The giving of a written enforceable undertaking to the TGA under section 42YL of the Act can provide an alternative to potentially lengthy and expensive court proceedings or the taking of other regulatory or administrative action in relation to a company or individual breaching a regulatory requirement.

They can allow those who are required to comply with the Act or Regulations to offer innovative and business efficient alternatives to formal litigation or regulatory action, whilst still allowing the TGA to protect the health of Australians. They can also be used in relation to conduct that may not amount to a breach but where the person or company and the TGA see some benefit in clarifying their positions in relation to that conduct. An enforceable undertaking is enforceable by the TGA in the Federal Court if the person giving the written undertaking (the Promisor) breaches or fails to comply with any of its terms.

In appropriate cases (for instance involving small companies, or where individuals are directors of a number of small companies), the TGA may accept an enforceable undertaking from both the company itself and from the director/s to ensure that all those likely to be involved are bound by the relevant provisions.

In negotiating an enforceable undertaking, the TGA will seek to achieve desired outcomes such as:

• where relevant, cessation of the particular activity that is alleged to be a breach or potential breach of the legislation⁵
• the taking of various specified actions to ensure compliance with the Act, or remedy the consequences of non-compliance
• in appropriate cases, destruction of the goods concerned at the Promisor's expense and providing the TGA with a certificate of destruction of those goods
• a commitment to future compliance with the requirements of the legislation, or particular requirements of the legislation, whether or not supported by the Promisor's use of expert assistance to formulate robust standard operating procedures when dealing with therapeutic goods, or any other means specified by the person in breach, noting that in order to be enforceable the undertaking has to be sufficiently specific for the Promisor to know exactly what is expected of them and so that any failure to comply will be readily apparent
• where relevant, a commitment to future adherence to the requirements of the Therapeutic Goods Advertising Code⁶ which might include corrective advertising or notices to rectify misleading conduct , noting that in order to be enforceable, the undertaking has to be sufficiently specific for the Promisor to know exactly what is expected of them and
• in addition to the mandatory publication of the details of the undertaking on the internet, using the publication of written undertakings as a public awareness tool to deter others from breaching legislation or the Code.

Footnotes

5. That is, the Act and the Regulations.
6. It is an offence under the Act to publish or broadcast an advertisement about therapeutic goods that does not comply with the Code and under the Therapeutic Goods Regulations, an advertisement for therapeutic goods will not be given approval if it does not comply with the Code.