Brexit and the potential impact on patients access to medicines and medical devices
The Brexit clock is still ticking, and we are now only a year from the UK becoming a third country. The agreement on the transition period and guidelines adopted by the European Council on Friday are critical, setting out the political will to ‘initiate work towards a balanced, ambitious and wide-ranging free trade agreement’.
However, nothing is agreed till everything is agreed. This means it will be the end of this year until companies know with absolute certainty, the amount of time they have to prepare until the UK leaves. EFPIA therefore continues to advise its members to prepare for every scenario and ensure that they have the right plans in place, so that patients across Europe and in the UK continue to access the medicines they need.
For medicines, 45 million patient packs go to the EU from the UK every month, and 37 million patient packs go from the EU to the UK. Products are developed in complex supply chains from across Europe.
The Brexit Health Alliance showed in a case study what potential impact Brexit could on the availability of medicines for prostate cancer patients. The manufacturer of this product has begun planning the duplication of quality testing and release facilities in an EU27 location.
However, the calculated duplication time for the manufacture and quality control testing is at least 42 months, with a risk of taking longer. This would affect the supply of this cancer treatment to patients, including up to 120,000 European patients each year.
Due to the technical complexity of the analytical methodology and specific equipment required, it will be extremely challenging to transfer such knowledge from the UK to testing laboratory within the EU27 by April 2019. This one example is indicative of the situation across the sector as companies aim to prepare for every eventuality.
As Article 50 negotiations progress to the next phase, clarity over the UK and Europe’s future relationship on the regulation, trade and supply of medicines needs to be provided as soon as possible. Alongside Europe’s patient groups and healthcare organizations, EFPIA will continue to advocate that the best outcome for patients is an agreement for the EU and the UK to continue to cooperate on medicines.