The European Medicines Agency (EMA) is requesting more often and more deeper collaboration with European level patient organisations such as EFA. In the last quarter of 2023, the agency held several meetings that involved EFA representatives to the Patients and Consumers’ Working Party, Isabel Proaño (Director of Policy) and Erna Botjes (President of EFA Dutch Member Stichting Voedselallergie).
EMA early contact with EFA on chronic hand eczema
In September, EFA conducted a targeted consultation with members active on atopic dermatitis to respond to a request from EMA on patients views on chronic hand eczema. This process, labelled “early contact with patients organisations” by the agency, started a few years ago with the aim to provide members of the EMA Committee on Human Medicinal Products (CHMP) with patient and careers considerations, to assess the benefits and risks of a medicine which has been submitted to market authorisation in the EU.
While EFA’s reply to EMA remains confidential, we value the opportunity to consult our community on key issues related to a disease and living with that disease, that patients expect to be addressed by new technologies entering the market.
EMA Joint PCPWP-HCPWP in November
In November, EFA actively participated in the two days joint meeting of the EMA working parties with patients and consumers and healthcare professionals. The topics discussed were tightly linked to the current legislative developments around (digital) health data (presentation), as well as on the implementation of the EU Health Technology Assessment Regulation (HTAR) (presentation).
The meeting also served to know more about agencies work on:
- the establishment of the Union critical medicines list, which is meant to anticipate/avoid shortages of key medicines and be better prepared to respond to health crisis
- the upcoming EMAs report on the lessons learnt from COVID;
- social media as a means to counter misinformation and disinformation.
The full meeting agenda and supporting documents are available in the European Medicines Agency website.
EFA participation in the HMA/EMA Big Data Stakeholder Forum 2023
In December, EFA participated in the fourth annual HMA/EMA Big Data Stakeholder Forum. Understanding when to have confidence in novel technologies and the evidence generated from Big Data benefits public health by supporting medicines development, improving treatment outcomes, and facilitating earlier patient access to innovative treatments. As such, this year’s edition of the Stakeholder Forum focused on the work of the Big Data Task Force, and topics related to the value of Real-World Evidence (RWE), novel technologies and methods driving changes in evidence generation, with keynote speakers from the EMA, patients and healthcare professionals’ representatives, payers and industry representatives, as well as academia.
For EFA’s work, the focus on the Patient Experience Data (PED) and its potential in EU medicine regulation was particularly interesting, as the inclusion of PED is detrimental in developing a pharmaceutical framework which is patient centric, and enhancing the impactful use of PED will lead to better patient outcomes.
EMA European Network of Paedriatic Research annual meeting
In October, EFA participated in the European Network of Paedriatic Research (Enpr) meeting which served to take stock of the advancements during the year. The network is composed mostly by clinicians and researchers while there is some patient representation. Their focus is addressing research questions that are specific to child patients, such as involvement of children in trials, retention of young patients in research, and the role of different professionals involved to enable research.
The full meeting agenda as well as information on the work of the Enpr is available in the European Medicines Agency website.