Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what changes have been made to the monitoring guidance on safety of (a) domestic and (b) imported blood products in each year since guidance was introduced.

United Kingdom blood donations have been tested for infections since the 1940s when testing for markers indicating syphilis for example, first began. Since then, testing for hepatitis B, human immunodeficiency virus, hepatitis C, and human T-lymphotropic virus has been introduced. Details are available at the following weblink:

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/570444/NHSBT_PHE_Data_Sources_and_Methods_2015.pdf

Hepatitis E testing was introduced in 2017.

The Medicines and Healthcare products Regulatory Agency is responsible for the safety and licensing of medicines in the UK. Human medicines, including those derived from blood components, require an authorisation to market, unless exempt and are manufactured or imported commercially under a manufacturer’s licence. Their manufacture or importation is subject to the provisions of the Human Medicines Regulations 2012 which reflect European Community law for human medicines. Previously medicines were subject to the 1968 Medicines Act. Every batch of manufactured or imported licensed human medicine is tested for conformity with its marketing authorisation to ensure its quality, safety and efficacy.

Each donation should be tested in compliance with European Union legislation and the European Pharmaceutical monograph “Human plasma for fractionation”. Plasma pools should also be tested according to this monograph. This is available at the following weblink:

http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500109627 .

Additional testing and specifications of plasma pools are required for specific products. This includes testing for hepatitis B, HIV antibodies, hepatitis C RNA of each fractionation pool and additional testing for Parvovirus B19V DNA for specific products, such as virus-inactivated pooled plasma and anti D immunoglobulins and hepatitis A RNA for virus-inactivated pooled plasma.

Individual donations are screened; the tests are defined in the following:

- Ph. Eur. monograph Human Plasma for Fractionation is available at the weblink:

http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500109627

- Council of Europe Recommendation No. R (95) 15 on the preparation, use and quality assurance of blood components is available at the weblink:

https://www.google.co.uk/url?sa=t&rct=j&q=&esrc=s&source=web&cd=4&ved=0ahUKEwjkpcqry4PVAhVCKFAKHfwhBCQQFgg3MAM&url=https%3A%2F%2Fwww.edqm.eu%2Fsites%2Fdefault%2Ffiles%2Fleaflet_blood_guide_18th_edition_2015.pdf&usg=AFQjCNGqDcIclacYoVQoiB32SGgznRH1ig

- Guideline on plasma-derived medicinal products 21 July 2011 is available at the weblink:

http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500109627

- Scientific data requirements for plasma master 15 November 2006 is available at the weblink:

http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003663