EMA cuts MHRA out of drug reviews ahead of Brexit

The European Medicines Agency (EMA) has reportedly put a stop to the UK’s role in evaluating new EU medicines for sale as Brexit looms.

The EMA, which is responsible for the protection of public and animal health in the EU, has stopped giving any work to the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), according to UK newspaper  The Guardian.

Drugs sold in Europe must go through an EMA authorisation procedure and national regulators, such as the MHRA, tender to undertake assessments of these drugs.

As part of the changes, existing contracts with the MHRA are also being reallocated to other EU members.

“The EMA said that because of the long lead time involved in assessing medicines it could no longer award the lead contracts to British people since there was no guarantee they would be part of the EU after March 2019,” said The Guardian.

After Brexit, if there is no deal in place, the UK will become a “third country” and won’t be able to engage as an assessor, known as a (co)-rapporteur, for new marketing authorisation applications.

In April, the EMA completed the redistribution of the UK's portfolio of more than 370 centrally authorised products to rapporteurs and co-rapporteurs from the 27 other EU member states plus Iceland and Norway, in preparation for Brexit.

This month, European assessors will receive a “knowledge transfer package” for each centrally authorised product, with UK assessors providing their knowledge on the regulatory and evaluation history of each product to EU counterparts.

A spokesperson for the MHRA said: “The UK’s position on medicines and medical devices regulation remains clear: we want to retain a close working partnership with the EU to ensure patients continue to have timely access to safe medicines and medical devices.”

In March, the UK’s Prime Minister Theresa May revealed that the UK would be willing to remain part of the EMA after Brexit, but European Council president Donald Tusk appeared to shoot down the possibility days later.

Then, in July this year, the UK Parliament voted in favour of the UK’s continued participation in the EMA.

However, the UK will fall outside of the EMA in the event of a no-deal Brexit, leaving the MHRA to take on the functions currently undertaken by the EU for medicines on the UK market. The MHRA is planning a public consultation in early autumn on some of the key proposed legislative changes to allow the agency to take on the functions.

Speaking to LSIPR, the MHRA’s spokesperson added that some elements of the agency’s role will change during the implementation period.

“For example, for medicines, as with all areas, the UK will no longer have voting rights in EMA and EU committees, and MHRA will no longer lead assessments on behalf of the EMA to inform their decision-making process,” they added.

The EMA is set to launch the third phase of its business continuity plan by October 1.

Last month, the agency announced plans to temporarily further scale back and suspend activities in order to cope with a more significant staff loss from the agency’s relocation than was originally expected.

The plan will intensify the EMA’s preparation for the move from London to Amsterdam in March 2019 and cope with significant staff loss.

LSIPR  reported in November last year that the EMA will relocate from its current headquarters, in a move sparked by the Brexit vote.

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