TWN Info Service on Health Issues (Nov09/01)
4 November 2009
Third World Network

TRIPS Council takes up public health, TRIPS/CBD, drug seizure issues
Published in SUNS #6806 dated 3 November 2009

Geneva, 2 Nov (Kanaga Raja) -- WTO Members, at meetings of the regular TRIPS Council on 27-28 October, amongst others, agreed to recommend extending by another two years an end-of-year deadline for Members to accept an amendment to the TRIPS Agreement in relation to TRIPS and public health.

The Council also heard concerns from India over the European Union's seizure of generic drugs while in transit in EU ports and bound for developing countries.

According to trade officials, on 27 October, WTO Members agreed to extend for another two years the 31 December 2009 deadline for Members to accept an amendment to the TRIPS Agreement concerning the issue of patents and public health.

The recommendation to extend the deadline for accepting the amendment to the TRIPS Agreement until the end of 2011 will now have to be formally agreed by the General Council.

According to trade officials, since the last TRIPS Council meeting in June, five more members have reported that they have accepted the amendment: Macao-China, Canada, Bahrain, Colombia and Zambia. Pakistan said that it has ratified the amendment and will formally notify the WTO soon.

A number of delegations urged all Members to accept the amendment.

Canada reported a second and final shipment to Rwanda of medicine made under compulsory licence.

According to trade officials, while some Members said that the Canada-Rwanda example shows that the system can work, some other Members said that the fact that the system has only been used once shows that it might be inadequate.

It was agreed at the meeting that Chairperson Ambassador Karen Tan of Singapore should consult with Members on how well the system is working.

Under the agenda item of "Other Business", India voiced its concerns over the seizure by EU Member States of generic medicines in transit through EU ports and destined for developing countries.

In a statement at the TRIPS Council, India, referring to 17 seizures by the Dutch authorities in the year 2008 on the basis of EU regulation 1383/2003, said that it thought that the Amsterdam seizures were the last because the EC had been giving assurances that they are putting in place systems to ensure that generic medicines are not seized.

India however said that in May, a consignment 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 while in transit through Frankfurt, Germany. The seizures were made on grounds of alleged trademark violation although GlaxoSmithKline (GSK) had confirmed to the German authorities that GSK is the former patent holder for "Amoxil", a brand name for amoxicillin, it added.

India said that it was alarmed to get information of yet another drug seizure. It has been informed by customs authorities at the Paris-Roissy airport that they have seized a shipment of 1,740,000 tablets of Clopidogrel - an anti-platelet drug used to prevent strokes and heart attacks in patients at risk for these problems. The consignment was in transit from Mumbai to Caracas, Venezuela, and was seized on alleged ground of patent violation.

India said that it has continued its bilateral efforts with the EC at the level of senior officials, Ministers and formal communications. However, in spite of its persistent urging, "nothing concrete has been done". There are yet no signs of review of EC customs Regulation 1383/2003, in spite of its inconsistency with provisions of GATT, the TRIPS Agreement and the spirit of the Doha Declaration on the TRIPS Agreement and Public Health.

Referring to an "Explanatory Note" dated July 31 issued by the EC to Member States on the application of the EC Regulation 1383/2003, India said that it shifts the blame to Member States for applying their national laws and the responsibility for interpretation to the National Courts. The Note totally disregards the permissiveness of the EC Regulation itself.

Prior to 2003, said India, the scope of EC Regulations covered only trademark and copyright infringements. The EC Regulation 1383 has expanded the scope to additionally cover patents and other IPRs and also extends to goods in transit and as shown by the drug seizures, it has provided a basis for Member States to apply IPRs extraterritorially and to goods in transit. The EC's Explanatory Note also repeats the timelines indicated in TRIPS Art 55 (Duration of suspension) which were hardly followed by Customs authorities in the various cases of drug seizures in 2008.

Noting the EC claims that there have been no drug seizures since December 2008, India said that these claims have been proven hollow with the Frankfurt and Paris seizures.

Further noting that the EC has attributed the seizures in part to its operation MEDI-FAKE, India said that here lies another one of the roots of the problem, i. e. dealing with sub-standard and spurious medicines through border measures and customs officials who can hardly be expected to be experts in public health issues.

Underlying the drug seizures is also a deliberate mixing up of the issue of spurious/sub-standard drugs etc with IPRs. India emphasised that the seizure cases involved legitimate generic medicines which are neither fake, nor counterfeit, nor pirated medicines. Moreover, the Frankfurt and Paris seizures happened much after operation MEDI-FAKE.

India said that the seizures, and the consequent denial of access, run counter not only to the spirit of the TRIPS Agreement but also the resolution 2002/31 of the Commission on Human Rights on the right to enjoy the highest standards of physical and mental health.

India also noted that while on the one hand developing countries, including the LDCs, are still adjusting to TRIPS, on the other hand, "we are witnessing an increasing spiral of ever-increasing levels of protection, thereby reducing the flexibilities and policy space left open under the TRIPS Agreement particularly for developing countries and LDCs".

"We also witness an orchestrated campaign for TRIPS plus enforcement norms by deliberately confusing quality issues with IPRs in international organisations (WHO), other TRIPS plus initiatives in WIPO, WCO and UPU, insistence on TRIPS plus elements in FTAs being negotiated and to top it all, negotiating the ACTA amid secrecy and exclusion of a vast majority of countries including developing countries and LDCs," said India.

India further said that the widespread and repeated seizures, under the EC Regulation 1383, have an adverse systemic impact on (i) the principle of universal access to medicines, (ii) national public health budgets, (iii) legitimate trade of generic medicines, (iv) South-South commerce, (v) use of TRIPS flexibilities, and also (vi) seriously impair the efforts of civil society organisations engaged in providing medicines and improving public health in the least developed parts of the world.

It called upon the EC to urgently review the Regulation and bring it in conformity with WTO provisions including GATT, TRIPS Agreement and the letter and spirit of the Doha Ministerial Declaration on Public Health.

According to trade officials, countries that supported India included Brazil, China, Peru, Ecuador, South Africa, Argentina, Chile, Egypt (African Group) and Peru.

According to trade officials, the EU said that its commitment to access to medicines was well illustrated and that this policy had not changed. While not hindering trade in generic medicines, it was important to stop dangerous fake medicines and for that purpose detention by customs to allow verification of the product by the right holder was legitimate and necessary, said the EU.

The discussion concerned a few cases of temporary detention of medicines, and all the consignments had ultimately been returned to their importers, the EU said. It further said that it had reacted effectively to India's and Brazil's concerns, as patent right holders had publicly committed themselves not to seize generic medicines for patent infringements, and no new cases had occurred.

The EU said that the regular review of Regulation 1383/2003 was open and could address any concerns that India and Brazil might still have.

There were divisions in the TRIPS Council on two issues.

One concerns the issue of non-violation complaints. The key question relates to whether the present moratorium on non-violation cases in TRIPS - not to bring a formal dispute on this kind of complaint - should be extended beyond the upcoming seventh WTO Ministerial Conference end November.

According to trade officials, consultations will continue on this issue. The US said that it had been flexible but could not agree to extending the moratorium when others are not flexible in other areas (in apparent reference to similar discussions on a moratorium on duties on electronic commerce).

There were also divisions on the issue of whether to amend the TRIPS Agreement to require patent applicants to disclose the origin of genetic material and associated traditional knowledge.

According to trade officials, while Members continued to agree that the objective is to reduce bio-piracy, there was continued disagreement on whether amending the TRIPS Agreement is the way to deal with the issue.

Some Members continued to link these issues (the relationship between the TRIPS and UN Convention on Biological Diversity, TRIPS disclosure etc) with two proposals on geographical indications (multilateral register for GIs for wines and spirits and extending the higher level of protection beyond wines and spirits).

For these Members, the disclosure proposal is essential to prevent bio-piracy and patents being granted when the genetic material and traditional knowledge used are not new.

According to trade officials, many Members also argued in favour of proposal TN/C/W/52 (which links the disclosure proposal to the two GI issues). According to trade officials, speakers included India, Colombia, African Group (Egypt speaking), Peru, Brazil, Least Developed Countries (Angola speaking), Tanzania, China, Cuba, Indonesia, Norway, EU, Pakistan, Switzerland and Guatemala.

Other Members continued to oppose the link, arguing that it complicates the discussion. The opponents of the "disclosure" issue also reiterated their view that this is an unsuitable way to deal with bio-piracy and inappropriate patenting.

Speakers included Argentina, El Salvador, Australia, New Zealand, Korea, US, Japan, Canada and Chinese Taipei.

The TRIPS Council also took up the eighth transitional review of China.

Meanwhile, on 28 October, the TRIPS Council met in Special Session, where the negotiations are focused on a multilateral register for GIs for wines and spirits. According to trade officials, positions remained largely unchanged.

The Chair of the Special Session, Ambassador Trevor Clarke of Barbados, said that he would seek to identify areas of convergence and remaining differences in a paper based on Members' discussions at recent meetings, with the hope that this would focus the discussion on key issues rather than debating each others' positions. +