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Results: We found a growing number of a wide range of policies being evaluated for health equity outcomes using a variety of research designs. The majority of studies employed an observational research design, most of which were cross-sectional, however, other approaches included experimental designs, simulation modelling, and meta-analysis. Regression techniques dominated the analytical approaches, although a number of novel techniques were used which may offer advantages over traditional regression analysis for the study of distributional impacts of policy. Few studies made intra-national or cross-national comparisons or collected primary data. Despite longstanding challenges of attribution in policy outcome evaluation, the majority of the studies attributed change in physical or mental health outcomes to the policy being evaluated. Conclusion: Our review provides an overview of methodological approaches to health equity policy outcome evaluation, demonstrating what is most commonplace and opportunities from novel approaches. We found the number of studies evaluating the impacts of public policies on health equity are on the rise, but this area of policy evaluation still requires more attention given growing inequities.

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 stakeholder needs, and discuss the challenges of gaining insight into why corporations embrace public–private partnerships. These theoretical perspectives are used to gain a deeper understanding of the corporate drivers that motivated TOTAL S.A. to approach UNESCO for cooperation on community development programmes in Myanmar.

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.

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.”

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.”

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

Another relevant issue facing us is the contexts in which humans naturally engage in altruistic behavior. Paleolithic human’s expression of familial or nonfamilial altruism endures for only a couple generations, with concern for future generations subsequently deteriorating (Dawkins, 1989). The fact is there used to be no compelling need for longer-term concern. However, such limiting of intergenerational interest leads to a shorter-term policy horizon than that needed to address today’s global problems. For instance, over the past half-century, western citizens have endorsed rising public indebtedness. Citizens thereby enjoy greater consumption than could be provided out of current income. This boosts positive hedonic sensations (more goods and services consumed today) while reducing negative hedonic sensations (lower taxes paid today) and is reinforced by the basic human predisposition for immediate gratification. However, at some point, any debt, even a public one, must be repaid: Public debt is delayed taxation. At that future point we face a set of conundrums; for as soon as we must repay, we necessarily experience a significant increase in negative hedonic sensations. Given that we dislike losses more than twice as much we like equal gains, we resist, which merely entrenches the unsustainable trends that eventually leads to crisis (Tversky & Kahneman, 1991). This insight further helps explain the lack of general concern for damage to the biosphere or humankind’s enduring faith in a “technofix” solution—it is easier to brush off emergent problems if you believe that a necessary fix will surely be found when needed by some future generation that you are not too concerned about in the first place.

Finally, research reveals that individuals often behave differently in group contexts than they would if acting alone (i.e. crowd psychology). Within a group setting individuals often take up the group’s identity, ignoring their own conscience, suspending judgment and accountability. The result is that individuals within groups participate in acts they would never commit separately. Social psychologists say that a participant enters a lower state of self-awareness called “deindividuation”. The resulting anonymity can have horrifically destructive effects on innocent lives and property, as witnessed during riots, genocides and wars (Cantril, 2002). Extending these insights, the anonymity associated with group behaviors coupled with limited future concern helps us to understand why individuals in developed nations can be insensitive to poverty, emigration, environmental destruction, water shortages and excessive debt on the global level. When one adds human flaws to an increasingly crowded planet, effects become amplified—there are over 7 billion of us all behaving much the same way.

The notion that debt matters, that spending must be financed sooner or later by taxes on someone, and that those taxes will be economically destructive, has vanished from Washington discourse on both sides of the aisle. The COVID-19 response resembles a sequence of million-dollar bets by non–socially distanced drunks at a secretly reopened bar: “I’ll spend a trillion dollars!” “No, I’ll spend two trillion dollars!” That anyone has to pay for this is unmentioned. 

And who is to blame the politicians for acting this way, really? Markets offer 1 percent long-term interest rates—negative in real terms. Blowout spending financed by the Fed printing money—which is no different from debt—has resulted in no inflation so far. In the face of the deep concerns of current voters, worry that our children and grandchildren might have to pay off debt is not particularly salient. They’re either in the basement playing video games or out protesting for the end of capitalism anyway. Politicians will take the cheap money as long as markets are happy to provide it. 

Unfortunately, beginning around 2015, we started to see unexpected and fundamental changes leading to a new order in which infectious and tropical diseases either emerged or returned. This book focuses on some of the major twenty-first-century forces responsible for this historic reversal, but here is a brief overview of some of the major determinants now driving up both vaccine-preventable diseases and NTDs.

Political Instability. One of the most potent and unanticipated drivers was political instability. Measles was declared eliminated from the Americas in 2016, but in Venezuela, the collapse of the economy interrupted and disabled its health system, allowing measles to come roaring back. However, measles was not the only infection to reemerge. Malaria also became widespread, as did a host of other NTDs transmitted by insects or snails. The so-called Northern Triangle area of El Salvador, Guatemala, and Honduras also suffered because of escalating drug wars and the resulting economic downturns that affected health systems. In the Old World, wars or Islamic State occupation in Syria, Iraq, and Yemen also promoted the return of vaccine-preventable diseases, including measles and polio, while the simultaneous collapse of insect vector control programs promoted an explosion in the number of cases of cutaneous leishmaniasis, a highly disfiguring disease that produces ulcers and permanent and socially stigmatizing scars. A deadly cholera outbreak, one of the largest ever recorded, swept across Yemen. Throughout war-torn Democratic Republic of Congo (DR Congo), Central African Republic, and South Sudan, measles also returned, as did another form of leishmaniasis known as kala-azar, which causes a leukemia-like illness that killed thousands. Ebola caused a new lethal epidemic in DR Congo in 2019, resulting in over 2,000 deaths, and even more fatalities occurred from measles and cholera. The bottom line was that new twenty-first-century wars, conflict, and political unrest were reversing global gains.

The 2012 World Health Assembly Global Vaccine Action Plan called for global access to new vaccines within 5 years of licensure. Current approaches have proven insufficient to achieve sustainable vaccine pricing within such a timeline. Paralleling the successful strategy of generic competition to bring down drug prices, a clear consensus is emerging that market entry of multiple suppliers is a critical factor in expeditiously bringing down prices of new vaccines. In this context, key target objectives for improving access to new vaccines include overcoming intellectual property obstacles, streamlining regulatory pathways for biosimilar vaccines, and reducing market entry timelines for developing-country vaccine manufacturers by transfer of technology and know-how. I propose an intellectual property, technology, and know-how bank as a new approach to facilitate widespread access to new vaccines in low- and middle-income countries by efficient transfer of patented vaccine technologies to multiple developing-country vaccine manufacturers.

Vaccine rollout in low- and middle-income countries (LMICs) routinely lags far behind rollout in high-income countries. As of 2010—a full decade after its introduction—87% of high-income countries included the pneumococcal conjugate vaccine in their immunization schedules, compared with only 2% of low-income countries.1 Although the Haemophilus influenzae type b (Hib) vaccine was being widely used in wealthy countries by the early 1990s, Hib vaccine coverage in Africa was estimated at 24% as of 2006.2 Twenty years after licensure of the hepatitis B vaccine, vaccine coverage was estimated at 90% in the Americas as opposed to only 28% in Southeast Asia, where hepatitis B is endemic.1 These timelines, unfortunately, are the norm rather than the exception for adoption of new vaccines in LMICs. The inequities of this situation are all the more indefensible because the vast majority of mortality from vaccine-preventable diseases occurs in LMICs3; it is estimated that more than 90% of deaths from pneumococcal disease,4 95% of deaths from Hib,5 and 80% of deaths from hepatitis B5 occur in developing countries.

So suddenly, the world is being left on its own. And what we're seeing is the world is not on autopilot. It doesn't self-organize. And that's the most worrisome thing going forward that this pandemic is both a reflection, but also an accelerant of that because the United States has not rallied the world to meet the challenge posed by this pandemic. And instead, we've pulled back we become much more national, kind of an island power, the rest of the world, it's on its own, it's not doing very well. And this is this is the reason I'm so worried that a lot of the trends that were in place, including them on America, much less involved in the world, nationalism, populism, the breakdown of international collaboration, all those things were in train before this pandemic, and now we're seeing them double down.

MEGHNA: So is the you're saying the world is not self-organizing right now, perhaps, at this moment? And at the same time, it doesn't? Is it feeling the loss of the centrality of American leadership? Because, I think we could argue that the way that, for example, international leaders do talk about the United States right now, at times, they're not necessarily feeling the loss of American influence.

Until the 1980s, despite spending much less on health care, Americans were doing better than other countries in their health outcomes (Frakt, 2018). Something happened to US health care spending after 1980. Confronted with fiscal pressures, as the share of gross domestic product (GDP) absorbed by health care spending began to get serious, other nations put measures in place to hold down spending but the US did not. The differential between what the US and other developed coun- tries pay for prescriptions and for hospital and physician services has continued to widen over time. Suppliers of medical inputs marketed costly technological innovations (Callahan, 2009). They found ready customers in hospitals and medical practices eager to keep up with rivals in the medical arms race. In 1980, health care expenditures in the US were $256 billion, exploding to nearly $2.6 trillion in 2010, a ten- fold increase (Meissner, 2013). Health care expenditures spiked further to $3.8 trillion in 2019. What began as a small gap in performance when compared to other countries is now a yawning chasm.

The per capita spending on health care in the US towers over all other developed nations, and yet health care outcomes as reflected by key health indicators are at best average. In other words, the US health care system consumes far more resources to produce the same or worse health care outcomes as compared to the health care systems elsewhere. For example, the US spent $11,582 per capita in 2019 compared to $5,418 in Canada, $4,653 in the United Kingdom, $4,823 in Japan, and $4,224, the average of the Organization for Economic Cooperation and Development (OECD) countries (OECD, 2020). In total health care spending, the US spends 17.7 percent of its GDP, which is almost the double that of the average spending of 8.8 percent of GDP for the OECD countries. In a comparison to the overall performance of the health care systems of 11 developed countries, the US was found dangling alone with high health care spending and low system performance (Schneider et al., 2017). Seven countries (Australia, Germany, the Netherlands, New Zealand, Norway, Switzerland, and the United Kingdom) bunch together and perform higher than the other four countries (Canada, France, Sweden, and the USA). Canada, France, and Sweden show mediocre performance with the US being the laggard.

The majority of new drug development now takes place at startups with little to no commercial revenue. Contrary to the claim that raising prices on old drugs drives innovation, large pharmaceutical companies, generally defined as those with $10 billion or more in annual sales, rarely discover new drugs. Large companies have bureaucratic research and development (R&D) processes, in which scientists have comparatively little incentive to innovate. Researchers at emerging firms, on the other hand, may be driven to innovate by the remunerative model such firms use — i.e,. researchers share more fully in the economic rewards of successful drug development. Therefore, the majority of new drugs are now discovered and brought into human clinical trials by emerging startup companies — defined as those with $500 million or less in annual sales, or less than $200 million in annual R&D spending — funded by venture capital and hedge funds. In 2020, early-stage, unprofitable companies brought nearly 62 percent of new industry-originated drugs approved by the FDA to the clinic, with no less than 54 percent of drugs brought to the clinic by emerging firms in each of the last seven years (2016–2022).

Emerging companies are taking their innovations to market without the help of Big Pharma. Large companies that fail to discover drugs in-house often assert that the venture capital used for drug innovation would disappear if large companies sold drugs at lower prices. This claim assumes large companies will purchase the rights to sell drugs developed by emerging companies, whether through licensing agreements to sell on the emerging company’s behalf or by acquiring the emerging company altogether. But this model of drug development, which peaked in the 2010s, is quickly fading as emerging companies increasingly bring new innovations to market on their own. Our analysis found that, in 2013, 23 percent of emerging companies that originated novel drugs retained marketing rights to those drugs through the entire FDA approval process. By 2022, that percentage had more than tripled, to 75 percent. In fact, some drugs originated by profitable companies are now licensed to emerging companies to sell. Of the 17 drugs originated by established companies in 2022, four are currently marketed by emerging companies.

Next, I examine the differential effects of mergers and acquisitions based on the size of acquiring firms. I categorize larger acquiring firms as those with an average market value exceeding the median and smaller acquiring firms as those falling below the median.

Subsequent event studies replicate the analysis from Figure 3, focusing on patents (Figure 5) and R&D spending (Figure 6). The results show that larger acquirers' behavior in terms of patents and R&D spending closely aligns with the baseline specification detailed in Figure 3. Larger acquirers tend to significantly reduce patent filings while simultaneously boosting R&D investments.

Regulators in both the United States and the European Union have expressed concerns about the effects of the surge in mergers and acquisitions, both broadly and in the pharmaceutical industry, on consumers.

Meanwhile, prior literature, theoretical and empirical, and industry experts give conflicting information about the impact of consolidation. In an effort to disentangle these opposing viewpoints, this study concurrently assess the effects increasing pharmaceutical consolidation has on innovation and prices.

The results show that between 2006 and 2017, the cost of pay-for-delay settlements on the Medicare Part D program ranged from $2.3 billion per year to $13.5 billion per year based on list price, and ranged from $303 million per year to $1.5 billion per year based on patient out-of-pocket costs. During the same time period, the cost of pay-for-delay settlements on the U.S. population ranged from $6.2 billion to $37.1 billion per year based on list price, and $619 million per year to $2.9 billion per year based on patient out-of-pocket costs.

By contrast, the FTC's estimate of the cost of these settlements was $3.5 billion per year. If one compares the FTC's figure to the study's estimate of the annual cost of pay-for-delay settlements, it is clear that the consequences of these deals on purchasers are drastically underestimated in the older FTC report. The lower end of the range the study calculated for the cost of these deals on the U.S. population, based on list price, $6.2 billion, is nearly twice that of the $3.5 billion calculated by the FTC. To put this number into perspective, $6.2 billion is roughly 2% of the average U.S. annual spending on drugs, and the average of this cost range, $19.2 billion, is roughly 7% of the average U.S. annual spending on drugs.

Nevertheless, there is reason to believe that pay-for-delay settlements may still make an appearance in biologic drugs in a manner that raises competition concerns. First, although biosimilars will encounter hurdles to market entry, other factors point to the likelihood that biosimilars will soon jump into the ring alongside the original biologic drugs. The U.S. biologic and biosimilar landscape faces what some call a “patent cliff 2.0,” in which patent losses for blockbuster drugs put pressure on large pharmaceutical companies to somehow retain exclusivity or major portions of their market share.115 A recent estimate suggested that 45 percent of the sales at risk looking forward from 2017 is for biologics.116 Other estimates say that the U.S. holds the majority of biosimilar potential across the world almost 60 percent of global biologic sales came from the U.S.117 Given that biologics are extremely lucrative, makers of reference biologics have strong incentives to try to retain portions of their monopoly rents.

Further, commentators have predicted that over time, the costs of developing a biosimilar will go down as a result of technological advances.118 Others have noted that while well-established biologic manufacturers have economies of scale working in their favor, biosimilar manufacturers may be able to use their newer technologies or innovative methods to bring down manufacturing, thereby decreasing prices for their products.119 Thus, although biologics and biosimilars do not have as high of a price differential as branded and generic small-molecule drugs, the differential is predicted to widen as the cost of making copycat versions of reference drugs decreases and interchangeable biologics replace biosimilars as a predominant alternative.120 Importantly, interchangeable status connotes a full-year exclusivity period alongside the reference biologic, as mentioned above. If more biosimilar drugs become interchangeable with reference biologics, reference companies may be threatened by the prospect of direct substitution and may be incentivized to settle patent infringement litigation, pay off biosimilar companies, and delay the biosimilar’s launch.121 In short, several factors have the potential to promote the widespread use of biosimilars: shrinking price differentials due to lower development costs; easier pathways to achieving “interchangeable” status from the FDA; health plans or buyer institutions mandating use; and increased prescriber or patient education leading to greater acceptance are just a few.122 If any or several of these factors gain traction, the possibility of paying a biosimilar to stay off the market will become increasingly tempting for biologic manufacturers.

The Biden administration on Wednesday said it will impose inflation penalties on 64 prescription drugs for the third quarter of this year, lowering costs for certain older Americans enrolled in Medicare.

President Joe Biden has made lowering U.S. drug prices a key pillar of his health-care agenda and reelection platform for 2024. A provision of Biden’s Inflation Reduction Act requires drugmakers to pay rebates to Medicare, the federal health program for Americans over age 65, if they hike the price of a medication faster than the rate of inflation.

Thanks to the Inflation Reduction Act, one of President Biden’s signature achievements, prescription drugs are set to become substantially more affordable for seniors. Yet many Americans seem unaware of just how monumental these changes will be.

Here are six things to look for:

The Inflation Reduction Act of 2022 enabled Medicare to negotiate prices for prescription drugs for the first time in the program’s history. In August 2023, Medicare announced the first 10 Medicare Part D drugs selected for negotiation. The U.S. Centers for Medicare and Medicaid Services submitted its initial offer for negotiated prices in February 2024, and the negotiated prices will be finalized and published in September 2024. The negotiated prices will take effect in January 2026. These 10 drugs are among those with the highest annual Medicare Part D spending, indicating very high prices and/or very high utilization rates. Given limited transparency in drug pricing, it is often difficult to estimate drug costs, especially because net prices, which are often unknown, differ from list prices and vary among payers.

This new Center for American Progress analysis builds on net per-unit Medicare Part D drug price estimates from the Commonwealth Fund, inclusive of discounts, rebates, and price concessions, to estimate net Medicare prices for a typical 30-day supply of the first 10 drugs up for price negotiation. From there, the center calculated the likely monthly savings that will result from Medicare’s price negotiation.