中国血液产品自给自足的挑战与策略

Challenges from self-sufficiency of blood products in China and related strategies

血浆是人源性资源,涉及社会伦理问题,受到政策及制度的调控、科学技术的挑战,其安全性保障关系到成本/效益比上涨。1975年WHO开始提出每一个国家的血液和血液产品应该自给自足,世界上很多国家都才朝着这一方向努力。随着我国经济快速的发展,人们对血液产品的需求也逐步增长,同时对血液产品的安全性也有更高的关注。强制性c GMP推行,增加病毒灭活工艺,临床研究经费提高,NAT检测,新病源体,如疯牛病、西尼罗河病毒、猴痘病毒等的出现,都成为原料血浆供应的新障碍,如何实现我国血液产品的自给自足是1个迫切需要解决的问题。要实现我国血液产品的自给自足,必须以扩大血浆来源以发展单采血浆作为主线,发展回收血浆作为辅助,通过开发小产品和现行工艺革新以提高血浆综合利用率;同时,国家应出台相应政策法规,加大对罕见病用药的扶持与倾斜,优化新药审评办法和流程,鼓励企业增加产品研发的投入,加大重组血液制品开发力度。

Plasma is a resource of human origin. Collection of plasma involves social and ethics issues and is regulated and controlled by government policies and regulations while facing technological challenges simultaneously. The demand for its safety increases with its benefit-cost ratio. In 1975,since WHO raised a claim that the blood and blood products of each country should be self-sufficient,many countries have been directing efforts to achieve this goal. With the rapid economic development in China,the overall demand for blood products has increased. At the same time,people began to pay more attention to the safety of blood products. New obstacles in supplying source plasma consisted of the following： the compulsory practice of c GMP implementation,the expansion of viral inactivation technology,the increase in the costs of the clinical research,the introduction of NAT test,and emerging pathogens,such as BSE,West Nile virus,and Monkey pox virus. Thus,accomplishing the self-sufficiency in supplying blood products has been an urgent problem that must be addressed. To achieve self-sufficiency,the primary effort should be devoted to the expansion of source plasma by the means of developing stations for plasmapheresis. Secondary efforts should be invested in the development of recovery plasma which means to make full use of plasma by the development of plasma proteins in low concentrations and technological innovation. At the same time,relevant policies and regulations should be formulated. More support should be given to drugs that are used to treat rare diseases. The review process on drugs should be optimized. In addition,the government should encourage investment in product research and development and the development of recombinant plasma products.