Agency chief seeks help from pharmacos with medicines shortages

Agency chief seeks help from pharmacos with medicines shortages

Over the past two years EU countries have begun reporting disruptions in the supply of some medicines, and faced a shortage of antibiotics for paediatric care in late 2022.

The EMA has only lately started to look more into the issue of shortages – particularly in public health emergencies or during so-called major events – after an extension of its mandate in 2022 to improve the agency's role in crisis preparedness.

National and EU regulators still heavily rely on information they receive from private companies, however, when assessing supply vulnerabilities.

“We have to encourage greater transparency because the only way to help mitigate [shortages] is if we understand. And we can only understand if we know,” EMA boss Cooke said.

The need to keep information flowing is undermined by the fact that manufacturers remain careful with the information they are willing to communicate to authorities.

“Honestly, I don't even believe these are competitive issues. There is more of a perception that companies need to not share them,” she pointed out.

Cooperation with pharmaceutical companies helped the EMA to understand better what is really under the control of private entities during a shortage, Cooke said.

“It's not a blame game. Some of it is the companies’ responsibility. Sometimes it is we’re part of the problem and we have to understand that too,” she added.

If manufacturers were more open to communicating the challenges they face, that would benefit the entire health ecosystem, according to Cooke: “Nobody wants a shortage – and it's not even in the interest of the companies. They want to sell their products.”

The EMA has recently published a list of critical medicines, identifying different vulnerabilities facing each product and actor, from patent holders to small suppliers.

This revealed that the root causes of different shortages can vary. “Everybody thinks there’s one solution, but there isn't. It's very much product-dependent,” said Cooke.

“Sometimes it's about manufacturing problems, sometimes it's that profit margins are either too low and/or there is pressure on the companies to supply too many markets at low cost,” she continued.

She stressed that there is no instant fix and that even the frequent request to simply step up production is more easily said than done as new manufacturing sites cannot be set up overnight.

Shortages are here to stay

The issue of drug shortages is expected to be high on the next EU executive’s agenda, with some preparatory steps already put forward during this mandate – such as the launch of a critical medicines alliance open to all stakeholders.

Supply issues will continue to affect the EU market for drugs due to a mix of factors such as a rise in demand, low production capacity, and shortages of raw materials, according to a communication published by the Commission last October.

According to Cooke, the Commission’s vaccine strategy was a game changer in uniting stakeholders with a common vision.

“Of course, this was done in a crisis situation, but it also shows that can be done,” she said, adding that some 'out-of-the-box' solutions found during the pandemic can be translated into a more sustainable and coordinated approach.

A new focus on shortages could offer an opportunity to build on the COVID-19 momentum and promote a collective ambition to make a difference in health at the EU level, even though the competence on the matter remains firmly in the hands of member states.

"The problem of shortages is not going to go away tomorrow. And it is not just a regulatory issue: it needs input from all stakeholders and concerted actions from all stakeholders,” she said.

The EU agency is now co-chairing the Medicines shortages steering group, a body that includes representatives from patients and healthcare professionals with responsibilities in managing and mitigating shortages across the bloc.

Other multi-stakeholder platforms have been recently set up, like the Joint Industrial Cooperation Forum, whose primary role is to identify bottlenecks across the supply chains.

“These platforms really help to have open and frank conversations and look at what we can do and what we cannot,” Cooke said. The work of platforms, in particular, helps companies predict demand for certain products in advance so they can keep on top of the order cycle.

“We’re asking companies to do shortage prevention plans where they look at the vulnerabilities in their supply chain and try to put in place measures to ensure they address that,” she said.