EU Pharma Package: A Landmark Political Deal Sealed

In the early morning of 11 December 2025, the Council and European Parliament reached a political agreement on the overhaul of the general EU pharmaceutical legislation (the “Pharma Package”) consisting of a new Regulation replacing current Regulation (EC) No 726/2004, and a new Directive replacing current Directive 2001/83/EC. This is the first major reform in over 20 years, and it comes nearly three years after the Commission’s initial proposal was published in April 2023.

The agreed texts have not yet been published. The full impact of the reforms will only be clear once the final versions become available upon formal adoption. It is not certain at this stage when this will be. Once adopted, an implementation timeline of 24 months would apply along with specific transitional measures.

What we know so far

• Regulatory data protection (RDP) and market protection: 8+2(+1) becomes 8+1(+1+1)
  • The agreement retains the current 8 years of RDP for new medicines, rejecting the Commission’s initial proposal to reduce it to 6 years.
  • The current 2-year period of market protection is reduced to 1 year with possibility to extend as follows:
    • One additional year of protection where:
      • the product addresses an unmet medical need, or
      • the product addresses a combination of conditions, comparative clinical trials have been conducted in more than one member state, and the EU application has been submitted within 90 days after the first submission for MA outside the EU. One additional year of protection if during RDP the marketing authorisation holder (MAH) obtains an authorisation for one or more therapeutic indications that bring significant clinical benefit
    • One additional year of protection if during RDP the marketing authorisation holder (MAH) obtains an authorisation for one or more therapeutic indications that bring significant clinical benefit
  • RDP and market protection combined cannot exceed 11 years in total. 
• Orphan market exclusivity (OME): 11 years for breakthrough orphan drugs
  • The baseline OME period is reduced from 10 to 9 years.
  • The notion of “high unmet medical need” is replaced with a new category, “breakthrough orphan drugs” applicable to conditions with no existing treatment in the EU and which demonstrate a clinically relevant reduction in morbidity or mortality for the target population. These will receive 11 years of OME.
• Transferable exclusivity voucher (TEV) for antimicrobials:+ 1 year RDP
  • A TEV of +1 year RDP for priority antibiotics is introduced but it may only be used for smaller-volume products (< 490m € in the past 4 years). The environmental risk assessment plan for antimicrobials shall include an evaluation of the risk for antimicrobial resistance.
• Bolar exemption: expanded to allow generics to participate in tenders before patent expiry
  • The wording of the Bolar exemption has been broadened to allow generic manufacturers not only to conduct the necessary studies and trials but also to participate in procurement procedures and public tenders prior to patent or supplementary protection certificate expiry, while the originator product remains under protection.
• Availability of medicines: Member States may request marketing authorisation holders (MAHs) to supply medicines in their territory
  • Co-legislators have kept Article 56(a) of the Directive that allows Member States to request a MAH to supply a medicine in sufficient quantities in their territory to meet domestic patient needs. According to the  Council press release, additional “safeguards have been added to the text clarifying obligations for companies and member states, and preventing the use of article 56a as an opportunity for parallel trade.” 
• Shortages: mandatory 6-month notification requirement for anticipated shortages
  • In addition, companies will be required to put in place and update shortage prevention plans for prescription medicines and other medicines identified by the Commission.
  • In particular, MAHs must notify anticipated shortages at least 6 months in advance, unless duly justified circumstances prevent compliance.
• EMA review timelines: standard 210 days procedure shortened to 180 days
  • The rules aim to simplify the functioning of the EMA and allow it to reach recommendations more rapidly.
• Transparency on public funding
  • MAHs shall publish information on direct financial support received from any public authority or publicly funded body as well as from philanthropic organisations or not-for profit organisations in relation to research and development activities carried out with respect to nationally or centrally authorised products.

Timeline:

• As mentioned above, the agreed texts have not yet been published, and no release date has been confirmed.
• The timelines therefore remain uncertain. According to press reports, the implementation timeline will be 2 years from the date of publication in the Official Journal.
• In addition, both the Regulation and Directive will include transitional provisions. The new RDP and OME periods will only be available to products authorised under the new legislation. Reference products for which a marketing authorisation application was submitted before the entry into force of the Regulation or Directive shall be subject to the protection periods set out in the current legislation. 

First impressions

At first glance, the agreement appears more supportive of innovation than the Commission’s original proposal. However, the full impact cannot be assessed until the final text is published. It will be essential to review the details carefully, as new obligations such as those related to supply obligations and availability are likely to have a significant impact on the industry.

For further details see here.