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 regulation will now be signed by both the Council and the European Parliament. It will then enter into force following publication in the EU’s Official Journal.
Useful links
Council of the EU Press Release – here.
Text of the Regulation – here.
EU Health Policy background information – here.
On April 24, 2024, the European Parliament adopted the European Health Data Space (EHDS). With 445 votes in favour, 142 against and 39 abstentions parliamentarians endorsed the provisional agreement between the Parliament and Council negotiators in mid-March.
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 Council will now formally adopt the new European Health Data Space regulation which is expected to be published in the Official Journal in autumn. 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
The European Commission released its pharma legislation proposal in 2023 to make access to medicines more secure and affordable, encourage innovation, and reduce the gaps.
One of the key changes it proposed was to shave two years off the amount of time new branded medicines have to themselves on the market before rivals launch, down from the current eight years to six.
The newly voted in the EP text bumps that up to seven and a half years of regulatory protection, with a cap of one extra year for those that qualify.
The Parliament’s directive proposal also includes new incentives not listed in the Commission’s original text: six more months of data protection for medicines in which “significant development, including clinical and preclinical” was carried out in the EU; or for where development was done in collaboration with university hospitals, centres of excellence, or bioclusters.
Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance)
Access the official text here https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2282