The U.S. blood system is in a period of uncertainty because of a shifting healthcare landscape. The fundamental needs and demands of the blood system are changing due to new clinical practices, less invasive surgeries, and the use of blood management techniques.1 These changes have resulted in a dramatic reduction in the number of units of blood transfused, from 13.2 million units in 2013 to 12 million in 2016.2 In response to these changes, there has been some consolidation among suppliers and community blood centers; however, the number of blood centers has remained relatively stable over that period.1
These changing dynamics prompted the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary of Health to engage the RAND Corporation to study the sustainability of the blood supply. RAND’s report, Toward a Sustainable Blood Supply in the United States: An Analysis of the Current System and Alternatives for the Future, was released in late 20161 and was considered by the HHS Advisory Committee on Blood and Tissue Safety and Availability at its most recent meeting in November 2016.
Findings of the report
RAND defines a sustainable blood supply as one “that (1) maintains or improves on current safety levels for blood and blood products, (2) provides blood for the full range of clinical applications consistent with standard practice, and (3) delivers blood in a timely fashion such that patient health and preparedness are not unduly compromised.1” RAND undertook a comprehensive review of the status quo of the blood system, performed an analysis of research questions provided by HHS, and presented policy alternatives to help improve the sustainability of the blood supply.
RAND concluded that while the U.S. blood system is in a period of flux and uncertainty, under the status quo it operates effectively, and in many cases efficiently. However, there are unlikely but possible scenarios in which the supply of blood would be disrupted which could affect the timing and type of care delivered to patients.1
Considerations for sustainability
As the safety of the blood supply faces growing threats from emerging infectious diseases, such as the Zika virus and protozoan parasite Babesia, a comprehensive review of policies impacting the U.S blood system is necessary. Sustainability of the U.S. blood supply remains a crucial component of the public health infrastructure. While the blood system may be operating effectively, there are significant risks facing sustainability. Risks include insufficient incentives for investment in innovation, consolidation in the marketplace, cost of regulatory compliance, and uncertain ability to respond to unanticipated needs.
These risks require unique policy considerations to maintain access to blood as a public good. Blood supply sustainability, including the capacity to rapidly respond to emerging pathogens, requires a coordinated effort among blood centers, product suppliers, hospitals, and government regulators.
Such a coordinated effort should, first, recognize the vital role that the private sector plays in developing new technologies for a safer blood supply. One of the core components of a sustainable blood system is the maintenance and improvement of current safety levels for blood and blood products. Much of the innovation that has transformed the blood sector originated from the private sector. A good example of the types of innovations the private sector has delivered is the blood screening assays for West Nile virus and the Zika virus. The speed with which industry developed and implemented these types of assays was remarkable and a testament to industry’s commitment to improving the safety of the blood supply. A holistic approach to sustainability should recognize the value that blood centers and their suppliers bring to ensuring the safety of the blood supply.
Second, the effort should reduce barriers to innovation. When industry is developing new products to improve the safety of the blood supply, a major consideration is the cost of obtaining regulatory approval. The Food and Drug Administration (FDA) manages the regulatory approval processes for the establishment of new blood centers, approves and monitors manufacturing of blood and blood products, approves devices used in the manufacturing of blood, and regulates blood products.1
There is a perception that the U.S. regulatory environment slows the adoption of new technologies. The regulatory environment should be modernized to reduce barriers to innovation, while continuing to ensure safety, to speed the introduction of novel technologies.
Third, the effort to ensure blood supply sustainability should update payment policies for blood and supplies to ensure that there are appropriate incentives for investment. The current way that blood and supplies are paid creates perverse incentives: there is little business incentive to invest in research and development of new blood screening tests when there is no FDA recommendation through a guidance document to screen donations for a particular disease. Often, the FDA only issues a screening guidance if that particular disease poses a significant threat. If industry does not have the right incentive to develop a screening test until the FDA issues a guidance, the response to that emerging disease is slower than it could be. There are 86 emerging or re-emerging infectious diseases1; this highlights the importance of a proactive approach to pathogen response. Payment policies, then, should encourage rapid response to emerging diseases and updating payment mechanisms to provide for a direct method of paying for new screening tests.
Fourth, the broader effort should encourage robust public/private partnerships to meet growing challenges. Maintaining the blood supply requires unique considerations because of its important role in public health. The general public benefits from having a safe and reliable supply of blood available for routine procedures and emergency situations. Given the non-traditional nature of blood, it should not be treated as a traditional commodity. Public/private partnerships serve as important collaborations to meet growing challenges and ensure the continued availability of this crucial public good.
Last, stakeholders should contemplate a national blood policy to comprehensively address the factors associated with a sustainable blood supply. Ensuring sustainability of the blood supply requires a multifaceted approach. Such an approach could ensure sustainability by addressing innovation, regulatory policies, a hemovigilence program, crisis response, and payment. A national policy could help achieve a “blood safety net” for the American people. In order to establish such a safety net, HHS should build relationships with all blood sector stakeholders, to ensure an inclusive approach to this complicated problem.
Working together
The blood business is different in important ways from most other businesses, and no one would dispute that the blood industry should be regulated. To say there should be less or different regulation is not to say there should be none. But the uncertainty for stakeholders in the U.S. blood supply raises important questions about the sustainability of the blood supply. A comprehensive approach to developing policy interventions that is inclusive of all stakeholders in the blood system will help improve sustainability.
REFERENCES
- Mulcahy A, Kapinos K, Briscombe B, et al. Toward a Sustainable Blood Supply in the United States: An Analysis of the Current System and Alternatives for the Future. RAND Corporation Report. 2016. http://www.rand.org/content/dam/rand/pubs/research_reports/RR1500/RR1575/RAND_RR1575.pdf.
- Basavaraju S. National Blood Collection and Utilization in the United States, 2015. Presented at the 2016 AABB Annual Meeting, October 24, 2016.
Jerry A. Holmberg, PhD, serves as Director, Scientific Business Development for Grifols.
Nicholas Uzl, JD, serves as Public Affairs Manager for Grifols.
