The Influence of India's New Ruling on HIV/AIDS Pharmaceuticals

via Reuters.com, by Kaustubh Kulkarni and Henry Foy

"India's move to strip German drugmaker Bayer of its exclusive rights to a cancer drug has set a precedent that could extend to other treatments, including modern HIV/AIDS drugs, in a major blow to global pharmaceutical firms, experts say."

On Monday, the Indian Patent Office effectively ended Bayer's monopoly for its Nexavar drug and issued its first-ever compulsory license allowing local generic maker Natco Pharma to make and sell the drug cheaply in India.

It is only the second time a nation has issued a compulsory license for a cancer drug after Thailand did so on four drugs between 2006 and 2008, also on affordability grounds. Thailand also issued licenses for HIV/AIDS and heart disease treatments.

"This could well be the first of many compulsory rulings here," said Gopakumar G. Nair, head of patent law firm Gopakumar Nair Associates and former president of the Indian Drug Manufacturers' Association.
"Global pharmaceutical manufacturers are likely to be worried as a result ... given that the wording in India's Patent Act that had been amended from 'reasonably priced' to 'reasonably affordable priced' has come into play now."

The new wording is seen as a lower threshold for compulsory licenses, which can be issued under world trade rules by nations that deem major life-saving drugs to be too costly. The licenses allow them to authorize the local manufacture or importation of much cheaper, generic versions.

Global drugmakers see emerging markets such as India as key growth opportunities, but remain concerned over intellectual property protection. Nair said HIV-related medicines were likely to be the most at risk by compulsory licenses in the future.

India has one of the world's fastest-growing rates of HIV and heart disease is also the country's biggest killer, but widespread poverty in Asia's third-largest economy makes many non-generic drugs unaffordable for millions.

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Mapping Pathways India: What We’re Hearing so Far

“Individuals should have a right to choose how they want to protect themselves, and different tools for prevention should be made available.” ~ Indian Activist

“Oral prevention is an irresponsible approach that would hurt overall prevention efforts.” ~ Indian PhD and Consultant

An important part of our project is to really learn what people think and feel about PrEP, not just through academic streams and studies but also through everyday wisdom and experience. What do the people who work daily with treatment and prevention and/or have first-hand experience of living with HIV think? What are their concerns? What information do they need about PrEP? Do they feel it can be a useful prevention tool in their country? Would they use it or prescribe it?

The Mapping Pathways online survey and in-depth stakeholder interviews are important ways for us to gain knowledge on these questions. Both are well underway, and already we’re hearing some interesting observations and ideas. Of course, this data is still preliminary but we thought we’d share some snapshots of what we’re hearing from Indian doctors, policymakers, and activists on the ground.

Some of the overall concerns about PrEP that we’re finding in India as well as the other countries are questions about how these strategies will be rolled out and made accessible and affordable. There is also worry that other preventions strategies such a condom promotion will be neglected and unintended consequences, like an increase in risky behavior, might occur. Many of the individuals we’re speaking with want to see more evidence on these strategies, and there are huge concerns about resistance to ARVs and their safety.

One Indian respondent said, “At the moment not even all the HIV infected people needing ARV's are receiving it and adding more numbers to these will only strain the healthcare system in the country more.” Another observed, “PrEP seems to negate moral changes that need to be made within society which is the only ultimate ‘cure.’”

When some of the respondents were asked what types of information they’d like Mapping Pathways to provide to help them when considering PrEP as a strategy for their country, there was real curiosity about finding out how acceptable the strategy is for people living with or at risk for HIV; data on the real cost and cost effectiveness, and more information on clinical trial results; and how to translate all this knowledge into behavior changes.

Other comments and observations so far include:

“It is an assumption that MSM and sex workers are at high risk of getting HIV/AIDS, but women in monogamous relationships are also at high risk.  Nobody can be excluded completely from being at risk.” – Indian politician and policy maker

“It is important to invest in a range of prevention efforts, not simply switching focus from one to another.  Individuals should have a right to choose how they want to protect themselves, and different tools for prevention should be made available.” – Indian activist and HIV consultant

“Global funding for HIV is shrinking, and if a person starts ARVs there is a cost to keeping them on ARVs.” – Indian PhD and consultant

“Oral prevention is an irresponsible approach that would hurt overall prevention efforts.  The HIV epidemic has forced the promotion for overall safe behavior, especially condom promotion and family planning.  These are integral not just for HIV prevention, but for general public health in India.”– Indian PhD and consultant

“From a women’s perspective any prevention tool that gives an individual control over preventing infection is important ...PrEP is a way for a person to take responsibility for their own health.” – Indian activist and HIV consultant

“There is an economic impact that the government needs to acknowledge.  Appropriate funding needs to be allocated to secondary care.” – Indian doctor

For some more insights on Indian reactions toward PrEP and HIV prevention, read our blog posts Notes from India: Concerns and Challenges Around PrEP and A Modern Day HIV Love Story.

We also encourage all Indian citizens who are interested in new ways to prevent transmission of HIV – and want to help shape our project goals and deliverables – to take a few minutes and fill in our survey.

Your efforts will be greatly appreciated!
 
Take the survey now.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]