Updates to the EU Pharmaceutical Reform 2026

After years of trilogue discussions and negotiations between the European Commission, European Parliament and European Council, the final EU Pharma Package texts have been published and are due to take force in 2028. The new Pharma Package comprises a new Directive (6367/26) and Regulation (6366/26).

The Regulation is a full replacement of key centralised authorisation/EMA and incentives regulation: it repeals Regulation (EC) No. 726/2004, Regulation (EC) No. 141/2000, and Regulation (EC) No. 1901/2006, and amends Regulation (EC) No. 1394/2007, and Regulation (EU) No. 536/2014. The Directive repeals Directive 2001/83/EC and Directive 2009/35/EC.

The key policy change areas include:

• Reworked regulatory data/market protection frameworks
• Reworked Orphan Drug Designation incentives and definitions
• Access/EU-wide availability of medicines
• Measures to incentivise research in antimicrobial resistance
• Bolar exemption expansion

In this article and the series to follow, we will investigate the key changes to the current pharmaceutical framework and highlight the implications of these changes. It will be important to all stakeholders to prepare and adjust future strategy to account for new incentives and revisions to product protections.

Regulatory Data Protection (during which other companies cannot make reference to the full dossier product data) and Market Protection (during which generic or biosimilar products cannot be marketed)

The “8+2(+1)” exclusivity framework has been re-designed following changes to Articles 80-83 of the revised Directive. This leads to a maximum achievable market protection of 12 years (see a breakdown in the figure below for reference).

Changes to Regulatory Data Protections

Regulatory data protection remains at 8 years following the granting of a marketing authorisation. In this period innovator data shall not be referred to by another applicant for a subsequent marketing authorisation. This period can be extended by 1 year if an exclusivity voucher is used in accordance with revised Regulation, Article 41(1) (transferable exclusivity voucher from the antimicrobial incentive).

Changes to market protection periods

Currently innovators receive a baseline of 2 years market protection, where a generic or biosimilar product cannot be placed on the European market, but regulatory preparation can take place for a launch during this period. Expanded Bolar exemptions will make this preparation easier for generic and biosimilars (more on this later). Under the revised directive this market protection is reduced to a 1-year baseline.

Additional market protection periods

The revised Directive introduces incentives to extend market protection by +1 year in the following circumstances (Article 81 of the directive):

• +1 year if the medicinal product addresses an unmet medical need or
• For medicinal products containing a new active substance where the MA applicant demonstrates:
  • The clinical trials supporting the MAA use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency and
  • The MAA has been submitted in the EU first or no later than 90 days after submission elsewhere

or

• For medicinal products containing a new active substance where the MA applicant demonstrates:
  • The clinical trials supporting the initial MAA use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency and
  • Clinical trials evaluating the efficacy of the medicinal product and used for the MA were conducted in more than 1 Member State

or

• For medicinal products containing a new active substance where the MA applicant justifies that a comparative clinical trial is not possible or appropriate and demonstrates that:
  • Clinical trials evaluating the efficacy of the medicinal product and used for the MA were conducted in more than 1 Member State and
  • The MAA has been submitted in the EU first or no later than 90 days after submission elsewhere
• The regulatory market protection period shall be extended by an additional year if, during the regulatory data protection the MAH obtains an authorisation for one or more new therapeutic indications (including a paediatric indication) which bring a significant clinical benefit in comparison with existing therapies. The extension of market protection period based on the authorisation of additional indication(s) can only be granted once.

Therefore, the maximum protection period that a drug could have is the following: 8 years of data protection + maximum 3 years of market protection if the criteria laid above are met. An additional year of regulatory data protection can be granted if an exclusivity voucher from the new antimicrobial incentive is granted.

Expanded Bolar Exemption (Article 85 of the revised Directive)

The revised Directive provides definitive text on what generics and biosimilar sponsors can prepare leading up to the expiry of innovator protections. Patent rights will not be infringed upon when these sponsor’s conduct the necessary studies, trials and other activities for the purposes of:

• Obtaining a MA of medicinal products
• Conducting health technology assessments
• Obtaining pricing and reimbursement approval
• Submitting applications on procurement tenders to the extent that it does not entail the sale or offering for sale or marketing of the medicinal product concerned during the protection period provided by patent rights or supplementary protection certificates.

This offers transparency for generic and biosimilar manufacturers and enables their preparation following innovator protection expiry, for pan-EU launches earlier than before.

Revision to the definition of unmet medical need (Article 83 of the revised Directive)

Medicinal product addresses an unmet medical need if at least 1 of its therapeutic indications relates to a life threatening or severely debilitating disease and either of the following conditions are met:

• There is no medicinal product authorised in the Union for such a disease
• The use of the medicinal product for such a disease result in a clinically relevant improvement in efficacy, or in safety with at least comparable efficacy in comparison with existing medicinal products authorised in the Union.

Revision of Orphan Medicinal Product classification (Article 70 of the revised Regulation)

The revised Regulation introduces the concept of breakthrough orphan medicinal products mirroring the previous proposal for orphan medicinal products addressing ‘high unmet medical need’.

Criteria for breakthrough orphan medicinal products:

• There is no product authorised in the Union for the orphan condition; and
• The use of the orphan medicinal product results in a clinically relevant reduction in disease morbidity or mortality for the relevant patient population

Applications based on bibliographic data will not be eligible for this breakthrough orphan medicinal product designation (Article 13 of the revised Directive).

Revisions to Orphan Medicinal Product Exclusivity (Article 71-72 of the revised Regulation)

The revised Regulation has changed the framework we know for orphan medicinal products significantly. Market exclusivity for orphan products offers protection against the authorisation of a similar medicinal product for the same therapeutic indication (unless specific derogations apply). Currently, orphan medicinal products receive 10 years of orphan market exclusivity +2 years upon completion of an agreed PIP. Additionally, where an applicant gets an extension of indication in another orphan indication, they receive a separate market exclusivity period of 10+2 years, for that specific indication.

Under the revised Regulation the duration of exclusivity shall be:

• 9 years for traditional orphan products
• 11 years for breakthrough orphan medicinal products
• 4 years for orphan medicinal products authorised based on bibliographic data (Article 13 of the revised Directive)

MAHs will no longer be able to hold separate market exclusivity periods for different MAAs of the same active substance. The duration of the market exclusivity shall start from the date when the first orphan marketing authorisation was granted in the Union and can be prolonged based on the criteria described below.

Orphan medicinal products (except those that were granted based on bibliographic data) can receive a prolongation of 1 year to their exclusivity if at least 2 years prior to expiration, the orphan MAH gets a MA for one or more new therapeutic indications for different orphan conditions. This may only be granted twice. Of note, prolongation of market exclusivity by indication extension is the only way to extend the protection period of orphan products.

Access/EU-wide availability of Medicines

The reform delivers regulatory tools to enable wider access to medicines to EU citizens. These include:

• Earlier access to generic medicines (bolar exemption discussed above)
• Incentives linked to increasing market protection for earlier application in the EU, and/or for multinational clinical trials (discussed above)
• Multicounty/multilanguage packages and electronic product information to facilitate easier distribution of medicines across member states
• Member states have now the right to opt-in, in mutual recognition or decentralised procedures
• Under the revised Directive Article 56a, within 1 year of the marketing authorisation of a product, a member state may request the MAH to place it on the market of that member state, so that the needs of patients are covered. Therefore, a member state may require the MAH to carry out one or more of the following: (a) submit a valid pricing and reimbursement application, (b) fulfil procurement procedures (c) establish a roll-out plan (outlining supply and timelines). If within 3 years of that request, the product has not been made available and supplied it continuously, then market protection (all medicines) or the right to extension of market exclusivity (for orphans), will not apply in that member state.

Conclusion

The publication of the final EU Pharma Package marks one of the most significant overhauls of the European pharmaceutical framework in decades. With the new Regulation and Directive due to be implemented in 2028, the landscape for data protection, market protection, orphan incentives, antimicrobial development, and generic/biosimilar entry will shift considerably.

Across the key policy areas examined in this article, several themes emerge:

• A rebalanced incentives framework – The move from the traditional 8+2(+1) model shifts towards a framework where incentives must be earned through unmet medical need, comparative evidence generation, early EU submission, multi‑state clinical trials, or new indications that bring significant clinical benefit.
• A reshaped orphan drug environment – The creation of breakthrough orphan medicinal products and the corresponding exclusivity of up to 11 years marks a meaningful attempt to refocus incentives on therapies targeting the highest unmet medical needs. However, the removal of multiple exclusivity periods for the same active substance is a major strategic change that may reduce the commercial value of expanding into new rare indications.
• Greater certainty for generics and biosimilars – The expanded Bolar exemption enables earlier, coordinated European launch strategies and reinforcing the EU’s commitment to competitive and sustainable pharmaceutical markets.
• Tighter expectations on EU‑wide availability and supply – The new incentives and/or obligations for timely supply to all Member States signal the EU’s intent to close access gaps.

What this means for industry

The new framework will require all stakeholders, innovators, generic and biosimilar sponsors, investors, and healthcare systems to rethink development, protection, and access strategies. The shift toward performance‑based exclusivity means companies must plan earlier and more holistically for comparator selection, multi‑Member State trial execution, unmet‑need justification, and EU‑first filing.

For orphan products, development and lifecycle management strategies must be revisited to understand maximise exclusivity and assess whether additional indications remain commercially viable.

Meanwhile, the operational burden associated with supply obligations will demand robust regulatory governance and forward‑looking compliance systems.

How DLRC can support

These reforms introduce both opportunities and risks—and navigating them will require expert regulatory interpretation, strategic scenario‑planning, and detailed product‑specific assessment. DLRC is uniquely positioned to guide companies through this transition by offering:

• EU Pharmaceutical Reform preparedness workshops
• Tailored impact assessments to map how the revised framework affects your current and future portfolio
• Strategic regulatory pathway planning aligned with the new exclusivity and incentive structures
• Support with scientific advice preparation, including comparator justification and clinical evidence strategy
• Orphan designation strategy and assessment under the revised definitions and breakthrough criteria
• Market access and HTA support

To get in touch with our expects, email hello@dlrcgroup.com.