Delay of EU pharma reform faces criticism from MEPs, stakeholders

The further postponement of the publication of the EU pharma legislation has caused tensions to rise among EU lawmakers and health stakeholders, who have demanded the Commission expedite it to start the legislative process on time.

The revision of the EU’s pharmaceutical legislation will set up a framework for the use of human medicines, from production, to clinical trials, to marketing authorisation.

But the publication of the much-anticipated revised legislation has been postponed for a third time, EURACTIV learned on Wednesday (22 March), with MEPs and NGOs highly critical of the added delay.

In a letter addressed to Commission President Ursula von der Leyen, French MEP Véronique Trillet-Lenoir (Renew) on Thursday urged the Commission to publish the revision of the legislation ‘no later than April 2023’ to allow the legislative process to start. 

“We all know that this legislative package was ready to be published. We all refrained in the past weeks to comment on the leaked version of the proposals,” Trillet-Lenoir wrote in the letter. 

“The report of this crucial legislation, without any justification and any alternative date of publication, is unacceptable”, the letter said. 

“This legislation is key to ensure the fair and equitable access of medicines to all patients, to all Europeans. It is time to listen to them and give them answers. They deserve to be heard as much as the pharmaceutical industry is,” the French MEP concluded. 

Socialist German MEP Tiemo Wölken shared Trillet-Lenoir’s position. “This is a huge victory for the pharmaceutical lobby who has been fighting hard to postpone the pharmaceutical package and an embarrassment for Commission,” he said in a tweet on Thursday. 

For Green MEP Tilly Metz, the situation is “unacceptable”.

“What could be more urgent than the health and well-being of European citizens? It is time to act now and to release the pharma package as soon as possible,” she also said in a tweet on Wednesday. 

Stakeholders not happy either

Stakeholders also expressed anxiety that the new timeline would limit the possibility of a thorough democratic discussion on the text before the end of the legislative mandate in 2024.

“Everything that is not put into the institutional machine by May will not be finalised,” Monique Goyens, director general at EU consumer association BEUC warned at an event on pharmaceutical strategy on Thursday.

Goyens added that even if the legislation was adopted in the coming weeks, MEPs will not have much time to review it. “This will be a very controversial proposal, this is not going to be an easy ride between the institutions,” she said.

Contacted by EURACTIV, the European Patients’ Forum (EPF) said that they took note of the delay, underlining that the legislation must “meet the needs of those who benefit from approved medicine: patients” and adding that they hope to see the proposal published as soon as possible.

On 9 March, a coalition of organisations representing civil society, patients, and healthcare professionals co-signed a letter addressed to EU Health Commissioner Stella Kyriakides asking to publish the revised EU pharma legislation no later than in March 2023.

“We obviously are disappointed that the Commission seems to have failed to give the pharmaceutical legislative revision the priority in their schedule we have called for,” a spokesperson from the European Public Health Alliance (EPHA), one of the signatories of the letter, told EURACTIV.

The EPHA spokesperson said that the letter highlighted issues that need to be addressed urgently such as shortages of medicines, sky-high prices, and limited availability to patients of the treatments they urgently need.

“Without reform of the sector with a revision of EU pharmaceutical legislation, these problems will only continue to grow,” the spokesperson concluded, adding that they hope the Commission “will realize this and so find space in its schedule to adopt their proposal without further delay”.

It is not the first time the revision of the EU pharma legislation is delayed. The publication of the text was first expected at the end of 2022, then mid-March, and now postponed again at the end of the month. 

As it stands, the adoption of the revision “will take place slightly later than the date currently indicated in the tentative agenda for forthcoming Commission meetings”, according to a Commission spokesperson.

Justifying the delay, the spokesperson cited the ‘very busy agenda’ of the College of Commissioners the past few weeks.

Commission to seek patient-centred, industry-friendly pharma rules reform

With only a few weeks before unveiling the EU’s revamped framework for pharmaceuticals, Health Commissioner Stella Kyriakides described the main drivers of the much-awaited reform, stressing the importance of finding the balance between patients’ and industry’s interests.

[Edited by Nathalie Weatherald]

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