Building trust through transparency and communication
EU medicines regulation involves our partners in the Member States and other institutions and a range of stakeholders, from patients, healthcare professionals, academia, pharmaceutical companies and the broader public. They all rely on timely and trusted communication. Good communication and transparency go a long way to building trust in medicines regulation and public health.
In 2023, EMA provided European citizens with comprehensive information on medicines by publishing product information, European public assessment reports, as well as clinical trial data but also through direct patient, healthcare and industry outreach and proactive media engagement. Throughout the year, all of our communications activities supported the strategic priorities outlined in the European medicines network strategy to 2025 and the Regulatory Science Strategy to 2025.
Transparency: clinical studies in the EU
The Agency aims to be as open as possible about the data that informs the decisions it makes. This is why EMA became the first regulatory authority in the world in 2016 to give open access to clinical data that companies submit to support their marketing authorisation applications for human medicines.
One of the aims of this initiative was to build confidence in our decision-making processes. At the end of 2018, EMA temporarily suspended all new activities related to clinical data publication to ensure business continuity during the Agency’s relocation to the Netherlands. This suspension was lifted to allow EMA to respond appropriately to the COVID-19 pandemic as part of its exceptional transparency measures.
In addition to continuing publication of clinical data on COVID-19 related medicinal products, in September 2023, the publication was restarted in a phased approach, beginning with non-COVID medicines with new active substance (initial marketing authorisation applications).
As of early 2024, clinical data packages are being published on the clinical data website.
Publication of electronic product information
In 2023, the Heads of Medicines Agencies (HMA), the European Commission and EMA published for the first time electronic product information (ePI) for selected human medicines harmonised across the EU. Digital platforms open new possibilities to share this information electronically, keep it constantly updated and make it more accessible to end users, including patients and healthcare professionals.
The creation and testing of ePI in real regulatory procedures was explored through a one-year pilot initiative by HMA, the European Commission and EMA to enable the transition to the electronic system for medicines evaluated both nationally and at European level. The ePI initiative is an action under the Pharmaceutical Strategy for Europe supported by the EU funding programme EU4Health.
Patient, healthcare professional and industry engagement
Understanding the views of patients and their carers on the use of medicines through the work of the Patients’ and Consumers’ Working Party (PCWP), and their benefits and risks, is of great value for EMA and the network’s decision-making. In 2023, work intensified to increase the use of ‘patient experience data’ in medicines development and regulatory decision making.
2023 marked the tenth anniversary of the establishment of EMA’s Healthcare Professionals' Working Party (HCPWP). In June, the HCPWP plenary meeting brought together former co-chairs to reflect with all members on the past, present and future of the working party and set the foundation for its focus in the coming years.
“You are the EU model on stakeholder engagement. Thank you!”
The Healthcare Professionals Working Party
with
past and current co-chairs
The Industry Standing Group (ISG) continued to provide a platform for the regular exchange of views, promote dialogue and receive feedback from industry stakeholders on issues of strategic interest related to human medicines within the European legal framework and facilitate implementation of the European Commission’s new legislative proposals.
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Read more about our engagement with stakeholders in the ‘EMA’s stakeholder engagement report for 2022-2023’
Relaunch of EMA's website
As EMA's primary communication channel, and a first point of contact for many, the corporate website is a comprehensive source of information and guidance on centrally authorised medicines and on medicines regulation in the EU. In 2023, the website underwent a major revamp, providing people with a trusted platform for information on medicines, with clearer navigation and a revamped ‘what’s new’ page.
Proactive media engagement
Our interactions with broadcasters, print journalists and online reporters is crucial to ensuring scientific information finds its way into the public domain. In the aftermath of the pandemic, with vaccine technologies and medicines shortages still in the headlines, there was high demand for EMA experts and their insights.
In 2023, we built on the proactive media strategies we adopted during the pandemic to keep media informed about EMA decisions and developments in medicines regulation. On any given day, EMA’s press team handled detailed requests from a range of media – specialist, local and international – all in search of reliable scientific information.
In 2023, EMA’s press office responded to 1,100 media queries and organised 35 interviews with media.
Alongside key news announcements throughout the year, in 2023 we collaborated with other EU agencies and the European Commission to co-ordinate additional public health updates. These included the state of respiratory diseases and treatments in the EU at a joint press briefing with the European Centre for Disease Prevention and Control (ECDC) in September, and the Union critical list of medicines in November.
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Watch videoJoint EMA-ECDC press briefing on current state of respiratory diseases and treatments in the EU/EEA
COVID-19: lessons from a health crisis
In December, a joint report issued by EMA and HMA reviewed the network’s response to the COVID-19 pandemic and highlighted the main learnings for any future health crises. Areas where lessons learned have been identified include transparency, stakeholder engagement and communication.
New approaches to social content
As the influence and impact of social media grows, so too do our efforts to engage audiences with new types of content about medicines regulation. In 2023, the Agency created high-quality and engaging audiovisual material in formats that resonate with different audiences and across platforms: from simple explainer videos that break down complex topics, to live expert interviews and campaigns on high priority public health issues.
We actively use three social media channels: LinkedIn, Instagram and X (former Twitter). X is mainly used to connect with journalists to publish and share the latest news. Increasingly, LinkedIn has grown as a channel that can connect EMA to healthcare, research, technology and academic audiences. A LinkedIn influencer account for EMA’s Executive Director now attracts over 22,000 followers. EMA’s corporate account has over 200,000 followers. To ensure better engagement with its audiences, EMA organised three LinkedIn Live interviews in 2023: one through a partnership with Linkedin News Europe on RNA technologies, and two on EMA’s own Linkedin page covering the first anniversary of DARWIN EU and veterinary medicines. All three sessions featured EMA experts addressing audience questions in real time.
Social media also allow us to proactively respond to public health issues. We ran short campaigns on antibiotic shortages and how to buy medicines safely online.
LinkedIn Live interview with Ivo
Claassen:
Tomorrow’s veterinary medicines for healthy animals and humans
Perception of EMA communication
In 2023, EMA published the results of its fourth communication perception survey, which was carried out in September 2022. According to the survey, 93 % of respondents value EMA’s communication as ‘important’ or ‘indispensable’.
EMA’s communication materials are mostly disseminated internally within respondents’ organisations (82 %), or externally through social media (36 %) or the organisations’ websites (34 %).
“My experience says that EMA is really open and transparent. I have been using EMA’s communication materials for many years. EMA’s communication is also honest and timely”.