This article is the product of a POLITICO Working Group presented by Sanofi.

BRUSSELS — The EU wants to arrange purchases of the newest medicines for countries that currently don’t have access to them — but some in the pharmaceutical sector are not happy about it.

The European Commission’s plan to use joint procurement to provide access to innovative drugs across the bloc risks overuse of this process and could drown out competition, according to David Elvira, global corporate public policy head at Sanofi.

Draft legislation drawn up to fix Europe’s chronic drug shortages contains plans to expand the circumstances under which joint procurement could be used. That includes critical medicines with vulnerable supply chains, such as those with single-country dependencies, as well as novel therapies unavailable in three or more EU countries. The latter are known as medicines of common interest in the draft Critical Medicines Act.

While joint procurement of widely used, critical, and often very cheap generic drugs was expected to be included in the legislation, the use of it for new, branded, and often expensive treatments — such as cell and gene therapies and cancer drugs — came as a surprise to many in the sector.

The concern is that “we opened the window of the risk with this medical product of common interest,” said Elvira.

“Because if the definition (of a medical product of common interest) is blurry, non-detailed, and we don’t know exactly what we want to solve with this, then we will start to have some overuse of the panacea of the joint procurement as the solution,” he said during a closed-door working group on the topic organized by POLITICO.

One politician also warned against overusing the tool, noting that many root causes need to be addressed to prevent drug shortages.

“Joint procurement is not a solution for all the (drug shortage) problems that we are facing,” Socialists and Democrats MEP Nicolás González Casares said. It can be useful to “give a boost for the market in order to obtain vaccines,” or to tackle shortages in some cases. But it “cannot solve all the problems,” he added.

Joint procurement as an EU tool for improving access to medicines only really “found its destiny” during the Covid-19 pandemic, said Olivier Girard, head of medical countermeasures at the European Commission’s Health Emergency Preparedness and Response Authority (HERA). During that time, the bloc purchased lifesaving vaccines for European countries.

Since then, it has become a more common tool in the EU’s public health arsenal, helping countries procure vaccines for bird flu, mpox and pandemic influenza.

Improving access in smaller countries

For countries, particularly smaller ones with limited market size and weaker buying power, joint procurement could help to improve access to critical and innovative medicines.

“Joint procurement for medicinal products are particularly in our interest as a small country,” said an official from an EU country with a small market size, granted anonymity to speak candidly. “And joint procurement is not just a part of the solution for shortages, but [also] access to innovation — equal access to innovation to all member states.”

Thanks to the EU-wide rollout of Covid-19 vaccines, citizens and the capitals also know the EU can deliver in this area.

“There is a strong case to support the development of the joint procurement,” Girard at HERA said. “We have built trust and we have demonstrated that we could deliver, so let us think how the model could evolve and be developed — only where there is added value for the member states.”

But the pharmaceutical industry argues that any changes should be made cautiously and with clear guidelines for everyone involved. The sector wants safeguards to support companies’ participation and to prevent market monopolies, which it argues could develop if a drugmaker wins a contract for a large volume of medicines across the bloc.

“If there is no potential competition in the way we are implementing these joint procurements for the future, and you are excluding players in the future, that will not be sustainable and that will create future concerns,” Elvira said.

Generic drugs sector also sounds alarm

Most critical medicines are generics, and the generics industry also has warnings for the negotiators. Adrian van den Hoven, director general of the sector lobby group Medicines for Europe, pointed to a few problems with the tool, including poor planning, countries’ lack of commitment to buy jointly procured medicines and different packaging requirements across countries.

Legislators should also ensure that there is no conflict with national procurements, he said.

“We have experience of member states doing both the European procurement, or the joint procurement, and the national procurement at the same time to see which one — we assume — delivers the better price,” he said. “But then that leaves the suppliers on the hook with a commitment to supply for both. And this is really something to avoid.”

The solution? The Commission and countries should consider incentives such as multi-award contracts, a minimum binding commitment from countries to buy, and criteria that go beyond price, to ensure adequate forecasting for companies and to secure a more sustainable supply.

Ultimately, it’s all about finding the right balance, said Claudia Louati, head of policy at the European Patients’ Forum.

“[Joint procurement] works for member states, it works for companies, it works for the whole ecosystem,” Louati said. “Let’s not miss this opportunity, and let’s try to make it right… We don’t want it to just be in legislation and not actually be implemented and being used.”

This article is the product of a POLITICO Working Group presented by Sanofi and was produced with full editorial independence by POLITICO reporters and editors. Learn more about editorial content presented by outside advertisers.