[Ip-health] IP-Watch: Panel: EU Accord Threatens India; World Customs Body Scales Back IP Enforcement

[Thiru Balasubramaniam]

http://www.ip-watch.org/weblog/2009/06/11/panel-eu-accord-threatens-india-w=
orld-customs-body-scales-back-ip-enforcement/

11 June 2009
Panel: EU Accord Threatens India; World Customs Body Scales Back IP
Enforcement
By David Cronin for Intellectual Property Watch @ 12:57 pm

BRUSSELS - India=92s status as a top world supplier of generic medicines
could be threatened by a free trade agreement its government is
negotiating with the European Union, a new study has concluded.
Separately, the World Customs Organization has abandoned its
intellectual property rights enforcement group, replacing it with a
non-policymaking information committee.

A draft of the proposed agreement, available here, put forward by EU
officials recommends that it should incorporate a wide range of
intellectual property issues. According to Carlos Correa, a professor
in the University of Buenos Aires, at least two of the provisions in
the draft could hamper access to affordable medicines for developing
countries.

In an analysis of the accord, available here [pdf], Correa concluded
that it could require India to forbid the manufacture of generic
versions of patented drugs for up to five years after the patents in
question expire. While the official rationale behind the EU=92s proposal
is that such an extension would offer compensation for the time it has
taken the patent-holder to obtain marketing authorisation for a
particular drug, Correa argued that it would have adverse consequences
for the poor as it would delay the reduction of drug prices.

Another provision would offer protection to test data submitted for
the approval of branded medicines for a certain length of time (the
precise duration has not yet been specified by EU officials). In
effect, this would bar makers of generic drugs from using that data.

Until now India has been opposed to introducing such a form of data
exclusivity, Correa noted, adding that the EU recommendations go
beyond the scope of the key international IP law: the World Trade
Organisation=92s Trade-Related Aspects of Intellectual Property Rights
(TRIPS) agreement.

The question of access to medicines was one of the main issues debated
at a public meeting held in Brussels on 10 June, organised by several
consumer and health action groups.

Peter Maybarduk from the Washington-based organisation Essential
Action said that a number of studies have estimated that the costs of
medicines can fall by between 40 percent and 80 percent once generic
versions of patented drugs become available. Despite the health
benefits associated with this reduction, he complained that a number
of governments from industrialised countries have been pursuing an
=93enforcement agenda=94 which places greater emphasis on the profits of
corporations than on public needs.

He cited the Anti-Counterfeit Trade Agreement (ACTA) that the EU, the
US, Japan and Switzerland decided to negotiate in 2007 as an example
of how several different IP issues are being conflated. There is no
clear, universally-accepted definition of what constitutes
counterfeiting, he suggested. Whereas the TRIPS agreement focuses on
violations of trademarks, the World Health Organization is more
concerned with deliberate attempts to mislead consumers about the
safety of medicines.

Because of the confusion resulting from this lack of clarity, a number
of fallacies have gained currency, he said. =93Fallacy number one is
that any infringement [of IP rights] can be loosely considered a
counterfeit or a pirated good,=94 he added. =93Fallacy number two is that
similar remedies can be applied for infringements of distinct rights.
And fallacy number three is that aggressively combating alleged IPR
[intellectual property rights] infringements protects public health.=94

Alexandra Heumber, an access to medicines campaigner for Doctors
Without Borders/M=E9decins Sans Fronti=E8res, protested at the series of
seizures of generic medicines that have occurred in EU ports in recent
times. Seventeen seizures of generic medicines, almost all of which
were being shipped from India, occurred in the Netherlands during
2008, according to information released by the Dutch authorities,
while a similar seizure also took place in Germany=92s Frankfurt Airport
last month. In every instance, the medicines were destined for
developing countries.

Heumber argued that EU rules set in 2003 give customs authorities the
power to intercept legal medicines in cases where it is suspected that
an infringement of a patent may have occurred. She urged the EU=92s
executive branch, the European Commission, to issue new guidelines
making it clear that such seizures should not be applied to generic
medicines.

=93While the seizure of counterfeit drugs is understandable, the seizure
of legitimate drugs in transit is not acceptable,=94 she said.

Patrick Ravillard, a trade official with the Commission, said that his
institution does not =93make any confusion between generic medicines and
fake medicines.=94 Stating that the EU is committing to boosting access
to medicines for the poor, he said that assurances have recently been
given by Europe=92s leading pharmaceutical firms that they will not
invoke EU rules to request the seizure of generic drugs. Such
assurances are =93very positive,=94 he claimed.

James Love from the organisation Knowledge Ecology International
attacked the lack of transparency surrounding the ACTA negotiations.
Documents under discussion and even the names of those taking part in
the talks have been withheld from the public. He also suggested that
leaks from the talks indicate that the title ACTA is something of a
misnomer. Rather than being confined to matters of counterfeiting, the
talks are dealing with a variety of other intellectual property
issues, with the EU even seeking to place geographical indications
(terms such as Bordeaux or Champagne that belong to food or drink from
particular locations) on the agenda.

WCO Scales Back Policymaking on IP Enforcement

Meanwhile, Brazilian diplomat Henrique Moraes said that public
interest groups should be wary of a phenomenon known as =93forum-
shopping=94 by governments where IP issues that have been rejected in
one institution appear on the agenda of another.

The little-known World Customs Organization, he noted, has been
discussing proposals aimed at allowing customs authorities throughout
its 174 member countries to seize goods in transit when it is
suspected that patents may have been breached. Such provisions went
beyond the scope of TRIPS, he added.

Protests raised by Brazil and some other developing countries appear
to have paid dividends, he added. During discussions held last week,
it was agreed that the WCO will replace its working group known as
SECURE (Standards to be Employed by Customs for Uniform Rights
Enforcement) with a new internal body. Unlike SECURE, its successor,
the counterfeiting and piracy group, will be restricted to exchanging
information on how customs officials deal with IP issues and will not
have a mandate to set norms or decide on best practices.


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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru@keionline.org


Tel: +41 22 791 6727
Mobile: +41 76 508 0997