Brexit Will Not Have a Major Affect on Drug Approvals in UK and Europe 
[Posted on: Thursday, June 30, 2016]

It has been a week since UK voted to leave the European Union. There have been rampant speculations on what this decision means for the drug industry. Dooms day scenarios painted by a several commentators would have us believe that most work by regulators in UK and the EU would be negatively affected. But a careful review of the existing processes and practical aspects of Brexit shows that it may not change much for the drug industry. The political changes may create a nuisance factor for the short term but over long-term the impact would be minimal. There is regulatory precedence for non-EU countries to participate in EMA. Britain and its regulatory agency the MHRA, will need to revise its system with regards to the centralized approval pathway. However, there are several mechanisms by which MHRA may choose to participate in the EMA.
MHRA may take the same approach with regards to EMA as that followed by regulators from non-EU members like Norway, Iceland and Switzerland. With MHRA not required to follow EU directives, it could update its national regulatory processes to accommodate standalone reviews with a relationship with EMA similar to what it does with the FDA. With the increasingly harmonized regulatory processes world-wide, MHRA only needs to adopt and adapt, but not necessarily invent new systems. Certainly the re-design of system at MHRA will create some short-term headache for all stakeholders but regulators on both sides of the English Channel benefit by maintaining a close relationship. The biggest impact will be on the drugs seeking centralized approval; it will be lower for those going for decentralized pathway and none on those approved via the national process. Yes, EMA will need to relocate its offices but it has 2 years or more for that. The relocation of offices will cause some temporary delays in reviews by EMA. Italy, Sweden, Denmark and Germany have announced their desire to step in to avoid delays. It would be in EU’s interest to minimize the impact of the move to show that it can function properly without UK. The greatest impact of this change could be on applications currently under review at EMA and MHRA. The two agencies will likely continue reviews of the pending applications as before and only apply new processes to new applications. It would be too much work to ask all applicants to submit again and restart the process. Companies seeking new approval in EU may choose to pursue the decentralized and national pathway meanwhile to avoid having to deal with the uncertain new processes for short-term. UK will still benefit from its geographic proximity to EU. From logistical and business perspectives, companies with headquarters in the UK can keep working as usual and do not need to move their headquarters. Similarly companies located in EU will see little impact on their business operations in the UK. The shockwave of UK leaving EU did raise concern across all sections of business. But as we review the situation carefully, and plan for the change, we could reduce the negative impact. Once the heated political rhetoric calms down, it is in the interest of all parties involved to find amicable solutions. For the industry, there are few reasons to panic.