Advances in science and healthcare technology have led to the development of replacement medicine with more human body components being collected for the preparation of medical products of human origin (MPHO). These encompass a wide range of medical products, from cells and tissues to blood and organs, from such anatomical components to secretion and excretion, all originating from the human body. Donated by a human with the goal to benefit others, these MPHO have saved and improved human life through their clinical application. From donation to the follow-up care of the recipient, however, MPHOs have a shared exposure to risks –breaches of ethical, legal and safety standards for example or the risk of disease transmission with a potential undesirable outcome.
The World Health Organization (WHO) launched an Organization-wide initiative on MPHOs in 2013. This builds on the ongoing work by the WHO to optimize the services involving MPHOs, from blood transfusion to cell, tissue and organ transplantation, as well as assisted reproductive technologies (ART). The objective is to recognize the human origin as an over-arching characteristic of MPHOs and identify any ethical, legal and safety standards required by the different types of MPHO. The approach highlights the common requirements for donation, preparation and human application of MPHO, while acknowledging the specificities associated with each individual type.
The initiatives for MPHO identified three global governance approaches that are necessary:
1) The consensus on and implementation of a set of principles common to all MPHO to guiding practices;
2) The use of ISBT128, the global Information Standard for Blood and Transplant which enhances traceability and transparency around the world;
3) The maximal sharing of vigilance and surveillance information globally.