Last reviewed 19 December 2019

A bio-sciences company has been sentenced for being in possession of high hazard infectious biological material without a licence.

In September 2017 concerns were raised in connection with Thermo Electron Ltd (trading as Fisher BioServices and part of the ThermoFisher Scientific group) regarding the nature of biological agents that had arrived at its site in Bishop Stortford, in a shipment from overseas.

Fisher BioServices supplies critical biological materials to support the advancement of cell therapies, good manufacturing practices (GMP) biologics, and population-based public health research. It provides customised, end-to-end chain of custody solutions for large pharmaceutical businesses and academia and government.

However, between April 2016 and February 2018, an investigation by the Health and Safety Executive (HSE) found that Thermo Electron was in possession of a large quantity of infectious avian influenza and West Nile virus. Both of these biological agents are specified as requiring a licence under the Specified Animal Pathogens Order 2008 (SAPO). Enquiries confirmed the company had obtained no such licence.

The company pleaded guilty at Chelmsford Magistrates’ Court to two breaches of s.73(a) of the Animal Health Act 1981 and was fined £40,000 and ordered to pay costs of £80,000.

Speaking after the hearing, HSE specialist inspector Dr David Johnson said: “The use of high hazard animal pathogens is tightly regulated in the UK to ensure that exotic animal diseases such as Avian influenza, are not introduced which could threaten the UK livestock economy. The licencing regime enables HSE to authorise possession of such agents and requires the implementation of strict conditions for those wanting to conduct work with specified animal pathogens. Companies like the defendant contribute to critical scientific research and in vast majority of cases the sector complies with the understandably stringent regulations in place.

“However, as soon as Thermo Electron Ltd became aware it didn’t have the appropriate licence, immediate steps could have been taken including safely destroying the material, returning it to the sender, or transferring it to an appropriately licenced site.

“There are lessons to be learnt here and we’d ask those involved in the biosciences sector to take note of this case.”