2007: The Year of Regulatory Change

Abstract 

Introduction

The two countries that performed the most organ transplants in 2006, the United States and China, initiated significant regulatory changes in 2007 that continue into 2008 and likely several more years. The purpose of this article is to highlight the reasons behind the regulatory initiatives, document the new regulations, and assess the impact thus far.

Methods

Review of US and Chinese governmental regulations emphasizing the underlying principles and impact.

Results

We evaluated the changes with respect to equity and transparency; understanding transplant policy; field strength; and informed consent. We found a number of similarities between the US and Chinese regulatory changes. The changes in the United States introduced new members into the team (independent donor advocates) and improved documentation, while China began the process of regulation by defining the process and identifying practices that are not allowed.

Conclusions

We found a number of similarities between the regulatory changes in the United States and China. Both countries have made significant progress in attempting to improve the process for both donors and recipients. The United States is a more mature system, while China is attempting to move toward an international standard. In the short term, there may be decreased overall access to transplantation while transplant centers and policies adjust to the new regulations in both countries.