1. What is the current legal landscape for pharma advertising law in your jurisdiction?

The Danish pharma advertising landscape is known as one of the strictest and is shaped by a tight interplay between hard law, self-regulation and EU-level digital and data rules. At statutory level, the Danish Medicines Act and the Danish Medicines Agency’s executive order and guideline on advertising of medicinal products set the core framework for what may be communicated to healthcare professionals and the public, including the prohibition on advertising prescription-only medicines to the public and detailed conditions for OTC advertising, samples, comparative claims and patient-facing materials. The Marketing Practices Act, enforced by the Consumer Ombudsman, adds general standards on fairness, misleading and hidden advertising and special protection of children and other vulnerable groups.

On top of this sits ENLI, the Danish pharmaceutical industry’s self-regulatory body supervising advertising and other promotional activity aimed at healthcare professionals and healthcare organisations. ENLI’s Promotion Code and guidance, including digital media rules, apply the broad legal concept of “advertising/promotion” across traditional detailing, meetings and hospitality as well as websites, social media, webinars, congress apps and cross-border activities. Related ENLI codes on collaboration with patient organisations, healthcare decision-makers and the use of consultants and healthcare professionals set more detailed – and in practice often stricter – expectations on transparency, remuneration and documentation than statute alone.

The digital environment is further shaped by horizontal EU regimes. GDPR, implementing acts and administration by the Data Protection Agency limit how tracking technologies, CRM data and external data sources may be used for segmentation and personalization, especially where health data or strong proxies are involved. The Digital Services Act restricts profiling-based advertising on online platforms using sensitive data and to minors and adds transparency duties that influence available targeting and platform policies. The forthcoming AI Act will require more structured governance around AI-assisted tools and health-data use, and Denmark’s tendency to implement early means global strategies often need specific tailoring for the Danish market.

2. What three essential pieces of advice would you give to clients involved in pharma advertising matters?

First, optimize work-flows with AI – there are many good options out there. But be careful not to deprioritize human oversight and responsibility. As in any other deployment of AI solutions skilled staff or consultants with domain expertise may be more important when the review processes pick up speed and holistic assessments give way to over-reliance on AI-generated output. AI can be a useful accelerator – for drafting, localisation, consistency checks and monitoring – but it cannot replace experienced judgement on pre-launch, off-label, comparative claims, etc.

Second, design digital engagement on the assumption that anything that looks like advertising could be treated as advertising, at least by the public. Disease awareness, service offerings, corporate reputation campaigns, patient-facing apps and social-media activity should all be analysed carefully for promotional effect and brand linkage. Clear internal criteria for what is promotion, what is information and how mixed-purpose content is handled, combined with strong documentation and audit trails, are key to avoiding inadvertent breaches and defending borderline situations. The forthcoming revision of the EU general pharma legislation (GPL) is expected to tighten and clarify the advertising framework, so it is prudent to stress-test existing concepts and design new initiatives with the future regime in mind.

Third, treat pharma advertising compliance as an integrated discipline rather than a narrow review of individual materials. Effective risk management requires aligning Medicines Act and ENLI requirements with marketing law, platform terms, GDPR, cookie rules, cybersecurity expectations and internal conduct standards. Governance should be organized around whole campaigns and customer journeys, not isolated assets, to better manage cross-border activities, re-use content and demonstrate control.

3. What are the greatest threats and opportunities in pharma advertising in the next 12 months?

AI is arguably the greatest threat and opportunity at the same time in pharma advertising. Assessments in this area are often subjective and involve nuanced judgements on large volumes of scientific evidence – for example whether a claim is exaggerated, selectively presented or potentially misleading in the eyes of a Danish regulator or ENLI. Generative AI models based on large language models (LLMs) can produce very polished and convincing assessments, but they are constrained by their training data, inherent bias, the quality of the prompts they receive and the lack of full context. For Legal, Medical and Regulatory reviewers (LMRs), well-governed AI can support faster and more consistent review – for instance by pre-classifying materials, flagging sensitive claims or surfacing previous decisions – but in inexperienced hands, or where experts drift into “autopilot”, it creates a systemic risk because it can dilute nuanced assessments and make it easier to embed and scale incorrect practices.

A second threat is the use of influencers and “ambassadors” in and around health-related campaigns. Following recent clarifications from the Consumer Ombudsman, commercial influencers who run a business are treated as traders, and activity that qualifies as commercial practice must comply with the Marketing Practices Act – not only explicit paid posts, but often also “organic” content. For medicinal products, Danish rules already prohibit public advertising for prescription-only medicines, and even non-sponsored posts can in some circumstances be regarded as advertising. Combined with chain responsibility, this makes influencer or ambassador concepts in therapy areas such as obesity and diabetes a high-risk zone that should be treated as a red-flag issue for LMR, with tight contracts, targeted training and a careful assessment of the influencer’s profile and audience.

Finally, regulatory friction around digital targeting and tracking remains a key threat. Enforcement practice under personal data protection frameworks, together with DSA-driven changes to platform advertising products and strict Danish practice on cookies and marketing consent, is tightening the space for behavioral advertising and fine-grained segmentation, especially where health conditions, patient communities or vulnerable groups may be involved. Companies that persist with opaque targeting logic, legacy privacy notices and cookie banners and complex consent flows risk investigations, corrective measures and loss of trust. On the opportunity side, there is still significant scope for building high-quality, compliant digital engagement with healthcare professionals and, within the limits of Danish law, with patients and the public. Companies that align early with stricter expectations on transparency, data use and security can deploy omni-channel strategies with confidence and use Denmark – and ENLI case law in particular – as a testing ground for “gold standard” global governance.

4. How do you ensure high client satisfaction levels are maintained by your practice?

We combine deep knowledge of the pharma advertising rules with a practical understanding of how clients actually run campaigns and engage with healthcare professionals and patients. In practice, that means translating statutory requirements, ENLI practice, platform rules and data-protection expectations into clear guidance that marketing, medical and compliance teams can use directly. Matters are staffed cross-disciplinarily so that regulatory, marketing law, data/AI and cybersecurity expertise are integrated from the outset, and we prioritize reusable tools – such as social-media guidelines and template collaboration agreements – rather than one-off memos. By investing time in each client’s brand, risk appetite and internal processes, we can calibrate advice to what is commercially realistic and support constructive dialogue between legal, compliance and the business.

5. What technological advancements are reshaping pharma advertising law and how can clients benefit from them?

AI and automation are already reshaping both the legal framework and market expectations around pharma advertising. Under the AI Act and related guidance, AI-enabled tools used to generate content, power chatbots or support segmentation and analytics will be subject to transparency and governance obligations, particularly where they interact directly with healthcare professionals or the public. At the same time, AI offers clear efficiency gains in drafting and localising materials, managing claims libraries, monitoring social media for off-label or user-generated content and analysing enforcement trends and customer feedback. Pharma companies who adopt AI within a clear governance framework – human review, guardrails on training data and documentation of outputs and decisions – can realise these benefits while demonstrating compliance and control.

Advances in digital platforms and data infrastructure are also critical. More mature consent- and preference-management tools, secure healthcare professionals portals and event platforms and improved analytics capabilities allow pharma companies to move away from third-party data and opaque adtech chains towards more transparent, first-party, relationship-based engagement. Pharma companies who engage proactively with these technological shifts – for example, by piloting AI-supported content workflows under strict controls, modernising their consent and CRM architecture and embedding cybersecurity requirements into agency and platform contracts – are well positioned to operate effectively in a demanding regulatory environment. Done well, technology becomes not only a compliance challenge but also a lever for more targeted, efficient and credible communication.