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From: *Gladys Baldew* <[log in to unmask] <mailto:[log in to unmask]>>
From: *Healthy Policies* <[log in to unmask]
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Healthy Policies: The TPPâs intellectual property provisions â a
blow for global health and access to medicines
<http://www.healthypolicies.com>
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The TPPâs intellectual property provisions â a blow for global
health and access to medicines
<http://feedproxy.google.com/%7Er/HealthyPolicies/%7E3/PjtW0BwgktU/?utm_source=feedburner&utm_medium=email>
Posted: 19 Oct 2015 11:36 AM PDT
/In this guest post, Dr. Deborah Gleeson
<http://www.healthypolicies.com/contributors/#Deborah%20Gleeson>
discusses the final negotiations of the recently agreed trade accord,
the Trans-Pacific Partnership, and resulting implications for access to
medicines. Deborah is a lecturer in the School of Psychology and Public
Health at La Trobe University in Melbourne, Australia. Her research
focuses on the impact of international trade agreements on health./
Battles over medicine monopolies almost completely derailed the
negotiations for the controversial Trans Pacific Partnership Agreement
in the final days of negotiations in early October.
At issue was the United Statesâ efforts to use the TPP as a vehicle to
extend market exclusivity for biologic products, an emerging class of
cancer and immunotherapy treatments and vaccines. Extending monopolies
on these very expensive products was expected to delay the market entry
of more affordable medicines for hundreds of millions of people in TPP
countries, placing them out of reach indefinitely for people in
developing countries and adding significantly to pharmaceutical
expenditure even in wealthy countries.
Transnational pharmaceutical companies headquartered in the US, and
their industry association PhRMA, had been very clear about their key
objective in the negotiations: to obtain 12 years of market exclusivity
for biologics
<http://phrma.org/note-media-elected-officials-support-12-years-data-protection-tpp>,
matching the length of the monopoly in US law. And according to the
Sunlight Foundation
<https://sunlightfoundation.com/blog/2014/03/13/tpp-lobby/>, the
pharmaceutical industry was by far the industry most actively lobbying
to influence the negotiations from 2009-2013.
That monopolies for biologic drugs became the final sticking point to be
resolved in the TPP reflects just how out of step the US intellectual
property settings are with the rest of the world, and how unpalatable
the US pharmaceutical agenda was to the other TPP countries. While Japan
and Canada provide eight years of exclusivity for biologics, most of the
TPP countries currently provide either five years, or none.
The Australian Government, responding to pressure from health and
community organisations, and fully aware of the degree of political
opposition to anything that would increase the cost of medicines,
refused to budge from its existing 5 years of data protection
<http://www.afr.com/news/politics/national/us-australia-drug-dispute-is-holding-up-settlement-of-the-trans-pacific-trade-deal-20151003-gk0r65>.
The US had to make a humiliating retreat in order to conclude the
agreement before the US election cycle made further negotiating progress
impossible.
So now that the dust has settled, where do things stand? And to what
extent does Australiaâs victory over biologics in the final hours
represent a real victory for global health?
The final text of the TPP has not yet been publicly released but in the
interim, Wikileaks has released <https://wikileaks.org/tpp-ip3/> a
leaked copy of the intellectual property chapter agreed between the
parties at the conclusion of negotiations.
While there is no doubt that some of the worst elements of the initial
US proposals for the TPPâs intellectual property chapter have been
mitigated along the way
<https://www.mja.com.au/journal/2015/202/6/costs-australian-taxpayers-pharmaceutical-monopolies-and-proposals-extend-them>,
the final outcome is still no less than a disaster in global health terms.
Many of the initial harmful provisions proposed by the United States
remain in the text. These include, among others: patents for new uses
and new methods of using existing products, a low inventiveness
threshold for issuing patents, patent term extensions for delays in
granting patents or processing marketing approval applications, at least
five years of data protection for new pharmaceutical products, and
patent linkage provisions likely to result in delays in marketing
approval for generics.
For the first time in a trade agreement, the TPP also includes a
provision requiring countries to provide a minimum of five yearsâ
market exclusivity for biologics. The wording of this provision is
ambiguous, allowing considerable room for the US to pressure other
countries to increase the length of the exclusivity period.
In some cases, the initial US proposals have been softened. For example,
the first US IP proposal sought to make it mandatory for countries to
provide patents for new forms, new uses and new methods of using
existing products. The other TPP countries refused altogether to accept
the requirement to provide patents for new forms, and the final TPP text
<https://wikileaks.org/tpp-ip3/> requires countries to provide
patents for âat least one of the following: new uses of a known
product, new methods of using a known product, or new processes of using
a known product.â The patent term extension and patent linkage
provisions have also been made more flexible and less onerous than
earlier drafts.
But there is still much in the IP chapter that will expand and extend
monopolies and delay competition from more affordable follow on products
in many countries. Even in wealthy countries like Australia, the TPP
obligations will lock in current intellectual property standards, making
it difficult or impossible to reform IP laws to improve access to
affordable medicines in future.
The four poorest countries â Vietnam, Malaysia, Mexico and Peru â
have been given transition periods
<https://wikileaks.org/tpp-ip3/pharmaceutical-transition/TPP%20Transition%20Periods%20on%20Pharmaceuticals.pdf>,
but at only three to ten years in length, these are far too short for
the realities these countries face, and they apply to far too few of
the TPPâs obligations. For example, Vietnam will only have three years
to implement a patent linkage process and three to five years to
introduce patent term extensions. When the TPP comes into force, Vietnam
will be immediately locked into a low inventiveness threshold and will
need to grant additional secondary patents.
Vietnamâs situation is of particular concern because, with the lowest
GDP per capita of the TPP countries, it already struggles to provide
affordable medicines for its population. A study based on the provisions
in a 2014 leaked draft of the IP chapter
<http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2536254> indicated
that, assuming its budget of 25.1 million USD for HIV treatment remained
constant, Vietnamâs treatment coverage for eligible people living with
HIV could fall from 68% to around 30%. Many of the provisions on which
this analysis was based remain in the final text.
The pharmaceutical industry has expressed disappointment
<http://phrma.org/media-releases/phrma-statement-on-the-transpacific-partnership-negotiations>
over the failure of the US to obtain 12 years of exclusivity for
biologics, but in reality it has gained enormous concessions. If the TPP
countries ratify the deal, Big Pharma will have succeeded in cementing
intellectual property standards that will stymie access to medicines for
up to 800 million people in the short term, and more if additional
countries sign up in future. Furthermore, the TPPâs intellectual
property chapter sets a new norm that is likely to become the template
for future trade agreements: its implications are global as well as
regional.
Civil society advocacy has blunted some of the most extreme US proposals
for the TPP. But if ratified and enforced, it will still prevent untold
numbers of people from gaining access to affordable medicines.
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