Geneva, 19 Feb (Kanaga Raja) — Sixteen public health, consumer and development groups have sent separate letters to the heads of the World Health Organization (WHO) and the World Trade Organization (WTO) voicing their concerns over recent seizures by Dutch customs authorities of Indian generic drugs shipped through the Netherlands en route to Brazil, Colombia and Peru.
In their letter dated 18 February to WHO Director-General Dr Margaret Chan, the NGOs asked her to “immediately undertake an assessment of the risks to public health programs presented by such seizures and any anti-goods-in-transit provisions that exist in current or proposed trade agreements, including those relating to anti-counterfeiting initiatives.”
In conducting the assessment, the WHO is asked to “interview developing country governments, UN agencies and other entities engaged in the trans-border delivery of generic medicines to developing countries, to fully document the extent to which medicines in transit are at risk regarding seizure or liability for infringement.”
In a separate letter to WTO Director-General Pascal Lamy, the groups called on him to “explore with the European Union the extent to which its customs rules and provisions in trade agreements present risks to goods in transit, and undermine the commitments made in 2001 in the Doha Declaration on TRIPS and Public Health concerning access to medicines.”
The sixteen non-governmental organizations that signed both the letters are BUKO Pharma-Kampagne; Consumers International; Consumers Union; Essential Action; HAI Africa; HAI Asia Pacific; HAI Europe; HAI Global; HAI Latin America and Caribbean; Health GAP; Iqsensato; Knowledge Ecology International; Medico International; Oxfam International; Third World Network; and U. S. PIRG.
“In a world with territorial patent rights, it is important that the rules for ‘goods in transit’ permit the transport of medicines from places where they can be made to places where they will be used. The Dutch seizures have drawn attention to this issue, as has the recent disclosure of MSF that they regularly transport and temporarily store medicines in Europe, in route to users in developing countries. We expect the leaders of the WHO and the WTO to lead on this issue,” said James Love of Knowledge Ecology International.
“It is time that the World Health Organization, the institution that we look to for a lead in international health and development gave strong and clear guidance on the interpretation of international trade agreements that so adversely affect health. The health of millions of people worldwide who depend on life-saving quality assured generic medicines will be in jeopardy unless action is taken now by the World Trade Organization to give clear guidance to its Members on goods in transit. This situation cannot be allowed to continue,” said Tim Reed of HAI Global.
In their letter to WHO Director-General Dr Chan, the groups said that in recent years there has been a flurry of activity regarding new trade agreements and rules to enforce patents and intellectual property rights. One important aspect of those rules are measures that concern “goods in transit.” Under some legal traditions and consistent with WTO rules, goods in transit are exempt from normal restrictions associated with patents or other intellectual property rights, when en route to a market where the use is legitimate.
“This approach is not uniform, however, as illustrated recently by several seizures of medicines by Dutch customs officials,” said the letter to Dr Chan.
The groups noted that the Dutch cases involved medicines manufactured in India, and then shipped to Brazil, Colombia and Peru, via the Netherlands. The medicines were seized by Dutch customs officials.
Citing industry reports, the letter noted that at least four cases of Indian generic medicines in transit in the Netherlands were seized by Dutch customs authorities from October 15, 2008 to December 12, 2008: Clopidogrel Bilsulphate API (to Colombia); Olanzapine 10 mg Tabs (to Peru); Rivastigmine 3 mg Tabs (to Peru); and Losartan – API (to Brazil).
According to the manufacturers, all products were legitimate generics and did not violate any patent rights in the exporting or the importing countries.
The groups said that the seizure of the shipment containing Losartan active pharmaceutical ingredients (APIs) destined for Brazil was made in connection with a complaint filed by Merck, as the licensee of European patents and Dutch Supplementary Protection Certificates (SPCs), pursuant to Dutch law and the procedures set out in EU Regulations. In the case of the Clopidogrel Bilsulphate API shipments to Colombia, the Dutch customs authorities reportedly asserted the generic APIs were counterfeits, and Sanofi Aventis sought destruction of the goods.
The letter to Dr Chan said that the European Union is currently seeking very aggressive provisions regarding customs procedures in a number of proposed bilateral and regional trade agreements. The topic of provisional measures is also a key element in the secret negotiations for a new Anti-Counterfeiting Trade Agreement (ACTA).
According to some reports, said the NGO letter, there are proposals in the ACTA negotiations to require the seizure of goods that infringe on patents, even for goods in transit. Whether intentional or not, additional risks to goods in transit are also found in the International Medical Products Anti Counterfeiting Taskforce (IMPACT)’s “Principles and Elements for National Legislation against Counterfeit Medical Products” and World Customs Organization’s “Provisional Standards Employed by Customs for Uniform Rights Enforcement (SECURE).”