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

Paul Fehlner pfehlner at revisiontx.com
Sat Mar 28 07:58:21 PDT 2020


This is really important and an exciting development. We must immediately deploy the world’s intelligence and energy against COVID-19 if we are to act in time. 

There is a further step to take, as a voluntary pool may not be sufficient, especially when the crisis intensity cools and public approbation for actions like Gilead’s Orphan designation abates. It requires minimal extra bandwidth, apart from a willing coordinator: aggregate data from ongoing trials worldwide and submit formal applications to health authorities to ensure approval of repurposed medicines on the best available evidence of safety and efficiency — even for emergency use. We think this is essential to protect patients and integrity of the health system. 

Furthermore, an entity dedicated to the public interest could obtain consequential legal exclusivities (Orphan drug designation, data and market exclusivity) and prevent opportunistic third parties from getting them. Other solutions would be unlikely to neutralize the ability of third parties to obtain these statutory exclusivities. Legislation required to eliminate them would almost certainly not pass in time for COVID-19, and such legislation may contravene broader policy interests in incentivizing new medicines. Ad hoc efforts to take rights granted by statute could result in litigation, with uncertain outcomes. 

There is even a chance of turning the existing system upside down. These exclusivities can be used to support the pool’s goals by giving the pool the power to use them for the public benefit, including making access to US, EU, and Japanese markets contingent on pooling patent rights, sharing data, and facilitating access in lower income markets. This crisis presents an immediate and urgent opportunity to wield the tools of exclusivity to promote access to medical products that may combat COVID-19.

Paul Fehlner
President & CEO
reVision Therapeutics, Inc.
+1.201.966.7474
pfehlner at revisiontx.com
www.revisiontx.com




> On Mar 28, 2020, at 1:32 AM, Thiru Balasubramaniam <thiru at keionline.org> wrote:
> 
> <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
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