Comprehensive Reform in EU Pharma Legislation: The European Union Pharma Package

Following a legislative reform process spanning over seven years, the European Parliament and the Council of the EU have reached a political agreement on the New EU Pharma Package. This package comprises two fundamental legislative instruments: a directly applicable Regulation and a Directive to be transposed into national law by Member States. It constitutes one of the most extensive overhauls of EU pharmaceutical law in recent history.

While the final text has not yet been published in the Official Journal (OJEU), statements issued by the European Parliament and the Council provide significant indicators regarding the reform's general framework and objectives. Following formal approval, the package will enter into force upon publication in the OJEU, with a transition period ranging from 24 to 36 months for its implementation.

New Exclusivity Periods and Market Access Regime

The new regulation intends to abandon the long-standing "8+2+1" regulatory exclusivity model in favor of an "8+1+1+1" structure. Under this model, the Regulatory Data Protection (RDP) period is maintained at eight years, while the Market Protection period is reduced to one year. However, it is possible to extend market protection by a maximum of two additional years if specific conditions are met.

Eligibility for such additional protection is contingent upon criteria:

• The product addressing an Unmet Medical Need (UMN); or

• The product containing a New Active Substance (NAS) with clinical trials conducted within the EU/EEA; and

• Obtaining authorization for new therapeutic indications that provide a significant clinical benefit compared to existing therapies.

  
  

The manner in which these criteria will be interpreted and the specific benchmarks to be applied may create regulatory uncertainty for Marketing Authorisation Holders (MAHs).

Timelines for Orphan Medicinal Products and Antimicrobials

The new package establishes a more restrictive and conditional structure for incentives granted to Orphan Medicinal Products (OMPs). Accordingly, the baseline Market Exclusivity for all orphan drugs is set at nine years, while an extension up to eleven years is reserved only for products addressing a High Unmet Medical Need (HUMN) and possessing a breakthrough character. Furthermore, generic and biosimilar applications may be submitted and validated during the final two years of the exclusivity period, though their market entry may be deferred.

To combat Antimicrobial Resistance (AMR), the reform introduces a system of Transferable Data Exclusivity (TDE) vouchers of 12 months, subject to strict conditions. However, the practical efficacy of this incentive is evaluated as potentially limited due to constraints such as the restricted number of vouchers, sales caps, and supply obligations.

Generic and Biosimilar Entry: Expansion of the Bolar Exemption

The scope of the Bolar Exemption is significantly broadened under the new regulation. Generic and biosimilar companies will be exempt from patent and Supplementary Protection Certificate (SPC) infringement not only for activities related to marketing authorization applications but also for:

• Health Technology Assessments (HTA);

• Pricing and Reimbursement (P&R) processes;

• Preparation of bids for public tenders.

It is assessed that this provision—granted on the condition that no actual sales occur—could lead to generic prices becoming effectively established with public authorities before the expiry of the patent or SPC period.

Market Launch and Supply Obligations

The package introduces a significant departure from the current system regarding market launch and supply obligations. Currently, MAHs are not required to launch their products in all Member States but are obligated to ensure adequate supply where they have entered. The new system, however, allows Member States to request that a Centrally Authorised Product (CAP) be placed on their national market within three years.

Failure to comply with this obligation—except for circumstances beyond the company’s control—may lead to severe sanctions, including the revocation of data and market protection for the relevant Member State. This approach is considered open to legal challenge regarding the integrity of the EU Internal Market and the principles of free movement.

Authorisation Procedures and Promotional Activities

The reform envisions reducing the European Medicines Agency’s (EMA) scientific assessment timeline from 210 days to 180 days and adopts a more flexible approach toward Paediatric Investigation Plans (PIPs). The actual impact of these changes will become clearer following the publication of the final text.

Furthermore, the new regulation explicitly prohibits advertisements that portray competitor products negatively or contain claims of superiority; exceptions are granted only for comparisons supported by the Summary of Product Characteristics (SmPC). This approach is assessed as potentially limiting companies' communication activities, even those based on scientific publications.

Conclusion

The New EU Pharma Package reshapes the existing equilibrium across multiple areas, from exclusivity periods and supply obligations to the OMP regime and generic/biosimilar pathways. While the primary objective is to enhance patient access and accelerate regulatory processes, the new obligations and incentive mechanisms are expected to have profound implications for the commercial and legal strategies of pharmaceutical companies. The publication of the final text and the ensuing secondary legislation will allow for a more precise evaluation of the reform’s impact on the sector.

AUTHORS

Nuri Melih İnce

Ahmet Çağrı Kılınç