Pharma Aff - Georgetown 2024

1ac
Plan
The United States federal government should repeal the march-in provisions of the 1980 Bayh-Dole Act.
Advantage 1 is Innovation
Currently the US leads the world in pharmaceutical innovation, due to its strong patent protections—however the Biden administration asserting latent march-in rights via the Bayh-Dole Act to drive down prices would collapse that innovation.
Damond, Edelman Global Advisory Health Chair, 2024 (Joseph Damond,, 2-6-2024, "Biden’s “march-in” rights threaten long-term innovation in pharmaceuticals and biotech," Edelman Global Advisory, https://www.edelmanglobaladvisory.com/insights/Biden-march-in-rights-threaten-long-term-innovation, DoA 6/8/2024)
When it comes to healthcare, a delicate balance exists between fostering innovation and ensuring patient access to life-saving medicines. The Biden administration recently announced plans to establish new rules broadening its authority to seize patents from pharmaceutical companies for new drugs that have benefitted from publicly financed research. These plans are not only controversial but also raise critical questions about the future of pharmaceutical innovation in the United States.
The US pharmaceutical and biotech sector has long been a global leader in innovative drug development—owing much of its success to a combination of effective life-science policies such as federally funded research grants, robust intellectual property protections, and technology transfer policies. These policies have historically, and effectively, provided companies with incentives to invest in high-risk and costly drug development, which has resulted in countless groundbreaking medical advancements that we benefit from today.
Established as part of the Bayh-Dole Act of 1980, the so-called “march-in” rights allow the government to seize and license a patent stemming from government-funded research should the manufacturer fail to make a drug available to the public under certain circumstances. The law establishing those rules was meant to promote private sector development of government research, and it has helped foster the explosive development of new medicines in past decades. Case in point: no federal agency has utilized “march-in” rights since the passage of Bayh-Dole 43 years ago.
A chief reason that the government has never made use of these rights is because the seizure of patents due to perceived high drug prices raises numerous legal and technical challenges. First, the original legislation makes no mention of prices in its provisions. The National Institutes of Health (NIH) has repeatedly denied petitions to exercise such rights, noting that pricing alone is not sufficient and that it “does not believe that use of the march-in authority would be an effective means of lowering the price.”[1] Second, the lack of clarity on crucial details—such as what constitutes “too high” a drug price, or the complexity of multiple patents protecting a single drug—adds further uncertainty to how these rights could be applied. Third, FDA standards for quality, safety, and efficacy must still apply, which pose logistical challenges for any potential new manufacturer and may introduce delays and additional expenses in the drug development process.
Scenario 1 is AMR
Innovation is key to new antibiotics against AMR.
Davies 6-4 (Professor Dame Sally Davies is UK Special Envoy on Antimicrobial Resistance; Thomas Cueni is Director General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), 6-4-2021, accessed on 6-11-2021, The Telegraph, "The silent pandemic of superbugs could be far deadlier than Covid-19 – we must fix it", https://www.telegraph.co.uk/global-health/science-and-disease/silent-pandemic-superbugs-could-far-deadlier-covid-19-must/)
*Says PASTEUR Acts could solve **Claims we need global action
In 2016, the United States National Security Council drew up a playbook on fighting pandemics so that the next response to an epidemic was better handled than the response to the spread of Ebola. The same year, the G7 put tackling antimicrobial resistance (AMR) on the agenda. Today, the twin global health security threats of viruses and bacteria are very real. Every corner of our health system depends on antibiotics. It’s thanks to antibiotics that illnesses such as pneumonia, meningitis and TB are now treatable. They are used for caesarean sections, routine operations such as arthroscopic knee surgery, and cancer chemotherapy. Worryingly, bacteria mutate, just as viruses do. As a result, increasingly people are dying of diseases where the existing antibiotics did not work. Since 2016, over 3.5 million people have died of a drug-resistant infection. Overuse of antibiotics and declining investment in research for new and novel drugs are the causes of this pandemic hidden in plain sight. Without urgent action, 10 million people globally could die annually as a result of AMR by 2050. The question is, how to make sure that one goes from policy papers, dire projections and simulations to action? In the case of Covid-19, against the odds and in record time, we already have a range of vaccines to protect against the SARS-CoV-2 virus. The speed of the response is thanks to decades of research on vaccine technologies. In contrast, research for new antibiotics that could stave off the worst of AMR has been stuck in the doldrums. And whilst there are exciting signs at the early end of the pipeline, this innovation is primarily happening in small companies without the infrastructure to take a promising product all the way to market. Between 2018 and 2020, four companies that had brought new antibiotics to market declared bankruptcy or put themselves up for sale, despite having survived the perilous, decade-long process of development and testing to get a new drug approved. To give a boost to the antibiotics pipeline, the AMR Action Fund has been created to develop two to four new antibiotics by 2030, thanks to close to $US 1 billion from pharmaceutical companies, topped up with support from the European Investment Bank and the Wellcome Trust. To ensure there is a healthy pipeline of antibiotics that keep up with bacteria’s natural evolution to build resistance, we need more than a fund to boost innovation. Once new antibiotics are approved, they need to be used sparingly to preserve effectiveness and slow the development of further resistance. While this makes sense for public health, it doesn’t support the level of investment needed to maintain a robust antibiotic pipeline. Despite the huge societal costs of AMR, our health care systems are not currently designed to recognise the value of new antibiotics. We need adapted market-based policy reforms, including reimbursement reform and new ‘pull’ incentives to create market conditions that enable sustainable investment in antibiotic R&D. We need industry to fully recognise the insurance value that antibiotics provide them. We need healthcare systems to pay their ‘fair share’ for innovation. And most of all, we need governments, researchers and life sciences companies to work together, to put patient needs at the forefront. Some governments have started to take decisive action to revitalise the antibiotics market. The United Kingdom NHS’s ‘Netflix’ model to value antibiotics differently and pay for them by subscription rather than per pill has been designed to empower the health service in England to keep watch over antibiotic use whilst also encouraging investment in developing the new treatments we all need. It is a positive example of what can emerge from collaborative dialogue between government, clinicians and industry. In the United States, the PASTEUR Act that is currently before Congress should create a predictable path to rewarding new antibiotics for their value to society via a subscription contract (valued at $750m to $3bn) that prepays for all US federal use of the drug. This would be a delinked pull incentive that is large enough to move the R&D needle, with powerful support for antibiotic stewardship. More generally, the global community is also moving to take action on AMR – 135 countries have finalised national action plans, but they must be fully funded and implemented. These are good actions and are pointing us in the right direction. But, if Covid-19 has taught us something, it is that global health security, as the name implies, needs to be truly global. As the G7 Health Ministers meet, it is crucial that they give AMR a last push and agree global action to strengthen research and development for new antibiotics, once and for all. Let us not fall into the trap of tunnel vision and squander the opportunity that we have been building up to over the past seven years, to fix this silent pandemic of AMR, which otherwise could have consequences far more deadly than Covid-19.
AMR is an existential threat, nonlinear, and has an invisible tipping point—its systematically ignored by pharma now.
Silverman ’16 (Rachel Silverman – MPhil with Distinction in Public Health @ the University of Cambridge, Senior Policy Analyst and Assistant Director of Global Health Policy @ the Center for Global Development, focusing on global health financing and incentive structures, “Confronting Antimicrobial Resistance: Can We Get to Collective Action?” 19 April 2016, https://www.cgdev.org/blog/confronting-antimicrobial-resistance-can-we-get-collective-action)
Antimicrobial resistance is already causing huge harm – and the worst is yet to come.To open the panel, Dr. Chan issued a serious warning about the size and scope of the AMR threat: “everyone will be affected if we do not address this problem.” AMR is already responsible for an estimated 700,000 global deaths each year, 50,000 of which take place in the US and Europe. Extensively drug-resistant (XDR) tuberculosis—cases where the most effective first- and second-line drugs are rendered useless—infected an estimated 47,000 people worldwide in 2014, only one ‘last-line’ antimicrobial is available to reliably treat gonorrhea, and few new antimicrobial drugs are in the development pipeline. According to the latest review, AMR could cause 10 million deaths each year by 2050, with knock-on effects draining many trillions from the global economy. Summers suggested that AMR and potential pandemics, alongside climate change and nuclear proliferation, represent the top three existential threats to life on earth as we know it. And as Dr. Chan explained, the worst-case scenario implies the end of modern medicine as we know it. Even worse, Summers suggested that AMR seems like a “quintessential non-linear phenomenon, and therefore more dangerous.” Year by year the effects are small and mostly invisible. But at some point in the future they could suddenly become catastrophic, like a “levee that doesn’t hold and unleashes a flood.” Dr. Chan concurred that “the tipping point is not predictable because…microbes are invisible. We don’t even know when they’re going to make the switch” to become resistant to existing drugs. Antimicrobial efficacy is a global public good threatened by serious market failures. In response to this huge threat, why don’t pharmaceutical companies invest in new antibiotics? “It does not pay” for them to do so, explained Osborne. Pharmaceutical companies want to invest in technologies that will make a lot of money, and soon; so long as other antibiotics remain effective, the market for new options will be tiny and unprofitable.
The next pandemic will cause extinction—now is key to capturing momentum from COVID before it’s lost—SARS proves that pharma will abandon efforts now.
Plump 5-18 (Andy Plump is the president for research and development at Takeda Pharmaceuticals and a cofounder of the Covid R&D Alliance. 5-18-2021, accessed on 6-12-2021, STAT, "The world needs to start preparing now for the next pandemic", https://www.statnews.com/2021/05/18/luck-is-not-a-strategy-the-world-needs-to-start-preparing-now-for-the-next-pandemic/)
As countries grapple with the worst global pandemic in a century, it’s hard to think about preparing for the next one. But if we don’t, it could be worse than Covid-19. Over the last 30 years, infectious disease outbreaks have emerged with alarming regularity. The World Health Organization lists an influenza pandemic and other high-threat viral diseases such as Ebola and dengue among the top 10 biggest threats to public health. The rate of animal-to-human transmission of viruses has been increasing, with the U.S. Centers for Disease Control and Prevention estimating that 75% of new infectious diseases in humans come from animals. These zoonotic infections can have profound effects on human life. The overall infection fatality rate is around 10% for severe acute respiratory syndrome (SARS), between 40% and 75% for Nipah virus, and as high as 88% for Ebola. While the infection fatality rate for Covid-19 is lower — likely less than 1% — the overall burden of death has been significantly higher since it has affected so many people, more than 160 million people as I write this. Luck is not a pandemic strategy Although the Covid-19 pandemic has been a human and health care disaster, by scientific measures the world was lucky this time. Covid-19 was far less lethal than its predecessors, less contagious than previous pandemic viruses, and we were able to quickly develop a cadre of effective vaccines. But luck is not a strategy. The same way the U.S. invests in and prepares for national defense, it must also prepare for another pandemic. Though the next viral outbreak cannot be prevented, the next pandemic can — but only with better preparation. There is no doubt that the global pharmaceutical industry, governments, nongovernmental organizations, and health care systems should have been better prepared for Covid-19 in part because the coronavirus that causes it, known as SARS-CoV-2, is closely related to other coronaviruses, particularly the one that caused the outbreak of SARS in 2003. In fact, coronavirus core proteins often share upward of 95% of their nucleic acid or protein sequences due to their close origins. In some cases, their active sites — the pockets to which antiviral therapies bind — are 100% identical. In short, coronaviruses are highly related, and where it counts they share complete or near complete identity. Had the drug discovery efforts initiated during the 2003 SARS epidemic been continued and come to fruition, antiviral medications to treat Covid-19 would have been on the shelf to help contain the pandemic, or at least better treat Covid-19 patients. Unfortunately, those efforts were abandoned once SARS seemed under control because there was no apparent market and no infrastructure to support ongoing research. The response to Covid-19 — if it can be sustained — suggests hope for the future and a springboard for preparedness, especially immediate and ongoing collaborations across the biopharmaceutical industry, academia, and government. Walls came down. Collaboration flourished. A tremendous amount of good science was conducted in diagnostics and clinical management, and the world witnessed spectacular efforts in vaccine development. The urgency of the crisis and the speed of drug development led the biopharmaceutical industry and governmental bodies to work in concert, streamlining regulatory processes in ways that must continue moving forward once the coronavirus crisis ends. Rethinking traditional practices is essential to pandemic preparedness, which must be approached with the same mindset as countries approach defense, with the goal of establishing a unified global bulwark against future disease outbreaks. Establish and fund infrastructure for collaboration Global health crises require organized structures and leadership. Governments and the biopharma industry need to create and coordinate a joint pandemic preparedness ecosystem. Such a structure would help governments, industry, academia, and others focus on their respective strengths for greater efficiency, partnerships, and preemptive research. Related: Real-time gene sequencing can help control — and may someday prevent — pandemics In March 2020, two dozen R&D leaders from the world’s leading biopharma companies, including my company, Takeda, came together to form the Covid R&D Alliance. It is showing that this type of industry collaboration is possible by rapidly assembling and coordinating therapeutic responses to the pandemic. At the national and international levels, this alliance and others are beginning to undertake early work to get ahead of drug development in advance of the next pandemic. But this effort must quickly be solidified before momentum and motivation are lost. The massive human suffering and economic impact of Covid-19 underscore the significant investment that must be made for future preparedness. Dedicated public and private funding of such an effort would demonstrate a commitment to global health care and create a defense against future pandemics that is founded on science and independent from political rhetoric. Identify leading threats and identify therapies for them The perpetrators of the next pandemic will likely come from the coronavirus or influenza families. Other possible culprits include flaviviruses such as the West Nile virus, filoviruses such as the Ebola virus, and alphaviruses known to associate with a number of human encephalitis diseases. Using a list like this to guide its work, the biopharmaceutical industry needs to begin creating an arsenal of antiviral molecules. Given the impossibility of predicting the future, it will be important to focus on broadly active compounds where possible, and virus-specific compounds to fill in gaps. In the coronavirus family, for example, SARS-CoV-2 is similar in structure to the 2003 SARS virus, and the virus that causes Middle East respiratory syndrome is only slightly different. It should be possible to develop a single antiviral molecule to be effective against all three. If a three-fer isn’t possible, then specific therapies should be developed for each potential pathogen. All therapeutic candidates should be evaluated against diverse viral strains as markers of future potential efficacy in future epidemics. There is no business model for preparing for a future pandemic. Without specific catalysts, interest in preparing for this unknown is likely to wane as Covid-19 comes under control. Whether it’s because businesses are thinking of investors, media, academia, or other audiences, the tendency is to go where the spotlight is shining — which would be a disaster for pandemic preparedness. What’s needed is a competitive environment to stimulate innovation. But without an established or obvious market, the necessary investment and entrepreneurism won’t materialize. Enabling future pandemic therapeutic preparedness will require establishing a novel, collaborative ecosystem in which biopharma companies, nongovernmental organizations, governments, academia, and other stakeholders are able to share information and coordinate areas of focus to maximize the collective efforts. The success of the whole will depend on the willingness and success of each individual piece. To prepare for the next viral pandemic, governments and nongovernmental organizations need to focus on preparing health care infrastructure and viral surveillance to predict the next outbreak. At the same time, academia and the pharmaceutical industry must focus on drug discovery, particularly antiviral therapies. These efforts must seamlessly interface. To enable future preparedness, the biopharmaceutical industry should leverage the ways of working that emerged during Covid-19 that included sharing assays, models, and data while concurrently focusing on competitive innovation. With the right level of coordination, and without massive resources, an arsenal of antiviral molecules can be created and tested on he

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