Amit Sengupta
General Secretary AIPSN*  

The initiative is being promoted, among others, by the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). IMPACT has not been mandated by the WHO, and is merely an initiative based on the declaration of a conference convened in 2006. The said conference had a very strong presence from the multinational pharma industry, led by the IFPMA (the global lobbying body of multinational pharma giants), as does IMPACT. Concurrently, the US, the EU and the drug MNCs are negotiating an anti-counterfeit trade agreement behind closed doors. This is a classic example of strategic forum in order to enforce strong patent protection. “Big Pharma”, led by IFPMA, has consistently called generic medicines — irrespective of their quality and legal status — counterfeit. 

  It is being proposed that counterfeit drugs be defined as those that infringe trademarks, and can include “products with correct ingredients/components, with wrong ingredients/components, without active ingredients, with incorrect amount of active ingredients or with fake packaging”. Thus even quality generic products can have the needle of suspicion pointing at them, pending investigation of alleged trademark violation. The issue also needs to be seen in the context of moves by the European Customs organisations to harmonise regulations regarding practices by customs authorities towards counterfeit goods across the globe. This could lead to seizing or delaying the transit of legitimate generic medicines on suspicion of being “counterfeit”. Clearly, the attempt is to introduce a global policing infrastructure, mandated to intrude into the affairs of sovereign states in areas of both manufacturing and global trade in medical products. 

  India, as the largest producer of generic medicines in the developing world, must be vigilant about the quality of medicines produced. But it should also develop sovereign laws and definitions so that it is not dictated by interests that seek to subvert its generic industry. 

  (*All India People’s Science Network)

Harinder S Sikka
Director (Corporate) Piramal Healthcare 

It’ll be an entry barrier for cheap, quality drugs 

   THE term ‘counterfeit’ encompasses categories such as spurious, fake, sub-standard, look alike and so on. Any person engaged in the above activities is liable for prosecution under criminal offence and can be punished, even with life imprisonment. Trademark violation, on the other hand, is an economic offense and cannot be equated with the first category. Simply put, you cannot charge a person for murder when he has been caught for theft. 

  Counterfeit drugs are deliberately produced with the intent to deceptively represent their origin, authenticity or effectiveness. But generic drugs contain correct ingredients. Besides, many countries today are using provisions of ‘Compulsory License’ under the TRIPS rule to acquire life-saving drugs. The above proposals could bring all such life-saving efforts to naught. 

  The European Parliament Resolution of May 8, 2008, on Trade and Economic Relations with the Asean attaches particular importance to the fight against counterfeit pharmaceuticals, but at the same time points out that nothing in the agreement should create legal or practical obstacles to the maximum use of flexibilities set out in the declaration. The new definition drafted by International Medical Products Anti Counterfeiting Task Force defines a counterfeit drug “when there is a false representation in relation to its identity, source or history” and “may include products with correct ingredients etc.” It mischievously replaces words like “medicines” with “medicinal products” and provides sweeping powers to select few. It is thus bound to create entry barriers for legitimate drugs and can halt exports of low-cost, high-quality drugs from India. 

  It’s a well thought out strategy, evolved with the sole purpose of providing ‘evergreening’ solutions to big players. India, along with Brazil, South Africa, Thailand, Argentina, Venezuela, Chile, Sri Lanka, Maldives, Cuba and Bangladesh are, therefore, expected to press for its modification at the WHO Bonn meeting in November. And one hopes that those in charge in our country would take the pharma industry into confidence before presenting the case to the World Health Assembly meeting in 2009. This is one battle that the developing countries cannot afford to lose.