UK Pharmacovigilance Post-Brexit: Lots of Questions, Few Answers

No one knows what is going to look like British pharmacovigilance after the UK left the EU and uncertainty puts many residents qualified person responsible for pharmacovigilance (QPPV) in the UK in a precarious situation.

According to the independent academic research unit on drug safety in the UK, which met last week on the subject of pharmacovigilance post-Brexit "At worst, it will cause a serious blow to British pharmacovigilance" as the Pharmaceutical companies "will not be required to carry pharmacovigilance in the UK and can not be expected to pharmacovigilance providers from the UK to carry out these studies."

Currently, the European Medicines Agency (EMA) runs the Pharmacovigilance Risk Assessment Committee (PRAC), which uses two members from each Member State and has been chaired since its inception in 2012 by the Agency June Raine regulation of medical products And UK Health (MHRA).

But after Brexit, the UK will not show PRAC, although representatives may present as non-voting observers, as Norway and Iceland do now.

"Pharmacovigilance is above policy," said Saad Shakir, director of the Research Unit on drug safety, last week at the "UK Pharmacovigilance Forum post-Brexit" according to the audio files sent By email to focus.

He also noted the large number of QPPV leaders based in the UK, adding: "We want them to remain part of the EU apparatus. These are national assets." But now, he said, they were "afraid of what is going to happen as the regulations indicate that QPPV should reside in the EU."

Shakir said he could have negotiated a mutual recognition system or a means for EMA and MHRA to continue collaboration.

Ian Hudson, general manager of the MHRA since 2013, said recently, according to Shakir, there had been some discussion about outsourcing regulation work in the UK, but "We do not know what this will look like en -traitance."

Virginia Acha of the British Pharmaceutical Industry Association also noted that pharmacovigilance times at the short end of the rod, as it works so well now.

"There is an enthusiasm to maintain most of the status quo, but the extent to which it is possible to publish Brexit is unclear," the Drug Investigation Unit said in a statement. "Once the UK leaves the EU, it is essential that the current UK-Europe cooperation in pharmacovigilance has improved a lot. Mutual recognition of market research and MHRA EMA is required as part of the Brexit negotiations. "

In addition to this meeting focused on UK pharmacovigilance, last weekend, the European Council established guidelines for the Brexit negotiations between the UK and the European Union.