Last week, MPs backed an amendment that will keep the UK in the European medicines regulatory network. In a series of industry comment, Part I is provided by David Hukin, head of pharmacovigilance at Quanticate, who highlights what this means for the wider industry.

"A key consideration for the pharma industry when it comes to Brexit is pharmacovigilance (PV). The current situation is that, from 30 March 2019, pharmacovigilance activities, which must take place in an EU member state (or other EEA territory), will no longer be able to be conducted in the UK.

"There is very little time to prepare for what the pharmaceutical industry will look like post-Brexit and it is likely that it will affect companies and sponsors at a wider business level. As we move forward, it is vital that the industry carefully monitors output from the EMA and UK MHRA to guide their strategy. The concerns surrounding Brexit and its impact on the wider industry, including the registration, manufacture and supply of medicines, mean that it will be all too easy for companies to take their eye off the ball when it comes to ensuring they meet the new PV regulations, so it is vital that departments ensure the necessary changes are made.

"In preparing for this, however, we are faced with a multitude of unknowns and an ever-moving target. On 17 July, parliament voted on an amendment tabled by Phillip Lee MP to require the government to negotiate an agreement with the EU for the UK to participate in and align with Europe on medicines regulations and framework.

"The government lost this vote (against the amendment) and so this is significant for PV and access to medicines in general as it could mean the UK remains much more tightly aligned to EU than in other areas. What that means regarding the licensing of medicines and alignment/co-operation on a range of PV factors is still unknown.

"Clarification on the following EU-led initiatives will need to be considered in the negotiations between the EU and UK:

EudraVigilance for the reporting and access to data on adverse drug reactions and medicinal product information

The use of single assessment for Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs)

The role of the Pharmacovigilance Risk Assessment Committee (PRAC) and location of the Qualified Person Responsible for Pharmacovigilance (QPPV) and Pharmacovigilance System Master File (PSMF).

"The Parliamentary vote to remain part of the European Medicines Agency is a promising sign that this could be simpler than previously thought.

"We trust that the ongoing talks between the UK and EU will be constructive and keep patients at the forefront of discussions, ensuring access to new medicines is not delayed and the huge efforts towards pharmacovigilance harmonisation, improving patient safety, are not undone. It is possible, however, that the UK will walk away from the negotiating table with no deal and no arrangements, transitional or otherwise, for the continued co-operation on the regulation of medicines and PV.

"Quanticate will continue to monitor developments through the close involvement of our highly experienced PV team with expert industry bodies and frequent interactions with regulatory agencies. Quanticate will ensure rapid responses to the changing regulatory landscape to minimise the impact of Brexit for existing and new clients. Our EU offices also have us well placed for any necessary transition of activities in the short or longer term."

David has a PhD in Cell Physiology and Biophysics and 15 years’ experience in the pharmaceutical industry, with more than 14 years working in the pharmacovigilance sector. David has worked in small, medium-size and large specialty pharma/biotech companies and has gained pre- and post-marketing experience in a range of therapeutic areas including gastroenterology, hepatology, neurology, oncology and psychiatric conditions as well as advanced therapy medicinal products (ATMPs) and orphan drug indication products for rare diseases. Since 2015, David has worked in the specialist pharmacovigilance service provider sector, leading multiple large teams responsible for clinical and post-marketing for Customers ranging from small pharma/biotech to large specialty and generic companies before joining Quanticate in 2018.

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