[Ip-health] News Medical: TPP Agreement: an interview with Judit Rius, MSF

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Wed Mar 13 04:42:03 PDT 2013

News Medical
Trans-Pacific Partnership (TPP) Agreement: an interview with Judit Rius,
Médecins Sans Frontières
Published on March 12, 2013

Interview conducted by April Cashin-Garbutt, BA Hons (Cantab)

Please can you give an introduction to the Trans-Pacific Partnership (TPP)
Agreement? Which countries are in negotiation?
The Trans-Pacific Partnership (TPP) is a trade deal currently being
negotiated between eleven countries of the Asia-Pacific region: Australia,
Brunei Darussalam, Canada, Chile, Malaysia, Mexico, New Zealand, Peru,
United States, Singapore and Vietnam.

But the scope of the TPP is potentially much broader than the current
eleven countries. Negotiators have said that they are structuring the
agreement in such a way that would allow more countries to join, and the
TPP could eventually include all twenty-one APEC nations. Thailand has
already announced its intention to join, and Japan and the Philippines are
actively considering it.

Even more alarming, U.S. negotiators have said the TPP will be the template
for future U.S. trade agreements across the globe, setting a damaging
precedent that could affect many more developing countries.

The TPP negotiations are being conducted in secret but leaked texts reveal
the most aggressive intellectual property (IP) measures ever suggested in a
trade deal with developing countries. The U.S. proposals threaten to roll
back internationally-agreed public health safeguards and would put in place
far-reaching monopoly protections that keep medicine prices high and out of
the reach of millions.

What are the aims of the TPP Agreement?
TPP government officials describe the TPP as a vehicle for greater economic
integration in the Asia Pacific region. The TPP represents a departure from
more traditional trade agreements in that it reaches further into
“behind-the-border” domestic regulation and aims to impose stronger
regulatory coherence, intellectual property rights and investor protections.

MSF and many public interest groups are concerned that the far-reaching and
precedent-setting terms being proposed will severely limit the ability of
governments to legislate and regulate in the interest of public health.

Why are the TPP negotiations being conducted in secret?
This is a question that MSF and many others have been asking – including
many members of Congress in the United States – and as far as MSF is
concerned, there has been no satisfactory response.

The TPP negotiators are making decisions that will affect at least 600
million people, and potentially hundreds of millions more, in complete
secrecy, and this is unacceptable. It is unfortunate that MSF and others
are forced to rely on leaked copies of an agreement that could have dire
health consequences for millions of people.

MSF is advocating for greater transparency that will allow for adequate
public scrutiny and debate before it is too late to affect the outcome of
the agreement. We know that trade negotiations can be, and have been,
conducted in a more transparent manner in the past, for example under the
auspices of the WTO. MSF is urging TPP negotiators to publish the draft
agreement and their negotiating positions, particularly as it relates to
matters affecting public health, so these vitally important issues can be
openly debated by those who will be directly affected.

Please can you tell us about the leaked texts regarding the TPP Agreement?
What did these texts reveal?
According to the leaked text that we have seen the proposed IP rules would
grant the pharmaceutical industry a wide-ranging set of legal mechanisms
designed to prolong monopoly protection for medicines and delay the
availability of more affordable generic versions.

This week we have released a new four-page TPP briefing that summarizes
some of our concerns. For example, one proposed TPP provision would require
governments to grant new 20-year patents for modifications of existing
medicines, such as a new forms, uses or methods, even without improvement
of therapeutic efficacy for patients. Another provision would make it more
expensive and cumbersome to challenge undeserved or invalid patents; and
yet another would add additional years to a patent term to compensate for
administrative processes. Taken together, these and other provisions will
add up to more years of high-priced medicines at the expense of people
needing treatment waiting longer for access to affordable generics.

The TPP proposal in the investment chapter also includes investor-state
investment dispute provisions that would allow corporations to file suit
against governments using private tribunals if they perceived that a
particular regulation negatively affected their anticipated profits. In the
case of access to medicines, intellectual property is explicitly mentioned
as covered by the investment chapter and therefore pharmaceutical firms
could use TPP investor-state dispute provisions to overturn national patent
(and other IP) laws that may be designed to protect public health. This is
in fact already happening in Canada, where Eli Lilly is threatening to sue
the government of Canada under similar rules included under NAFTA because
Canada rejected a drug patent considering it did not adequately meet the
criteria for patentability.

If the agreement was to finally include the US proposals as they currently
stand, we believe it will be the most harmful trade deal ever for access to
medicines in developing countries. These demands represent a complete
repudiation of previous global health commitments, including the 2001 WTO
Doha Declaration on TRIPS and Public Health and the 2008 WHO Global
Strategy and Plan of Action on Public Health, Innovation, and Intellectual
Property. The U.S. is walking away from its own 2007 bipartisan trade
policy, which promised to scale back some of the harshest IP provisions in
trade deals with developing countries.

What concerns do Médecins Sans Frontières have over the TPP Agreement?
As a medical humanitarian organization working in more than 70 countries,
MSF is concerned that if the TPP terms are imposed on developing countries,
competition from price-lowering generic medicines that are so vital to the
viability of our programs, and to the health of the people we treat, will
be severely restricted.

As a medical treatment provider, MSF relies on affordable, quality generic
medicines to treat many diseases, including tuberculosis, malaria, HIV/AIDS
and other infections that afflict the poorest and most vulnerable
populations. For example, MSF relies on affordable quality generic
medicines for its programs in Myanmar and in Cambodia. We can access
affordable medicines thanks to public health safeguards that enable
competition, which brings down prices of medicines and allows more lives to
be saved.

Many developing countries have implemented safeguards in their national
patent laws to promote competition; India, the pharmacy of the developing
world, is a prominent example. But the U.S. is demanding that TPP countries
accept provisions that would grant pharmaceutical firms extended and
stronger monopoly protections on high-priced medicines, keeping affordable
generics out of the market for longer. If the US gets its way, TPP
countries will not be allowed to implement many of these key legal
safeguards, what will mean drugs priced out of reach for longer. And
because the TPP is what the U.S. intends as the new norm, this would then
become entrenched as a baseline in new trade agreements in the future,
potentially sweeping up many more developing countries struggling to
improve access to medicines for millions in need.

But it is not only MSF that will be affected. Major international treatment
initiatives and agencies, including the Global Fund to Fight AIDS,
Tuberculosis and Malaria, the U.S. President’s Emergency Plan for AIDS
Relief (PEPFAR) program and UNITAID, also depend heavily on affordable
generic drugs to scale up urgently needed treatment programs. For example,
more than 98% of the antiretroviral medicines purchased by PEPFAR to treat
HIV/AIDS are low-priced, quality-assured generic medicines.

Governments that pay for treatment programs, either directly or by funding
global health treatment initiatives, have both an interest and a
responsibility to ensure that new roadblocks are not put in the way of
generic competition, or they risk jeopardizing the effectiveness of the
very programs they support.

How many people in developing countries currently don’t have access to the
medicines they need?
It is difficult to measure, but the World Health Organization estimates
that at least two billion people have no regular access to medicines. (1)
There are many reasons why patients still lack regular access to affordable
medicines, but the high price of existing medicines or the fact that they
do not exist because they are not seen as financially viable are two
important causes.

Many people still die from diseases like AIDS, TB and other diseases that
disproportionally affect poor people in developing countries due to the
high prices of medicines. But the burden of disease in developing countries
is changing and non-communicable diseases (NCDs) such as diabetes,
cardiovascular disease, and cancers, are now also a leading cause of death
in developing countries.

Prices for newer medicines – including second-line HIV drugs and treatments
for hepatitis, tuberculosis, cancer and many other diseases – are climbing
rapidly and can cost hundreds of times more than a person’s average annual
income posing a life treating access barrier to increasing numbers of

What impact do you think a lack of vital medicines will have on the spread
of diseases such as HIV/AIDS?
The story of access to HIV medicines is a great illustration of the overall
problem. Between 1990 and 2000, explosive growth of the HIV/AIDS epidemic
in developing countries, especially in Africa, was characterized with a
devastating lack of access to life-saving antiretroviral treatments that
were, by then, broadly accessible in developed countries. In 2000, ARVs
were priced at more than $10,000 per patient per year -- out of reach of
the vast majority of people living in developing countries.

But international pressure forced multinational pharmaceutical firms to
make groundbreaking concessions, triggering generic competition and massive
ARV price reductions that brought the price of treatment down by 99 per
cent, from over US$10,000 per person per year a just over decade ago, to
just $120 today. These prices have made it possible for eight million
people in developing countries to be on treatment today and for
international organisations like the Global Fund to Fight AIDS,
Tuberculosis and Malaria and PEPFAR (the U.S. government-backed HIV
initiative) to reach many more people.

But, half of those in need of HIV/AIDS treatment are still not receiving
it. Furthermore, many HIV patients we treat now have to move to second and
third line treatment as they develop resistance to first line regimes.
Sadly, patents now exist on most new and second-line drugs, allowing
pharmaceutical companies to restrict competition and price them out of
reach for many. As a result these drugs – which are far better and have
fewer adverse side effects – are only available in countries that have the
capacity to cover the high cost. Poor patients are forced to wait until the
patents expire or prices are brought down through international advocacy

How do you think access to medicines in developing countries should be
Lowering the price of health commodities is essential for developing
countries. The lack of access to medicines – and other health commodities –
can be attributed to multiple factors, but one of the most fundamental
barriers is high prices.

The most effective and sustainable way to bring down the price of a drug is
through competition between different manufacturers. Developing country
governments need to have the flexibility to design patent laws and other
health-related regulations in a way that meets the health needs of their
populations, and in most cases this is by enabling access to generic

Another major factor limiting access is that the medicines and other health
innovations that people in developing countries need are often simply not
developed. This is because medical innovation - the development of new
drugs, diagnostics and vaccines - is overwhelmingly steered towards
products that will give commercial rewards and not towards the greatest
medical needs.

In the current predominant medical innovation model, companies recoup
research and development (R&D) investments through sales revenues, so its
R&D costs are inevitably “linked” to product prices. This means that
development of products needed primarily by populations unable to pay high
prices is simply not pursued.

There is a need to develop alternative strategies for medical innovation
that respond to developing country priorities and that break the link
between the cost of research and the price of the final product. This
‘delinkage’ ensures affordability of medical innovation from the outset.

We think the TPP countries could construct a much better trade agenda that
promotes both innovation and access to medicines if they were to encourage
innovative incentive mechanisms that better respond to patient-needs,
instead of monopolies and policies that break the balance between
commercial interests and public health.

What plans does Médecins Sans Frontières have in place to influence the TPP
MSF is working on several fronts to raise awareness about the dangerous
provisions in the TPP that will hurt our patients, including speaking out
and raising the issue in media, as with this interview.

Specifically, MSF is urging the U.S government to withdraw, and all other
TPP governments to reject, harmful provisions that will hurt access to
medicines. MSF is asking all TPP negotiators to insist on language that
protects public health safeguards, fulfils existing international public
health commitments, and enables countries to effectively balance commercial
interests and public health. As noted above, MSF is also urging negotiators
to increase transparency because we think that if more stakeholders with an
interest in public health were able to look at the proposed text their
proponents will be forced to improve it.

As TPP negotiators meet in Singapore this week for the sixteenth round of
negotiations and under pressure to meet the announced October 2013
deadline, we are especially concerned because there has not been
substantive discussion on access to medicines among TPP negotiators for
over a year now. In March 2012 during the Australia round of negotiations,
it is our understanding that many of the negotiating teams rejected the US
draft chapter on intellectual property rights. While the U.S. government
has stated that it would be resubmitting a revised chapter on this issue,
they have not done so and access to medicines is once again not on the
agenda this week in Singapore.

With the October 2013 deadline approaching, time is running out and these
dangerous provisions could be shoe-horned into the final, precedent-setting
agreement without adequate debate and public scrutiny.

We are asking the U.S. to end stall tactics on access to medicines and
revise its proposals for what otherwise promises to be the most harmful
trade deal ever for access to medicines in developing countries.

Where can readers find more information?
For more information on the TPP and access to medicines, visit
http://www.msfaccess.org/tpp. For more information on the broader issues
related to a lack of access to medicines in developing countries, visit:

About Judit Rius
Judit Rius Sanjuan currently works as the US Manager of the Access Campaign
for Doctors Without Borders/Médecins Sans Frontières (MSF) in New York. The
MSF Access Campaign's purpose is to ensure greater access to, and the
development of, life-saving and life prolonging medicines, diagnostic
tests, and vaccines for patients.

Prior to joining the MSF Access Campaign, Judit worked at Knowledge Ecology
International (KEI), providing technical assistance to developing countries
on intellectual property law and in negotiations at the World Health
Organization and the World Intellectual Property Organization.

In addition, Judit was an adjunct professor at Georgetown Law School where
she co-taught a human rights fact-finding seminar on access to essential
medicines in Central America.

Judit also worked in the legal departments of an international
pharmaceutical company, an information technology consulting firm, and a
software company.

Judit received a Licenciatura en Derecho (JD equivalent) from Pompeu Fabra
University in Barcelona, Spain, and a Master's Degree in International
Studies from Pompeu Fabra and Geneva Universities.

In January 2006, she graduated from Stanford Law School with an LLM in Law,
Science, and Technology.

2011. Available from:

Joanna Keenan
Press Officer
Médecins Sans Frontières - Access Campaign
P: +41 22 849 87 45
M: +41 79 203 13 02
E: joanna.keenan[at]geneva.msf.org
T: twitter.com/joanna_keenan


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