[Ip-health] Don’t forget consumers and patients in the Trans-Pacific Partnership

Judit Rius Judit.Rius at newyork.msf.org
Mon Apr 27 08:42:42 PDT 2015

Dear all,

Find below the joint AARP and MSF op-ed on TPP and access to medicines, 
which appears in The Hill's Congress section today. 


April 27, 2015,
Don’t forget consumers and patients in the Trans-Pacific Partnership
By Nancy LeaMond and Sophie Delaunay 
No matter who you are or where you live, it’s time to pay attention to the 
Trans-Pacific Partnership (TPP) trade deal. If signed in its current form, 
the TPP will lock in high, unsustainable drug prices, delay the 
availability of less expensive generic medicines, and price millions of 
people out of the medical care that they need.   
Today, AARP and Doctors Without Borders/Médecins Sans Frontières (MSF) 
express our deep concerns about the TPP’s impact on drug prices. 
Intellectual property provisions being proposed by the U.S. put too much 
emphasis on drug industry priorities at the expense of consumer and 
patient needs. 
Various provisions in the TPP would delay the introduction of lower-priced 
drugs and worsen an already failing system of research and development 
that awards patents and other monopolies to companies for producing 
‘me-too‘ medicines that provide little to no therapeutic benefits over 
existing treatments. 
More troubling are demands by the U.S. to mandate 12 years of data 
exclusivity for biologic medicines, which include vaccines and drugs used 
to treat conditions like cancer and multiple sclerosis. Data exclusivity 
blocks competing firms from using previously generated clinical trial data 
to gain approval for generic versions of these drugs and vaccines. 
With annual prices that can reach $400,000, the high cost of biologic 
drugs not only has negative effects on consumers and patients, but also on 
health care payers, including programs like Medicare and Medicaid, as well 
as children in developing countries who are most vulnerable to dying from 
vaccine-preventable diseases. 
It is noteworthy that the proposed 12 years of data exclusivity, or when 
clinical trial data are protected, goes well beyond the monopoly 
protections already provided in the U.S. Today, biologic drug 
manufacturers receive four years of data exclusivity that runs 
concurrently with 12 years of market exclusivity, or when the FDA is 
blocked from approving generic versions of a brand name product. 
The Obama administration has made it clear that it disapproves of these 
protections by repeatedly proposing in its federal budgets to reduce the 
market exclusivity period to seven years. This puzzling contradiction 
raises the question: Why is the U.S. pushing for even more monopoly 
protections in the TPP? Twelve years of data exclusivity is unprecedented 
in any previous trade agreement and is not the law in any of the other TPP 
negotiating countries. 
If pharmaceutical companies get their way, brand-name biologic drugs would 
not face direct competition for excessively long periods of time while 
patients, medical providers like MSF, and taxpayer-funded government 
programs endure unnecessarily high prices. AARP and MSF strongly believe 
the final trade agreement should not bind the U.S. or other negotiating 
countries to a 12-year data exclusivity period for brand-name biologic 
In its current form, the TPP could negatively affect the health and lives 
of millions of people who rely on access to affordable medicines, and 
fundamentally contradicts and undermines the U.S. government’s own 
commitments and investments in both domestic and global health. Global 
health programs supported by U.S. taxpayers like the U.S. President’s 
Emergency Plan for AIDS Relief (PEPFAR), Gavi, the Vaccine Alliance, and 
the Global Fund to Fight AIDS, Tuberculosis and Malaria all heavily rely 
on the availability of price-lowering competition in medicines and 
vaccines to effectively run their programs. 
AARP, MSF, and many other organizations, including public health experts, 
Nobel Prize winners, and civil society groups, have communicated their 
concerns publicly and directly to the U.S. Trade Representative on 
numerous occasions. 
The only ones supporting 12 years of data exclusivity are pharmaceutical 
companies and the patient groups they fund. There is now an organized 
campaign of op-eds and letters to scare the public into believing that the 
breakthroughs of tomorrow can only be guaranteed by blocking access to 
affordable medicines for at least 12 years. There is simply no good 
evidence for this; on the contrary, the Federal Trade Commission finds 
that 12 years is unnecessary to promote innovation in biologic drugs. 
Relying on monopoly pricing to promote innovation leaves us with 
higher-cost programs, higher out-of-pocket costs, and generally 
unaffordable medicines, often with very little to show in terms of true 
As TPP negotiations continue, it is essential that the U.S. and other 
negotiating countries work to protect existing public health safeguards 
and to promote a public health-driven biomedical innovation system. We 
strongly believe that consumer and patient needs, not drug industry 
profits, should be the U.S. government’s primary concern as it finalizes 
the TPP. 

LeaMond is AARP’s chief advocacy and engagement officer. Delaunay is 
executive director of Doctors Without Borders/Médecins Sans Frontières 
(MSF), USA. 

Judit Rius Sanjuan
U.S. Manager & Legal Policy Adviser, Access Campaign
Medecins Sans Frontieres/ Doctors Without Borders (MSF)
333 7th Avenue, 2nd Floor
New York, NY 10001 USA
Office: +1 212 655 3762 // Mobile: +1 917 331 9077
Email: judit.rius at newyork.msf.org // Twitter: juditrius

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