[Ip-health] IP Watch: WTO Forum: Bypassing International Agreements May Hamper Medicines Access

[Malini Aisola]

http://www.ip-watch.org/weblog/2009/10/11/wto-forum-bypassing-international=
-agreements-may-hamper-medicines-access/

WTO Forum: Bypassing International Agreements May Hamper Medicines
Access

October 11, 2009
By Catherine Saez

Access to medicines in developing countries may be put at risk by
European customs regulations and more broadly by trade provisions in
most free trade agreements between developed and developing countries,
said speakers at the recent World Trade Organization Public Forum.

The WTO Public Forum is a yearly gathering of a variety of stakeholders
to discuss trade issues. This year=E2=80=99s forum from 28-30 September was
entitled, =E2=80=9CGlobal Problems, Global Solutions: Towards Better Global
Governance.=E2=80=9D

The detention of medicine in transit is having health consequences in
developing countries and a change of the European Union customs laws is
in order, according to speakers at a panel organised by M=C3=A9decins Sans
Fronti=C3=A8res (MSF).

Michelle Childs of MSF said that in the case of the Netherlands
detaining shipments of Indian-manufactured generic medicines, patents
neither existed in the country of origin, nor in the country of
destination, and the drugs were not meant for domestic consumption in
the European Union.

Many developing countries lacking manufacturing capacities have to
import affordable drugs so trade between those countries is essential,
she said.

For Carlos Correa, professor at the University of Buenos Aires, this is
a legal issue. Article 5 of the WTO General Agreement on Tariffs and
Trade (GATT) states that member countries must insure freedom of transit
and all charges and regulations imposed are to be reasonable, he said,
adding that preventing the transit of medicine did not seem reasonable.

Patent rights are territorial by nature, Correa said, and they can only
be exercised in the jurisdiction in which they have been granted. The
detention of goods in transit for alleged IP infringement goes against
the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS)
agreement, he said.

Neither Dutch nor any other EU customs officials are competent
authorities to determine if there is a patent infringement in the
country of importation, Correa said.

In the pharmaceutical sector, there is a major proliferation of patents
around any single active ingredient, Correa said, adding that the EU
Commission, in a report on competition in the pharmaceutical industry,
said that for one blockbuster drug, there were about 1,200 patents or
patent applications in the EU.

So it is extremely difficult for a customs officer to determine whether
there is infringement in the first place, he said. The EU regulation
must be reviewed, Correa said, for the matter of goods in transit but
also for its applicability to patent infringement, which, as it stands
now =E2=80=9Cis really prone to abuses by patent owners=E2=80=9D who can us=
e these
thickets of patents to prevent legitimate trade.

For Sunjay Sudhir, counsellor at the Permanent Mission of India, EU
customs regulations have a negative impact on universal access to
medicines, national public health budgets, legitimate trade in generic
medicines, and they =E2=80=9Cimpair the efforts of civil society organisati=
ons
engaged in providing medicines and improving public health in the least
developed part of the world.=E2=80=9D

EU regulation 1383/2003 concerning customs action against goods
suspected of IP infringement is open to interpretation, Sudhir said.
=E2=80=9CThe Damocles sword is always hanging,=E2=80=9D and by experience, =
the sword
falls more often on generic drugs than on mobile phones, he said.

Sudhir said it is ironic that the EU provides funds for public health
programmes in developing countries and at the same time creates barriers
to legitimate trade in generics, hampering access to medicines.

There are fears that decisions taken under regulation 1383/2003 reflects
a larger design for tougher enforcement of IP rights, part of which is a
campaign of deliberately confusing quality concerns with IP rights in
international organisations. The issue has arisen in the World Health
Organization, and can be noticed in TRIPS-plus elements in bilateral
free trade agreements, and the Anti-Counterfeiting Trade Agreement
(ACTA) under negotiation to the exclusion of many countries, including
developing and least-developed countries, according to Sudhir.

Regulation 1383/2003 should be reviewed and brought into line with
TRIPS, GATT, and the Doha Declaration on the TRIPS agreement and public
health, he said.

Much =E2=80=9CNoise=E2=80=9D About Nothing?

Luc Devigne of the European Commission trade directorate said very few
cases of medicine detention happened in 2008, so there was =E2=80=9Cmuch no=
ise
about nothing.=E2=80=9D Devigne said the discussion was about a very limite=
d
number of cases, all in the past, and which had been explained in
detail. The European Commission disagrees that it could be considered as
a policy. =E2=80=9CWe are probably talking about a nano-percentage=E2=80=9D=
 of the
medicine transiting through the EU, he argued.

The EU goal is not to hamper generic medicines, he said, and the Union
remains totally committed to its policy of access to medicines. =E2=80=9CWe=
 are
committed to the Doha Declaration,=E2=80=9D and to the global fund on HIV/A=
IDS,
Devigne said. The main objective of the customs regulations is to
prevent IP rights infringement and the trade of counterfeit goods, which
is a growing concern, he said.

=E2=80=9CIt is true that the two issues of generics and fakes are separate =
but
it is also true that the EU customs probably saved lives around the
world by stopping fakes,=E2=80=9D Devigne said.

A review of the EU customs regulation is foreseen, he said,
independently from the detentions, and anyone who has an interest can
provide comments for the review. =E2=80=9CI have heard what has been said h=
ere,=E2=80=9D
he said.

Seizures under 1383/2003 are an attempt at extraterritorial enforcement
of patent rights, said Jose Estanislau do Amaral, counsellor at the
Permanent Mission of Brazil. This regulation can potentially disrupt
international trade in generic medicines since the impact is not
confined to individual transactions. Repeated seizures create
uncertainty and may lead countries to try to avoid certain transit
routes, bringing unnecessary transactional costs that might be added to
the price of the medicine, he said.

Silke Trommer, researcher for the Centre of Excellence in Global
Governance Research at the University of Helsinski, Finland, in a
separate panel about access to medicines in developing and
least-developing countries warned against provisions in free trade
agreements.

In several agreements, she said, the scope of patent protection is
extended by patenting the new use of an old product, for example, in
what is called evergreening of existing patents.

FTAs can also contain restrictive marketing approval procedures. For
example, in a US-Chile agreement, the approval of a generic drug was
prohibited during the patent term unless it was authorised by the patent
holder. =E2=80=9CThis does not exist under TRIPS,=E2=80=9D Trommer said. Th=
ere also
might be an attempt at preventing compulsory licensing by limiting the
practice to national emergency situations only.

Catherine Saez may be reached at csaez@ip-watch.ch.


--
Malini Aisola
Knowledge Ecology International
1621 Connecticut Avenue NW, Suite 500, Washington DC 20009
malini.aisola@keionline.org|Tel: +1.202.332.2670|Fax: +1.202.332.2673