With less than a year left for the UK to leave the EU, ensuring an undisrupted flow of medicines in between the UK and the EU following Brexit is a growing concern among drug developers and regulatory agencies.
On 23 August the UK’s Department of Health and Social Care has asked pharmaceutical companies that supply drugs to National Health Service (NHS) patients to ensure a minimum of six weeks of additional supply of medicines over and above their usual buffer stocks, due to a potential disruption of medicine imports from the EU in the event of a no-deal Brexit. While the UK still may remain part of the EU’s drug approval system following Brexit, the uncertain regulatory environment post-Brexit is urging drugmakers to prepare for the worst.
The actions that will need to be implemented by the pharmaceuticals industry, such as stockpiling of medicines, duplicating facilities in both the UK and the EU area, and establishing alternative trade routes are expected to be highly costly measures. In order to facilitate this process, the European Medicines Agency (EMA) has issued a guidance to help companies prepare for the UK’s exit from the EU. However, drugmakers are on their own to implement these changes, and recent survey results reported by the EMA indicate that some drugmakers have not taken sufficient steps to maintain the continuous supply of their products following Brexit.
According to this survey, the makers of more than 58% of the 694 centrally authorised products with an important step in their regulatory process located in the UK are on track with their regulatory planning to ensure marketing authorisation remains valid following Brexit. On the other hand, the survey results indicated that for 108 medicines with manufacturing sites located in the UK only, the necessary regulatory steps to maintain validity of the marketing authorisation post-Brexit will not be carried out in time. Perhaps more worrisome is the lack of feedback from companies that market 10% of the products included in this survey. The EMA is liaising with these companies and determining medicines with risks of supply shortages, and is assessing how critical these are in an attempt to mitigate the prospective supply shortages.
No deal: minimising the impact
Unlike local drugmakers, the global pharmaceutical companies have already unveiled plans to minimise the impact of a no-deal Brexit on continuous supply of medicines. AstraZeneca is planning to increase its medicine stockpile by about 20% in preparation for a no-deal Brexit, and is already duplicating all its quality control processes in Sweden.
Similarly, Sanofi is implementing changes based on a no-deal Brexit and is increasing stocks of prescription drugs from the currently ten weeks in country stock of medicines to 14 weeks as from April 2019. The company has also made arrangements for additional warehouse capacity for medicine stockpiles based on a scenario of no-deal Brexit. Merck & Co. is planning to stockpile as much as six months of supply and to create alternative trade routes, and is considering asking customers to take on up to two months’ worth of additional stocks of medicines in advance.
While Big Pharma can bear the additional costs associated with all these measures, it is uncertain whether smaller drugmakers would be willing to assume these costs. The high cost of ensuring a continuous medicine supply post-Brexit is expected to come at the expense of research and clinical development irrespective of the size of the drugmaker.
According to the Association of the British Pharmaceutical Industry (ABPI), drugmakers are being forced to divert funds away from research in order to prepare for an uncertain regulatory environment following Brexit. While addressing the short-term effects of Brexit, divesting from the R&D space could in the long run lead to longer duration, or termination, of clinical development programmes, which will have severe consequences for patients.
It is estimated that between 50,000 and 80,000 pallets worth of medicines are requested for stockpiling by the UK Government. The current industry figures indicate that more than 2,600 drugs have some stage of production in the UK, which could be impacted in some way by Brexit. Every month, a total of 45 million patient packs of medicines are supplied from the UK to the other European countries, while another 37 million flow in the opposite direction. Delivering the additional supply of medicines across the industry by the time the UK leaves the EU on March 29, 2019 and ensuring uninterrupted flow of medicines between the UK and the EMA beyond Brexit will undoubtedly be a massive challenge, which can only be accomplished by timely and mutual agreement on the terms of the UK’s withdrawal and a future relationship based on cooperation that prioritizes and protects public health.