[Ip-health] Matthew Rimmer in SBS News: Comment: Julia Gillard, Big Pharma, patent law and public health

Thiru Balasubramaniam thiru at keionline.org
Sun May 17 21:49:12 PDT 2020


Comment: Julia Gillard, Big Pharma, patent law and public health

It takes a lot of bravery for governments to stand up to big business, and
the Gillard government has shown a lot of guts during its term, writes
Matthew Rimmer from Australian National University.

UPDATED 03/09/2013

By Matthew Rimmer, Australian National University

It takes a lot of bravery for governments to stand up to big business. But
the Gillard government has shown a lot of guts during its tenure.

It stood up to Big Tobacco in the battle over plain packaging of tobacco
products and has defended individuals and families affected by asbestos. It
took on Big Oil in its Clean Energy Future reforms and stood up to the
resource barons with the mining tax.

The government is now considering Big Pharma – the pharmaceutical industry
and their patents – and has launched several inquiries into patent law and
pharmaceutical drugs.

The evils of evergreening

One of Julia Gillard's finest speeches in the Australian Parliament was on
the topic of dodgy drug patents. She took the Howard government to task for
allowing patent owners to engage in the nefarious practice of
“evergreening” – extending the life of patents beyond their natural term by
making minor changes.

The context for the speech on August 4 2004 was a debate over the
Australia-United States Free Trade Agreement.

In October 2012, the Australian government announced an inquiry into
pharmaceutical drug patents. The Parliamentary Secretary for Industry and
Innovation Mark Dreyfus QC observed, “In certain circumstances,
pharmaceutical patents can be extended by up to five years beyond the
normal patent term. These provisions were introduced back in 1998, and are
due for review.”

An expert panel will consider a number of matters relating to patent law,
the pharmaceutical industry, health care and competition.

Medicines Australia, which represents big brand-name pharmaceutical drug
companies, has demanded direct patent term extensions. Its chief executive,
Brendan Shaw said, “Given it takes as long as three years to get a new
medicine listed on the Pharmaceutical Benefits Scheme, and rejection rates
by the Pharmaceutical Benefits Advisory Committee are increasing, it's
timely to look at whether patent terms are long enough.”

In fact, brand-name pharmaceutical companies are alarmed about the expiry
of patents on blockbuster drugs. Such companies have been demanding direct
and indirect patent extensions to obtain some final windfall benefits from
these medicines.

But such special pleading is unjustified by either patent policy or
empirical evidence. Patent term extensions – whether they take the form of
direct term extensions, or indirect evergreening – undermine the
fundamental objectives and purposes of patent law.

As Justice Michael Kirby observed in the case on reflux drug Losec, patent
law “should avoid creating fail-safe opportunities for unwarranted
extensions of monopoly protection that are not clearly sustained by law.”

Inquiry into compulsory licensing

Compulsory licensing is a public interest mechanism recognised under
international law, which allows for the use of a patent without the
permission of the patent owner, subject to procedural constraints and
adequate remuneration.

India – the world's leading supplier of generic medicines – has weathered
challenges to its patent regime from Big Pharma.

Thailand has engaged in compulsory licensing for essential medicines, as
has Malaysia and Indonesia – much to the indignation of patent owners. By
contrast, Australia lacks the effective mechanism of compulsory licensing
to allow for access to patents for the greater good of public health.

The Productivity Commission is conducting an inquiry into compulsory
licensing under patent law. The inquiry's purpose is to assess, advise and
recommend on the impacts and mechanisms of compulsory licensing invoked by
the Patent Act's public interest and anti-competitive safeguard. The
Commission has released an issues paper on the topic of patent law and
compulsory licensing.

Taking a maximalist stance, Medicines Australia has opposed modernising
Australia's compulsory licensing regime. The lobby group maintains, “The
fact that no compulsory licenses have ever been granted in Australia for
pharmaceutical products proves that there are other, much more effective,
means available to all members of the Australian community to resolve
patent related disputes.”

Somewhat dourly, AusBiotech has complained about Australia's neighbours,
such as India and Thailand, engaging in compulsory licensing.

By contrast, the Department of Health and Ageing has recommended
“simplifying the use of the Crown Use and Compulsory Licensing provisions”.
The department insists that such mechanisms are “an important safeguard for
governments to be able to ensure access to a patented technology in the
event that this is required to provide equitable access to affordable

And the Australian Fair Trade and Investment Network argues that public
interest mechanisms – such as compulsory licensing – should not be
curtailed by trade agreements. There's some concern that the Trans-Pacific
Partnership may curtail access to essential medicines.

Exporting essential medicines

It has taken nearly ten years for the Australian Government to prepare
legislation – Intellectual Property Laws Amendment Bill 2012 (Cth) – to
implement the WTO General Council Decision 2003 that allows for the export
of essential medicines.

So far, very few countries have implemented an effective regime to allow
for the export of essential medicines. Indeed, there's only been one
instance of the WTO General Council Decision 2003 being used – where the
Canadian generic manufacturer Apotex relied upon the export mechanism to
send drugs to Rwanda.

Indeed, it would be fair to say that, over the course of the last decade,
various Australian governments have been slow to respond to the matter of
patent law and access to essential medicines.

After long debate in 2011, Trade Minister Craig Emerson and the
then-Innovation Minister Kim Carr promised better access for medicines for
countries in need. Emerson said, “Pandemics and other serious health issues
remain a terrible problem in many of the world's poorest countries.
Anything Australia reasonably can do to alleviate the suffering in these
countries should be done and we are delighted to be able to help through
this initiative.”

Australia's proposed regime – contained in the Intellectual Property Laws
Amendment Bill 2012 (Cth) – is quite narrow and rigid in its design. The
draft legislation seems overly eager to appease brand-name pharmaceutical
drug owners. The drafters should revise the scheme so there's an effective
mechanism for the export of essential medicines in Australia.

The key test is whether the regime has a positive health impact. There's a
need to enable generic manufacturers to export medicines and other
humanitarian inventions to developing countries to address public health
concerns, such as HIV/AIDS, tuberculosis, malaria, and other diseases. An
effective compulsory licensing regime should be a part of a larger strategy
in respect to intellectual property and global health research and

Dr Matthew Rimmer is an Australian Research Council Future Fellow, working
on Intellectual Property and Climate Change. He is an associate professor
at the ANU College of Law, an associate director of the Australian Centre
for Intellectual Property in Agriculture (ACIPA), and a member of the ANU
Climate Change Institute. Dr Matthew Rimmer receives funding as an
Australian Research Council Future Fellow working on "Intellectual Property
and Climate Change: Inventing Clean Technologies" and a chief investigator
in an Australian Research Council Discovery Project, “Promoting Plant
Innovation in Australia”.

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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