[Ip-health] Stat: Pressure mounts to widen access to medical products that may combat Covid-19

Thiru Balasubramaniam thiru at keionline.org
Fri Mar 27 22:21:02 PDT 2020


<SNIP>

Access and affordability emerged last month in the U.S., in fact, when
Secretary for Human and Health Services Alex Azar initially refused to
commit to ensure that any Covid-19 product researched with taxpayer funds
would be accessible to Americans. He later backtracked, but by then a
debate emerged over access to medical products in a time of a pandemic.

The voluntary pool, however, would become a mechanism administered under
the auspices of the WHO and create a pathway for numerous governments,
industry, universities, and nonprofit organizations to contribute research
data, cell lines, copyrights, and blueprints for manufacturing, as well as
patent rights for medical products.

<SNIP>

The voluntary pool, in any event, is a more ambitious and encompassing
effort than other moves attempted this month in response to the pandemic.

--

https://www.statnews.com/pharmalot/2020/03/27/covid19-coronavirus-compulsory-licensing-monopoly/


PHARMALOT
Pressure mounts to widen access to medical products that may combat Covid-19
By ED SILVERMAN @Pharmalot
MARCH 27, 2020


As more companies gear up to fight the spread of the novel coronavirus, a
growing number of government officials, lawmakers, academics, and advocacy
groups are seeking to ensure widespread access to medical products for
combating Covid-19.

Over the past two days, more than 30 members of the European Parliament and
dozens of advocacy groups separately urged the European Commission to avoid
granting monopolies that might allow manufacturers to eventually charge
prices for medicines, vaccines, or diagnostics that would be out of reach
for poorer populations around the world.

And World Health Organization Director General Tedros Adhanom Ghebreyesus
tweeted that he “welcomes” a proposal made this week by Costa Rican
President Carlos Alvarado Quesada to create a voluntary pool to collect
patent rights, regulatory test data, and other information that could be
shared for developing products. A WHO spokeswoman, though, told us a
decision has not yet been made

While no decision has been made, World Health Organization Director General
Tedros Adhanom Ghebreyesus tweeted that he “welcomes” a proposal to share
information for developing products.
As more companies gear up to fight the spread of the novel coronavirus, a
growing number of government officials, lawmakers, academics, and advocacy
groups are seeking to ensure widespread access to medical products for
combating Covid-19.

Over the past two days, more than 30 members of the European Parliament and
dozens of advocacy groups separately urged the European Commission to avoid
granting monopolies that might allow manufacturers to eventually charge
prices for medicines, vaccines, or diagnostics that would be out of reach
for poorer populations around the world.

Meanwhile, the idea of a voluntary pool gained support from UNITAID, dozens
of academics and advocacy groups, and a European Medicines Agency
management board member. The concept was also favored by the former chief
patent officer at Gilead Sciences (GILD), which at times has tussled over
access to its HIV and hepatitis C medicines and is now testing an
experimental drug to fight Covid-19.

The flurry of activity underscores mounting concern not only about
combating the pandemic, but also the ability of untold numbers of people to
benefit from new inventions and reworked products eligible for patent
protection. And the chorus of lawmakers, academics and advocates argue that
products developed with publicly supported funding should be accessible.

“The danger is exclusive rights can mitigate universal access needed to
respond to the pandemic quickly, so we’re trying to change the rules of the
game, but we’re playing catch-up in some cases,” said Brook Baker, a
professor at Northeastern University School of Law and a senior policy
analyst for the Health GAP advocacy group.

“People are realizing that unless you take proactive steps, exclusive
rights might be baked into existing agreements with companies. And if the
agreements don’t provide equitable access to research and broad
manufacturing, we may get insufficiently available quantities of products
that may be priced at unaffordable levels. This is why you need equitable
licensing principles and broad permission for quality manufacturing to
speed production of needed new technologies that can be distributed
globally.”

Access and affordability emerged last month in the U.S., in fact, when
Secretary for Human and Health Services Alex Azar initially refused to
commit to ensure that any Covid-19 product researched with taxpayer funds
would be accessible to Americans. He later backtracked, but by then a
debate emerged over access to medical products in a time of a pandemic.

The voluntary pool, however, would become a mechanism administered under
the auspices of the WHO and create a pathway for numerous governments,
industry, universities, and nonprofit organizations to contribute research
data, cell lines, copyrights, and blueprints for manufacturing, as well as
patent rights for medical products.

“There has never been a more appropriate time to pool together our
knowledge and resources — including intellectual property, know-how, and
research — against a disease as there is now. This can be done in a way
that respects and rewards everyone’s contributions and investments and that
improves our ability to advance science toward combating this pandemic,”
former Gilead patent officer Gregg Alton said in a statement.

In response to the growing clamor for a voluntary pool, Thomas Cueni, who
heads the International Federation of Pharmaceutical Manufacturers and
Associations, issued a statement saying, “While voluntary pooling of
intellectual property and other assets can be a tool to stimulate R&D and
facilitate access under certain conditions, its effects to address the
current situation will likely be very limited.”

He argued that tools already exist for governments to access needed
medicines and are being used in a “number of cases.” He cited the Medicines
Patent Pool, a nonprofit that works with drug makers to widen access to
medicines. “In view of the scale of the collective challenge, including
ensuring that health systems are supported in these challenging times, we
would prefer to focus on responding to the public health crisis at hand,”
he added.

Alton, by the way, signed the letter as an individual, but his support is
notable, given that he was one of the architects of Gilead’s controversial
strategy for dealing with complaints over access for HIV and hepatitis C
drugs. In particular, the drug maker was widely criticized over pricing for
hepatitis C pills, which strained public and payer budgets alike in country
after country across the globe.

To mollify critics, Gilead licensed numerous generic makers to supply its
medicine in dozens of poor other countries, although it still faced
resistance because pricing remained out of reach for some middle-income
nations. The company subsequently faced a series of patent challenges in
different countries as part of a concerted effort by some advocacy groups
and academics.

Earlier this week, Gilead made news again when it asked the Food and Drug
Administration to rescind orphan status for an experimental drug called
remdesivir, which is being tested to combat Covid-19. This status confers
additional marketing exclusivity and tax credits for medicines that treat
diseases with 200,000 patients or less. But the company was criticized for
seeking what amounted to an additional monopoly when it was clear the
number of coronavirus patients would easily exceed that threshold.

The voluntary pool, in any event, is a more ambitious and encompassing
effort than other moves attempted this month in response to the pandemic.

A growing number of countries have explored compulsory licensing. 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 known as the Trade-Related Aspects of Intellectual
Property Rights, or TRIPS.

The concept is hardly new. For more than a decade, licensing has been a
controversial flashpoint between cash-strapped governments and drug makers,
which argue that licenses eviscerate their patent rights. The new pandemic,
however, has ratcheted up this sort of activity.

Over the past week, Canadian lawmakers have passed a bill that would speed
the process of issuing compulsory licenses, and lawmakers in Chile and
Ecuador passed resolutions urging their governments to explore licensing.
Israel, meanwhile, approved a license for an HIV pill, prompting the
manufacturer to relinquish patent rights and waive restrictions on generic
supplies on a global basis.

Also on Friday, Doctors Without Borders issued a statement calling “for no
patents or profiteering” on medicines, diagnostics, or vaccines used to
thwart the pandemic. “Governments must be prepared to suspend and override
patents and to take other measures, such as price controls, to ensure
availability, reduce prices, and save more lives from this disease caused
by a novel coronavirus,” the nonprofit said.

About the Author
Ed Silverman
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


More information about the Ip-health mailing list