"Disposal Approach" to meet the challenges in provision of high volume donations for diagnostic industry in Europe

Background

The global shortage of available blood is not only a major challenge for transfusion medicine and the pharmaceutical industry, but also for diagnostics manufacturers worldwide. The political situation during and after the pandemic with the current Ukraine war and the open conflict over the island of Taiwan leads to a partial separation of the global markets, especially between the USA, Europe and China.

Methods

Should the next president of the USA declare "America First" again, this could jeopardize the supply of blood products from the USA to Europe. While Europe is making great efforts to increase the amount of blood available in the region, this does not include the diagnostic industry. With a steady growth of more than 10% even after the pandemic in the diagnostics industry, the demand for blood products will also lead to increased parallel activities in the field of proprietary blood product collection worldwide. Competition between national blood donation systems and suppliers to diagnostic manufacturers must and can be prevented.

Results

To ensure sufficient quantities of plasma and serum for diagnostics in Europe, a "90-to-10 Approach" is being discussed internationally, which should secure 10% of the available blood products for diagnostics. Approximately 1 million liters of blood products collected throughout Europe would be made available annually for diagnostics, from today's perspective a significantly too large quantity.

Of all the blood components collected, approx. 1% are not suitable for use in transfusion medicine for a variety of reasons (infectiology, cooling process, quality of blood bulks, etc.). This quantity would mean an extensive coverage of the European demand for diagnostics and would also be ensure production during crisis situations.

Conclusion

Our "Disposal Approach", as a milder, preliminary version of the "90-to-10 Approach" requires national regulations to ensure that all blood components to be discarded are offered to the suppliers of the diagnostics industry, thus preventing the ethically difficult destruction of high-quality clinical material.

Offenlegung Interessenkonflikt:

nothing to declare