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Regulation of Medicines

Volume 633: debated on Thursday 14 December 2017

13. What progress the Government have made on negotiating with the EU continuing co-operation on the regulation of medicines after the UK leaves the EU. (902941)

We worked intensively with our European partners to settle the issues in the first phase of negotiations, and as the hon. Gentleman knows, we published a joint report. We now want to focus our efforts on quickly agreeing the detail of a time-limited implementation period to give certainty to people and businesses. As the Secretaries of State for Business and for Health emphasised in their open letter to the Financial Times earlier this year, as we enter the next phase we want to work closely with the European Medicines Agency and international partners in the interests of public health.

The high costs of not maintaining regulatory alignment for medicines were recently laid bare in evidence to the BEIS Select Committee. If alignment is not achieved, how much would prescription charges have to go up? Is regulatory alignment the Government’s objective? If so, what is the point in all this?

As part of our exit negotiations, we have been clear that we want to discuss with the EU and member states how best to continue co-operation in the field of medicines regulation in the best interests of businesses, citizens and patients in the UK and the EU. Of course, what we cannot do is prejudge the outcome of those negotiations.