The European Federation of Pharmaceutical Industries and Associations has released the results of a survey it conducted among its membership into how patient access to medicines could suffer after the United Kingdom exits the European Union.
The European Federation of Pharmaceutical Industries and Associations (EFPIA), a pharmaceutical industry group representing 43 drug companies and 33 national associations, has released the results of a survey it conducted among its membership into how patient access to medicines could suffer after the United Kingdom exits the European Union.
The survey found that the following issues gave industry stakeholders concerns:
Supply Issues Under WTO Rules
A so-called “no-deal” Brexit (a scenario in which the United Kingdom and the European Union do not reach a trade agreement) has become increasingly probable. In such a case, World Trade Organization (WTO) rules will apply to trade between the United Kingdom and the remaining EU member states.
According to EFPIA’s survey, 45% of the organization’s membership expects trade delays if WTO rules govern EU—UK trade. Currently, 45 million patient-ready packages of medicine are supplied to the European Union from the United Kingdom each month (the United Kingdom, conversely, receives 37 million packages each month from Europe), and delays could cause significant issues for patients who rely on these medicines.
EFPIA reports that 400 products—representing 45% of all centrally authorized products—are registered with UK-based entities. Additionally, 2400 marketing authorizations are currently housed with UK legal entities, and each such authorization will have to be transferred to entities in EU member states. EFPIA’s members expect that the labor burden of transferring their authorizations will total approximately 5000 review months (based on a 60-day standard timeline).
Disruption to Industry
As all centrally authorized medicines must have a site of batch release within the European Union, UK manufacturers will have to transfer their batch release locations to remaining member states. With approximately 60% of EFPIA members currently releasing batches of approximately 1300 products from the United Kingdom, the membership estimates the labor burden of moving sites to be approximately 4000 review months (based on a 90-day standard timeline).
Ongoing Clinical Trials
Currently, there are over 1500 clinical trials being conducted in EU member states that are being sponsored by UK entities. Over half of these trials are expected to continue beyond the United Kingdom’s deadline for leaving the European Union, and EFPIA says that the critical importance of these trials highlights the need for scientific collaboration between the United Kingdom and the European Union post-Brexit.
EFPIA’s director general, Nathalie Moll, said of the survey’s results, “Even in the context of the Brexit negotiations where all sectors are looking for clarity on the future, it is important to recognize that the medicines sector is different. The medicines we make impact directly on peoples’ health.” She added, “Securing ongoing cooperation on medicines regulation between the [United Kingdom] and [European Union] is the best way of ensuring that patients across Europe continue to have access to safe and effective medicines.”