Related to the fact, that HEV infection is widespread and blood/plasma donors are often asymptomatic, there is a risk for viraemic blood donations. Transfusion related cases of HEV infection has been documented in several countries, e.g. in United Kingdom, France, Japan, Saudi Arabia and People’s Republic of China. The recent analysis of donations of blood and plasma has identified HEV-infected donors in Germany, Sweden, and United Kingdom. In these studies, the frequency of viraemic donations ranged between 1:4000 and 1:7000.
Thus the EMA recognised that further information is needed on the safety of plasma-derived medicinal products with respect to HEV.
Therefore, an expert workshop will be organised in 2014 to address the relevant issues. The following points should be addressed:
This workshop will provide the basis for deciding what further action may be needed, including the possible update of current guidance on plasma-derived medicinal products and/or development of a reflection paper specifically on viral safety of plasma-derived medicinal products with respect to hepatitis E virus.
Please see the complete document entitled "Concept paper on viral safety of plasma-derived medicinal products with respect to hepatitis E virus".