The evaluation of the EU legal frameworks on blood, tissues and cells found that the majority of the respondents consider that the legislation had made blood, tissues and cells safer in the EU.
However, they also find that the legislation is not up-to-date with scientific, technological, epidemiological or societal developments and that the process of updating is not flexible or quick enough to adapt to them. They also believe that some requirements might be missing or are inadequate, among them:
- Inadequate provisions for the protection of the living donors;
- Lack of requirements to ensure quality of blood, tissues and cells, as opposed to safety;
- Lack of demonstration of safety and efficacy in the recipient;
- Absence of provisions for ensuring sufficiency of supply.
To read more about this on the European Commission website, go to: http://ec.europa.eu/newsroom/sante/newsletter-specific-archive-issue.cfm?archtype=specific&newsletter_service_id=327&newsletter_issue_id=8412&page=1&fullDate=Mon%2023%20Apr%202018&lang=default