The Association of the British Pharmaceutical Industry (ABPI) announced its latest Brexit contingency plans at the PIPA Conference 2019, stating that it still firmly believes that leaving European Union with deal in place is best way to minimise potential disruption.
The organisation pleads that a ‘no-deal’ scenario must be avoided, and that it has been engaging with the government in the form of meetings with ministers and advisers, as well as seeking confirmation from the Medicines and Healthcare products Regulatory Agency (MHRA) that it is seeking European Medicines Agency (EMA) regulatory participation.
The ABPI also stressed that it wants as close regulatory alignment with the EMA as possible, and reminded that the branded medicines bill will not grow by more than 2% in any of the next five years – a pro-innovation deal that is “particularly” important as the UK leaves the EU.
The scheme – the Voluntary Scheme ‘VPAS’ – includes a commitment from NHS England to increase uptake of new medicines for the five highest health gain categories in line with the top performing countries in the world.
Steve Hoare, director of Regulatory Science, Safety and Quality Policy at ABPI, said at the conference: “We’ve been seeing the MHRA on an almost weekly basis. We’re engaging with them on many different levels, and have their inspectors and policy people coming to us with specific questions. Our members can ask questions and then we can share them with everyone – common themes are often around lack of clarity in the guidance.
“We still have certain medicines that we’re concerned about; the ABPI has done everything within our control, however the issues of additional freight capacity and flights are out of our control.”
He also urged that “individuals should not stockpile their own medicines, because it causes problems further up the supply chain.
“The concern is still there – mainly around the lack of information about the transport and ferries situation, etc. Also issues such as what paperwork is required, and the fact that there is such a lack of information with just four weeks to go, that’s a concern.”
He finished by saying, “It’s untried territory, so it’s difficult to make predictions.”
Other ABPI Brexit preparations include calling on the UK Government to implement a temporary restriction on parallel exports from the UK to the EU in advance of a possible no-deal, and ensuring continued UK participation in EU regulatory and medicines safety processes.
