HealthIndustryResearch & Innovation

Building a Strong European Health Union: Blazing a trail in the European pharmaceutical sector

By Sandra Gallina, Directorate-General for Health and Food Safety

The start of the decade has crystallised the importance of healthcare policy, particularly due to the COVID-19 pandemic. This global crisis has revealed to us all the need for collective action to protect and enhance the well-being of our Union’s citizens.

While the pandemic was not the initial catalyst, it served as a focal point that strengthened our determination to continue the ongoing efforts to improve our Union’s health and pharmaceutical industry.

The journey to reform and rejuvenate the regulatory framework of the European Union’s pharmaceutical sector was urged by both the European Parliament and the EU Council at the beginning of the Commission’s mandate.

In 2020, as a response to the darkest days of the pandemic, the Commission’s response took a new dimension with the proposal to establish the European Health Union (EHU).

Since then, new mandate for the European Medicines Agency has entered into force, the European Centre for Disease Prevention and Control has been given a stronger role in supporting the EU and its Member States in the prevention and control of communicable disease threats, and the European co-legislators have agreed on the “software” Regulation on serious cross-border threats to health providing a stronger health security framework for the EU.

The EHU also provided us with the Pharmaceutical Strategy for Europe, aiming to establish a regulatory framework for the 21st century. This strategy addresses market failures and puts patient needs at its core by supporting research and technologies in the industry.

As the flagship action under the EHU, the Commission has proposed the revision of the EU’s pharmaceutical legislation, the first in over two decades. This proposal centres around the patient, providing greater access to affordable medicines while boosting the competitiveness of the European pharma industry and considering the environmental dimension too. It is fair to say that this reform would not have been the same if Europe and the world had not gone through the COVID-19 pandemic. We have seen, for instance, the power of solidarity through Europe’s vaccine strategy. As Member States joined forces, all EU citizens benefitted from access to vaccines at the same time, under the same conditions.

A focus point in the strategy and the reform is to ensure access to affordable medicines for patients and to address unmet medical needs, including for rare diseases. Despite their name, rare diseases affect a significant number of Europeans, with up to 36 million people in the EU suffering from such conditions.

The EU supports research efforts related to rare diseases through programs like Horizon 2020, which has allocated close to €900 million to over 160 collaborative projects.

Access to medicines is a crucial aspect of an efficient healthcare system. Our vision for a strong European Health Union includes a modern pharmaceutical system that is resilient in times of crisis and meets the daily needs of citizens. Whether it is treating allergies, vaccinating children, or providing innovative medicines to cancer patients, citizens should have access to the medicines they need regardless of where they live.

To maintain Europe’s position as a trailblazer, the domestic pharmaceutical industry must retain its competitive advantage. Our strategy leverages innovation to offer quality, state-of-the-art, effective medicines domestically, while addressing medicine shortages. Additionally, the strategy enhances crisis preparedness and response mechanisms, diversifies, and secures supply chains, while maintaining the highest standard in quality, efficacy, and safety.

A key focus of our efforts is minimising the carbon footprint in line with the goals of the European Green Deal. While we address the challenges such as medicine shortages, weak supply chains, and unequal access to medications among Member States, the European Union is committed to resolving these issues alongside concerted efforts to protect the environment.

To incentivise innovation in our pharmaceutical sector, we must adopt a new way of thinking. This involves implementing rules that leverage the power of research while streamlining official processes and reducing administrative costs by €300 million. Establishing a clear and uninterrupted path from research laboratories to manufacturers and ultimately to patients is crucial for a robust healthcare system.

To build a strong European Health Union, we need to prioritise access to medicines, improve transparency, reduce costs, and encourage innovation. Empowering citizens, enhancing collaboration, and establishing a streamlined pharmaceutical system that works for all: industry and patients, and will form the foundation of this strong European Health Union we are building together.

The Pharmaceutical Strategy for Europe also aims to increase the affordability of medicines more generally by promoting voluntary cooperation among Member States on pricing, reimbursement, and payment policies, while respecting their national competences in this area. We are supporting this cooperation through the group of National Competent Authorities on Pricing & Reimbursement (NCAPR), where Member States can share best practices to ensure affordable medicines.

We will need to have our house in order when countering existing and future health threats. The threat of antimicrobial resistance (AMR) comes to mind. Though it may lurk beneath the surface of our consciousness, this growing threat already claims around 35,000 lives in Europe every year.

The revision of our pharmaceutical legislation, together with the new Council Recommendation on AMR will drive EU action in this area, along with the help of incentives to reward the successful development of antimicrobials.

To face such threats, only an approach that considers the health of humans, animals, and plants, as well as the environment, can ever be effective. This One health approach will be the inspiration needed to bring about a strong European Health Union. A project that will undoubtedly be looked back upon as a pivotal moment in the history of the EU, and one of its greatest achievements. After all, there is no greater investment than in our health.