Robert Flello – 2016 Parliamentary Question to the Department of Health

The below Parliamentary question was asked by Robert Flello on 2016-03-02.

To ask the Secretary of State for Health, what the guidance is on licences applied for to the Human Fertilisation and Embryology Authority being granted before receiving ethical approval; and what proportion of such licences have been so granted in each of the last three years.

George Freeman

The Department has not had any discussions with the Human Fertilisation and Embryology Authority (HFEA) after its authorisation of a licence for gene editing of human embryos by means of CRISPR-Cas9 about the process of ethical approval being granted for such a licence.

The Francis Crick Institute, which made the licence application to the HFEA, is intending to place copies of the information given to patients or donors explaining this research on its website, once the final draft has been agreed.

There is no statutory requirement for ethical approval to be in place before an HFEA research licence can be granted. However, the HFEA has developed guidance for its licensing committee that such approval should be in place before a licence is granted and research is allowed to proceed.

In 2012, none of the three licences granted had ethical approval in place and a condition was therefore placed on each licence that licensed research could not proceed until such approval was in place. In 2013, five research licences were granted, all of which had ethical approval in place. In 2014, seven licences were granted, all of which had ethical approval in place. In 2015, one of the 15 licences granted did not have ethical approval in place and a condition was therefore placed on the licence that licensed research could not proceed until such approval was in place.