Product contamination & extortion - a protocol for the therapeutic goods industry

Industry Government Crisis Management Committee

23 February 2004

The document Product Contamination & Extortion - A Protocol for the Therapeutic Goods Industry has been developed by the Industry Government Crisis Management Committee1 (IGCMC) as a joint industry-government initiative, with the aim of assisting managers in responding to a product contamination and/or extortion event directed at the therapeutic goods industry.

The Protocol is intended to optimise the way in which an incident involving therapeutic goods is managed. It designates key stakeholder responsibilities and outlines procedures that should be followed during a product contamination or extortion event. Ultimately adherence to the Protocol will assist in ensuring public safety and continued confidence in therapeutic goods.

The Protocol supplements the information contained in Crisis Management Guidelines - For the management of actual, potential or threatened tampering of medicines, complementary healthcare products and medical devices, previously endorsed by the IGCMC, and available to sponsors from therapeutic goods industry associations or the TGA.

In order to maintain the usefulness of the Product Contamination & Extortion Protocol, its availability is being limited to legitimate therapeutic goods industry stakeholders.

Where a sponsor of therapeutic goods is a member of an industry association, access to the Protocol should be sought through that association in the first instance. In many cases, the Protocol will be accessible through the 'Members Only' section of the association website.

Where a sponsor of therapeutic goods is not a member of an industry association, a written request for a copy of the Protocol can be forwarded to the TGA. Such a request should be signed by a duly authorised person occupying a senior position within the sponsor's business organisation. Written requests should be forwarded to:

The Secretary
Industry Government Crisis Management Committee
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

Any requests for a copy of the Protocol by persons who are not sponsors of therapeutic goods will be considered on a case by case basis and may be referred to the IGCMC for advice on whether release would be in the best interests of the therapeutic goods industry.

  1. The IGCMC was established in June 2000 as a result of tampering crises in the consumer medicines industry. The Committee comprises representatives from the various sectors of the therapeutic goods industry, the TGA, State and Territory Health Departments, State and Territory Police, consumers, pharmacy and retailers. The primary role of the IGCMC has been to develop strategies aimed at preventing, or minimising the effect of, similar crises in the future.

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