U.K. industry reiterates Brexit concerns

The Association of the British Pharmaceutical Industry (ABPI) highlighted that its primary concerns around a "no-deal" Brexit include the continuity of the pharmaceutical supply chain and sharing of data between the U.K. and European regulatory authorities. The bodies have yet to agree on specifics of a long-term cooperation regarding the regulation, trade and supply of medicines following U.K's exit from the union.

In oral testimony before the U.K. Parliament's Exiting the European Union Commons Select Committee, ABPI's CEO Mike Thompson told MPs that while U.K. industry is preparing for a "no-deal" Brexit by stockpiling essential medicines, concerns remain around whether available storage is sufficient to stockpile biologics, which require temperature-controlled environments. Thompson added that should no deal be reached between the U.K. and the EU, a customs border might be put in place. This would raise additional concerns about the logistics of efficiently transporting medicines to and from the continent, as 45 million packs of medicines move from the U.K. to the EU every month, 90% of which go through the single port of Calais, France.

"The thing of most concern to us is now in our planning, the government has given us guidance that in preparing stockpiles of medicine, we should assume six weeks for the delays that may be at the border," Thompson told the committee. "If that number is wrong, then that would cause serious consequences for us."

He also warned MPs that should no deal with the EU be reached, the U.K. regulator MHRA would no longer have access to data held by EMA and vice versa, which could seriously impact pharmacovigilance and the review of new medicines.

"In a no deal, we don't have the agreements we have in the withdrawal agreement with the regulator, and therefore the transfer of information between the two regulators is at some risk. And obviously having an effective regulator is critical for an industry like ours."

The committee hearing was focused on contingency planning in the event of a deal not being reached before the U.K. leaves the EU at the end of March.