Why Does the Precautionary Principle Suffice for Blood Regulation?

Area of Science:

• Transfusion Medicine
• Regulatory Science
• Immunology

Background:

• Traditional blood product regulation prioritizes zero-risk for viral transmission, often reacting to past tragedies like HIV and Hepatitis C outbreaks from factor VIII concentrates.
• Current haemovigilance for general adverse events is inconsistent, hindering robust benefit-risk assessments for blood products.
• The efficacy of many blood products has not been systematically studied, complicating regulatory evaluation.

Purpose of the Study:

• To highlight the need for objective efficacy measures and formal benefit-risk analysis for convalescent plasma (CP), particularly in the context of COVID-19.
• To emphasize that assessing CP requires moving beyond infectious agent screening to include efficacy and quality attributes.
• To argue for an updated regulatory philosophy for blood products to accommodate novel therapeutics like CP.

Main Methods:

• Review of traditional blood product regulatory principles and haemovigilance systems.
• Analysis of the specific challenges in evaluating convalescent plasma (CP) as a therapeutic agent.
• Identification of key adverse events (TRALI, TACO) and quality attributes (antibody titre) relevant to CP assessment.

Main Results:

• Traditional regulatory frameworks are insufficient for evaluating novel blood products like CP.
• Objective efficacy data and defined quality attributes are essential for a scientific and ethical benefit-risk assessment of CP.
• Established adverse events like TRALI and TACO must be considered alongside efficacy and quality.

Conclusions:

• A paradigm shift in blood product regulation is necessary to incorporate efficacy and quality assessments.
• Formal benefit-risk analysis for CP requires robust data on both safety and therapeutic effectiveness.
• Defining product quality attributes, such as antibody titre, is critical for the successful implementation of CP therapy.