[Ip-health] PharmaTimes - Australian copyright law amendments boost generics

Press HAI Europe Press at haieurope.org
Mon May 16 01:34:41 PDT 2011


Australian copyright law amendments boost generics

 

World News | May 13, 2011

 

Lynne Taylor

 

Australian copyright law amendments boost generics

 

Australian consumers and health professionals will have more ready
access to generic drugs following the federal parliament's passage of
new amendments to the Copyright Act this week, says the government.

 

The newly-approved Therapeutic Goods Legislation Amendment (Copyright)
Bill 2011 was introduced as a result of increasing claims by originator
drugmakers that product information approved by the Therapeutic Goods
Administration (TGA) for generic versions of their products was
essentially the same as the original and therefore constituted a breach
of copyright. 

 

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Brand-name pharmaceutical manufacturers have sought to use this argument
to delay or prevent generic versions of their products from entering the
market, but the new amendments will ensure that product information is
consistent across different versions of equivalent medicines without
constituting any breach of copyright, according to Ministers.

 

The TGA requires pharmaceutical manufacturers to submit a product
information document providing advice to health professionals and
consumers about the medicine, and this information must be the same for
all brands of the same medicine to ensure that they are used
appropriately, said Catherine King, Parliamentary Secretary for Health
and Ageing.

 

This consistency is critical, because any difference in the text of
product information "could be misinterpreted as reflecting differences
between the brands where in fact none exists," she added.

 

Ms King said she welcomed the passage of the amendments because any
delay in generic medicines entering the market means a delay in their
listing on the Pharmaceutical Benefits Scheme (PBS), "leading to higher
costs for consumers and the government."

 

She also emphasised that the government has ensured that the amendments
"go no further than is absolutely necessary," and that it believes they
will "restore the appropriate balance between ensuring safe and timely
access to medicines and encouraging R&D in the pharmaceutical industry
through appropriate protection of intellectual property."

 

The bill's passage was welcomed by the Generic Medicines industry
Association of Australia (GMiA) as "important public policy." If
parliament had done nothing about the allegations of copyright
infringement, generics firms could not only have been prevented from
providing the information that accompanies their products but also from
supplying generics to the Australian market, the industry group claimed.

 

Links

 

www.tga.gov.au

www.health.gov.au

www.gmia.com.au




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