[Ip-health] Pharmalot: Glaxo widening access to its medicines in poor countries

Zack Struver zack.struver at keionline.org
Thu Mar 31 08:19:13 PDT 2016


Glaxo widening access to its medicines in poor countries

MARCH 31, 2016

In an unusual step, GlaxoSmithKline is revamping its patent policies in
order to improve access to its medicines in the world’s poorest countries,
many of which are located in Africa.

Glaxo will no longer seek patent protection in the so-called
least-developed countries, which number 48, according to the United
Nations, as well as other low-income countries. By eschewing patent
filings, generic drug makers would more readily be able to launch copycat
versions of Glaxo medicines.

In addition, the company plans to issue licenses to generic drug makers in
some lower-middle-income nations. Yet another gesture may involve licensing
a dozen or so cancer medicines, which are still being developed, to the
Medicines Patent Pool, a nonprofit that works with drug makers to widen
access to medications. For the most part, the organization has focused on
drugs for HIV and hepatitis C.

“We need to have a flexible vision about how intellectual property is
applied across the world,” Andrew Witty, Glaxo’s chief executive, said
during a media briefing this morning. “We want to take a more uniform
approach (to the global patent system), and we think this will help drive
access in the poorest counties. … It helps to, once and for all, articulate
intellectual property in our industry.”

According to the terms of a World Trade Organization agreement,
least-developed nations are exempt from granting and enforcing
pharmaceutical patents through 2033. This means that generic companies are
already free to market copycat drugs in those countries. But some countries
do accept such filings, creating a patchwork system and inconsistent
accessibility to medicines among the world’s poorest people.

Witty further explained Glaxo will take a “graduated approach” toward
defending patents over the next decade as poor countries improve their
economic standing. Additionally, the drug maker will allow access to its
patent portfolio in these countries. And he also said Glaxo will, on a
case-by-case basis, consider issuing licenses to generic drug makers so
they can sell copycat medicines in middle-income countries, where there are
also many people who can’t afford drugs.

The moves come amid sustained criticism that, with few exceptions, the
pharmaceutical industry has failed to sufficiently make medicines available
to poor and low-income countries. Drug makers have been criticized for
selling their medicines at unaffordable prices or using patents to block
generic companies from making lower-cost alternatives.

The Glaxo move, however, won praise from one long-standing industry critic.

“This is the strongest and most important offer by any drug company to
expand access to new medicines,” said Jamie Love, who heads Knowledge
Ecology International, which advocates for improved access to medicines and
often criticizes patent systems. He called the decision to forego patent
filings a “welcome initiative.”

Not everyone was as sanguine.

“I think patients in some countries may come out ahead, but in
middle-income countries, they may lose. It depends on the disease, the
drug, and the country, but many are being cut out,” said Tahir Amin,
director of intellectual property at the Initiative for Medicines, Access &
Knowledge. His group has filed court challenges to patents that Gilead
Sciences holds on its Sovaldi hepatitis C drug in India, China and other

“Right now, this will let generic companies create demand for smaller
markets, while the global companies keep the bigger ones for themselves,”
he said. “These kinds of Band-Aids will not fix the problem.”

Similarly, Rohit Malpani, policy director for the Doctors Without Borders
access campaign, argued that Glaxo – and other drug makers – should broaden
their efforts to guarantee countries the right to pursue licenses when
there is a dispute over pricing. “They need to acknowledge that governments
have the right to look for different arrangements to gain access to
medicines and that this is not just something that companies get to
decide,” he said.

Nonetheless, Love said he is encouraged by Glaxo’s decision to license
cancer medicines and urged other drug makers that sell cancer treatments —
Roche, Novartis, Bayer, and Bristol-Myers Squibb — to do the same. “The
details will be important, as always,” he said. But if the licenses to the
Medicines Patent Pool don’t hamstring the generic drug makers, “this will
be a very important step forward.”

We should note that Glaxo last year exited the oncology business by
swapping its existing cancer treatments business to Novartis for a vaccines
unit as part of a deal in which the drug makers also formed a joint venture
in consumer health products.

Witty offered a caveat, by the way, concerning the cancer drugs. Not all of
the treatments, he indicated, may be appropriate for poor countries where
health care systems are underdeveloped.

Zack Struver, Communications and Research Associate
Knowledge Ecology International
zack.struver at keionline.org
Twitter: @zstruver <https://twitter.com/zstruver>
Office: +1 (202) 332-2670 Cell: +1 (914) 582-1428

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