The creation of a single market for medicines in the EU

The unprecedented disruptions caused by the pandemic have once again placed healthcare at the forefront of public policy.

Oliver Thansan
Oliver Thansan
26 April 2023 Wednesday 15:39
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The creation of a single market for medicines in the EU

The unprecedented disruptions caused by the pandemic have once again placed healthcare at the forefront of public policy. In Europe, it is now more evident than ever that, when it comes to protecting citizens' health, the EU is stronger when we act together. It is precisely this lesson that has given rise to the European Health Union, a work in progress since 2020 and a project based on the opportunities offered by the crisis to deal with the challenges and deficiencies that have long affected the healthcare systems throughout our Union.

Medicines are a good example of this. Access to medicines is one of the most powerful symbols of an efficient healthcare system.

The current reality is that medicines do not reach all patients quickly enough, as innovative and promising medicines that are on the market are not always equally available in all Member States. In addition, there are still too many diseases for which there are no prevention or treatment options.

At the same time, many patients and healthcare systems cannot afford certain drugs because of their high prices, and drug shortages are a chronic problem that can leave patients without the therapies they need.

Geopolitical tensions have also highlighted the vulnerabilities and dependencies of our healthcare systems, which expose us to the vigilance of third countries. Meanwhile, more pressing priorities, such as the rise of antibiotic-resistant bacteria, are not being addressed as quickly and efficiently as needed.

Europe needs a radical change in medicine. Since the current EU rules were established more than twenty years ago, new scientific and technological megatrends have revolutionized the healthcare and pharmaceutical landscape. Our regulatory framework cannot afford to fall behind.

A modern pharmaceutical system, which is resilient in the face of crises and can serve citizens on a daily basis, is a key element of the strong European Health Union that we are building against the backdrop of Covid-19. Whether it's to soothe a headache, treat an allergy, vaccinate a child or treat a cancer patient with the latest breakthrough drug, these are essential products that citizens must have access to. In 2019, medicines were prescribed to 51% of people in Spain.

However, while patients in some larger Western Member States have access to 90% of newly approved medicines, in some small Eastern Member States the amount is 10%. The waiting time to access it also differs quite a bit, as patients have to wait several years in some Member States and only a few months in others.

Specifically, this means that some patients are unable to obtain effective treatment options for their disease. This is why it is so crucial to ensure that patients have access to innovative and affordable medicines and that, at the same time, our world-leading pharmaceutical industry remains strong and competitive on the international stage.

Our equal rules for everyone and a fragmented single market for medicines are part of the problem. Incentives must be offered to our innovative industry, but these must be more closely linked to responding to the needs of patients and healthcare systems. It is essential for us to guarantee patient access to medicines in the twenty-seven Member States.

This is why, as a top priority, we will promote rules to ensure that medicines reach all patients in the EU, facilitating competition which in turn lowers prices and ensures the sustainability of healthcare systems in all member states. We need to create a single market for medicines.

Second, something that is equally essential is the support for innovation with rules that stimulate research and reduce bureaucratic burdens on the system. Our approach will save 300 million euros in unnecessary administrative procedures.

To prevent shortages, it is also necessary to improve the supervision of medicine supply chains, in particular to determine the need to boost the EU's strategic autonomy with respect to its manufacture and establish the need to require stocks of contingency of certain medicines.

Finally, antimicrobial resistance must be squarely addressed before this "silent pandemic" becomes our next global crisis. Currently, 35,000 people in the EU lose their lives each year due to drug-resistant bacteria. We will propose bold instruments, such as transferable exclusivity bonds for new antimicrobials, public procurement mechanisms and prudent use measures, to address the issue and stimulate a product range that has been very underproductive for decades.

The key to the success of this reform lies in a single word: "balance". The European pharmaceutical industry must stay at the forefront of innovation, while we must ensure that EU rules play their rightful role in supporting the delivery of this innovation to citizens and patients across the EU .