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Therapeutic Goods (Charges) Amendment Bill 2010

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2008-2009

 

 

 

 

 

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

 

 

 

 

 

HOUSE OF REPRESENTATIVES

 

 

 

 

 

 

 

THERAPEUTIC GOODS AMENDMENT (2009 MEASURES NO. 3) BILL 2009

THERAPEUTIC GOODS (CHARGES) AMENDMENT BILL 2009

 

 

 

 

 

 

 

 

 

 

CORRECTION TO THE EXPLANATORY MEMORANDUM

 

 

 

 

 

 

 

 

 

 

 

 

 

(Circulated by authority of the Hon Mark Butler MP, Parliamentary Secretary for Health)



THERAPEUTIC GOODS AMENDMENT (2009 MEASURES NO. 3) BILL 2009

THERAPEUTIC GOODS (CHARGES) AMENDMENT BILL 2009

 

CORRECTION

 

Replace page 4 with the following :

 

What are human cell and tissue therapies (HCTs)?

 

In summary, tissue therapy involves the use of tissues as therapeutic goods, while cell therapy involves the use of isolated living cells either as therapeutic goods or as replacements for cells that are defective or deficient in particular disorders. 

 

The distinction between cell therapy and tissue therapy may sometimes be blurred.  A therapy may make use of living cells organised as tissues to grow or differentiate to treat a condition, or tissues may be purified to extract certain cells that may be used for therapeutic benefit.

 

Some examples of tissue therapies currently being used are:

·          skin replacement after severe burns;

·          transplantation of heart, kidney, liver, lung or pancreas; 

·          bone, tendons and ligaments to repair injuries;

·          heart valves to replace defective heart valves; and

·          corneas to restore eyesight.

 

Some examples of cell therapies currently being used, or currently under development, are:

 

·          chondrocytes used for cartilage regeneration;

·          isolated pancreatic islet cells for the treatment of diabetes; and

·          mesenchymal progenitor cells for the treatment of musculoskeletal defects and in a range of other clinical applications such as cardiovascular repair.

What is the nature of the industry producing HCTs in Australia?

In the past, HCTs have primarily been “manufactured” by not-for-profit tissue banks (who have traditionally processed and stored tissues for future use) and by hospitals (who develop tissue therapies in house for use in particular patients).  However, with recent advances in cell and tissue technology, there appears to be increasing involvement of the private sector in the manufacture of HCTs and the creation of small start-up companies and clinics within larger hospitals.  During consultations, on the draft consultation RIS during the development of ANZTPA, it was also noted that medical devices manufacturers may, in the future, incorporate HCTs into the manufacture of medical devices.

 

As the TGA does not currently regulate all HCTs (refer discussion below), it is not possible to identify all organisations involved in the manufacture of HCTs.  However, the TGA is aware of a number of companies (including small start-up companies) and organisations undertaking such work. 

 

The table at Attachment A has been based on information available as at December 2008 regarding the organisations within each jurisdiction that are believed to be undertaking work involving HCTs (or who are currently subject to TGA regulation). The information does not include any HCTs manufactured overseas that are currently regulated (as therapeutic devices) or may seek inclusion on the ARTG.