Pharmaceutical companies, in accordance with the European Directive for Medicinal Products for Human Use, are required to have a scientific service responsible for their medicine-related information [1]. They are permitted to send correspondence, possibly accompanied by non-promotional material, to answer a specific question about a particular medicinal product [1]. Medical Information services are well established within pharmaceutical companies, and are expertly placed to answer enquiries from patients, caregivers and members of the general public (MOPs) as well as healthcare professionals (HCPs). Responses are developed by appropriately qualified staff who follow well-defined procedures, codes of practice and regulations. As such, they serve as reliable sources of medicine-related information.

Medical Information Leaders in Europe (MILE) is an industry association founded in 2018—it has an ultimate goal to advance access to trusted medicine-related information. Membership is open to all pharmaceutical companies that hold marketing authorisations for the use of human medicinal products in Europe. The MILE association works to share knowledge and best practice around the function of Medical Information by facilitating collaboration, raising standards and simplifying access to appropriate information.

To improve the quality of the patient experience and build further confidence in the pharmaceutical industry, MILE collated and published a framework of best-practice principles for handling unsolicited requests for medicine-related information from this subset of enquirers. These principles are summarised below and accessible on the MILE website [2]. For the purposes of this article and the related MILE principles, the term ‘patient’ collectively includes patients, caregivers and MOPs.

Over the years, patients have developed an increasingly active interest in their medical care and treatment choices, seeking information beyond what can be obtained during their face-to-face consultation with their treating healthcare professional (HCP) or from the approved Patient Information Leaflet (PIL) accompanying their prescribed medicine. While many patients have a good understanding of their clinical condition and treatment options, health literacy can vary. The increasing complexity of modern medicines and treatment protocols can also prompt further medical questions.

A 2023 UK survey of over 2000 patients highlighted some limitations regarding the current PILs [3]. While 93% reported that they read the PIL when a new medicine was first prescribed for them, less than 10% do so for a repeat prescription and potentially miss important updates. Furthermore, 68% did not completely understand the PIL, 55% cited readability issues (e.g., text size, quantity and relevance) and 27% raised comprehension concerns (e.g., use of technical language). With delays in accessing healthcare, time-limited appointments with their HCPs, and frequent concerns regarding the readability and understanding of the PILs, patients are looking to alternative sources to meet their medicine-related information needs.

Patient associations play an important role in supporting and listening to patients, facilitating their involvement in the early stages of pharmaceutical research and development and improving access to high quality health-related information. Although patient associations are a reliable source of advice, the scope of support does not focus on individual prescribed medicines and not all patients reach out to them [4].

The scale and scope of medicine-related information needs of patients is not precisely known. However, an extensive European community survey on the use of Information and Communication Technologies has tracked and reported health information seeking behaviours [5]. The 2020 survey identified an increase in the proportion of citizens across the European Union (EU) who had sought health information online (the survey considered activity within a three-month period)—activity increased from 34% in 2010, to an estimated 55% in 2020. Significant diversity between countries was also noted, with over 70% activity in Finland, Netherlands, Norway and Denmark but less than 30% in Bulgaria and Romania. While the UK was not included in the EU report, data from the same study demonstrated an increase in activity from 32% in 2010 to 63% in 2020 [6].

The internet and social media have facilitated widespread access to health- and medicine-related information for patients. However, the extensive volume of information from multiple sources (which may not always be accurate or reliable) can lead to anxiety, confusion, poor treatment compliance, and strain the relationship between patients and their HCPs rather than improve their health literacy or foster a collaborative relationship [7]. Similarly, a systematic review has demonstrated that online information can adversely impact the relationship between patients and physicians, as well as undermine trust in doctors due to the low quality of online health information and limited physician–patient communication time [8]. This can also affect patients' beliefs about medicine usage and negatively influence adherence to their treatment [8].

Misinformation (false or inaccurate information) and disinformation (deliberately misleading, biased or manipulated information) has been recognised globally as harmful to patient care, especially during infectious disease outbreaks and disasters [9]. Patients can experience challenges in differentiating trustworthy sources from misinformation and disinformation [10]. Patients, especially those with low health literacy, may also lack awareness of the importance of carefully evaluating online information [11]. Artificial intelligence (AI) tools have been progressing in recent years, but it is recognised that they do not currently provide reliable responses to medicine-related questions and caution is advised [12].

Article 98 of the European Directive 2001/83/EC relating to the regulation of medicinal products for human use defines that pharmaceutical companies must have a scientific service responsible for their medicine-related information [1]. Most companies achieve this legal requirement with a non-commercial Medical Information service which provides professional enquiry responses. Importantly, Article 88 of the same Directive prohibits the promotion of prescription medicines to the public and Article 86 clarifies how answers to specific questions about medicines are not considered to be advertising [1].

The European Medicines Agency (EMA) also requires all medicines to be supplied with package insert for patients and users—this is commonly known as a PIL. These PILs are formally approved within the marketing authorisation process and must be in line with the standard EMA-Quality Review of Documents (QRD) template—this defines the content and supports their linguistic clarity and accuracy [13]. This template also requires the inclusion of a standard statement ‘For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder’, and provides the relevant company name, address, telephone number and email address. Typically, the contact details for the Medical Information service are provided. However, while such PILs are user-tested for readability and include practical information, as highlighted above, they are not always referred to and some questions remain unanswered [3].

The European Federation of Pharmaceutical Industries and Associations (EFPIA) also clearly recognise the need to improve access to quality medicine-related information for patients, and this is included in their regulatory innovation publication [14]. The EFPIA is working with Regulators and HCPs to actively support and advocate the implementation of electronic product information (ePI) including the electronic patient information leaflet (e-PIL).

From a national self-governance perspective, approximately half of the member associations of the pharmaceutical industry within Europe include standards for interactions with patients within (or linked to) their ethical codes of practice; however, there is very limited consideration of the Medical Information service aspects [15].

MILE have considered the various regional regulations and codes of practice during the development of the best practice principles for handling unsolicited requests for medicine-related information from patients.