Table 1 Principles to be considered for faecal microbiota transplantation regulation
From: Faecal microbiota transplantation: a regulatory hurdle?
Principle | Explanation |
|---|---|
Regulatory harmonization | The regulation of faecal microbiota transplantation must be comparable around the world. Some countries have regulated faecal microbiota transplantation ad interim (e.g. by regulatory discretion in the USA), some countries have a liberal faecal microbiota transplantation regulation (e.g. Austria) and various countries do not have any legal framework at all regarding faecal microbiota transplantation (e.g. various European Union member states). Hence, safe and regulated access to faecal microbiota transplantation currently still majorly depends on the country where the patients are living in. |
Patient Empowerment | Patients should be empowered and allowed to make informed decisions. Providing patients with adequate, scientifically sound information to allow them to, together with their physician, weigh the possible benefits and risks attached to faecal microbiota transplantation and to take an informed decision. From the point of view that every person must be allowed self-determination regarding their health. |
Quality | Faecal microbiota transplantation must be conducted with faeces that meets rigorous quality standards (e.g. absence of pathogens and infectious transmittable diseases) to limit the risks to the recipient. |
Donor anonymity | Frequently, relatives/partners are donors given their comparable microbiome. Since long-term adverse events seem until today unclear, one could question donors to be blamed when such long-term adverse events would occur. Hence faeces donation must be conducted in an anonymous, but traceable, way. |
Efficacy | The efficacy of faecal microbiota transplantation must be monitored by an independent organisation (e.g. the competent authorities) to safe-guard patients and to allow the practise of evidence-based medicine. |
Information | All stake holders must be provided with adequate information. For example, the patient must obtain all relevant information available and must be made aware of possible long-term risks, possibly currently unknown. |
Pharmacovigilance | Adequate monitoring of patients though time must be maintained to detect e.g. late adverse effects and to allow pharmaco-epidemiology and pharmaco-economics. |