Regulatory Divergence From EMA Would Have Serious Consequences, Says UK Report

Kelly Davio

Given reliance on industry fees to pay for the review of medicines, as well as the pharmaceutical industry’s potential inability to sustain the level of fees required to review all new medicines without cooperation with the European Medicines Agency (EMA), the United Kingdom could have to reduce the number of drug marketing authorizations it grants each year, or raise the funds elsewhere.

According to a report issued this week by the UK Parliament, if the United Kingdom leaves the European Union without an agreement to continue to participate in the European Medicines Agency’s (EMA) regulatory system or to recognize the EMA’s decisions on drugs, applications for marketing authorization of new medicines would have to be submitted separately to both the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and the EMA for approval.

Given the MHRA’s reliance on industry fees to pay for the review of medicines, as well as the pharmaceutical industry’s potential inability to sustain the level of fees required for the MHRA to review all new medicines without cooperation with the EMA, the United Kingdom could have to reduce the number of drug marketing authorizations it grants each year, or raise the funds elsewhere.

The approximately 1000 drugs already made by UK-based companies and authorized for marketing in the European Union would have to be transferred to EU member states, a process that would likely be expensive and administratively challenging, as remaining member states may be overwhelmed by applications as the Brexit deadline nears.

Furthermore, the report says, the UK market comprises approximately 3% of the global drug marketplace, while the European Union comprises approximately 25%; attracting drug companies who typically target the largest pharmaceutical markets first could be a daunting challenge for the United Kingdom. Given the added cost of approximately £45,000 ($60,625) to gain a UK-specific marketing authorization, the United Kingdom risks “losing out entirely,” says the report, on gaining access to new therapies.

While the report notes that some stakeholders have argued that divergence from the EMA would provide the opportunity for greater flexibility in the timelines of approvals for new drugs, it warned that “what little benefits there may be of regulatory divergence would be greatly overshadowed by the costs and loss of markets and influence the United Kingdom would face.”

The report urged the UK government to prioritize retaining a form of membership in the EMA in order to avoid having to replicate regulatory functions for medicines, to retain some EMA staff in the United Kingdom to support a continued relationship, and to secure a reasonable period of time for the United Kingdom to transition from its current EMA membership.

Rachel Reeves, Member of Parliament and chair of the Business, Energy and Industrial Strategy Committee, said in a statement that “The government must do all it can to reach an agreement that not only protects the United Kingdom’s status as a world leader for pharmaceuticals but also allows patients across the continent to continue to be provided with the medicines they need."