Indian policy on clinical research restrictive: US pharma cos

American pharma companies and their advocacy groups today rued at the alleged restrictive India policies on clinical research, saying such policies are harming the companies.

"Clinical research has become a highly politicised topic in India fuelled, at least in part, by a sensational press," John J Lewis, from the Association of Clinical Research Organization (ACRO) told the US International Trade Commission (USITC).

The USITC, a quasi-judicial federal agency, conducted a hearing in connection with its investigation 'Trade, Investment, and Industrial Policies in India: Effects on the US Economy' as asked by lawmakers.

Describing the current situation in India as "troubling", Lewis said as a result not only is the health of the Indian people and the Indian economy suffering, but US (and Indian) companies are unable to conduct lifesaving biomedical research and global health is suffering.

Noting that US companies are harmed by Indian policies on clinical research, Lewis said the reality is that they can relocate their research to more hospitable countries in Eastern Europe or China.

"The real loss is to the global research environment that is critical to the efficient development of new treatments and therapies for patients in need, in the US, India and around the world," he said.

Testifying on behalf of Biotechnology Industry Organisation (BIO) Roy Zwahlen said difficulty in obtaining and enforcing intellectual property rights in India remains a barrier to biotechnology companies.

"In the past year, the Government of India has taken a number of very serious steps to revoke protection on widely-patented biopharmaceutical products," he said, alleging that these actions amount to what are "localisation barriers to trade".

By systematically curtailing the IP rights of innovative biotechnology and pharmaceutical companies – US industry's research and development investment is negatively impacted, he said.

Beyond the short-term financial impact these actions have on US companies operating in the Indian market, these actions have an extended impact on US companies in other markets, as Indian companies are now in a position to legally export these medicines to third countries where US companies do not normally seek patent protection, but would have otherwise turned to US companies to meet their pharmaceutical needs, he said.

Zwahlen said the Indian government claims that in instituting such anti-intellectual property (IP) policies, it is taking steps to keep the prices of medicines down and improve access to medicines.

"However, we contend that these actions are in reality a form of industrial policy designed to improve local commercial interests at the expense of US biotechnology companies. These steps by the Indian government benefit in a very tangible manner its domestic pharmaceutical industry," he said.

"The medicines being targeted, such as Bayer's Nexavar, Pfizer's Sutent, BMS' Sprycel, Roche's Tarceva, and Novartis' Gleevec, are highly specialised anti-cancer medicines that benefit a small fraction of India's patient population, and only those who can already afford the highly specialised medical talent and facilities to properly diagnose and treat the relevant forms of cancer," he added.

Zwahlen said the Indian policies on clinical research, is impossible to implement.

"The most controversial of these new guidelines were provisions regarding financial compensation to human subjects and their families in cases of death or injury. These guidelines were widely viewed to be impossible to implement given that compensation, including medical management, would be given even in cases where placebos were administered to the subject or the investigational drug did not have the intended therapeutic effect," he said.