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[James, 7-21-2024, Newsweek, “Kamala Harris Can Beat Donald Trump With This Running Mate, Polls Suggest,” https://www.newsweek.com/kamala-harris-chances-vs-donald-trump-according-polls-1927944, accessed 7-21-2024, CM]

Concern over the age and mental agility of 81-year-old Biden erupted in the aftermath of the first presidential debate on June 27, during which the president appeared at several points to lose his train of thought mid-sentence. In the weeks that followed a growing number of prominent Democrats, including lawmakers and actor George Clooney, urged Biden to step aside from the race so his party can select another nominee.

[Christian, 7-21-2024, The Hill, “Does Kamala Harris give Democrats a better chance to win?,” https://www.vox.com/2024-elections/361750/biden-drop-out-harris-endorse-polls-against-trump-democrats-dnc, accessed 7-21-2024, CM]

Harris backers have plenty to point to in the aftermath of June’s presidential debate.

[Mark, 7/21/2024, NBC news, “How Kamala Harris fares against Trump in the 2024 polls”, https://www.nbcnews.com/politics/2024-election/kamala-harris-trump-2024-polls-biden-rcna162934, accessed 7/21/2024, LR]

With President Joe Biden exiting the 2024 presidential race, Vice President Kamala Harris now becomes the overwhelming front-runner to be the Democratic Party’s presidential nominee.

[Rachel, 7/21/2024, Newsweek, “Democrats' Strongest Candidate Against Donald Trump, According to Polls”, https://www.newsweek.com/donald-trump-kamala-harris-2024-election-democrats-polls-1928185, accessed 7/21/2024, LR]

After President Joe Biden dropped out of the 2024 presidential race on Sunday afternoon, he endorsed Vice President Kamala Harris, who, according to recent polling data, is the strongest candidate to take on former President Donald Trump.

[Julia Mueller, ‘The Hill’ staff writer, 7-21-24, “Harris vs. Trump: What the polls tell us,” https://thehill.com/homenews/campaign/4785009-kamala-harris-polls-donald-trump/, 7-21-24, EP]

Harris is also “the easiest one” among the prominent Democrats being floated for the hypothetical nominee to slide into Biden’s place, given the mechanics of the process, Tranter said.

[Sarah & Rachel Cohrs, 7-21-24, STAT, “Harris health care agenda swiftly hailed by progressives and reproductive rights groups”, , accessed: 7-21-24, AngH]

While some progressive biotech entrepreneurs and health care venture capitalists were willing to endorse Harris, others withheld their views. Some health care analysts worried about the uncertainty the upheaval in the presidential race could create.

(Daryl, 2024, Arms Control Association, “Nuclear Dangers and the 2024 Election”, https://www.armscontrol.org/act/2024-01/focus/nuclear-dangers-2024-election)

As the new year begins, the existential risks posed by nuclear weapons continue to grow. A crucial factor in whether one or more of today’s nuclear challenges erupt into full-scale crisis, unravel the nonproliferation system, or worse will be the outcome of the U.S. presidential election.

[Saurabh, 7-21-24, Politico Magazine, “15 Experts Predict What Biden’s Dropout Means for the 2024 Election”, , Accessed 7-21-24, AMH]

I never thought Joe Biden would step down, because everyone who could force him to do so from his staff to the DNC rules committee were heavily incentivized for him to stay at the top of the ticket. The one exception was the donors. It’s no coincidence that Biden’s resignation announcement came the day after FEC records showed a disastrous drop in donations to the Biden campaign, especially compared to President Trump’s.

[Jennifer, 7/21/2024, The Washington Post, “How a Harris presidential campaign would transform the race”, https://www.washingtonpost.com/opinions/2024/07/21/kamala-harris-campaign-2024-biden/?utm_campaign=wp_for_you&utm_medium=email&utm_source=newsletter&wpisrc=nl_personalizedforyou&utm_content=readinghistory__position4, accessed 7/21/2024, LR]

So let’s assume that Harris would head the ticket. What then? She could make this a very different race in multiple ways.

By European standards, Biden’s actions are moderate. Most countries negotiate the price of drugs purchased by public health systems. While drug prices are still high across Europe, putting severe strain on overburdened health systems, they are a fraction of the price paid by Americans. What makes Biden’s action so significant is precisely that, up to now, Big Pharma has always had the upper hand in the US, using its power to extract whatever profits it likes from the American public. Despite the unpopularity of the industry, only a few brave politicians would stand up to it.

What’s changed? First, it’s difficult to overstate the impact of the so-called “opioid crisis” on American society. Hundreds of thousands of Americans have died from opioid overdoses. The real scandal is that the major contributor to this epidemic was a drug company called Purdue Pharma, which spent years pushing an opioid called OxyContin on patients. The drug is so strong and addictive that it shouldn’t be prescribed for any but the most serious, end-of-life, pain. But Purdue spent a fortune cajoling doctors into prescribing the drug for even moderate pain, pretending there was little chance of getting hooked. The levels of addiction and death that followed hollowed out whole towns, as can be seen in the recent dramatisation by Netflix, Painkiller.

Katherine, October 9, 2021, ‘The Guardian, How biodiversity loss is jeopardising the drugs of the future’, https://www.theguardian.com/environment/2021/oct/09/how-biodiversity-loss-is-jeopardising-the-drugs-of-the-future, Accessed July 16, 2024, CT

Traditionally used as a painkiller for headaches, snowdrops are now known to slow the onset of dementia. In the 1950s, a natural alkaloid called galantamine was extracted from the bulbs. Today, a synthesised version of this is used to treat Alzheimer’s disease and scientists are investigating further to see if snowdrops might also be effective in the treatment of HIV.

The transmission–virulence trade-off hypothesis posits that from an evolutionary point of view, it is not beneficial for the pathogen to kill its host before being passed to another host. In this regard, it is similar to the avirulence hypothesis. However, the replication of the pathogen within the host causes some inevitable damage to the host. Thus, an increase in the number of pathogens increases both transmission and virulence. Both replication and transmission require a living and, in many cases, active host. If the host is dead, it can no longer help the reproduction of the pathogen, nor can the host take an active part in transmitting it. High virulence is detrimental to the pathogen, and so it is bound to evolve to a lower level of virulence to better spread. In plain words, if a pathogen causes its host to lay in bed or even to die instead of happily going around and transmitting the infection, it will be outcompeted by mutants that cause less damage to the host and allows it to produce more pathogens and infect other hosts. This is the verbal description of the transmission–virulence trade-off.

While Big Pharma is ripping off Americans, and breaking health systems across Europe, it’s also failing to provide the medicines people across the world most need. The search for goldmine drugs means research into diseases suffered by less wealthy people, in less wealthy countries, takes a back seat. So does research into potentially catastrophic epidemics or new-generation antibiotics. Even though antibiotic resistance is likely to lead to tens of millions of deaths a year in coming decades, it’s simply not profitable enough for corporations used to making eye-watering returns.

For two decades, the US government barred Medicare from negotiating drug prices. At the same time, drug companies have gamed the patent system to prevent competitors from selling lower-cost generic versions of their products. Meanwhile, for decades drugmakers’ congressional allies blocked legislation designed to help pharmacists and wholesalers import medicines at lower world-market prices and sell them at discounted rates in the United States.

The end result: Americans pay the highest prices per capita among residents of wealthy countries for prescription drugs — even though the American public subsidizes research and development (R&D) costs on essentially every drug approved for sale in the United States.

We want innovation, we want research and development to address many of the terrible illnesses which are afflicting the American people today, whether it is cancer or Alzheimer's or heart disease. But in instance after instance, what you find is that despite what they say, these companies put more money in stock buybacks and dividends to their shareholders than they do into research and development.

Even when you talk about what we refer to as “research and development,” the average person might assume that they're working on Alzheimer's or cancer. Sometimes they are, but often they’re not. They are also working on what we call “me-too” drugs, which are modest modifications of existing drugs so they can get a new patent to extend their monopoly. So it's not all that it seems to be.

Drug discovery and development is a long, costly, and high-risk process that takes over 10 to 15 years with an average cost of over $1 to $2 billion for each new drug to be approved for clinical use.

For any pharmaceutical company or academic institution, it is a big achievement to advance a drug candidate to phase 1 clinical trials after drug candidates are rigorously optimized at the preclinical stage. However, nine out of ten drug candidates would fail during phase 1, 2, 3 clinical trials and drug approval.

Traditional knowledge is disappearing at a rapid rate.27 Research conducted from 2000-2009 found that traditional knowledge from an Amazonian community was being lost at a rate that ranged from 9% to 26% with most of the loss happening 17. Intellectual Property and Bioprospecting, supra note 5, at 268 (defining “Preliminary hit”) (“[T]he compound that is selected from a large number of compounds because of either its phenotype or process which is relevant for the disease being researched.”). 18. Intellectual Property and Bioprospecting, supra note 5, at 268; Daniel S. Fabricant & Norman R. Farnsworth, The Value of Plants Used in Traditional Medicine for Drug Discovery, 109 ENV’T HEALTH PERSPS. 69, 72 (2001). 19. Intellectual Property and Bioprospecting, supra note 5, at 268. 20. Patents, Disclosure, and Biopiracy, supra note 15, at 550. 21. Intellectual Property and Bioprospecting, supra note 5, at 268. 22. Id. at 269. 23. Id. 24. Id. 25. Id. 26. See id. 27. Id. at 261. 221104 Soto Macro.docx (Do Not Delete) 3/21/2023 11:42 AM 2022] Piracy by Patents 487 in communities living closer to cities.28 As urbanization of rural communities increases, the rate at which traditional knowledge disappears will also increase.29 Two major reasons traditional knowledge is being lost at this rate: the use of oral transmission, instead of written documentation, among indigenous peoples and local communities, and the protectionist trend which restricts access to traditional knowledge. 30 Almost 200 countries have agreed to increase access to traditional knowledge and genetic resources by signing the Convention on Biological Diversity (CBD).31 However, in response to the absence of legal protection for traditional knowledge in other nations, megadiverse countries are participating in a protectionist trend.32 The rising protectionist trend in megadiverse countries limits access to the traditional knowledge that has proven to be valuable for biopharmaceutical research.33 An increase in restrictions will decrease opportunities to collaborate in bioprospecting and will slow down innovation because megadiverse countries make up almost 70% of the world’s diversity.34 If the protectionist trend continues, it will be difficult to maintain bioprospecting relationships with megadiverse countries.35 This trend would be less problematic if the restrictive measures of the megadiverse countries would lead to the creation of new products based on their own traditional knowledge.36 These countries, however, usually do not have the capacity to use their traditional knowledge to create and produce new products.37 By failing to protect traditional knowledge, the United States is making it more challenging for its researchers to access essential resources in biodiverse countries.38

[Yuqin, Winter 2011, Transnational Law & Contemporary Problems, “Necessity: Enacting Laws to Protect Indigenous Intellectual Property Rights in the United States”, vol. 19, no.¶ 3, pg. 954-956, Heinonline, accessed 6/29/2024, LR]

B. Modern Patent Law Theories as a Basis for Indigenous IP Law

If the goal of protecting traditional medical knowledge is to allow Indigenous¶ communities to engage with the greater scientific community to leverage that¶ knowledge to benefit their communities, then discussing how academic scientists¶ and pharmaceutical companies use traditional medical knowledge is beneficial.¶ Such a discussion could also dispel arguments that protecting traditional medical¶ knowledge would unreasonably impede scientific research. Traditional medical¶ knowledge is often used as inspiration for new research projects or clues to solve¶ research questions.

95 Protecting traditional medical knowledge would not foreclose¶ any use of the knowledge in scientific research, just unauthorized uses.¶ 96 Scientists¶ would only need to obtain licenses or other permission to use the knowledge, just¶ like any other protected intellectual property they may wish to use.97

The United States spends $45 billion annually on the National Institutes of Health (NIH), which in turn goes to fund new drug research. Every drug that the US Food and Drug Administration (FDA) approved for sale between 2010 and 2019 benefited from research funded by the NIH, according to a 2020 study from the Institute for New Economic Thinking.

Because the United States so heavily subsidizes R&D, reducing profits on top drugs by 15 to 25 percent would have a negligible effect on the number of new drugs introduced over the next decade, according to a 2021 study from the federal, nonpartisan Congressional Budget Office.