[Ip-health] Stat: U.K. lawmaker challenges the government to issue a compulsory license for Vertex drug

Thiru Balasubramaniam thiru at keionline.org
Mon Feb 4 01:52:47 PST 2019


U.K. lawmaker challenges the government to issue a compulsory license for
Vertex drug
By ED SILVERMAN @Pharmalot
FEBRUARY 1, 2019

The ongoing row over access in the U.K. to a Vertex Pharmaceuticals (VRTX)
cystic fibrosis treatment has taken an unexpected twist, with a member of
parliament challenging the government to issue a compulsory license so that
a lower-cost version of the medicine could eventually become available.

In a statement, MP Bill Wiggins suggested the government pursue a so-called
Crown Use license that could pave the way for an alternative supply of the
Orkambi treatment, “because Vertex refused the largest ever financial offer
the National Health Service has made in its entire history for this
medicine.” And he noted the NHS offered approximately $650 million over
five years for patient access.

“Crown Use licensing can prevent pharmaceutical companies from taking
advantage of incredibly vulnerable people. Orkambi is a very expensive drug
to treat cystic fibrosis. At ($136,000) per patient per year, it is not
currently available under the NHS,” said Wiggins, who will raise the issue
in Parliament on Monday. “However, we have a power under U.K. patent law
that hopefully will enable the government to lift the monopoly on Orkambi.”


The stalemate grew testy last summer, when the NHS called the Vertex offer
“unsupportable,” and Vertex chief executive Jeff Leiden fired back with a
letter to U.K. Prime Minister Theresa May that the NHS showed a lack of
flexibility and commitment to patients. The drug maker then subsequently
declined to provide information about a forthcoming treatment to NICE,
delaying the approval process used to make the drug available to patients.


As a result, the House of Commons is schedule to debate the issue and hear
from witnesses on March 7. The various parliamentary moves were hailed by
David Ramsden, who heads the Cystic Fibrosis Trust, an advocacy
organization. In a statement sent to us, he said that patients and their
families “are desperate for progress and despair at all those responsible
for failing to deliver a deal. The wait must end!”

The battle has become emblematic of the intensifying struggle between
cash-strapped governments and the pharmaceutical industry over the cost of
medicines. As a salve, a growing number of countries are exploring
compulsory licenses, which may be granted to a public agency or a generic
drug maker to copy a patented medicine without the consent of the
brand-name company that owns the patent.


Typically, lower and middle-income countries, such as Colombia and
Malaysia, have pursued licensing, but more recently, wealthier countries
have either considered the notion or been urged to do so. In late 2017, the
health minister in the Netherlands threatened to explore licensing. And
this week, the Swiss government was urged by a non-government organization
to issue a license for a Roche cancer drug.


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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