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| Image by Getty Images via @daylife |
Dr Unni Karunakara, International President of Medecins Sans Frontieres,
has written an open letter to Indian Prime Minister Dr Manmohan Singh,
setting out MSF's concerns over remaining provisions in the EU/India Free
Trade Agreement that would prove harmful for access to medicines:
The Honourable Dr. Manmohan Singh
Prime Minister of India
South Block, Raisina Hill
New Delhi -110 011
India
Geneva, 8 February 2012
Honourable Prime Minister,
Ahead of the India-Europe Summit on 10 February 2012, where a roadmap to
conclude the EU-India free trade agreement (FTA) is set to be agreed, the
international medical humanitarian organization Medecins Sans Frontieres
(MSF) would like to draw your attention to specific harmful provisions in
the proposed intellectual property (IP) and investment chapters, that if
included would have serious implications for access to affordable medicines
in India and throughout the developing world.
MSF today relies overwhelmingly on affordable generic HIV/AIDS medicines
produced in India to treat nearly 180,000 people in 20 countries, as well
as using medicines from India to treat other diseases such as tuberculosis
and malaria. India has played a pivotal role in supplying affordable
generic versions of drugs used throughout the developing world. It is
vital therefore that further barriers are not created that threaten the
supply of affordable generic medicines from India.
As such, the March 2011 official statement by Minister Anand Sharma,
against the introduction of 'data exclusivity' was welcomed by MSF and
others given the harmful effect it would have on access to affordable
medicines produced in India. We urge the Indian government to stand strong
in this and in future free trade agreements, such as the one currently
being negotiated with the European Free Trade Association countries of
Switzerland, Iceland, Norway and Liechtenstein.
However the enforcement and investment provisions within the draft
agreement are still a matter for serious concern as unchanged they will
have significant negative implications for generic production critical for
ensuring access to affordable medicines in India and throughout the
developing world.
We therefore urge India to take a similarly strong stand in relation to the
remaining harmful provisions, particularly:
Enforcement provisions:
- The European Commission's proposed text is broad
in scope and goes well beyond what has already been agreed and implemented
by India under the TRIPS Agreement.
- The EC had reproduced some of the enforcement measures contained in the Anti-counterfeiting Trade Agreement (ACTA) over which the Indian government has raised serious concerns at the
WTO, stating that the agreement will 'impede legitimate competition and
shift the escalated costs of enforcing private commercial rights to
governments, consumers and taxpayers' [1].
The EU is proposing an ambitious enforcement agenda that:
Widens the enforcement net so that life-saving legitimate medicines,
under alleged trademark infringement, could be detained or destroyed
at the border when being exported, simply because their label appears
similar to the originator product. Although this is often justified
on the basis of protecting the public from fake medicines, this issue
is entirely separate, and will do nothing to improve medicines
safety. It would in fact have a negative impact on access to
treatment, as is evident from the recent seizures of Indian generic
medicines in EU countries. The impact of any such detentions will be
felt directly by patients awaiting the arrival of crucial generic
medicines in the many countries that do not have manufacturing
capacity to produce medicines, and therefore rely on importing more
affordable generics from India;
Substantially increases the penalties for alleged patent and
trademark infringements. On a mere allegation - and not proof -
including allegations brought by a competitor, generic suppliers
allegedly infringing a patent or a trademark may face a ban on
production, delay or destruction of goods, disproportionate damages,
and potential bankruptcy;
Limits the Indian courts' ability to balance commercial and public
health interests and the Indian Constitution's guarantee to the right
to life, by making use of a variety of alternative remedies rather
than as the EU proposes, routinely granting provisional injunctions;
and
Extends liability to third parties, thereby putting at risk of
injunctions and provisional measures a wide variety of public health
stakeholders, including: suppliers of active pharmaceutical
ingredients used for producing generic medicines; distributors and
retailers who stock generic medicines; NGOs such as MSF who provide
treatment; funders who support health programmes; and drug regulatory
authorities who examine medicines. This could act as a significant
deterrent to anyone involved in the production, sale or distribution
of affordable generic medicines.
Investment Chapter: The European Commission is also pushing for the trade
deal to be expanded in scope so that it covers investments, including
intellectual property, and supports an 'investor-to-state' mechanism.
This would allow multinational drug companies to bypass the Indian
judiciary and take the Indian government to private arbitration courts over
investment disputes in relation to intellectual property, in order to seek
to reverse domestic health policies like tobacco warnings and measures to
reduce prices of medicines. Pharmaceutical companies must be given no
additional avenues to pressure India on policies and laws that promote
access to medicines. India is already reeling from multiple litigations
filed by companies like Novartis and Bayer against health safeguards
enshrined in India's patent law.
In order to ensure that the EU-India FTA does not undermine access to
medicines, the additional threats posed by the enforcement and investment
provisions must be addressed. At a minimum, we would urge the Indian
Government to request the following safeguards are contained in the roadmap
to ensure that damage caused to people's access to medicines is minimised:
The withdrawal of the IP enforcement measures, and as a minimum
safeguard, the deletion of patents from the entire scope of the
enforcement section;
The withdrawal of third party liability from the enforcement
provisions;
The withdrawal of specific provisions dealing with injunctions from
the enforcement provisions in order to preserve the existing
flexibilities of the Indian judicial system;
Border enforcement should be limited to the requirements of the TRIPS
Agreement and as such exclude exports and trademark infringements;
and
The withdrawal of IP and the investor-to-state mechanisms from the
scope of the investment chapter.
India has already shown that it is prepared to stand firm against harmful
demands from the European Commission. As the negotiations are reaching
their final stages we urge you to maintain your vigilance and commitment to
preserving the space for continuation of the generic production of
medicines that we and so many in India and beyond rely upon.
Yours sincerely,
Dr Unni Karunakara
International President
Medecins Sans Frontieres
c.c. Honourable Minister of Commerce and Industry of India Shri Anand
Sharma
c.c. Honourable Minister of External Affairs of India Shri S. M. Krishna
[1]
http://arstechnica.com/tech-
Joanna Keenan
Press Officer
Medecins Sans Frontieres - Access Campaign
E: joanna.keenan[at]geneva.msf.
T: @joanna_keenan
II Part
Reputable manufacturers exporting medicines into countries of high
temperature and/or humidity are clearly testing their medicines and making them fit
for climate zone III and IV in particular when a drug regulatory authority
of the importing country makes it a prerequisite. Appropriate testing
requiremens can be found, for example at the homepage of the World Health
Organization:
http://www.who.int/medicines/
ry_standards/en/index.html
Unfortunately, on national scale, many countries accept much lower drug
development standards for medicines moving into commerce. For example, in
India, all products are labelled "to be stored below 25 degree Celsius". Here,
local manufacturers are pushing the responsibility for product stability
downstream into the supply chain, for example to the shop keepers and consumers.
This is nationally accepted standard and done even though knowing that
medicines is frequently sold in drug outlets openly without air conditioning or even
a refrigerator. As India gradually became "the pharmacy of the developing
world" these low standards moved along with them. And you just saw the
consequences.
Yours sincerely
Richard Jähnke, PhD
Project Management
Global Pharma Health Fund e.V. (GPHF)
Otto-Meßmer-Straße 1, 60314 Frankfurt, Germany
Head Office: T +49-69-962387-600, F +49-69-962387-609, info@gphf.org
Project Office: T +49-69-46939-662, F +49-69-46939-852,
richard.jaehnke@gphf.org
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