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The pharmaceutical industry is responsible for the research, development, production, and distribution of medications. The market has experienced significant growth during the past two decades, and pharma revenues worldwide totaled 1.48 trillion U.S. dollars in 2022.

Top pharmaceutical companies

[Michael, 07/16/2024, PharmaVoice, “Has pharma emerged from the ‘age of uncertainty’?,” https://www.pharmavoice.com/news/pharma-blockbuster-obesity-glp1-biotech-market/721386/#:~:text=Following%20the%20COVID%2D19%20pandemic,the%20face%20of%20unknown%20risks., accessed:07/17/2024, shl]

After years of disquiet and unpredictability in the pharma markets, a new age of megablockbusters, normalized M&A and more clarity around the Inflation Reduction Act has emerged, bringing the industry’s trajectory into better focus.

[Maia, 07/11/2024, Healthcare Brew,“Why private equity investors are going all in on the pharma services sector,”, https://www.healthcare-brew.com/stories/2024/07/11/why-private-equity-investors-are-going-all-in-on-the-pharma-services-sector, accessed: 07/16/2024, shl]

Private equity (PE) investors have long poured money into the healthcare industry, commonly investing in physician practices and hospitals. But in the past couple of years, a new sector is gaining momentum among investors: pharma services.

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.

The Commonwealth Fund recently published a report that compares prices for those first ten drugs in the United States with those in Australia, Canada, France, Germany, Japan, Switzerland, and the United Kingdom—all of which have government price caps. Sanders and his allies will surely point to this report, as it finds that those ten drugs cost three times as much here as they do in our seven peer countries.

But one of the costs of price caps is a lengthy wait for access. Just three of the ten medicines, on average, were available in the seven comparator countries within a year of their launch.

Newly emerging and reemerging infectious viral diseases have threatened humanity throughout history. Several interlaced and synergistic factors including demographic trends and high-density urbanization, modernization favoring high mobility of people by all modes of transportation, large gatherings, altered human behaviors, environmental changes with modification of ecosystems and inadequate global public health mechanisms have accelerated both the emergence and spread of animal viruses as existential human threats. In 1918, at the time of the ‘Spanish flu’, the world population was estimated at 1.8 billion. It is projected to reach 9.9 billion by 2050, an increase of more than 25% from the current 2020 population of 7.8 billion (https://www.worldometers.info). The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) responsible for the coronavirus disease 2019 (COVID-19) pandemic1,2,3 engulfed the entire world in less than 6 months, with high mortality in the elderly and those with associated comorbidities. The pandemic has severely disrupted the world economy. Short of lockdowns, the only means of control have been limited to series of mitigation measures such as self-distancing, wearing masks, travel restrictions and avoiding gatherings, all imperfect and constraining. Now with more than 100 million people infected and more than 2 million deaths, it seems that the addition of vaccine(s) to existing countermeasures holds the best hope for pandemic control. Taken together, these reasons compel researchers and policymakers to be vigilant, reexamine the approach to surveillance and management of emerging infectious disease threats, and revisit global mechanisms for the control of pandemic disease4,5.

Emerging and reemerging infectious diseases

[John K. Reid, Special Projects/Technology Editor, 3rd year Oklahoma College of Law student, 1-1-2009, American Indian Law Review, Volume 34, Number 1, “Biopiracy: The Struggle for Traditional Knowledge Rights,” https://digitalcommons.law.ou.edu/cgi/viewcontent.cgi?article=1121&context=ailr, 6-30-24, EP]

Offering greater protection may force companies to contract and give Indigenous peoples further bargaining power during contract negotiations. Anything that limits pharmaceutical companies' rights to resources, however, has the potential to limit drug development. With past contracts, availability of resources did not always mean results. Merck's contract with Costa Rica did not yield any new drugs. Shaman's contracts did yield a few medical developments, but they did so at such a cost that Shaman ended up in bankruptcy. The more control indigenous peoples have over these resources, the more expensive access to them will become, leading to a decrease in development. 

The advancements mentioned by Kaylor and Salib highlight the remarkable progress made in the life sciences and pharmaceutical industry, with significant advancements in cell and gene therapy, targeted oncology treatments, and male birth control options.

These developments can transform medical treatment, improve patient outcomes, and promote shared responsibility in reproductive health. However, it is crucial to acknowledge the ongoing challenges — including the need for equitable access to these groundbreaking treatments and therapies — and address the cost and availability of these innovations to ensure that they benefit all individuals who could benefit from them.

The U.S. Supreme Court has precedents going back to 1792 against issuing advisory opinions to help us interpret its decisions. However, the Roberts court has shown no obligation to precedent. It should break this one to explain its ruling on presidential immunity in Trump v. United States. As it stands, the ruling causes enormous confusion over the nation’s most fundamental laws and principles, with little guidance on how courts and juries should apply it. Now, if an ex-president breaks the law while in office, they must decide on a case-by-case basis whether he or she is immune to prosecution. The decision raises enough questions to occupy lawyers, scholars, the judiciary, presidential ethics experts and the Supreme Court itself for years to come. It will fill the high court’s docket with appeals. The best outcome would be for a future court to reverse it. But in the meantime, the current justices owe us a more detailed explanation of their ruling and much better guidance on how they expect it to be applied. Writing for the majority, Chief Justice John Roberts described three categories of presidential actions: those clearly within the president’s official constitutional and statutory duties; those on the “outer perimeter” of those duties; and those that are private acts. Presidents have absolute immunity in the first category, qualified immunity in the second, and no immunity in the third. Roberts acknowledged that this “raises multiple unprecedented and momentous questions about the powers of the president and the limits of his authority under the Constitution,” and that “Distinguishing the president’s official actions from his unofficial ones can be difficult.” For guidance, he offered two principles, both questionable. First, “courts may not inquire into the president’s motives” because that would be “highly intrusive.” Yet motives have everything to do with whether a president’s acts are personal or official. Stripped of motive, Donald Trump’s speech to supporters on Jan. 6, 2021, was simply a president using his bully pulpit. But if his motive was to incite an insurrection and prevent the constitutional transfer of power, that would seem a private act for personal gain. Roberts’s second principle is that courts can’t rule that an action was unofficial merely because it violated a law. In other words, presidents can escape prosecution for lawbreaking simply by arguing that the potential infraction was an official act, which Roberts acknowledges is difficult to determine. The court has ample reason here to break its tradition against advisory opinions. Candidate Trump, the far-right’s instructions to him through Project 25, and MAGA members of Congress describe a wide variety of actions Trump should take if he wins back the White House. Many would violate presidential norms or appear to violate federal laws or the Constitution. It would be most useful to lower courts — and preemptive for future presidents — if the Supreme Court were to go down the list of these threats and suggest whether a president could be immune from prosecution for each. For example: Can a president violate the constitutional rights of his adversaries or ordinary citizens whose views he doesn’t like? The Constitution guarantees the rights of speech and assembly. Trump’s aides have urged him to invoke the Insurrection Act and deploy the military against demonstrators. During a June 1, 2020, talk on law and order, Trump said he was an “ally of all peaceful protesters. Minutes later, Washington D.C. police used tear gas as Park Police and the Secret Service needlessly broke up a peaceful protest of citizens exercising their rights of speech and assembly at Washington’s Lafayette Park. If this occurred to facilitate a Trump photo-op, as some asserted at the time, would this deprivation of First Amendment rights have been an official act deserving immunity? Ordinary citizens can be prosecuted for unprotected speech in which they slander other people to ruin their reputations, incite violence, or level “true threats” against opponents. If Trump were president, would he be immune from liability for using his bully pulpit for that kind of speech? Trump’s conviction for defaming E. Jean Carroll suggests not. Trump threatens to use the Justice Department to prosecute his enemies. However, a previous Supreme Court ruled in 1994 that the Fourth Amendment prohibits malicious prosecution. Can a president order it anyway? Can he be held accountable if he does? When the U.S. is a formal party to an international treaty, its commitments have the force of domestic law. Can a president violate or ignore those commitments with impunity? Can a president order the U.S. military to commit war crimes or crimes against humanity? Trump proposes to impound federal funds appropriated by Congress, as when he tried to coerce the president of Ukraine to dig up dirt on Joe Biden. Do presidents have the authority to violate the separation of powers? In 2022, referring to his false claim that the 2020 election was fraudulent, Trump wrote on Truth Social, “A Massive Fraud of this type and magnitude allows for the termination of all rules, regulations, and articles, even those found in the Constitution.” Does a president have that power? The immunity ruling could come back to bite the conservatives and MAGA groups who are praising it. Could a future president who wanted to prevent more mass shootings order the confiscation of all privately owned firearms? After all, presidents are obligated by the Constitution to “make sure that the laws are faithfully executed.” The Roberts court has produced several rulings that are stiff competition, but Trump v. United States will likely go down in history as the most dangerous and ill-considered ever issued by a U.S. Supreme Court. An advisory opinion won’t redeem it, but maybe the ruling would look less like a license for future presidents to impose tyranny upon our constitutional democracy.

The Roberts Court has continuously been overturning precedent, potentially causing chaos in the lower court levels.

Democrats in Congress have been developing proposals for the reform of the Supreme Court for years—and this week, we learned that President Joe Biden is warming to the idea. Although a series of controversial cases recently decided by the Court has given new impetus to this movement, the need for an overhaul lies less in the rulings’ seeming rightward swing and more in the pretexts the justices have used to reach them. The Court’s reasoning is becoming more and more incoherent as the conservative majority tosses aside even its own recent jurisprudence in order to serve ideological dogma. This month’s Supreme Court decision granting presidents at least presumptive immunity from criminal prosecution for much of what they do in office is a case in point. It seems reasonable on its face: A democracy can hardly function if the Justice Department is free to prosecute a former president for executing policies that some successor happens to dislike. Read as an effort to ward off such a scenario, the concept is sound—but the details choke it. How is a prosecutor to distinguish “official from unofficial actions,” the opinion wonders, before offering guidance for answering that question. To the dismay of Donald Trump’s critics as well as many historians and legal scholars, the Court staked out expansive boundaries for the “official” category. The ruling’s generosity runs entirely counter to a separate body of jurisprudence stemming from a series of cases on public corruption. There, the Court clearly defined what counts as an official act and what does not. The answer? Not much makes the grade. If that precedent were respected, no item listed in the federal indictment of former President Trump for trying to reverse the outcome of the 2020 election would qualify as an official act. But the only way the Roberts Court could achieve its objective of erecting a shield around the nation’s chief executive was to contradict its own rationale for shielding a state’s chief executive. Eight years ago, Chief Justice John Roberts signed the opinion in McDonnell v. United States,a decision that was stunning for its unanimity as much as for its content. It overturned the jury conviction, upheld on appeal, of a former Virginia governor for corruption. Governor Bob McDonnell had accepted some $175,000 worth of loans, cash handouts, and presents from Jonnie Williams, a businessman who dabbled in repurposing tobacco for supposedly benign products. In return for his money and bling, this would-be pharmaceutical executive wanted McDonnell to induce Virginia state universities to conduct clinical trials on a tobacco-based formula with a view to obtaining FDA approval. At the very least, Williams hoped that McDonnell could get the pills, which he claimed could treat inflammation, covered under the Virginia government employees’ health plan. Proving bribery under U.S. laws, which have defined the act more and more narrowly over the past several decades, is not easy. You have to tie the briber’s gifts directly to something the public official does in return. Such an explicit quid pro quo transaction represents a tiny subset of the clever ways that well-heeled individuals and corporations make it worth an official’s while to further their interests. Still, in the McDonnell case, prosecutors met the standard. They satisfied the jury that the quidand the quowere closely connected in the governor’s mind. For example, according to time stamps on emails, only minutes elapsed from when McDonnell checked with his benefactor about a promised $50,000 loan to when he asked his chief counsel to join him on devising strategies for clearing obstacles to the clinical trials Williams wanted. Jurors and appellate-court judges had no doubt, in other words, that McDonnell had leveraged his position as governor to help Williams. But such help qualifies as part of a quid pro quounder the federal bribery statute only if the steps the officeholder takes to fulfill his side of the bargain are “official acts.” So, just like Trump v. United States, McDonnell hinged on which acts count as official. Overturning two lower-court rulings, a unanimous Supreme Court decided in 2016 that none of the ways prosecutors showed McDonnell helping Williams counted as an official act. McDonnell’s activities deemed not to be official included: instructing his subordinates to meet with and listen favorably to Williams, having his staff organize a gala event at the governor’s mansion aimed at persuading state-university researchers to conduct clinical trials, and leaning on subordinates to make the decisions Williams wanted. “To qualify as an ‘official act,’” Roberts spelled out, “the public official must make a decision or take an action on” a matter that “must involve a formal exercise of governmental power”—a lawsuit, for example, or a determination before an agency. Although “using [an] official position to exert pressure on another official to perform an ‘official act’” is an official act in its own right, “simply expressing support” does not equate to such pressure, according to this interpretation. What are the implications of this McDonnell precedent for U.S. presidents? The August 2023 indictment of Trump for conspiracy to defraud the United States (among other counts) includes a list of actions that the then-president and his alleged co-conspirators took to further their objectives. According to prosecutors, the president and his associates tried to “get state legislators and elections officials to subvert the legitimate election results,” and they discussed opening investigations with Justice Department officials and options for blocking certification proceedings with then–Vice President Mike Pence and members of Congress. To use Roberts’s own words, the co-defendants were “simply expressing support” for a course of action in calls and meetings with other officials. Under McDonnell,that activity is ordinary political practice and does not amount to deciding anything or even using governmental authority to pressure those officials to do anything. The defendants also organized meetings of fraudulent state electors that, in the words of this month’s ruling, were allegedly “attempting to mimic the procedures” that real electors follow. But according to the McDonnell decision, “setting up a meeting” or “hosting an event” does not equate to “a formal exercise of governmental authority” or “qualify as an ‘official act.’” Americans who believe that their president should be subject to the same laws as they are might reasonably take heart. Lower courts that are now charged with making specific determinations on each of Trump’s actions should be free to apply the same standards of official conduct that the Supreme Court laid out in McDonnell. The recent immunity ruling would still have the effect of stalling the January 6 case, but at least it would not serve as an invitation to Trump, if he is reelected, to behave even more egregiously in the future. But that world of logical consistency is not the one that the Roberts Court has fashioned. Nothing in its recent history, or in the text of the Trump opinion itself, suggests that the majority has that much respect for its own prior work. Instead, Roberts has ignored, even contradicted, the precedent that he himself authored. In his guidance on how to tell official and unofficial acts apart, for example, he instructs lower courts not to “deem an action unofficial merely because it allegedly violates a generally applicable law.” That is, a decision or an order may be illegal, but it still enjoys presumptive immunity. The exceptions to McDonnell continue. Trump, Roberts writes, met with “senior Justice Department and White House officials to discuss investigating purported election fraud.” Yet those discussions with subordinate officials are no longer considered informal chitchat, as they are under McDonnell: Even though no “decision or action” is taken on a matter resembling a determination before an agency, “Trump is absolutely immune from prosecution for the alleged conduct involving his discussions with Justice Department officials.” As for discussions with Vice President Pence in which Trump expressed support for obstructing the congressional certification of the 2020 election, the former president enjoys “presumptive immunity.” The slightly weaker formulation is due only to Pence’s alternate role in that context as president of the Senate, answerable to another branch of government, rather than as a subordinate to the chief executive. The same inconsistency applies to Trump’s interactions with state officials and private citizens. Under McDonnell, such conversations—none of which reached the level of a decision or a formal action—are unofficial. But again, the Roberts Court reverses its prior determination, saying that each exchange must be examined for potential connections to Trump’s constitutional duty to “take care that the laws are faithfully executed.” Even social-media posts and speeches to partisans favoring his second-term candidacy may, in this rendition, qualify as official acts. Americans puzzled by these two contradictory Supreme Court rulings should take note of one striking consistency: whom the outcome favors. By defining the same plain words in opposite ways, each decision shelters a chief executive from legal review. McDonnell could not be convicted, because almost nothing he did as governor qualified as an official act; Trump’s prosecution could not move ahead, because Roberts’s guidance called almost everything the then-president did official, and therefore safe from scrutiny. After the Supreme Court’s deeply unpopular Dobbs v. Jackson Women’s Health Organization decision in 2022, which similarly disdained precedent by effectively repealing the 1973 ruling in Roe v. Wade, Roberts went on a campaign to shore up the Court’s flagging reputation. “The legitimacy of the Court,” he told a Colorado audience that year, “depends on the fact that it satisfies the requirements of the statute and the constitution, as John Marshall put it, to ‘say what the law is.’”

What happens now? Can businesses stop following the rules? How do we know which regulations will be impacted by this case?

This decision will not allow firms to completely ignore federal regulatory policy. In most cases, Congress passes clearly defined laws that are not ambiguous that firms must obey. In situations where the law is vague, courts will make a ruling which will be legally enforceable. But firms will likely issue more challenges where regulatory agencies go beyond or provide more specificity than Congress does in the legislation. The Loper ruling gives Congress more incentive to write clearer laws.

[Michael and Hal, “China’s Threat to Global Democracy” Journal of Democracy, vol. 34, issue 1, pgs. 65-79, January 2023, https://www.journalofdemocracy.org/articles/chinas-threat-to-global-democracy/ Accessed 7.22.24 GDI-HB]

A sixth aspect of forward defense involves more actively fighting the information war. China’s strategy involves relentlessly touting the supposed benefits of its own model, while fanning the flames of political discord in democratic societies. Exposing fake civil society groups or media outfits that are tools of Chinese influence is obviously vital. Equally important, though, is to be more aggressive in turning the tables on Beijing by spreading word of its rights abuses, mounting economic and social problems, rampant corruption, predatory overseas-lending practices, and other CCP crimes and shortcomings. The United States accumulated plenty of experience with such efforts during the Cold War, when institutions such as the now-defunct U.S. Information Agency told the truth about the Soviet bloc while contesting communist lies about the free world.34 Today, similar messages may not resonate with kleptocratic foreign leaders who are bankrolled by Beijing—but such communications will help to make the global information environment less favorable to CCP propaganda.

[Michael and Hal, “China’s Threat to Global Democracy” Journal of Democracy, vol. 34, issue 1, pgs. 65-79, January 2023, https://www.journalofdemocracy.org/articles/chinas-threat-to-global-democracy/ Accessed 7.22.24 GDI-HB]

China’s rulers also have long understood what political scientists have proven empirically: Autocracies often fall in waves, as revolutionary activity in one country inspires popular uprisings in others.12 A democratic domino effect brought down communist regimes across Central and Eastern Europe in 1989. The self-immolation of a Tunisian fruit vendor in late 2010 set much of the Arab world aflame. The lesson is that revolution anywhere is a threat to autocracy everywhere. Xi Jinping knows this: Not long after the Arab Spring, he privately fretted to President Barack Obama and Vice-President Joe Biden that China was a target of “color revolutions” and vulnerable to the type of upheaval engulfing the Middle East.13

[Michael and Hal, “China’s Threat to Global Democracy” Journal of Democracy, vol. 34, issue 1, pgs. 65-79, January 2023, https://www.journalofdemocracy.org/articles/chinas-threat-to-global-democracy/ Accessed 7.22.24 GDI-HB]

This is no exaggeration. The infamous Document Number 9, a political directive issued almost a decade ago at the outset of Xi’s presidency, shows that the CCP sees a liberal world order as inherently threatening.6 “Because China and the United States have longstanding conflicts over their different ideologies, social systems, and foreign policies,” a Chinese military document stated in the 1990s, “it will prove impossible to fundamentally improve Sino-U.S. relations.” For decades, in fact, Chinese officials have alleged that Washington has been waging a deliberate, well-orchestrated campaign—a “smokeless World War III,” in Deng Xiaoping’s words—to weaken and fatally subvert the CCP.7 Deng blamed the United States for being behind the “so-called democrats” who dared to protest in Tiananmen Square in 1989.8

[Michael and Hal, “China’s Threat to Global Democracy” Journal of Democracy, vol. 34, issue 1, pgs. 65-79, January 2023, https://www.journalofdemocracy.org/articles/chinas-threat-to-global-democracy/ Accessed 7.22.24 GDI-HB]

The Sources of Chinese Conduct

Another complication is the fact that A.I., unlike Bitcoin mining or online shopping, can be used to reduce humanity’s impacts. A.I. can improve climate models, find more efficient ways to make digital tech, reduce waste in transport, and otherwise cut carbon and water use. One estimate, for example, found that A.I. -run smart homes could reduce households’ CO₂ consumption by up to 40 percent. And a recent Google project found that an A.I. fast-crunching atmospheric data can guide airline pilots to flight paths that will leave the fewest contrails.

[Marion, “Could Artificial Intelligence deliver a green transition?” Grantham Research Institute on Climate Change and the Environment, 31 August, 2023, https://www.lse.ac.uk/granthaminstitute/news/could-artificial-intelligence-deliver-a-green-transition/ Accessed 7.21.24 GDI-HB]

An opportunity to grasp

[Muhammad, “Human Inventions and its Environmental Challenges, especially Artificial Intelligence: New Challenges Require New Thinking” Environmental Challenges vol.16, July 2024, https://www.researchgate.net/publication/382143771_Human_Inventions_and_its_Environmental_Challenges_especially_Artificial_Intelligence_New_Challenges_Require_New_Thinking, Accessed 7.21.24 GDI-HB]

3.10.5. Potential and new opportunities AI offers an array of novel possibilities for promoting and enhancing environmental sustainability. AI-powered smart grids optimize energy distribution and minimize inefficiencies, leading to more sustainable energy usage patterns (Gomes, 2023; Liu and Sun, 2023). AI applications in waste management enhance recycling procedures and minimize the utilization of landfills (Stecyk and Miciuła, 2023; Yadav and Singh, 2023). Moreover, using AI in climate change mitigation measures, such as enhancing carbon capture techniques and optimizing resource allo-cation, showcases AI’s substantial influence on global sustainability endeavors (Wankhede et al., 2024). These groundbreaking applications highlight the profound impact that AI may have in shaping a sustainable future.

[Devika, “10 looming climate tipping points that imperil our planet” The Week, July 1, 2024, https://theweek.com/environment/climate-tipping-points-un-report, Accessed 7.22.24 GDI-HB]

The world is rapidly approaching the "brink of multiple risk tipping points," the United Nations said in its 2023 Interconnected Disaster Risks report. Risk tipping points, the U.N. said, are "when the systems that we rely on for our lives and societies cannot buffer risks and stop functioning." Throw in accelerating climate change, and "the very practical consequence will be that much more people will live under very precarious conditions — so loss of life, loss of livelihood and loss of opportunities," Zita Sebesvari, one of the lead authors of the report, said to the Los Angeles Times. "It does have cascading impacts."

[Joe, “Post breakthrough: How AI can lift climate research out of the lab and into the real world” World Economic Forum, May 29, 2024, https://www.weforum.org/agenda/2024/05/ai-lift-climate-research-out-lab-and-real-world/ Accessed 7.22.24 GDI-HB]

3. Accelerating the prototyping phase of technology development