The warning letter to EU chief negotiator Michel Barnier and UK Brexit Minister David Davis follows days after senior UK Ministers said the country will develop its own drug approval rules but would “look to continue to work closely with the European Medicines Agency.”
The comment – which was accompanied by a pledge that UK drug reviews post-Brexit will take no longer than they do at present – was interpreted as an effort to reassure the pharmaceutical industry.
The response from the ABPI, AESGP, EFPIA, EuropaBio; Medicines for Europe, the BGMA, the BIA and the PAGB suggests industry is still concerned.
While the organizations welcomed the UK Government’s desire to work with EU regulators, they warned that time is running out to set the terms of such a relationship.
They wrote: “The recent letter published by the UK Business Secretary, Greg Clark MP and the Health Secretary, Jeremy Hunt MP, signalled an opportunity to secure cooperation on the regulation of medicines as part of the negotiations.
“We would like to explore this possibility to maintain close regulatory ties between the EU and the UK and to begin these discussions immediately.”
Regulatory co-operation vital
Drug review capacity is one area that needs to be addressed according to the industry groups, which pointed out that the Medicines and Healthcare products Regulatory Agency (MHRA) makes a significant, Europe-wide contribution.
They wrote that the UK’s “withdrawal would mean a loss of capacity and expertise for the network for the review of medicines as well as the capacity across Europe for the surveillance and safety supervision of products. A capacity building exercise would be needed leading to duplication of assessment work at EU and national level.”
The industry groups also highlighted that drug safety monitoring will be impacted by Brexit, suggesting that “UK based Qualified Persons Responsible for Pharmacovigilance (QPPV) would need to be relocated, trained or replaced.”
The examples are in keeping with comments made by the European Commission in May, when it warned UK drug makers that EU law requires that authorisation holders have a base in a member state.
Unorderly Brexit
The consequences of failing to secure cooperation, both regulatory and in terms of movement of goods, between the UK and EU on medicines would be dire according to the industry groups.
They wrote that “in the case of an unorderly withdrawal there is a risk that all goods due to be moved between the UK and EU could be held either at border checks, in warehouses or manufacturing and or subject to extensive retesting requirements.”
“In fact, this would lead to a severe disruption of most companies’ supply chains, which would lead to potential supply disruptions of life-saving medicines.”
The warning is in keeping with previous comments by the ABPI, which has said that members would prioritize larger, more easily accessible markets ahead of the UK.
The next round of Brexit negotiations are due to start later today.