The unprecedented disruption caused by the pandemic has returned health care to the center of public policy. It has never been more clear in Europe that when it comes to protecting citizens’ health, the EU is much stronger when we act together. It is this experience that led to the creation of the European Health Union, an ongoing activity launched in 2020 and a project based on the opportunities presented by the crisis to address long-standing problems and shortcomings affecting health systems in the Union.

Medicines are an eloquent example of this. Access to medicines is one of the strongest symbols of an effective health care system. Currently, medicines do not reach all patients quickly enough, because innovative and promising medicines that are brought to the market are not always equally available in all Member States.

In addition, there are still too many diseases that have no options for prevention or treatment. At the same time, many patients and many health care systems cannot afford certain drugs because of high prices, and drug shortages are a chronic problem that can deprive patients of needed therapy. Geopolitical tensions have also highlighted vulnerabilities and dependencies in our healthcare systems that expose us to dependence on third countries. At the same time, urgent priorities, such as the growing number of infections caused by bacteria resistant to antibiotics, are not being addressed with the necessary speed and efficiency.

Europe needs a radical change in medicine. Since the introduction of current EU rules more than 20 years ago, new scientific and technological megatrends have revolutionized healthcare and pharmaceuticals. Our regulatory system cannot afford to fall behind.

A modern pharmaceutical system, resilient to crises and able to meet the needs of citizens every day, is an integral part of the strong European Health Union that we are building in the context of the experience gained during the COVID-19 pandemic. Whether it’s treating a headache or allergy, vaccinating a child or treating a cancer patient with the latest revolutionary drug, these are essential products that citizens should have access to. In 2019, 23% of people in Romania used the prescribed medicine.

However, while patients in some western and larger Member States have access to 90% of newly approved medicines, in some eastern and smaller Member States this percentage is 10%. The waiting time for access to these medicines also varies greatly, with patients having to wait several years in some Member States and only a few months in others. Specifically, this means that some patients are left without effective treatment options for their disease. That is why it is so important to ensure that patients have access to both innovative and affordable medicines, while our world-leading pharmaceutical industry remains strong and competitive around the world.

Our universal rules and fragmented single market for medicines are part of the problem. Incentives for our innovative industry must be created, but they must be more closely linked to meeting the needs of patients and health care systems. Ensuring patient access in all 27 member countries is important to us.

That is why we will, as a top priority, promote rules that ensure that medicines reach all patients in the EU, while allowing competition, which in turn will lower prices and ensure the stability of healthcare systems in all Member States. It is necessary to create a single drug market.

Second, but no less important, is to support innovation through regulations that stimulate research and reduce red tape in the system. Our approach will save €300 million by avoiding an unnecessary administrative burden.

In order to prevent shortages, it is also necessary to improve the supervision of medicine supply chains, in particular establishing the need to strengthen the EU’s strategic autonomy in the production of medicines and to determine the need for emergency stock calls for certain medicines.

Finally, antimicrobial resistance must be addressed head-on before this “silent pandemic” becomes our next global crisis. Currently, 35,000 people in the EU die each year from antimicrobial-resistant bacteria. We will propose bold tools, including data exclusivity vouchers for new antimicrobials, public procurement mechanisms and prudent use measures, to address this challenge and stimulate the development and production of a wide range of products that have been lacking in recent years, decades.

The key to the success of this reform can be found in one word: “balance”. The European pharmaceutical industry must remain at the forefront of innovation, and at the same time we must ensure that EU rules facilitate access to this innovation for citizens and patients across the EU.