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E.U. Begins Blood, Tissue and Cell Regulations Update

Public comments are being accepted via online questionnaires through April 15.

Cord blood banks in Europe are encouraged to submit comments to the E.U. Commission as it begins an assessment and update of directives for human blood, tissues and cells. The current directives are more than 16 years old. The Commission wants to propose new directives by the fourth quarter of this year.

In comments submitted early this month, the Cord Blood Association is urging the E.U. Commission to:

European-Commission-logo

  • harmonize cord blood and perinatal tissue banking regulations that currently vary from country to country throughout the European Union
  • achieve regulations that are specific to cord blood and perinatal tissue banking and that don’t place banks under regulations developed for solid organ transplants or blood transfusion
  • expedite the regulatory approval of birthing tissue-derived advanced therapy medicinal products (ATMPs), without sacrificing safety and quality.

Coordinated Initiative

CBA-member banks in Europe have organized a task force that is coordinating interaction with the E.U. Commission. Chairing the task force is Wolfgang Knirsch, PhD, chief executive officer of Vita 34 AG based in Leipzig and a member of the CBA Board of Directors.

The European Section task force has retained a lobbying firm to assist with its government relations, prepared the association’s responses to the Commission’s online questionnaires, and is seeking an early meeting with Commission representatives.

Many banks throughout Europe have been contacted with information on how to provide their own comments to the Commission by the April 15 deadline. The task force is also contacting other health care organizations, cord blood patient and donor organizations, companies that provide products and services to cord blood and perinatal tissue banks, and key opinion leaders.

The overall objective is to achieve harmony throughout Europe for the rules and regulations that promote quality and safety for cord blood and perinatal tissue products and services. Among the tools that CBA representatives will be using are Model Criteria for Regulation of Cord Blood Banks and Cord Blood Banking, developed by the association’s Government and Global Affairs Committee. The model criteria were prepared by representatives of banks from 15 countries over a period of 18 months and published in STEM CELLS Translational Medicine. 

Two Questionnaires

Any interested organization or individual can submit recommendations to the E.U. Commission via two online questionnaires – a Public Consultation Questionnaire for all interested parties, and a Targeted Consultation Questionnaire for stakeholders. Responses can be submitted for either or both.

The questionnaires are somewhat lengthy and tedious. Many of the questions do not pertain specifically to cord blood and tissue banking, so a “No response” or “N/A” answer is frequently appropriate. CBA’s responses to the questionnaires have been posted online and can be used as a guide: 

        CBA Public Questionnaire Response

        CBA Targeted Questionnaire Response

Association leaders have been advised that a robust response from the cord blood and perinatal tissue banking community can be beneficial as the development of new directives moves forward.