Drugs: Free Trade Agreement that would prove harmful to access to medicines


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Source: List E-Drugs                                En Castellano 


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-policy/news/2010/06/india-launches-offensive-against-acta-cites-due-process.ars

Joanna Keenan
Press Officer
Medecins Sans Frontieres – Access Campaign
E: joanna.keenan[at]geneva.msf.org
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/areas/quality_safety/quality_assurance/regulato
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

About Ruben Roa

Medico especialista en Medicina Familiar. Magister en Epidemiologia, Economia de la Salud, Felowship en Medicina Familiar. Ex-Secretario Ejecutivo Confederación Iberoamericana de Medicina Familiar, miembro del Board de Educación Médica Continua WONCA. Senior Research at Agencia de Tecnologias Santiarias ISALUD.
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