In 2023, the European Commission proposed a comprehensive update of the key EU pharmaceutical legislation (the "Pharma Package") to address critical challenges facing the sector. This reform represents the most significant overhaul of EU pharmaceutical legislation in decades, aiming to enhance patient access to medicines, strengthen supply chain resilience, and reduce product shortages across member states, as well as introducing necessary updates. The package builds upon the existing framework established by Directive 2001/83/EC (“the Directive”)while introducing new provisions to adapt to evolving market conditions, technological advancements, and public health priorities. The European Parliament adopted its amendments on the proposals for a new Directive and Regulation in April 2024. 

On the 2^nd of June 2025, the Council of the European Union established its position^[1] on the Pharma Package^[2]. This version introduces key updates and new provisions regarding the advertising of medicinal products, refining the existing framework to address current challenges and technological advancements. This article explores the key changes to pharmaceutical advertising rules in the Pharma Package. First, we provide a general overview of the Pharma Package proposals, followed by specific provisions for advertising to the general public and healthcare professionals. We then analyze key differences between the existing Directive and the new proposal (the “Proposed Directive”), highlighting significant changes in misleading advertising provisions, advertising definition, shortage-related controls, information access, enforcement frameworks, and inducement provisions. Finally, we discuss strategic implications for pharmaceutical marketing under the new regulatory framework.

See our overview article on the Council position and links to our coverage of other Pharma Package topics here.

1. General Picture

The Proposed Directive maintains the requirement for objective, unbiased product information while introducing specific prohibitions with direct compliance implications:

• Explicitly forbids negative highlighting of other medicinal products
• Prohibits claims suggesting superior safety or efficacy unless objectively supported by product characteristics data
• Specifically bars misleading claims about biosimilar interchangeability
• Expands the definition of advertising to include promotion of 'unspecified medicinal products'
• Incorporates enforcement mechanisms from Directive 2006/114/EC

1. Advertising to the General Public

The Proposed Directive maintains core prohibitions while introducing critical new provisions for advertising to the general public.

• Prohibited Products: Member States must prohibit advertising to the general public for prescription-only medicinal products and those containing psychotropic or narcotic substances.
• Permitted Products: Only medicinal products designed for use without medical practitioner intervention may be advertised to the public, with pharmacist advice as needed.
• Member State Discretion: States retain authority to ban advertising of reimbursable products and unbranded disease awareness communications.
• Vaccination Exception: Industry vaccination campaigns approved by competent authorities are exempt from general prohibitions.
• Direct Distribution: Member States must prohibit direct distribution of medicinal products to the public for promotional purposes.
• Shortage-Related Suspension: Member States gain authority to suspend product advertising during shortages or risk of shortage, creating new compliance obligations for marketing authorisation holders.
• Healthcare Professional Rules: Member States may apply stricter measures for advertising to healthcare professionals qualified to administer medicinal products.
• Clear Identification: All advertising to the public must explicitly identify itself as an advertisement and clearly identify the product as medicinal.
• Minimum Information Requirements: Advertising must include product name, usage information, and instructions to read the package leaflet. Member States may permit simplified "reminder advertising" showing only product name, active substance, or trade mark.
• Prohibited Content: The reform maintains prohibitions against content that suggests medical consultation is unnecessary, guarantees effects, targets children, cites celebrities, or makes misleading claims about natural origins or recovery rates.
  
  b. Advertising to Healthcare Professionals (HCPs)

The Proposed Directive largely maintains existing HCP advertising provisions while emphasizing information access requirements.

• Required Information: All HCP advertising must include essential information matching the Summary of Product Characteristics (SmPC). Member States may require pricing and reimbursement details. Simplified reminder advertising is permitted.
• Supporting Documentation: All promotional materials must include required information, creation/revision dates, and accurate, up-to-date, verifiable data. Scientific citations must be precisely reproduced with clear source attribution.
• Medical Sales Representatives: Representatives must receive adequate training, possess scientific knowledge, provide Summaries of Product Characteristics, and include pricing/reimbursement details if permitted by national law.
• Information Access: The reform establishes Member State responsibility to ensure HCPs have access to neutral, objective product information. It clarifies that prescription product information may be provided to qualified administrators, recognizing complex product education needs.
  
  2. Focus on Key Differences

The Proposed Directive introduces substantial refinements to pharmaceutical advertising regulation:

1. Enhanced Specificity on Misleading and Comparative Advertising: 

The Proposed Directive replaces general prohibitions with specific violations, including:

• Explicit ban on 'negatively highlighting another medicinal product'
• Prohibition of unsubstantiated superiority claims
• Specific protection for biosimilar products against misleading interchangeability claims. This intervention addresses competitive practices in complex market segments, establishing clear boundaries for permissible competitive messaging.
   

b. Expanded Advertising Definition:

The Proposed Directive explicitly extends regulatory jurisdiction to communications about “unspecified medicinal products.” This impacts disease awareness campaigns, therapeutic class promotion, and corporate communications that may implicitly encourage pharmaceutical interventions. By eliminating this regulatory safe harbour, these subtle promotional forms become subject to the same scrutiny as product-specific advertising. Organisations should revise policies governing corporate communications, public relations, and disease awareness initiatives to ensure compliance.

c. Shortage-Related Advertising Controls: 

The Proposed Directive introduces unprecedented authority for Member States to suspend advertising during product shortages. This represents a significant expansion of regulatory power with novel commercial speech restrictions. Key considerations include:

• Substantial discretionary power with limited procedural safeguards;
• Potential jurisdictional complexity if Member States make contradictory determinations;
• Questions about proportionality under EU legal principles;
• Commercial liability for marketing authorisation holders with suspended campaigns.

This provision creates a direct commercial consequence for supply failures, establishing an economic incentive for shortage prevention and supply chain resilience. Marketing authorisation holders will need to integrate potential advertising suspensions into their strategic planning, introducing a new layer of regulatory risk and uncertainty, particularly for products with supply vulnerabilities or those critical for public health.

This provision demonstrates the Pharma Package commitment to supply security by adding demand-side management to traditional supply-side interventions. This creates a more comprehensive shortage management framework addressing both supply constraints and demand drivers, evolving from passive notification systems toward active market intervention during public health emergencies.

d. Neutral Information Access Mandate: 

The Proposed Directive establishes an affirmative obligation for Member States to ensure HCPs have access to 'neutral, objective' information sources. This aims to counterbalance industry promotional channels and support evidence-based prescribing decisions, potentially moving toward publicly funded independent drug information resources that could establish reference standards for evaluating therapeutic claims.

e. Enforcement Framework Integration: 

By referencing Directive 2006/114/EC mechanisms, the Proposed Directive aligns pharmaceutical advertising oversight with broader EU consumer protection and advertising law. This suggests a move toward standardised procedures, consistent definitions of misleading and comparative advertising, and more efficient enforcement through existing legal precedents and administrative structures.

f. Missing Inducement Provisions: 

The Proposed Direcitve text lacks detailed provisions on inducements, hospitality, and free samples that exist in Directive 2001/83/EC. This gap requires clarification regarding whether these provisions are maintained elsewhere, implicitly covered, or delegated to Member States.

3. Strategic Implications for Pharmaceutical Marketing

Under the Proposed Directive, pharmaceutical companies face several strategic imperatives that require immediate attention and proactive planning:

• Heightened scrutiny for comparative claims, particularly regarding biosimilars, requiring rigorous SmPC-based substantiation and comprehensive medical-legal review processes;
• Development of robust contingency planning for advertising suspensions during shortages, including cross-border coordination strategies for multinational campaigns potentially affected by differing Member State decisions;
• Comprehensive review of disease awareness campaigns, unbranded communications, and corporate messaging now captured by the expanded advertising definition;
• Strategic shift toward scientific exchange and independent medical education as neutral information access gains prominence, necessitating new approaches to HCP engagement and knowledge dissemination;
• Reassessment of cross-border digital marketing strategies to address potentially divergent Member State interpretations of the expanded advertising definition;
• Investment in enhanced pharmacovigilance and supply chain monitoring systems to prevent shortage-triggered advertising suspensions that could disrupt global marketing strategies;

Forewarned is forearmed - pharmaceutical companies should anticipate the Proposed Directive's wide-ranging impacts and take action to:

• Comprehensively review and update internal compliance policies and procedures across all EU markets, ensuring consistent implementation throughout global operations;
• Develop protocols for responding to shortage-related advertising suspensions, including cross-functional coordination between supply chain, regulatory affairs, and marketing departments;
• Implement stricter review processes for comparative claims with particular attention to biosimilar messaging, incorporating scientific affairs and legal review at earlier stages of content development;
• Audit all corporate communications potentially captured by the expanded advertising definition, including patient advocacy initiatives, disease awareness campaigns, and digital media strategies;

By taking these proactive measures, companies can not only aim for compliance with the new requirements but potentially gain competitive advantage through superior preparedness. The new regulatory landscape presents challenges but also opportunities for organisations willing to invest in sophisticated policy frameworks, cross-functional coordination, and strategic foresight. Companies that adapt most effectively to these changes will be best positioned to maintain market presence while fulfilling their essential role in ensuring patient access to medicines across the European Union. 
 

[1] https://data.consilium.europa.eu/doc/document/ST-9285-2025-INIT/en/pdf.

[2] Proposal for a Directive of the European Parliament and the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC