A new report from Creative Ceutical examines the availability of blood products in the EU and addresses some of the regulatory challenges impacting their supply.
The report, An EU-wide overview of the market of blood, blood components and plasma derivatives focusing on their availability for patients, was commissioned by the European Commission’s Executive Agency for Health and Consumers (EAHC), and features commentary by stakeholders from various industry groups, patient organizations and health authorities from the EU and its member states.
In the EU, millions of units of blood and plasma products are transfused or distributed to healthcare providers each year. While blood and plasma products are critical for patients, they are often in short supply as they rely on voluntary human donors and usually cannot be replaced by artificial substances. Additionally, in the EU, most Member States prohibit paid blood and plasma donation.
According to a 2011 report from the European Directorate for the Quality of Medicines and Healthcare (EDQM), only 25 in 1,000 Europeans donate blood each year on average, resulting in about 37 donations per 1,000 inhabitants.
Regulating Blood Products
While there is a critical need for blood and plasma products, it is equally important for these products to be strictly regulated to ensure that they are safe for the patients who rely on them.
Human blood and plasma products were first regulated in the EU under Directive 89/381/EEC, which established standards for measuring, screening and manufacturing. The directive also instructs Member States to encourage voluntary, unpaid donation in order to be self-sufficient in the supply of these products. More than a decade later, Directive 2002/98/EC, and its implementing directives, 2004/33/EC, 2005/61/EC and 2005/62/EC, further developed standards for the quality and safekeeping of these products.
Finished plasma products are generally regulated as pharmaceuticals; however, as they are created from blood components, the regulations impacting human blood also play a significant role in plasma products' regulation. Additionally, plasma products are required to maintain a Plasma Master File (PMF), which contains "all relevant detailed information on the characteristics of the entire human plasma used as a starting material and/or a raw material for the manufacture of … medicinal products or medical devices incorporating stable derivatives of human blood or human plasma."
One of the major debates surrounding blood and plasma availability is centered on incentives for blood donation. Both the World Health Organization (WHO) and Council of Europe recommend unpaid donations. However, the scientific community has mixed opinions on the risks and benefits of paid donation. Some researchers have argued that paid donation can lead to higher rates of transmissible disease due to transfusion. Others have argued that these claims are not supported, and that "arguments against compensated donation have little basis in evidence."
Another issue is that there is no accepted definition of "self-sufficiency" for blood and plasma products in Europe, which makes it difficult for regulators to measure performance in this area. While many European countries are able to maintain an adequate supply of blood products, sourcing plasma is a significant challenge. One study found that more than 50% of plasma-derived products used in Europe were sourced from US-based donors.
Suggestions from Plasma Suppliers
The International Plasma Fractionation Association (IPFA) has raised concerns that clinical trial and data collection requirements in the EU are adding unnecessary costs to plasma product production, without necessarily resulting in improved safety or quality for patients. The group also pointed to differences in the regulation of plasma donation in the US and EU as an issue leading to duplicated efforts on the part of producers.
The Plasma Protein Therapeutics Association (PPTA) argues that there are unnecessary burdens for good manufacturing practice (GMP) inspections between the US and EU. The EU requires plasma product suppliers to undergo a regular GMP inspection by an EU Competent Authority every two years, even if they have been inspected by the US Food and Drug Administration (FDA). PPTA argues that "major savings could be achieved, without adding risk to the patient," by reducing this overlap.
Creative Curia Report