Indian drug exporters fear that their exports to the world could be held up in transit in Europe. While this happened repeatedly in 2008, it stopped after India took the EU to World Trade Organisation's dispute settlement body. But a recent WHO discussion document on medicines in transit has triggered fears that it could become a problem again.
The issue of medicines in transit will be taken up at a WHO meeting from November 28 to December 1 in Geneva. A discussion document prepared by the WHO secretariat outlines criteria that could justify a country's customs authorities intervening to check medicines passing through their ports on grounds of public health concerns. With the past experience of European countries seizing Indian drugs to Latin America transiting through Europe, it is feared that these new criteria are an attempt to legitimise such practices.
In 2008, 17 shipments (16 from India and one from China) were detained in Europe on grounds of infringement of intellectual property. India had taken the issue to WTO's disputes settlement body in May 2010 against the EU and Netherlands, where the shipments were detained. Brazil, Canada, Ecuador, China, Japan and Turkey had joined the dispute. A settlement was reached in 2011 and the EU agreed not to seize generic drugs transiting through its territory. However, the case remains pending and if there is any breach, India has the option of reagitating the case, Rajiv Kher, former commerce secretary said.
The WHO discussion document details circumstances in which customs officials would be justified in "intervening" in medical products in transit on grounds that they are substandard, falsified and unregistered/unlicensed or a genuine threat to public health or environment. Saying such products have the potential to endanger the health of patients, it argues that "part of the function of national customs authorities is to protect the health and safety of their populations".
Kher dismisses the argument. "Customs documentation is very clear that the medicines are meant for a non-EU market. Then why should EU have a valid reason to withhold the medicines? The customs have no authority to open any consignment unless it is meant for EU territory or there is apprehension that it would be adverse to their citizens," he said.
R V Anuradha, an international trade and customs lawyer, pointed out that if there were any concerns regarding quality, all the EU customs authorities needed to do was to alert the destination country, unless the seizure was based on the suspicion that the medicine was going to be placed on or diverted to the market of the country in which it was 'in transit', one of the criteria in the WHO document.
"A transit country doesn't have the jurisdiction to intervene, unless it had grounds to believe the drugs are being diverted to its market, endangering its citizens," said Anuradha. She said the overarching criteria proposed by WHO also potentially clash with the principle of freedom of transit, a fundamental component of GATT, which has been amplified under recently concluded WTO Agreement on Trade Facilitation. "The Trade Facilitation Agreement that recently came into effect mandates that the transit country will ensure the least trade restrictive means to address its concerns and won't apply its technical regulations, i.e. impose its standards of quality or conformity assessment, on goods in transit," said Anuradha.
Source: timesofindia.indiatimes.com