In February 2022, the European Medicines Agency (EMA) updated its Engagement Framework on relations with patients, consumers and their representing organisations concerning medicines for human and veterinary use. The objective of the framework is to ensure that the patient voice is included in a medicine’s lifecycle’s regulatory activities, with a view to improving the trust in the regulatory decision-making and in medicines placed on the EU market.
EMA, its management Board and its Scientific Committees have a responsibility to strengthen engagement with patients and consumers and define the framework for providing them with clear and useful information. EMA also acknowledges the necessity to further develop patients’ capacities, including training and other support measures.
Patient engagement within EMA activities has proven to have many positive effects on transparency and trust in regulatory processes. It also increases mutual respect between regulators and the community of patients and consumers, while informing patients on the safe and rational use of medicines. EMA also acknowledges that patient contribution complements and enriches the quality of the opinion given by the scientific committees and working parties during the evaluation of medicines.
A report on stakeholder engagement will be presented to the EMA Management Board on a regular basis, complemented by a biennial satisfaction survey among patients and consumers contributing to EMA activities.
The diabetes community considers it essential to engage people living with diabetes (PwD) in the regulatory activities of a medicine’s lifecycle in a knowledge-based, fully informed and meaningful way.
According to João Manuel Valente Nabais, IDF Europe representative at the Patients and Consumers Working Party, European Medicines Agency, ‘The input of people living with diabetes is a key added value to the discussions and recommendations provided by EMA as they are the end users of newly authorised medicines and technologies.’ Prof. Nabais regards EMA’s stakeholders’ involvement as an example of best practice on how to engage with health NGOs and increase patients’ voice in a range of decision-making processes.
Diabetes is a chronic disease and its life-long, relentless self-management makes people living with diabetes true experts in the management and care of their condition. IDF Europe and the diabetes community welcome this co-decision process in the development and evaluation of medicines and look forward to ongoing collaboration in the future.