If the latest government figures are any witness, the United Kingdom Life Sciences industry is a thriving £60 billion market, employing 220,000 people, and any potential threat to its growth is quite understandably worrisome. So, even when BREXIT (Britain’s exit from the EU) is at least two long years away, the current atmosphere is marked with constant speculations of its long-term impact on the strategic Life Sciences industry.
Before delving into the possible consequences, one must carefully note that the ways of how this seemingly life changing decision would impact the Life Sciences & Healthcare sectors which largely depends upon the kind of relationship model the United Kingdom adopts with respect to the European Union (EU). While an agreement to remain in the European Economic Area (EEA) might result in minimal changes, the aftermath could be quite extensive if the UK decides to keep safe distance from the EU.
Let us do a quick review of few inevitable changes that might occur in the wake of the UK’s exit from the European Union.
Paradigm shift of the Key Industry leadership
The United Kingdom being haven to European Medicines Agency (EMA) has eventually resulted in several small and medium-sized clusters. So, once the health authority is left with no choice but to relocate elsewhere in the EU, life sciences organizations might follow suit, leaving the UK fending for the power and prominence they were so used to. EMA’s pivotal role in terms of setting the research agenda or drive policy-making initiatives may take a backseat.
In the current scenario, the UK businesses enjoy the third-highest amount of funds under the EU’s FP7 program within which small businesses receive close to 10% of the total allocated funds. Once the Brexit terms comes into existence, this funding might be at risk.
If the restriction on freedom of movement is imposed, it would limit the UK Life Sciences companies to recruit the required talent in the global market, which in turn would lead to skills shortage. And this crisis would only deepen if the British scientists and other skilled employees opt for greener pastures elsewhere. In such a scenario, choosing a suitable partner specialized in contract staffing services for staff augmentation is a necessity in order to seamlessly execute time-critical projects in hand.
The Life Science organizations across the UK might face certain regulatory concerns in the wake of Brexit. It still remains to be seen if the EU’s current medicine regulations continue to apply to the UK as before but if the need arises for the UK organizations to develop its own authorization process, it would take time to set the all-new regulatory system up and running. In the wake of such crisis management, Regulatory consulting services and service provider companies could prove to be of immense help.
Obtaining Marketing Authorisations
Before any given medicine is made available to patients in the EEA, it must first be authorized, mainly through the centralized route which is valid in all EU Member States as well as in the EEA, providing the authorisation holder is situated in an EEA state. Following Brexit, if the UK decides to opt out of the EEA, a whole new national authorisation would need to be obtained to enter the market. This would lead to an increased administrative burden of separate applications to be documented in the EU and UK. Regulatory service provider companies specialized in terms of Submission & Publishing services among other Regulatory functions could be roped in to ease the Regulatory procedural complexities and allow a smooth transition.
Whatever the final agreement may look like, given the UK’s strong and steady paced past in this industry, with close to a 25% major chunk of the EU market in its firm hold, it is expected to remain a key player doing business as usual. After all, Switzerland, a non-EU nation stands tall as a thriving example as to how the Life Sciences industry can effectively flourish even outside the safe precincts of the European Union.