Way Cleared for Improved Access to Generic Medicines
Australian consumers and health professionals will have more ready access to generic medicines following the passage of legislation through the Senate today.
View by date:
Previous MinistersPDF printable version of Way Cleared for Improved Access to Generic Medicines (PDF 49 KB)
11 May 2011
Australian consumers and health professionals will have more ready access to generic medicines following the passage of legislation through the Senate today.
Parliamentary Secretary for Health and Ageing Catherine King said the Therapeutic Goods Legislation Amendment (Copyright) Bill 2011 will ensure originating pharmaceutical companies can no longer use copyright of product information to delay or prevent generic medicines entering the market.
The amendments are a response to an emerging practice of pharmaceutical companies arguing that the product information approved by the Therapeutic Goods Administration (TGA) of a generic version of a medicine breaches copyright by being essentially the same as the original.
“These amendments will ensure that product information documents for medicines continue to be consistent across different brands of the equivalent medicine without this constituting a breach of any copyright,” Ms King said.
“I welcome the passage of this Bill because any delay in generic medicines entering the market means a delay in their listing on the Pharmaceutical Benefits Scheme leading to higher costs for consumers and the Government.”
To ensure that all Australians receive the best advice about their essential prescription medicines, the TGA requires pharmaceutical companies to submit a product information document which advises health professionals and consumers about the medicine.
“The product information of all brands of the same medicine should be the same, to ensure they are used appropriately,” Ms King said.
“This consistency in information, as required by the TGA, is critical because it is used by doctors, pharmacists and other health professionals to safely and correctly prescribe, dispense and administer medicines and provide patients with information about the medicine they are being given.
”Any difference in the text of product information used in relation to different brands of the same medicine could be misinterpreted as reflecting differences between the brands where, in fact, none exists.
”We have ensured that these amendments go no further than is absolutely necessary.
“The Government believes that they will restore the appropriate balance between ensuring safe and timely access to medicines and encouraging research and development in the pharmaceutical industry through appropriate protection of intellectual property.”
Ms King said the passage of the Bill would ensure even greater choice, more ready access and greater peace of mind for consumers and health professionals when dealing with important prescription medicines.
For more information, please contact the Parliamentary Secretary's Office on (02) 6277 4230
Help with accessing large documents
When accessing large documents (over 500 KB in size), it is recommended that the following procedure be used:
- Click the link with the RIGHT mouse button
- Choose "Save Target As.../Save Link As..." depending on your browser
- Select an appropriate folder on a local drive to place the downloaded file
Attempting to open large documents within the browser window (by left-clicking)
may inhibit your ability to continue browsing while the document is
opening and/or lead to system problems.
Help with accessing PDF documents
To view PDF (Portable Document Format) documents, you will need to have a PDF reader installed on your computer. A number of PDF readers are available through the Australian Government Information Management Office (AGIMO) Web Guide website.