The European Commission has proposed a new rules that strengthen the supply and availability of important medicines and prioritize EU -based suppliers in public procurement.
advertisementThe EU executives included a new ‘purchase European’ mechanism that included a long -awaited proposal for an important pharmaceutical law that was released on Tuesday, the main health law of this semester. The proposal came on time to meet the 100 -day imposition deadline at the office of the Health Chairman Olivér Várhelyi.
This accelerated timeline for this proposal has no comprehensive impact assessment and stakeholder feedback has been limited to controversy, but the committee said that it is urgently needed in consideration of the lack of medicine.
This law aims to ensure high levels of public health protection and security by securing a stable and reliable supply chain within the EU.
“Critical Medicines Act allows EU patients to access the time they need at a low price and where they need them. In the current designated context, this has been much larger, ”Várhelyi said.
This proposal is a strategic EU goal that establishes the security of the supply and availability of important medicines. To achieve this, a high -ranking assembly admitted that the adjusted approach was needed in both the state and European levels.
This law aims to be an important medicine included in the important drug list of the EU written by EMA (EUROPEAN MEDICINES Agency) in 2023, and focuses on drugs with drugs or limited alternatives used to treat serious conditions.
What is the problem?
This proposal, especially for essential drugs such as antibiotics, insulin, and painkillers, tries to solve the serious shortage of the EU. Many of these medicines have become difficult to obtain due to a limited number of manufacturers or countries.
The Commission recognizes the EU’s dependence on foreign suppliers to active constraints (APIs) and the risk of suspension of exports. Covid-19 Pandemic exposed these vulnerabilities to emphasize the need for a more flexible supply chain.
Pharmaceutical companies are responsible for guaranteeing sufficient supply of medicines, but individual EU member states supervise the distribution in the territory. Most of the shortcomings are currently managed at the national level.
‘European purchase’ is a solution
The new proposal aims to reduce external dependence by promoting investments in essential medicines and major ingredients within the EU.
The main action is a kind of ‘European purchase’ principle, which introduces the standard for public procurement that sets the priority of supply security by price alone.
In fact, if the vulnerability of the supply chain and the dependence on a single third country are confirmed, the EU contract authorities will apply advanced procurement requirements to suppliers that manufacture a large portion of these important medicines within the EU.
Such measures will be implemented in accordance with the union’s international commitment. An EU official said, “This is to increase EU production capacity and diversify the supply chain to do more flexible work and use demand.”
Joint Procurement Plan?
This proposal also introduces the novelty, which is the category of pharmaceuticals according to the close review: Commonly interested pharmaceuticals. This includes three or more EU member states, such as what is used to treat rare diseases, and contains almost no availability and accessibility.
In this pharmaceutical, the Commission proposes a adjusted procurement mechanism with its member states to prevent inequality and supply gap.
advertisementThis can be seen as an attempt to practice the procurement of medicines at the EU level by supporting the European Commission, which uses various joint procurement tools for European drugs and various collaboration procurement tools for other common drugs.
The proposal also introduces the concept of strategic projects with the goal of strengthening the EU’s important drug manufacturing and development capabilities.
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Lack of ambition (and money)
Reviewing this proposal, Luxembourgish Green Mep Tilly Metz demanded a bold initiative to reproduce European medical production. EURONEWS said, “It is not enough to accelerate joint procurement and processes.
advertisementMeanwhile, Romania’s liberal MEP VOICULESCU welcomed the proposal as a positive stage for a greater approach to cheaper medicines.
“It’s a start. As soon as possible, we hope to be supported by funds, budgets and national laws. ”VOICULESCU told Euronews.
Concerns about financing still remain. Others are mostly feared that the EU4HEALTH program will be insufficient for 88 million euros in 2026-2027.
Ahead of the proposal, the 11 EU Health Secretary advocated the scope of the upcoming EU defense funding system and included important medicines. One of the signators, Frank Vandenbroucke, called the Belgian Minister of Health, urged the Commission to integrate this law into European security and defense frameworks.
advertisement“Medical security is as important as defense or energy security. Our collective safety depends on it. ”
