Edition of 26 February 2021

The proposal for a Regulation on European data governance (Data Governance Act) is the first of a set of measures announced in the 2020 European strategy for data, aiming to create a single market for data that will boost Europe’s global competitiveness and data sovereignty. The instrument aims to foster the availability of data for use by increasing trust in data intermediaries and by strengthening data-sharing mechanisms across the EU. Setting up a new European approach to data governance aims to facilitate data sharing across sectors and Member and boost the development of trustworthy data-sharing systems, providing better healthcare, improving personalised treatments, helping cure rare or chronic diseases.

The public consultation on the European strategy for data ran from 19 February to 31 May 2020. The objective of the consultation was to collect views/opinions on the European strategy for data and to obtain input for several planned initiatives related to the access to and re-use of data, including notably a legislative framework on common European data spaces and an implementing act on a list of high-value datasets. The consultation targeted all interested stakeholders from the public and private sectors, including governments, local authorities, commercial and non-commercial organisations, experts, academics and citizens and received 806 contributions.

The report of the key highlights of the public consultation has been published on the European Commission website. This report revealed that 97,2% of respondents confirmed the need for an overarching data strategy to enable the digital transformation of society, 90% of the respondents considered that data governance mechanisms are needed to capture the enormous potential of data, and 91% of the respondents considered that standardisation is necessary to improve interoperability and ultimately data re-use across sectors. Concerning specific questions about high-value datasets, 82,2% of respondents considered that the establishment of a list of high-value datasets is a good way to ensure that public sector data has a positive impact on the EU’s economy and society. The respondents considered the availability of datasets under uniform conditions across the entire EU as a relevant or very relevant factor to be taken into account when defining high-value datasets, the dataset’s availability via an application programming interface 5API), and the dataset’s availability free of charge.

This public consultation was part of a broader stakeholder consultation process that will contribute to the preparation of several data initiatives, including a legislative framework on the common European data spaces and an implementing act on a list of high-value datasets, expected in 2021.

International legislation, policy reports, youth health strategies, such as the World Health Organization with “The European child and adolescent health strategy 2015– 2020”, and medical societies have recognised the importance of participation of children, and more particularly adolescents, in decisions affecting them.

According to the Council of Europe Strategy for the Rights of the Child (2016-2021), children have the right to be heard and participate in decisions affecting them, both as individuals and as a group. Moreover, according to the United Nations Convention on the Rights of the Child (UNCRC), children are rights-holders with a progressively evolving ability to make their own decisions. The European Convention on Human Rights and Biomedicine of the Council of Europe (1997) also stated that the opinion of the minor shall be taken into consideration as an increasingly determining factor in proportion to his or her age and degree of maturity.

However, there is uncertainty as to how the increased recognition of their decision-making capacity concerning their health and general wellbeing should be addressed. As stated in the Strategic Action Plan on Human Rights and Technologies in Biomedicine (2020-2025), finding the right balance between protection and autonomy conceptualised as “the child’s right to an open future” is a challenge when considering that children’s rights are situated within a larger set of parental rights and responsibilities which also focus on their best interests. Despite the legal recognition of children’s participation rights, with discrepancies in national laws regarding the recognition for minors of a right to participate in treatment and research decisions, there is evidence that legislation is not always translated into healthcare practice. 

In this context, the Council of Europe launched an initiative on children rights participation in decision making in the biomedical field to define how the increased recognition of their decision-making capacity should be addressed. This initiative includes a survey aiming to identify practices in areas that need specific considerations, such as rare diseases and advanced therapies in order to develop a guide, dedicated to healthcare professionals and accessible to the children’s parents and legal representatives, to good practice concerning the participation of children in the decision-making process on matters regarding their health. This guide will include consideration of the rights of the child, the rights and responsibilities of the child’s legal representatives, and the child’s interests interconnected with those of their family members.

The Orphanet nomenclature is a multilingual, standardised, controlled medical terminology specific to rare diseases, that includes all clinical entities registered in the Orphanet database (www.orpha.net). Each clinical entity (disorder, group of disorders, or subtype of a disorder) is associated with a unique numerical identifier named ORPHAcode, as well as a preferred term, synonyms, and a definition.

In order to facilitate the informatic access to nomenclature data and allow flexible implementation into the various IT systems in use in the different countries and/or settings, web-based applications development by Orphanet was foreseen during the RD-Code project, co-funded by the European Union’s Third Health Program. Application Programming Interface intends to support Member States in the implementation of the ORPHA nomenclature to rare diseases-specific codification systems.

In this context, the Orphanet Data visualisation tool (https://dataviz.orphacode.org/) was delivered in December 2020, allowing to search for the clinical entities (groups of disorders, disorders, sub-types) that are present in the nomenclature pack (here) in all the Application Programming Interface languages.