April 17-18

By Jose Drabwell

I was glad to attend the meeting organised by the European Medicines Agency (EMA) for the patients and consumer organisations as well as for healthcare professionals in London on April 17-18.
The EMA is monitoring closely the European Commission’s actions in placing digital at the core of its strategies, which should allow for better connection and sharing of health data for research across borders and faster diagnosis through a decentralised European digital health infrastructure. Real world evidence is becoming more important to understand the long-term consequences of medicines taken by patients with chronic diseases.
The importance of common terminologies, quality control and shared standards was also discussed, and special focus was given to the registries. An action plan to improve electronic product information will be developed in collaboration with patients, consumers, healthcare professionals, industry and academics. The aim of such plan will be to improve the information provided to patients and consumers on their medicines.

The second day of the meeting commenced with an update on the relocation of the EMA to Amsterdam which will bring some consequences. Reduced activities, uncertainty about the number of staff relocating and the need to recruit new staff were some of the identified issues.  Other topics discussed during the second day:

• European Immunisation Week: as part of the World Health Organisation global immunisation week, the EMA launched a video to promote immunisation and increase awareness amongst the general public. IPOPI leaflets on vaccines were shared amongst participants.
• Increasing transparency in clinical trials on the basis of the European legislation. The legislation foresees the creation of a new EU clinical trials’ portal, so the submission of the data by companies and the access to the information by researchers and public can be eased. There are aspects such as the IT system that will be used and the anonymisation of data that are still being discussed.
• Access to medicines in a context of possible risk of shortages due to Brexit, supply chain disruption and communication. A task force was created, composed of EMA and the national medicines agencies, to discuss and address these challenges.
• EMA collaboration with the European network for health technology assessment (EUnetHTA) on engagement with patients and healthcare professionals in assessment activities of health technologies.