How to challenge an HTA licensing decision

In certain circumstances the Human Tissue Act 2004 makes provision for a Licence Holder or Designated Individual or Licence Applicant to make Representations against a proposed licensing decision and / or make an Appeal to the HTA about a licensing decision. This section provides information about this process.

The entitlement to make Representations about proposed licensing decisions ensures that licensing decisions are subject to general principles of due process, proportionality and transparency. 

If the person making Representations remains dissatisfied with the outcome of the Representations Hearing then reconsideration of the licensing decision can be undertaken by an Appeals Committee. Similarly, if following a decision by an Appeals Committee the appellant considers that, there is a point of law that has not been satisfactorily resolved, an appeal may be made to the High Court. The right to make Representations is laid out under schedule 3 of the Human Tissue Act. The right to make Reconsiderations is laid out in section 19 of the Human Tissue Act.