UK Regulator Releases Corporate Plan to Address Brexit Uncertainty

April 26, 2018
The Center for Biosimilars Staff

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has released its Corporate Plan for the coming 5 years. The plan seeks to address some of the uncertainty generated by ongoing negotiations between the United Kingdom and the European Union in light of the upcoming Brexit.

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has released its Corporate Plan for the coming 5 years. The plan seeks to address some of the uncertainty generated by ongoing negotiations between the United Kingdom and the European Union in light of the upcoming Brexit.

“There are big changes ahead, not least the impact of the [United Kingdom’s] exit from the [European Union], but I am confident that the Agency, with its globally unique concentration of expertise in data, standards and regulation will continue to offer our customers a full range of services and products which is not replicated anywhere else in the world,” wrote Michael Rawlings, GBE, chair of the MHRA, in a preface to the report.

Despite calls from the UK Prime Minister Theresa May for the United Kingdom to remain a member of the European Medicines Agency—which were met with skepticism from the European Commission—the MHRA plan acknowledges that “The exact nature of the Agency’s relationship with EU regulators after exiting the [European Union] will be determined through the negotiations,” but underscored the fact that the government intends to “Retain a close working partnership with both EU and other global regulators in the interest of ensuring patients continue to have timely access to safe medicines and medical innovations.” The report points to precedents for collaboration between the European Union and non-EU partners such as Switzerland and Turkey.

Despite these hopes, the UK regulator says that it is preparing to deliver a smooth exit from the European Union under any scenario, including the “very unlikely” scenario in which no mutually satisfactory UK—EU agreement can be reached. According to the report, by 2023, the agency hopes to continue to have a major role in regulation, having managed the outcomes of the Brexit negotiations. To achieve these goals, the MHRA will need to broaden its income base by instituting a fee schedule for its work, and will also need to improve its efficiency.

Other objectives outlined in the plan include supporting innovation through legislative and regulatory measures and focusing on priority areas of scientific development; delivering proactive surveillance of medicines and devices through the use of real-world data and enhanced information-sharing; ensuring the safe production and supply of medicines; and delivering a flexible organization with an appropriate skill mix to respond effectively to market needs.