including:
It is understood that these notices will be updated following the outcome of the MHRA consultation. Key points from the No Deal Notices include:
- Whilst the new EU Clinical Trials Regulation will not apply to the UK (assuming there is no implementation period until end 2020), the government will align where possible with the Regulation without delay (subject to usual Parliamentary approvals).
- All centrally authorised Marketing Authorisations will automatically be converted into UK MAs on 29 March 2019 (subject to opt-out), and MA holders will have a period of time to provide MHRA with baseline data.
- Post-exit, it will be necessary to make an MA application to the MHRA but the MHRA will take a 'streamlined approach', and where licensing procedures are in progress at the time of exit, it will 'take EU decisions into account where possible'.
- New generic applications will have to be based on reference products that have been authorised in the UK.
- Consultations will be issued on the MHRA's approach to pharmacovigilance, orphan medicines, proposals for a UK Paediatric Investigation Plan and any changes required in relation to packaging and leaflets.
- The UK will unilaterally align to the EU/EEA exhaustion regime for parallel imports on exit day in order to provide continuity for imports into the UK. As discussed in our recent bulletin, many questions in relation to parallel imports remain unanswered, and again a consultation will follow, alongside a research programme.
- For a time limited period, the UK will recognise medical devices approved for the EU market and CE-marked, with further detail being the subject of consultation.
- Also for a time limited period, the UK will continue to accept batch testing of medicines carried out in countries named on a set list, which will include EU/EEA countries and those third countries with which the EU has a mutual recognition agreement. Further details of the batch testing requirements are in the Notice.
- Legal presence requirements:
- Clinical trials: the Notice says that while the UK will preserve the requirement that a sponsor or legal representative should be based in the EU/EEA, it is anticipated that it will be necessary to have an individual in the UK.
- Marketing authorisation holders: should be established in the UK by 2020 but until then a contact in the UK will be required.
- Qualified Person for Pharmacovigilance: the QPPV should be established in the UK from day one but those without a current UK presence will have until the end of 2020 to establish one (provided certain requirements are met).
Letters to the industry
In August, Matt Hancock, the Secretary of State for Health and Social Care, wrote two letters to the industry setting out the necessary contingency planning steps for a no deal scenario. This includes ensuring that 'stockpiles of medicines are adequate to cope with any potential delays at the border that may arise in the short term' – by ensuring that the UK has an additional six weeks' supply of medicines in case imports from the EU are affected. Of course, what this means is that the industry has to ensure it has a minimum of such stocks available, over and above what it usually maintains by way of an operational buffer. As for products with short shelf lives, the Government asks relevant suppliers to arrange plans to air freight those products.
Earlier this year, the EMA carried out a Brexit preparedness survey, which indicated concerns about potential supply shortages for 108 medicines. It has however now reduced this number down to 39 centrally authorised products and continues to analyse how to minimise supply disruptions and any resulting impacts.
It has also identified cut-off dates for the MHRA/Veterinary Medicines Directorate to participate in a number of activities and confirmed that it has entered, as from 1 October 2018, the third phase of its Business Continuity Plan which includes the temporary suspension or reduction of a number of activities to allow for redeployment of resources. This is necessary given that the EMA currently expects a staff loss of about 30% as a result of the forthcoming move to Amsterdam.