EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods Information (Stakeholder Consultation on Database of Adverse Event Notifications) Specification 2012
The Therapeutic Goods Act 1989 (the Act) provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.
Section 61 of the Act lists a number of persons or organisations such as the World Health Organisation and State or Territory authorities that have functions relating to therapeutic goods, to whom the Secretary may release specified kinds of therapeutic goods information.
The Therapeutic Goods Information (Stakeholder Consultation on Database of Adverse Event Notifications) Specification 2012 (the Specification) is made by the Minister under subsection 61(5AB) of the Act and specifies the kinds of therapeutic goods information that the Secretary may then release under subsection 61(5AA) of the Act, the kinds of persons to whom the Secretary may release such information under s.61(5AA) and the purposes for which the Secretary may release that information to those persons.
The Specification has the effect of permitting the Secretary to release therapeutic goods information of a kind mentioned in the Specification to the bodies and the kinds of persons mentioned in the Specification, for the purposes set out in the Specification.
Therapeutic goods information in this context is defined in subsection 61(1) of the Act as, relevantly, information in relation to therapeutic goods that is held by the Department (of which the TGA is a division) and which relates to the performance of the Department’s functions.
The Specification commenced on the day after it was registered on the Federal Register of Legislative Instruments.
BACKGROUND
In June 2011 the Australian and New Zealand Governments agreed to proceed with a joint scheme for regulation of therapeutic goods. The creation of a joint regulatory scheme across both countries will safeguard public health and safety, while encouraging economic integration and benefitting industry in both countries. The scheme will be administered by a single regulatory agency, the Australia New Zealand Therapeutic Products Agency.
As part of the staged approach to achieving that goal, the Australian and New Zealand Governments agreed that the TGA and Medsafe would begin a program of joint projects to maintain the momentum for the establishment of the agency. One of the projects is the establishment of a single, publicly accessible database of adverse event notifications relating to medicines in both Australia and New Zealand.
The establishment of such a database is expected to provide a number of benefits to both the TGA and Medsafe as well as for health-related industries and consumers, including permitting consumers to trace the number of events reported relating to particular products.
The establishment of this database will also address one of the recommendations of the Report of the Review to improve the transparency of the TGA (released on 21 July 2011), as recommendation 20 of that Report stated that the TGA make its adverse events database available to, and searchable by, the public in a manner that supports the quality use of therapeutic goods. The Government agreed to the recommendation in December 2011.
The release of adverse event information relating to Australia as part of that joint, publicly available database will be supported by a separate legislative instrument under subsection 61(5D) of the Act. Subsection 61(5D) enables the Minister to specify in an instrument kinds of therapeutic goods information, which the Secretary may then release to the public under subsection 61(5C) of the Act.
Currently, however, the proposed database (the Database of Adverse Event Notifications, or DAEN) is not yet in its final form, and there is a need for it to be evaluated and tested by informed users in order to provide feedback to the TGA to assist in finalising the database and the content of the reports proposed to be available to those using the database.
It is therefore proposed that access to a prototype of the DAEN be given for a short period to a number of bodies that represent specific industries relating to therapeutic goods (such as Medicines Australia and the Complementary Healthcare Council of Australia) as well as to important relevant consumer bodies (the Australian Consumers Association (Choice) and the Consumers’ Health Forum of Australia), the Australian Medical Association and Medsafe and the New Zealand Ministry of Health, so they can provide comments on the prototype database.
The Specification has the effect of permitting the Secretary to release to these bodies, and to their employees, members or agents, the kinds of therapeutic goods information relating to adverse events reported in Australia that is proposed to be released by the TGA from the new database, for the purposes of obtaining feedback from those bodies and persons about the functionality, suitability (in terms of informing the public about adverse events involving medicines) and presentation of the proposed database.
An adverse event is defined in the Specification as any untoward medical occurrence in a patient administered medicine and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicine, whether or not considered related to this medicine.
The information proposed to be released by the Secretary through access to the prototype of the database will be in either of two forms:
- a list of reports of adverse events in relation to a medicine that contains a short description of each adverse event occurring in relation to the medicine reported within a specified period (‘list of reports’); and
- a summary of adverse events in relation to a medicine that contains a summary of all adverse events occurring within a specified period (‘medicine summary’).
The information proposed to be released in response to a request for the first type of report (the list of reports) includes the name of the medicine involved in an adverse event, the nature of the adverse event (in the form of the descriptive term relating to the relevant reaction set out in the Medical Dictionary for Regulatory Activities (MedDRA)[1]) and the patient’s age.
The information proposed to be released in response to a request for the second type of report (the medicine summary) includes the number of adverse events reported during the specified period, the system organ class terminology, as described in the MedDRA, for the part of the body which each adverse event was reported as affecting and the MedDRA adverse event description term that relates to each reported adverse event.
The kinds of therapeutic goods information that the Secretary can decide to release, the bodies and kinds of persons to whom the Secretary can decide to release that information and the purposes for which the Secretary can decide to release that information, are set out at Schedule 1 to the Specification.
CONSULTATION
The measures set out in the Specification are considered to be minor and machinery in nature, because the release of the kinds of therapeutic goods information, to the bodies and kinds of persons specified in that instrument, is designed for the specific purpose of testing a prototype of the TGA’s proposed new database by relevant stakeholders.
The Specification is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
In relation to compatibility with human rights, it is considered that the Specification is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011, and a Statement of Compatibility setting that out in further detail is attached.
ATTACHMENTS
1. Statement of compatibility for a legislative instrument that does not raise any human rights issues (Therapeutic Goods Information (Stakeholder Consultation on Database of Adverse Event Notifications) Specification 2012).
[1] MedDRA is an internationally recognised set of terms relating to medical conditions, medicines and medical devices, maintained and distributed by the MedDRA Maintenance and Support Services Organisation (MSSO). The MedDRA is available for viewing by subscribers to the MSSO’s services from www.meddramsso.com.