Future regulation of cell and tissue therapies

By Robyn Baker and Janine Jansen.

Key Points:
A new Regulatory Impact Statement proposes regulating them as a discrete class of therapeutic goods.

A national regulatory framework for human cell, tissues and cellular and tissue-based products has been on the agenda since mid-2002, when the Australian Health Ministers' Conference recommended that the Therapeutic Goods Administration ("TGA") develop one and that the legislation be amended accordingly.

Following that recommendation, the TGA released its first draft Paper of a proposed regulatory framework for cell and tissue therapies, dated January 2004.

The proposed definition of "human cell and tissue and cellular based products" ("HCT/Ps") in the Paper was to be defined according to the US model as follows:

"articles containing or consisting of, or derived from, human cells or tissues that are intended for implantation, transplantation, infusion or transfer into a human recipient".

In the Paper, three classes of HCT/Ps were proposed, with varying levels of regulation applying on the basis of the level of risk posed. A series of "rules" were to be applied in order to categorise a product into a Class and exemptions were also contemplated.

Latest developments

In September 2004, the TGA released the Regulatory Impact Statement ("RIS") for cell and tissue therapies which was developed in relation to the Paper and reviewed the options available to the TGA for the regulation of these products. Three options were put forward in the RIS and were evaluated in the context of the concerns and preferences that had been expressed by stakeholders and the impact they would have on key groups (ie. manufacturers of HCT/Ps, tissue banks, consumers and Government):

• retain the status quo
• regulate HCT/Ps as medicines or medical devices, or
• regulate HCT/Ps as a discrete class.

Of these three regulatory options the RIS concluded that the most appropriate would be to regulate HCT/Ps as a discrete class of therapeutic goods. Adoption of this approach to the regulation of cell and tissue products will result in a number of changes which will, subject to the applicable exemptions, include:

• in order to manufacture and supply HCT/Ps, the HCT/P would need to be covered by a HCT/P licence;
• a rule-based risk classification scheme would establish three classes of HCT/Ps; and
• HCT/Ps would be subject to compliance with minimum national standards relating to good tissue practice.

A final RIS will be prepared and presented to the Australian Health Ministers' Conference before a decision is made on the manner in which HCT/Ps will be regulated and how such regulation will be implemented. In preparing the final RIS, the TGA will consider the views of New Zealand officials in relation to this issue. Should New Zealand agree with the TGA's preferred approach to the regulation of these products, this regulation may be implemented under the new trans-Tasman legislation.

For further information, please contact Robyn Baker.