[Ip-health] PLoS Speaking of Medicine Blog Post: How a Free Trade Agreement Threatens Your Health and the Health of the People You Care About

Reshma Ramachandran reshmagar at gmail.com
Fri Dec 6 07:04:44 PST 2013

 How a Free Trade Agreement Threatens Your Health and the Health of the
People You Care About
By PLOS Guest Blogger<http://blogs.plos.org/speakingofmedicine/author/plos_guest_blogger/>
Posted: December 6, 2013

*Reshma Ramachandran and David Carroll warn that the Trans-Pacific
Partnership will trample over access to affordable medicines*

Last month, Wikileaks <http://wikileaks.org/> posted the complete Intellectual
Property (IP) Chapter <https://wikileaks.org/tpp> of the
secretly-negotiated Trans-Pacific Partnership
Agreement<https://www.youtube.com/watch?v=Voa7Lc9pX38> (TPP)
confirming public health advocates’ worst fears of the agreement’s impact
on patients worldwide. The TPP is the largest free trade agreement to date
between the United States and 11 other countries (Australia, Brunei,
Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore,
Vietnam) comprising over 40 percent of global
This landmark agreement is expected to “set the standard for 21st century
trade agreements going
While free trade agreements are designed to lower barriers for the
importation and exportation of goods between countries and strengthen the
global economy through mechanisms such as lowered tariffs, the TPP goes far
beyond past traditional trade regulations with the inclusion of over 20
chapters on a variety of non-trade related issues including domestic food
safety, health, labor, environmental
Two of these chapters on investment and intellectual property will have far
reaching consequences on the public health of populations worldwide. The
TPP has been shrouded in secrecy, with only the negotiators and an
“advisory committee” of over 700 industry representatives allowed to read
drafts of the agreement. Even congress and congressional staffers have been
barred from examining drafts of this far-reaching

Since the previous leak of the IP Chapter in
several professional and civil society organizations including Doctors
Without Borders<http://msfaccess.org/content/msf-open-letter-tpp-countries-dont-trade-away-health>
, American Association of Retired
, Public Citizen<http://keionline.org/sites/default/files/TPPApunchlist_18may2011.pdf>,
and the International Federation of Medical Students
sent letters and presented at the closed-door negotiating rounds to the United
States Trade Representative <http://www.ustr.gov/> (USTR) expressing
concerns that the proposed provisions patients will severely restrict
access affordable, innovative medicines. The Wikileaks posted
text<http://wikileaks.org/tpp/> revealed
that the USTR and Obama Administration have decided to aggressively
prioritize the interests of multinational pharmaceutical and medical
companies over patients worldwide and at home. In fact, according to emails
submitted to Intellectual Property-Watch <http://keionline.org/node/1833> under
the Freedom of Information Act, the USTR has actively solicited
input of industry groups, giving them special access to the negotiating
text while consumer and health groups have had to resort to requesting
special meetings with negotiators. The USTR is also one of the best
examples of a revolving
government and industry. Since the turn of the century, at least a dozen
USTR officials have taken jobs with companies that favour stronger
copyright and patent protection. Peter Maybarduk, Director of Public
Citizen’s Global Access to Medicines Campaign, described meetings with US
negotiators as, “…a complex diplomatic exercise, it’s not like a frank
exchange of information about what is actually

Indeed, the recently leaked TPP chapter reflect these corporate interests
as evidenced by the still-included provisions. In the text, the USTR has
proposed a number of provisions that will further strengthen patents and
data exclusivity for pharmaceuticals. Such provisions will bar the entry of
generic competition into the market allowing for brand-name drug companies
to retain their monopoly market and set drug prices at exorbitantly high
prices. These provisions include:


   Lowering patent standards allowing for
   or the granting of patents for newer forms of existing medicines including
   new formulations or minor modifications even in the absence of a
   therapeutic benefit

   Mandating that surgical, therapeutic, and diagnostic methods must be
   patented making medical practitioners in TPP member states liable for
   infringement and restricting their choices for treatment

   Imposing data exclusivity on all pharmaceuticals, including biologics
   with the minimum period for this class to be set at 12 years (despite the
   fact that the White House is publicly in favor of a 7 year data exclusivity
   period and the FTC has stated that there is no need for any data
   exclusivity period at all) thereby not allowing drug safety regulators from
   accessing clinical data to grant market approval for generic and biosimilar

   Adjusting patent term periods to account for “unreasonable delays”
   including patent prosecution periods ranging from two years to more than
   four years extra further delaying generic drug entry into the market

   Adjusting patent term periods for regulatory approval periods allowing
   for patent extensions for both new pharmaceutical products as well as
   methods for producing or using new pharmaceutical products halting any
   potential innovation

   Linking patent status and drug marketing approval causing drug
   regulatory authorities to take on the additional task of early patent
   enforcement, allowing for bogus patents to be a barrier to generic drug

Such proposals go beyond current U.S. and international
the World Trade Organization’s Trade Related Aspects of Intellectual
Property Rights
Agreement. Additionally, the TPP has the potential to jeopardize millions
of lives in the participating countries by driving up the costs of
medicines significantly. Even in the United States, there has been a public
outcry from physicians regarding the high cost of medicines. Earlier this
year, over 100 oncologists came together to write a perspective piece in
the journal Blood<http://bloodjournal.hematologylibrary.org/content/early/2013/04/23/blood-2013-03-490003.full.pdf>
the prices of brand-name cancer drugs “astronomical, unsustainable, and
perhaps even immoral.” The United States health care system has in fact
greatly benefited from the entry of generic competition. On May 9, IMS
Health released a report entitled Declining Medicine Use and Costs: For
Better or Worse<http://static.correofarmaceutico.com/docs/2013/05/20/usareport.pdf>?,
which found that many Americans had forsaken much needed doctor visits,
medicines, and other treatments as they struggled to afford health care. In
light of this, it is appalling that U.S. negotiators would continue to push
provisions that would further exacerbate the cost burden of healthcare for
patients not only abroad, but at home.

The week following World AIDS Day, trade ministers will convene again in
Singapore as a potential “end game” to the negotiations planning on making
large trade-offs on various trade topics including copyright, Internet
issues, and medicines in order to make a grand announcement that they “have
a deal” by the end of the year. Despite opposition from both civil society
and other TPP governments, the USTR is aggressively pushing the
participating countries to accept these dangerous IP provisions during this
meeting to finalize the agreement. The USTR recently claimed that the “United
States is a leading voice for strong [intellectual property rights]
protections and for access to medicines for the world’s poor, including in
developing country [Trans-Pacific Partnership]
These good intentions are admirable but are overshadowed by the actions of
the USTR, as it continues to trade away health and true innovation to cater
to Big Pharma profits. To keep the promise of an AIDS-Free
the ability to provide access to affordable medicines, the trade ministers
must put a stop to these harmful provisions at the upcoming Singapore

If you want to make a difference, you can write or tweet to USTR Michael
Froman and tell him to stop attacking access to lifesaving medicines
Organisations can write too and feel free to use our recently sent
a template.

*Reshma Ramachandran is a joint medical and public policy student at Alpert
Medical School at Brown University and Harvard Kennedy School. David
Carroll is a medical student at Queen’s University Belfast .They can be
found on Twitter @reshmagar and @davidecarroll.*

*Competing Interests:*

*Reshma Ramachandran is a member of the American Medical Student
Association, the oldest, independently run association representing medical
students in the United States and chair of its PharmFree Campaign, which
advocates for ethical interactions between the pharmaceutical industry and
healthcare professionals and academic medical centers.*

*David Carroll is involved in the student networks PharmAware and
Medsin-UK, who both advocate for ethical interactions between the
pharmaceutical industry and healthcare professionals. He is also co-founder
of the Open Access Button <http://www.openaccessbutton.org/>.*

Reshma Ramachandran
Harvard Kennedy School of Government '15
Warren Alpert School of Medicine at Brown University '15
PharmFree Chair, American Medical Student Association
m: 786-271-1531

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