The European Medicines Agency (EMA) is preparing the 
guidance on the impact of EU data protection legislation on the secondary use of health data in support of the development, evaluation and supervision of medicines.
TEDDY Network provided its contribution to the discussion paper, in particular stressing the importance to spend particular attention to the data collected from minors.
In order to gather input, from patients, consumers and healthcare professionals as data contributors as well as from medicines developers, EMA invited all the stakeholder to provide their contribution. The deadline to send any comments was 10 July 2020. This was a good occasion for TEDDY to underline the lack of specific provisions covering paediatric peculiarities in the rules introduced by GDPR, especially in the case of secondary use of data in international projects as well as the necessity of new overall governance of personal data processing for health research in order to reduce the risk of infringements of fundamental and child’ rights.
Moreover, TEDDY underlined the importance to use multiple databases to foster scientific research and suggested making specific reference to minors in different sections of the document, such as “Establishing the legal basis for processing personal data”, “Rights of the data subject” and “Transparency” .
It is possible to read the complete TEDDY’s consideration and comments to the Discussion Paper by clicking here.
