Debate the attached as if you were citizen for safe and effective pharmaceuticals.

Words: 795
Pages: 3
Subject: Uncategorized

Debate
To be resolved: India requested consultations with the European Union through the WTO regarding the
repeated seizures on patent infringement grounds of generic drugs originating in India and China but
transiting through ports and airports in the European Union (specifically the Netherlands) to third
country (non-EU) destinations.
India alleges that the measures at issue are, in several respects, inconsistent as such and as applied, with
the obligations of the European Union and the Netherlands under Articles V and X of GATT 1994 and
under various provisions of the TRIPs Agreement, namely, Article 28 read together with Article 2,
Articles 41 and 42, and Article 31 read together with the provisions of the August 2003 Decision on TRIPs
and Public Health.
Background
17 seizures of generic drugs took place in EU on grounds of patent infringement as per EC Regulation
1383/2003. These drugs were in transit to and from developing countries (not-EU members), but the
drugs were passing through the Netherlands on their way from the producing countries (e.g. India). The
drugs were seized on the suspicion of patent infringement. The drugs were developed based on
prescriiption medications created by EU-based pharma companies like Sanofi, Bayer and Merck.
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an international legal
agreement between all the member nations of the World Trade Organization (WTO). It sets down
minimum standards for the regulation by national governments of many forms of intellectual property
(IP) as applied to nationals of other WTO member nations. TRIPS requires WTO members to provide
copyright rights, covering patents; trademarks; and undisclosed or confidential information. TRIPS also
specifies enforcement procedures, remedies, and dispute resolution procedures. Protection and
enforcement of all intellectual property rights shall meet the objectives to contribute to the promotion
of technological innovation and to the transfer and dissemination of technology, to the mutual
advantage of producers and users of technological knowledge and in a manner conducive to social and
economic welfare, and to a balance of rights and obligations.
Called “the pharmacy of the developing world,” India exports 2/3 of the drugs produced to developing
countries which cannot produce drugs on their own, but also cannot afford the “brand name” drugs
from countries like the US, Canada, Japan and Europe. The challenge for the WTO and other
international organizations is to balance the needs of patients in less-developed countries to receive the
drugs they need, but also to protect the intellectual property rights of the drug developers

Roles:
European Commission’s Directorate-General for Health and Consumers – The European
Medicines Agency (a Sub-agency of the directorate) is responsible for scientific evaluation,
supervision, and safety monitoring of medicines developed by pharmaceutical companies
for use in the EU. The EMA has four goals – Facilitate development and access to medicines,
Evaluate applications for marketing authorization, Monitor the safety of medicines across
their lifecycle, and Provide information to healthcare professionals and patients. The EMA is
concerned that 1) Indian generic medications undercut the development of new medicines
by limiting profitability of original patent medications, 2) generic medications in India do not
have the same safety considerations in place as EU medicines, and 3) the monitoring of the
long term effects and safety of Indian medications is not as strong as that for EU
medications. This is particularly problematic for antibiotics, whose continued liberal over-
use produces antibiotic resistant “super bugs” which are immune to the effects of
antibiotics.
Citizens for Safe and Effective Pharmaceuticals – The Citizens for Safe and Effective
Pharmaceuticals opposes generic drugs produced in countries like India. CSEP instead has a
position that the wealthy nations of the world should subsidize the purchase of
pharmaceuticals for people who cannot afford them.
European Intellectual Property Protection Association – The EIPPA is funded by major
industries in the European Union to ensure protections are in place to defend the IP rights
of its members.
Indian Ministry of Health and Human Welfare – The Indian Ministry of Health and Human
Welfare believes that India’s position as a major producer and seller of pharmaceuticals
helps the country to develop and grow while providing a valuable service to the rest of the
world.
Indian Pharmaceutical Industry Association – IPIA supports the goals and interests of Indian
Pharmaceutical Industry and its constituent companies.
Global Citizens for Universal Access to Medication – GCUAM wants all the people of the
world to have access to life-saving and enhancing medications, and believes that generic

Let Us write for you! We offer custom paper writing services Order Now.

REVIEWS


Criminology Order #: 564575

“ This is exactly what I needed . Thank you so much.”

Joanna David.


Communications and Media Order #: 564566
"Great job, completed quicker than expected. Thank you very much!"

Peggy Smith.

Art Order #: 563708
Thanks a million to the great team.

Harrison James.


"Very efficient definitely recommend this site for help getting your assignments to help"

Hannah Seven