Brook Baker

Brook Baker

  • Joined: February 1, 2012
  • Articles: 77

New ViiV license with the Medicines Patent Pool expands access but eviscerates transparency

[Brook Baker] The Medicines Patent Pool (MPP) has announced a new licensing agreement for dolutegravir (DTG) with ViiV for four countries (Azerbaijan, Belarus, Kazakhstan, and Malaysia) excluded from earlier licensing agreements. Reports about this new announcement, which resulted from negotiations that directly involved the affected countries’ governments (unlike many past MPP licenses), have missed significant shortcomings in the deal.

South Africa and India’s Proposal to Waive Recognition and Enforcement of Intellectual Property Rights for COVID-19 Medical Technologies Deserves Universal Support, But Countries Also Have to Take Domestic Measures

On October 2, India and South Africa petitioned the World Trade Organization (WTO) to allow all WTO members to bypass granting or enforcement of patents, trade secrets, industrial designs, and copyrights on COVID-19-related drugs, vaccines, diagnostics and other medical technologies for the duration of the pandemic – until global ‘herd immunity’ is achieved. The proposed “Waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19” should be promptly and emphatically supported by governments, international institutions, global health initiatives, and all of civil society—from health workers, to academics, and access-to-medicines activists.

US-, China- and EU-First Nationalism and COVID-19 Technology Hoarding Push the Rest of the World to the End of the Line

[Brook Baker] With the world racing to find new vaccines and therapies to respond to the escalating COVID-19 pandemic, the world’s biggest economies are pursuing nationalistic policies, racing to the front of the line with sweetheart deals to fund research and development in exchange for preferential access to life-saving health products. These same countries (along with others) have also imposed selfish and unnecessary export controls limiting supply of needed health supplies to other countries.[1] This unbridled nationalism, interlinked with a broken, profit-driven pharmaceutical system risks obstructing access to life-saving medicines worldwide. This should be a moment for transformative, systemic change, but instead of an innovative response and true global solidarity we’re seeing the same old business-as-usual.

Gilead Remdesivir Licenses: Half measures are not nearly good enough

The deadly public policy of letting Big Pharma companies like Gilead control access to COVID-19 therapies is clearer now than ever before. While promising “global access” out of one side of its mouth, Gilead has shown its true intentions with new, confidential bilateral licenses negotiated with five generic companies in India and Pakistan. These licenses only cover approximately 52% of the global population leaving the other 48% of the whim of Gilead’s monopoly-based predations. These licenses exclude people living in at least 73 countries and territories, including, outrageously, 30 low- and middle-income countries. Gilead wants to exercise total monopoly control over manufacture and sale in those 73 countries, giving it unfettered freedom to charge prices far in excess of the estimated $5-$10 per treatment that it costs to manufacture remdesivir.

Drug Companies are Running Scared – Let’s Make Them Run Faster

Big Pharma notched a regrettable victory in the early days of the COVID-19 response when it successfully blocked an enforceable reasonable-pricing clause from inclusion in the first $8.3 billion emergency spending bill. Although the bill contains a provision requiring “fair and reasonable pricing” for federal acquisitions and another authorizing the Secretary of Health and Human Services to take steps to ensure that coronavirus vaccine, treatments, and tests “will be affordable in the domestic market,” those provisions lack any meaningful enforcement mechanism. Moreover, drug companies inserted text that prevents the government from using lack of affordability as a reason to delay development of a medicine... What a difference two weeks have made.

Rationale for Supporting Costa Rica’s Proposal for Emergency COVID-19 Technology IP Pool for All Countries

The world is behind in developing and being able to supply the diagnostics, vaccines, therapeutics, medical devices, and other well adapted medical supplies [medical technologies] needed to respond to the COVID-19 pandemic which is sweeping across the globe. Although scientific and medical urgency are building, we need to ensure that the needed medical technologies will be developed and tested urgently, efficiently, and ethically with maximum degrees of open data, open science, and collaboration in the development stage and maximum degrees of universal and equitable access thereafter to all people in all countries. We therefore support the creation of a voluntary emergency Technology Intellectual Property Pool [TIPP] that will accelerate scientific discovery, technology development, proof of safety/efficacy/quality, and broad sharing of the benefits of scientific advancement and its applications in furtherance of the right to health.

Access to Medicines Activism: Collaboration, Conflicts, and Complementarities

Abstract: This chapter address three phases of access to medicines [A2M] advocacy. The first phase started in the late 1990s and continuing into at least the mid 2000s when global cooperation and collaboration between A2M advocates grew as they confronted the terrible scourge of HIV compounded by the refusal of pharmaceutical companies and rich country governments to take measures to increase affordability of newly effective ART.

The Trump Administration’s New Green Paper is Full of Give-Aways to Big Pharma

On December 6, the Trump Administration released a new Return on Investment Initiative Draft Green Paper full of give-aways to Big Pharma and other private companies that piggyback on U.S. funded research and reap monopoly rights to sell resulting innovations at bloated prices. These IP-maximalist proposals, including curtailing of government-use rights and march-in rights with respect to technology transfer of federally funded research, (if implemented) would inevitably lead to higher prices contrary to President Trump’s rhetoric about lowering drug prices.

MPP-AbbVie License on Glecaprevir and Pibrentasvir (G/P): Backtracking on Geographic Coverage but with Options for Oppositions, Compulsory Licenses, and Negotiated Territorial Expansion

AbbVie and the Medicines Patent Pool have negotiated a royalty-free licensing and sublicensing agreement on a priority hepatitis C direct acting antiviral, glecaprevir and pibrentasvir (G/P).  This G/P combo is recommended by the WHO as a pan-genotypic adult first-line regimen with ongoing Phase 3 trials for adolescents and children.  G/P has a high resistance barrier and the shortest treatment duration of any HCV regimen to date.

A Sliver of Hope: Analyzing Voluntary Licenses to Accelerate Affordable Access to Medicines

Abstract: As a result of global AIDS activism, governments' latent and exercised powers to bypass pharmaceutical monopolies, and halting pharmaceutical industry accommodation, a new form of voluntary licensing has emerged focused on first permitting and then facilitating generic production of certain pharmaceutical products for sale and use in many but not all low- and middle-income countries (LMICs). These so-called "access" licenses are pluralistic in detail and not free of commercial motivations for either originators or generic producers, but they do differ from arms-length, purely commercial licenses that have been broadly used in the industry for decades. Although the first of these access licenses were negotiated bilaterally by innovators at the receiving end of AIDS activism and threats of government action, including the issuance of compulsory or government-use licenses, the leading model of more public-health oriented voluntary licenses can be traced to the formation of the Medicines Patent Pool under the financial sponsorship of Unitaid in 2010.

Wink, Wink: Pfizer Agrees to Roll Back Price Hikes

In a staged play designed to give cover both to President Trump and Big Pharma, Pfizer has announced a temporary roll back of its extortionate price hikes on 41 medicines averaging nearly 9% over and above its existing monopoly prices.  A scene-by-scene recap reveals the cozy, mutually beneficial farce that Trump and Pfizer are enacting. Scene One:  Drug companies like Pfizer use their patent and data-protection monopolies to set prices at whatever the market will bear, with U.S. purchasers paying nearly twice as much as is paid in countries with more rational approaches to trying to prevent abusive pricing.

Misleading Ab”Use” of Percentages in Drug Price Escalation

As misleading as it is when drug companies say they use R&D costs, therapeutic value, or "market forces" when they set the initial price of new medicines, Big Pharma is equally duplicitous when talking about their repetitive price increases on existing medicines via their direct and indirect references to ordinary inflation rates and the consumer price index.