PIA Ensures: Brexit, Life Science and Healthcare. What’s Next?
With the deadline growing ever closer and it being the talking point of most tv channels, the talk and impending execution of Brexit is almost here, whether we wanted it or not. With a lot of things remaining unclear (even at this late stage) we here at PIA Commercial decided to gather some information and shed some light on the current situation that surrounds the industries that we provide insurance for; The Life Science and Healthcare sectors.
With a heavy dependence on global collaboration, funding, research and best practice sharing, the ever-growing UK life science community is understandably concerned.
So, how will Brexit and the UK leaving the EU move the needle on these industries?
Will it be business as usual?
The actual effect within the life science, biotechnology and healthcare industries will depend upon which economic model the UK will apply with any future dealings with the EU. Ideally the UK would remain in the EEA (European Economic Area) and have minimal changes as a result, however with the deadline looming closer and closer, this looks very uncertain.
What the UK should be looking to do is follow the lead that Switzerland has given, as they are not a member of the European Union but have affectively shown how they can grow sector x, y and z whilst being outside of the EU ‘club’.
What does this mean for Pharmacovigilance?
The language of EU legislation that oversees the rules and procedures for pharmacovigilance throughout the EU is fairly inclusive, requiring a full need for risk management, timely data collection and adverse reaction reporting. This system is organised by the EMA (European Medicines Agency) who; ensure effective and co-ordinated analysis, risk evaluation, best practice sharing and sporadic checks on market-authorisation holders throughout the EU.
When Brexit comes into effect and one of the end results is a lack of collaboration, best practice sharing and information, then as a result pharmacovigilance would be less efficient and more costly. This would be seen as a huge risk but an unlikely one as pharmacovigilance has a huge handcuff to public safety and the resulting positives of best practice sharing are abundantly clear.
How about Clinical Trials?
“No matter what the outcome of negotiations, the UK is committed to offering a competitive service for clinical trial assessment.” This was the message from the MHRA (Medicines & Healthcare products Regulatory Agency) in regards to the implementation of the new clinical trail regime overhaul which be the result of the EU Clinical Trails Regulation (CTR) (No 536/2014). This basis of this regulation which provides for a single application for clinical trails across the EU from a portal with an associated EU wide database, is purposely designed to drastically reduce the admin burdens on applicants and in turn allows for a simplified process where the investigational medical product poses a lesser risk.
With all sectors under the cloud of growing uncertainty surrounding Brexit there is a need for greater clarity, sooner rather than later, which would allow professionals to detail the future relationship between the UK and the EU, whilst allowing people to factor in ‘No Deal’ planning. However, we have a belief that respectful long term collaboration arrangements may be put into place in order to reduce any of the inefficiencies that arise as a result of Brexit for the Clinical Trials space.
“No matter what the outcome of negotiations, the UK is committed to offering a competitive service for clinical trial assessment.” – This is one of many statements from the current government regime in regards to the UKs commitment to not only clinical trials but the science development community in general. With the issue of public health and safety being a high priority, along with ensuring that the UK remains of the best locations in the world for the development of scientific innovation, it is very difficult to see the end result of Brexit having large barriers that stunt the development and growth of the community.
“From the research and insight we’ve commissioned and had active involvement in, it does appear that the UK government is committed to maintaining the countries position as one of the most proactive health and life science sectors, not only in the EU but the World.” Says Mike Cherrington, Life Science Insurance Manager at PIA Commercial. “The UK has always been at the forefront of scientific innovation, research and developing ground breaking treatments that can transform and improve the quality of peoples lives.” “You can also be assured that here at PIA Commercial, a cloud of uncertainty regarding Brexit and the effects does not loom. You will be covered for all circumstances in your scheme and the relevant adjustments will be altered if and needs be.”
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The ABPI does recommend the following steps to its members, in the result of a ‘No Deal’ scenario so that everyone can have full clarity on how to proceed into this ‘New World’.
- Understand your own processes
- Understand the implications for suppliers/partners/vendors
- Ensure you are up-to-speed with regulatory announcements from the EMA, Coordination Group for Mutual Recognition and Decentralised Procedures – Humans (CMDh) and MHRA
- Read the UK Technical Notices on the ‘No Deal’ scenario
- Companies and individuals should continue to discuss individual portfolios with the MHRA
- Any company decisions should be informed by their own legal advice