March 5. 2024. 9:34

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EU’s first list of critical medicines and other key measures to tackle shortages

The European Medicines Agency (EMA) will publish the first critical medicines list next week, as part of the EU’s strategy aimed at avoiding shortages, which also foresees other measures like stockpiling and diversifying the supply chain.

Last winter the European Union faced critical medicine shortages, which, according to the European Commission was due to a rise in demand, low production capacity, shortages of raw materials, and issues throughout the supply chain.

Health Commissioner Stella Kyriakides stressed on Tuesday (5 December) the need to look beyond the EU borders and take a broader approach to be better prepared for the future.

“We need to be able to see what the crises are and respond to them effectively before they happen,” she said.

With this aim, the EMA, together with the Health Emergency Response Authority (HERA), will publish a critical medicines list that will identify those medicines at risk of experiencing shortages.

“Together we will then identify the best measures to address and avoid shortages, from diversification and de-risking to increase manufacturing in Europe,” Commission President Ursula von der Leyen said on Tuesday during the 2023 HERA Conference.

The first list will be published on 14 December and will include between 200 and 230 medicines.

Laurent Muschel, director general of HERA, explained that the list will help to do a vulnerability assessment of the products, look at the security of the supply chain and identify the weaknesses.

Once the EMA publishes the list, HERA will look at key products on the list and how to support their diversification and security.

“Then the legal obligations [for the companies] will come into the pharma package when it is fully adopted by the concerned parliament,” Muschel said.

Belgium looks to get a head start on medicine shortages

Despite the short and long-term initiatives already in the pipeline, health ministers are eager to further expedite action on medicines shortages and secure an open strategic autonomy on health.

A complex set of causes

Muschel explained that preventing shortages is complex due to the different causes and always needs dialogue with the industry.

“The problem is matching the supply and demand. And that’s the challenging part”, he said.

According to HERA, the level of infections during the last winter was not foreseen and it was an exceptional situation caused by low levels of immunity in people after the COVID pandemic.

“It’s always hard to guess, but we need to be as accurate as possible to prevent any shortage and give the right signal to the market,” explained Muschel.

However, there can be other reasons that come directly from the supply chain, such as the lack of active pharmaceutical ingredients that could create a bottleneck in the process.

The new proposal for the pharmaceutical legislation, currently being discussed in the EU institutions, aims to tackle this as all pharmaceutical companies marketing medicines will be expected to have shortage prevention plans for their medicines, as well as notify potential shortages and withdraw more quickly.

Stakeholders highlighted the need to anticipate and have the information from the industry as soon as possible to be able to take the necessary measures.

“I think it is really important for the industry to be proactive and to notify shortages or potential shortages early because that makes a huge difference in being able to do something. and we don’t see that. I have to be completely honest about that,” said EMA’s Director Emer Cooke.

“Industry tells us on a Friday evening before the shortage is going to happen on a Monday. And that’s very, very difficult,” she added.

HERA’s director explained that most companies are already producing at full speed and do not have a lot of margin.

“If suddenly you say, listen, we are in shortage of amoxicillin, but they are already at full capacity they will not be able to produce more. You need to create a new supply chain and that is a huge investment which takes time,” he said.

Another issue stakeholders highlighted is the need to ensure the EU’s competitiveness in manufacturing. They explained that innovation and new medicines are coming but are produced in third countries.

Muschel explained that this also increases the risk of shortages. If one product, critical for patients, is only produced by one company outside the EU, there is a risk of unexpected problems that will disrupt the market in European countries, evidencing the need for diversification.

“Europe has an amazing biotech ecosystem with some of the most innovative startups in the world, and now with HERA they will find a new ally,” said von der Leyen.

EU new pharma rules strengthen efforts in tackling drug shortages

Some main features of the long-awaited reform of the EU’s pharmaceutical rules address the risks of drug shortages by making the industry more responsible for the security of supply and granting the EU medicine agency an increased coordination role.

Ongoing work on the solution

According to stakeholders, finding solutions is not easy due to the complexity of the problem and the need for a long-term sustainable approach.

However, Muschel highlighted a few measures that can help ease the current situation.

The first one is the stockpiling of critical medicines for which the European Commission announced in a Communication in October that will develop a common strategy in cooperation with member states in early 2024.

The Commission’s text stresses that stockpiling should be done before shortages occur to “help to bridge the supply gap before production increases or provide the input materials in shortage, needed to boost the quantities that can be manufactured”.

HERA’s director general agreed that it is a question of timing and should be done only where there is no tension in the market.

However, the Commission warned that national stockpiling can impact the availability of medicines in other countries, and be costly and potentially wasteful if not used together with mitigation measures to address the shortage itself.

Another tool the EU can use to mitigate shortages is joint procurement, as was done to purchase vaccines during the pandemic.

Muschel explained that joint procurement can also help tackle inequalities between countries when it comes to access to medicines.

He explained that HERA has a mechanism where they ask EU member states if they want to participate in the joint purchase of a certain medicine and the agency then negotiates with the companies on their behalf.

“By joining forces, the companies are more interested in negotiating with us because we are bringing together smaller member states,” he explained.

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