Ministerial statement on proposed EU Pharmaceutical Legislation

Most European countries are facing challenges with medicine shortages. The consequences of shortages are serious, particularly for the patients and health care systems. To tackle this, the European Commission presented its proposal for a new pharmaceutical legislation in the first half of 2023. The purpose is to improve security of supply and ensure quick and fair access to safe and effective medicinal products, at a reasonable price, for all patients within the EU. This new legislation will be fundamental to both the pharmaceutical industry and the health care system. 

The Swedish Government supports the overall aim of the proposal and will work to ensure that the negotiations result in a legislation that is fair, effective, predictable and sustainable over time. It is important that the legislation enables the sustainability of the health care systems and access to efficient and safe medicines, while providing robust incentives for investment in research and development.

In order to secure long-term competitiveness, the statutory data protection for new medicinal products must be strong to be able to mobilise large investments. We cannot afford to jeopardise access to innovative treatments for patients in Sweden and the EU. 

In 2022, approximately 860 000 people were employed in the pharmaceutical industry in Europe. At the same time, pharmaceutical exports in Sweden alone accounted for a total of SEK 141 billion, which corresponds to approximately 7.5 per cent of the exports of all product groups in Sweden. Adequate incentives, such as data protection, are an essential factor to encourage innovative pharmaceutical companies to invest, develop and manufacture medicinal products within the EU. The clinical development of drugs is extremely costly and time-consuming – even more so for transformative technologies, such as biologics as well as cell and gene therapies, where timelines associated with research, development and clinical evaluation are often longer than for the average medicinal product. This also results in higher costs for development to meet regulatory requirements for market authorisation.

However, regulatory protection is just one of many ways to secure competitiveness and pharmaceutical innovation. An enabling environment for innovation also includes reduced bureaucracy, faster regulatory approvals and strong patient involvement.

For many patients, especially those living with chronic diseases, medicines are an essential aspect of treatment. With the increasing use of precision medicine and orphan drugs, the importance of pharmaceuticals will most 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 medications such as antibiotics and children’s paracetamol. 

The geopolitical uncertainty calls for adequate strategic autonomy in critical infrastructure. The Swedish Government will therefore work to ensure that a new regulatory framework provides for a transparent, predictable and efficient system with beneficial conditions for both large and smaller pharmaceutical companies, as well as the health care system. The opposite would risk patients’ access to vital medicines and treatments.