US fears for patents on next-generation drugs in India

accreditation
iStock
The United States has voiced concern over protection of patents on safer and more effective next-generation medicines in India, amid fears that authorities are considering allowing more Indian firms to make new varieties of cheap generic drugs still on patent.

An Indian committee is reviewing up to a dozen patented drugs to see if so-called compulsory licences, which in effect break exclusivity rights, can be issued for some of them, two senior government officials said last month.

Read: J&J says won't enforce Aids drug patent in Africa

"I understand that India has issued one compulsory licence, but there's a lot of concern about what additional licences are being considered," US Assistant Secretary of State Nisha Biswal told reporters in the Indian capital.

Protecting next-generation drugs

"There's concern about . . . whether next-generation drugs would be protected, and how do you ensure that investments that are being made to develop ever-more effective drugs can then be continued."

In 2012, India issued its first-ever compulsory licence to domestic drugmaker Natco Pharma Ltd on a kidney and liver cancer drug, Nexavar, patented by Germany's Bayer AG.

That and a series of recent decisions on patented drugs in India, as part of New Delhi's push to increase access to life-saving treatments, is at the centre of trade friction between Asia's third-largest economy and the United States.

Like other emerging markets, such as South Africa and China, India is battling to bring down healthcare costs and boost access to drugs to treat diseases such as cancer, HIV/Aids and hepatitis.

Read: Judge strikes down patent on cancer genes

Western drugmakers, including Pfizer Inc, Novartis AG, Roche Holding AG and Sanofi SA, covet a bigger share of the fast-growing drugs market in India.

Only 15 percent have health insurance

But they have been frustrated by a series of decisions on patents and pricing, as part of New Delhi's push to increase access to treatments in a country where only 15% of the 1.2 billion people have health insurance.

"The constant threat of compulsory licences hangs like a Damocles sword over patent-holders," Ranjit Shahani, vice chairman and managing director of Novartis' India unit, told Reuters in an interview.

"Over the past two years, the government of India has issued several intellectual property decisions that disproportionately impact innovative biopharmaceutical companies," he said. "Not only is this a concern for business in the Indian market, but also in other emerging markets that may see India as a model to be emulated."

India is on the US government's Priority Watch List – countries whose practices on protecting intellectual property Washington believes should be monitored closely.

Possible action

US industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA) believes Washington should take a tougher line by downgrading it to a Priority Foreign Country, a classification for the worst offenders, which could trigger possible actions, sources said last month.

If India is relegated by the US to Priority Foreign Country level, it would join Ukraine as the second country in that segment. Countries in the Priority Watch List include China, Indonesia, Pakistan, Russia, Thailand and Argentina.

Read more:

SA tackles drugs patent reform

Court rules on patenting of human genes

Landmark patent decision sets precedent

We live in a world where facts and fiction get blurred
In times of uncertainty you need journalism you can trust. For 14 free days, you can have access to a world of in-depth analyses, investigative journalism, top opinions and a range of features. Journalism strengthens democracy. Invest in the future today. Thereafter you will be billed R75 per month. You can cancel anytime and if you cancel within 14 days you won't be billed. 
Subscribe to News24
Voting Booth
Have you entered our Health of the Nation survey?
Please select an option Oops! Something went wrong, please try again later.
Results
Yes
28% - 9933 votes
No
72% - 25919 votes
Vote