In this article we have focused on role of WTO on
protection of Public Health
The World Trade Organization (WTO) plays a
significant role in shaping global trade policies, including those related to
public health. The organization has implemented various agreements and
initiatives to balance trade liberalization with the need to protect public
health.
Paragraph 6 of the Doha Declaration:
In
June 2001, the African Group requested the WTO TRIPS council to include in its
agenda an item on “access to
medicines”, which eventually resulted in the Doha Declaration on TRIPS and Public Health. In the last 15 years, this has been the only contribution of the WTO to the access to medicines issue. The so-called
“Paragraph 6” mechanism of the Doha declaration, or the Decision of 30th August 2003, was a mandate of the WTO ministerial conference in Doha (2001) to solve, in an “ad hoc” manner,
a problem that affected the poorest countries. The problem still lacks a solution 15 years later. it is stated that any product manufactured
under a compulsory license “shall be
authorized predominantly to meet the supply of the domestic market”. This can be applied to countries
with the capacity to manufacture medicines and limits the volume of medicines that can be exported when their
production has been enabled by a compulsory
license. Such disposition affects mainly those countries that lack the
manufacturing capacity to produce medicines, i.e. the least developed countries. This is the reason why Paragraph
6 of the Doha Declaration gives a mandate to find an expeditious solution to
this problem.
After two years of negotiations, on 30th August 2003, WTO Member States reached an agreement
on the regulatory modification that would allow countries to import generic
medicines at a lower price and manufactured under compulsory licenses,
in case they lack local manufacturing
capacity. After reaching this Decision, the President of the General Council
read a declaration to clarify the
way in which this Decision should be interpreted and implemented by WTO members. The purpose of this statement
was to ensure to industrialized countries that the Decision would not be abused, it was never clear whether the
statement by the President of the Council was part of the decision or not.
The decision on Paragraph 6 contains a number of conditions, requested by industrialized countries, to ensure that beneficiary countries can import generic medicines without undermining the patent system. These include measures to prevent drugs from being diverted to inappropriate markets, and provisions requiring governments using this system to keep all other Members informed.
All
WTO Member countries are allowed to import under this decision, but the
decision lists 23 developed countries
that voluntarily announced that they would not use the system as importing Members: Australia, Austria, Belgium,
Canada, Denmark, Finland, France, Germany, Greece, Ireland, Iceland, Italy, Japan, Luxembourg, New Zealand, Norway,
Portugal, Spain, Sweden, Switzerland and the United Kingdom.
After
joining the EU in 2004, 10 more countries have been added to the list: Cyprus,
Slovenia, Estonia, Hungary,
Latvia, Lithuania, Malta, Poland, the Czech Republic
and the Slovak Republic.
Subsequently,
several potential exporting countries amended their laws and regulations with
the aim of applying the exceptions
and allow production exclusively for export: countries such as Norway, Canada, India and the EU among
others. The 2003 exceptions are provisional in nature; the ultimate goal is to modify the TRIPS Agreement itself,
which would enter into force when two-thirds
of Members accept it. Thirteen years after the “expedited solution” agreed by
WTO Member States, the mechanism has
not been ratified, and only one country, Rwanda, has used it once, with an import of antiretroviral
medicines from Canada. The manager of the Canadian generic firm stated,
after export, that the system was so complicated that his firm had no intention of using
it again.
At
the end of the aforementioned seminar, organized by the South Centre at the
WTO, Suerie Moon, Research Director
at the Global Health Centre of the Graduate Institute in
Geneva, concluded by citing the
recommendations of the UN High Level Panel: “WTO member States should review the decision in Paragraph 6
to find a solution that would allow for a quick and convenient export of pharmaceutical products
produced under a compulsory license.
WTO member States should, as
appropriate, adopt an exception and a permanent reform of the TRIPS Agreement.”
The WHO Proposal to Solve the Problem :
In
2002, WHO published a document on the implications of the Doha Declaration on
TRIPS and Public Health.
This document describes
possible solutions to the so-called
“paragraph 6 problem” from a public health perspective.
These characteristics include: a stable international legal framework; transparency and predictability of the rules to
be applied in countries engaged in exportations and importations;
simplicity and speed of legal proceedings in exporting and importing
countries; equal opportunities for countries in need of medicines, including
for products patented
in the importing country; multiplication of potential providers
of needed medicine; and a wide coverage in terms
of health issues and different drug types. Thus, the basic public health principle is clear: people
in a country that does not have the capacity for domestic production of a needed drug should not be less protected by the
provisions of compulsory licenses (or
other safeguards of the agreement on TRIPS), nor should they have more
procedural obstacles compared to people living in countries with the capacity to
produce the drug.
Among
the solutions that have been proposed, the limited exception under article 30
is the most consistent with these
public health principles. Under the mandate of the Doha Declaration, this solution would give WTO member States
expeditious authorization to enable third parties to manufacture, sell and export patented medicines and other health
technologies to address public health needs.
THE WORLD INTELLECTUAL PROPERTY ORGANIZATION
According to Carolyn Deere, WIPO is the largest
donor providing training
on intellectual property
issues to developing countries. Between 1996 and 2006, WIPO spent more than US
$400 million on technical support. The problem is that this technical advice,
according Carolyn Deere, was used to
introduce stronger intellectual property management in developing countries, with the philosophy that “the more
patents, the better”. All of this is done through the provision of computers, computer equipment,
salaries, invitations to conferences and consulting contracts, as a means of
influencing decision-makers to strengthen the use of intellectual property.
When reviewing
the agendas of the different
WIPO training programs,
published on their website,
including online training courses, none of those programmes include contents
referring to the flexibilities of the TRIPS agreement. For those who have been following this debate for the last 15 years, it is clear that
WIPO is more a part of the problem than the solution in terms of public health. WIPO is certainly
responsible for the proliferation of patents on trivial innovations that result in expensive pharmaceutical
products. In the WIPO website, WIPO identifies its main activity, in the field of medicines, to be the fostering of a
trilateral cooperation between the WHO,
the WTO and WIPO. This point has been already mentioned and analyzed in the
section referring to WHO.
The webpage
concludes by saying:
“The three organizations meet regularly, exchange
information on their respective work programmes, discuss and plan,
within the possibilities of their
respective mandates and budgets, common activities. The trilateral cooperation
is intended to contribute to
enhancing the empirical and factual information basis for policy makers and supporting them in addressing public
health in relation to intellectual
property and trade.” There is no
reference to what part of the work of the tripartite collaboration is devoted
to supporting countries in the
use of TRIPS flexibilities.
Conclusion
The
World Trade Organization plays a crucial role in protecting public health by
implementing agreements and initiatives that balance trade liberalization with
the need to ensure access to affordable medicines and healthcare services. By
navigating the complex issues at the intersection of trade and health, the WTO
works to promote global health equity and support sustainable development.
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