This refers to so-called supplementary protection certificates—a mechanism that extends exclusive rights for new drugs. According to the European Commission’s plan, the bonus year will be granted to drugs with a new active ingredient, proven efficacy in clinical trials across several EU countries, and at least part of their production taking place within the EU.
Brussels believes that without such incentives, Europe risks falling behind the U.S. and Asia in the race for biotechnology investments, according to Euronews. European Commissioner for Health Oliver Varheli stated that new drugs would otherwise reach the EU with a delay.
“If we don’t do this, such drugs will most likely only become available in Europe after patent protection expires,” he said.
But enthusiasm is noticeably lower in national capitals. Several countries fear that additional protection will simply delay the arrival of cheaper generics and increase healthcare costs.
Malta has openly stated that it is not prepared to expand the privileges of pharmaceutical companies at the expense of the budget. The country’s representative, Christopher Farrugia, emphasized that small markets often pay more and receive medicines later than larger EU countries.
The figures confirm this: according to industry data, only 17 new innovative drugs were introduced in Malta between 2020 and 2023, compared to 156 in Germany and 142 in Italy.
Similar concerns have been raised by Estonia and other countries. They are calling not only for measures to stimulate innovation but also for guarantees that medicines will remain affordable.
Poland has also questioned the European Commission’s calculations. Deputy Health Minister Katarzyna Kacperczyk stated that it remains unclear whether the measure will actually have the desired effect or whether it will strain budgets and harm competition.
Nevertheless, the European Commission insists that without stronger incentives, Europe will lose out in the global competition for new developments. Even amid disputes over protection, the ministers still found common ground. They agree that clinical trials need to be conducted more quickly and easily, that red tape must be reduced, and that rules across different EU countries should be harmonized.
