Blog September 10, 2018

As Brexit Approaches, Concerns about Impacts Abound

Brexit flagsOn March 29, 2019, the United Kingdom is scheduled to leave the European Union (EU). Since the UK passed the referendum in 2016 to leave the economic bloc, there have been plenty of uncertainties on how this will affect not only biopharma companies but also healthcare professionals, clinical trial personnel and more. Within the UK, the pharmaceutical and life sciences industry is subject to more EU-wide legislation than most other industries. Thus, the potential impacts of Brexit on the UK will likely be considerable, and the effects of the UK’s departure on those within the EU will be strongly felt as well.


Brexit is necessitating the European Medicines Agency’s (EMA) relocation from its London home to Amsterdam by March 2019. While Amsterdam was determined more acceptable to most EMA staff than other locations, the move is already having a deleterious effect on the Agency’s resources. Recent projections estimate the loss of as much as 30% of EMA staff, including a large number of experienced mid-term employees. Further complicating this, 135 short-term contract staff will no longer be able to work for the EMA because of Dutch employment laws. As a result, the EMA has determined that it will need to slow down or scale back several activities, including international collaborations, development and revision of guidelines, and publication of clinical data. Delays and shortages of experienced staff could also potentially lead to a slowing of drug approvals.


In addition, the EU has raised concerns that UK companies — both drug manufacturers and those who hold marketing authorizations — are not well prepared for Brexit as it affects issues such as labeling and supply chains for both drugs and raw materials, which could lead to drug shortages. These concerns are leading European-based companies like Novartis and Sanofi to stockpile their drug supplies in the UK, in fear of a hard Brexit that would leave the UK without any trade agreements in place. A no-deal Brexit could also keep the EU from receiving important cancer and cardiovascular medicines, according to UK-based AstraZeneca, because AstraZeneca manufactures and quality-tests many of its products in the UK. To help alleviate the risk, the company is setting up a parallel quality testing operation in Sweden, an EU member nation, in order to ensure continued distribution in the EU. But the need to test twice will likely add to drug costs.


In the area of clinical trials, the UK Medicines and Healthcare Regulatory Agency (MHRA) recently issued a statement to reassure people about the impact of Brexit on clinical trials for new drugs. UK and EU have agreed to an implementation period for Brexit-related changes from March 30, 2019 until December 31, 2020. During this time, the UK will no longer be a member state of the EU but access to each other’s markets will continue on current terms, and EU rules and regulations will remain in place.


But uncertainties remain around this implementation. In 2020, a new EU Clinical Trials Regulation (CTR) is due to be implemented in order to enable a streamlined application process, harmonized trial assessment procedures, a single IT portal for all EU clinical trials, and simplified reporting procedures. The UK was heavily involved in developing the new regulation, which has been welcomed by clinical trial sites, researchers and industry alike.  In April, the UK MHRA committed to implementing the CTR regardless of Brexit negotiations. If the negotiations on new trade agreements go as planned and the CTR is implemented on schedule during the transition period, the UK government will codify it into UK law.


However, if the CTR is delayed or Brexit negotiations fail, problems could emerge with respect to the UK participation in the shared IT portal and the “single assessment model,” a uniform framework for the authorization of clinical trials through a single trial assessment that is then accepted by all EU states. In this case, the UK may need to negotiate a separate agreement to participate in the clinical trials portal and database, or to implement its own regulatory process for clinical trials approvals. In the latter scenario, drug sponsors wanting to conduct multi-national trials involving the UK would have to apply to the MHRA as well as to individual EU states for trial approval. If this happens, the MHRA says that it will make every effort to ensure the parallel submission will be streamlined and a decision reached within the timeframe mandated by the EU process.