What will be the priorities for the next round of Brexit talks?
MPs are urging UK and EU Brexit negotiators to put patient safety at the top of their priority list in the next round of talks.
In its report, Brexit: medicines, medical devices and substances of human origin, the Health and Social Care Committee says both sides must look to secure the ‘closest possible regulatory alignment’. Chair of the committee Dr Sarah Wollaston said ‘failure to do so would signal a triumph of ideology over the best interests of patients’.
The Committee welcomed the government’s intention to maintain regulatory alignment with the European Medicines Agency (EMA) but said the ‘entire supply chain of pharmaceuticals, from research and development through to the product being available on a pharmacy shelf, will be adversely affected by regulatory divergence and seriously so in the event of a “no deal” Brexit’.
However, the committee added that it was essential that there is scrutiny of the Department of Health and Social Care’s contingency planning for a ‘no deal’ situation.
The MPs want continued participation in Europe-wide clinical trials; mutual recognition of pharmacovigilance mechanisms by the Medicines and Healthcare Products Regulatory Agency and the EMA; and continued membership of all the major EU pharmacovigilance systems and databases, including the European Database on Medical Devices (EUDAMED) and Eudravigilance.
Parliament: Report summary