Stringent IP enforcement will limit access to generic drugs

Written by fe Bureaus | New Delhi | Updated: Aug 27 2009, 05:10am hrs
Civil society organisations, led by Centre for Trade and Development, have sent a strong missive to the Confederation of Indian Industry (CII), urging it to be careful about associating with multinational corporations and developed countries that are keen to push more stringent intellectual property (IP) enforcement laws in India . The letter is in response to an international conference recently hosted by CII to enhance IP standards and their enforcement.

Stressing that stricter IP enforcement laws will limit the access of life-saving generic drugs to people in developing countries, the letter asks CII to not view IP as only a business tool but also look at the larger scheme of things, given Indias social and economic realities.

The letter also pointed to the controversial seizure of generic drugs shipped from India to Africa by customs authorities in the European Union. Though the drugs were not patent-protected in India or the consignee countries, EU authorities seized them in transit, arguing that the rights of patent-holders in Europe were being infringed. Freedom of transit for legitimate trade is clearly laid down under GATT. The Trade-Related Aspects of Intellectual Property (TRIPS) Agreement also emphasises that measures to protect intellectual property should not pose barriers to legitimate trade. Both India and Brazil had taken up the matter with the European Commission and the WTO, clearly pointing out the illegality of European measures dealing with border enforcement.

The letter also stressed that the Indian pharmaceutical industry is a victim of the TRIPS and IP enforcement standards. In 2008 alone, 17 consignments were seized during transit in Europe using the EU Directive on IP Enforcement, which allows the seizure of goods in transit. Last month, minister of state for external affairs, Preneet Kaur, had raised the issue at the United Nations Economic and Social Council (ECOSOC), saying, We are concerned that these recurring seizures are creating a negative trend that impairs the access and availability of affordable essential generic drugs in developing countries and LDCs and runs counter to the Doha Declaration on Public Health by creating barriers to the legitimate trade of generic drugs.

The letter emphasised that some developed countries have unilaterally enhanced their IP enforcement strategy to force other countries, especially developing ones, to accept the same through various multilateral organisations, chiefly the World Customs Organisation (WCO), WHO, Universal Postal Union (UPU), Interpol, WIPO and the World Trade Organisation (WTO). These organisations collectively requested CII to participate in a more creative discussion on IP and development, rather than simply accepting the simplistic and largely discredited view that stronger IP regime leads to more innovation and is necessary for socio-economic development.

Anjan Das, senior director, intellectual property division at CII, agreed with the concerns over the drug seizures but pointed out that such seizure in the EU border is different from counterfeiting and piracy. These conferences are a way to share best practices and experiences of different nations and finding solutions that are best suited to our countrys economic and social scenario. Counterfeit drugs and products cause grave damage to public health and representatives of different states must join hands to prevent such a global problem, Das explained.

Dismissing concerns about CII cosying up to MNCs, Das said, Counterfeiting causes an irreparable loss to the domestic industry. Several Indian companies like Tata Motors and Crompton Greaves are suffering immense damage because of counterfeiting. Access to drugs cannot be guaranteed by not having streamlined IP laws but such IP laws can guarantee more breakthrough innovations, something India needs right now to fight pandemics like malaria and dengue, said Richard H Kjeldgaard, deputy vice-president of Pharmaceutical Research and Manufacturers of America. India has a strong generic market but still lacks innovations in the pharma sector. Also, the invention rate is too low, owing to the lack of investments in R&D. In order to attract international partnerships to boost investments India needs a more streamlined IP regime, he added.