Business as usual
After Brexit (2019+) the impact upon the life sciences and healthcare sector largely depends upon what model the UK adopts for its relationship with the EU. If the UK remains in the European Economic Area (EEA), then the changes may be minimal. If the UK joins the European Free Trade Association (EFTA) and negotiates sector specific access to the single market, then the landscape depends on the exact nature of that relationship. If the UK distances itself further from the EU, then the changes may be more extensive.
Whatever the relationship ultimately is, the UK has a strong track record in the life sciences and healthcare sector with tax incentives, investment and funding, R&D and other key drivers high on its agenda. We would expect that to continue. The UK accounts for approximately 25% of the EU market and will remain a key market. Switzerland (which is not in the EU) is a prime example of how the sector can develop effectively outside of the EU.
In terms of specific key areas, the precise changes remain to be seen. However, the below are some of the possible issues. We will keep you updated as matters develop.
The current clinical trial regime in the EU is due to be overhauled by the new EU Clinical Trials Regulation (No 536/2014) which is expected to be in force by October 2018. The new Regulation will modernise the current framework for clinical trials and ensure a greater level of harmonisation within the EU. The new Regulation, which provides for a single application for clinical trials across the EU via a single portal with an associated EU wide database, is designed to significantly reduce administrative burdens on applicants and allows for a simplified process where the investigational medical product poses less risk.
If the UK is not within this system, then this could pose extra administrative burdens on companies wishing to conduct multi-centre clinical trials in the EU and the UK. Separate centralised and national clinical trial authorisation procedures need to be followed. However, mutual recognition arrangements may be arranged to minimise any such inefficiencies brought about by Brexit.
Regulation of quality assurance of medicinal products
Regulation is managed at a national level. In order to ensure that high quality standards are maintained in respect of medicinal products for consumption in the UK, they must be manufactured in accordance with UK laws based upon EU Directives which lay down the principles of good manufacturing practice (GMP). This requires all manufacturers and importers of medicines located in the EEA to hold a manufacturing authorisation. The medicines regulatory authorities in each EU member state carry out periodic checks to ensure that GMP is being complied with. The current UK/EU GMP are similar to those within other developed countries such as the USA.
Even if Brexit resulted in the UK being outside the EEA, manufacturers in the UK would be able to continue exporting medicines to the EU and vice versa so long as the UK and EU regulatory frameworks remain equivalent. The UK is likely to maintain the GMP standard in order to facilitate mutual recognition agreements with the EU and other trading partners and aid imports into those areas. The cost of imports into the EU from the UK may, however, increase if additional checks would be required for non-EU imports.
Obtaining marketing authorisations
All medicines must be authorised before they can be marketed and made available to patients in the EEA. There are two main routes for authorising medicines: a centralised route and national routes. Via the centralised route a single application is submitted to the European Medicines Agency (EMA) and a single marketing authorisation is obtained. Once granted a centralised marketing authorisation is valid in all EU Member States as well as in the EEA. The authorisation holder has to be situated in an EEA state.
Following Brexit, if the UK is outside the EEA then a separate national authorisation would need be obtained for the UK. There could be an increased administrative burden of separate applications in the EU and UK. However, EU marketing authorisations could be taken into account (as they are in Switzerland) and the systems are likely to stay aligned. The European regulator, the EMA, is situated in London and it is expected to relocate to the EU.
EU legislation which governs the procedures for pharmacovigilance throughout the EU is comprehensive, calling for prompt collection of data, adverse reaction reporting, risk management, and transparency on marketing authorisation holders, national competent authorities and the EMA. The EU pharmacovigilance system is coordinated by the EMA which ensures effective and coordinated analysis, evaluation of risk, information sharing and periodic checks on market-authorisation holders throughout the EU.
Following Brexit, the UK competent authority would have smaller data sets than those in the EU, and the EU would be deprived of data from the UK. If Brexit results in less co-operation and sharing of expertise and information, the resulting pharmacovigilance would be less efficient and more costly. However, whether that transpires is debatable. These are issues directly relevant to public safety, the benefits of co-operation are clear and the EMA is a close partner of its UK equivalent.