[Ip-health] Pharmalot: U.K. patients want government to override Roche patent on cancer drug

Zack Struver zack.struver at keionline.org
Thu Oct 1 12:15:48 PDT 2015


U.K. patients want government to override Roche patent on cancer drug

Ed Silverman
October 1, 2015

A new flare up over prescription drug costs is taking place in the U.K. In
a letter to the U.K. Health Secretary, a coalition of cancer patients,
physicians, and advocacy groups has asked the government to override
patents on a Roche breast cancer treatment – and they have already lined up
an unnamed drug maker to produce a lower-cost version of the medicine,
known as Kadcyla, if the government agrees.

The request comes as patient access to the drug has grown more difficult.
Last year, the National Institute for Health and Care Excellence, a
government watchdog that measures cost effectiveness of drugs, recommended
that Kadcyla not be covered due to the price. The coalition notes the Roche
drug, which is known generically as TDM-1, costs about $155,000, or nearly
four times the 2014 per capita income of $40,000 in the U.K.

The decision riled patient groups in the U.K. And their concern grew
following recent cutbacks at the Cancer Drugs Fund, which is run by the
National Health Service and pays for medicines considered too expensive
under the usual coverage mechanism. As of next month, coverage is no longer
extended to new Kadcyla patients.

And so, the coalition wants the government to issue a compulsory license
that could be used to produce a cheaper version of Kadcyla. Countries can
issue licenses so a copy of a patented medicine can be made without the
consent of the drug maker that owns the patent. A World Trade Organization
agreement says countries are free to determine grounds for granting a

The coalition members note that the purpose of a compulsory license is to
widen access to medicines and that, by doing so, Roche would face
competition and, presumably, the cost would drop.

“If the U.K. government begins a serious review of this petition, it
instantly improves its short term bargaining position with Roche, and it
begins to map out a future where cancer patients have a better chance to
get the drugs they need,” said Manon Ress of Knowledge Ecology
International, a coalition member, in a statement.

The pharmaceutical industry sees compulsory licenses as a threat to
intellectual property and has sought the assistance of the U.S. Trade
Representative to discourage countries from issuing licenses. Earlier this
year, PhRMA, the U.S. industry trade group  tried to persuade the U.S.
Trade Rep to take a more narrow view by arguing licenses should be “granted
only when there is a true health emergency and as a measure of last resort.”
We asked the U.K. health ministry for comment and will update you

The coalition, by the way, also suggested what it called “more ambitious
strategies” to obtain access to a lower-cost version of the medicine. These
include requiring Roche to disclose its know-how for manufacturing the
medicine, sanctioning Roche for excessing pricing, and allowing for faster
and smaller clinical trials to support developing of a cheaper version,
among other things.

As for Roche, a spokeswoman wrote us that, “we understand the financial
pressures the NHS is under, [but] patients in the U.K. should not be denied
access to innovative and clinically effective medicines that are routinely
available to patients in Europe.” There needs to be “a pragmatic, flexible
and sustainable way of assessing cancer medicines” and that “access to
these medicines will only be achieved with long-term reform.”

She adds that the drug maker will continue to hold talks with the NHS until
Nov. 4, when the delistings on the Cancer Drugs Fund becomes official.

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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