Commonwealth of Australia Explanatory Memoranda

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THERAPEUTIC GOODS (CHARGES) AMENDMENT BILL 2009

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.