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  Healthy Policies: The TPP’s intellectual property provisions – a
  blow for global health and access to medicines
  <http://www.healthypolicies.com>

	

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The TPP’s intellectual property provisions – 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 States’ 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 Australia’s 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 TPP’s 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 years’ 
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 “at 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.” 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 – Vietnam, Malaysia, Mexico and Peru – 
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 TPP’s 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.

Vietnam’s 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, Vietnam’s 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 TPP’s 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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