4.1 ETHICAL BREACHES, FRAUDULENT, ILLEGAL PRACTICES

The increasing commercialization of MPHO in some countries has multiplied profit-making opportunities and increased the risk of clinically unsafe and unethical practices, particularly in tissue procurement. 2011 scandals in the United States and other countries involving non-consented procurement underline the urgent need for a common global technical and ethical framework. Although a number of regulations on transplantation have been adopted in the past several years or are currently under discussion, national regulation and oversight of transplantation is limited or inefficient in many countries.

 
Progress has been made through the EU-funded SOHO V&S project (Vigilance and Surveillance of substances of Human Origin) with the development of guidance on the detection and investigation of illegal and fraudulent activities in the fields of tissues and cells. Procedures for enforcement actions by regulators have been recommended.