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Agreement on the pharmaceutical package.
During a conference on 6 June 2025, the Ministry of Health announced that Member States, under the Polish Presidency, had adopted a common position on the revision of the pharmaceutical package. As a result, the Council of the EU can now proceed with further negotiations with the European Parliament and the European Commission with a view to finalising the text of the legislation.
As part of the agreed position of the Member States, a number of solutions have been adopted, aimed at, among other things, increasing the availability of medicines for patients, better managing the risk of shortages, ensuring the sustainable development of the pharmaceutical sector, supporting innovation and enabling faster market entry for generic medicines.
The most important of the planned solutions include:
- Ensuring the availability of medicinal products by allowing Member States to request the marketing authorisation holder to make the medicinal product available and supply it to the market of a given country in sufficient quantities to meet the needs of patients;
- Introducing a system for managing medicine shortages, including an obligation to report the risk of shortages in advance and a requirement to have plans in place to prevent shortages, as well as cooperation between Member States to reduce cases where medicines are unavailable in one country while there are surpluses in another;
- Introduction of a solution in the form of transferable data exclusivity vouchers, aimed at supporting the development of new antibiotics;
- Maintaining the maximum data exclusivity period at 8 years and shortening the basic market protection period by one year, which will secure both the market launch of modern drug therapies and the development of the generic industry. In addition, companies will be able to receive an additional year of market protection if certain conditions are met;
- Strengthening the so-called Bolar exception, which will allow generic companies to prepare for market entry while data protection is still in force, by enabling them to submit registration and reimbursement applications, conduct HTA analyses and participate in tenders;
- Introduction of electronic leaflets;
- Introducing a new tool in the form of so-called ‘regulatory sandboxes’, which aims to create a safe environment for testing and developing modern drug therapies;
- Increased scientific and regulatory support for companies;
- Reform of the EMA to increase decision-making power, shorten the time taken to evaluate medicinal products and improve cooperation.
This is the first major reform of EU pharmaceutical market regulations in 20 years. We eagerly await the presentation of the final text of the new regulations.
Link provided by the Ministry of Health: