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.
Marketing Authorizations
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.”
Budget Impact Analysis of Biosimilar Natalizumab in the US
Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Eye on Pharma: BI Cyltezo Partnership; Europe Ustekinumab Launch; Mexico Biosimilar Approval
July 24th 2024Boehringer Ingelheim (BI) partners with GoodRx to offer its unbranded adalimumab biosimilar to patients at an exclusive low price; a new ustekinumab biosimilar launches in Europe; and Mexican officials approve a bevacizumab biosimilar.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Real-World Study: No Increase in Health Resource Costs After Infliximab Biosimilar Introduction
July 20th 2024Although biosimilars reduce drug purchasing costs for hospitals, it’s unclear whether those savings might be offset by increased health resource utilization following a non-medical switching initiative.