Implications of the Historic Brexit Verdict
Since the final votes of the Brexit were counted, a majority of the UK’s decision to leave the EU has appeared pessimistic for the Biotech and Pharmaceuticals industries. As a result, there has been very little talk about any positive outcomes for the Life Sciences. Yet, can we truly say that the Brexit is all bad? The answer is no. The vote may have caused several uncertainties for the industry and left us all with many questions, such as the futures of funding and drug prices, but what fewer people are talking about is the UK’s opportunity to become a significant Life Sciences hub in the world.
Becoming the “Third Global Cluster”
Britain’s Life Sciences industry will face many challenges as a result of the Brexit. Drug regulation and the ability to trade are two of the most prominent concerns. However, there are four main components that make up the UK’s opportunity to continue its climb toward the next global Life Sciences cluster following the vote:
1) Making a Political Deal
It will now be in the hands of politicians to come up with an arrangement among the UK and the EU. The perfect deal would result in the UK being able to sustain a relationship with the EU even after exiting in order to continue participating in the regulatory processes.
The chief executive officer of the U.K.’s BioIndustry Association (BIA), Steve Bates, told the Life Sciences Law & Industry Report that the UK’s Life Sciences are “resilient.” He explained how the BIA will continue its efforts to uplift the UK to be recognized as the third global cluster for Life Sciences, “We will work closely with government and relevant agencies to see how this ambition can be delivered in the new political context we now find ourselves in as a country.” Mike Thompson, CEO of the Association of the British Pharmaceutical Industry (ABPI), interviewed with The Telegraph, “I do believe a deal can be struck in the best interests of patients… When a new Government is formed, with a taskforce to negotiate on Brexit, the pharmaceuticals industry is keen to participate to make that come about so that we have a solution.”
2) Convincing the Rest of the World
In order to reach a higher level of recognition in the industry, the UK will need to maximize its efforts to persuade the world that Britain is an excellent place to bring new drugs to market and will continue to be even after the Brexit.
Thompson spoke of the UK’s assets in the industry; the National Health Services (NHS) and its reputable sciences base.
3) Following Equivalent Quality Assurance Regulations
It is not a surprise that the UK’s drug production will be affected following the UK’s exit, however, as long as UK manufacturers continue to follow regulations equivalent to the EU’s regulatory framework, drugs will remain eligible for export and import.
Before the Brexit vote, all drug regulation was handled at a national level. UK regulations were based on EU Directives, which laid the foundation of good manufacturing practice (GMP). The UK also had additional regulatory laws, which ensured high quality standards for manufacturing. After the official Brexit takes place, the original regulation laws will remain in effect. Until the time comes if or when the UK government elects to change the laws, national manufacturers will continue to run under relevant amendments being made to the European Communities Act.
4) Joining the European Economic Area (EEA)
The European Medicines Agency (EMA) provides corporate approvals that are valid in the EEA. The Life Sciences industry is looking to the UK to join the EEA following the formal departure from the EU since the country will no longer be a member of the EMA. Business Finance News explains that joining the EEA would benefit Life Sciences companies by providing faster drug approval and access to the EMA for single marketing authorization to launch new drugs throughout Europe. If the UK decides not to become a part of the EEA, companies will need to apply for separate approvals from a UK regulator in order to release new products in the UK.
There is no doubt that the Brexit will impact Britain’s Life Sciences industry. Some outcomes may be negative, however, it is also clear that the result of the vote is not all bad. These results should not be classified as consequences to the UK’s Life Sciences, but as challenges; challenges that have solutions. Aside the many concerns of the verdict, a great opportunity lies ahead.