Statement by Minister for Health Care Acko Ankarberg Johansson on proposed EU pharmaceutical legislation

SWEDEN, November 29 - Europe’s patients risk going without vital medicines if the EU fails to boost competitiveness. Historically, we have held a strong position in the pharmaceutical sector, boasting leading research institutes, European pharmaceutical companies, and groundbreaking medical breakthroughs. But, in an era of increased global competition, we need to ensure that Europe maintains this position. It is about continuing to create the conditions to attract research, development, production, and market introduction of pharmaceutical products. This applies to both older and new advanced medicines, all of which are crucial in providing patients with good health and medical care.

It has been almost a year and a half since the European Commission presented its proposal for new pharmaceutical legislation. Since then, intensive, and constructive negotiations have taken place. Sweden’s position has been clear from the start and is resolute – we need a competitive Europe, and we need a regulatory framework that supports it.

The Government supports initiative to achieve equitable access to medicines within the EU. But a prerequisite for this is maintaining current data protection for new medicines. Even though Sweden supports the ambition of ensuring fair prices, weakening data protection compared to today’s is not the way to go. If we do not have access to medicines, it does not matter how cheap they are in theory. There must be incentives for companies to develop and introduce new medicines in Europe. 

We should therefore rethink data protection while also strengthening competitiveness in other ways. This applies, for example, to simplifying rules and ensuring efficient procedures. Ensuring a regulatory-efficient system is fundamental for securing competitiveness, innovation and thus access to new treatments.

For many patients, especially those living with chronic diseases, medicines are an essential part of treatment. With the increasing use of precision medicine and orphan drugs, the importance of pharmaceuticals is likely to increase even more. New medicines are not reaching patients in the EU quickly enough, while most European countries are facing shortages of common medicines such as antibiotics, insulin, and children’s paracetamol. 

Europe has a proud history of being at the forefront of the development of new medicines and cutting-edge medical advances. This is not something that comes by itself or that can be taken for granted in a climate of fierce global competition, such as with the United States and Asia. The deteriorating security situation has also highlighted the need to provide an attractive, innovation- and competitiveness-friendly environment that also facilitates the production of pharmaceutical products in Europe.

The Swedish Government is working to ensure a new regulatory framework that is transparent, predictable and efficient, with favourable conditions for both large and small pharmaceutical companies, as well as for the health care system. The opposite would risk patients’ access to vital medicines and treatments. 

It is high time to act before we lose the battle for vital medicines. Ultimately, it is about our ability to save lives.