EFPIA launches guide to improve sector's patient communications

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a practical guide on how pharmaceutical companies can develop clear, patient-focused communications. Its purpose is to equip patients and carers with the knowledge needed to make informed treatment decisions and take an active role in their healthcare.

The EFPIA guide is structured around four main pillars: establishing health literacy and plain language as a starting point, setting out the core principles of patient-centred communication, identifying strategies to embed these principles across the industry, and providing conclusions and a call to action for all stakeholders.

Health literacy

The guide opens with health literacy, a fundamental driver of health outcomes. Health literacy encompasses a person's ability to access, understand, and use health information and services to make suitable health decisions. The aim is to improve health literacy and enable individuals to be healthier, more engaged, and more involved in their care.

It stresses that patient-facing materials must be accurate, accessible, inclusive, and actionable, empowering patients to make informed choices and take steps to improve their health.

Plain language

The guide treats health literacy and plain language together, emphasising that plain language is the primary means to achieve strong health literacy. As outlined by the ISO standard referenced in the guide, information should be relevant, meaning recipients get what they need, and easy to find, understand and use.

In practice, patient information should be centred on the needs of its audience, written from the recipient’s perspective, and stripped of unnecessary technical or medical jargon. The aim is for patients to clearly understand the message and any required actions or decisions.

Core principles 

The guide sets out eight key principles to underpin patient-centred communication in the pharmaceutical industry.

• Purpose. Companies should identify the intended audience and objective, ensuring the message is clear at first reading.
• Language. Communications should be clear, concise, factual, and non-promotional language; avoiding unnecessary technical terms, double negatives, euphemisms and colloquialisms, maintaining consistent terminology throughout.
• Structure and format. Information should be organised clearly, using headings, lists, tables and graphics to aid readability, with the main message presented before providing supporting details.
• Use of numbers. It recommends that numbers are presented clearly, with digits preferred over words, whole numbers over decimals and, where possible, frequencies instead of percentages.
• Visual aids. The guide recommends the use of symbols, images, pictograms, and infographics to enhance understanding and retention of medical information, especially for patients with lower literacy or language barriers.
• Other media. Digital tools such as videos, audio content, health apps and online resources, should be used to enhance the accessibility and interactivity of medical information.
• Accessibility. Materials should be accessible to those with visual, hearing, or cognitive impairments, through inclusive design, compatibility with assistive technology, subtitles, transcripts, and adherence to accessibility standards.
• Consistency. Companies should maintain consistent terminology and style across all patient-facing materials, supported by reference glossaries and standardised templates.

Principles in practice

The guide sets out clear, practical steps for the pharmaceutical industry to put these principles into practice, using plain language throughout. 

The recommendations include training staff and providing digital tools, such as terminology databases and writing assistants, to support writing in plain language. Standard templates should be developed and thoroughly assessed to ensure all information is presented clearly and consistently.

Patients and representative involvement in the design and review of materials should go beyond the minimum required under Directive 2001/83. Companies should also make the most of electronic formats by using mobile apps, QR codes, personalised content, real-time updates, and multilingual support.

When translating materials for use across the EU, translators should be given clear instructions and the flexibility they need to adapt tone and style to different languages and cultures, so that plain language is preserved.

Legal considerations

A section of the guide is dedicated to the legal considerations of using materials written in plain language. Three main risks are highlighted. Materials could be seen as promotional or potentially coercive, that all content must be consistent with the summary of product characteristics and other public sources, such as scientific publications, to ensure accuracy, and that patients might mistakenly view these materials as a substitute for professional medical advice.

To address these risks, the guidance advises companies to use a neutral and non-promotional tone in patient materials, add clear disclaimers, and make it explicit that the information is not a substitute for advice from a healthcare professional.

The guide also looks at using generative artificial intelligence (AI) tools to help write in plain language. However, it points out that these tools can introduce errors, inaccuracies, or misinterpret medical terms. Because of these risks, it is essential for medical experts and plain language specialists to check all information created by AI. This human review helps make sure that the information is accurate and does not put patient safety or treatment adherence at risk.

Osborne Clarke comment

The EFPIA guide closes with a clear call to action for everyone involved. It encourages all stakeholders, regulators, healthcare professionals, patient organisations, and the pharmaceutical industry, to work together to build agreement on patient-centred communication. It also recommends that the regulatory framework should allow enough flexibility for companies to put these principles into practice, without undermining safety or compliance. Finally, it calls for a coordinated approach across the EU, so best practices can be shared and adapted, while respecting the different languages and cultures in each country.

The guidance is relevant to everyone who drafts, reviews, or oversees patient materials in medicines and medical devices. This includes teams working in regulatory and medical affairs, pharmacovigilance, patient engagement, corporate communications, legal and compliance, as well as regulators, health authorities, and patient organisations.

Pharmaceutical companies in the EU should review their patient-facing communications to make sure they are transparent, accessible, and clear.

Companies should consider adopting internal plain language policies, updating templates and approval processes, involving patients in the design and review of materials, and making more use of digital formats. 

Osborne Clarke can advise on putting these recommendations into practice within your organisation. Please contact one of our experts for further discussion and information on the guide and its implications for businesses and organisations.