Brexit, Brexit, Brexit. It’s all anyone can talk about and yet nobody can tell you with certainty what to expect. As the UK’s impending withdrawal from the European Union looms ever closer, industry professionals fervently speculate on how it will affect the country’s position as one of the world’s great life sciences powerhouses.
As part of our soon to be published ‘Healthcare and Life Sciences Review UK’ report, we have spoken to some of the leading bosses in the industry to get an overall picture of the future landscape. The feedback we received was often contradictory. Some expressed feelings of great unease around added regulation, whilst others were relaxed in the knowledge they were organised for all eventualities – even in the event of a ‘no deal’.
Yesterday, the Association of the British Pharmaceutical Industry (ABPI) released a statement in response to the Brexit ‘no deal’ planning guidance from the government.
“The pharmaceutical industry is doing everything in its power to minimise disruption of medicine supply in every possible Brexit outcome – including a ‘no deal,'” reassured Mike Thompson, CEO of ABPI.
However, looking back on our conversations with industry leaders, it is clear that many companies were worried about the possible implications of any regulatory de-alignment with EU norms and what this might practically mean for product launch timelines and approval frameworks.
Sanofi’s leadership, for example, was quick to point out that Britain may lose its appeal as a first-tier product launch destination as a result of the additional bureaucracy. “Were the UK to end up requiring a separate regulatory submission, the market will automatically sequence behind America and the EU for product launches in much the same way as we see for other mature markets that possess their own distinctive regulatory frameworks such as Canada, Australia and Switzerland… this means the market entry for new products will likely occur later than in the past with the result that patients will have to wait longer,” bemoans Sanofi’s chairman of the Brexit committee and UK managing director, Hugo Fry.
Others seemed uncertain about the possible logistical complexities around having two parallel jurisdictions. Lupin’s Ben Ellis asserts “Many people do not appreciate that so many products come through the EU regulatory process and products manufactured outside the EU are tested and quality released in EU laboratories. It is not clear what is going to happen going forward and whether these activities need to happen in the UK specifically or in any EU member state which is currently the case. This leaves companies like ours having to try and second guess a hard or soft Brexit and put in contingency plans to cover a broad range of eventualities”.
The concern is highest around what is termed a ‘Hard Brexit,’ whereby the UK would give up full access to the single market and full access of the customs union along with the EU. Tillotts’ Jeremy Thorpe confides that “If we have a ‘Hard Brexit,’ I anticipate that changes will be necessary as the regulatory status of products in the UK will change. Marketing authorisations held in Europe will have to be transferred to the UK, and visa-versa. Batch release will have to be conducted in the UK and there will be VAT implications as the customs status will change, there may also be delays at customs clearance and disincentives to supply the UK.”
Roche’s Richard Erwin is more optimistic. “From a business point of view, we have to accept the Brexit decision and work to make the most of it. The impact on Roche is likely to be limited. We manufacture in Switzerland and the US exclusively, so we are already importing our products from a third country with very high-quality standards. Our role in the UK consists of ensuring we have a continuous supply and we are confident that, by working closely with the government, this can be achieved.”
Clinigen’s Shaun Clinton is positive about the country’s prospects, noting that, “irrespective of what is going on around Brexit, the UK is still a fantastic source of innovation and talent and a great base for building successful international companies.”
That is certainly what many established pharma companies are advocating and expecting. “Under the best-case scenario, nothing really changes except the address of the European Medicines Agency (EMA) to Amsterdam. Our hope is very much that the current tight-knit relationship between the Medicines and Healthcare products Regulatory Agency (MHRA) and EMA can survive intact. The UK has, after all, contributed so very much to the design of regulatory reform and health technology assessment (HTA) mechanisms. Personally, I can’t imagine the UK losing its prowess in life sciences anytime soon. The UK will remain a fantastic arena for understanding genomics and undertaking early drug discovery,” forecasts Biogen’s Terry O’Regan.
Meanwhile, the government has been at pains to reassure the industry that any disturbance will be kept to a minimum and that stability will be the name of the game. Any member of the scientific community fretting about being cut off from EU research funding can also rest easy from the news that the UK government will match or better any available grants.
The consensus seems to be that whatever type of Brexit occurs, companies across the UK and Europe share enough common goals to find workable solutions for the sake of their populations.
“By agreeing to recognise and use medicines and vaccines licensed and manufactured in the EU, the UK Government has taken an important step to protect patients. We urge the EU Commission to do the same”, Mike Thompson continued in yesterday’s statement. “We need to be clear that a ‘no deal’ scenario is not in the interest of patients. Both sides must rapidly agree the terms of the UK’s withdrawal and a future relationship based on cooperation to protect public health, control infectious diseases and manage medicine safety.”