The pharmacovigilance and regulatory scene saw many interesting developments in 2016, not least the UK’s vote to leave the EU back in June.  Advances were also made in drug development with approval of the new HIV drug by NHS England as well as further progress in the cure for Ebola and Zika virus.  Here we look back as some of those news items and reflect on what it means for the pharmaceutical industry in the future.

The most memorable news of 2016 had to be Brexit.  After months of thrilling campaigning, the UK voted to leave the European Union (EU) in the referendum held on 23rd June. Before the vote, the pharmaceutical industry stressed the importance of remaining in the EU to their businesses and workforces. Consequently, the pharma, life science and healthcare sectors strongly supported the Remain campaign. Since the vote to leave the EU, there is still almost no clarity on what Brexit will mean for the industry, or even the UK as a whole.

One major regulatory issue is that the EMA is likely to be forced to move out of London and the UK will no longer be able to use it as its main regulatory body. The MHRA has been suggested as a potential replacement for the UK. In addition, the UK could also lose its position as the EU’s most popular location for Phase I trials. Researchers in the country will no longer be eligible to apply for EU grants or participate in EU-wide projects.

But what will Brexit mean for the UK dominance in the PV world? There are a number of potential impacts and concerns including the loss of UK PV experts, the loss of business for UK service providers and the loss of jobs. A big question remains unanswered – can the EU law be directly transposed into UK law? This raises issues on the preparation of a new legislation. Will we have to completely re-design a new law? Is the timeline of 2 years too short?

It is clear that there are a number of questions and little answers. This is likely to be the case until at least the formal process of leaving the EU begins (by activation Article 50). The government is hoping that this will happen by March 2017, however this might be seen as un realistic since the High Court has ruled that the Brexit process can only start after a vote in parliament.

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