Restricting innovation is hurting Indian patients, says USIBC's Coalition for Healthy India

The US-India Business Council supported Coalition for Healthy India has released the findings of its report on 'The Value of Incremental Pharmaceutical Innovation: Benefits for Indian Patients and Indian Business.' This highlights and substantiates the impact of restrictive policies in India, with respect to medical and pharmaceutical innovation. The report adds a patient-centric perspective to the public discourse on intellectual property rights (IPR) and drug patents and points out the positive impact that incremental innovation can have on patient care in India.

Report Highlights:

   The CHI report notes that in the early 1990's in India, pharmaceutical R&D as a percentage of sales jumped from 0.4% to as much as 4.8% by 2004.

   By 2006, after India began to allow patents on pharmaceutical products, India's three largest pharmaceutical firms - Dr Reddy's, Sun Pharmaceuticals and Ranbaxy - were investing almost 12-18% of their annual sales revenue in R&D. That's on par with the leading global innovator firms.

     Extending patent protection to incremental pharmaceutical innovation should encourage Indian pharmaceutical companies to expand further their investment in innovation and ultimately become major sources of new drug products for both the Indian and global markets.

The Coalition for Healthy India is a USIBC initiative, aimed at ensuring that Indian patients have access to the latest and most effective treatments and cures. CHI brings together like-minded members of the US and Indian business communities, non-governmental organizations, patient advocacy organizations and health professionals to coordinate and support improved access to quality healthcare in India.

According to Greg Kalbaugh, director and counsel at the USIBC, 'It is unfortunate that the voice of the patient seems to have been lost in the debate on intellectual property and drug patents. Incremental pharmaceutical innovation has very real benefits for Indian patients, since it leads to the development of life-saving drugs as well as drugs that markedly improve quality of life for Indian patients. By no means are these innovations minor.' He continued with a vivid example: 'Heat stable versions of anti-retroviral drugs may not be critically important to people in large cities where there's easy access to electricity and refrigeration, but they're surely important to people in rural areas. Citizens in rural areas deserve to know that when they take a drug, it's going to work whether they have access to refrigeration or not. Unfortunately, section 3(d) of India's patent law actively discourages just that sort of life-saving innovation. For the sake of patients, it needs to change. And it needs to change for the sake of their employers, all of whom count on having healthy employees.'

In recent years, incremental pharmaceutical innovations have accounted for as much as 65% of new drug approvals by regulatory agencies. Over 60% of the drugs on the World Health Organization' list of essential medicines reflect incremental improvements of older drugs.

'The conclusion is clear: by preventing many valuable pharmaceutical innovations from receiving patent protection, Section 3(d) of India's Patents Act inhibits the development of safer, more efficacious and more useful drugs for Indian patients,' stated the author of the report, Raj Gandesha, a senior lawyer with the global law firm of White & Case. Mr Gandesha continued: 'It is critically important that we actively encourage the discovery of new forms and uses of existing chemical compounds or substances. These efforts in-turn will lead to the development of safer, more efficacious and more useful drugs that are better-suited to particular patient profiles or needs and ultimately result in improved patient compliance and greater overall well-being.'

Addressing concerns about so-called 'ever-greening,' Mr Kalbaugh pointed out that Ever-greening is a made-up controversy. 'A patent on an incremental pharmaceutical innovation does not bar a generic company from selling a generic version of the original drug product once the patent covering that product has expired. In fact, generic competition can constrain the price of products based on later incremental innovations. Moreover, incremental pharmaceutical innovations themselves can increase price competition, by increasing the number of different drugs that exist within a given class.'

The speakers noted that the report is intended to add a patient-centric perspective to the public discourse, which till now has been largely dominated by more powerful economic constituents. Several participants pointed out that the Mashelkar Committee report, recently accepted by India's government, bolsters the message that Section 3(d) is in need of reform.