Introduction

Blood transfusion has been essential and critical to healthcare for at least a century, while organ transplantation has developed over the past fifty years to become a mainstay of the therapy for end stage organ failure with more than 120,000 transplants performed each year.  Tissue (excluding blood and organs) and cell therapies also are increasing in numbers and applications. The need for these products to be donated, while maintaining quality and safety, have harmonized some of the approaches for MPHO safety and efficacy. Availability of MPHO has been a constant challenge, with some products being scarcer than others. Patients are dying on waiting lists for organ transplantation, women are crossing national boundaries to gain access to assisted reproductive therapy with donors’ oocytes, and corneas are sent often to other continents where eye banks have not been developed. Wherever severe shortages of life-saving MPHO exist (as with human organs in many parts of the world) exploitation and human trafficking have occurred.  The transplant community rejects such activity and has joined to formulate the Declaration of Istanbul delineating the fundamental principles for ethical organ donation and transplantation. There are multiple quality, safety, availability and ethical issues associated with the retrieval and use of MPHO. 

Donation is a recognized civic gesture and national organizations are striving towards an equitable burden of donation to achieve self-sufficiency. MPHO donation as a voluntary activity, free of coercion and exploitation is a recognized objective for WHO.  The definition of self-sufficiency is not strict and can vary from local to national, regional, or even global needs.  It depends on MPHO-specific criteria, including preservation limits, extent of processing, compatibility constraints, emergency needs, and other responsibilities. Throughout the expansion of MPHO availability and use, governments maintain responsibility to the public that the MPHO are safe and effective.  Despite the universal recognition that coercion and exploitation of people is best avoided through voluntary donation, MPHO availability practices continue to vary across the globe, some even using compensation.  During the early expansion of MPHO development, a tradition to compensate live donors (including blood and reproductive tissue) was commonplace. Despite the recognition that compensation introduces ethical and product safety concerns, payment for some plasma products and semen is still permitted to ensure availability. 

However, irrespective of source and whether the donation was truly voluntary, national governments are responsible for ensuring that the MPHO product for clinical application meets quality and safety standards through effective oversight.

There are significant concerns for effective governmental oversight of MPHO.  All MPHO start with a donation, but the diversity of living or deceased donation events, and the volume of products resulting from processing or manipulation, creates complexities for governmental agencies.  The public needs assurance that an adverse event for a specific recipient was not the result of quality or safety errors in the retrieval and release of the MPHO, or that if there is a safety concern, others receiving a MPHO from the same donor can be quickly identified and, where necessary, treated.  The challenges across the spectrum of MPHO are prodigious.

In the same way that blood transfusions have progressively become regulated and standardized through testing and quality oversight, effective use of all MPHO will require the same approach for their acquisition, use and distribution. It may be perceived that all MPHO are of high quality and safely provide the purported benefit, but that is not universally verifiable nor demonstrably true. ICCBBA thus convened a forum with global stakeholders, regulators and providers to discuss the diverse uses of MPHO and the real and potential gaps in safety, quality and availability.  A summary of the topics covered is provided in this paper together with a table of recommended actions.

Safety of MPHO

Blood transfusion has been essential and critical to healthcare for at least a century, while organ transplantation has developed over the past fifty years to become a mainstay of the therapy for end stage organ failure with more than 120,000 transplants performed each year.  Tissue (excluding blood and organs) and cell therapies also are increasing in numbers and applications. The need for these products to be donated, while maintaining quality and safety, have harmonized some of the approaches for MPHO safety and efficacy. Availability of MPHO has been a constant challenge, with some products being scarcer than others. Patients are dying on waiting lists for organ transplantation, women are crossing national boundaries to gain access to assisted reproductive therapy with donors’ oocytes, and corneas are sent often to other continents where eye banks have not been developed. Wherever severe shortages of life-saving MPHO exist (as with human organs in many parts of the world) exploitation and human trafficking have occurred.  The transplant community rejects such activity and has joined to formulate the Declaration of Istanbul delineating the fundamental principles for ethical organ donation and transplantation. There are multiple quality, safety, availability and ethical issues associated with the retrieval and use of MPHO. 

Donation is a recognized civic gesture and national organizations are striving towards an equitable burden of donation to achieve self-sufficiency. MPHO donation as a voluntary activity, free of coercion and exploitation is a recognized objective for WHO.  The definition of self-sufficiency is not strict and can vary from local to national, regional, or even global needs.  It depends on MPHO-specific criteria, including preservation limits, extent of processing, compatibility constraints, emergency needs, and other responsibilities. Throughout the expansion of MPHO availability and use, governments maintain responsibility to the public that the MPHO are safe and effective.  Despite the universal recognition that coercion and exploitation of people is best avoided through voluntary donation, MPHO availability practices continue to vary across the globe, some even using compensation.  During the early expansion of MPHO development, a tradition to compensate live donors (including blood and reproductive tissue) was commonplace. Despite the recognition that compensation introduces ethical and product safety concerns, payment for some plasma products and semen is still permitted to ensure availability. 

However, irrespective of source and whether the donation was truly voluntary, national governments are responsible for ensuring that the MPHO product for clinical application meets quality and safety standards through effective oversight.

There are significant concerns for effective governmental oversight of MPHO.  All MPHO start with a donation, but the diversity of living or deceased donation events, and the volume of products resulting from processing or manipulation, creates complexities for governmental agencies.  The public needs assurance that an adverse event for a specific recipient was not the result of quality or safety errors in the retrieval and release of the MPHO, or that if there is a safety concern, others receiving a MPHO from the same donor can be quickly identified and, where necessary, treated.  The challenges across the spectrum of MPHO are prodigious.

In the same way that blood transfusions have progressively become regulated and standardized through testing and quality oversight, effective use of all MPHO will require the same approach for their acquisition, use and distribution. It may be perceived that all MPHO are of high quality and safely provide the purported benefit, but that is not universally verifiable nor demonstrably true. ICCBBA thus convened a forum with global stakeholders, regulators and providers to discuss the diverse uses of MPHO and the real and potential gaps in safety, quality and availability.  A summary of the topics covered is provided in this paper together with a table of recommended actions.

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