[Ip-health] STAT+ - U.S. officials lash out at the Dutch government for moves that ‘undermine’ pharma patent rights

Thiru Balasubramaniam thiru at keionline.org
Thu Feb 6 22:14:11 PST 2020


https://www.statnews.com/pharmalot/2020/02/06/netherlands-patents-compulsory-licensing-compounding/


PHARMALOT
U.S. officials lash out at the Dutch government for moves that ‘undermine’
pharma patent rights
By ED SILVERMAN
@Pharmalot
FEBRUARY 6, 2020


In an unusual move, the U.S. Embassy in the Netherlands is taking the Dutch
government to task for policies that would purportedly undermine patent
rights held by drug makers, drawing criticism from consumer advocates who
argue such declarations place pharmaceutical industry profits over patients.

Late last month, the embassy issued a missive criticizing Dutch officials
for plans to expand compulsory licensing and pharmaceutical compounding,
which would “send a clear message” to companies that patents in the
Netherlands “can be undermined or circumvented for short-term financial
benefits.”

The statement maintained such changes could allow patented medicines to
“simply be replaced by a cheaper, non-patented copy” and that, apart from
any problems concerning patents, such moves “could pose unnecessary risks
to public health.” The embassy then added that “strong” patent protections
are “essential” for the Dutch government to successfully a create life
sciences hub.

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The effort was quickly denounced by consumer advocates.

“The embassy statement uses veiled threats about the potential damage to
the Dutch investment climate, conjures a misguided and unfounded image of
risks to patient safety and public health posed by the pharmaceutical
compounding, and gives the impression of cheap copies of patented medicines
flooding the market,” said Health Action International, in a statement.

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“This is nothing short of scaremongering in an effort to put the brakes on
attempts by a country to exercise its sovereign right to use legitimate and
legal tools to protect public health and promote access to medicines for
all. … As health systems come under increasing pressure from ever more
expensive medicines coming on to the market, it is more important than ever
that intellectual property management conducive to protecting public health
is considered an integral part of the policymakers toolkit.”

The embassy assertion follows a series of clashes between the
pharmaceutical industry and the Dutch government which, like many
countries, is attempting to control the rising cost of prescription
medicines. Toward that end, Dutch officials have at times criticized and
challenged drug makers for their pricing practices.

For instance, the government is examining whether to pursue compulsory
licensing. Countries may grant licenses to a generic drug maker, allowing
it to copy a patented medicine without the consent of the company that owns
the patent. This right was memorialized in a World Trade Organization
agreement known as Trade-Related Aspects of Intellectual Property Rights,
or TRIPS.

Over the past year, the health minister wrote an open letter to the
pharmaceutical industry and threatened to publicly rebuke an unidentified
drug maker if the company did not explain its reasons for the price of a
particular medicine. And the government lashed out at Novartis (NVS) for
boosting the price of a cancer drug more than six times — to roughly
$26,000 for an infusion — in a case that spurred debate about orphan drug
status and the ability of local hospitals to compound lower-cost
alternatives.

In the midst of these developments, the pharmaceutical committee of the
American Chamber of Commerce in the Netherlands fired back by arguing the
business climate is “under pressure” and questioned policies that are
“increasingly undermining” the ability to develop and market new drugs.

More recently, though, Amsterdam University Medical Centers resumed
compounding a medicine used to treat a rare genetic metabolic disease. An
earlier version was available for decades at a low cost, but was purchased
by a company that later took it off the market. In 2017, however, the
company was granted marketing exclusivity by regulators and, at the
re-launch, boosted the price many times over. The episode prompted an
advocacy group called the Pharmaceutical Accountability Foundation to file
an antitrust complaint with authorities.

It is hardly unusual for the U.S. government to get involved in patent
matters in other countries that concern the pharmaceutical industry. The
U.S. Trade Representative issues a report each year that regularly singles
out different countries for allegedly failing to uphold patent rights,
often at the urging of the pharmaceutical industry group PhRMA in the U.S.

In recent years, both the Obama and Trump administrations leaned on
Colombia after the government threatened to issue a compulsory license for
a Novartis cancer medicine. The U.S. Trade Representative threatened to
derail membership for Colombia in the Organization for Economic Cooperation
and Development if the Latin American country did not overhaul practices
for making medicines available.

In late 2018, U.S. embassy officials in Malaysia began pressuring the
government to scrap a plan to sidestep patents and issue a license to allow
generic makers to produce a version of a Gilead Sciences (GILD) hepatitis C
pill. Also involved in the effort were representatives from the Office of
the U.S Intellectual Property Enforcement Coordinator, which is part of the
Office of Management and Budget.

About the Author

Ed Silverman

Pharmalot Columnist, Senior Writer

Ed covers the pharmaceutical industry.

ed.silverman at statnews.com
@Pharmalot


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


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