INTERVENTION by INDIA – TRIPS Council June 2009 Agenda item ‘M’ – OTHER BUSINESS – Seizure of generic drug consignments at EC ports
Madame Chair, When India and Brazil raised the issue of seizure of generic drug consignments at EC ports in the TRIPS Council meeting of March 3, we did not foresee that we will need to raise the issue again in
today’s meeting. Going by EC’s intervention at the last TRIPS Council meeting, confirming their
commitment to the Doha Declaration on Public Health, we thought that the matter will get the
attention it deserves and get resolved. Regrettably, this has not happened and we are
compelled to raise the issue in this meeting
. We have neither received a satisfactory
response from the EC to our formal communication to them in Brussels, nor have we seen any
review of the relevant EC regulation or actions by Customs authorities. Seizures have continued
with the latest one being at Frankfurt last month.
We have received information that a shipment of a generic antibiotic, Amoxicillin, manufactured in
India and destined for a Least Developed Country, the Republic of Vanuatu in the Pacific, was seized by customs officials on 5 May, 2009, while in transit through Frankfurt,
Amoxicillin is an essential medicine used to treat a wide range of bacterial infections.
We understand that the consignment worth approximately 28,000 Euros consisted of 3,047,000
tablets of Amoxicillin (250 mg), equivalent to 76,000 courses of treatment. The seizures were
made on grounds of alleged trademark violation although GlaxoSmithKline (GSK) has confirmed to
the German authorities that GSK is the former patent holder for “Amoxil”, a brand name for amoxicillin. There seems no valid reason for detaining these medicines especially since the name “Amoxicillin” is an international nonproprietary name (INN). In the last TRIPS Council meeting, and subsequently in our formal communications to Brussels, we had asked the EC to provide details of all drug consignments seized by customs authorities and the grounds of such seizures. We have not yet received such information from the EC so far.
However, in response to a request made by Health Action International (Europe) under the
Freedom of Information Act, the Dutch government have provided limited information. The
information shows that the case of Losartan exported from India to Brazil, and seized at
Amsterdam, was just the tip of the iceberg. We have come to know that there have been 17
seizures by the Dutch authorities in the year 2008 on the basis of EU regulation 1383/2003.
Of these 16 consignments originated in Indian and one in China. These
consignments were bound for Brazil (1 consignment),Peru (x5), Colombia (x4), Ecuador (x2),
Mexico (x2), Portugal (x1), Spain (x1) and Nigeria (x1). The drugs were for diseases such as
cardiological ailments, AIDS, dementia and schizophrenia. It needs to be noted that all 17
consignments originated in developing countries and 15 of the 17 were destined for developing
We have followed closely the different grounds mentioned by the EC for such seizures. The grounds stated by EC include counterfeits, fake drugs, substandard, potentially dangerous products, patent violations and so on
. The EC have also made allegations of
after three months of seizure of a particular consignment. These are serious
allegations and we take serious exception to such unsubstantiated and wild allegations. The fact that the drugs were subsequently released are a proof that the allegations were
Seizures have continued to take place at EC ports. The multitude of allegations and the spread
across several EC ports, imply an emerging pattern to disrupt and create barriers to
legitimate trade of generic drugs and to challenge the Doha Declaration on Public Health. The basic principle of transparency of procedures has also been violated
by the inability of
the authorities to share and explain the specific cause of action under EU regulations.
EC has sought to justify the action of customs authorities to control goods in transit suspected of
infringing IPRs as a means to stop “traffic of potentially dangerous products, such as fake
medicines, even when the shipments were destined for any country.” It seems that it has been
ingrained very deeply within the EC authorities that IP violative products are synonymous with
potentially dangerous substances.
This clearly is an untenable logic. We doubt such simplistic
linkages. Moreover, we are talking about generic medicines, which neither infringe IPRs nor are
they ‘potentially dangerous’. EC takes pride in its claim that “EU customs actions in the past had
saved lives in the final destination countries which were often developing countries.” We wish to
remind the EC that the concept of 'territoriality' is a key stone in the edifice of the TRIPS Agreement
and a widely understood and accepted principle. In our view, sovereign functions of
the country of destination should be exercised by the country itself and other countries may assist
in enforcement of their law, if requested. It may be farfetched to claim that the country of transit will have sound understanding of the IPR laws of country of destination or origin and will have the authority to enforce them during transit. It would also be incorrect to presume that the sovereign
countries, to which pharmaceutical goods are consigned, are not responsible for ensuring health,
safety and expectations of consumers in their countries. In such situations, an information sharing mechanism is what is needed and definitely not action under the laws of the country in transit.
If there is a reason to doubt the quality of goods, enforcement action should
follow from domestic regulations in importing country and not from WTO rules, which do not provide for the same or from rules of a third country. The seizures run counter to the spirit of the TRIPS Agreement and the resolution 2002/31 of the
Commission on Human Rights on the right to enjoy the highest standards of physical and mental
health. In this context let me draw Members’ attention to the report of the Special Rapporteur on
the right of everyone to the enjoyment of the highest attainable standard of physical and mental
health submitted to the 11th Session of the Human Rights Council last week. I quote - “The Special
Rapporteur is concerned with reports of IP enforcement measures that have resulted in multiple
seizures at some ports of shipments of generic medicines heading to developing countries and
Widespread and repeated seizures have an adverse systemic impact
on legitimate trade of
generic medicines, South-South commerce, national public health policies and the principle of
universal access to medicines. The importance of generic drugs to public health in developing
countries and particularly in the LDCs is obvious. Such barriers to legitimate trade of generic drugs will also seriously impair the efforts of civil society organisations engaged in providing medicines and improving public health in the least developed parts of the world. I would like conclude by reminding the EC that trade of generic drugs is perfectly legitimate.
Moreover, it is also desirable from the public health and access to medicine perspective. It is
ironical that while on one hand WTO has taken steps to promote access to affordable medicines
and remove obstacles to proper use of TRIPS flexibilities, on the other hand some Members seek
to negate the same by seizing drug consignments in transit and creating barriers to legitimate trade.
Since seizures have been recurring at different ports and on different grounds, it is therefore clear
that rather than just being a problem of implementing a law by Dutch Customs authorities, it is the EC regulation 1383/2003 itself that is problematic and can be misused, and has been
misused, to create barriers to legitimate trade
. We, once again, call upon the EC to urgently review the Regulation and the actions of the national authorities based on the Regulation, and bring them in conformity with the letter and spirit of the TRIPS Agreement, the rules based WTO system and the DMD on Public Health
. Madame Chair,
India attaches the highest importance to protection and enforcement of IPRs in accordance with the TRIPS Agreement. However, we do not see the Agreement as divorced from the Objectives and Principles set out in Art 7 and 8 of the Agreement. Enforcement of IPRs in disregard of these
Objectives and Principles and efforts to enshrine new, maximalist TRIPS plus enforcement provisions in other multilateral forums will seriously undermine the delicate balance in the TRIPS Agreement and raise systemic issues, particularly for developing countries. Madame Chair, my delegation will like this Council to take note of these points.
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