Prof. Emeritus Brook K. Baker, Northeastern U. School of Law Sept. 30, 2024 With little opportunity for consultation and input from civil society and other interested parties, the Government of Indonesia is considering...
Read MoreBrook K. Baker, Professor Emeritus Northeastern U. School of Law David Deakin, MBA; BA(Hons), Independent Access Advocate AIDS activists, researchers, and service providers are challenging Gilead’s decision to enter into...
Read More[Brook Baker] Switzerland and Mexico have recently filed a communication entitled “TRIPS Council discussions on COVID-19 therapeutics and diagnostics: Evidence and questions on intellectual property challenges experienced by Members” at the TRIPS Council. This communication (IP/C/W/693) purportedly provides evidence on the supply and demand landscape of therapeutics and diagnostics, voluntary licensing and the affordability and accessibility of these products, but it does so on a highly misleading basis. Switzerland and Mexico claim, based on their self-selected information, that the international community is not facing a situation where there is an IP-induced lack of manufacturing capacity or affordable access to COVID-19 therapeutics and diagnostics. As a consequence, they argue that no adjustments to the IP system are required and further that the WTO TRIPS Decision, if extended, would have a significant detrimental effect leaving the world ill-equipped to fight the COVID-19 and future pandemics effectively.
Read More[Brook Baker] The voluntary licensing agreement reached between ViiV and the Medicines Patent Pool for long-acting cabotegravir has received significant media attention, criticism, and protests because of the millions of people excluded from direct or indirect access to in upper-middle-income countries excluded from the license. … One aspect of the licenses that has not yet received much attention is the precise listing of: (1) the 90 countries included in the licensed territory (including those having public sector access only and a 5% royalty obligation); (2) the 31 countries/territories that can be supplied by ViiV/MPP licensees in the future because of a provision in the license agreement that allows supply to a country if there is no pending or granted patent on CAB-LA in that countries; and (3) the 19 upper-middle-income countries totally excluded supply by a ViiV/MPP license unless a compulsory license is issued in the country of importation or use.
Read More[Brook Baker] In the aftermath of the recent WTO Ministerial Decision on the TRIPS Agreement (adopted June 17, 2022), there may be some confusion about the many options that countries have for overcoming intellectual property barriers to allow alternative production, distribution, and use of COVID-19 countermeasures. Of course, visibility into the patent landscape for particular products is essential to understanding freedom to operate in terms of products, ingredient, and manufacturing processes, and that work is complicated, though aided by the Medicines Patent Pool MedsPaL and VaxPaL databases and work done by other researchers on COVID-19 vaccine and therapeutics patents . Overcoming patent barriers on ingredients will not be a significant barrier if existing, patent-owning/licensed suppliers have adequate supplies and will sell at an affordable price. If compulsory licenses need to be issued that cover export/import sources of ingredients, the process for gaining freedom to operate becomes that more difficult.
Read More[Brook Baker] Twenty months ago, India and South Africa proposed a comprehensive but temporary waiver of enforcement of WTO intellectual property monopolies on COVID-19 vaccines, medicines, diagnostics, and other medical supplies that would have triggered a faster, more affordable, and more equitable COVID response. Rather than respond with alacrity and solidarity, the rich countries of the world, acting on behalf of Big Pharma, united with delay, distortion, and disinformation. The result is an illusory, do-nothing text, cobbled together by the WTO Secretariat, that the U.S., European Commission, Germany, Switzerland, and the U.K. are trying to cram down the neck of developing countries already choking on a steady diet of broken promises and immeasurable death, suffering, and economic disruption.
Read More[Brook Baker] The EU draft proposal entitled “Ideas on the points of convergence on the TRIPS issues for discussion” (below) tries to make a silk purse out of a cow’s ear, by relying on moderately revised compulsory licensing on patents as the sole IP solution to the glaring problem of artificially restricted supplies, profiteering prices, and grossly inequitable distribution of COVID-19 health products.
Read More[Brook Baker] The complications and limitations of compulsory-license-reliant measures to respond to the COVID-19 pandemic need to be better explained. The European Union and several other countries espousing reliance on TRIPS-compliant compulsory licenses to overcome patent barriers have opposed the India/South Africa temporary intellectual property (IP) waiver proposal on COVID-19 health technologies at the World Trade Organization. Although compulsory licenses (CLs) on patent alone may be sufficient to allow generic production of small molecule medicines, CLs are unlikely to suffice with respect to vaccines, biologic medicines, including monoclonal antibodies, and more complex diagnostic tests, medical devices, and respirators.
Read More[Brook Baker] If the European Union’s Communication to the TRIPS Council – Urgent Policy Responses to the COVID-19 Crisis has no real substance, then it is fair to conclude that its true purpose is disinformation, diversion, and delay. The Communication purports to address clarifications needed to make existing TRIPS flexibilities more operational for countries that might need to issue compulsory licenses to access COVID-19 vaccines and therapeutics. However, the proposed clarifications have no substance beyond what is already well established in the text of Articles 31 and 31bis of the TRIPS Agreement and of the Doha Declaration on the TRIPS Agreement and Public Health. When a powerful group of nations, like the E.U., offers a set of “pseudo” proposals with no substance, we can look beyond the façade to see that their real intention is to misinform decision-makers, the press, and the public and to divert attention from the proposal by India, South Africa and 61 other countries to the WTO to waive intellectual property protections on COVID-19 health products and technologies for at least three years.
Read More[Brook Baker] This Policy Brief from the People’s Vaccine Campaign, written by Prof. Brook K. Baker, is highly relevant to the discussions of the India/South Africa TRIPS waiver proposal at the WTO. The Policy Brief distinguishes between (1) industry controlled efforts to manage the global supply of COVID-19 vaccines and other health technologies that results in the inevitable consequence of inadequate supply, needlessly high prices, and grossly inequitable distribution and (2) government-led efforts to free additional qualified manufacturers from intellectual property and technology transfer barriers that stand in the way of building near-term and sustainable biopharmaceutical manufacturing capacity in underserved developing country regions around the world.
Read More[Brook Baker] The world was unprepared for COVID-19 despite other recent coronavirus outbreaks and despite multiple warnings from the World Health Organization (WHO) and others. Although there was an initial sharing of research among scientists and an unleashing of significant public, charitable, and private funding to develop, test, and expand manufacturing capacity of new COVID-19-related medicines, vaccines, and diagnostics, the status quo of exclusive rights ownership and commercial control by the multinational biopharmaceutical industry continues unabated. Existing intellectual property rules that allow private entities to maintain monopoly rights over the development, clinical testing, regulatory approval, pricing, supply, and distribution of essential medical products have not been altered.
Read More[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.
Read MoreOn 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.
Read More[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.
Read MoreThe 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.
Read MoreBig 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.
Read MoreThe 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.
Read MoreAbstract: 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.
Read MoreOn 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.
Read MoreAbbVie 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.
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