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

Drug makers would give 12 months' stop notice

Shortages of pills for ADHD, a condition that makes it hard to focus, and of hormone patches and drip fluids have hit Australians hard. This bill would give patients and doctors more warning. It would let the drug watchdog ask about any medicine's supply, and firm up powers to inspect drug trials.

Official name: Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026

Who it affects

• Patients on prescription drugs: They and their doctors would get more warning when a medicine is going off the market.
• Doctors, chemists and hospitals: They would get earlier and fresher news to plan for shortages and switch patients.
• Medicine companies: They must give longer notice before they stop selling, report changes fast, and answer supply questions for any medicine.
• Drug trial sites: Inspectors can enter, search and inspect them without a warrant, under the main law.
• Companies selling products made from human tissue: Similar products could share one entry on the official list.

Medicine shortages hit Australians hard

A medicine shortage happens when there is not enough of a medicine for the patients who need it. Causes include factory problems, wars overseas, natural disasters and sudden jumps in demand.

Australia buys most of its drugs from overseas and is a small market. So it is at risk when world supply chains break. Supply chains are the factories and shipping that bring goods here.

Recent shortages have hit drugs for ADHD, hormone patches, some birth control pills, Ozempic and drip fluids. Ozempic is a diabetes drug also used for weight loss.

Stopping a medicine for good is different from a shortage. It means a company has decided to stop selling a medicine in Australia for good.

The Therapeutic Goods Administration is the national watchdog for drugs and medical products. Call it the drug watchdog.

Since 2019, the companies behind many drugs have had to report shortages and plans to stop selling. The law calls these companies sponsors.

The watchdog asked people for views on changes in 2024 and 2025. It heard that patients and health workers needed earlier warning. It also heard that some vital drugs were not covered.

Twelve months' notice

Some drugs must be reported when they run short. These are prescription drugs, tightly controlled drugs, and some other drugs the minister names. Call them reportable drugs.

Today a company must give 12 months' notice if stopping a reportable medicine would have a critical impact. That means it could seriously harm patients and there is no good swap. For other reportable drugs, only 6 months' notice is needed.

Companies often find it hard to judge what counts as critical. A medicine used by only a few people can still be vital to them.

The bill removes the split. Companies behind all reportable drugs would have to give at least 12 months' notice before they stop selling.

A company may not be able to give that much notice. For example, an ingredient may suddenly run out. Then it must tell the watchdog as soon as it can. The watchdog can choose when to make the news public, so people do not panic-buy.

Say you rely on a powder medicine that only a small group of patients use. Under the new rule, you and your doctor should hear about a plan to stop it a year ahead. That gives time to find another option.

Updates when plans change

Once a company has given notice, it would have to tell the watchdog if the plan changes. That includes a new stop date, or a decision to keep selling after all.

For drugs on the Medicines Watch List, the update is due within 2 working days. The Watch List is the official list of drugs whose shortage could cause serious illness or death. For other drugs the update is due within 10 working days.

A company that fails to report a change could face a fine set by a court. The top fine is 100 penalty units for a person and 1,000 penalty units for a company. A penalty unit is a set dollar amount used in federal law.

The government says other steps would usually be tried first, such as an on-the-spot fine.

Questions about any supply

Right now the watchdog can only demand supply details from companies behind reportable drugs.

But shortages of other products have caused serious problems for hospitals. These include some drip fluids, dyes used in medical scans, and radioactive drugs used in tests.

The bill lets the head of the health department ask the company behind any approved medicine about its supply. This is done by written notice. The company would have to say whether there is a shortage or a plan to stop selling it.

For example, hospitals may warn that a product is getting hard to find. The watchdog could then ask the company what is going on.

Similar biologicals grouped

Biologicals are medical products made from human cells or tissue. Examples are skin and bone grafts, which are pieces used to repair the body. Stem cell products are another example.

Ordinary drugs that differ only a little can already share one entry on the official list. Biologicals cannot. So each small change needs its own entry and yearly fee.

The bill lets the health department head set up groups of similar biologicals. They could then share one entry on the list.

A second bill goes with this one. It is the Therapeutic Goods (Charges) Amendment Bill 2026. It lets the government set one yearly charge for each group.

Clinical trial sites inspected

A clinical trial tests a new medicine or device on volunteers before it is approved. Call it a drug trial.

Over 95% of trials in Australia are reported to the watchdog through a scheme where it does not check the product itself. But the watchdog does inspect trial sites. It makes sure trials follow world standards of good practice and keep volunteers safe.

The powers to enter, search and inspect trial sites now sit in detailed rules the government writes without a vote. The government says strong powers like these belong in the main law passed by Parliament. The bill moves them there.

Approved inspectors could enter a trial site without a warrant or the owner's OK. A warrant is written permission from a judge or official. They could search, take samples, take photos and copy records.

They cannot enter a home without the owner's OK or a warrant. The watchdog says most visits are announced about 4 weeks ahead. Surprise visits are only for urgent safety reasons.

Watch list kept current

The Watch List includes vaccines from the national list of free vaccines, called the National Immunisation Program.

Today the Watch List can only copy that vaccine list as it stood on one date. So it falls behind when the vaccine list changes several times a year. The bill lets the Watch List follow other papers as they change over time.

The bill also fixes a typing mistake in a vaping crime, so the law works as first planned. It removes out-of-date rules.

It also tidies the wording about the Poisons Standard. That standard sorts drugs and chemicals by how tightly they are controlled.

Waiting in the Senate

All of the bill would start the day after it becomes law. A bill becomes law when the Governor-General signs it. The Governor-General is the King's stand-in in Australia.

The 12-month notice rule applies to decisions made after that. The rule on updates also covers plans to stop selling that were reported before the bill starts.

The government brought the bill to the House of Representatives on 2 July 2026. It was sent to a group of senators who look at health and community bills. They were asked to report by 1 September 2026.

The House passed the bill on 12 August 2026. It went to the Senate the same day. The Senate is the second house of Parliament, which checks bills. The Senate now needs to debate and vote on it.

Its journey through Parliament

Official sources

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

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