E-DRUG: WHO is asked to create a voluntary intellectual property pool to develop Covid-19 products
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https://www.statnews.com/pharmalot/2020/03/24/covid19-coronavirus-costa-rica-intellectual-property/
PHARMALOT
WHO is asked to create a voluntary intellectual property pool to develop
Covid-19 products
By ED SILVERMAN
@Pharmalot
MARCH 24, 2020
Seeking to widen access to medical products for combating Covid-19, the
Costa Rican government has asked the World Health Organization to create a
voluntary pool to collect patent rights, regulatory test data and other
information that could be shared for developing drugs, vaccines and
diagnostics.
The move comes amid a worldwide race to fight the novel coronavirus, but
also mounting concerns that some products may not be accessible for poorer
populations. By establishing a voluntary mechanism under the auspices of
the WHO, the Costa Rican government is hoping to create a pathway that will
attract numerous governments, as well as industry, universities and
non-profit organizations.
'Given the urgency of this matter, Costa Rica proposes that the WHO develop
an initial concise memorandum of understanding' on sharing technologies
funded by the public sector and other institutions, wrote Costa Rican
President Carlos Alvarado Quesada and Health Minister Daniel Salas Peraza
in a March 23 letter to WHO Director General Tedros Adhanom Ghebreyesus.
They added that the pool should allow free access or licensing on
'reasonable and affordable terms, in every member country' but specific
assets that would be shared and the terms for doing so can be determined
later. The officials also asked the WHO to create a database of research
and development activity related to Covid-19 products, including estimates
for clinical trial costs and any subsidies provided by governments and
charities.
A WHO spokeswoman wrote us that Tedros will respond directly to Costa Rica.
She added that the 'WHO is committed to promoting measures that ensure
equitable and affordable access to health technologies for all people who
need them, including safe and effective technologies arising from current
COVID-19 research.'
To an extent, the effort builds on moves by countries to consider
compulsory licensing for unaffordable medicines. 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. This right was memorialized in a World Trade Organization
agreement.
The new pandemic, however, has ratcheted up this sort of activity. Just
over the past week, lawmakers in Chile and Ecuador passed resolutions
urging their governments to explore licensing. Separately, Israel approved
a license for an HIV pill, prompting the manufacturer to relinquish patent
rights and waive restrictions on generic supplies on a global basis.
However, a voluntary pool of the sort envisioned by the Costa Rican
officials goes much further by seeking to pull in technologies from a
larger number of players, rather than on a drug-by-drug, country-by-country
basis. In doing so, they hope to create more equitable access and avoid the
sort of disjointed affordability that has typified some products.
'This is not an attack on intellectual property. It's the right magnitude
of response given the magnitude of the problem. It's a big problem and you
have to think big,' said Jamie Love, who heads Knowledge Ecology
International, an advocacy group that tracks access to medicine and patent
issues. The group worked with Costa Rican officials on the crafting the
idea.
'People will contribute and buy into it this if it's in their interest.
Under current circumstances, the answer should be yes. You want people to
be able to combine treatments, for instance, that can be beneficial without
worrying about acquiring rights. This can provide the freedom to operate
and that is part of innovation. And if you want capacity and lower prices,
you better think about opening up access. Otherwise, we're stuck in our
rooms for the rest of our lives,' Love said.
The issue emerged late last month in the U.S., in fact, when Secretary for
Human and Health Services Alex Azar initially testified before Congress and
refused to commit to ensuring that any Covid-19 product that is researched
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.
We asked PhRMA, the trade group that represents drug makers in the U.S.,
and the International Federation of Pharmaceutical Manufacturers and
Associations for comment, and will pass along any reply. Both
pharmaceutical groups arranged media briefings last week where different
company executives discussed plans for fighting Covid-19. We also asked
Advamed, a trade group for device makers, and will update you accordingly.
Meanwhile, one physician who has studied models for prescription drug
pricing suggested the proposal arrives at a precipitous moment.
'This raises an interesting question, because we've become completely
hypnotized by a model that says we only get new treatments from private
corporations that create them - and that's the innovation model', said
Peter Bach, who heads the Center for Health Policy and Outcomes at Memorial
Sloan Kettering Cancer Center.
'But there's a trade-off, because when we depend on for-profit industry, we
won't necessarily get treatments that promote health to the extent needed.
Evidence suggests we are moving toward narrower treatments for narrower
populations, but societies aren't necessarily gaining. It's clearly
inefficient,' Bach said. 'We have to ask ourselves if we are at an
inflection point in public health, and if so, do we want to pursue a
collective action aimed at solving a collective health issue, one that
challenges private incentives? And if we did that, can we get more health
gains?'
Ed Silverman
Pharmalot Columnist, Senior Writer
Ed covers the pharmaceutical industry.
ed.silverman@statnews.com
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru@keionline.org