[Ip-health] Ed Silverman: Chilean lawmakers support compulsory licensing for coronavirus medicines and vaccines

Luis Gil Abinader luis.gil.abinader at keionline.org
Thu Mar 19 08:39:40 PDT 2020

Chilean lawmakers support compulsory licensing for coronavirus medicines
and vaccines

By ED SILVERMAN @PharmalotMARCH 18, 2020

Concerned about access to treatments for the fast-spreading coronavirus,
Chile’s lower house of Congress passed nearly unanimously a resolution that
would permit the government to issue compulsory licenses for any medicines,
vaccines, or diagnostics for combating the pandemic.

The resolution supported by the Chamber of Deputies would also have the
Chilean health ministry ask the World Health Organization to collect
information on R&D costs directly associated with products used for
preventing, detecting, and treating COVID19, including public and private
investments. The vote, by the way, was 127 in support, but none against,
with eight abstentions (see English translation here).

“This is an important step towards strengthening available legal tools for
access to technologies that are useful for fighting this pandemic in
Chile,” said Luis Villarroel, who heads Corporacion Innovarte, an advocacy
group that fought for the resolution, in a statement. He argued that
improving transparency into R&D costs should allow a better understanding
of the roles played by government and industry.

Added Chilean congressman Giorgio Jackson: “Hopefully, all governments do

The Chilean Pharmaceutical Chamber and the Industrial Association of
Pharmaceutical Labs could not be reached for comment, although an industry
source noted that the resolution is not binding on the government.

The move comes against a backdrop of mounting angst over the rising cost of
medicines, which has prompted a growing number of countries to consider the
use of compulsory licenses, a move that has been debated in Chile, for
instance, for more than a year.

A country may grant such 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. This right was memorialized in a
section of a World Trade Organization agreement known as the Trade-Related
Aspects of Intellectual Property Rights, or TRIPS (here is a primer).

A year ago, another industry group, Our Health Latin America, argued that
initial legislative efforts in Chile to support compulsory licensing
“undermined innovation.”

The issue may take on an added urgency now, though, in the wake of Covid-19
amid concerns that a therapy or vaccine might be priced out of reach for
any number of people.

The notion rose to the top of many radar screens late last month when U.S.
Secretary for Human and Health Services Alex Azar initially testified
before Congress and refused to commit to ensuring that any product that is
research with taxpayer funds would be accessible to Americans. He
subsequently backtracked, but by then a debate emerged over access to
medical products in a time of a pandemic.

Whether the Chilean government adopts the resolution remains to be seen,
but some believe the move may spark similar efforts elsewhere.

“This is the first of what will likely be many actions on compulsory
licensing relating to this pandemic, if patented inventions are deemed
useful,” predicted Jamie Love, who heads Knowledge Ecology International,
an advocacy group that tracks access to medicine and patent issues, and
first reported the vote.

The Chilean resolution also references a controversial resolution that was
adopted last May by the World Health Assembly in a bid to improve access to
medicines. That resolution, which was vehicle for cash-strapped governments
to control their drug spending, was designed, in part, to provide greater
transparency into R&D costs. However, the final wording limited access to
such information.

The issue is of concern due to the role that R&D costs play in the larger
discussion about drug pricing. The pharmaceutical industry regularly argues
that many medicines, especially those that are used to treat cancers and
rare diseases, require substantial outlays that must be recovered to not
only cover costs, but provide incentives to conduct further research.

As we noted at the time, patient advocacy groups and a growing number of
lawmakers have been asking the pharmaceutical industry to open its books in
order to better understand the relationship between costs and pricing. Drug
makers, however, have been consistently unwilling to do so, arguing that it
is extremely difficult to assign costs to a specific product.

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