E-DRUG: IP-Watch: International Health Groups warn WHO, WTO on medicines
seizures
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21 February 2009
International Health Groups Warn WHO, WTO On Medicines Seizures
By William New @ 5:47 pm
Leading international public health advocates have sent letters to the
heads of the World Health Organization and World Trade Organization
calling on them to act to prevent possible circumvention of
international trade rules for intellectual property rights relating to
shipments of legal generic drugs bound for developing countries.
The concern arose after the governments of India and Brazil spoke out
at a high-level WTO meeting about intercepted shipments of such drugs
by Dutch authorities.
The letters dated 18 February also were sent to the heads of the World
Customs Organization (WCO), World Intellectual Property Organization,
WTO General Council and WTO Council for TRIPS (Agreement on Trade-
Related Aspects of Intellectual Property Rights).
The letters, available on the Knowledge Ecology International (KEI)
website, assert that between October and December there were four
shipments seized and held by the Netherlands as they were passing
through the country. The issue is ripe to explode as generics exports
are seen as vital to economies such as India's, are critical to the
survival of patients in developing and least-developed nations, and
fears have been stoked that developed-nation pharmaceutical industries
and governments are working to construct new ways to slow generics
trade that competes with their brand-name markets.
As stated in the letters, the concern has cropped up in several
national and international contexts, including WHO's foray against
counterfeit medicines, WTO's past attempts to amend its intellectual
property rules, and the WCO's rocky effort to increase customs
involvement against counterfeit and pirated goods. Also on the
forefront are national efforts, new custom rules being developed by
the European Union, and the fast-tracked negotiation of an Anti-
Counterfeiting Trade Agreement led by the nations holding the majority
of the world's IP rights - the United States, Europe and Japan. KEI
recently released text it claimed is part of ACTA, showing possible
stronger customs measures for IP enforcement. There also is talk of
strengthening enforcement activities at WIPO.
For developed nations, new measures are needed to slow ever-rampant
global piracy and counterfeiting. But to developing countries, the
anti-counterfeiting initiatives being undertaken by the rich, rights-
holding nations are seen as a potential source of new restrictions and
trade barriers to products and services from poorer trading partners.
The delay of legitimate generics passing through a country like the
Netherlands out of concern that they might be counterfeit is exactly
the sort of action that might confirm developing country fears.
India and Brazil told the WTO General Council in early February (IPW,
WTO/TRIPS, 3 February 2009) that under international rules, transit
countries do not have the right to block goods passing through. They
cited Article V of the General Agreement on Tariffs and Trade (GATT),
which the letters quote as defining any territory that goods pass
through as "in transit", which the nongovernmental groups say are
exempt from normal restrictions associated with patents or other
intellectual property rights when in route to a legitimate market.
Holland violated that notion when it seized generics from India
heading to Colombia, Peru and Brazil, they claim.
"The European Union rules and actions are clearly in conflict with WHO
resolution WHA61.21, which states that 'international negotiations on
issues related to intellectual property rights and health should be
coherent in their approaches to the promotion of public health'," the
letter to WHO Director General Margaret Chan said. It also cites a
provision in the resolution to take into account the impact on public
health of adopting measures reaching beyond the TRIPS agreement, which
they argue the EU measure does.
They further raised concern about the risks to the work of development
and public health agencies such as WHO, UNAIDS, the Global Fund, and
UNITAID. They urged WHO to "immediately undertake an assessment of the
risks to public health programs" from such seizures and "goods-in-
transit" provisions in current or proposed trade agreements. WHO is
called upon to interview developing country governments, UN agencies
and others. And if WHO determines EU regulations to contain threats to
public health, it should communicate its concerns and provide
technical advice to the EU, with the request that the EU re-examine
its provisions.
The other letter to the WTO and the rest addressed similar issues,
citing TRIPS Article 51 on "suspension of release by customs
authorities," Article 41.1 of TRIPS which states that enforcement
measures should not create barriers to legitimate trade, and Article
42.2 which says procedures must be "fair and equitable." It also cites
WTO accords such as the 2001 Doha Declaration on TRIPS and Public
Health, which reinforces the right of WTO members to protect public
health and access needed medicines.
A major concern has been the seeming blurring of the definition of
counterfeit, substandard and generic medicines in some of the
initiatives. The seizures serve to reinforce that concern as well.
"Oxfam International is concerned with what appears to be confusion
between counterfeit medicines that kill people and generic medicines
that save lives," said Elise Ford, Oxfam International's head of the
EU office.
To honour its international commitments, the European Union "should
immediately review and modify its counterfeiting regulation, if the
regulation wrongfully allows European countries to seize legal generic
medicines that are merely transiting through Europe," Ford said. "It
is nonsensical that a regulation intended to save lives could instead
be jeopardising the ability of doctors and nurses in developing
countries to protect them."
The letters assert that brand-name companies Merck and DuPont led
Dutch authorities to act to intervene in the shipments. "So far, far
too little attention has been directed at these corporate criminals
who are acting with impunity to thwart lawful generic competition even
in countries of export and import (India and Latin America) where
their patents and marketing rights have no effect," said Brook Baker
of Health GAP. He called the "embargo of medicines" a direct violation
of the Doha Declaration and "an unconscionable violation of the human
right of access to essential medicines enshrined in multiple
international treaties."
The letters were signed by 16 groups (counting four regional branches
of one group). The groups are: BUKO Pharma-Kampagne, Consumers
International, Consumers Union, Essential Action, Health Action
International, Health GAP, IQsensato, Knowledge Ecology International,
Medico International, Oxfam International, Third World Network and US
PIRG.
TRIPS Council Meeting
The issue of the seizures could come up at the 3-4 March TRIPS Council
meeting, although this was unclear at press time. The meeting agenda
is likely to address the same topics as recent meetings, and there is
expected to be a special session on a mandate to establish a register
of geographical indications.
Two other proposals could find a way into the meeting as well:
extension of higher level GI protection to other products than just
wines and spirits, and an amendment of the TRIPS agreement to include
a requirement for the disclosure of origin of genetic resources in
patent applications.
On GI extension and CBD amendment, proponents are answering questions
and offering clarifications on their previous proposal from last July,
a government official said. While the Doha Round talks generally are
moving slowly at this point, the expectation is that the WTO director
general or a designee will reconvene discussions on these two TRIPS
issues at some stage, sources said.