The EU Pharmaceutical Package: Key takeaways from the latest reform

This morning’s client conference provided a comprehensive and practical overview of the forthcoming European Union Pharmaceutical Package (the “Pharma Package”), one of the most significant regulatory overhauls of EU pharmaceutical legislation in over two decades. The reform is now at an advanced stage: a political agreement was reached in February 2026, and the legal and linguistic finalisation of the text is currently underway prior to formal adoption and publication.

Once published in the Official Journal, the new framework will enter into force after 20 days, triggering a general two year transition period for implementation or application, depending on the instrument. However, several provisions - particularly those relating to supply security - will apply earlier.

This article sets out the main pillars of the reform as presented during the session, focusing on regulatory protection, market access obligations, supply security, advertising rules, intellectual property aspects, antimicrobial incentives and the broader industrial policy context.

1. Regulatory data protection and market protection: A recalibrated balance

One of the most closely watched aspects of the reform concerns regulatory data protection (RDP) and market protection.

The final compromise preserves the eight-year baseline for regulatory data protection, abandoning the European Commission’s initial proposal to reduce it to six years with modular extensions.

By contrast, market protection undergoes a structural shift:

• The baseline is reduced from two years to one year;
• A possible additional year can be obtained if certain conditions are met.

These conditions are linked to policy objectives, including:

• Addressing unmet medical needs;
• Conducting high-quality comparative clinical trials;

Prioritising EU market filings (e.g. EU-first submission or near-simultaneous global filings).

Additional incentives remain available, for example where new therapeutic indications bring significant clinical benefit.

Overall, the reform seeks to rebalance incentives: maintaining strong baseline protection while introducing performance-based extensions aligned with public health priorities.

2. Launch obligation: A new access mechanism

A central innovation of the Pharma Package is the introduction of a “launch obligation”.

Under this mechanism, Member States may require marketing authorisation holders to:

• Place a medicinal product on the market;
• Ensure sufficient supply to meet patient needs;

The obligation applies where a product has marketing authorisation and still benefits from regulatory or market protection.

Authorities may impose concrete requirements, including:

• Submission of pricing and reimbursement applications;
• Participation in public procurement procedures;
• Preparation of rollout and supply plans.
• The consequences of non-compliance are particularly significant: loss of data protection or market protection in the relevant Member State, potentially enabling earlier entry of generic or biosimilar products.

This marks a shift from an incentive-based system to enforceable access obligations.

3. Supply security and shortage management: From reactive to proactive regulation

The reform introduces a major overhaul of supply chain regulation, aiming to address recurrent shortages.

The new framework is characterised by:

• Harmonised EU definitions of shortages and critical medicines;
• Stricter notification obligations, with timelines extending up to 12 months for permanent withdrawals;
• A shift towards proactive planning, including mandatory shortage prevention plans.

In addition, marketing authorisation holders may be required, before withdrawing critical medicines, to:

• Transfer the marketing authorisation; or
• Grant access to another operator to maintain supply.

The reform also strengthens coordination through:

• EU-level monitoring mechanisms;
• A “voluntary solidarity mechanism” enabling cross-border redistribution of medicines during shortages.

Importantly, certain provisions - particularly those relating to critical medicines - will apply immediately upon entry into force, underscoring the urgency of supply security concerns.

4. Advertising and promotion: Evolution rather than revolution

The new rules on pharmaceutical advertising introduce incremental but impactful changes.

Key developments include:

• A broader definition of healthcare professionals, now including those who administer medicines (e.g. nurses);
• A prohibition of gifts of negligible value, tightening compliance expectations;
• The express prohibition of advertising that disparages competing products;
• Stricter conditions for comparative claims, which must be supported by the Summary of Product Characteristics (SmPC).

The reform also codifies case law by clarifying that communications not referring to a specific product (e.g. disease-awareness campaigns) may still qualify as advertising.

Despite these updates, the framework remains largely directive-based, meaning continued national divergence in implementation is expected.

5. The bolar exemption: Expanded scope

The reform significantly broadens the scope of the Bolar exemption, which allows certain activities to take place prior to patent expiry.

Key extensions include:

• A wider range of exempt activities, including manufacturing, storage and supply-related actions necessary for regulatory approval;
• Inclusion of third parties (e.g. suppliers, contract manufacturers);
• Coverage of pricing, reimbursement and procurement processes.

The expanded Bolar exemption is likely to have uneven effects across Member States. In some jurisdictions, it will largely confirm existing case law, particularly as regards third parties. In others, where guidance has so far been mostly doctrinal, it will provide much-needed clarification, especially for borderline activities such as manufacturing and preparatory steps.

At the same time, the inclusion of pricing, reimbursement and procurement procedures represents a genuine novelty, potentially shifting the traditional view that participation in tenders before patent expiry may constitute infringing conduct.

However, the reform does not eliminate uncertainty. Key questions remain open, including the application of the exemption to non-EU authorisations and its availability to originators.

The interaction with the UPC will also be critical. While the UPC has not yet interpreted Article 27 UPCA, it has already treated pre-launch activities (including pricing and tenders) as relevant to establishing an imminent infringement risk. The broadened Bolar exemption may therefore reframe this analysis, making it harder to rely on such conduct as a basis for preliminary injunctions.

6. Antimicrobials: New incentives and stewardship measures

The Pharma Package introduces targeted measures to address antimicrobial resistance.

A key innovation is the transferable data exclusivity voucher, granting an additional year of protection:

• Available for priority antimicrobials;
• Transferable (subject to conditions) to another product.

This is complemented by:

• A potential EU-level subscription procurement model;
• Obligations on stewardship, including appropriate packaging, disposal and education;
• New requirements for antimicrobial resistance information and risk management.

These measures reflect a dual approach: incentivising innovation while promoting responsible use.

7. Digitalisation and patient information

The reform also modernises patient communication:

• Member States may allow electronic-only package leaflets;
• Patients must retain access to a free paper version;
• QR codes and multilingual electronic access will enhance usability.

8. The Critical Medicines Act: An emerging industrial policy layer

Alongside the Pharma Package, the EU is developing a Critical Medicines Act, with a strong industrial policy dimension.

Its objectives include:

• Strengthening EU manufacturing capacity;
• Reducing dependence on external supply chains;
• Introducing resilience criteria in public procurement.

The Act will also promote:

• Strategic projects with fast-track funding and approvals;
• Joint procurement mechanisms across Member States;
• Preference for EU-based production where supply chains are vulnerable.

Conclusion: A structural shift in EU pharmaceutical regulation

The Pharma Package represents a systemic transformation of the EU pharmaceutical framework. It moves beyond a purely regulatory model to integrate access, supply security and industrial policy objectives.

For pharmaceutical companies, the reform will require:

• Early preparation for new obligations, particularly regarding supply and market access;
• A reassessment of lifecycle strategies in light of revised protection regimes;
• A comprehensive review of promotional practices and internal compliance frameworks.

With publication expected in the coming months and key provisions applying shortly thereafter, the window for preparation is already open.