The Association of the British Pharmaceutical Industry (ABPI) has welcomed the announcement of the Withdrawal Agreement and political declaration on the UK’s future relationship with the EU as an “important step towards securing a Brexit deal”.
The ABPI welcomed the agreement of a transition period, which will enable companies to get medicines to patients in March 2019, alongside the approach taken in the declaration on the future UK – EU relationship.
Although significant contingency planning has been put in place by pharmaceutical companies to ensure that patients continue to get medicines in any Brexit scenario, the ABPI has continually maintained that this would be challenging in a ‘no deal’ scenario.
Mike Thompson, CEO at the ABPI, said: “We welcome this important step towards securing a Brexit deal. Agreeing a transition period will mean that our members can continue to supply medicines to patients without delay or disruption come March 2019.
“There’s much to build on. But there’s more work to be done. We are committed to working with the UK and the EU so that close cooperation on scientific research and medicines regulation are central to a future partnership agreement for the benefit of all’.
Brexit Secretary Dominic Raab resigned the day after the draft agreement was announced, swiftly followed by more Cabinet Ministers.
Pf recently featured a roundtable piece on the potential impact of Brexit and the relocation of the European Medicines Agency. Meanwhile, in October, the Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation on a no-deal Brexit in preparation for all potential outcomes surrounding the UK’s exit from the European Union in the event of the UK not securing a deal with the EU after Brexit, with no Implementation Period.
This consultation covers changes to four different Statutory Instruments (SIs): the Medicines for Human Use (Clinical Trials) Regulations 2004, the Medical Devices Regulations 2002 and the Human Medicines Regulations 2012 (HMRs) and the Medicines (Products for Human Use) (Fees) Regulations 2016.