During Poland’s presidency of the Council of the European Union, member states agreed on a common position regarding the pharmaceutical package – the biggest reform of EU drug legislation in 20 years. The reform aims to reduce disparities in access to therapies between member states, currently stretching to two or even three years. It also addresses shortages of life-saving medicines and the lack of therapies for over 6,000 rare diseases. The new rules are designed to ensure faster access to medicines, strengthen the competitiveness of the sector, and secure supply chains.
“We managed to reach what is called the general approach of the Council, which is the position of governments represented in the Council. Previous presidencies – Spanish, Swedish, Belgian, Hungarian – were unable to achieve this, but Poland conducted negotiations in such a way that we now have a common approach and have already started trilogues, meaning dialogue between the Parliament and the Council, with the participation of the Commission,” said Dr. Adam Jarubas, MEP from the Polish People’s Party (PSL), in an interview with Newseria.
This pharmaceutical package is the first major revision of EU pharmaceutical law since 2004. It aims to better meet patients’ needs, boost Europe’s competitiveness, and support innovation. It introduces new rules for all medicines, including those for rare diseases (“orphan drugs”) and pediatric medicines.
Currently, there are over 6,000 rare diseases without any therapy. Another major challenge is the delay in the introduction of medicines across member states. According to the 2024 EFPIA report, new drugs become available in Germany an average of 126 days after approval, compared with 804 days in Poland.
“We want medicines to be more accessible. Today we see big differences between EU countries. Often it is two or more years between countries such as Poland, Germany, and the Netherlands, because in those states drugs are introduced two to three years earlier than here,” Jarubas explained.
In 2024, only 69 of 167 medicines approved in Europe between 2019 and 2022 were available in Poland, compared with 147 in Germany. The average delay in reimbursement decisions in Poland is about 2.5 years.
The reform also seeks to ensure greater supply security. In cases where a medicine is lacking in one country, solidarity mechanisms will allow access to be guaranteed across borders.
Expanding the Bolar Exemption
The reform includes an expansion of the so-called Bolar exemption, which allows generic drug makers to prepare for market entry during the period of data protection. They may file registration and reimbursement applications, conduct HTA analyses, and participate in tenders. This is expected to accelerate access to more affordable medicines.
Currently, in addition to patent protection, innovative drugs enjoy eight years of data exclusivity, preventing competitors from using registration data. The new rules maintain the maximum data exclusivity at eight years but shorten the basic market protection period by one year, while allowing innovative firms to gain an extra year if they meet certain conditions that enhance EU competitiveness and address patient needs.
The European Commission estimates that reducing data protection by two years could cut annual costs for public payers by €1.13 billion, while stimulating the generics market, adding around €266 million annually in savings.
“We want generics producers to have earlier access to the necessary data, so they can prepare faster to launch cheaper medicines. That’s why the Bolar exemption has been extended – so they can act before exclusivity periods expire,” Jarubas said.
Securing Critical Medicines
The COVID-19 pandemic revealed that 80% of active pharmaceutical ingredients (APIs) used in EU medicines come from outside Europe, mainly China and India. In response, the European Commission has proposed a Critical Medicines Act to rebuild production in Europe and establish secure supply chains with trusted partners.
“When supply chains collapse – whether due to a pandemic, blockades, sanctions, or geopolitical problems – Europe cannot be left without access to life-saving raw materials. Hence the idea of a critical medicines list and the establishment of a Critical Medicines Alliance, bringing together producers and governments to better monitor availability, especially for life-saving drugs. It cannot be that one day a drug disappears and people start dying in hospitals without a war even happening,” Jarubas warned.
Call for a European Critical Medicines Fund
Jarubas stressed that new regulations should also include financial mechanisms for smaller companies and start-ups developing medicines. He supports creating a European Critical Medicines Fund to prevent a situation in which only wealthier member states can subsidize their industries – an idea also highlighted in Enrico Letta’s report on the future of the single market.
“Such a European fund could attract business and help bring back production of substances and therapies that Europe desperately needs. Otherwise, richer countries will be able to afford this, while Central and Eastern European countries will struggle. I believe we can convince negotiators, within the Critical Medicines Act, to make such a European investment fund possible,” Jarubas concluded.
