Consent given pursuant to sections 14 and 14A to the supply of the therapeutic goods specified by Baxter Healthcare

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, aiming to protect public health by ensuring the quality, safety, and efficacy of these goods. The Act provides the legal framework for the control of therapeutic goods through the Therapeutic Goods Administration (TGA). This legislative piece was introduced to address the need for stringent oversight of therapeutic products to safeguard the health of the population. On 27 May 2015, the delegate of the Secretary of the Department of Health granted a consent under sections 14 and 14A of the Act for the supply of FEIBA products by Baxalta, following a sponsorship change from Baxter. The consent, which is subject to specific conditions ensuring a smooth transition and continuity of supply, reflects the policy objective of maintaining the availability of essential medicines while managing potential disruptions during sponsorship changes.

Scope and Application

The Therapeutic Goods Act 1989, under sections 14 and 14A, applies to Baxter Healthcare's application for consent to supply specific FEIBA-NF products that do not fully comply with the labelling requirements of the Therapeutic Goods Order No 69. The consent granted by the delegate of the Secretary of the Department of Health pertains to the supply of FEIBA-NF factor VIII inhibitor bypassing fraction products with Baxter's details on the labels for a 24-month grace period, effective from 1 July 2015 to 30 June 2017. This consent is specifically tailored to the change in sponsorship from Baxter Healthcare to Baxalta, with the latter assuming responsibility for the products on 1 July 2015. The application of this Act ensures that the transition in sponsorship does not disrupt the supply of these critical therapeutic goods and maintains patient safety and communication through the stipulated grace period.

Key Provisions

Sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) outline the process for obtaining consent from the Department of Health for the supply of therapeutic goods that do not fully comply with the labelling requirements set out in Therapeutic Goods Order No 69. In this case, the delegate of the Secretary of the Department of Health has granted consent to Baxter Healthcare for the supply of FEIBA-NF factor eight inhibitor bypassing products (AUST R 104896, AUST R 104911, and AUST R 172236) with Baxter's details appearing on the labels for a grace period of 24 months, starting from 1 July 2015. This consent is in effect until 30 June 2017. Under the Act, the obligations imposed on the parties include the submission of relevant change of sponsorship forms before the global day 1 for separation, which is 1 July 2015. The transfer of sponsorship is determined by the date the legal agreement between the relinquishing and accepting sponsors takes effect. Additionally, there must be an assurance that Baxter-labelled stock will be used for two years, ending on 30 June 2017, to ensure continuity of supply. Baxalta-labelled stock is required to be in the country six months before the labelling grace period ends. Furthermore, processes and measures need to be implemented to ensure there are no gaps in the communication of medical information to patients and safety reporting during the labelling grace period. Lastly, arrangements must be in place for prompt referral of any queries or complaints concerning the products to Baxalta Australia Pty Ltd. Failure to comply with the conditions set out in the consent may result in both civil and criminal consequences. The Act provides for penalties for breaches of its provisions, including fines and imprisonment. The specific penalties for breaches related to the consent granted under sections 14 and 14A are not stated in the legislation, but the general penalties for breaches of the Therapeutic Goods Act 1989 can include fines of up to $1,650,000 for a corporation and imprisonment for up to five years for individuals, as well as additional penalties for repeat or serious offences. The Therapeutic Goods Administration has the authority to take enforcement action against parties who fail to comply with the Act and the conditions of the consent.