The current situation surrounding the UK’s departure from the EU remains uncertain. At present, following the European Council’s decision to grant the UK’s request for an extension for time, the UK is legally due to leave the EU on 12 April 2019. The potential threat from the Brexit chaos to cause shortages or disruptions to the supply of medicines and medical devices in both the UK and the EU remains one of the critical issues at stake.

UK v EU Medicines Shortages Perspective

EU Position

The European Medicines Agency (“EMA”) has recently published its latest Q&A surrounding the UK’s departure from the European Union, and how this will impact the remaining Member States going forward in relation to avoiding a shortage of medicines in the EU. The Q&A can be accessed here.

In summary, the key points to note from the Q&A are as follows:

· as no withdrawal agreement has yet been agreed between the two sides, the position is unclear regarding the EU’s position to prevent a potential shortage of medicines. If a withdrawal agreement is agreed, then the provision and supply of medicine will continue and the current arrangements will not be affected during the transition period. If no withdrawal agreement is reached, and the UK exits without a deal, then some companies may have to make urgent regulatory changes to remain compliant with their obligations under EU law;

· under EU law, pharmaceutical companies are obligated to perform certain regulatory functions in the EU and EEA, which allows them to sell medicines within it. As a result, if some companies have previously been undertaking these functions in the UK, they will have to make the necessary arrangements to transfer these operations to an EU/EEA Member State to retain this ability;

· whilst the regulatory bodies cannot compel companies to make the necessary regulatory changes, it is in companies’ best interests to put in place the above measures to enable the continued supply of medicines once the UK is no longer a Member State. It is important to note that despite companies taking the necessary steps, there still remains a risk of issues outside the authorities’ control that could affect distribution;

·it is not yet clear which medicines, if any, are at risk of a shortage. The EMA has provided a link to their ‘shortage catalogue’, which is updated as and when;

· Brexit will have no impact whatsoever on the usability of medicines and the safety of them and the evaluation of medicines that are currently being carried out by the UK will be picked up by the remaining EU/EEA Member States; and

· it is important to not over-subscribe for medicines as this will potentially cause an unnecessary strain to the provision of medicines within the EU/EEA area.

UK Position

The Association of the British Pharmaceutical Industry (ABPI), which represents the UK pharmaceutical Industry, has recently called for short term restrictions on the exportation of drugs from the UK to the EU. The principal aim being to safeguard the stock of companies who have stockpiled medicines in the UK in the event of a no-deal Brexit, to prevent delays at the borders:

· the ABPI has raised concerns with the Department of Health over concerns that the drop in the value of sterling has created an opportunity for wholesalers of medicines who have export licences to sell products intended for the use in the UK within the EU, as it could be more profitable; and

· although companies with export licences cover a small proportion of the UK market for medicines, the ABPI is concerned that the disruption Brexit could bring could mean the selling of medicines by these companies could cause shortages for patients.

UK Medical Device Recognition in the Future

The current position surrounding the recognition of UK medical devices in the EU remains unclear, as the two largest healthtech trade associations, MedTech Europe and COCIR have highlighted the risk to patients if an appropriate system is not put in place for the recognition of such devices. In particular, in a recent bulletin by the ABHI, the UK’s largest medtech trade association, they point out the potential impact on the European healthcare system as severe and substantial and that contingency measures need to be put in place to mitigate this risk. Further, as we have previously flagged in this blog, they note:

· UK notified bodies cover between 30-40% of products certified for use in the EU; and

· for certain fields, UK notified bodies cover over two thirds of certified products for use in the EU.

Outside the EU, certain countries are adapting their processes to ensure continuity of recognition of such devices. For example, in Australia, the Therapeutic Goods Administration (TGA) has provided guidance to mitigate the disruption caused, by putting in place measures to ensure the continuity of UK certified medical devices coming to Australia. They note that:

· in the event of a no-deal Brexit, certain legislation will be modified to ensure new applications for the Australian Register of Therapeutic Goods (ARTG) inclusion of UK medical devices; and

· under the UK Prime Minister’s proposed withdrawal agreement, if it is accepted, there will be no immediate impact on the certification of UK medical devices.

Julia Gillert is a Senior Associate in the Corporate Department of Baker & McKenzie's London office and is a key member of the Healthcare industry group within the London office and European and Global networks. Julia advises both domestic and international companies in the med-tech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters. Julia has contributed to a variety of regulatory healthcare related publications and practice handbooks and co-edits the firm's European Healthcare Newsletter. Julia sits on the ABHI's Legal Issues Committee.

Els Janssens is a senior associate in our Abu Dhabi office and provides knowledge management support to Baker & McKenzie’s global and MENA Pharmaceutical and Healthcare industry group. Els started her career in 2000 at Baker and McKenzie in Brussels focusing her practice on pharmaceutical law and commercial litigation. She has worked six years in London as a legal adviser with the European Medicines Agency (EMA). During this period she has supported the EMA’s activities in medicines oversight and regulation and interacted with the European Commission on legal matters relating to medicinal products. She also worked one year as senior legal counsel in Johnson & Johnson’s European legal department providing regulatory advice regarding various medicinal products and supporting the public affairs function on new legislation.