The New EU “Pharma Package:” EU Reaches Landmark Deal on Pharma Package

On December 11, 2025, the Council of the European Union and the European Parliament reached provisional agreement on the long-awaited “Pharma Package,” (see the announcement here). The Pharma Package is a comprehensive and major overhaul of the EU legislative framework for pharmaceuticals, which replaces the more than 20-year-old Directive 2001/83 and Regulation 726/2004 and incorporates (and updates) the separate regulations on orphan and pediatric medicines (Regulations 141/2000 and 1901/2006 respectively).

The changes are designed to enhance patient access to essential medicines, strengthen the life sciences sector, and ensure a fair and competitive market throughout Europe. Agreement on these reforms marks a pivotal moment for the European pharmaceutical sector, promoting innovation and competition, reducing regulatory burdens, and reinforcing affordable medicine availability and public health resilience.

Over the summer of 2025, we analyzed the key changes proposed by the Pharma Package in our weekly client alert series (all nine alerts are available here). Now that provisional agreement has been reached, we provide an overview of what changes are likely to be finally adopted.

What is changing?

Regulatory data protection

Regarding data exclusivity, the Council and Parliament have agreed to abandon the previous “8+2(+1)” formula and replace it with a new “8+1(+1)(+1)” formula. This means that new medicines will benefit from an eight-year data exclusivity period, ensuring exclusive rights over data from pre-clinical and clinical studies during that time. Afterwards, one year of market protection is guaranteed, with the possibility of two additional one-year extensions for innovative drugs meeting specific criteria.

Pharmaceutical companies will be eligible for additional periods of market protection if any of the following apply:

• the particular product addresses an unmet medical need (12 months);
• it contains a new active substance, fulfilling a combination of conditions on comparative clinical trials, clinical trials carried out in several Member States, and the obligation to apply for market authorization within 90 days after the submission of the application for the first marketing authorization (MA) outside the EU (12 months); or
• if the company obtains an authorization for one or more new therapeutic indications that bring a significant clinical benefit in comparison with existing therapies (12 months).

The provisional agreement envisages a cap of a maximum of 11 years on the combined regulatory data protection period (which is also the maximum protection period that is currently available).

The new system is in line with the initial position of the Council before the start of the trilogues.

As initially proposed by the Parliament, orphan medicinal products addressing a disease with no currently available medicinal treatment (“breakthrough orphan medicinal products”) will benefit from up to 11 years of orphan market exclusivity. In the provisional agreement, the terminology has been changed from “high unmet medical need” to “breakthrough” products.

For more information on the legislative history, see the second client alert in our Pharma Package series (on Regulatory Data Protection).

The regulatory process

On a practical level, the regulatory process will be overhauled and the procedures will be streamlined:

• the time allowed for the Committee for Medicinal Products for Human Use (CHMP) to issue a scientific opinion under the centralized procedure is reduced from 210 to 180 days; and
• the decision-making process for the subsequent Commission Implementing Decision must now not exceed 46 days (as opposed to 67 days).

Furthermore, the functioning of the European Medicines Agency (EMA) will be made smoother. It will now be possible to treat MA applications more rapidly in a centralized procedure due to, for example, the submission of electronic MA applications in a common format for all Member States. Also, membership and voting rights are secured for patient organizations and health care professionals in the committees of the EMA.

Lastly, regulatory sandboxes will be introduced for the development and testing of new, innovative therapies.

Ensuring continuous availability of medicines

Member States will be able to require manufacturers to supply sufficient quantities of medicines benefiting from regulatory data protection in order to ensure that patient needs are met. Added safeguards clarify obligations to prevent misuse and protect supply chains.

Shortage prevention plans will not be required for all medicinal products but will be required for all products subject to prescription or for which the Commission has identified that a shortage prevention plan is required. A list of critical shortages in the EU will be established and updated by the EMA.

Furthermore, the article 56a “access conditionality” as initially proposed by the Council was adopted in the provisional agreement. Member States will therefore be able to request that a pharmaceutical company bring a medicinal product to market. If the company does not comply, it will lose its market protection for that product, which will allow generic competitors to enter the market earlier than foreseen.

For more information on the legislative history, see the seventh client alert in our Pharma Package series (Access conditionalities and Shortage measures).

Broadening of the Bolar exemption

The provisional agreement confirms and broadens the Bolar exemption, which allows generic manufacturers to prepare products for a day-one launch ahead of patent and supplementary protection certificate (SPC) expiration.

The revised legislative text clearly states that patent and SPC rights will not be infringed if the studies, trials, and other activities are necessary for the purposes of obtaining an MA. The new wording also makes it clear that conducting health technology assessments, obtaining pricing and reimbursement approvals, and complying with the subsequent practical requirements are all covered by the exemption, as are submissions for procurement tenders. This will hopefully lead to a more harmonized application of the Bolar exemption across the EU. However, the question now arises of how this will impact preliminary injunction success rates and the practice of so-called launches at risk as activities such as P&R applications or participation in tenders have in the past often been viewed as sufficient proof of a threat of an imminent infringement.

For more information on the legislative history, see the sixth client alert in our Pharma Package series (The “Bolar” exemption).

Incentives to combat antimicrobial resistance – the transferable exclusivity voucher

The Council and the Parliament have agreed to introduce the transferable exclusivity voucher (TEV) to incentivize and reward companies for developing priority antimicrobials to combat antimicrobial resistance (AMR). The TEV provides for a 12-month extension to the data exclusivity period which can be used once for the antimicrobial product or for another centrally authorized medicinal product of the same or a different MA holder.

The Parliament agreed to maintain the Council’s proposed “anti-blockbuster” limitation. The additional year of data exclusivity provided by the TEV cannot be applied to high-revenue (“blockbuster”) products, thereby safeguarding healthcare budgets. A blockbuster product is a product with average annual gross sales exceeding 490 million EUR for the past four years.

Other measures to combat antimicrobial resistance include mandatory prescription for all antimicrobials (with minor exceptions) and clear warnings about misuse, and the harm from misuse, of antimicrobials. In addition, when applying for an MA for an antimicrobial product, the company will need to provide an antimicrobial study plan and an evaluation of the AMR risk as part of the mandatory environmental risk assessment.

For more information on the legislative history, see the third client alert in our Pharma Package series (The transferable exclusivity voucher).

When is it changing?

The agreement still needs formal approval by both the Council and the Parliament in accordance with the EU’s ordinary legislative procedure before final adoption and publication in the EU’s Official Journal. Once published in the EU’s Official Journal, the new Directive and Regulation will enter into force 20 days after publication and the transitional period (likely between 18-36 months) will then begin. During this transitional phase, the Regulation will not yet take effect, and the Member States will have time to transpose the Directive into their national laws.

For more information about these important changes, or if you would like to discuss how the Pharma Package will affect your business, please do not hesitate to contact our team.