EU Faces Global Governance Challenge to Inspection of Pharmaceutical Shipments
ECONOMICS, ENVIRONMENT & HEALTH, INTELLECTUAL PROPERTY, HUMAN RIGHTS, LAW & JUSTICE
Wednesday, September 9, 2009
Over the past year, there have been several instances of customs authorities in Europe temporarily detaining for inspection pharmaceutical products manufactured in India that were bound for developing countries such as Brazil and Nigeria. The goal of the European Union is to prevent the sale of fake and potentially dangerous medicines to developing countries. Unfortunately, to circumvent EU attempts to protect the intellectual property rights of pharmaceutical companies, Brazilian authorities are taking their case to politicized international organizations.
In December 2008, Dutch authorities held for inspection a shipment of Indian-made Losartan, a drug used in the treatment of hypertension that was on board a Brazilian-bound vessel docked in a Netherlands port. The Dutch customs officials released the shipment to its owner after 36 days.
The seizure of generic medicines produced in India meant for distribution in developing countries has evoked angry responses from the Brazilian and Indian governments. At a February 2009 meeting of the World Trade Organization’s (WTO) General Council, Brazil asserted that seizures of medicines in transit “have an adverse systemic impact on legitimate trade of generic medicines…and the principle of universal access to medicines.”
Tensions over this issue were exacerbated when, on May 5 of this year, officials in Frankfurt, Germany delayed the shipment of 3 million Amoxicillan pills, an antibacterial drug, on suspicion of trademark violations. In response to this action, India and Brazil each filed an intervention under the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”).
In response to criticism from the Brazilian and Indian governments, EU representatives have cited provisions of EU law and Article 51 of the TRIPS Agreement, which provides that holders of intellectual property rights may apply to customs officials to suspend for a time the importation of goods that violate those rights. Specifically, the joint holders of the patent on Losartan, namely Merck & Co, Dupont Co., and Merck Sharp & Dohme, acting on reasonable suspicion that the drugs in question violated their rights, contacted the Dutch authorities under this provision, prompting the inspections in December.
Despite legal support for its customs inspections under both EU law and the TRIPS Agreement, the EU still faces the threat that a WTO dispute settlement complaint will be filed against it by Brazil, India, or any other country disgruntled with measures taken by its customs officials. A conclusion by a WTO panel that the EU customs officials were violating international trade law would require the EU to change its domestic laws immediately, an action that poses an obvious threat to the national sovereignty of the United States, itself a member of the WTO.
While a WTO complaint is still only a threat at this time, Brazil also intends to introduce a resolution at the upcoming meetings of the Human Rights Council later this month condemning the use of relevant provisions of the TRIPS Agreement by EU officials to justify inspections of pharmaceutical products in transit.
Jim Kelly is the President of Solidarity Center for Law and Justice, P.C., a public interest civil and human rights law firm based in Atlanta, Georgia. The opinions expressed herein are his own.
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