Trump has generic drugs in Australia in its sight. And nobody talks about it

While Australia was busy defending the pharmaceutical benefits program against threats from the United States in recent weeks, another issue related to the supply and trafficking of drugs was flying under the radar.

Buried Page 19 The allegations of Trump’s administration about trade barriers was a single paragraph associated with Australia’s access to generic drugs. These are cheaper alternatives for branded drugs that are no longer under the patent.

The United States is concerned about how many pharmaceutical companies noticed that Australia will introduce the overall version of their product. After melting a single general version of the drug on PBS, the price will drop. The US claim that the lack of prior notification is a trade barrier.

Is pressure That Australia imitate the aspects of the American system in which pharmaceutical companies can delay general copies their drugs by 30 months.

If the US is playing hardball in this matter, perhaps in exchange for other concessions, this may delay Australia’s access to cheaper generic drugs.

It would also mean significant pressure on Australia’s drug budget, because the government can be forced to pay for more high-priced brand versions to provide supply.

What is the current process?

Pharmaceutical companies operate patents to protect intellectual property and prohibit other manufacturers of copying the drug. The standard patent term in Australia is 20 years, but the time that the product is protected by patents can be expanded in many ways. When patents expire, other companies can introduce general versions to the market.

The general producer who wants to sell his medicine in Australia must apply for the administration of therapeutic goods (TGA) for regulatory approval. Before granting approval must ensure TGA certificate, which states or:

a) that the product will not violate an significant patent, or

b) that he informed the patent holder about the intention of selling the product.

The certificate can be delivered after the general TGA assessment – before it ensures approval.

If the general company selects the “A” option, the manufacturer of the patented product may not find out that the competitive product will be launched as long as TGA approves it.

The patentist may then apply for a judicial order to temporarily stop the general entering the market, while legal battles are fighting for patent problems.

However, if the first general was already launched and added to PBS, it starts it Automatic price drop by 25%. This affects all versions of the drug, including a patented product.

In Australia, patented pharmaceutical companies that try to delay genetic drugs, taking legal actions without a reasonable reason, can face penalties and be obliged to pay compensation.

Patented pharmaceutical companies do not like this system. They want to be as early as possible that he plans to start general so that they can initiate legal activities and prevent or delay the overall entry and related price reductions.

Is the Australian system compatible with our commercial responsibilities?

Australia has introduced its patent notification system at the US’s request to comply with Australia-Usa Free Trade Agreement (Ausfta). The World Trade Organization does not require a patent notification.

The Australian system differs from the United States system. But This is in line with the rules negotiated between two countries.

American pharmaceutical companies have long argued that the Australian system is a trade barrier. They want Australia to change it more like the US system.

Why do the USA argue that this is a trade barrier?

. Trump administration report on foreign trade barriers The states of “USA and Australian pharmaceutical companies expressed concerns about delays” in the patent notification process.

The report also mentions concerns about the potential of penalties and compensation when the patent owner undertakes legal action against the general company.

This report reflects long -term fears of the American pharmaceutical industry. In March, his drug creators Trade Association He wrote to the US sales representative Complaining that “lack of adequate notification” is an unfair commercial practice. He argued that this causes uncertainty for patent owners, prevents the resolution of patent challenges before entering the generic market and the patented penalty of companies lying on an attempt to protect their rights.

Medicines Australiawhich represents Australian subsidiaries of many vast patented drugs, resembles these fears.

What do the United States want instead?

The US patent notification system is much more favorable for patented pharmaceutical companies than Australia.

In the United States, the general company must notify the patented pharmaceutical company within 20 days of submitting an approved application.

Then, within 45 days of receiving the notification, the patent holder may ask the regulator to impose a 30-month delay on general approval.

This means that there is an automatic 30-month delay in general start, unless patents expire in the meantime or the court decides earlier that valid patents are not violated.

What could happen if Australia bowed to the US pressure?

The change in the Australian system, in order to resemble the United States more, would delay genetic drugs entering the market in Australia and maintain a higher price of drugs.

The faster generic can be added to PBS, the less the government pays. When the first general is replaced in PBS, all versions of the product used a 25%price reduction, including a patented version.

Over time, as more generic, the prices still fall. Having high general competition can ultimately cause prices lower than PBS’s co -caravity, which causes savings for consumers.

In the long run, lost savings from the timely list of generic drugs on PBS would reduce the value for money and augment cost pressure.

Over time, it can also delay savings for drug consumers priced below PBS co -orientedness.

Both main parties say that they do not operate PBS as a tender chip in negotiations with the USA regarding tariffs. They must also resist pressure to sluggish down access to generic drugs.