Big Pharma Attacks Coronavirus Price Controls

“On April 15, Rep. Jan Schakowsky, D-Ill., along with Reps. Peter DeFazio, D-Ore., Rosa DeLauro, D-Conn., and Lloyd Doggett, D-Texas, laid out basic principles for the development and pricing of coronavirus therapies and vaccines. Their demands were simple: Pharmaceutical companies should have to set reasonable prices for their drugs and vaccines used to treat or prevent Covid-19. They should be required to make the costs of research and manufacturing of these products public. During the pandemic, the legislators said, companies should not be able to profit exclusively from these potentially lifesaving drugs.

“Exclusivity determines who has access, who can manufacture, and how we scale up production to meet the need,” the members of Congress noted in a press release at the time….

Few have spoken out against the protections that were designed to ensure equitable access to lifesaving medicines — at least publicly. But privately, a coalition of conservative groups attacked the proposed patient protections as “dangerous, disruptive, and unacceptable.” In a May 7 letter, representatives of 31 groups, including Hudson Institute, the Council for Citizens Against Government Waste, and Consumer Action for a Strong Economy, called on Congress to reject the drug pricing guidelines and defended patents and the exclusive right to profit from drugs as “America’s great assets.” …

Perhaps most galling to the Democratic lawmakers is the fact that the vast majority (if not all) of the drugs they seek to protect from exorbitant pricing have been developed at least in part with taxpayer dollars. Between 2010 and 2016, every drug approved by the Food and Drug Administration benefited from science funded with federal research through the National Institutes of Health, according to the advocacy group Patients for Affordable Drugs. During that time, taxpayers spent more than $100 billion on that research.

Although American taxpayers are the “angel investors” of pharmaceuticals, as Doggett put it, many cannot afford the treatments they’ve bankrolled….

On Friday, the World Health Organization unveiled a global effort to pool intellectual property, data, and research related to Covid-19. While 36 countries have already announced their support for the project, the U.S. was not among them. Just as WHO was detailing its plan to broadly share the benefits of scientific advancement, President Donald Trump was announcing his plan to withdraw from the global organization.”

FOIA: Film industry lobbies South Africa’s Parliament to suspend Copyright Amendment Bill | Knowledge Ecology International

“Through a Freedom of Information Act (FOIA) request, Knowledge Ecology International (KEI) has obtained 311 pages of correspondence between officials from the Office of the US Trade Representative (USTR) and employees of the Motion Picture Association (MPA), the Recording Industry Association of America (RIAA) and other entities including law firms on matters regarding South Africa and copyright policy. The FOIA request was filed by Claire Cassedy on October 29, 2019. The 311 page document is available here: https://drive.google.com/file/d/1wUYHzgwtYUaYiMLLeGfV7ucxk5Q1tpu0/view?usp=sharing

The correspondence dates from December 2018 to November 2019 and reveals an assiduous campaign mounted by the MPA and RIAA to thwart the passage of South Africa’s Copyright Amendment Bill in the South African Parliament and to prevents its signing by the President of South Africa, Cyril Ramaphosa. The MPA and RIIA, working in concert with the International Intellectual Property Alliance (IIPA) petitioned USTR to impose higher tariffs on South Africa (by revoking the Generalized System of Preferences) over concerns with, inter alia, the fair use provisions contained in South Africa’s Copyright Amendment Bill….”

FOIA: Film industry lobbies South Africa’s Parliament to suspend Copyright Amendment Bill | Knowledge Ecology International

“Through a Freedom of Information Act (FOIA) request, Knowledge Ecology International (KEI) has obtained 311 pages of correspondence between officials from the Office of the US Trade Representative (USTR) and employees of the Motion Picture Association (MPA), the Recording Industry Association of America (RIAA) and other entities including law firms on matters regarding South Africa and copyright policy. The FOIA request was filed by Claire Cassedy on October 29, 2019. The 311 page document is available here: https://drive.google.com/file/d/1wUYHzgwtYUaYiMLLeGfV7ucxk5Q1tpu0/view?usp=sharing

The correspondence dates from December 2018 to November 2019 and reveals an assiduous campaign mounted by the MPA and RIAA to thwart the passage of South Africa’s Copyright Amendment Bill in the South African Parliament and to prevents its signing by the President of South Africa, Cyril Ramaphosa. The MPA and RIIA, working in concert with the International Intellectual Property Alliance (IIPA) petitioned USTR to impose higher tariffs on South Africa (by revoking the Generalized System of Preferences) over concerns with, inter alia, the fair use provisions contained in South Africa’s Copyright Amendment Bill….”

Trump Administration Would ‘Eviscerate’ Copyright, Say Industry Players

““The Trump Administration should not permit the Office of Science and Technology Policy (OSTP) to eviscerate the key constitutional and economic function of copyright law by forcing US intellectual property owners to give away their copyrighted works for free to China and the rest of the world.”

EU Joins In The Bullying Of South Africa For Daring To Adopt US-Style Fair Use Principles | Techdirt

“As part of its copyright reform, South Africa plans to bring in a fair use right. Despite the fact its proposal is closely modeled on fair use in American law, the copyright industry has persuaded the US government to threaten to kill an important free trade deal with South Africa if the latter dares to follow America’s example. If you thought only US copyright companies were capable of this stunningly selfish behavior, think again. It seems that the European copyright industry has been having words with the EU, which has now sent a politely threatening letter to the South African government about its copyright reform (pdf)….”

How the academic publishing oligopoly skews debates on the cost of publishing | Samuel Moore

[…]

Financial matters have always been an area of dispute within OA debates, particularly over how much publishing should cost and how much profit should be returned to shareholders. Some people advocate for a more efficient publishing process (whereby an individual article is cheaper to produce) or a transparent market to inform purchasing decisions, while others argue for an entirely non-profit space or a restriction on the profiteering of large commercial publishers. Both of these are ideological arguments that either reflect faith in market outcomes to produce efficient results or distrust in markets and the need for interventions to generate healthier publishing cultures. (of course, this is not a simple binary for many people but a broad generalisation.)

Yet what gets lost in the debates about the cost of publishing is the nuance around what publishing actually is and who publishers actually are. Publishing isn’t a specific practice by a certain kind of organisation, but instead reflects a multitude of practices, business models, formats, political modes, and so on. But this diversity is obscured by the fact that publishing is also a highly concentrated industry. The skewed debate exists not just because publishing means a range of different things, but also because 5-6 publishers have a market share of roughly half of the entire academic publishing industry. This means that the way in which many researchers interact with publishers is largely influenced by the oligopoly, even though publishing represents a plurality of practices.

[…]

WHITE HOUSE: Scientific research executive order on hold — Friday, February 21, 2020 — www.eenews.net

“The White House issued a notice Wednesday seeking comment on its effort to enhance public access to federally funded research. It’s an old idea creating new controversy.

White House Office of Science and Technology Policy Director Kelvin Droegemeier is pushing back against publishers that in December said the administration was quietly pursuing an executive order to require immediate free distribution of taxpayer funded research (Greenwire, Dec. 17, 2019).

Publishers feared the plan could upend their fee-based business model. But this week, Droegemeier formally assured them that his office is still seeking public input on the topic….”

Trump’s administration may address the outrageous academic publishing market.

“In December, in the midst of the political wrangling associated with President Trump’s impeachment, a news report gave me hope. According to it, Trump’s administration was working on an executive order that would require publishers to grant immediate free access to all journal articles that result from federally funded research. Predictably, the publication industry rapidly issued a scathing critique of the idea, signed by 140 publishers and academic societies. Although the Trump administration is widely viewed to be anti-science, it would be a mistake to interpret the presence of academic societies on this letter as representing the interests of science writ large. Within two days of the industry letter, a coalition representing 210 academic and research libraries wrote an open letter to the White House supporting changing federal policy in exactly the way the executive order is rumored to do. Indeed, there have long been calls for opening access to research results. This is an area where U.S. lags behind Europe in policy and Latin America in development of open access journals and databases.

In an era when most presidential actions are viewed primarily through partisan lenses, it is worth taking a step back and considering why this rumored proposal elicited a polarized response, but one that did not fall along partisan lines. A lot of money is at stake. But so too are the essences of scientific communication and scientific self-governance….”

What to Expect in the Publishing World in 2020 – Against the Grain

“Earlier this month, a rumor began to circulate that the US government was planning on passing an executive order that would mandate all papers from federally funded research be open access immediately upon publication—abolishing the 12-month paywall allowed under current rules.

In response, more than 135 scientific societies and academic publishers penned an open letter to President Donald Trump’s Administration strongly opposing such a policy, warning that the proposed changes would “jeopardize the intellectual property of American organizations engaged in the creation of high-quality peer-reviewed journals and research articles and would potentially delay the publication of new research results.” The letter has been widely criticized by academics and open-access advocates on social media….

Although the [Plan S] coalition has managed to gain some international members, the overall response to Plan S has been lukewarm outside of Europe. India’s government, for example, decided to forgo joining the coalition and develop its own national effort to advance open access, despite earlier indications that it would be joining the group. In Latin America, where Argentina has joined cOAlition S, academics have raised concerns about the initiative’s focus on pay-for-publishing models. One worry is that if funders or universities are required to cover fees for publishing open access in commercial journals, financial resources could be diverted from their current system, under which journals are free to publish in and free to read—and scientific publications are owned by academic institutions….”

Epic’s call to block a proposed data rule is wrong for many reasons – STAT

“Epic, the nation’s largest electronic health record (EHR) company and a major beneficiary of a $48 billion Obama-era federal program to promote the adoption of EHRs, has launched a full-scale effort to block the flow of data out of its software and into apps that benefit doctors and patients. That’s wrong for many reasons.

Epic is attempting to scuttle finalization of a rule from the Department of Health and Human Services that would implement the interoperability and information blocking provisions of the 21st Century Cures Act. The thoughtfully crafted rule, proposed by the Office of the National Coordinator for Health Information Technology, and now under final review at the Office of Management and Budget, requires that EHRs operate seamlessly with third-party apps, and prevents EHR vendors and health care systems from blocking or inhibiting the flow of information between health information technology systems or to patients. The rule is intended to underpin a digital ecosystem on top of the government’s investment to transform the health care system….”

Offline: Scientific publishing—trust and tribulations – The Lancet

“Signatories [to the AAP letter to Donald Trump] wrote about their role “fostering the American leadership in science that drives our economy and global competitiveness”. They suggested that an open access mandate “would significantly harm the system of peer-reviewed scholarly communication that fuels America’s leadership in research and innovation”. They urged the president to oppose this proposal. Many who signed the letter were indeed US-based organisations (such as the American Medical Association and American College of Physicians). But others would probably consider their missions to go beyond “fostering…American leadership in science”. They would almost certainly claim they had a global remit, not one narrowly confined to advancing “American competitiveness”. The letter was signed, for example, by the New England Journal of Medicine, Wiley, Wolters Kluwer, and The Lancet’s publisher, Elsevier. At last week’s Academic Publishing in Europe annual meeting, held in Berlin, Professor Günter Ziegler (President of the Free University of Berlin) mocked the catastrophist language used by publishers in this letter. “There is no such thing as American science or American publishing”, he said. Science is a truly global enterprise. His reprimand showed how far apart the values of science and science publishing have drifted in recent years….

Publishers are understandably nervous. Coalition S, a consortium of research funders that includes the Wellcome Trust, Bill & Melinda Gates Foundation, and WHO, has called for the research they pay for to “be published in Open Access Journals, on Open Access Platforms, or made immediately available through Open Access Repositories without embargo”. Their policy will be implemented in 2021. Publishers have held decisive power in shaping the dissemination of science for over 300 years. That power is now being challenged. It is an uncomfortable reset. But from the funder’s perspective it is entirely reasonable they have a voice in the way the science they support is reported. The result of this accelerating shift in power has been an escalating conflict between traditional scientific publishers and funding bodies. Yet, despite the anomaly of that ill-judged letter to President Trump, there were signs in Berlin that both sides were seeking an accommodation….

Scientific publishers as we know them today remain a threatened species. They will have to do more to prove their added value to science and society. Unless they do so, they may not deserve to survive.”

Message from the APS Board of Directors – Association for Psychological Science – APS

“On Friday, December 13, 2019, Research!America confirmed to the broader scientific community that the US White House Office of Science and Technology Policy (OSTP) would soon issue an Executive Order (EO) requiring open access immediately for all scientific publications resulting from research supported by US federal grants. Such an immediate change would inject chaos into the current means of disseminating research findings and potentially cause serious financial challenges for many scientific societies.

Over the ensuing weekend, two public letters were drafted to the US presidential administration and other American politicians. One letter was led by the American Chemical Society (which focused on the impact of the EO on scientific societies) and the other letter was led by the Association of American Publishers (that focused on the economic impact of the EO). The goal was to insist that the US administration reconsider any impulsive action so journals and societies could evaluate and adapt to the proposed change in an orderly way. There was no opportunity for APS to offer edits….”

To APS Members From the Board of Directors – Association for Psychological Science – APS

“Today, January 24, 2020, the APS Board sent a letter to the Trump Administration, expressing regret for having signed a letter, led by the Association of American Publishers, in protest of an impending executive order from the Trump Administration to mandate immediate open access for all publications reporting on US federally-funded research. This letter is to you, our members, and to the wider scientific community. It builds on our statement of December 23, 2019 and represents our current thoughts on the situation….”

The Mess That Is Science Publishing — The James G. Martin Center for Academic Renewal

“Researchers have been grumbling about the state of scientific publishing for years. Now, rumor has it that the Trump administration (yes, those science-haters!) may be trying to fix at least one problem: access to reports of government-funded research.

The rumored proposal will require free, immediate access to all reports of government-funded scientific research. The rumor is credible enough that an association of 210 academic and research libraries has written to the president in support of the idea. The research-publication system is a mess, and open access would be one small step toward a fix….”