EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods Information (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), which is part of the Department of Health and Ageing, 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 which the Secretary may release specified kinds of therapeutic goods information.
The Therapeutic Goods Information (Database of Adverse Event Notifications) Specification 2012 (the Specification) is made by the Minister under subsection 61(5D) of the Act and specifies the kinds of therapeutic goods information that the Secretary may then release to the public under subsection 61(5C) of the Act.
The Specification has the effect of permitting the Secretary to release therapeutic goods information of a kind mentioned in the Specification to the public.
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 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 towards 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 the New Zealand Medicines and Medical Devices Safety Authority (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 publicly accessible database of adverse event notifications relating to medicines used in Australia and New Zealand.
The establishment of such a database – to be known as the Database of Adverse Event Notifications, or the DAEN - is expected to provide a number of benefits to both the TGA and Medsafe as well as for health-related industries and consumers, including providing consumers with more information about the number and types of adverse events reported relating to particular medicines (and therefore assisting consumers to be better informed about their safety), and supporting therapeutic research and analysis relating to the incidence of adverse events.
The establishment of this database also addresses one of the recommendations of the Report of the Review to improve the transparency of the TGA (released on 21 July 2011). 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. A copy of this Report is available from the TGA website, www.tga.gov.au. The Government agreed to the recommendation in December 2011.
The purpose of the Specification is to support the release to the public of adverse event information relating to Australia contained in the DAEN by identifying, under subsection 61(5D) of the Act, the kinds of information that the Secretary may publish under subsection 61(5C) of the Act (in the form of the new database).
Subsection 61(5D) of the Act empowers the Minister to, by legislative instrument, specify kinds of therapeutic goods information for the purposes of subsection 61(5C) of the Act.
Under subsection 61(5C) of the Act, the Secretary may release to the public therapeutic goods information of a kind specified by the Minister under subsection 61(5D) of the Act.
The information that will be released by the Secretary through access to the DAEN 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 reported as having occurred in relation to the medicine within a specified period (‘list of reports’); and
- a summary of all adverse events reported as having occurred in relation to a medicine 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 reported as being involved in an adverse event, the reported nature of the adverse event (in the form of the descriptive term relating to the relevant event set out in the Medical Dictionary for Regulatory Activities (MedDRA)[1]) and the patient’s reported age and gender.
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 as being related to a medicine 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 medicine summary would also include, in relation to a medicine for a specified period, the number of reported adverse events in which the medicine was reported to have been the sole suspected medicine involved (that is, the only medicine noted by the person reporting the adverse event as having been related to the event), and the number of reported adverse events noted by those providing the information as having resulted in death.
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 that medicine. 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 the medicine.
The kinds of therapeutic goods information that the Secretary can decide to release is set out at Schedule 1 to the Specification.
CONSULTATION
A number of key stakeholders were consulted in relation to a prototype of the DAEN and its functionality, suitability (in terms of informing the public about adverse events involving medicines) and presentation.
These stakeholders included a number of bodies that represent specific industries relating to therapeutic goods (including Medicines Australia, the Generic Medicines Industry Association of Australia, the Australian Self-Medication Industry Incorporated and the Complementary Healthcare Council of Australia), relevant consumer bodies (the Australian Consumers Association (Choice) and the Consumers’ Health Forum of Australia) and the Australian Medical Association, as well as Medsafe, the New Zealand Ministry of Health, the New Zealand Pharmacovigilance Centre, University of Otago, New Zealand and the New Zealand Self Medication Industry Association Incorporated.
The stakeholders made a number of comments which have now been considered by the TGA. A number of changes have, as a result, been incorporated into the version of the DAEN that will be released to the public.
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 (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.