On January 21 2025, the Council of the European Union adopted the European Health Data Space (EHDS).
Background
This groundbreaking initiative, put forward by the Commission in May 2022, has two main aims:
- to place citizens at the centre of their healthcare, granting them full control over their data, to achieve better healthcare across the EU;
- to allow the use of health data for research and public health purposes, under strict conditions.
Thanks to the new rules, citizens will benefit from immediate and simple access to their digital health data when in the EU, regardless of their location. For instance, when a patient seeks healthcare abroad, healthcare professionals will be able, when necessary, to access key information from the patient’s home Member State. This will improve evidence-based decision-making, reduce repetition of tests and examinations and enhance patient care.
The EHDS also establishes a strong legal framework for the re-use of health data for research, innovation and public health purposes in full compliance with strict EU data security and access criteria, fundamental rights and cybersecurity rules. The data will help develop life-saving treatments and personalised medicines and improve European crisis preparedness.
Next Steps
The new European Health Data Space regulation will be published in the Official Journal. It will then become applicable in different stages according to the use case and data type.
For More Information
EHDS Press Release
EHDS Factsheet
Source: European Commission
On 14 October 2024, the Council of the European Union has formally adopted the agreement on the European Disability Card, which aims to enhance mobility for people with disabilities across the EU. This is a positive development for Europeans living with a rare disease, many of whom are affected by a related disability.
The new rules will establish an EU-wide disability card to ensure that persons with disabilities have equal access to preferential conditions, such as reduced or zero entry fees, priority access, and access to reserved parking. As outlined in the adopted text, individuals participating in mobility programmes such as Erasmus+ and third-country nationals.
The European Disability Card will be issued in physical format and, when available, in digital format, and will be issued and renewed free of charge. Depending on the country, costs could be charged for loss and damage to the card.
Next steps
Member States are to implement the directive by 5 June 2028.
Read more here
On Monday, May 27, 2024, the European Council adopted new rules on substances of human origin (SoHO).
The regulation on substances of human origin (SoHO) will ensure better protection for donors and recipients, as well as for children born following medically assisted reproduction. The new rules aim to strengthen the existing legal framework while also increasing flexibility in order to keep up with scientific and technical developments.
Voluntary and unpaid donations
Member states will be able to compensate living SoHO donors, following the principle of voluntary and unpaid donation and based on transparent criteria, including fixed allowances or through non-financial forms of compensation. The conditions for such compensation will be established in national legislation.
Promotion and publicity activities in support of SoHO donations (for example, campaign billboards or posters, television, newspaper or magazine advertisements) must not refer to compensation. National authorities will therefore have to ensure that compensation is not used as an incentive to recruit donors.
Safeguarding supply
EU countries will establish and regularly update “national SoHO emergency plans”, setting out measures to ensure the security of supply for critical substances.
Next steps
The SoHO Regulation will come into force three years after its publication in the Official Journal of the European Union. The new rules will facilitate the cross-border exchange of SoHO in the EU, improve patients’ access to necessary treatments in all Member States, and promote greater cooperation between national public health authorities.
Useful links
Council of the EU Press Release – here.
Text of the Regulation – here.
EU Health Policy background information – here.
Formally inaugurated on April 24, 2024, the Critical Medicines Alliance (CMA) was officially launched the next day in Brussels. The EHC, represented by Daria Camilli, Communications and Education Manager, participated in the closed-door launch together with the representatives of other members of the CMA as well as the European authorities.
The full member list can be found here.
Background
This Critical Medicines Alliance is a new consultative mechanism bringing together national authorities, industry, civil society, the Commission, and EU agencies to identify the best measures to address and avoid shortages of critical medicines. It complements regulatory measures in the proposed EU pharmaceutical reform and is at the centre of the new strategic and coordinated industrial approach to enhance the security of supply of the most critical medicines.
The work of the Alliance will focus on critical medicines that face the greatest vulnerabilities, based on the ongoing Commission vulnerability analysis for a sub-set of substances listed on the Union list of critical medicines, first published by the European Medicines Agency (EMA) in December 2023.
More about CMA here.
Next steps
The Alliance will use the outcome of the pilot assessment of critical medicines
as a point of reference
➔ As of May, members of the Alliance will collaborate in thematic Working Groups
➔ Throughout Q4 2024, the Working Groups will make recommendations
based on the identified vulnerabilities
➔ By the end of 2024, the Steering Board will come forward with a Strategic
Plan, which the Alliance Forum will consider and endorse
➔ This plan will establish a multi-annual set of actions aimed at guiding the
work of EU decision-makers
➔ The initial mandate of the Alliance is of 5 years
Further reading
More about the CMA on the EC website here.
Union list of critical medicines here.