EU institutions have been warning for several years about the European Union’s dependence on global supply chains for medicines and active pharmaceutical ingredients (APIs), pointing to the need to strengthen the resilience of Europe’s pharmaceutical system. The EU’s response is expected to come through a reform of the pharmaceutical market and two key sets of documents adopted by EU institutions: the Critical Medicines Act and the EU Pharmaceutical Package. Among other goals, the Pharmaceutical Package aims to reduce gaps in medicine availability across individual EU markets.
“At present, the European Union is heavily dependent on imports of medicines and active substances, mainly from Eastern markets. This is difficult for patients and for the system because— as the pandemic and the full-scale war in Ukraine showed— supply chains are vulnerable to delays, disruptions in transport, or production problems, including the transport of starting materials used to manufacture APIs, i.e., active substances. In a sense, the EU has been deprived of stability in terms of pharmaceutical security,” says Dr. Anna Banaszewska, legal counsel, in an interview with Newseria.
According to European Commission data, around 80% of APIs used in medicines available on the EU market and about 40% of finished medicines sold there come from outside Europe—primarily from China and India. Growing reliance on API supplies has contributed to a partial loss of the EU’s capacity to produce active substances domestically, creating a potential risk to public health in Member States.
A further challenge is the worsening shortage of medicines. Analyses by the European Medicines Agency indicate that shortages can affect all categories of medicines, including innovative patented products, off-patent generics, and vaccines. The situation becomes critical when a country lacks adequate alternatives and coordinated EU action is required to address the problem. EU countries faced critical shortages between January 2022 and October 2024, when 136 medicines were unavailable. This is why, in December 2025, the EU adopted the Critical Medicines Act, which concerns medicines deemed essential from the standpoint of health security.
“The Critical Medicines Act will, on the one hand, make it possible to create additional preferential conditions for manufacturers, and on the other, enable joint procurement across EU Member States. It will also help strengthen the presence of critical medicines in all EU markets in the same way,” Dr. Banaszewska explains.
The European Commission stresses that the regulation is intended to strengthen supply-chain resilience and reduce differences in medicine availability that arise from the size and attractiveness of individual markets.
In parallel, the Pharmaceutical Package is meant to address unequal patient access to new therapies. An EFPIA (European Federation of Pharmaceutical Industries and Associations) report published last year—covering access to 173 new medicines approved in Europe between 2020 and 2023—shows that at the beginning of 2025, patients in Poland had access to 68 of them. That translates into availability of roughly 39%, compared with an EU average of 46%. At the same time, about 85% of medicines reimbursed in Poland are available with restrictions (e.g., only for certain patient groups), and the average waiting time for reimbursement of new therapies is 723 days (for comparison: 128 days in Germany).
As the expert emphasizes, differences in access to medicines stem in part from market size and attractiveness, as well as national reimbursement rules that influence companies’ decisions on whether and when to launch products. The EFPIA report also points to systemic factors, such as the speed of regulatory procedures, the timing of market-access assessments, duplication of evidence requirements, and delays in reimbursement processes.
“Poland is the least attractive country in terms of reimbursement for medicinal products. We have the lowest possible prices, which is both beneficial and not. It means treatment costs are low, but on the other hand, many manufacturers decide to stop launching products in Poland. As a result, beyond shortages caused by production issues or limited availability of active substances, there are often situations where it is simply more profitable to sell a medicine to another country than to Poland,” she says.
It is precisely such market problems that the comprehensive reform of EU pharmaceutical law is intended to address.
“The Pharmaceutical Package will promote and, in a way, compel the maintenance of equal availability of medicines across all EU countries. If a company fails to meet its availability commitment, it could, for example, lose one year of market exclusivity. So EU authorities will grant benefits on the one hand, but on the other they will implement instruments that make it possible to enforce certain behaviors by marketing authorization holders,” Dr. Banaszewska says. “The most important areas of the package concern ensuring population-level pharmaceutical security, but it will also support and incentivize the production of modern antibiotics. It will streamline the authorization process for medicinal products and create additional conditions for the market entry of generic medicines—i.e., products launched after patent protection expires.”
One of the most important elements of the agreement is an eight-year period of data exclusivity for companies bringing a medicine to market, covering data from pre-clinical and clinical studies. After this period, other companies may use the data to develop generic versions. Under certain conditions, the period can be extended, with a maximum total protection of 11 years.
“The idea is to maintain data exclusivity while shortening market protection—meaning the period during which no generic can enter the market. This period will be shortened by one year, but the rules allow for extensions depending on whether certain conditions are met. For example, if a company launches a medicinal product that addresses the most important population needs, the market-exclusivity period could be extended in total up to 11 years,” the expert explains.
The Pharmaceutical Package also introduces a transferable voucher designed to support the development of modern antibiotics. The mechanism is intended to encourage companies to invest in therapies that are particularly important for public health, but are often less attractive commercially.
“This voucher can be used for any product in a company’s portfolio, except those whose turnover exceeds EUR 450 million. The aim is to ensure that the instruments introduced do not distort competition—so that a monopolistic position cannot be maintained on the market,” Dr. Banaszewska explains.
Under the new rules, the so-called Bolar exemption will also be expanded. This will allow generic manufacturers to prepare earlier for production and market entry, including participation in public tenders even before patent protection expires.
