Is your patient organisation concerned about Brexit? It should be!
Brexit is a daily topic of discussion in the “Brussels bubble”. But perhaps surprisingly, its seriousness for the remaining 27 EU Member States has gone relatively unnoticed.
However, Brexit will have an impact beyond the UK itself. In the past year EPF has been working actively as part of an informal coalition of stakeholders, to inform political decision-makers with the aim of preventing any possible negative implications of Brexit for European patients. In this article we take a closer look at the implications of Brexit for patients and show what patient organisations can do in their own countries to help minimise negative effects.
What is Brexit and why does it matter?
On 29 March 2017 the United Kingdom notified the European Council – the heads of EU Member States – of its intention to leave the EU, following the referendum held in June 2016. This is in accordance with Article 50 of the Treaty on European Union (TEU). No Member State has ever done this, so there is no precedent for such an agreement. The UK will leave the EU on 30 March 2019, after which there may be a transition period, depending on what agreement is reached between the UK and the EU.
There are several possible changes that can affect patients post-Brexit. Given this, the lack of clarity regarding the exact consequences is striking. This unclarity stems from the very slow process until now, and the many remaining question-marks that the sluggish negotiations have left us with.
What might change, and how can it affect patients?
Concrete changes can be anticipated in several fields, ranging from clinical trials and medical research generally, to patients’ rights and to the supply of pharmaceuticals and medical devices in the EU.
Clinical trials. At the moment, the UK plays a vital role in conducting clinical trials, and many UK-based patients participate in trials that benefit all EU citizens. It is vital that the UK continues to apply the EU Clinical Trials Regulation which is due to come into application in 2019. Unless the final agreement between the EU and UK makes this possible, there could be an interruption or delays in the supply of investigational medicines needed for trials, due to possible future barriers to the free movement of goods. This can also affect trials in the EU27. The UK’s future involvement in the EU Regulation should therefore be fully explored. This should include granting UK-based organisations access to the EU clinical trials e-portal and databases.
The Commission published a notice to stakeholders on clinical trials rules which explains what will happen unless otherwise agreed.
Authorisation of medicines. When it comes to the authorisation and production of medicines, the UK has played a very active role, often being the rapporteur or co-rapporteur on assessments of medicines. In 2016 the UK was the most active EU Member State. This represents a significant amount of scientific expertise.
Because of Brexit, the European Medicines Agency is forced to relocate its operations from London to Amsterdam by 30 March 2019. The EMA is doing significant preparation and dedicating huge resources to ensuring that it will be able to continue its core business during and after the relocation process. The EMA is working based on the scenario that the UK will become a “third country” as of 30 March 2019, and will no longer be able to engage as (co)-rapporteur for new marketing authorisation applications (not knowing the results of the negotiations). The workload is already being distributed between other Member States. Nevertheless, it is clear that the capacity of the EMA will be negatively affected, in particular for those activities which are not designated as “core priorities) but still an important part of its responsibilities.
Medical devices. According to the British Standards Institution, around 45% of all medical devices CE-marked in Europe used UK notified bodies for their conformity assessment; and 70% of non-EU based manufacturers use the services of UK notified bodies as a springboard into the EU. Unless a solution is found, UK notified bodies will no longer be able to operate in the EU27. This might have a significant impact in the availability of medical devices for EU patients.
Shortages. Shortages of medicines are an issue in many EU countries, and are not per se related to Brexit. However, Brexit may worsen the problem. EU law requires that the company having an EU marketing authorisation for a medicine needs to be based in the European Economic Area, as do its responsible for pharmacovigilance, and certain manufacturing sites) in order for the company to be able to market the medicine in the EU. Now companies are adapting their processes, logistics, supply chains and contracts, or possibly relocating some manufacturing sites to ensure that the marketing authorisation remains valid. The European Medicines Agency is continuing to monitor the issue and aims to take steps to correct any imbalances in the system. As of 24 September, there were concerns around 39 centrally authorised medicines.
Patients’ rights and cross-border healthcare. It is unclear to what extent the current reciprocal arrangements with regard to healthcare, for example, will continue under the new relationship. This topic is addressed under the broad heading of citizens’ rights. Currently it looks like some reciprocal arrangements are agreed, at least during the transition.
What if there is no deal?
The Commission has urged stakeholders, such as the pharmaceutical and medical devices industries, to develop contingency plans in case the UK “crashes out of the EU” without a deal. This may not be the most likely scenario, but it also cannot be ruled out. Much depends on UK internal political developments. British politics has become unpredictable.
What is EPF doing?
The EU and UK patient organisations speak with a single voice. EPF will continue to call for guarantees that no patients across Europe will suffer negative effects as a result of Brexit, regardless of the outcomes of negotiations. We will make efforts in reiterating this message to both the UK government and the European Commission – they have a responsibility to ensure there is no adverse impact on patients.
Patients throughout Europe should continue to participate in international clinical trials; have speedy access to medicines, medical devices and any innovation; and most importantly, not have their safety compromised in any way.
The key asks:
In July 2018, EPF met with representatives of the European Commission’s Article 50 Task Force (which is in charge of negotiations with the UK), together with Cancer Research UK and our members AMRC (UK) and IPPOSI (Ireland). We voiced the concerns of UK and EU patient organisations and urged the Commission to ensure that patients are at the table when decisions are made. Our views should be included in the political declaration of the future relationship between EU and the UK, due to be finalised before end of 2018.
The Commission shared information with us on the specific work streams of the Task Force that are relevant to patients. As a result of our meeting, the Commission promised to publish a notice to stakeholders on clinical trials, similar to the one it had already published on pharmaceuticals. The notice was subsequently published on 6 September.
What can EPF member organisations do?
Although the European Commission is responsible for negotiating with the UK, ultimately it is the Member States will need to agree to any political agreement. The uncertainties relating to the future relationship, including the length of any transition period and what happens during and after this, are not likely to be resolved soon. The first agreement – the political declaration - will be a “divorce agreement”, after which specific issues will need to be ironed out sector by sector.
We believe our member organisations across the EU Member States can and should make the views and concerns of patients known to their national governments, as this might be an effective way of influencing their positions in the negotiations.
For more information please contact Kostas Aligiannis, email@example.com
- European Commission Brexit webpage
- European Medicines Agency Brexit webpage
- Brexit Health Coalition joint statement – co-signed by EPF
- Brexit infographic
- Brexit notices from DG Sante