Miscellaneous Supplement - Michigan 2024 DGW

Notes
thanks to kabeer kochar, connor rosenstein, saanvika gandhari, aarav iyer, hannah wang, and eva chakrabarti for their work on this file!!!
Waivers Neg
PPP CP
this cp is supplement evidence to allow the public/private advantage cp to apply to the waivers affirmative.
1NC – PPP CP – Solves Waivers
Instead of waivers, the government can establish a public-private partnership, which avoids the development DA
Harvey Rubin and Nicholas Saidel ’21 [Harvey Rubin is a Professor of Medicine and Computer Science from the University of Pennsylvania; Nicholas Saidel is Associate Director - Institute for Strategic Threat Analysis & Response (ISTAR) at the University of Pennsylvania; “Innovation beyond patent waivers: Achieving global vaccination goals through public-private partnerships”, Brookings, August 31 2021, https://www.brookings.edu/articles/innovation-beyond-patent-waivers-achieving-global-vaccination-goals-through-public-private-partnerships/]//bcp-kk
The international effort to achieve global COVID-19 vaccination goals faces a dilemma. Stakeholders in this space are at odds over how to treat intellectual property (IP) rights now that viable vaccines are on the market but are inaccessible to vulnerable populations in low- and middle-income countries (LMICS). A key aspect of this debate is whether to grant patent waivers for COVID-19 vaccines and therapeutics. We suggest looking beyond patent waivers with an innovative solution based on public-private partnerships (PPPs), an approach that could be more effective in combating the on-going COVID-19 pandemic and simultaneously help prepare LMICS for future health crises.
Background
Created in 1995, the World Trade Organization (WTO) provides a forum for member states to lower barriers to international trade. The WTO also serves as a legal and institutional framework for executing multilateral agreements related to the global trading system. One of these agreements is known as Trade-Related Aspects of Intellectual Property Rights (TRIPS). TRIPS governs the protection of IP rights, such as patents and trademarks. Technologies that prevent, contain, and treat COVID-19—the death toll from which exceeds 4.3 million people with over 200 million infected—are protected under TRIPS. This intersection of global public health and international trade regulations has spurred a debate as to whether an exception to TRIPS for COVID treatments is warranted. The two schools of thought on the patent waiver issue can be roughly characterized as follows:
Pro-patent protection: The first school that patent protections on COVID-19 vaccines are necessary because pharmaceutical companies will otherwise be disincentivized to innovate and invest in vaccine research and development, and they will unfairly lose market share to competitors and adversarial nations such as China. This theory also that removing IP protections will not serve the intended objective of increasing vaccination rates as the developing world lacks the infrastructure and expertise to roll out effective domestic production. Advocates of patent protection argue that the WTO already allows countries to apply for “compulsory licensing,” which waives IP during emergencies such as the COVID-19 pandemic. Proponents of continued patent protection see voluntary commitments from industry, developed world governments, and large NGOs as a more effective means of addressing the problem.
Pro-patent waiver: Conversely, others removing IP protections is a necessity as companies located in high-income countries hold most, if not all, of the COVID-19 vaccine IP and sell the vaccines to governments mostly in the developed world. According to this view, the price of these vaccines, combined with export restrictions and the inability of LMICs to manufacture their own vaccines at a lower price and without fear of litigation from patent holders, are among the main reason why vaccines are not reaching the world’s most vulnerable communities. They further that the compulsory license process is both time consuming and cumbersome and that providing basic medical services for these vulnerable communities should be prioritized over industry profits. Finally, a more diffuse global vaccine manufacturing architecture would be more effective and in line with health as a human right.
The patent waiver issue gained traction in response to the stark disparity in global health outcomes as COVID-19 vaccines and therapeutics were brought to market. Data from May 2021 indicates that “people living in G7 countries were 77 times more likely to be offered a vaccine than those living in the world’s poorest countries.” Data from the end of June 2021 reflects that “46% of people in high-income countries had received at least one dose of the COVID-19 vaccine compared with 20% in middle-income countries and only 0.9% in low-income countries.”
This global health inequity is in part due to high-income countries purchasing more vaccines than they need. For example, Canada has secured vaccine doses for 434% of its population. Another issue is vaccine price in relation to cost and LMIC’s purchasing power: One report states that Pfizer/BioNTech and Moderna have been charging governments up to 24 times the potential cost of production. Furthermore, Pfizer/ BioNTech are charging their lowest reported price of $6.75 to the African Union, yet one dose costs the same as Uganda spends per citizen on health annually. These incongruities represent an injustice to the world’s underserved populations, and they demand the development of innovative ideas regarding how to overcome price and access obstacles.
In October 2020, India and South Africa led a group of LMIC’s request to the WTO to waive certain TRIPS provisions. The request, modified as of May 25, 2021, asks for a three-year waiver of IP protection for products and technologies related to COVID-19 prevention, treatment, and containment. Normally, WTO protections for IP last around 20 years. The Biden administration is currently on board with the waiver, and the EU is open to negotiations. However, some EU member states like Germany remain steadfast in rejecting this idea, and the EU has proposed its own non-waiver plan. The WTO will likely take months deliberating this matter, and it usually renders decisions unanimously, though a TRIPS waiver would technically only require a three-quarters majority to pass. As it stands now, talks at the WTO stalled in late July with little progress and are now on hold for the summer holiday.
Solution
An optimal solution to the currently inequitable global distribution of COVID-19 vaccines requires more innovation than a temporary waiver of patents. A process is needed whereby LMICs can take some level of ownership over the manufacturing and distribution of critical vaccines and medicines without the bureaucratic red tape associated with compulsory licensing. We suggest that PPPs between pharmaceutical companies and relevant governmental ministries that are well-funded by access to the capital markets through impact bonds is [are] a comprehensive, sustainable solution to the problem of achieving global vaccination goals.
A PPP can be defined as:
Co-operation of some sort of durability between specific public and private actors in which they jointly develop infrastructure, products, and services (including knowledge and dissemination of information) and share risks (financial and/or prestige), cost and resources, which are applied in the development and delivery process.
This solution has three essential components: first, identifying the incentives for the private sector to participate in the partnership; second, inducing the public sector to transfer some of its mission and responsibilities to the partnership; and third, access to capital markets.
As the current authors wrote in 2016: Private sector entities can profit from PPPs—especially with LMICs that present a new or unsaturated market for a wide range of a pharmaceutical company’s products. Increased brand recognition, increased market penetration, entry into new markets, preserving the existing customer base, gaining new customers, and garnering favorable status for introduction of new products are all attractive concepts for private sector partners. Relaxed barriers to market entry (e.g., tariffs and taxes) and access to LMIC raw data would also motivate a private sector entity to forge a relationship with public entities.
The public sector can be incentivized to formalize a PPP for pharmaceutical and vaccine-related issues like supply chain management, data capture and analysis, quality control, and inventory optimization. PPPs would assist in speeding up the scaling required to develop sufficient quantities of COVID-19 vaccines and medicines, and LMICs would be better prepared for future pandemics.
2NC – PPP CP – Solves BioTech/Pandemics
PPPs streamline the process for combating pandemics and help increase funding into R&D
National Institute of Health 20 [“NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options”; National Institute of Health; 04-17-20; https://nih.gov/news-events/news-releases/nih-launch-public-private-partnership-speed-covid-19-vaccine-treatment-options#:~:text=The%20National%20Institutes%20of%20Health%20and%20the%20Foundation%20for%20the,the%20U.S.%20Food%20and%20Drug]//bcp-kk
The National Institutes of Health and the Foundation for the NIH (FNIH) are bringing together more than a dozen leading biopharmaceutical companies, the Health and Human Services Office of the Assistant Secretary for Preparedness and Response, the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration and the European Medicines Agency to develop an international strategy for a coordinated research response to the COVID-19 pandemic. The planned Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership will develop a collaborative framework for prioritizing vaccine and drug candidates, streamlining clinical trials, coordinating regulatory processes and/or leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics. This is part of the whole-of-government, whole-of-America response the Administration has led to beat COVID-19.
“We need to bring the full power of the biomedical research enterprise to bear on this crisis,” said NIH Director Francis S. Collins, M.D., Ph.D. “Now is the time to come together with unassailable objectivity to swiftly advance the development of the most promising vaccine and therapeutic candidates that can help end the COVID-19 global pandemic.”
Coordinated by the FNIH, ACTIV government and industry partners will provide infrastructure, subject matter expertise and/or funding (both new and in-kind) to identify, prioritize and facilitate the entry of some of the most promising candidates into clinical trials. Industry partners also will make available certain prioritized compounds, some of which have already cleared various phases of development, and associated data to support research related to COVID-19. The partnership is being developed with input from a steering committee managed by the FNIH which includes leaders from NIH, FDA and the research and development organizations of the companies.
“COVID-19 is the most significant global health challenge of our lifetime, and it will take all of us working together as a global community to put an end to this pandemic,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “We will need to harness the best ideas from multiple stakeholders, including governments, regulatory authorities, academia, NGOs and industry to stop COVID-19. At Johnson & Johnson, we are committed to working closely with FNIH, IMI and are part of other important consortia to speed solutions to stop this pandemic.”
“Battling the COVID-19 pandemic is far too great a challenge for any one company or institution to solve alone,” said Mikael Dolsten, M.D., Ph.D., Chief Scientific Officer and President, Worldwide Research, Development and Medical, Pfizer. “We are seeing an unprecedented level of collaboration across the innovation ecosystem to address this global health crisis, and this potentially powerful NIH initiative may allow us to further accelerate the delivery of much needed therapies to patients around the world.”
The research community is currently striving to sift through more than 100 potential preventives and therapeutics for COVID-19. ACTIV will aim to provide guidance which can be used to prioritize the plethora of vaccine and therapeutic candidates in development and connect clinical trial networks to test new and repurposed candidates quickly and efficiently.
“Using the most advanced clinical trial methods to rapidly test multiple interventions will help get the answers we need as soon as possible to expedite potential prevention and treatment approaches to fight COVID-19,” said FDA Commissioner Stephen M. Hahn, M.D. “Collaboration is a critical ingredient for success and the FDA will continue to use every tool possible under our Coronavirus Treatment Acceleration Program(link is external) to speed the development of safe and effective medical countermeasures.”
ACTIV will have four fast-track focus areas, each of which will be led by a highly motivated working group of senior scientists representing government, industry and academia:
Standardize and share preclinical evaluation methods in an open forum that allows for comparison and validation by:
Establishing a centralized process and repository for harmonizing and sharing methods and evaluating models
Extending access to high-throughput screening facilities, especially in biosafety level-3 laboratories, with a goal of testing all compounds that have been in human clinical trials to identify the potential to apply these compounds to COVID-19
Increasing access to validated animal models
Enhancing comparison of approaches to identify informative assays
Prioritize and accelerate clinical evaluation of therapeutic candidates with near-term potential by:
Establishing a steering committee with relevant expertise and objectivity to set criteria for and rank potential candidates submitted by industry partners for first wave and subsequent evaluation
Developing a complete inventory of potential candidates with different mechanisms of action and acceptable safety profiles
Designing, launching and openly sharing master protocols with agreed upon endpoints, sampling and analysis for evaluating candidates
Using a single control arm to enhance trial efficiency
Maximize clinical trial capacity and effectiveness by:
Connecting existing networks of clinical trials to build capacity and capabilities, including specialization in different populations and disease stages
Leveraging infrastructure and expertise from across NIH networks, including:
Adjuvant Discovery and Adjuvant Development Programs
AIDS Clinical Trials Network
Clinical and Translational Science Awards Program
Clinical Trials in Organ Transplantation
Cooperative Centers on Human Immunology
HIV Prevention Trials Network
HIV Vaccine Trials Network
Human Immunology Project Consortium
International Network for Strategic Initiatives for Global HIV Trials (INSIGHT) Network
National Cancer Institute Community Oncology Research Program
National Cancer Institute’s National Clinical Trial Network
Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network
Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN)
T and B Cell Discovery Programs and Immune Epitope Database
Vaccine Treatment and Evaluation Units
Establishing a coordination mechanism across networks to expedite trials, track incidence across sites and project future capacity
Advance vaccine development by:
Creating a collaborative framework to share insights into natural immunity and vaccine candidate-induced immune response by:
Mapping epitopes and developing assays
Establishing protocols for sampling and immunological analyses and reagents
Collecting clinical data on immunological responses and endpoints, to enable meta-analysis of correlates of protection
Engaging with regulators on surrogate endpoints for clinical evaluation
“This powerful public-private partnership will focus and expedite R&D activities required to combat COVID-19,” says Maria C. Freire, Ph.D., President and Executive Director, FNIH. “Working in lock-step, the public and private sectors will maximize the chances of success and provide a roadmap to pre-emptively manage future threats.”r
With these PPPs, vaccine companies can reach agreements faster, in turn rolling out vaccines faster
Alex Knapp 21 [Alex Knapp is a senior editor covering healthcare, science, and cutting edge technology who joined Forbes in 2011. He has a B.S. in biochemistry from WPI and a J.D. from the University of Kansas School of Law; “Patent Waivers Won’t Impact Big Pharma’s Bottom Line—But Could Slow Covid Vaccine Rollouts”; Forbes; May 7 2021; https://www.forbes.com/sites/alexknapp/2021/05/07/patent-waivers-wont-impact-big-pharmas-bottom-line-but-could-slow-covid-vaccine-rollouts/]//bcp-kk
On Friday, vaccine manufacturer Novavax, which has reached an agreement with the private-public global health partnership Gavi to provid[ing] 1.1 billion vaccine doses to low income countries, stated its opposition to the WTO waiving patents, arguing that it “could further constrain resources by diverting them to entities incapable of manufacturing safe and effective vaccines in the near term.”
2NC – PPP CP – Solves – Empirics
Governments cooperating with private sector business has worked before – COVID shows
Chris Borges 23 [Chris Borges is a program manager and associate fellow with the Geoeconomics Center at the Center for Strategic and International Studies (CSIS). He earned an MA in international science and technology policy from George Washington University and a BA in psychology from the University of Wisconsin-Madison; “TRIPS Waivers and Pharmaceutical Innovation”; CSIS; March 15 2023; https://www.csis.org/blogs/perspectives-innovation/trips-waivers-and-pharmaceutical-innovation]//bcp-kk
Global trends such as climate change, urbanization, and rising meat consumption make future pandemics more likely. It is critical that the United States maintain a dynamic and innovative pharmaceutical industry to combat this threat. Government action, in partnership with private industry, in the early days of the pandemic accelerated the rapid development and scale up of COVID-19 vaccines. Through a myriad of policies such as pre-ordering millions of vaccine doses, Operation Warp Speed expedited the development and roll-out of vaccines by months, saving thousands of lives.
2NC – PPP CP – Say Yes
Corporations want to do PPPs
Martin Lehmann and Julie LaFrance 05 [“Corporate Awakening – Why (Some) Corporations Embrace Public–Private Partnerships”; Research Gate; 07-2005; https://www.researchgate.net/publication/227673722_Corporate_Awakening_-_Why_Some_Corporations_Embrace_Public-Private_Partnerships]//bcp-kk
Predominantly since the 1992 Rio Summit, corporations have been increasingly pursuing partnerships with public institutions including governments, international organizations and NGOs that aim to contribute to sustainable development activities. Partnerships have become more common as corporations react to mounting pressure from corporate stakeholders, civil society and government on the responsible nature of their business practices. The corporate awakening towards a broader role of business in society and the trend of corporations embracing partnerships has led many to question the driving factors that motivate corporations to pursue partnerships. In this paper, the authors examine the underlying drivers of corporate organizational behaviour from the theoretical perspectives of both legitimacy and stakeho

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