§ Mrs. CaltonTo ask the Secretary of State for Health what assessment has been made of the possibility of urine-based drug therapies providing a route for human-to-human transmission of(a) CJD and (b) other diseases. [162496]
§ Miss Melanie JohnsonThe possibility of urine based drug therapies providing a route for human-to-human transmission of Creutzfeldt-Jakob disease (CJD) and other diseases has been considered by the Committee on Safety of Medicines (CSM) and at a European level by the Committee for Proprietary Medicinal Products (CPMP). There is no evidence of human-to-human infection of CJD caused by urine based drug therapy and epidemiological evidence does not suggest a risk for urine-derived medicinal products from patients with sporadic CJD. However, as a precautionary measure, the CSM has advised that urine from a country with one or more cases of variant Creutzfeldt-Jacob Disease (vCJD) should not be used as a source of human urine to produce medicinal products for the United Kingdom.
All UK medicinal products are manufactured in accordance with European regulatory guidelines and it is a requirement that all urinary derived products use validated manufacturing process which are capable of 231W providing assurance that the risk of viral infectivity is minimised. These requirements are assessed by the Medicines and Healthcare products Regulatory Authority for all urinary derived products. Bacterial infection should not be an issue, as these products are for injection and are therefore required to be sterile.