Human Tissue Authority

The regulator for human tissue and organs

Regulation of faecal microbiota transplant

Faecal microbiota transplants (FMT) are recognised as an emerging treatment for recurrent Clostridium difficile infections in patients where antibiotic and other lines of treatment have failed.

This treatment works by introducing enteric bacteria from the faeces of healthy donors into the gut of the recipient, restoring bacterial balance.

In March 2014, the National Institute for Health and Care Excellence (NICE) issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on FMT for recurrent Clostridium difficile infection .

This guidance states that current evidence on the efficacy and safety of FMT for recurrent Clostridium difficile infection is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit.  

The HTA has received enquiries from establishments seeking to perform this procedure, as to whether FMT falls under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations) and, consequently, is regulated by the HTA

In determining whether FMT should be regulated under the Q&S Regulations, the HTA has considered whether faeces contain tissues and cells  and whether the product is intended for Human Application. 

EU Legal Opinion

In June 2014, the HTA raised the regulation of FMT as a question at the Tissues and Cells Competent Authorities meeting. In December 2014, a legal opinion was subsequently provided by the EU Commission. 

This considered that for the purposes of the EU Tissues and Cells Directive (EUTCD) faeces are a combined substance, in the sense that they contain cells and a number of other components. 

Many substances commonly considered tissues or cells under the EUTCD are 'combined substances’.

The Commission considered that the EUTCD covers 'combined substances' only where the human tissues and cells contained therein are the active component of the substance.

The Commission concluded that for the purposes of FMT, the cells are not the active component of this substance and therefore are not ‘intended for human applications’ within the meaning of EUTCD.

In reaching this conclusion the Commission however noted that Article 168(4)(a) TFEU allows for the adoption of measures setting high standards of quality and safety for all substances of human origin. A legal mandate therefore exists for the potential future regulation of FMT.

The HTA Position 

On the basis of the legal opinion provided by the Commission, the HTA does not consider that faecal microbiota transplantation is currently within the scope of the Q&S Regulations. 

As best practice, the HTA advises that establishments conducting this procedure act in accordance with the HTA's Guide to Quality and Safety Assurance for Tissues and Cells for Patient Treatment (The Guide), in particular with respect to seeking informed consent, performing donor serology testing and the traceability of samples from donor to recipient.

Establishments can contact the HTA with enquiries about the standards set out in The Guide. 

Establishments seeking to perform FMT should contact the MHRA Medicines Borderline Section for further advice. 

Revision history

Date approved: 3 June 2015

Next review due: 3 June 2016

Audience: