By Conor Griffin
The key concern for the international biopharma industry as the UK prepares to leave the European Union is regulation.
Things are unlikely to change drastically in the next two years, but as the practical realities of a separation from the EU unfold there will be a gradual shift in the UK’s relationship with European regulators.
Most crucially there also will be a relocation of the London-based European Medicines Agency (EMA), which is currently the largest EU body in the UK. Ireland, Sweden and Italy are among the countries lobbying to be its new home.
The UK, meanwhile, must work out a new marketing authorisation system, likely to involve the Medicines and Healthcare Products Regulatory Agency (MRHA).
Most people expect the MRHA to align itself closely with the EMA, but with the shift in regulation, process and expertise, this will be a challenge for the already stretched organisation.
In terms of medicines, we will continue to see many hard choices about which innovative drugs the NHS can afford to use. This issue will be compounded further with the added difficulty that many drugs may have to be imported from markets with a stronger currency.
This will inevitably affect big pharma’s own choices about which drugs are appropriate for a launch in the UK, given the market uncertainty.
Another consideration is that UK must navigate the complexity of reorganising the CE Mark* for medical devices with a UK-only system, without compromising companies’ ability to sell abroad.
It is in the pharma industry’s interests to keep rules in UK aligned with those across the EU, but there will surely be a significant loss of influence over the future direction of policy, which may affect the UK’s reputation as a centre of R&D.
The Association of British Pharmaceutical Industry (ABPI) has already voiced concerns about the effect of Brexit on the clinical trial industry in the UK, if data generated within British borders no longer count across the EU.
This in turn will affect the UK’s standing as one of the most important centres for clinical trials in the EU. Then, there is a knock-on issue of research funding and the reduction of cross-EU programmes as UK-based academics and researchers would become ineligible to apply for EU grants.
Combined with the likely restrictions on immigration, we may also see a reduced talent pool to draw on which may also have a detrimental effect on the UK’s standing as a world centre for science and innovation.
There are signs that the UK government is preparing the ground with some positive reassurances. When announcing her commitment to Brexit, the British PM made it clear that she wanted “a positive outcome for science as we exit the EU”.
In a further show of commitment, after many years of successive governments underinvesting in science and technology, the Chancellor’s autumn statement announced a £4.7 billion increase in government investment in the sector, making it clear that this would be additional money to replace lost funds for EU research programmes after Brexit.
Invariably, however, with all this uncertainty, the UK’s position as a leader in science and innovation will be tested. It remains to be seen how Brexit will play out in practical terms as it is unchartered territory.
One thing is for sure, the road ahead needs to be paved with a lot more than just good intentions; the separation process will be a complex one and will need to be planned and implemented with a lot of clear thought and careful consideration if the UK is going to weather so much change without being diminished.
The uncertainty around Brexit is already damaging the EU’s standing in global science and innovation with many companies putting projects on ice until more is known about the impact on the region.
Currently the European Research Area provides about one third of the world’s output. This is mainly down to the ease of flow between member countries enabling them to benefit from a huge pool of talent.
Taking one of the biggest players out of this mix will inevitably make the EU a lesser force. Even in the months leading up to Article 50 being even invoked, valuable initiatives have being moved to US, Australia and Asia to avoid becoming embroiled in the confusion.
Tensions are building as other member countries are becoming frustrated with the UK’s decision and there has already been a backlash of UK researchers being dropped from pan-EU projects.
As the separation becomes all the more real we will likely see a schism developing in valuable research programmes which will not be to the benefit of anyone.
Conor Griffin is managing director of Hume Brophy’s International Healthcare Division
*CE is the abbreviation of French phrase “Conformité Européene” which literally means “European Conformity”. The term initially used was “EC Mark” and it was officially replaced by “CE Marking” in the Directive 93/68/EEC in 1993.