New laws for autologous human cell and tissue products

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By Dr. Teresa Nicoletti, Partner and Helaena Short, Lawyer

On 1 July 2018, changes to the regulation of human cells and tissues were introduced which affect several biologicals[1] and blood products, especially those intended for autologous application – many of which were previously exempt from the therapeutic goods regime. The affected biologicals, often referred to as ‘stem cell treatments’, are subject to additional manufacturing, supply and advertising requirements. Affected suppliers and service providers should ensure that they are familiar with the new laws and able to comply with the new requirements. Partner, Dr Teresa Nicoletti and Lawyer, Helaena Short discuss.

Human cell and tissue (HCT) products are those that comprise, contain or are derived from human cells and tissues including:

  1. blood, being whole blood collected from a single human donor and processed either for transfusion or further manufacturing;
  2. blood components, being therapeutic components that have been manufactured from blood (red cells, white cells, platelets, plasma) by centrifugation, filtration or freezing, but not products derived through fractionation of plasma or haematopoietic progenitor cells; and
  3. biologicals, being things that are comprised of, contain or are derived from human cells or tissues and which are intended to be used for a therapeutic purpose.

Biologicals are regulated under the Biologicals Regulatory Framework (BRF). Alternatively, blood and blood components are regulated as medicines under the relevant part(s) of the therapeutic goods regime.

In April 2018, the TGA released a guidance document on several proposed changes to the regulation of HCT products generally, and specific changes to the BRF.[2]

Relevantly, several amendments to the Therapeutic Goods Regulations 1990 (TG Regulations) commenced on 1 July 2018 which, inter alia, affect the advertisement of all HCT products and establish a new framework within the BRF for the classification and supply of autologous HCT (A-HCT) products specifically.[3] Those changes are discussed in further detail below.

Advertising HCT products

In accordance with one change proposed by the TGA in April, as of 1 July 2018, the advertising of all HCT products to the public is prohibited.

The prohibition applies to advertising material on traditional media (e.g. television, radio, print media and posters/displays) and electronic media (e.g. websites, emails, blogs, discussion forums and social media).

Accordingly, all suppliers, medical practitioners, laboratories and other persons who are involved in the provision of HCT products or therapies should takes steps to ensure that any advertising material which is likely to contravene the new prohibition is removed from publication.

Notably, the advertising of ‘services’ will still be permitted provided that such advertisements do not specify the use of any HCT(s). Therefore, permissible advertisements must not:

  1. mention the name or trade name (or colloquial name, such as ‘stem cells’) of any HCT product(s); and/or
  2. provide information or advice in relation to different HCT products or therapies and/or their suitability for different patients (or other persons).

New supply arrangements for some A-HCT products

Historically, A-HCT products manufactured and used by, or under the supervision of, a medical practitioner for the treatment of a single patient were largely excluded from the therapeutic goods regime under item 4(q) of the Therapeutic Goods (Excluded Goods) Order No. 1 of 2011 (EGO).

However, as of 1 July 2018, the Therapeutic Goods (Human Cells, Tissues and Organs) Determination 2018 has replaced items 4(o), 4(p), 4(q) and 4(r) of the EGO and prescribes new criteria which HCT products must satisfy in order to be excluded from the regulatory framework.

Relevantly, only A-HCT products which are used in hospitals are now excluded from the therapeutic goods framework altogether. Notably, the following HCT products are no longer excluded from the regulatory framework:

  1. Fresh viable human organs, or parts of human organs, for direct donor-to- host transplantation and used in accordance with applicable laws and standards;
  2. Fresh viable human haematopoietic progenitor cells for direct donor-to-host transplantation for the purpose of haematopoietic reconstitution; and
  3. Reproductive tissue for use in assisted reproductive therapy.

Accordingly, many of these A-HCT products will be subject to the full scope of regulatory requirements for biologicals or medicines (as applicable) under the therapeutic goods regime.

These requirements are not insignificant and include:

  1. compliance with all applicable standards;
  2. reporting obligations in relation to adverse events;
  3. compliance with conditions relating to records and reporting;
  4. advertising restrictions;
  5. inclusion in the ARTG (where applicable); and
  6. manufacture in a facility(ies) which holds a GMP manufacturing licence or certification (where applicable).

Notwithstanding the above, some A-HCT products may be exempt from some specific requirements if they satisfy certain criteria, for example, if the product has been subject to no more than “minimal manipulation”.

However, making an assessment of whether a product has been more than minimally manipulated is far from straightforward. It involves an analysis of whether the process or processes to which a product has been subjected to have:

“…altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.”[4]

Accordingly, in order to determine whether an A-HCT product is excluded from some of the new regulatory requirements, providers will require intimate knowledge of the mechanism(s) of action involved in the product’s manufacturing process(es), alongside expertise in understanding the boundaries of the new regulatory framework.

Concluding remarks

Overall, the comprehensive changes to the regulation of HCT products, particularly in relation to A-HCT products, have been said to address: “growing global concern in relation to the risks that such [HCT] products and related treatments may pose to patient safety, and in relation to the advertising of such products directly to consumers.[5]

The amended regime is likely to require several HCT product suppliers and service providers (which were previously exempt) to comply with several obligations which will now apply. This may involve substantial changes to several businesses’ current advertising, supply and/or manufacturing activities.

Importantly, some transitional arrangements will apply to HCT products affected by the TGR Amendment for up to one year – i.e. until 1 July 2019.

Industry participants who are likely to be affected by the changes should seek advice to fully understand the impact of the changes and navigate the best available pathways to satisfy the regulatory framework with limited disruption to their business.

[1] cf. biological medicines. Please note that biologicals and biological medicines are regulated under different regulatory frameworks.

[2] TGA, ‘Biologicals regulatory framework proposed changes to start on 1 July 2018 Including changes to regulation of autologous human cell and tissue products and classification of biologicals’ (Version 1.0, April 2018).

[3] See, e.g. Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018.

[4] Therapeutic Goods Regulations 1990 (Cth), new regulation 3b.

[5] Explanatory Memorandum, Therapeutic Goods (Human Cells, Tissues and Organs) Determination 2018.


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