Brexit was a big turning point for many industries such as the pharmaceutical industry, banking industry, car manufacturing among many others too. It has caused many uncertainties with no clear solutions. Nobody fully knows how UK’s exit from EU will work. The only country to have left the EU was Greenland in 1985, however the UK has a far larger economy. This blog will have a look at a few potential implications on what it could mean for Pharmacovigilance that could occur from the Brexit fallout.
Short Recap on Brexit
Over 30 million people voted in a referendum which was held on Thursday 23rd June 2016 to choose whether the UK should leave or remain in the EU. Leave won the vote with 51.9% to 48.1%. The UK had to invoke Article 50 of the Lisbon Treaty. This gives both the UK and EU two years to agree the terms of the split. This was triggered on the 29th March 2017, as a result the UK is scheduled to leave the EU on the 29th March 2019.
What looks certain?
Firstly, what is certain is that the EMA (Europeans Medicines Agency) will definitely have to leave the UK and relocate to another country in the EU. The EMA’s purpose is to evaluate the safety of medical products for the European single market and is crucial to the UK’s reputation as a force of scientific development. Companies could therefore be forced to pay for a separate assessment to clear new drugs for use in the UK. Additionally, patients in the EU were able to access medications and treatments between 6-12 month sooner than patients in Australia and Canada. With the EMA leaving the UK, it would mean an increase in drug prices and an increase in waiting times for treatments in the UK.
Many global companies have their hubs in the UK due to the close proximity to the EMA whilst English speaking global companies have their hub here due to the language. As a result, these companies may have to consider moving their hubs elsewhere once the EMA leaves whilst still trying to maintain that close proximity to the EMA.
A large number of EU QPPVs currently reside in UK. Due to circumstances caused by Brexit, it has caused difficulties and has raised lots of questions as to where EU QPPVs based in UK should do. Regulations says that QPPVs have to reside in the EU (Article 8 of Directive 2001/83/EC & Article 74 of Directive 2001/82/EC). Companies will have to take steps to prepare for Brexit
As a result:
Additionally, there are many other considerations, for example, Marketing Authorisations (Centralised, Decentralised & Mutual recognition) will become invalid in the UK and would therefore expect a new system in place. The marketing authorisation holder will therefore normally need to transfer its marketing authorisation to a holder established in the Union (EEA). Centralised Marketing Authorisations covering the EU held by UK companies will have to be transferred to companies based in EU countries unless there is an agreement put in place.
Furthermore, particular laws relating to the validity of EU Orphan drugs and paediatric drugs will likely to become invalid in the UK unless there will be some sort of agreement.
The UK is home to several important databases used in PHV. The quality of databases available will decrease once UK has left EU and UK users may have to resort to reporting adverse effects on systems such as VigiBase which has been said to be scientifically sub-standard to those that are used in UK.
As we can see there are many things that are certain whilst there are plenty of other things are still left to discussed. We can only truly know what the final consequences are once all the final decisions have been made.
We take no pleasure from the fact that we believe it was and is inevitable that either being based in the UK, holding an MA in the UK, or having your EUQPPV in the UK will be affected by the UK’s decision to leave the European Union. We have already been contacted by many concerned companies looking to either move or adapt to this situation, including providers of Pharmacovigilance services based in the UK. We also believe that MAs will need to be adapted to work with this situation.
As a full-service provider of Consultancy, Regulatory Affairs and Pharmacovigilance with offices in both the Republic of Ireland and Central Europe, we are not affected in any way by Brexit, except for the fact that we are in a unique positon to support companies from a Strategic, Regulatory AND Pharmacovigilance perspective in terms of working around the Brexit deadline.