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Resource centre on India's rural distress
 
 

ACTA will make life saving drugs costlier for the poor-Rachit Ranjan

Joseph Munyi, a Kenyan citizen, has been living with HIV for 8 years and, much like other HIV patients, is unemployed. He has been receiving his medication free of charge on account of government programmes and outreach programmes of Medicine Sans Frontieres. His medication comes in the form of generic drugs.

However, this situation may not last long as economic interests of few may end up impeding many a public spirited citizen of the world from executing her bounden duty as a human to ameliorate the conditions of the underprivileged. This threat comes in the form of the recent Anti Counterfeiting Trade Agreement (ACTA) that is a plurilateral agreement negotiated between eleven parties including the European Union.

The agreement has been executed with the objective of combating trade in counterfeit in goods. The provisions of ACTA have the potential of not only affecting the very existence of generic medicine industries but also of raising serious concerns over affordable access to life saving drugs. The core discussion with respect to the dangers posed to public health by ACTA is focused on three issues.

First, ACTA incorporates a much wider interpretation of 'counterfeit' (as compared to the TRIPS Agreement) by stretching it to forms of IP infringement that would not fall within the ambit of counterfeiting as per conventional wisdom.

The negotiators of ACTA have always maintained that the objective of the agreement is to protect the public from unsafe products and that public safety is risked by deliberate, fraudulent use of trademark on products that either do not contain the stated ingredients at all or have them in insufficient quantities or of suspect quality. In doing so, the ACTA seeks to establish a direct mapping between quality and counterfeiting and tends to also hint that a 'generic' version of a patented product may actually mislead the consumer through inappropriate use of trademarks or trade-names.

However, provisions of ACTA stretch its ambit to civil trademark infringement, which has no relation to a product being counterfeit. By applying such a liberal interpretation of counterfeit, generic medicines may be targeted as the names of many branded medicines and their generic versions are based on international non-proprietary names. Also for easier consumer identification of their bioequivalent properties, they may necessarily also bear similar trade names or adopt easily recognisable trade dress.

It may be readily argued that if indeed there were to be a trademark infringement it can be appropriately addressed in ordinary court proceedings and labeling the same as something posing a risk to public safety may stretch the jurisprudence on intellectual property infringement. The contextual use of counterfeit also goes beyond the WHO definition, which considers counterfeit medicine to be one that is fraudulently mislabeled and compounded using the wrong ingredients or insufficient active ingredients.

The second core issue flows from the application of border measures on in-transit goods. While ACTA excludes patents from border measures, it applies all its proposed border measures to all other forms of IPRs. Under these proposed border measures it would be eminently possible that generic medicines in transit between to non-ACTA parties can be seized by the customs officials in an ACTA party following a request by the concerned right holder or by way of ex-officio action if it can be shown that any of the IPRs such as trade names, trade dresses, designs of packaging boxes, etc. are infringed even if patents are not. While well researched public health advocacy beset ACTA to exclude suspected patent infringement from its purview, the threat of such seizures still remain due to reasons owing to infringements of other IPRs.

First, there exists no clear guideline on what constitutes sufficient evidence to establish risk of diversion of 'counterfeit' goods into the local market when such goods are in transit, thereby conditions warranting the seizure of the same may be vague and arbitrary. Second, the application of law of the in-transit country instead of application of the law of the importing country may be considered a violation of the intent of the TRIPS. Moreover, these measures are in violation of members' commitment under Article V of GATT, which establishes freedom of transit in international trade.

The third core issue aims at introducing both civil and criminal sanctions for third-party suppliers which may be involved in providing essential ingredients and logistical services to the manufacturing industry even though they may make no collusive contribution to counterfeiting itself. It introduces civil enforcement measures that seeks to impose injunctions on third parties to prevent infringing goods from entering channels of commerce.

This provision may prove to be an unruly horse and may be twisted to bring even relief workers and international aid missions within the sphere of such civil and criminal actions. Although, ACTA will not come into effect until it is ratified by at least six nations, its goals are rumoured to be already being furthered through bilateral trading pressures.

As per the statistics revealed by UNAIDS in 2010, three and a half crore people around the world are suffering from AIDS. Out of this number 90% rely on generic medicines to sustain life. The rising costs of healthcare and growing inaccessibility of life saving drugs are only likely to be compounded by an agenda as insensitive as ACTA. Innovation and hard work must be compensated but such compensation must not come at the cost of denying most basic of human rights, life itself.

(The author is Legal Research Fellow, Centre for WTO Studies)