Research published by several investigators in UK universities, including York University, King’s College, London and Queen Mary University, London, states that “the uncertainty of a “no-deal” outcome has already started a domino effect that could lead to the UK pharmaceutical industry’s collapse” (European Medical Writers Association, December 2018). In the recent article, several three potential scenarios for Brexit consider three clear options: a “mild” scenario event, presumably following the UK/EU Withdrawal Agreement; a “doomsday” scenario, where “no deal” is reached between the UK and the EU, “leading to the rapid decline of the UK pharmaceutical industry”; or a “severe” scenario, which falls somewhere between the “mild” and the “doomsday” options. As indicated at time of press, many commentators are concerned that “no deal” by March 29th, 2019, will cause “catastrophic” events, cited by others including the British Medical Association (BMA), most especially in respect of pressures on both patients and NHS doctors.
According to UK university authors, considerable uncertainty impacts free of movement across the EU, including industry investment and funding. The European Federation of Pharmaceutical Industries and Agencies have commented that many employees would have a “negative impact on and EU academic research and small and medium enterprises”. In the university research analysis, five authors have stated that, “newspapers from across the political spectrum, within the UK and abroad, have painted very dark possible scenarios. The possible damage has been compared to post-war shortages (e.g. food, medicine, and power shortages) within a few days after a no-deal Brexit, due to the UK’s dependency on “just in time” supply chains. In this “doomsday” scenario, the knock-on effects on food, travel, IT networks, and avail ability of personnel could stretch pharmaceutical industry contingency plans to breaking point”.
In an associated industry report by PWC (PricewaterhouseCoopers) several concerns indicate that pharma may choose not to include UK in clinical study designs, or potentially to include the UK only at a later stage of clinical research development. A UK government white paper has proposed an “association agreement” between the UK with the EMA, related to the current EU Clinical Trial Directive however, it may be uncertain if any divergence between UK and EU may alter subsequent regulation. Regardless, authors have commented that until there are concluded negotiations, there may be a loss of funding in the interim. Aside from pharmaceutical industry activities, there are additional academic clinical research issues highlighted by the UK Parliament Office of Science & Technology, which commented that, “any loss of funding through this pathway could threaten the UK’s position as a world leader in the life sciences. Although the UK Government has committed to replacing any funding from the EU until 2019, stakeholders are concerned that this may not continue for funding rounds after 2019. Some UK academics have expressed concerns that their inability to act as lead investigators on large EU wide grants post-Brexit could reduce the opportunity for the UK to partake in cutting edge clinical research” (Parliament Office of Science & Technology). In another Drug Discovery Today research article, concerns compound that, “addition to Brexit barring British patients from participating in EMA clinical trials, the WTO (World Trade Organisation) pathway is potentially damaging to patients throughout the EU, because the union could refuse to accept the efficacy, quality, or safety standards of MHRA post Brexit” (Mackey & Annaloro, July 2018).