[Ip-health] Big Pharma’s insatiable greed for profit: The case of Thailand and India

Fri Aug 17 06:03:08 2007

=09Big Pharma=92s insatiable greed for profit: The case of
Thailand and India

=09The pharmaceutical industry ranks by far as the
world=92s most profitable business, and is among the
most influential industries of all time.  But looking
at its recent agendas, a critical question arises: is
the drug industry still devoted to the research and
development of life-saving medicines? Indeed it spends
an average of 13.9 percent of its revenues on research
and development, compared to up to 32 percent on
marketing, advertising, and administration costs.
Judging from the pervasive influence of the
pharmaceutical industry on U.S. policies and trade
negotiations, one would strongly agree with Dr. Marcia
Angell when she states in her book =91The Truth About
the Drug Companies=92 that:
=09"Nothing drug companies do is as profitable as
stretching out monopoly rights on their blockbusters."
=09Drug companies employ a number of tactics and
strategies against many countries in deliberate
attempts to block generic competition, which could
lead to lesser profit for them. But also in order to
extend patent protection and pressure or deter these
countries from utilizing TRIPS flexibilities to
address public health crises.
=09The Thai case: Thailand=92s Ministry of Public Health
issued a compulsory license (CL) for Merck=92s
first-line anti-retroviral drug =91efavirenz=92 marketed
under the trade name =91Stocrin=92 on November 29, 2006.
Then a compulsory license was issued for Abbott
Laboratories=92 second-line anti-retroviral drug
=91lopinavir/ritonavir=92 marketed under the trade name
=91Kaletra=92 on January 24, 2007. Finally, on January 25,
2007, the government issued a compulsory license for
Sanofi-Aventis and Bristol-Myers Squibb=92s clopidogrel
marketed under the trade name =91Plavix=92.  The decision
to issue compulsory licenses won high praise the world
over as a move to put life before trade interest. It
encourages greater generic competition which leads to
cheaper price as the generic market expands.  Most
importantly, it raises a critical question about the
patent system as the right mechanism to promote
greater access to medicines for the people.
=09However, since issuing the compulsory licenses
Thailand has faced enormous pressure from drug
companies and the governments of those developed
countries that have given precedence to profit over
people.  They have employed every possible tactic,
including objections, protests, and lobbying campaigns
to mount attacks against the decision to issue
compulsory licenses.
=09In the numerous meetings between the Thai minister of
Health, other responsible ministers- and ambassadors
or senior officials from the U.S., EU, France, and
Switzerland, they showed their discontent over
Thailand=92s compulsory licensing which they said was
done without prior negotiation with the patent
holders. They admitted, however, that it was not
required under either national or international legal
frameworks.
=09Abbott Laboratories decided to take punitive action.
They announced to the Thai Food and Drug
Administration (FDA) the withdrawal of the
registration applications for ten new medicines,
including a second-line anti-retroviral drug =91Aluvia=92
in Thailand which is a heat-stable formulation of the
drug Kaletra.  The company=92s decision was made in
protest at the Thai government=92s compulsory licensing
of its patented anti-retroviral drug
=91lopinavir/ritonavir=92 or Kaletra.
=09According to the news report by Matichon and the Wall
Street Journal, =93Abbott will not submit applications
or register new medicines and will withdraw current
applications in Thailand until the government changes
its position to give precedence to intellectual
property and to drop the compulsory licenses".
=09Moreover, in late June Abbott sought to silence
French AIDS activist group Act-Up Paris by suing the
group for launching an attack on the company=92s
website.  The attack was a response to Abbott=92s
rejection of Thailand=92s legitimate use of compulsory
licensing and the withdrawal of its applications to
sell new drugs in the country.  The drug company=92s
reaction is in effect holding patients hostage.

=09The pharmaceutical industry=92s public relations and
media campaigns are no less threatening.
=09Several international news media, the Wall Street
Journal in particular, sharply criticized Thailand for
having infringed intellectual property.  Many others
deliberately use misleading turns of phrase such as
=91breaking the patent=92 or =91overriding the patent=92 that
imply an act of nonconformity with the law, despite
indicating in their news stories that the compulsory
licensing is a legal provision within WTO rules.
=09Yet the most biased, misleading, and deceptive of all
are the myths created by =91USA For Innovation=92 who
claimed to be a non-profit organization.  It bought
ads in Thailand and international news media, and
built a website to publicly condemn Thailand=92s
military-installed-government who, it claimed, was
turning the country into a repressive regime like its
neighboring Myanmar for issuing unlawful compulsory
licensing.  It also launched an attack on the AIDS
drug =91GPO-vir=92 manufactured by the Government
Pharmaceutical Organization (GPO) and claimed  the
medicine was neither safe nor effective.  Furthermore,
it has released open letters to members of the U.S.
Congress urging them to =91confront recent threats by
Thailand=92.
=09Not long after that, on May 1st, 2007, the Office of
the U.S. Trade Representative (USTR) elevated Thailand
from Watch List to Priority Watch List.  The US
Ambassador Ralph L. Boyce, Jr. said that the move was
neither related nor due to the Thai government=92s
decision to issue compulsory licenses.  However, in
its Special 301 Report, the USTR clearly stated that:
=09"In recent years there was a growing concern that
disrespect for intellectual property was proliferating
in Thailand.  Yet, in late 2006 and 2007, there were
further indications of a weakening of respect for
patents, as the Thai Government announced decisions to
issue compulsory licenses for several patented
pharmaceutical products=94.
=09Moreover, James Caruso, Chief of Economic Affairs at
the US Embassy in Thailand reiterated the lack of
transparency and due process in Thailand=92s compulsory
licensing.
=09All of these are tactics employed primarily to
undermine Thailand=92s compulsory licensing decision in
order to prolong the pharmaceutical industry
monopolies.
=09The Indian case:  India=92s generic production has long
been the world=92s major source of affordable medicines
including for Thailand. However, India has now been
challenged by the drug industry that seeks to root out
the country=92s patent regime. ? the safeguards in
India=92s Patents Act?
=09In early 2006, India Patent Office in Chennai
rejected Swiss pharmaceutical giant Novartis=92 patent
application for its anti-leukemia drug Imatinib
Mesylate marketed under trade name Gleevec on the
ground that it was only a new form of an older
molecule.  Moreover, generic companies in India such
as Cipla, Hetero, Natco, and Ranbaxy have long been
able to produce generic equivalents.  Novartis sell
Gleevec at 2,500 US$ (120,000 rupee) per patient per
month, while generic versions from India are available
at just 175 US$ (8,000 rupee) per patient per month.
=09Instead of accepting the court verdict, Novartis
filed two petitions in the Chennai High Court:
=09First, it challenged Chennai Patent Office=92s order,
which rejected Novartis=92 patent application for
Gleevec.  In this litigation, the Lawyers Collective
HIV/AIDS Unit appeared in court for the Cancer
Patients Aid Association (CPAA) who filed opposition
to the patent claim.  Cancer patients expressed their
fear that the Novartis=92 legal action would cause a
shortage of generic versions of Gleevec.  The
challenge also raised deep concerns over the pending
applications for other medicines in four Patent
Offices in India. The Gleevec case would indeed set an
important legal precedent for pharmaceutical patent
examination and prosecution.
=09Second, Novartis challenged section 3(d) of the
Indian Patents Act, claiming the provision violated
the Indian constitution.
=09The drug giant claimed that   section 3(d) of the
India Patents Act, which denies patents for minor
modifications to molecules already invented, is
inconsistent with the WTO's Agreement on Trade-Related
Aspects of Intellectual Property (TRIPS) and as a
result violates the Indian constitution.
=09But in reality, countries can make use of the public
health safeguards within the TRIPS framework, which
India has included into its own patent legislation.
In addition, the Doha Declaration on the TRIPS
Agreement and Public Health signed by WTO members in
2001 reaffirms the right of countries to make full use
of the safeguard provisions of the TRIPS Agreement.
=09Section 3(d) is of critical importance.  The India
Patents (Amendment) Act, define as inventive an
invention that involves technical advances compared to
the knowledge already available or has an economic
significance or both.
=09The rationale for the provision of the section 3(d)
is to ensure more effective, efficient and thorough
patent examination, and to improve the quality of
innovations that can apply for patent protection.
Moreover, the provision is designed to prevent
frivolous patenting and ever greening of patents that
could threaten to undermine potential advance in
innovation and patients=92 access to medicines.

=09Thus, the Thai Network for People Living with
HIV/AIDS (TNP+) has joined force with the Indian
Network for People Living with HIV/AIDS (INP+), the
People=92s Health Movement, the Center for Trade and
Development (Centad), and an international
humanitarian organization M=E9decins Sans Fronti=E8res
(MSF), to urge Novartis to drop the cases immediately.
 More than half a million of people from 150 countries
also signed up to the petition. Finally, on 6th
August, the Madras High court dismissed Novartis=92 case
by section 3 (d) does not violate the Indian
constitution because of
Vagueness. As Anand Grover, Director of the Lawyers
Collective HIV/AIDS Unit states =93The Court clearly
recognized that Section 3(d) was enacted by the Indian
Parliament to provide easy access to life saving drugs
and to meet its constitutional obligation to provide
good healthcare to its citizens,=94.

=09Whether the drug industry=92s insatiable greed for
profits=97at the cost of people=92s lives=97will be
satisfied or not, it depends on the strength of the
civil society, scholars, professionals, the people=92s
organizations, government officials and policy makers,
and their true commitment to the public=92s best
interest.  This also requires concerted effort at
national and international level to stand firm on the
principle that the right of access to affordable
medicines is the most basic right of all humans that
we all must protect.

Kannikar Kijtiwatchakul
Campaigner for Access to Essential Medicines
M=E9decins Sans Fronti=E8res (MSF)-Belgium (Thailand)

Kannikar KIJTIWATCHAKUL (Kar)
Access Campaigner
MSF Belgium - Thailand Mission,
522 Mooban Nakorn Thai 14,
Ladphrao Soi 101/1,
Bangkapi, Bangkok 10240
Tel (+66) 2370 3087
Fax (+66) 2731 1432
Mobile (+66) 85-0708954

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