UK pharma calls for cooperation as EMA continues Brexit split

Britain’s pharma trade body has issued a fresh Brexit warning, saying it would be disadvantageous to both the UK and the EU if drugs regulation diverges as a result of the political changes.

The industry body issued the warning after European Medicines Agency continued its Brexit split from the UK system, assigning a chunk of the work previously down by the Medicines and Healthcare Products Regulatory Agency (MHRA) to other European agencies.

The MHRA and the Veterinary Medicines Directorate acted were acting as coordinators for hundreds of already-approved drugs that were being monitored by the EMA’s scientific committees.

In a statement the EMA, which is also set to move to a new Amsterdam headquarters from its current location in London, said that new rapporteurs and co-rapporteurs have been found for 370 centrally authorised products.

The move indicates that the EMA is not waiting for the outcome of negotiations over drug regulation arrangements set to take place this year, and whether there will be a transition period after March next year when Brexit will officially begin.

The EMA said the changes will be communicated to marketing authorisation holders before the end of the month.

The redistribution plan covers the post-authorisation stage in a medicine’s lifecycle, and was based on  member state regulators’ expertise with specific classes of medicines.

[caption id="attachment_21182" align="alignnone" width="179"] The ABPI's Mike Thompson[/caption]

In response, Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry (ABPI), said: “Given that the MHRA assesses up to 20 per cent of EU medicines, it is clearly in the EMA’s interest to continue to draw on its expertise.”

"It would also be disadvantageous for the EU to be unaligned with the UK as the largest biopharmaceutical cluster outside of the US.”

"The UK government has been clear that cooperation on medicines is a priority and we urge both sides to come to an early agreement in the interest of patients and public health.”

The EMA's distribution plan builds on existing knowledge by transferring medicines to the current co-rapporteur for a particular product, or to the peer reviewer involved in the marketing authorisation application.

The reallocation plan takes into account the type of product. Generic medicines were allocated to national regulators who traditionally have participated less in EMA evaluations but have indicated that they would like to increase their involvement with such medicines.

Clusters of products with the same international non-proprietary name (INN) and/or belonging to the same marketing authorisation holder have been allocated to a single rapporteur in order to improve efficiency within the network.