Interview

‘Counterfeit’ must not be equated with ‘generic’

Pharmaceutical Research and Manufacturers of America (PhRMA) represents 30 of the world's leading pharmaceutical research and biotechnology companies. In the past, PhRMA has expressed concern on the status of India's patent laws and has squared off against Indian generic players. In India recently for CII's Life Science Conclave 2009, Nancy Adams, Deputy Vice President, Asia, PhRMA took a few queries from Viveka Roychowdhury on PhRMA's stand on related issues

Different countries have specific priority disease areas, can you give a global perspective and relevance to India?

The incidence of chronic diseases such as diabetes, cardiovascular diseases, and stroke is growing around the world, including in India. In the meantime, in countries like India infectious diseases-such as AIDS, TB, and malaria-have not gone away. All of these require new medicines and treatments which in turn require substantial amounts of R&D investment.

In PhRMA's view, what should be the role of Indian generic pharma companies in the context of improving delivery of medicines & healthcare facilities in the domestic as well as international markets?

Generic manufacturers play a critical role both in India and internationally. Their focus and expertise is in bringing to markets older, more established medicines at competitive prices. When competitively priced, they can help societies control healthcare costs, while allowing societies to invest in newer medicines and provide incentives towards R&D. India as well as all countries across the Globe need both 'Access to Healthcare' and 'Continuous Innovation'. These are not mutually exclusive goals and achieving both is necessary to stay a step ahead of diseases.

Some Indian generic players feel that they are being unfairly branded as makers of counterfeit medicine and trademark violations are being deliberately confused with quality concerns. They feel the definition of 'counterfeit' is being manipulated to put them at a disadvantage, and choke exports to pharma markets. What is PhRMA's perspective, and what is the solution? How should they react: give up on exports and focus on the domestic market?

Stopping counterfeit or spurious medicines from entering the channels of trade is needed to protect the safety interests of patients in India and around the world. The interests of Indian generic companies and PhRMA members are or should be aligned on this point as Indian producers of generic medicines are also the targets of unscrupulous actors who substitute spurious or counterfeit products for legitimate products. PhRMA has consistently explained that the term ‘counterfeit’ must not be equated with ‘generic’ and will continue to do so.

What are the means to overcome 'resistance' to IPR, patents, innovation protection?

A full and accurate understanding of the role of innovation in product development, the cost and risks of developing new medicines, and the conditions that create and relieve problems of lack of access to health care and medicines in particular will be helpful in resolving concerns regarding intellectual property. As India's innovative biopharmaceutical industry expands its capabilities, these high risks and the challenges of financing R&D without adequate patent protection, regulatory data protection and protection of critical incremental innovations will be absolutely clear. Thus, the potential role of strengthening India's intellectual property regime to provide incentives for domestic companies to innovate should be a focus of government and industry consideration. Additional information about the role of intellectual property and innovation can be found at http://innovation.org/index.cfm/InsideDrugDiscovery.

How can generic companies be made part of the innovation cycle?

Generic companies in India are already moving up the value chain by investing more in research and development. Numerous Indian companies already contribute to the development of new drugs through partnerships with innovator companies around the world. Additional incentives for companies are needed to make the necessary investments, such as stronger IP protection and free market pricing.

What is PhRMA's take on the controversy and resistance to WIPO's Patent Co-operation Treaty, also known as the Global Patenting treaty?

PhRMA has not developed a position on changes being considered for the Patent Cooperation Treaty and for that reason does not have a comment at this time.

What is PhRMA's reaction and involvement with President Obama's planned healthcare reform in the USA?

America's pharmaceutical research and biotechnology companies support comprehensive health care reform, guaranteeing that every American has access to high-quality, affordable health care coverage and services. The biopharmaceutical industry's strong and constructive engagement as a partner with the White House and the Congress from the outset of the debate is solid evidence of support for that goal.

viveka.r@expressindia.com