By Francesco Guarascio

(Reuters) – The European Union might consider signing a supply contract with Merck in order to purchase its COVID-19 drug. But that will be only after Merck begins the process of getting approval from the EU, a top EU official indicated on Tuesday.

Ridgeback Biotherapeutics developed the oral antiviral drug molnupiravir. Merck filed for an emergency use authorization in the United States on Monday. This authorisation has secured approximately 1.7 million courses molnupiravir, at $700 per course.

A joint EU procurement of molnupiravir is possible “if Merck contacts EMA”, an EU official said to Reuters. This refers to the European Medicines Agency.

The EU signed advance buy agreements to purchase experimental vaccines against the new virus during the pandemic. Companies applied for EMA before the official stated that this has now been changed as the EU-27 bloc is entering a new phase of the emergency.

ROLLING REVIEW

The official stated that the EU now only signs advance agreements when the drugs are at least undergoing a rolling review with EMA. The EU regulator now assesses the data when they become available rather than waiting to receive a formal request after all necessary information has been collected.

Unspoken for the EU Commission, a spokesperson did not say whether rolling reviews were required in order to enter into an agreement with a drugmaker. The EU Commission and at least four EU governments would have to be supportive of a joint procurement in order to make it possible.

Last week, EMA stated that it will be considering whether or not to initiate a rolling review of molnupiravir. Reuters was informed Tuesday by EMA that the rolling review hadn’t started.

Merck didn’t respond to our request immediately for comment.

An EU official stated that talks had not begun with Merck and that it was still uncertain how many treatments Merck could provide. Pricing would also be a factor.

The EU can reserve a certain number of vaccines or treatments under advance purchase agreements. EU members who sign the contract are eligible to purchase their part of the reserved doses, provided that the medicines have been authorized by the EMA (or a national regulator).