Life Sciences Insights

21 September 2005

Welcome to the September edition of Clayton Utz Life Sciences Insights. In this edition we look at the changes to advertising rules which are the first step to the trans-Tasman scheme.

We'll also examine two key compliance issues: privacy in clinical trials and continuous disclosure.

We'll look at changes to the TGA's enforcement powers, consumer product safety system, and negligence laws.

Finally we'll learn about when it is not an infringement to use a patented invention for the development and submission of information under a US Federal law regulating the manufacture, use or sale of drugs.

The TGA gets set to get tough: Likely new enforcement options

By Amanda Turnill and Jodi Ainsworth.

Amanda Turnill and Jodi Ainsworth look at the proposed amendments to the TGA's enforcement options.

Code 2005: The first Australian regulatory step towards a trans-Tasman scheme

By Andrew Morrison and Lisa Kurian.

The new Therapeutic Goods Advertising Code not only brings in new obligations for sponsors, but as Andrew Morrison and Lisa Kurian show, it is also an important step towards the new trans-Tasman regulatory scheme.

Advertising prices of prescription products to be made clearer

By Julieann Ahern.

The draft Price Information Code of Practice should simplify advertising, says Julieann Ahern.

Quick dose

In brief: forthcoming legislation, patent certification relaxed, pathology services review, drug subsidy transparency, and drug pricing scheme scrutinised.

Australian consumer product safety: fundamental reform not needed, just improvements

By Andrew Morrison and Sara Dennis.

Andrew Morrison and Sara Dennis examine proposed changes to consumer product safety reform.

Health information privacy - Another layer of protection

By Greg Williams and Emma Salkavich.

New privacy laws in NSW will affect clinical trials, as Greg Williams and Emma Salkavich explain.

If you dice the mice you must pay the price

By Robyn Baker and Paris Petranis.

Amidst all the industry specific regulation, it is easy for listed entities to forget how strict their continuous disclosure obligations are, but as Robyn Baker and Paris Petranis show, failure to comply can have serious consequences.

The US Supreme Court decides an exceptional patent case

By Nicholas Tyacke and Rohan Higgins.

Under US patent law, it is not an infringement to use a patented invention for the development and submission of information under a US Federal law regulating the manufacture, use or sale of drugs - but how far does that exemption go? Nick Tyacke and Rohan Higgins look at the answer given by the US Supreme Court.

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