Amongst the many uncertainties thrown up by the Brexit vote on 23 June 2016, is the impact of the UK leaving the EU on the regulatory regime governing the granting of marketing authorisation ("MA") applications for medicinal products, as well as, the implications for the CE marking system for medical devices.
Currently there are four routes through which an MA for a medicinal product can be obtained: (i) the centralised procedure; (ii) the decentralised procedure ("DCP"); (iii) the mutual recognition procedure ("MRP"); and (iv) the national procedure. The first three are governed by EU law, under the centralised procedure MAs take effect across the entire EU and DCP, and MRPs require cooperation between the national competent agencies of the EU Member States.
In relation to medical devices, the CE marking regime is based upon three European Directives that have been implemented in the UK. Two of these Directives are due to be replaced by two European Regulations in 2017, and it is highly likely that these will take effect in the UK before the terms of Brexit have been agreed with the EU.
The UK's decision to leave the EU will necessarily impact upon the way in which these procedures and regimes operate. The precise extent of the impact will not be clear for some time, and will depend upon the negotiations between the UK and the remainder of the EU after Article 50 has been triggered, as well as the nature of the UK's relationship with the EU once it leaves. Predicting with any certainty how these issues will manifest is clearly very difficult, and we do no seek to do so here. Instead we highlight a number of the key questions to consider and provide some initial comments on where the Brexit negotiations could end up in relation to the life sciences sector.
First, when considering any future Brexit negotiations in the context of the life sciences sector, it is important to note the following facts:
- The UK is a sizeable life sciences market within the EU and applicants will be likely to want to have MAs in both the EU and the UK. Adopting a system in which completely separate applications are needed will increase the costs for applicants as well as the workload of the MHRA and EU regulators.
- The MHRA is a well-respected regulator for both medicines and medical devices. It often takes the role of the Reference Member State ("RMS") during DCPs, and frequently carries out assessments on behalf of the EMA. If the MHRA was not available to provide that role, it would put additional pressure on other EU regulators and may impact on the experience and expertise available to applicants in the current EU system.
- It is unclear what would happen to MAs that had been granted through MRPs or DCPs where the MHRA had been the RMS. In these circumstances, the MHRA will hold the dossier and will have carried out the assessment. These functions will need to be transferred if the UK is not able to take part in these procedures going forward, and that too would put additional pressure on other EU regulators (and on the MHRA to transfer those assessments). The same is true where the MHRA is a Concerned Member State ("CMS"), but in such cases the impact will only be on the MA in the UK.
- Any medical device manufacturer will want to be able to place their CE marked device on the UK market, and will not want to go through separate procedures for the UK and the EU.
Taking all of these points into account, it is clear that there would be a benefit to both the applicants and the regulators of MAs for the MHRA to remain part of the centralised procedure, DCP and MRP post-Brexit. The question remains whether or not it is possible to achieve this, which will depend upon the precise nature of UK's future relationship with the EU and the exit deal that is concluded.
Drawing from current relationships between some non-EU States and the EU, there are a number of possible models that the UK could follow post-Brexit. For instance, European Economic Area ("EEA") states (Iceland, Liechtenstein and Norway) are able to participate in DCP and MRPs, and centralised MAs also apply in those countries. So if the UK became a member of the EEA then the route is well-trodden, but is membership a likely option given the need to accept free-movement of people?
Switzerland, on the other hand, is a European Free Trade Association ("EFTA") state (like Iceland, Liechtenstein and Norway) and although it has access to the free market, it does not participate in the regulatory procedures. Something more than a trading agreement with the EU will be needed in order for the UK's role in the regulation of medicines and medical devices in Europe to be maintained. What that would look like, however, is unclear at this stage.
We believe that there is reason to be optimistic that a negotiated solution will be reached in which the efficiencies of the current systems are maintained, not only because such a scenario would benefit the EU and the users of the system as well as the UK, but also because the UK life sciences sector enjoys an excellent reputation globally and so its continued pre-eminence, and easy accessibility, is likely to be a priority for the UK Government.
In the meantime, the MHRA has – encouragingly – made it clear that "taking a full, active role in European regulatory procedures for medicines remains a priority" (Read the full statement).