In December 2025, the European Parliament, together with the Council of the EU and the European Commission, reached an agreement on revising the EU pharmaceutical package. This means that the most far-reaching reform of the sector in two decades is moving closer to implementation. The new rules are intended to support innovation and market competitiveness while also benefiting patients by improving access to therapies.
The pharmaceutical package marks the first major overhaul of EU pharmaceutical legislation since 2004. The European Commission first presented its proposal in April 2023. During Poland’s presidency of the Council of the EU, the Council agreed its negotiating position on 4 June 2025, and on 11 December the Council and the Parliament reached a final compromise on the shape of the new regulations.
“The trilogue is now complete, so we are essentially waiting only for formal approval of the biggest reform of the medicines market in over 20 years. One phrase that captures the essence of these rules is ‘greater accessibility’. On the one hand, we want to create incentives for innovative medicines, for the research sector and for companies that develop new drugs—because for medicines to be accessible, they must first be invented, and that often involves enormous costs measured in billions of euros. On the other hand, for a medicine to be accessible, it must also be affordable—for us as patients and for us as Member States that reimburse part of these medicines from public budgets,” said Dr Adam Jarubas, Member of the European Parliament from the Polish People’s Party (PSL) and Chair of the European Parliament’s Committee on Public Health (SANT), in an interview with the Newseria agency.
One of the most important elements of the agreement is the introduction of an eight-year period of data exclusivity for companies bringing a new medicine to market, covering data from pre-clinical and clinical trials. After this period expires, other companies will be allowed to use this data to produce generic medicines. Under certain conditions, this exclusivity can be extended, with the maximum total protection period capped at 11 years.
“The biggest dispute concerned the length of data and market exclusivity. On one side were the interests of the innovative pharmaceutical industry—Big Pharma. On the other were patients and generic drug manufacturers, because we should remember that once this protection expires, prices typically fall by 30 to as much as 90 percent,” explained Dr Jarubas. “We managed to reach a balanced solution. The basic data protection period is eight years, but it can be extended if manufacturers meet specific additional requirements. These include addressing so-called unmet medical needs, developing new therapeutic indications, conducting additional studies or undergoing health technology assessment (HTA) procedures. These are very detailed provisions.”
Among the exceptions included in the new framework is the situation in which a company obtains authorization for one or more new therapeutic indications that deliver significant clinical benefits compared with existing therapies.
“Another very important element is the so-called Bolar exemption. The idea is that once data or market protection expires, the medicine should be immediately available for sale or generic production. That is why we have ensured that, before the protection period ends, future manufacturers will already be allowed to conduct studies and preliminary registration procedures for a given drug. In practice, this means that cheaper medicines will reach patients sooner,” the SANT Committee chair explained.
As he emphasized, the reform is also designed to level out access to medicines across different EU markets.
“At present, some medicines are available in Western Europe—on larger, wealthier markets—two or three years earlier. Manufacturers were not obliged to offer their products on smaller markets. This will now change. Once a product is authorized, manufacturers will be encouraged—under the threat of losing market exclusivity in certain countries—to make these medicines available also in countries such as Poland, Romania or Bulgaria,” Dr Jarubas said.
The reform also provides for a simplification of internal procedures at the European Medicines Agency (EMA). As a result, applications for marketing authorization should be processed more quickly. Submissions are to be made electronically, and authorizations will, by default, be granted for an unlimited period. The aim is to reduce unnecessary administrative burdens.
“An additional element that we also adopted in the European Parliament’s SANT Committee is the Critical Medicines Act. Together, these two documents will form a new ‘medicines constitution’. They complement each other and will help ensure that medicines reach our patients earlier,” the PSL MEP stressed.
On 15 December 2025, the SANT Committee adopted its position on the Critical Medicines Act, which is intended to reduce the European Union’s dependence on third countries for access to medicines. MEPs are calling for changes to public procurement procedures, enabling, among other things, joint purchases by at least three EU Member States, or procurement involving the European Commission and at least five Member States. This is expected to increase the supply of medicines, particularly those for rare diseases, as well as antimicrobials and other innovative, costly or highly specialized treatments.
The document also proposes the creation of an EU-level mechanism to coordinate national stockpiles and emergency reserves of critical medicines. MEPs want the European Commission to have the authority, in the event of shortages or supply disruptions of key medicinal products, to decide on their redistribution from one national stockpile to another, or to several other countries.
“Both regulations could be very beneficial for Poland’s biotechnology and pharmaceutical sector. That is why, during work on the pharmaceutical package and the Critical Medicines Act, we closely consulted both innovative and generic manufacturers. The generic sector, in particular, is very satisfied with these rules, as they could provide a strong impulse for rebuilding production that previously moved out of Europe and for attracting it back in certain categories. Poland has very strong capabilities in some types of insulin, so companies operating here may benefit significantly,” the MEP concluded.
