On 11 December 2025, the Council of the European Union (the “Council”) and the European Parliament (the “Parliament”) provisionally reached an agreement on the first major reform of EU pharmaceutical rules since 2004. The agreement (known as the “Pharma Package”) aims to increase patients’ access to medicinal products across the EU and to boost the competitiveness of the pharmaceutical industry.
The European Commission first published proposals for the Pharma Package in April 2023 (see previous publication here). The Parliament adopted its position in April 2024, followed by the Council in June 2025, with the Parliament and Council now agreeing their joint position. The text of the agreement has yet to be made public, but see below the key components of the agreement:
Data and market protection periods
Companies which place new medicinal products on the market will continue to have an 8 year data protection period, meaning that they retain exclusive rights to data from pre-clinical tests and clinical trials for 8 years. Market protection has been decreased from two years to one year for pharmaceutical companies, during which time only they can sell their new medical products without competition from other companies selling generic alternatives. However, companies may benefit from an additional year of market protection where they satisfy certain criteria, such as where the product meets an unmet medical need.
Extra protection for antimicrobial resistance medicines
The Pharma Package offers pharmaceutical companies a transferrable exclusivity voucher which grants companies an extra year of market protection for a pharmaceutical product of their choice which helps to combat antimicrobial resistance by developing priority antibiotics. However, the ‘blockbuster clause’ stipulates that the transferable voucher cannot be used on medicinal products with annual gross sales of more than €490 million in the preceding four years.
Supply of medicines
Companies who benefit from regulatory protection periods will be required to supply medicine in sufficient quantities to meet patient needs. This is to prevent a lack of supply in the temporary absence / reduction of competition from other pharmaceutical companies during protection periods.
Extension of the ‘Bolar exemption’ to protection periods
The agreement maintains an intellectual property exemption allowing competitors to take necessary steps to conduct studies and trials during protection periods to ensure that generic versions of medicinal products can be made available as soon as intellectual property rights expire. This is known as the ‘Bolar exemption’ and the Pharma Package clarifies that it will also allow competitors to engage in procurement and tender procedures during protection periods with the aim of developing generic alternatives to certain pharmaceutical products.
Next steps
While the Pharma Package has been provisionally agreed, the Council and Parliament will now need to both formally approve the final agreement. Once formally adopted, the implementation process will begin. This is likely to be a lengthy process and it is expected to be approximately two years before the new legislation takes effect within the EU.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
[View Source]
