Pharma influencers – doctors, scientists, patient advocates, and informed patients who have built substantial credibility and engagement online – are reshaping how information about medicines is delivered. Their posts often reach far beyond the typical audience of medical journals or professional conferences, and their insights inspire a level of trust that traditional advertising frequently struggles to achieve.
Driven by both digitalisation and shifts in health communication preferences, these influencers represent a major opportunity for pharmaceutical companies. However, their activities unfold in the shadow of uneven regulation, which in Europe, and particularly Portugal, is quite stringent.
The concept of pharma influencers
Not every healthcare personality with an online presence qualifies as a “pharma influencer”. This term generally applies to those who actively use digital platforms to promote discussion about diseases, treatments, and occasionally specific medicinal products, leveraging their expertise and authenticity to educate and engage the public.
The intersection between information, education, and promotion is complex. For example, a physician sharing general insights about diabetes care and new treatment options is providing a valuable service to patients and peers. However, if these communications reference specific medicines, they may quickly cross into the territory of medicinal products advertising, especially under Portuguese law, which is restrictive in nature.
As the boundaries between professional information, patient education, and subtle product promotion blur, pharma companies and influencers alike must tread carefully.
Challenges and opportunities
Pharma influencers open exciting new possibilities for promoting health, including expanded reach, real-time patient engagement, and improved health literacy. Their trusted voices often fill gaps left by traditional campaigns, making them valuable allies in public health. The promptness and customisation inherent to digital platforms make it easier than ever to share tailored, timely guidance.
Yet these benefits come with new challenges.
Regulatory uncertainty
Portugal stands out for its expansive and rigorous rules on medicinal product advertising. National law, derived from EU frameworks but stricter, defines “advertising” broadly, encompassing any act (even unintended) that directly or indirectly promotes a medicinal product. Further, the prohibition on offering benefits extends beyond healthcare professionals to include the general public. This means that even seemingly impartial communications, such as an influencer’s social media post reviewing a medicine, may be considered advertising under Portuguese law.
Strict limitations exist regarding the public promotion of prescription-only medicines; any direct or indirect advertising to the general public is prohibited. Over-the-counter (OTC) medicines have a somewhat more permissive regime, but specific requirements and mandatory disclaimers apply, particularly since the publication of Infarmed’s 2024 Regulation approving good practices for advertising OTC medicines through digital channels (“Regulation on advertising through digital channels”).
Therefore, influencer communications about OTC medicines must be navigated with care. For example, the advertising message must be clear, truthful, sufficiently complete, and enable the recipient of the advertisement to verify the features of the medicinal product for themselves. All these features must be compatible with the information contained in the package leaflet and the summary of product characteristics. The Regulation on advertising through digital channels explicitly states that, when advertising through social media, the advertising message must also clearly advise the user to carefully read the information contained in the medicine’s primary packaging and package leaflet. This warning must be made available on the main page with a zoom function and a link to the medicine’s package leaflet must also be provided.
A case for self-regulation and guidance
In response to the evolving landscape, the Portuguese Pharmaceutical Industry Association (APIFARMA) issued a guidance for digital promotion, aligning with the standards of the European Federation of Pharmaceutical Industries and Associations (EFPIA). This guidance offers practical recommendations but remains voluntary, leaving some regulatory uncertainty for non-members and those working with influencers.
Compliance and ethical considerations
Collaborations with pharma influencers demand careful planning. Content credibility, transparency around sponsorships, and scientific accuracy are non-negotiable. Portuguese authorities, like equivalent authorities in other countries, expect rigorous oversight, and both companies and influencers share responsibility for lawful and ethical communication.
Misinformation is a primary concern. As such, digital campaigns should avoid spreading unverified or misleading claims.
Where does Portugal stand?
The Portuguese approach is marked by caution, with strict legal requirements that set clear limits on the involvement of influencers. For now, Portugal maintains a stance focused on strict enforcement of the law, prioritising the protection of public health and minimising risks over experimenting with new forms of communication. This choice is understandable given the sensitivity of the sector and the potential risks associated with health communication in uncontrolled digital environments.
The absence of comprehensive legal reform relating to the digital context, which would help clarify, for example, the boundaries between personal testimony and advertising, or establish a specific regime for collaboration with health professionals on social media, perpetuates regulatory uncertainty, particularly regarding the digital promotion of POM and the involvement of the general public.
The Future: Navigating evolution
As pharma influencers continue to gain influence across Europe, the need for clear, harmonised, future-focused regulation is pressing, especially in markets like Portugal, where strict legal requirements intersect with the realities of digital transformation. Establishing a dedicated framework that accommodates the unique challenges and benefits of influencer-driven communications could unlock more effective and responsible promotion, benefiting patients, health professionals, and industry alike.
Conclusion
The future of pharmaceutical promotion lies at the intersection of digital innovation and regulatory oversight. In Portugal, the Medical Products Act and applicable European standards, in particular Directive 2001/83/EC, establish a demanding legal framework that strictly delimits the scope of action of pharma influencers.
Building a collaborative, transparent and well-regulated environment for the activities of these new players, which respects fundamental public health safeguards and citizens’ rights, is both an ethical imperative and a condition for the responsible exploitation of the opportunities offered by digital technology. This path necessarily involves strengthening legal clarity, cooperation between regulatory authorities, industry and healthcare professionals, and ongoing adaptation to the transformations of a rapidly evolving sector.
The need for a universally applicable, legally clear framework is evident, as influencers and the companies that engage them face mounting compliance complexity, reputational risk, and the spectre of regulatory enforcement.
