Industry plans for disruption amid Brexit uncertainty

With the EMA’s relocation to Amsterdam showing no signs of becoming painless, the European Parliament’s health committee has signaled its intention to review the governance of agencies as an opportunity to ensure it plays an active role in future decisions. This stance has come from members of the Committee on the Environment, Public Health and Food Safety (ENVI) and is a direct result of grievances over the handling of the relocation of the European Medicines Agency (EMA).

ENVI has identified an opportunity to ensure that the European Parliament not be shut out of decisions relating to European Union agencies in the future. In light of governance challenges related to the EMA and other EU agencies, another parliamentary committee is preparing a report that will look into political oversight of arm’s-length institutions. ENVI wants to get its views on the EMA’s move into the report. With the EMA’s situation and capability to manage the impact of losing the MHRA post-Brexit looking increasingly perilous, the United Kingdom health minister has dismissed rumors that the government has asked the drug industry to stockpile 20 weeks’ worth of medicines as a result of FMD and Brexit. However, in a separate exchange, another minister left the door open to the extension of the government’s current request for a six-week stockpile. It is unclear whether the UK could resolve a breakdown of trade with the EU within six weeks, and it has recently emerged that the industry is unsure how the government came up with the six-week figure.

With preparations for a no-deal Brexit still continuing in earnest despite the recent positive rhetoric from both sides, the former EU Brexit secretary Dominic Raab was quoted as saying that “government and the pharmaceutical industry already liaise on stockpiling for far longer periods in other circumstances, including in relation to vaccines. This is something the industry is used to doing and we are used to cooperating with it.” However, the primary concern from the industry leaders is that the UK lacks the cold-chain capacity to meet the request for a six-week stockpile – not to speak of storage capacity for a 20-week stock pile for all medicines – and that the system will simply collapse under the weight of such movement of goods. The UK government is working to bring additional cold-chain capacity online, but there are doubts about whether it will have the space to store six weeks of temperature-sensitive products by the time the UK leaves the EU in March 2019.

Meanwhile, the EMA has stated that marketing authorisation holders (MAHs) that submit Brexit-related type IA variation filings in December will receive acknowledgements of the validity of submissions within 30 days. The time frame is the standard response window for minor, type IA variation submissions. MAHs can make type IA variations and then inform the EMA of their actions, either immediately or within 12 months depending on the nature of the revision. Type IA changes cover some of the modifications necessitated by Brexit – such as updates to the names of manufacturers – and, in the past, the EMA has said that notifications related to the UK-EU split must be filed by late May 2019.

While the EMA is sticking to its standard timeline for Brexit-related notifications, filings about other variations may take longer to process. The EMA is encouraging MAHs to submit type IA notifications by the end of November 2018. The agency will acknowledge the validity of these submissions before it closes for Christmas on 21 December.