06 December 2005
Key Points:
The "Working Together" Guide
On 28 November 2005, the Minister for Health and Ageing, Tony Abbott, launched the "Working Together" Guide and Supplementary Materials which serve as a guide to relationships between health consumer organisations (not-for-profit organisations that represent the interests and views of consumers of health care) and pharmaceutical companies.
Health consumer organisations and pharmaceutical companies regularly work together to address the needs of health consumers. The Guide and Supplementary Materials are designed as a reference tool on how these bodies can better work together offering basic principles and suggestions that can be adapted to suit the individual needs of bodies.
The Guide and Supplementary Materials were jointly developed by the Consumers' Health Forum of Australia and Medicines Australia. A wide range of representatives from both health consumer organisations and the pharmaceutical industry were consulted and the process was managed by a joint Steering Committee.
The Consumers' Health Forum of Australia and Medicines Australia would appreciate comments on the Guide. The Guide is to be reviewed a year from its release and feedback will help refine the document and determine whether any changes should be made to future editions. Feedback should be provided by 31 October 2006.
New TGA proposal: public access to the ARTG
Consumers may soon be able to access a wide range of information about any therapeutic good entered on the Australian Register of Therapeutic Goods ("ARTG") under the new proposal advanced by the Therapeutic Goods Administration ("TGA") as part of its attempt to increase transparency of the regulatory system. Currently, information on therapeutic goods is held on the ARTG database and in hard copy form with approximately 63,800 products on the ARTG as at 30 September 2005.
Under the Therapeutic Goods Act 1989, the TGA is limited in the range of information that it can publicly release and to whom. The associated Therapeutic Goods Regulations 1990 ("the Regulations") permit the release of certain information only if it is specified in the Regulations and then only if a person applies for the release of such information.
The new proposal to publicly release therapeutic goods information, including via the internet, will allow the public to access all the details of the therapeutic goods listed in regulation 46(2), plus some additional items such as the ARTG label name, product and component ID (these are computer generated numbers that assist in presentation of the information), product type and pack size, shelf-life information, visual identification information and any product warnings. However, information that is genuinely commercially sensitive, such as product formulation details, will continue to be protected.