The European Union is in the midst of the biggest shake-up of its pharmaceutical rulebook in a generation, racing to secure supply chains, speed up drug development, and keep Europe competitive against the US and Asia; all without loosening the safety net patients rely on. Sandra Gallina, Director-General for Health and Food Safety at the European Commission, lays out what this wave of legislation will actually mean for both patients and industry once it hits the ground.

 

What are the EU’s top public health priorities right now – particularly the issues best tackled at EU level because they cross borders – and how do the various pieces of health and pharmaceutical legislation currently moving through the system fit into delivering on them?

The EU’s top public health priorities are very clearly reflected in what has been proposed during this mandate. A good example is the Health Package presented in December 2025, which brings together major initiatives such as the Biotech Act, the simplification of our rules on medical devices, and the Safe Hearts Plan. At its core, the Health Package is about safeguarding Europe’s unique healthcare model while preparing it for the future. That means creating the conditions for pharma, biotech and medtech innovation to thrive here in Europe, strengthening prevention in a much more targeted and personalised way, and ensuring that people across Europe can access the best possible treatments.

But it is important to see this Package in the wider context of our broader health agenda. Other major initiatives, including Europe’s Beating Cancer Plan, the pharmaceutical reform, the Critical Medicines Act and the European Health Data Space, are all part of the same overall effort. These are not isolated actions. They are complementary and mutually reinforcing, and together they will make Europe stronger and more resilient in health, to the benefit of patients across the EU.

For example, the reform of the EU’s general pharmaceutical legislation – the first such overhaul in 20 years – is designed to to make medicines more available, more accessible and more affordable for Europeans, while ensuring that Europe’s regulatory framework is as conducive and as supportive as possible to medical innovation. We have reinforced this further through the Critical Medicines Act, which aims to prevent shortages, strengthen supply chains, and support more production of critical medicines in Europe.

The Biotech Act is another key element of this approach. An important part of the Biotech Act is the targeted revision of the Clinical Trials Regulation, which aims to make Europe a more competitive location for clinical research. It aims to increase clinical trials in Europe – for both innovative medicines and academic research – by shortening timelines, simplifying procedures and reducing unnecessary burden, while maintaining high standards for patient safety and data robustness.

The revision introduces a more risk-based approach, simplifies multinational trials through measures such as a core dossier for investigational medicinal products, increases flexibility for trial adaptations and supports innovative therapies, including ATMPs. By making clinical development faster and more predictable, it will help shorten time to market and enable earlier patient access to innovative treatments. These improvements are already being tested through initiatives such as FAST EU[1] and the Combined Pilot[2], demonstrating the benefits of stronger Member State cooperation.

The European Health Data Space is equally transformative. It will empower people to access and control their own health data, under the strictest data protection safeguards. At the same time, this data will support scientists, academics and industry in developing the next generation of breakthrough, life-changing medicines.

Then there are the Safe Hearts Plan and Europe’s Beating Cancer Plan, both of which are highly ambitious in their efforts to improve prevention, early detection, treatment and after-care for two of the biggest health challenges facing Europeans today.

These are only some of the initiatives we are advancing under the European Health Union. We are also doing extensive work on health security and crisis preparedness, mental health, rare diseases, and much more. Health policy is never something that is fully complete – there is always more to do. But the Health Union, with the initiatives I have mentioned, is clearly moving us in the right direction.

 

The revised pharmaceutical legislation, which includes a restructuring of the current 8+2 data exclusivity model, is now heading toward formal adoption after years of negotiation. What do you see as its biggest practical impacts for patients and industry once it takes effect?

The revised EU pharmaceutical legislation is indeed nearing formal adoption and will have immense practical benefits once it is implemented. You may want to see it as the engine of our authorisation system: if the engine is running more smoothly and faster, it benefits both developers and patients and is good for innovation and competitiveness in the EU.

The new EU pharmaceutical legislation enables not only faster regulatory assessment but also speeds up the time in which innovative products reach patients across Member States. There is a lot to unpack. For example, the reform will enable companies which produce innovative medicines and medicines combining pharmaceuticals and medical devices to benefit from new regulatory tools such as platform approaches, sandboxes and adapted frameworks for certain non-standard treatments, like personalised therapies.

The legislation creates stronger incentives to move promising medicines through the system more efficiently, especially where there is a clear public health interest. The objective is clear: scientific progress should translate more rapidly into real patient benefit. In areas like rare diseases, we are making our incentives even stronger, including through a new “breakthrough orphan” status to encourage the development of treatments where no options currently exist.

It facilitates generic and biosimilar competition and allows patients and healthcare systems to have earlier access to more affordable treatments. Enabling necessary studies and trials during the patent protection period with reference medicinal products for regulatory purposes allows generic and biosimilar products to enter the market from day one after the regulatory protection periods of the reference medicinal product expire.

On antimicrobial resistance (AMR), the reform introduces targeted incentives to stimulate the development of new antimicrobials, including the very innovative concept of a transferable data protection voucher for priority antimicrobials, alongside measures to promote prudent use and preserve effectiveness.

Therefore, while improvements will gradually materialise with implementation, the EU pharmaceutical legislation lays down the pathway for bringing medicines on the market faster.

 

The Critical Medicines Act moves EU procurement away from lowest-price criteria toward supply security, addressing the fact that around 80 percent of the EU’s imported active pharmaceutical ingredients come from just five countries, with China alone accounting for nearly half. Beyond procurement reform, does DG SANTE have a position on encouraging more medicines manufacturing to happen within the EU itself?

On 12 May, the Council and the European Parliament reached a landmark agreement on the Critical Medicines Act, which the Commission had proposed within the first 100 days of this mandate. This was a very important milestone for strengthening the resilience of Europe’s health sector, essential for our broader health security.

At its core, the Critical Medicines Act is about reinforcing Europe’s strategic resilience and reducing vulnerabilities in pharmaceutical supply chains. The Act will promote the diversification of supply chains and support manufacturing of critical medicines within the EU, while enabling Member States to cooperate more closely to improve access to medicines in Europe. The aim is to move away from a system that simply reacts to shortages, towards one that builds stronger industrial capacity here in Europe.

Public procurement rules that support resilient supply chains are indeed a key part of this to ensure that investments for critical medicines are sustainable in the long run. For critical medicines, procurers will need to support more diversified and reliable sources of supply. And where we are dealing with vulnerable medicines that depend heavily on one or a small number of third countries, contracting authorities will be required to give preference to manufacturing in the EU.

The Act also gives Member States the possibility to purchase medicines together with the support of the Commission to tackle disparities in the availability of and access to critical medicines, orphan medicines and other medicines of common interest across the EU.

Additionally, the Act introduces Strategic Projects, which can receive support to create, modernise or expand manufacturing facilities in the EU for critical medicines or their active substances. These projects will benefit from easier access to national or EU funding, administrative support and faster permitting procedures. Projects for the manufacturing of orphan medicines will also benefit from accelerated permitting.

 

Europe is often described as the only major global region without a dedicated biomanufacturing strategy, a gap industry groups argue leaves it lagging the US and Asia. What will the Biotech Act change on the ground for a company trying to scale up production in Europe?

Through the proposed European Biotech Act, Europe is laying out an ambitious strategy to ensure the competitiveness of its biotech sector. It fits under the broader European Life Science Strategy aiming to position Europe as the world’s most attractive place for life sciences by 2030.

Building on Europe’s world-class science, the Biotech Act aims to make Europe a more attractive place to develop, manufacture and launch new therapies, for the benefit of both our economy and, above all, our patients.

It contains a comprehensive response to key challenges in terms of regulatory simplification, access to capital and, notably, biomanufacturing. The latter is indeed a key element in the biotech product lifecycle. To grow, biotech startups and scale ups need access to pilot facilities to evaluate the industrial scalability of their innovation, train their biomanufacturing workforce, optimise processes, build their proof of concept and eventually produce at scale.

This is at the core of what the Biotech Act aims to achieve by proposing to pool and boost biomanufacturing capacity through selected strategic projects at European level. Smart public investment can act as a catalyst to attract further private capital into this strategic sector.

For companies aiming to scale up, the Act proposes instruments to support their funding, both at the early stage of development and later stages. The Commission has proposed an ambitious multi-year budget from 2028 with significant possibility for investments into innovative health technologies and companies. To bridge the period until the next multi-year budget is deployed, the European Investment Bank and the Commission have launched the BioTechEU initative which aims to mobilise EUR 10 billion in investment for the sector this year and the next alone.

Taken individually, measures in the Biotech Act will make a difference; Regulatory simplification can significantly reduce the time-to-market for European biotech innovation, without lowering any safety or quality standard; Better access to risk capital can help European companies develop, grow and generate value in Europe and enhanced biomanufacturing can contribute to production taking place in the EU.

Taken together, these measures con can help reverse trends in the global biotech landscape, such as the observed shift of clinical trial activity towards the US and Asia.

 

The medical devices simplification is meant to ease a regulatory burden that has led to shortages. Where’s the real risk in getting that balance between speed and safety right, and how does this legislation address it?

Europe’s medical technology sector is one of its great strengths. It supports close to one million jobs, brings together more than 34,000 small and medium-sized enterprises, and accounts for a market valued at approximately EUR 170 billion. Medical devices will play a central role in shaping the future of healthcare. Europe must continue to lead globally in this strategic sector. Our objective is to ensure that Europe remains an attractive place for innovation, while upholding the very highest levels of patient safety.

At the same time, the current regulatory framework creates avoidable costs, bottlenecks, and uncertainty for companies, and can lead to serious delays for patients in accessing important technologies. That is why we have put forward simplification measures designed to make the system more effective and better adapted to its purpose, without compromising patient safety in any way.

The EU is seeking the right balance: preserving rigorous safety standards while making the rules more streamlined and innovation-friendly. The Commission’s aim is to build a system that continues to protect patients, while also enabling innovative devices to reach them more quickly. This is the foundation of the revised EU rules we have proposed.

Patient safety is not open to compromise. The existing regulatory framework was established to strengthen safety, enhance requirements for clinical evidence, improve traceability, and reinforce market surveillance. The reform continues to place patients at its core.

Robust, evidence-based oversight remains essential to maintaining public confidence. The future framework will continue to rest on solid clinical evidence and expert scientific evaluation, so that innovation goes hand in hand with trust in the safety and performance of medical devices.

 

References

[1] https://www.hma.eu/fileadmin/dateien/FAST-EU_sponsor_guidance_v1.2_-_2026-04-23.pdf

[2] https://health.ec.europa.eu/medical-devices-topics-interest/combine-programme/combine-project-1-pilot-all-one-coordinated-assessment_en