Medicines in Europe: We must address affordability and availability

The EU market for medicines remains fragmented. Member States don't have the same access to sometimes life-saving medicines. This model is not sustainable, argues MEP Alex Agius Saliba.

By Alex Agius Saliba

Alex Agius Saliba (S&D, Malta) is a member of the Committee on the Internal Market and Consumer Protection 

13 Dec 2023

There will be no future for the European Union without a strong social Union. Healthcare is one of the 20 principles of the European pillar of social rights, and access to medicines at affordable prices is a key objective of the European Health Policy.  

Regretfully, despite the many efforts, it seems that a genuine European single market for medicines has not been achieved, and the fragmented EU market for medicines remains a complex web of barriers, which often delay access to sometimes life-saving medicines.  

This situation affects in particular smaller or poorer Member States and millions of patients across Europe, who often have to wait years before a pharmaceutical product becomes available to them, or face paying a significant price difference between countries.  

As commissioner for health, Stella Kyriakides, remarked on the revision of the EU’s pharmaceutical legislation, citizens in western and bigger Member States have access to 90 per cent of newly approved medicines; citizens in eastern and smaller Member States have access to only 10 per cent. 

Such fragmentation is not justified and it breaches citizens’ fundamental right to timely access to affordable, preventive and curative healthcare of good quality.  

Common European solutions, giving prominence to patients and the public health dimension of medicinal products, are key if we want to achieve real affordability and accessibility to medications in the EU. To this end, the European Commission put forward a “pharmaceutical package” on 26 April, which goes in the right direction; however it does not go far enough. 

There has been a lot of debate on the proposed incentives to encourage companies to make their medicines available to patients in all Member States. The rationale of incentives should inspire industry to develop products to the benefit of patients. Unfortunately, such incentives often hinder access to treatment of more than a third of EU patients.  

Extended patents, through the supplementary protection certificate and the data protection periods, are acting as a barrier to the entry of generic products on many of the EU markets, which the market authorisation holders are not interested in supplying. While the Commission claims it is trying to solve this problem, its proposals, announced on 27 April, to introduce a single procedure for the granting of supplementary protection certificates throughout the EU will only compound the problem.   

Furthermore, the proposed measures will only apply to new products that come on to the market, whereas it is also important to address products introduced before the new framework comes into force. In this regard, there should be an obligation on the market authorisation holder of a centralised product to supply all Member States. 

While it is clearly unfeasible for industry to manufacture in the reduced quantities needed to fulfil the requirements of the smaller Member States, the current solution not to supply these Member States at all is out of step with EU principles.  

Negotiations on pricing at the cost of human life is not acceptable

Consequently, it is important to create single packs, which may be marketed in all Member States and which may move freely across the EU. Existing digital tools can make this happen. Such an approach would also facilitate joint procurement and increase competition for generic products in the smaller markets.  

Negotiations on pricing at the cost of human life is not acceptable. In this regard, it is important to include within the EU legislative framework an additional instrument requiring transparent pricing mechanisms for innovative medicines and also transparent pricing.  

The current model which results in delays in markets supplying medicines to smaller countries with lower GDP is not sustainable.  

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