11.10.2023 | Petra Tirkkonen, Deputy Managing Director
The pharmaceutical industry is a critical part of Europe's strategic autonomy
EU legislation must be taken in a direction that is industry- and innovation-friendly. Finland has an important role.
Pharma Industry Finland shares the concerns of the entire European pharmaceutical industry about the impact of ongoing EU legislative projects on Europe's competitiveness and crisis preparedness.
Global crises have highlighted the importance of ensuring the strategic autonomy of the European Union (EU) in all critical sectors. The pharmaceutical industry is one of these sectors. Medicines and vaccines are a critical part of a well-functioning society.
It is a prerequisite for the strategic autonomy that new treatments are introduced in Europe without delay for the benefit of patients, and the accessibility is ensured. Similarly, it must be ensured that pharmaceutical companies are willing and able to continue investments in research and production in Europe in the future. All this requires an innovation-friendly regulatory framework.
The EU has an important role in responding to global health threats and environmental crises. Therefore, it must be ensured that regulation itself does not lead to new crises. This threatens to happen, for example, in connection with the pending EU legislative proposals on intellectual property rights and environmental protection.
For pharmaceutical companies, intellectual property rights are at the core of all research activities and the most important incentive. New innovations are results of long-term RDI activities. That being said, the Commission's proposal on compulsory licensing of inventions protected by intellectual property rights in crisis situations is concerning. As it stands, the proposal would substantially jeopardize research incentives.
The Commission has also issued its proposal to reform the EU pharmaceutical legislation, which threatens to weaken the regulatory data protection for pharmaceuticals. Regulatory data protection is an important means for many pharmaceutical companies to cover the costs of a long-term research.
With the legislative changes, environmental requirements for the production of medicines also threaten to become excessive in the EU; Such legislative changes include, for example, the revision of the Urban Waste Water Treatment Directive, new rules on packaging, and restrictions on compounds used in the manufacture of medicines and vaccines.
While environmental protection is of paramount importance, it should not pose a threat to access to vaccines and medicines.
All these legislative reforms together send a significant signal to pharmaceutical companies about Europe discouraging innovation. Research activities are already shifting from Europe to the United States and China. If the current trend continues, it will undoubtedly also have an impact on Europe's crisis preparedness.
At the same time, it is concerning how we will succeed in attracting health sector investments to Finland in the future if the EU regulatory framework is taken strongly in a direction that limits innovations.
We believe that Finland has an important role in bringing these perspectives to the European debate and thereby ensuring the competitiveness of not only Europe, but also Finland as an investment environment for the pharmaceutical industry and the entire health sector.