[Ip-health] Stat: Did a pharma trade group try to sabotage a Dutch government report on compulsory licensing?

Thiru Balasubramaniam thiru at keionline.org
Wed Jul 8 00:19:32 PDT 2020


Did a pharma trade group try to sabotage a Dutch government report on
compulsory licensing?
By ED SILVERMAN @Pharmalot
JULY 7, 2020

A Dutch government commission on compulsory licensing was nearly sabotaged
last month after one of its members leaked information to a pharmaceutical
industry trade group, according to a report that was subsequently issued by
the head of the committee and another commission member.

The commission was created last year to research the use of compulsory
licenses as a way for the Dutch government to cope with rising prices for
prescription medicines. Under world trade rules, a country may grant a
license to a public agency or a generic drug maker, allowing it to copy a
patented medicine without the consent of the brand-name company that owns
the patent.

However, the commission encountered an unexpected division of opinion and
subsequently learned that one unnamed member had “violated the trust” held
in the group by “sharing” the draft, according to the final report that was
submitted last week by the economics minister to the Dutch parliament. One
commission member told us the information was shared with the HollandBio
trade group.

In a tweet made in response to a Dutch newspaper story, the trade group did
not deny the accusation:  “As an interest group, we provide people and
organizations within and outside the sector, solicited and unsolicited,
with information, analyses or lines of reasoning. This has also been the
case with the compulsory licenses committee. That is no secret. In fact, it
is at the heart of what we do.”

A HollandBio spokesman wrote us that the “media attention paints a very
one-sided picture that borders on a conspiracy theory.”

Despite the fracas, the head of the commission, who is a former civil
servant, recommended to the Dutch economics minister that compulsory
licenses should be considered as a useful negotiating tool to blunt
pharmaceutical pricing. In the Netherlands, the economic minister has
jurisdiction for pursing this approach, although the health minister has
previously indicated support for licensing.

More specifically, the report suggested the government work with other
countries – such as Belgium and Luxembourg – to negotiate with drug makers
and, if talks fail, to issue licenses. The report also recommended a change
to European law to waive requirements for data exclusivity, which could
make it easier for generic companies to gain the right to make lower-cost
versions of brand-name drugs.

“In my opinion, action should be put into words,” wrote commission head
Andre de Jong in his report to economics minister Eric Wiebes. “The
credible threat of a compulsory license (can have) an effect on the
negotiations… Such a step can then have a preventive effect on future
negotiations.” Wiebes, in turn, wrote to the Parliament that the report was
“helpful” in thinking about compulsory licensing.

Related: Novavax, maker of a Covid-19 vaccine, is backed by Operation Warp

This is not the first time that compulsory licensing has caused a stir in
the Netherlands. Over the last couple of years, the health minister has
angered the pharmaceutical industry by expressing interest in licensing as
a means to control the health care budget.

In late 2017, for example, the health minister suggested that the
government could explore issuing a compulsory license as negotiations
stalled over a cystic fibrosis drug from Vertex Pharmaceuticals (VRTX).
There were also government efforts to support a pharmacist at the Hague who
sought to make a version of an expensive Novartis (NVS) cancer drug. And
earlier this year, the U.S. Embassy in the Netherlands took the Dutch
government to task for policies that would purportedly undermine patent
rights held by drug makers.

The issue has taken on greater urgency, though, for two reasons. One is the
expected arrival of a growing number of pricey medicines, particularly for
hard-to-treat or rare diseases. The other factor is the recent emergence of
the Covid-19 coronavirus, which has raised tense debate over the extent to
which any vaccine or medicine will be affordable and accessible on a global

The concern has already triggered debate over so-called vaccine nationalism
in which governments seek to ensure needed supplies by awarding contracts
to manufacturers, especially those based in their countries. To blunt such
worries, the World Health Organization recently created a voluntary patent
pool to collect Covid-19 know-how, but the pharmaceutical industry has
ignored the effort.

Related: Brazilian lawmakers propose compulsory licensing for Covid-19

Meanwhile, more countries are pursuing legislation to make it easier to
issue a compulsory license. These include Germany, Canada, Ecuador and
Brazil. Israel already issued a license for one drug. And last week, the
Africa Union, which represents dozens of countries, encouraged its members
not to let patents stand in the way of obtaining Covid-19 medical products.

One member of the Dutch commission suggested the Netherlands may now join
the list.

Already, one lawmaker asked the government to address data exclusivity
rules and also reverse a decision to forsake compulsory licenses. In 2017,
the Netherlands was one of 37 countries that opted out a world trade
agreement, making them no longer eligible to import drugs made and patented
in another country, and where there is a compulsory license issued for
exporting to other countries.

“The report is significant, because the Netherlands is clearly serious
about studying compulsory licensing to deal with drug pricing,” said
commission member Ellen ‘t Hoen, who is a senior researcher in the global
health unit at the University of Groningen in the Netherlands and a former
executive director of the Medicines Patent Pool.

“If the effort continues, it will help the (Dutch) ministers in their
negotiations with companies so they can tap on the table a little louder
than they can today. But it may also lead to changes in European law and
most of all, it signals a growing appetite among high-income countries to
use this instrument. With Covid-19, we’ve seen more countries sharpening
their legislation around compulsory licensing.”

About the Author

Ed Silverman

Pharmalot Columnist, Senior Writer

Ed covers the pharmaceutical industry.

 ed.silverman at statnews.com

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

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