[Ip-health] Nature article about high cost of cancer drugs in India

Claire Cassedy claire.cassedy at keionline.org
Wed Aug 14 10:40:13 PDT 2013


India spurns cancer patents

Nation seeks to cap high cost of drugs to treat non-infectious diseases.

By Erika Check Hayden

Once the scourge of the developing world, infectious diseases such as
malaria, tuberculosis and AIDS can now be fought with cheap drugs. But as
people in poorer nations live longer and adopt Western habits,
non-communicable diseases such as heart disease, diabetes and cancer have
become the main killers — and paying for their treatment has become a
thorny problem.

India may now be drawing a line in the sand. In the past three weeks,
officials there have refused patents on two breast cancer drugs — the
latest in a series of decisions to limit patents on pricey brand-name
medications. These moves reflect a tension: India now surpasses the United
States in terms of annual cancer deaths, and wants to find ways to treat
the disease cheaply. But this desire runs counter to the goals of drug
makers, who see middle-income nations as central to their growth plans.

The first of the recent rejections occurred on 27 July, when an Indian
federal board of patent officials revoked a patent on a slightly modified
version of the breast cancer drug lapatinib, sold as Tykerb by London-based
pharmaceutical firm GlaxoSmithKline. Then, on 4 August, Swiss drug company
Roche reported that a patent office in the city of Kolkata, a hub of the
national patent system, would not grant patents on a version of the
company’s drug trastuzumab, sold as Herceptin. Indian officials allowed
other patents that will protect both drugs from generic competition until
2019. But the rulings will stop the companies from extending their patent
protection beyond that date, opening a window for manufacturers of generic
drugs to then step in.

The fight echoes one in the late 1990s and early 2000s over drugs for
treating infections such as HIV. That dispute was largely resolved when
drug makers allowed developing-world companies to create cheap generic
medicines. Today, antiretroviral treatments can be bought for less than
US$100 a year, compared with more than $10,000 a year in 2000, according to
international aid organization Doctors Without Borders (Médecins Sans
Frontières), based in Geneva, Switzerland.

But drugs for non-communicable diseases — particularly cancer — will be
much trickier to negotiate. “There’s no easy compromise that’s going to
arise around non-communicable diseases the way that we saw around HIV,”
says Thomas Bollyky, a lawyer with the Council on Foreign Relations in New
York who fought for affordable HIV medicines in the 1990s.

In India, a $15,000 course of trastuzumab can cost more than ten times the
average annual wage. And there are no older, off-patent drugs that could
serve as an alternative, because none of them target the specific type of
breast cancer as well as trastuzumab.

Yet drug makers are reluctant to cut prices in middle-income countries such
as India, China and Brazil, which are projected to account for much of the
industry’s growth in the near future (see ‘Drug money’). Although Africa’s
ability to pay for HIV drugs was never going to be high, some people in
middle-income nations can afford expensive medicines. Drug makers do not
want to erode that niche market through lower-cost drugs, even if the vast
majority of people in need cannot pay, says James Love, director of
Knowledge Ecology International, a non-governmental organization in
Washington DC that advocates for social justice in access to knowledge.

A number of ideas to skirt the impasse have been floated, but none are
simple. Drug makers argue that governments of middle-income nations should
broaden insurance programmes and access to health care. They also argue
that drugs will become more affordable as economies grow and people earn
more money. By reducing support for intellectual property, India is
undermining incentives for drug development and foreign investment that
will allow for growth, says Amy Hariani, director and legal policy counsel
for life sciences at the US–India Business Council, an industry group based
in Washington DC. “The best way for the Indian economy to grow is by
rewarding innovation,” she says.

“We think the answer is to make the price of drugs really cheap.”

Another idea comes from the World Health Organization, which for the past
five years has been trying to broker an international treaty that would see
member states supporting the development of lower-cost medicines with
prizes and research funding rather than patents. “We think the answer is to
make the price of drugs really cheap, and to provide funding as a reward
for innovation rather than through a monopoly on a drug,” says Love.

There is also increasing pressure on drug companies to adopt pricing models
that allow people in the same country to be charged different prices for
drugs, depending on their ability to pay. Companies, including Roche in the
case of trastuzumab, say that they already offer such differential pricing
through special access programmes. Still, Roche’s own figures show that it
sold enough trastuzumab last year to treat only 3,700 Indian breast cancer
patients — 15% of those who need it.

The battles may end up being mere skirmishes if India goes further and
allows local companies to disregard Roche’s trastuzumab patent altogether
and manufacture a cheaper generic version, using a ‘compulsory licence’.
Last year, India issued such a licence on a cancer drug sold by German firm
Bayer. And in January, India’s ministry of health recommended compulsory
licences for trastuzumab and two other cancer drugs.

Indonesia issued compulsory licences for seven drugs in 2012, and China and
the Philippines have tweaked their laws to make such licences easier to
issue. Prashant Yadav, director of the health-care research initiative at
the University of Michigan in Ann Arbor, says that these moves portend an
unsettling future. India may be the main battleground today, but the war
over cancer-drug access seems likely to bleed beyond its borders unless a
compromise is reached. “This requires some kind of diplomacy now,” says

Nature 500, 266 (15 August 2013) doi:10.1038/500266a

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