Belgium’s EU presidency to ‘firmly’ focus on critical medicine shortages

Proposals to address critical medicine shortages will be given firm attention during Belgium’s stint as Presidency of the European Council, which starts in January 2024, a Belgian official told Euractiv.

In May, the Belgian government, in collaboration with 23 fellow EU member states, presented a proposal to institute a Critical Medicines Act (CMA) designed to address and “Improve the security of medicines supply in Europe.”

Speaking to Euractiv, a Belgian official stated the development of the adoption will be given “a firm place during our Presidency conferences and in the Presidency meetings leading up to the EPSCO Council Conclusions (working parties, EPSCO meetings).”

In continuous dialogue with the EU and other member states, the European Commission adopted a set of actions on 24 October.

In an official communication, Health Commissioner Stella Kyriakides announced a set of short-term and longer-term actions to address shortages of medicines and enhance the security of supply in the EU.

The key goals act to prevent or mitigate critical shortages at the EU level and “to assure a particular focus on the most critical medicines” for which “security of supply needs to be assured at all times.”

“To make the Critical Medicines Act operational, careful analysis of the vulnerabilities in the supply chains of critical medicines is needed”, the Belgian official said.

“We also need to map what the problematic dependencies are, and what the production potential is in Europe [..] important for the design of the Act,” the official added.

Furthermore, there is a lack of suitable financial instruments at the EU level, as most instruments target innovative sectors.

Belgium is currently proposing to include the production of critical medicines and components in the Strategic Technologies for Europe Platform (STEP) as a partial solution to this problem. This is also being discussed in the European Parliament.

“We intend to work with the Commission to further work out this strategy,” they concluded.

Moreover, Belgium will try to make as much progress as possible in the Council negotiations on the pharmaceutical legislation.

“As a country that attaches great importance to innovation, equitable access and affordability, we will carefully listen to the different perspectives of the member states and try to map avenues for compromise”, the official noted.

Urgent action required

During the winter of 2022-2023, many member states experienced shortages of critical medicines. To prevent this from happening this winter, the Commission, in its communication, calls on the European Parliament and the Council to ensure swift adoption.

Due to the dependence on outsourcing medicines and other complexities, a high incidence of medicine shortages has been a growing trend in European countries for years, even before the onset of the COVID-19 pandemic.

Belgian Health Minister Frank Vandenbroucke emphasised the challenges faced today are “part of a broader trend” [..] where he states, “the overreliance on a limited number of global manufacturers has left Europe vulnerable to market disruptions and shortages.”

According to a survey conducted among pharmacists in 29 European countries as part of the European Community of Pharmacists (PGEU) “Medicines Shortage Survey 2022,” 100% of respondents reported experiencing a shortage of medicines. Most countries noted that “the situation had worsened in the previous year (75.86%), while the rest reported it had remained the same (24.14%).”

The survey also highlighted a complex regulatory landscape across different countries, impacting the ability of pharmacists to respond effectively to medication shortages.

Certain restrictions, such as the requirement for a new prescription, can introduce complexities and time-consuming processes for patients and pharmacists.

Belgium faces critical drug shortage for type II diabetes patients 

One shortage which has made headlines in Europe and across the globe is the unavailability of the drug “Ozempic”, used by adults with type II diabetes. A sudden high demand has occurred due to its off-label use as a weight loss drug, causing a shortage of the drug for those who need it most.

People with type II diabetes need this prescription to ensure that their bodies can release insulin and control associated symptoms. The FAMHP’s Task Force on Unavailability in Belgium recently met to address the issue.

The Task Force recommended that Belgian healthcare professionals prescribe the drug exclusively to those with type II diabetes, referring people with obesity and overweight to medications designed explicitly for their conditions.

Meanwhile, the Commission’s actions will involve establishing a list of essential medicines, ranging from 100 to 350 drugs, expedited to present an initial list by the end of 2023.

Looking more long term – establishing the Belgian proposed “Critical Medicines Alliance” is expected in 2024.

An over-reliance on a limited number of global manufacturers has left Europe vulnerable to market disruptions and shortages. Therefore, an analysis of supply chains for chosen medicines will be conducted, with measures to address the issue.

Europe’s share of global production in Active Pharmaceutical Ingredients (APIs) has declined significantly, dropping from 53% in 2000 to 25% by 2020.

The Alliance will enable national authorities to collaborate with industry and the EU to address shortages and enhance supply chain resilience.

[By Caoimhe Kelly – Edited by Vasiliki Angouridi | Euractiv.com]

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