[Ip-health] MSF: The Trans-Pacific Partnership: A Threat To Global Health?

Jennifer Reid Jennifer.Reid at newyork.msf.org
Tue May 12 11:45:53 PDT 2015


Please see the below oped by Doctors Without Borders/Médecins Sans 
Frontières (MSF)-USA Board of Directors President, Dr. Deane Marchbein, on 
the the impact the Trans-Pacific Partnership (TPP) Agreement could have 
for global health, featured in Health Affairs' blog: 

http://healthaffairs.org/blog/2015/05/08/the-trans-pacific-partnership-a-threat-to-global-health/
The Trans-Pacific Partnership: A Threat To Global Health?
Deane Marchbein
May 8, 2015

Lost in the political discussions over the passage of the Trans-Pacific 
Partnership (TPP)—a trade agreement currently being negotiated in secret 
between the U.S. and 11 other Pacific-Rim nations—is the very real 
negative impact it would have on global health.

Doctors Without Borders/Médecins Sans Frontières (MSF) works in over 60 
countries, and our medical teams rely on access to affordable medicines 
and vaccines. We are deeply concerned that the TPP, in its current form, 
will lock-in high, unsustainable drug prices, block or delay the 
availability of affordable generic medicines, and price millions of people 
out of much-needed medical care.
The public health repercussions of this deal could be massive. The 
negotiating countries represent at least 700 million people, and U.S. 
negotiators refer to the TPP as a “blueprint” for future trade deals. The 
TPP attempts to rewrite existing global trade rules and would dismantle 
legal flexibilities and protections afforded for public health.

Problematic Provisions
We have concerns with several U.S. government demands in the TPP. For 
example, the TPP would lower the standard for patentability of medicines. 
It would force TPP governments to grant pharmaceutical companies 
additional patents for changes to existing medicines, even when the 
changes provide no therapeutic benefit to patients. These provisions would 
facilitate “evergreening” and other forms of abuse of the patent system by 
lengthening monopolies and delaying access to generic competition.

Another concerning provision in the TPP involves so-called “data 
exclusivity” for biologics, a new class of medicines that includes 
vaccines and drugs used for cancer and multiple sclerosis treatment. Data 
exclusivity blocks competing firms from using previously generated 
clinical trial data to gain approval for generic versions of these drugs 
and vaccines. If pharmaceutical companies have their way, the TPP will 
block generic producers of biologics from entering the market for at least 
12 years, during which patients would be forced to endure astronomical 
prices.

The rationale given for such an exclusivity period is that it will promote 
innovation by allowing originator companies enough time to charge high 
prices and recoup their research and development investment. This simply 
isn’t supported by the evidence. On the contrary, the Federal Trade 
Commission finds that no years of data exclusivity were necessary to 
promote innovation in biologic drugs.

Twelve years of data exclusivity is not only unprecedented in any trade 
agreement, it is not the law in any of the TPP negotiating countries 
outside of the U.S., and it would keep lifesaving medicines out of reach 
of millions of people. The Obama Administration has actually called for 
data exclusivity to be reduced to seven years at home, so it is puzzling 
that the U.S. Trade Representative would be aggressively pushing for these 
terms in the TPP.
These provisions and others currently included in the TPP are at direct 
odds with the U.S. government’s own long-standing commitments to global 
health. U.S. taxpayer-supported initiatives like PEPFAR, the Global Fund 
for AIDS, TB and Malaria, and Gavi, the Vaccine Alliance, rely on 
affordable, generic medicines in order to operate effectively.

Research And Development
As an organization caring for patients worldwide, Doctors Without 
Borders understands that there should be incentives to recover research 
and development investments and to promote innovation. Unfortunately, the 
public is in the dark on what this research and development truly costs. 
We are told that it costs billions to research and develop a new medicine, 
although a significant amount of early research and development actually 
happens at publicly funded centers and universities.

We are told that the only way to ensure that people receive the medicines 
they need is by increasing intellectual property provisions, such as those 
encapsulated in the TPP. In reality, the existing monopoly-based 
innovation system that the TPP is attempting to standardize has left us 
with more patents and fewer medical breakthroughs.

The most recent and dramatic example of this failure in innovation played 
out just last year, when Ebola raged through West Africa. Doctors Without 
Borders and other global health actors were ill-equipped to fight a 
disease that was identified 40 years ago but for which there are still no 
adequate diagnostics, treatments, or vaccines.

As TPP countries aim to conclude negotiations in the next few months, it 
is essential that the United States and other negotiating countries work 
to protect existing access to medicines’ safeguards and to promote a 
public-health driven biomedical innovation system.

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