World Patient Safety Day 2023 - Engaging patients for patient safety

I always say that the patient is key to all we do at EMA. This is particularly true when it comes to the crucial role that patients play in ensuring the safety of medicines.

This year for World patient safety day, the World Health Organization invites us to think about how we can give patients, their families, and communities the opportunities to raise their concerns, expectations and preferences in order to advance patient safety. As medicines regulators, we believe it is important to provide platforms and structures which give patients a voice in the medicines’ evaluation and supervision process.

Patients ?have been formally represented in most EMA scientific committees starting over 20 years ago, and most notably in our safety committee the PRAC (Pharmacovigilance and Risk Assessment Committee ). Two patient representatives sit permanently on the PRAC. The PRAC regularly reaches out to patients’ representatives to discuss risk minimisation measures and to help review our safety communications.? These reviews are a key step in ensuring that the messages are clear and relevant to patients and consumers of medicines.

EMA monitors the safety of medicinal products at every stage of their lifecycle from pre-submission activities throughout the regulatory assessment and during post-authorisation monitoring. We engage with patients and patient organisations across a wide range of disease areas and representing diverse patient groups, to obtain relevant input for each of the different phases. Understanding patients' perspectives and involving them closely is essential to the Agency's safety work.

Before a medicine can be approved for use its benefits and risks are evaluated, and the medicine is only authorised if the benefits outweigh the risks. EMA typically involves patients in the benefit/risk discussions through scientific advisory groups where individual patient experts are invited to discuss specific questions.

When appropriate, members from patients’ and consumers’ organisations may act as experts for the (Invented) Name Review Group (NRG) which performs reviews of the names of medicinal products being assessed. The group's main role is to consider whether the name proposed by a product's manufacturer, and under which the medicine is marketed and sold, could create a public-health concern or potential safety risk. This helps avoid medication errors.

Medicines are generally safe when used appropriately, but all medicines also have risks. Adverse events may result from a wide variety of factors. The collection of reports of suspected adverse drug reactions is one of the pillars of the EU safety monitoring system. The Agency works with patient organisations to channel awareness and encourage reporting . If a person experiences a side effect, this should be reported to a healthcare professional or the competent national authority. Everyone has a role to play in keeping medicines safe.

EMA has always had a strong culture of stakeholder engagement and patients are the drivers for many of our activities. During the COVID-19 pandemic, open dialogue and proactive engagement with patients and consumers became more important than ever. Thanks to public stakeholder meetings we were able to gain insights into the concerns of specific groups of patients. Patients were the voice of civil society in EMA's Emergency Task Force. They helped us meet the specific information needs of certain patient groups and brought public health messages to communities to support the safe and effective use of treatments and vaccines.

I invite patient representatives and organisations to participate in our dedicated training programme to help them engage in regulatory activities. Patients can also register their interest in working with EMA and join our patient database if they are interested in becoming advisers themselves. We are committed to ensuring that patients continue to be involved at all levels , from representation in governance structures such as our Management Board to their participation in discussions on risk minimisation measures and review of safety communications.

To find out more about the Patients' and Consumers' Working Party (PCWP) watch the video