On 29 March 2019, the United Kingdom will leave the European Union.
Unless the current negotiations set another date or provide for a transitional period, the EU-regulations will no longer apply to the United Kingdom, which will be considered a third country to the European Union as from 30 March 2019.
The (very likely) scenario of a hard Brexit would have repercussions on “more than 3,000 medicines” exported or imported from France to the United Kingdom. The professional organisation of pharmaceutical companies operating in France (LEEM) points out that the United Kingdom is France’s 4th largest export and 7th largest import trading partner and that a hard Brexit would pose customs and regulatory problems for trade in medicines.
In anticipation of a major drug shortage, following the « Yes referendum », some pharmaceutical groups had begun to accumulate drug reserves. Now the British government is stockpiling the equivalent of six weeks’ worth of treatments, which will cost an additional €2.2 billion according to the anti-Brexit organisation Best for Britain. But it will not only be the British who will suffer. The European Medicines Agency (EMA) is concerned about the availability of some of the 108 medicines manufactured exclusively in the United Kingdom. Every month, 45 million boxes of medicines are shipped from the British Isles to the EU.
Thus in France, the ANSM reminds MA holders that they must ensure an appropriate and continuous supply of the national market, and take all necessary measures to prevent and remedy any supply difficulties. To this end, and whatever the origin, they must inform the ANSM without delay of any shortage or risk of stock shortage on drugs of major therapeutic interest.
Another consequence: All medicines sold in Europe are subject to a long authorisation process before they are made available to health services. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) generally studies and authorises 20-30% of European medicines.
In 2018, for the centralised procedures (https://www.ema.europa.eu/en/about-us/uks-withdrawal-eu/brexit-related-guidance-companies#centrally), the EMA set up a procedure for the reallocation of files. Countries were asked about resources and their capacity to take on more cases. The dossiers for which the United Kingdom is currently rapporteur have been proposed by the EMA to the other Member States; the EMA has designated “target” countries. France accepted almost all the proposals submitted to it in the first round.
For other MA procedures (national, MRP, DCP) (http://www.hma.eu/535.html) the distribution of cases for which the United Kingdom is the reference Member State is monitored by the CMDh (Co-ordination Group for Mutual Recognition Centralized Procedures – Human).
Another consequence of Brexit is that the EMA, which has been based in London since its creation in 1995, is moving to Amsterdam because it has to transfer its headquarters to a European country. This transfer could lead to delays in drug evaluations carried out on behalf of pharmaceutical companies, and therefore to a loss of revenue.
Sources: https://www.leem.org ; https://www.ansm.sante.fr