Before ParliamentHealth & Care Introduced in the House of Representatives, 02 Jul 2026

Similar biological products could share one fee

Some companies sell medical products made from human cells and tissue. They pay a yearly fee for each product on the national list. This bill would let a group of near-identical products share one spot on the list and one fee.

Official name: Therapeutic Goods (Charges) Amendment Bill 2026

Who it affects

• Companies that sell biologicals: If they have several very similar products, they could pay one yearly fee for the group.
• The Therapeutic Goods Administration: This is the medicines watchdog. It would collect a little less money from these fees.
• Patients: Nothing changes for them directly. The products are still checked for safety as before.

One fee for every product

The Therapeutic Goods Administration is the medicines watchdog. It checks that medicines and medical products are safe and work. We will call it the watchdog.

Most of these products must be on an official national list before they can be sold. The list is called the Australian Register of Therapeutic Goods. The company in charge of a product on the list is called its sponsor.

Sponsors pay a yearly fee for each spot on the list. The watchdog uses this money to keep an eye on products once they are for sale. It also checks that companies follow the rules.

The fee amounts are set in detailed rules. The government writes these rules without a new vote in Parliament.

This bill is a partner to a bigger bill. That one is called the Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026. It deals with times when medicines run short, checks on medical trials (tests of new treatments on people), and other changes.

One of its changes lets similar biologicals share a single spot on the list.

Why grouping biologicals matters

A biological is a product made from, or containing, human cells or tissue. It is used to treat or find illness, or to change how the body works.

Examples include skin, bone and eye tissue grafts and stem cell products. Stem cells are cells that can grow into other kinds of cells. Products made from healthy gut germs are another example.

Normal medicines can already be grouped. If several versions differ only in small ways, they can share one spot and one yearly fee. Biologicals have their own separate rules. Those rules never allowed grouping.

So a sponsor with five almost identical tissue products must keep five spots and pay five yearly fees. That is true even when the only difference is a small change in how a product is made. It is also true when the only change is a new use for it.

What the bill changes

This bill changes the law that sets the watchdog's fees. It lets the detailed rules set one yearly fee for a group of biologicals that share one spot on the list.

Say a company sells bone graft products in three slightly different forms. Once the watchdog groups them, the company could hold one spot and pay one yearly fee.

The fee must be paid for any year when the group is on the list, even for part of the year.

The government says the amount will match the cost of checking these products for safety. Its policy is that industry pays the cost of the checks it needs. The watchdog will talk to the industry before setting the fee.

The bill puts no top limit on the fee. The government says any limit would be picked out of thin air and would confuse people. Parliament can still vote to cancel the rules that set the amount.

Waiting in the Senate

This bill starts at the same time as the partner bill. The partner bill starts the day after it is signed into law. If the partner bill never starts, this one does not either.

The new group fee applies from the first money year that begins after the bill starts.

The government brought the bill into the House of Representatives on 2 July 2026. The House passed it on 12 August 2026 and sent it to the Senate, Parliament's second house, the same day.

Both bills were sent to a group of senators to look into. The Senate now needs to debate the bill and vote on it.

Its journey through Parliament

Official sources

• Bill page on aph.gov.au
• Text of the bill
• Explanatory memorandum
• Bills Digest

Open the full interactive page