[A2k] India's Commerce Secretary Expresses Serious Concern over Generic Drug Seizures and Anti-counterfeiting Campaigns against Indian Pharmaceutical Products

[Yogesh Pai]

--
[ Picked text/plain from multipart/alternative ]
Dear All,

Some recent international events on generic drug seizures and
anti-counterfeiting campaigns  have taken India by surprise. In an
epoch-making address by India's Commerce Secretary Mr. G K. Pillai to their
excellencies Ambassadors from African Countries on 24th April 2009, the
Government's strong disapproval of the high-handedness of developed
countries on issues at the core of health care is appreciable. It is
expected that the Indian Government will take up these matters at
appropriate forums and register its protest with the same tenor. Suitable
remedial measures, including a challenge at the WTO Dispute Settlement Body
must be explored on priority basis.

Centre for Trade and Development (Centad), New Delhi, has been at the
forefront of informed discussion, research and advocacy on issues that can
have tremendous impact on trade and public health. It has been supportive o=
f
low-cost and safe generic drug availability to further the cause
of universal access to health care.

*A brief summary of the Commerce Secretary's speech is produced herewith*:

The Commerce Secretary began by recounting two important incidents that had
recently taken place. The first concerned the repeated seizure and detentio=
n
of generic pharmaceutical products by customs authorities in Europe,
particularly those in the Netherlands. The second was with reference to som=
e
recent and ongoing attempts to conflate issues of alleged intellectual
property (IPR) violations with drug quality and safety.

On the issue of seizure of generic drug consignments, the Secretary noted
that these products were being exported from India to nations in Africa and
Latin America, including Brazil, in all of which they did not receive paten=
t
protection. However, they were targeted by customs authorities on the
grounds that they were patent-protected in Europe and therefore, infringed
upon the rights of patent-holders there. This was in spite of the absence o=
f
any evidence that the products would be diverted towards European markets.
Freedom of transit for legitimate trade is clearly laid down under GATT. Th=
e
TRIPS Agreement also emphasizes that measures to protect intellectual
property should not pose barriers to legitimate trade. The Secretary
explained that India and Brazil had taken up the matter with the European
Commission and the World Trade Organization, clearly pointing out the
illegality of the European measures dealing with border enforcement. Anothe=
r
important incident having far-reaching consequences on healthcare needs of
African countries was the detention in the Netherlands of anti-AIDS drugs
being sent from India to Nigeria on the grounds that they were
patent-infringing. The Secretary stated that India was preparing to take th=
e
matter to the WTO dispute settlement body.

He explained that TRIPS had originally reflected the concerns of developed
nations, particularly their pharmaceutical industries, for the protection o=
f
their investments. It was only after sustained efforts by developing nation=
s
that certain flexibilities were added to the Agreement. These included a
longer transition period in which the TRIPS regime for product patents was
to be implemented in least developed countries, limited exceptions to paten=
t
rights as well as provisions allowing compulsory licenses and parallel
imports.

The Secretary contended that generic consignments from India were being
targeted because of the latter=92s strong position as a producer and export=
er
of generic drugs that were far less expensive than their patent-protected
counterparts. This had huge implications for the healthcare needs of
developing countries. He believed that the incidents in Europe were part of
a larger plan to ensure that intellectual property rights (IPRs) were
stringently upheld even at the cost of the public health concerns of
developing countries.

The second issue that the Secretary brought up was regarding the
introduction of anti-counterfeiting legislations in a number of African
countries, which allow for the enforcement of IPRs even on products that ar=
e
not patented in such countries. Explaining the overreaching implications of
a recent Kenyan legislation, the Secretary took the example of a
pharmaceutical product that is registered for patent-protection in Jordan,
but not in India or Kenya. Under the Kenyan law, he explained, a generic
version of this drug exported from India to Kenya could have legal action
taken against it by the African nation. The Secretary asserted that such
legislations went beyond the requirements of TRIPS, especially the principl=
e
of territoriality, as per which a right is enforceable within the territory
in which a patent has been registered.

The Secretary took note of the Doha Declaration of 2001, according to which
members may grant compulsory licenses for exporting medicines to countries
that lack manufacturing facilities. He emphasized that this provision would
be rendered meaningless if African nations enacted laws that restricted
legitimate trade in generic medicines. The Secretary also pointed out that
the Doha Declaration stated that the TRIPS =93Agreement can and should be
interpreted and implemented in a manner supportive of WTO members=92 right =
to
protect public health and, in particular, to promote access to medicines fo=
r
all.=94

Next, the Secretary drew attention to the efforts of multinational
pharmaceutical companies backed by the developed nations like the USA, the
EC and Japan to protect and enforce IPRs in a maximalist manner, thus
skewing the balance between IPRs and public policy objectives in favour of
the former. He pointed out that this was taking place in a number of
international fora like the World Customs Organization, the World Health
Organization and the Universal Postal Organization etc. He also noted with
dismay the efforts by some WTO members to push for TRIPS-plus provisions on
issues such as patent term extension, data exclusivity and the limitation o=
f
grounds for compulsory licenses etc. which were increasingly being included
in regional trade agreements. He termed this to be subtle way to
circumscribe the flexibilities in TRIPS, which otherwise allow developing
countries to safeguard their public health interests.

The Secretary highlighted the magnitude of public health issues in the
Indian sub-continent and Africa, pointing out the close relationship in
these regions between poverty and health. He explained that both regions ha=
d
to address water-borne diseases, respiratory diseases with environmental
triggers, the effect of malnutrition, tuberculosis, malaria and most
importantly, HIV/AIDS. All of these diseases, he contended, involve
prolonged treatment and take place on an immensely large scale. He stressed
upon the dangers of an IPR-maximalist system, painting a picture of a marke=
t
in which only branded and patent-protected medicines are allowed and
generics are not, thus creating total dependency on a small group of
multinationals and causing a tremendous rise in the costs involved.

The Secretary then addressed the highly misunderstood notion that generic
drugs are of poor quality. He distinguished between spurious drugs and
counterfeit ones, identifying the former as sub-standard and constituting a
public health issue while the latter merely involved an issue of IPRs. The
Secretary took pains to emphasize that counterfeit issues relating to
alleged IPR violations were entirely different from issues of production an=
d
sale of spurious drugs. He stressed India=92s commitment to manufacturing
safe, high-quality drugs, pointing out that after the USA, India had the
largest number of USFDA-approved manufacturing plants. This amply proves
India=92s commitment to the production and trade in good quality drugs,
perhaps, the best in the world.

The Secretary asserted such unfair efforts against developing countries mus=
t
be tackled on a war footing basis so as to prevent a new form of dependence
by developing nations on developed ones. He concluded by reiterating India=
=92s
willingness to provide any assistance required by Africa in this direction,
including the setting up of manufacturing plants, undertaking capacity
development, and any other assistance which is necessary for African
Governments to understand the importance of generic medicines in their
public healthcare obligations.

Credits:
Vasudha Reddy, V Year Law Student, NUJS, Kolkata
Summer Intern @ Centre for Trade and Development, New Delhi, India.

--
SNAIL MAIL:
Yogesh A. PAI
Associate Fellow
Consortium for Trade and Development (Centad)
A-1/304, Safdarjung Enclave,
New Delhi -110029, INDIA.
Ph: +91-11-41459226 Fax: +91-11-41459227
Mobile: +91-98 99 976 110
Email: yogesh.pai@centad.org legaloracle@gmail.com