E.U. plans blood, cell, tissue regulations update

European Commission is seeking public comments through Dec. 14.

The European Commission has announced a plan to update its directives for the regulation of human blood, tissue and cell donation, collection and testing.  The current directives have been in place for 16 or more years.

The Commission is proposing to either European-Commission-logo(1) coordinate and strengthen quality and safety regulations at the national level in the 27 EU countries, or (2) create EU-level standards and audits administered by the European Directorate for the Quality of Medicines & Healthcare (EDQM), or (3) seek EU legislation for safety and quality.

The premises stated by the Commission are:  

  • patients currently are not well protected
  • country-to-country variables in regulations are detrimental to safety and quality
  • donors have avoidable risks
  • current regulations lag behind therapeutic innovations
  • the supply of therapies is vulnerable to interruptions

Specifically mentioned in the Commission’s announcement is “the banking of umbilical cord blood for family use.”  One of the issues that has prompted the Commission to move at this time is concerns about the safety of convalescent  plasma used to treat COVID-19.

The Commission says that it will undertake a comprehensive assessment of blood, tissue and cell regulations in the first-through-third quarters of 2021, and issue its recommendations in the fourth quarter.

The European Commission opened a period for public comment through Dec. 14.