The Future Is In WTO Hands

Here’s What You Need to Know…
Negotiators from the United States, European Union, India, and South Africa are “iron[ing] out” what the World Trade Organization (WTO) head calls “the last few tweaks” in a proposed compromise to allow countries to waive intellectual property rights for COVID-19 vaccines. Public affairs professionals both in – and outside – the life sciences sector should pay close attention. Last year, President Biden reversed the U.S.’ long-standing opposition to an IP waiver at the WTO due to pressure from activists and access to medicines groups, who argued that an IP waiver on COVID-19 technologies would solve the problem of global vaccine inequity. We warned at the time, “While this may seem like an arcane debate over trade rules … there is far more at stake for the pharmaceutical industry and its ability to develop future health technologies.”

Fast forward to 2022, about two-thirds of the world has been vaccinated against coronavirus and “2.3 billion vaccine doses” currently sit unused, according to a recent market analysis. Moreover, the U.S. alone has already delivered hundreds of millions of vaccines to countries around the world, and several vaccine manufacturers have pledged not to enforce their patents on COVID-19-related technologies in low-income countries. Yet despite the wide availability of COVID-19 vaccines, South Africa, India, and a global campaign of activists continue to seek a COVID-19 IP waiver at the WTO, hoping to set a precedent that they can ultimately use to unwind IP protections on drugs for a range of other diseases, such as HIV/AIDS, cancer, and tuberculosis, among others. The waiver’s implications could also reach far beyond the drug industry and pave the way for activists to fight patents on any technologies they believe should be a global public good. That is why public affairs professionals operating in any IP-heavy sector ought to pay close attention. To do so, here is what you need to know.



While activists and supporters of the waiver push have been quick to blame patents for hindering access to COVID-19 vaccines in low-and-middle-income countries (LMICs), many global health experts paint a very different picture. Rutgers Global Health Institute director Dr. Richard Marlink, MD, for example, blames vaccine inequity on the lack of health infrastructure in LMICs, noting, “The majority of the world’s countries lack the capacity,” including “funding, manufacturing facilities, raw materials, and laboratory staff,” needed “to produce and distribute COVID-19 vaccines, and especially at the scale required to get this pandemic under control.” Pfizer’s vaccine alone requires 280 components from 86 suppliers in 19 countries as well as complex and sensitive equipment and highly skilled personnel. Even with a COVID-19 IP waiver, these LMICs would still not have the capacity to navigate complicated technology transfers between collaborators or build the global supply and manufacturing networks necessary to this task.

Even if countries could overcome the manufacturing complexities, many LMICs lack the necessary infrastructure to facilitate distribution and administration to populations. India, for example, is one of the main forces behind the waiver push. Yet it is struggling to distribute its own surplus of COVID-19 vaccines due to various logistical barriers. Serum Institute of India Chief Executive Adar Poonawalla acknowledged, “All over the world, there is enough supply, but it is getting the jabs in arms which will take some time.”


Though China would technically be excluded from the proposed agreement due to the large amount of vaccines it exported during the pandemic, U.S. Trade Representative Katherine Tai has acknowledged the real and significant concern about China gaining from a waiver of intellectual property rights at the WTO. Removing IP protections on COVID-19 vaccines would be open season for China to manipulate platforms like mRNA, an innovative technology that may prove valuable in treating everything from the flu to cancer. Given free access to the mRNA recipes used for COVID-19 vaccines, China could reverse engineer the technology and potentially beat U.S. companies to market with its own vaccines and therapeutics.

The other primary benefactor of any patent waiver would be India, both the largest manufacturer of generic prescription drugs and the largest vaccine distributor in the world. “The World’s Pharmacy,” as one analysis called India, would be positioned to access key technologies without needing to pay for licensing or acting as a producer of other companies’ products. In addition, the waiver would advance anti-patent activists’ true agenda: upending the system that protects intellectual property rights to spur innovation with one that relies upon government-led research to bring to market public goods.


Both lawmakers and those in the pharmaceutical industry see the push for an IP waiver at the WTO as a slippery slope that could lead to an eventual overhaul of the current research and development system and undercut long-standing patent and intellectual property protections, disincentivizing future innovation and development. Through a COVID-19 IP waiver, activists are hoping to “set a powerful precedent” for expanding access to medicines for other diseases, such as HIV/AIDS, cancer, and tuberculosis, among others. In fact, they are already pointing to other health crises they claim necessitate IP sharing; for example, activists are warning of a “cancer crisis” in South Africa and demanding expanded access to certain treatments. Likewise, Dr. Anthony Fauci urged the world to apply the lessons of the COVID-19 pandemic to the global tuberculosis crisis, arguing “all countries need to realize that they have ‘a moral responsibility’ to see infectious diseases, even if not affecting their own citizens, as their problem.”

Beyond the pharmaceutical sector, the WTO’s decision could impact intellectual property rights for other industries. Any global crisis could open the door for activists to argue that innovative, proprietary technology be made a global public good. Environmental activists are already lobbying the Biden Administration to rescind the intellectual property rights of companies working on technologies that curb CO2 emissions, citing the global climate crisis. The Paris Climate Agreement itself addresses the desire for such technology in LMICs and encourages participants in the treaty to enable technology transfer to these countries. Many of those same activists argue the climate crisis will increase global hunger and malnutrition, which could lead to challenges of IP protections for biotechnological and agricultural sector innovations as activists argue such patent protections limit the opportunities of farmers around the world to grow certain crops and feed those in need. If the global pandemic necessitates compulsory licensing, surely the global climate crisis or a global hunger crisis would too.


If ratified by the WTO, a COVID-19 IP waiver could set a dangerous precedent that threatens our ability to address future health challenges at home and around the world. Public affairs professionals in any industry governed by trade rules shaped by the WTO should be aware of the long-term consequences. Understanding who is shaping the debate, what their real agenda is, and how it will impact your interests will ensure your industry can stay ahead of the curve.

Waiving goodbye to patents?

Here is what you need to know…

As COVID-19 vaccines are rolled out across the world, pharmaceutical companies and their intellectual property are being thrust into the political spotlight as the media, activists, and policymakers raise questions around distribution, access, and equity. Even as citizens expect their country to secure adequate access to vaccine supplies, global health activists are demanding free and equitable distribution of limited vaccine production to countries around the world regardless of wealth.

This debate garnered new attention in the U.S. last month when over 400 advocacy organizations — many of which have no ties to global health — called on President Biden to support developing countries’ push for the World Trade Organization (WTO) to approve a waiver to intellectual property rules they claim wrongly prevent countries from helping to increase the world’s supply of COVID-19 vaccines.  The United States, which under the Trump Administration opposed the waiver, is now facing a growing number of international and domestic calls to support it, including from prominent Congressional Democrats like Senators Bernie Sanders (I-VT) and Elizabeth Warren (D-MA).

While this may seem like an arcane debate over trade rules amidst the urgency of a global pandemic, there is far more at stake for the pharmaceutical industry and its ability to develop future health technologies. As this debate unfolds, here’s what public affairs professionals need to know about how we got here and where the debate may go next.

Intellectual property debates went global as COVID-19 spread.

Prior to the  COVID-19 pandemic, activists were driving a debate around intellectual property (IP) provisions and access to medicines in the developing world.  Prominent public health-focused organizations such as Unitaid and Médecins Sans Frontières had supported local campaigns for years encouraging developing countries to use compulsory licensing, a practice in which “a government allows someone else to produce a patented product or process without the consent of the patent owner.” Many in the pharmaceutical industry expressed concern that compulsory licensing would lead to a decline in medical innovation and research, and trade rules often made it more difficult for countries to enact such licenses.

As the pandemic spread across the globe, access to medicine activists – who were separated by regions and often focused on particular diseases – coalesced into a global campaign for a COVID-19 People’s Vaccine – “available to all, everywhere, free of charge.” According to supporters of the People’s Vaccine, the pharmaceutical industry’s “business as usual approach is unacceptable and will be ineffective” in ensuring global equitable access to COVID-19 treatments and vaccines. This line of argument – that patent-oriented R&D and “relentless focus on pharmaceutical profits” lead to “market failures” – has been prevalent among anti-patent groups since well before the pandemic.

The pharmaceutical industry – which opposes a People’s Vaccine as impractical – has promised equitable distribution of the vaccine and contributed financially and materially to the World Health Organization’s (WHO) mechanism aimed at increasing distribution of vaccines to low- and middle- income countries. However, these contributions have not been enough for supporters of the People’s Vaccine, who have joined South Africa and India, among other countries, in a push for a WTO waiver on COVID-19 related intellectual property.

The waiver fight is about patents not pandemics.

The waiver, originally proposed by South Africa and India, has now gained the support of over 55 countries concerned about access to vaccines that were developed by pharmaceutical companies with the support of rich countries. Pointing to the slow roll out of vaccines in developed countries, supporters of a waiver have argued for sharing the intellectual property and know-how of COVID-19 vaccines to increase the global supply. Opponents of the waiver, including at least four Republican senators, raise concerns that the waiver would impact long term innovation and “stop the development of new vaccines or boosters to address variants in the virus.” They also argue the waiver “wouldn’t increase the supply of vaccines because of the tremendous time and resources needed to build new manufacturing plants and acquire the know-how to produce these complex medicines.”

Getting a waiver for COVID-19 treatments would bring supporters of the People’s Vaccine closer to achieving their long-held goal of removing IP protections for drugs on a range of diseases, such as HIV/AIDS, cancer, and tuberculosis, among others. These intentions were made clear in recent comments from Ellen ‘t Hoen, director of access to medicine non-profit Medicine Law & Policy, who wrote, “COVID-19 is now in the spotlight. But we should not lose sight of the need to work to increase access to other new essential medicines. Including those to treat diabetes, cancer and cardiovascular diseases. After COVID, I believe cancer will prove to be the next big challenge … to have impact. There is increasing demand and treatments are improving. Nonetheless they are priced well beyond the ability to pay for most people and communities in the developing world.”

A global campaign brings pressure at home.

Biden, whose campaign team considered seizing patents to increase vaccine production, has pledged to donate $4 billion to the WHO mechanism aimed at increasing distribution of vaccines to low- and middle- income countries. This step soon may lead to others, as Biden’s pick for U.S. Trade Representative, Katherine Tai, has committed to examining the proposed WTO waiver “thoroughly to determine its efficacy in enhancing our global health security and saving lives.” Biden also lifted the U.S. opposition to the nomination of the new WTO Director-General, who has advocated for a “third way” approach to a waiver “based on voluntary licensing of patented vaccines to generic manufacturers in the global south.”

Access to medicine activists, however, are not only focusing on the global debate. They are also focused here at home, calling for reform of the U.S. Patent and Trademark Office (USPTO). Using data showing the pandemic has “disproportionately harmed Black and brown people,” they claim “Structural racism has a long history in our patent system” and want President Biden to select a USPTO director who will “make it more difficult to extend the life of a patent or make it easier for generic manufacturers or others acting in the public interest to challenge unjust patents.” Amidst the pandemic and a continuing public debate around racial equity and drug pricing, these calls add heightened pressure to pharmaceutical companies that rely on the patent system to protect their innovations and bring life-saving treatments to the people who need them.

Pandemic as precedent.

Even when the pandemic subsides, the global coalition of health activists targeting the patent system at home and abroad will remain. They have made clear they believe improving the cost of and access to medicines across a range of diseases and ailments requires upending the system of trade rules and intellectual property protections on which pharmaceutical companies have relied for many years. Meanwhile, governments in the U.S. and Europe have shown an increased willingness to tighten their control over access to medicines when it suits their short-term interests. These trends make for an even more challenging environment for public affairs professionals advising the pharmaceutical industry. To navigate these challenges successfully, it will be crucial to understand and anticipate the messages, strategies, and tactics of the activists and policymakers engaging in this debate to find allies and overcome opposition.

Pharma’s post-pandemic policy outlook

Here’s what you need to know…

As the first COVID-19 vaccines were delivered this week, pharmaceutical industry leaders recognize that there are still many challenges ahead. While the industry overcame the herculean task of developing and distributing a vaccine in unprecedented time, the pandemic has brought previously obscure issues such as international patent rights and the global supply chain of pharmaceutical ingredients to the forefront of major public policy debates worldwide. With this heightened scrutiny and increased pressure from policymakers and the public, the pharmaceutical industry will have to continue to navigate these debates in 2021 and beyond.

To help prepare pharmaceutical industry public affairs professionals for what 2021 will bring, we will be launching a new occasional trends report in January focused on the political and reputational risks facing the industry. Below is a preview of some of the issues the trends report will cover, and we hope you will sign up to receive full editions of the report when they are published.

 Cross-partisan pressure and scrutiny on drug prices will continue in the Biden era

Prior to the pandemic, policy makers on both sides of the isle debated how to address what many perceive as the high price of pharmaceuticals. While in most areas the Biden administration is likely to divert from President Trump’s policy direction, in this debate there may be more continuity than conflict. In September of this year President Trump signed an . While this will  likely end up being challenged in court, it likely will not deter the incoming Biden administration from seeking to advance a similar approach to reduce drug prices, which was also included in the House Democrats’ drug pricing plan endorsed by progressive groups.

Beyond this specific proposal, pharmaceutical companies can expect more scrutiny from Washington. President-elect Joe Biden’s pick to lead Health and Human Services (HHS), California Attorney General In addition, Congress is likely to continue oversight hearings similar to those seen earlier this year and in prior years seeking to question the industry’s practices and pricing with

The pandemic has globalized the fight over patent rights as activists seek to upend the industry

As the industry’s search for COVID-19 cures and treatments began in earnest, a People’s Vaccine movement emerged to demand any vaccine be made a “global public good” available for free and equitably distributed to both the developing and developed world simultaneously. This movement didn’t crop up overnight. For years, activists and groups advancing this campaign have been involved in fights across the developing world advocating for compulsory licensing laws to increase access to medicines. The People’s Vaccine movement has culminated with a fierce campaign advocating for World Trade Organization member states to back a proposal by India and South Africa for a waiver on intellectual property related to COVID-19 and calling for wealthy countries and pharmaceutical companies to back international intellectual property pools. This proposal remains under consideration and the debate over it will continue into 2021.

This movement to challenge patent rights has been building for a long time in the developing world, typically focused on specific regions and access to drugs that treat HIV/AIDS, Hepatitis, Tuberculosis, and other illnesses where advances in medical technology have not always been widely available in low and middle income countries. However, COVID has allowed this movement to become more global in its focus as it seeks to leverage the pandemic to reshape the model of how we fund and commercialize health technology. As one prominent activist in that movement, Medicines Law & Policy Director Ellen ‘t Hoen, recently stated, “We should not lose sight of the need to work to increase access to other new essential medicines. … After COVID, I believe cancer will prove to be the next big challenge,” with treatments “priced well beyond the ability to pay for most people and communities in the developing world.”

 2020 brought heightened scrutiny on drug supply chains. 2021 could bring action to force them home.

As we wrote this past spring, the pandemic “exposed cracks in the worldwide supply chain for pharmaceuticals and medical supplies necessary to create and administer vaccines.” In hopes of addressing this, President-elect Biden has made clear that one of the goals of his administration will be to bring pharmaceutical supply chains and manufacturing back to the United States. On the campaign trail, Biden endorsed the creation of a national “Critical Drugs List” as part of an overarching plan to address supply chains shortages and encourage US-based manufacturing of prescription drugs.

Meanwhile, Congressional Republicans have joined bipartisan calls to spur greater U.S. drug manufacturing. This shift in approach by many free market-oriented Republicans stems from growing voter concerns regarding globalization as well as the national security threats associated with reliance on China – both of which have been exacerbated by COVID-19. However, the price tag that comes attached to bringing these supply chains and manufacturing abilities back to the United States has some industry leaders concerned, with one leader saying that it is “unrealistic” to think that it could be done in part to due to steep regulatory hurdles, while others

Stay Ahead with Actionable Insights

As 2020 comes to a close and we approach the inauguration of new administration, the challenges the pharmaceutical industry will face in the year(s) ahead have come to the forefront of the public policy debate. Our team of analysts will continue to dig deeper and monitor developments that will impact the industry. Sign up for our trends report to keep you ahead of the curve, and feel free to reach out for more in-depth analysis on any or all of these challenges and opportunities facing the industry.

(Vaccine) Trial by Fire

Here’s what you need to know…

Bringing any new drug treatment to market is an arduous process with the potential for significant public and regulatory scrutiny even in normal times. Now, as pharmaceutical manufacturers prepare to bring hundreds of millions of doses of coronavirus vaccine to market, the stakes are anything but normal. As drug manufacturers tackle the complex science of creating a safe and effective vaccine at warp speed, public scrutiny will be even more aggressive.

In the current age of organized activism and lightning fast (mis)information sharing, no good deed goes without deep and exhaustive scrutiny from a wide range of policymakers, news outlets, competing advocates, and other stakeholders. This new reality means drug firms will need to lean on the expertise of their public affairs professionals to skillfully navigate the likely political and reputational risks as they seek to educate policymakers and the public about the benefits and reliability of their COVID-19 vaccines and their responsible and fair business practices.

The challenge of navigating such public scrutiny has never been more daunting, and if anything, is a sign of what’s to come for future public health challenges. To be successful, they will need to anticipate and prepare for six important questions:

Who gets the vaccine and in what order?

As global leaders prepare to embark on the “largest immunization campaign the world has ever seen,” questions remain about who should be eligible to receive early COVID-19 vaccine doses that will be in limited supply for some time. While pharmaceutical companies will work hard to ensure that billions of regimens are available as quickly as possible, the reality is it could take many months before those can be manufactured and distributed. That expected reality has patient advocates and political leaders debating how governments should prioritize the administration of the vaccination in the short term. Some argue that those in high-risk groups or those with significant co-morbidities should be at the top of the list, while others insist that health care workers and essential employees should go first. Others say that racial and ethnic groups that appear to be more susceptible to the virus, such as African Americans and Native Americans, should be top priority. This debate has global dimensions too, with concerns that first world nations with the ability to develop and pay for its administration will hoard the vaccine while it’s still in short supply, making a country’s ability to pay the chief determinant in whether or not its people are protected. No matter which groups are chosen to receive the first round of vaccinations, there will be those in other groups who wanted it but could not get it, leaving governments, health care organizations, and manufacturers facing an inevitable public backlash for which they must prepare.

Even if there’s a vaccination available, who will take it?

Amid the clamor to be first for the vaccine is another reality that many will be resist being among the first to try it in an uncontrolled setting. In fact, Gallup reported this week that one in three Americans would not receive a COVID-19 vaccination, while another survey showed as few as 50 percent of Americans are prepared to receive it. These individuals aren’t all traditional anti-vaxxers who refuse to vaccinate their children or receive a flu shot, but rather, are simply skeptical of a new vaccine’s efficacy and safety or skeptical of public health directives post-lockdown. Their hesitation is likely to fuel a cycle of public debate similar to that over masks, where the more the media and policymakers demand lockstep compliance, the more some citizens will feel that their concerns, legitimate and otherwise, are being disregarded. Such a debate will increase existing divisions and rancor while undermining needed public health outcomes, particularly if government bodies at various levels attempt to compel people to take the vaccine. For public affairs professionals in the life sciences community, the potentially Sisyphean task will be to ensure science and health facts are not lost amid the debate, particularly if and when reports, whether they are truth or myth, emerge to suggest the vaccine is ineffective or unsafe.

How will leaders address concerns of racial disparities in access and outcomes?

In recent months, the nation’s and, indeed, the world’s attention has turned to the subject of systemic inequality. While the discussion has largely focused on police practices and economic disparities, some say that coronavirus clinical trials do not accurately reflect the full diversity of the population, leaving researchers with a poor study population that may not demonstrate how the vaccine will perform with wide use. Still others fear that America lacks a plan on “how to reach racial and ethnic groups that have not only been devastated by the virus but are also often skeptical about government outreach in their communities,” according to Politico. Every aspect of the vaccine’s distribution, administration, and effects will happen in the context of this heightened scrutiny and social unrest regarding racial disparities. Meanwhile, public health officials and public affairs professionals will have to convince groups already disproportionately harmed by the coronavirus that efforts to distribute a vaccine in their communities are meant to help, not hurt, them.

Can the supply chain meet the demand fast enough?

Securing the supply chain is a crucial step to distributing the forthcoming COVID-19 vaccine. This task will be tough, as coronavirus has already exposed cracks in the worldwide supply chain for pharmaceuticals and medical supplies necessary to create and administer vaccines. Moreover, recent reports about limited quantities of crucial component parts, like hard-to-make vials, make it harder for health care professionals to actually administer the vaccination. Meanwhile, media and Congressional scrutiny on the Trump Administration’s decision to give substantial loan to Kodak after the photography company dedicated a record amount of money to lobbying the Administration for the aid has undermined plans to have the company help fill this supply gap and could dissuade other potential manufacturers from offering aid. Once companies begin sending a COVID-19 vaccine around the globe,  scientists are worried about supply chain viability issues such as counterfeiting and maintaining the necessary conditions to keep the vaccine cold enough for future use. For those representing the life sciences industry, they must be ready for new levels of scrutiny regarding their business practices, assuring the public and policymakers that they are behaving responsibly and competently, even in the midst of the chaos of crisis response. Renewed scrutiny could last long after coronavirus is under control, potentially establishing a new precedent in the oversight and regulation of the pharmaceutical industry.

What ownership does the public have?

For years leading up to the coronavirus pandemic, some advocates have argued that because a lot of basic scientific research is publicly funded via government grants and public universities, the public should have at least partial ownership in scientific discoveries made on their dime, whether the ownership takes the form of patents, data, or the product itself. With governments across the globe making multibillion dollar investments in pharmaceutical companies’ pursuit of COVID-19 vaccinations, some advocates say taxpayers should have ownership or rights to these treatments once they hit the market, an expansive and possible precedent-setting argument heard from activists who have long argued that in pursuit of universal health care, pharmaceuticals should be classified as a global public good. Because of this governmental investment, many argue that it should be totally free to the public, with some suggesting it be free for the entire global community. Pharmaceutical companies are trying to balance protecting their intellectual property with commitments and partnerships to make their product readily available when doses are urgently needed. In the long term, however, innovative life-saving treatments require intellectual property protections if there is going to be an incentive to develop and manufacturer them. Industry representatives will have to continue their efforts to make clear why these protections matter even as their firms contribute institutional knowledge, administrative costs, and corporate investment towards tackling the world’s greatest health care challenge in a century.

Has the immense focus on COVID-19 undermined efforts to develop and distribute treatments for other ailments?

Even as the world has seen nearly 21 million cases of coronavirus and 750,000 deaths associated with it, people all over the world are still dying of more predictable causes – around 150,000 of them each day. Heart disease, Alzheimer’s, diabetes, cancer, autoimmune diseases, and tuberculosis are still some of the most common causes of death, and among those living in low income countries, communicable diseases are 7 out of the 10 most likely ways people die. The life sciences community provides hope for cures and treatments that can extend, improve, and save lives. Leading up to coronavirus, great strides had been made to address a variety of illnesses and disease. Much of this research, including hundreds of vital clinical trials regarding other health challenges, has been stalled or canceled entirely as scientific efforts are directed to solve the immediate crisis of coronavirus. With economic stagnation and university closures to prevent COVID-19 transmission, labs are now empty, too. In the U.S. alone, important life science research on tumors, strokes, anemia, and cancer has come to a halt. As coronavirus becomes better managed, the illnesses and deaths of those not infected by COVID-19 will return to focus, and fairly or unfairly, so, too, will questions about the reversal of medical progress during this critical time.

We know a lot more about coronavirus than we did when it began. Care has improved, and a vaccine will soon be available. For those in the life sciences industry, this is unchartered territory – and for more than just the scientists racing to develop safe and effective vaccines. For public affairs professionals, the coronavirus crisis presents new challenges in policymaking and public relations, and they must be prepared to answer the tough questions about creating and distributing this desperately sought-after vaccine. Their ability to shape the knowledge and opinions of world leaders and the global population will be indispensable in the fight to eradicate this deadly disease and many others.

TL;DR: The Chain Drain: Rethinking Pharmaceuticals After COVID

Here’s What You Need To Know …

As the dust begins to settle from the coronavirus pandemic, the impact on the pharmaceutical industry is becoming clearer. Whether or not American drug manufacturers are ready, policymakers are scrutinizing the industry’s global supply chain and considering what steps to take to derisk it before another pandemic or other disruption hits. This scrutiny on supply chain and related trade issues had been mounting for some time before the pandemic, driven by the broader shift in public sentiment surrounding the benefits of free trade and globalization in the face of U.S. job losses, particularly in the manufacturing sector, that some attribute to unfair trade agreements.

Now policymakers in Congress and the Administration are advancing measures they hope will spur greater pharmaceutical manufacturing in America, protecting our national interests and returning high wage jobs to America. Indeed, some of these policymakers have been sounding the alarm for years about the economic and national security risks associated with keeping critical parts of our strategic industries, including the biomedical sector, overseas. Now the convergence of events and public sentiments has given them an unprecedented opportunity to advance their desired solutions.

Caught in the middle are pharmaceutical companies that must navigate these policy demands that could require enormous investments in new infrastructure amid a shake-up of the international supply chain. Meanwhile, other countries are watching, and their response to America’s policy direction could have its own implications for drug manufacturing and development. To understand how we got here, what policy shifts are underway, and how those shifts could impact the industry, here’s what you need to know.

How Did We Get Here?

Blame Trump And China: Mounting public concerns about free trade and global supply chains were heightened by President Donald Trump’s 2016 campaign, which focused in large part on holding China accountable for its trade practices. His aggressive posture on China, coupled with a slew of events in the past several years that raised awareness of China’s human rights practices, has sent American public opinion about the nation plummeting. Today, a record 66 percent of Americans hold unfavorable views of China, an astonishing 40-point margin reflecting its worst reputation in recent history due in part to the country’s widespread failures in responding to the coronavirus and its refusal to be honest about the virus’s severity.

The New Bipartisan Consensus: Labor unions and progressive voices within the Democratic Party have fought against free trade for decades. They argued that overseas operations eliminated domestic manufacturing jobs that were the bedrock of the American economy. Republicans long resisted these protectionist pleas, insisting that unfettered free markets drove down the cost of goods, making them more affordable to Americans while bringing about economic growth that would buoy the American workforce.

Now, with too many factory towns still empty and growing public sentiment that globalization destroyed higher paying American jobs, some prominent free market-oriented Republicans have shifted their approach to addressing America’s wealth inequality. This new approach connects that gap with economic and security threats associated with unreliable trading partners like China, arguing those threats endanger the American people far more than they would benefit from cheaply-made goods. One example of this approach is Sen. Marco Rubio’s (R-Fla.) extensive China plan, released in February 2019, for a more aggressive U.S. response to China’s strides for global dominance. This plan came amidst a growing bipartisan consensus on the need to protect strategically important industries for both national security and economic interests.

Safety And Supply Concerns Before Coronavirus: U.S. regulators have expressed concerns about the safety and efficacy of Chinese-made pharmaceuticals, cautioning that their quality control and health standards are lower than those at U.S. facilities. Despite governmental warnings that the Chinese government is “inadequately resourced to oversee thousands of Chinese drug manufacturers” and, thus, imperil drug safety, the U.S. still sought its most common and needed drugs from China. Even prior to the coronavirus outbreak in the U.S., experts warned that problems in China could cause severe shortages of approximately 150 drugs upon which Americans rely, and the U.S. Department of Commerce reports that large majorities of over-the-counter and basic prescription drugs come from Chinese manufacturers, including many commonly used, low-cost generics.

However, the challenge is much greater than cost competition. Among the most glaring issues facing the U.S. in biomedical innovation is the significant amount of raw materials necessary to develop vital cell and gene therapies that is produced in China. Despite the FDA requiring these therapies be developed in the U.S., American companies are still relying upon China to provide the raw materials for life-saving treatments and cures. Indeed, as STAT notes, “the number of facilities making [so-called active pharmaceutical ingredients] in China has more than doubled since 2010.”

What Policies Are On The Horizon?

Congressional Action To Stop China From “Weaponiz[ing]” Drug Exports: Lawmakers on both sides of the aisle now fear China’s ability to “weaponize” drug exports, which could leave Americans with diminished access to critical pharmaceuticals. Sen. Tom Cotton (R-Ark.) and Rep. Mike Gallagher (R-Wisc.) introduced the Protecting our Pharmaceutical Supply China from China Act to address this challenge. The bill would “prohibit pharmaceutical purchases from China or products with active pharmaceutical ingredients created in China” and “create transparency in the supply chain by instituting a country of origin label of all imported drugs.” To alleviate some of the new burdens on American manufacturing, the bill would also provide economic incentives for manufacturing drugs and medical equipment in the U.S. Meanwhile, Sen. Marco Rubio (R-Fla.) joined forces with a bipartisan group of senators, including Sen. Elizabeth Warren (D-Mass.), to introduce the Strengthening America’s Supply Chain and National Security Act, which would “combat America’s supply chain risk and dependence on China for pharmaceuticals.”

Trump’s Huge Pharma Deal: In May, the Trump Administration assigned one of the largest-ever government contracts from the Biomedical Advanced Research and Development Authority to Richmond, Va.-based Phlow Corp., now tasked with producing generic medicines and pharmaceutical ingredients necessary to treat COVID-19 but that are currently made overseas, particularly in India and China. The contract, which could total upwards of $812 million over the next decade, is a “historic turning point in America’s efforts to onshore its pharmaceutical production and supply chains,” President Trump’s trade adviser Peter Navarro explained, arguing the project “will not only help bring our essential medicines home but actually do so in a way that is cost competitive with the sweatshops and pollution havens of the world.” 

Buy American Iron And Steel … And Maybe Drugs: The Phlow deal isn’t the Trump Administration’s first effort to return manufacturing to the U.S. In July 2019, President Trump issued an executive order to strengthen “Buy American” laws. According to the American Action Forum, the order declared that “55 percent of the cost of manufactured domestic end goods must be made in the United States (up from 50 percent),” and, “The order further strengthened domestic requirements for iron and steel products.” According to a statement from Trump trade czar Peter Navarro in May 2020, President Trump is considering expanding this policy further to include “medical products and pharmaceuticals.” Navarro says this step would need to be accompanied serious deregulation to make it easier for pharmaceutical companies to do business in the U.S.

“Made In America” Sounds Good, But It Comes With Tradeoffs.

Supply Chain Reliability And Trade Consequences: Some critics of applying the so-called “Buy American” policy to pharmaceuticals say they’re worried that a supply chain that is not diversified could cause shortages and real problems in emergencies. According to a letter from the U.S. Chamber of Commerce and dozens of biomedical and other business groups, efforts to return manufacturing of health-related goods are worthwhile, but, “The United States simply does not produce all of the raw materials or intermediate goods that are essential to drug development,” and the policy “would only exacerbate the supply shortages.” The groups also expressed concern that, “as the world’s most innovative economy, the United States cannot shut itself off from the rest of the world. Turning our backs on trading partners during a crisis could damage our relationships long after this pandemic ends. If we implement localization requirements, many of our trade partners would assuredly follow our lead.”

Costs Passed To Patients: More than 250 economists signed a National Taxpayers Union letter expressing concern that a “Buy American” policy for biomedical products could make vital care more expensive for patients in the U.S. and harm our trading position with partners around the globe. The letter also notes, “A Buy America directive can also hamstring the ability of U.S. pharmaceutical and medical equipment manufacturers to meet our future needs if firms are denied access to essential foreign supplies.”

Meanwhile, the Pharmaceutical Research and Manufacturers of America says that building a single new biopharmaceutical manufacturing facility can take 5 to 10 years and cost as much as $2 billion, meaning increased investments by these companies are passed on to consumers. The American Action Forum has also warned about the economic costs, saying that any executive action would make only a minimal impact on purchasing via federal health care programs while driving up the costs and reducing the accessibility for many more consumers.

Risks to Intellectual Property: A common complaint among critics of a “Buy American” biomedical manufacturing policy is that it could devalue the intellectual property of researchers and companies who invested time and money into developing pharmaceuticals and vaccines. Their fears are well-founded in the context of the current pandemic, as anti-patent groups are already questioning how it will be possible to ensure equitable access to a future coronavirus vaccine if the companies producing the vaccine maintain the intellectual property, and researchers are facing mounting pressure to take the Open COVID Pledge to contribute their findings towards developing coronavirus treatments without maintaining intellectual property claims to their work. Amidst this pressure and scrutiny, actions by U.S. policymakers could force reactions by other countries that further undermines protections for the intellectual property developed by American pharmaceutical manufacturers, even though such protections are critical to creating life-saving treatments for COVID-19 and other illnesses the world faces.

Preparing For The Debate Underway

As support for bringing biomedical manufacturing home increases, so, too, do the challenges facing biomedical innovators. They must be prepared for the reputational risks associated with passing on investment costs to their customers, as well as the potential of losing their intellectual property rights. With threats arising from across the globe and across the political spectrum, pharmaceutical companies must be armed with the competitive intelligence necessary to advocate for their organizations and the patients they serve. Delve is ready to help.

Narrative-Driven Media and Pandemic Perceptions

Here’s what you need to know…

In January, we took a look at growing media concerns over the potential for misinformation spread by online bots and irresponsible political entities to disrupt the 2020 election. As we wrote at the time, the media says “consumers of information are going to have to scrutinize stories and sources to make sure that the news they’re viewing is a true representation of events – rather than a made-up or entirely obfuscated piece of clickbait. But what if seemingly well-intentioned reporters at reputable organizations run stories misreporting events, stating opinions as facts, or otherwise misrepresenting developments?”

The real challenge, we noted, was not so much Russian bots and erratic tweets, “but rather how fake the real news can be.” This “symptom of our current media age,” we wrote, “must be addressed in a serious and meaningful way if the press is to regain its footing as a crucial institution underpinning democracy.” Axios concurred, expressing concern that “the public’s confidence is so low in key people and institutions [including the news media] that no one is likely to be a trusted referee” in a crisis.

Fast forward to a new Pew Research Center poll that found 50% of Americans say they find it “difficult to distinguish what’s true from what isn’t when it comes to the pandemic.” While CNN’s Chris Cillizza blames President Trump and his press briefings, the reality is that he and the rest of the media have been just as culpable, if not more so, in spreading confusion and misinformation.

As the below examples illustrate, the media is overwhelming Americans with often conflicting information as they obsessively drive a predetermined narrative rather the provide sober information Americans need.

Labradoodle Breeder or Public Health Expert? Intent on driving a narrative that the Trump Administration was ill-prepared for handling this crisis, many in the media have been eager to portray about Administration officials working on the response as scientifically illiterate and unqualified. The most ridiculous depiction can be found in a widely-circulated Reuters story entitled, “Special Report: Former Labradoodle breeder was tapped to lead U.S. pandemic task force.” Journalists, commentators, and activists piled on, happy to downplay Department of Health and Human Services (HHS) Chief of Staff Brian Harrison’s two decades serving in senior positions across multiple administrations, all because his family owned a Texas-based dog breeding business.

Another example comes from CNN, which dedicated an entire story to undermining the credentials of the official tasked with unveiling the federal government’s findings regarding environmental impacts on the coronavirus’s lifespan. “Homeland Security official who detailed effect on coronavirus isn’t a scientist,” the headline proclaims, as though Bill Bryan, Undersecretary for Science and Research at DHS, was personally conducting the studies himself and not presenting the research of scientists at DHS’ bioterrorism lab.

Questionable Presidential Guidance or Fish Tank Cleaner Whodunit? After President Trump touted the potential benefits of anti-malarial therapeutic hydroxychloroquine, the media was keen to portray it as unsound medical guidance that endangered Americans. So the media quickly jumped on the story of an Arizona woman claiming President Trump caused her to accidentally poison her husband with a fish tank cleaner called chloroquine, a similarly named but entirely different substance. She told reporters the President’s comments led her to persuade her husband to take a spoonful as a safeguard from the virus.

No mainstream outlet seemed curious about why an “intelligent, level-headed engineer” with a science education and no prior history of erratic behavior would make such an irrational decision. When the Washington Free Beacon’s investigative reporter Alana Goodman dug into the claim, she discovered that not only was his wife an ardent Trump opponent who would have been extremely unlikely to rely on his public health advice, but she also had an extensive history of behavioral issues that would give any prudent journalist suspicions she could be lying about the circumstances of her husband’s death. As has often been the case with Trump era media coverage, the first day headline gave way to a much different reality when other reporters dig into the actual facts.

Process Stories and Gotcha Journalism Obscure Important Public Health Information. An unfortunate byproduct of the media instinct to prove Trump wrong at all costs is the stigmatization of hydroxychloroquine, a common therapeutic for mosquito-borne malaria and autoimmune diseases, such as lupus and rheumatoid arthritis. By all accounts, this drug is safe to use, and many Americans rely upon it to maintain a healthy quality of life. Dr. Anthony Fauci, who leads the National Institute of Allergy and Infectious Diseases, has noted the side effects to the drug are minor, scant, and almost always reversible. But for many Americans, it will be remembered incorrectly as the fish tank cleaner that killed a man because President Trump told him to take it. Meanwhile, governors were forced to treat the drug as a partisan wedge issue, and in the process disrupted access to the treatment for those who need it.

Desperately Seeking Light. Similarly, when the White House Coronavirus Task Force announced government scientists had discovered that light, humidity, and disinfectant all greatly diminish the lifespan of COVID-19, the media focused only on President Trump’s disinfectant gaffe. Even though these findings were the result of an extensive laboratory study conducted at the U.S. federal government’s bioterrorism lab and since confirmed in part by German governmental scientists, the media only asked public health officials about the gaffe.

White House Coronavirus Response Coordinator Dr. Deborah Birx lamented that this relentless focus “caused the public to miss some vital information coming from scientific studies about sunlight and coronavirus.” Indeed, the groundbreaking research provided the American people with critical information about a virus whose many unknowns had made life pretty scary and confusing. It also offered the country cautious optimism that the upcoming summer months could give us needed reprieve from this deadly virus. Instead, the media coverage left the American people no better off or more informed.

Navigating “Slicey And Dicey” Information Overload. Scandalous headlines might bring news outlets clicks and eyeballs, but they come at a great cost. As Dr. Birx explained, “I think the media is very slicey and dicey about how they put sentences together in order to create headlines … the reporting maybe accurate in paragraph three, four, and five. But I’m not sure how many people actually get to paragraph three, four, and five.”

The challenge for companies and industries is that agenda-driven journalism such as the examples above obscures worthwhile medical guidance, which contributes to public hysteria that has real life consequences and significantly weakens our ability to accurately assess risks in the world around us. It also reduces our willingness to trust and follow legitimate direction from public health and governmental leaders.

As we wrote in January, “This ‘fakeness’ of real news means companies and trade associations will need to rely on a range of primary and secondary sources when monitoring developments in order to gain a more complete and accurate picture of their operating environments and the key trends impacting their interests.” Now, more than ever, organizations must carefully sift through the noise to find out for themselves what is real and what will impact their futures.

To help, starting this month, in addition to these Saturday analyses, we will be offering a Tuesday Tip each week on how you and your colleagues can do just that. We hope that this new free service will help your organizations better navigate this crisis.

Mitigating risks to international investments in health and life sciences

The Challenge: Local NGOs in key regions around the world were mounting sophisticated efforts to influence government policies and actions in ways that could undermine policies that are crucial to international investment in health and life sciences. The client was seeking to better understand who was funding and supporting these on-the-ground efforts so they could anticipate and mitigate those efforts.

The Solution: We began by producing a network overview report that detailed how international groups and global funders supported and directed the activities of local, seemingly-grassroots organizations. The overview report identified the key groups involved, which countries they were active in, the funding and other technical and legal support they provided, and how the groups at various levels coordinated and collaborated to influence national government and multilateral policies.

We then stood up an ongoing monitoring program informed by the network overview to provide regular analysis on activists messaging and influence efforts, collaboration among the various groups, and communication with national government and multilateral officials.

The Result: The network overview helped the client understand the nature and scope of the challenge they were facing. The monitoring alerted the client to issues before it was too late to mitigate their impacts.

Pharmaceutical company facing inexplicable opposition to a next generation drug


A pharmaceutical company had developed a next generation treatment for a significant life-threatening disease. The company’s engagement with patient advocates and other stakeholders had proven mostly successful and won them significant support for the future release of this drug. However, there was one very vocal organization that vociferously opposed this next generation treatment at the FDA and elsewhere.


We were engaged to help the firm understand the motivations of this opponent and provide a roadmap for overcoming this opposition in order to successfully win approval for this lifesaving drug. Through our research, we exposed this group’s true motivation for breaking from other stakeholders and opposing the drug. We discovered that the main source of revenue for this organization was treatment clinics that used the current generation of drug treatments that aided but did not prevent the disease. The organization had a history of similar controversy and loud objections that could reduce their credibility, as demonstrated by the range of key voices among patient advocates and other stakeholders we were able to identify who were highly critical of this organization.


The materials and insights we provided allowed the pharmaceutical company to build a narrative that marginalized the organization and successfully overcame their objections.

Rx For Lower Drug Prices

TL;DR: RX For Lower Drug Costs, Donation Protestations, And Facts And Credibility

Here’s what you need to know…

President Trump’s rhetoric toward drug companies, which he has accused of “getting away with murder,” has been heated at times. That is why the industry and others in the health care space were watching closely when the Administration’s plan to lower prescription drug prices was unveiled last Friday. The plan, entitled “American Patients First,” would be a step to fulfilling the President’s campaign promise to reduce the costs that U.S. patients pay for their medications, which are the highest in the world. Here is what you need to know about the plan:

  1. What The Plan Does: Despite the President’s past rhetoric and initial industry fears of “biting” action, the plan included few specifics that would immediately impact prices and no large reforms to the way the system currently operates. The plan seeks to “increase competition, improve negotiation and create incentives to lower list prices of prescription drugs and out-of-pocket costs for consumers,” and some of the ways it proposes to do that is by implementing rebate-sharing in Medicare drug plans (an idea supported by the Obama Administration), promoting generic versions of drugs, including drug pricing in trade negotiations with foreign countries, and requiring manufacturers to publish prices in advertisements. After Trump’s plan was criticized for being light on substance, Health and Human Services Secretary (HHS) Alex Azar briefed reporters on concrete actions he can take as HHS Secretary “with [his] pen” to make changes to the pharmaceutical marketplace without Congressional approval, suggesting the Administration’s seriousness about ultimately backing up its rhetoric.
  2. The Industry’s Reaction To The Plan: The gravest concern for the industry was that the proposal would allow the federal government to negotiate lower Medicare drug prices directly with insurance companies. When this did not come to pass, biotech and pharmaceutical stocks went soaring, as well as those of the pharmacy benefit managers like Express Scripts and CVS – “middlemen” previously condemned by the President. While drug companies that engaged in lobbying the executive branch in hopes of helping shape the plan may be relieved in having been spared from drastic changes to the operating landscape at this time, there is a possibility that the President may diverge from his current course, meaning that companies should continue to remain vigilant in monitoring developments in this policy area.
  3. What Remains Unclear Going Forward: The timeline for the implementation of the plan’s policy changes remains uncertain, as is the extent to which the HHS Secretary will use his pen to implement proposed changes in the marketplace. Because of this, parts of the industry are already signaling a more public lobbying campaign in the coming months while the plan is being debated. Particularly in the runup to the midterm elections, the industry may be a prime target for further public shaming, as well as more robust regulatory attention from both the Administration and Congress, that may impact research and development efforts and raise the specter of greater political risk.

As Trump’s FDA Commissioner Scott Gottlieb has noted, there is no “silver bullet” to bring down the costs of drug prices, especially when many Americans have unrealistic expectations regarding the trade-offs that would be required to implement policies to lower them. As long as these expectations persist, actual policy proposals will pale in comparison to the rhetoric used in the public arena and contribute to an operating landscape fraught with political and reputational peril for the industry.

News You Can Use


The Bay Area has become one of the wealthiest regions in the country and many tech moguls have already pledged to give away much of their fortunes, yet how some have chosen to donate their wealth has attracted scrutiny due to the potential benefits they receive in doing so. The Atlantic investigated the increasing popularity of a donor-advised fund, which is a certain type of charitable account that allows “donors to receive big tax breaks for giving money or stock” with “little transparency and no requirement that money put into [the account] is actually spent.” The rise in use of these funds has also correlated to a drop in donations to more traditional charities and private foundations in the Bay Area.

However, supporters of donor-advised funds point to the benefits of the accounts, which are better-equipped to accept non-liquid assets like stock, reduce the costs of operation needed by traditional nonprofit organizations, allow wealth to accumulate and grow like a charitable savings account, and incentivize people to get more bang for their philanthropic buck as opposed to giving more money in taxes to the federal government. So, while donor-advised funds may become another front in the public affairs campaign against Silicon Valley or the wealthy, as with all narratives in the public arena, there is more than one side to this story.


If you thought you knew the cause of the decimation of manufacturing jobs in the United States, think again. In fact, you would not be alone. Although economists’ popular consensus is that Chinese trade is the leading cause, a key expert disputes this consensus, pointing to research he recently posted that links job loss in manufacturing to the displacement of jobs resulting from automation.

China is blamed for the decline of the manufacturing sector largely based on a body of work that shows China’s 2001 entry into the World Trade Organization coincided with stalled growth in the American manufacturing economy, but Carl Frey – the Oxford economist whose study found that automation still has “a significant impact” while controlling for Chinese trade – disagrees, based off of his findings from examining automation anxiety and the 2016 election. For those trying to highlight the benefits of free trade in an operating landscape where consensus is constantly evolving, and where we all at times have only partial information, a competitive advantage that makes sense of the mass of information flows available is more important than ever in achieving their policy objectives.


Much of the focus on curbing the rise of fake news has been on top-down government regulation of tech companies and their platforms, but to curb fake news in favor of a more elevated, fact-based debate may instead require a grassroots approach. Felicia Cravens is a conservative activist who started the Unfakery Facebook page, which hunts for fake news, fake profiles, baiting spammers from overseas, and other forms of misinformation targeting conservatives online.

Since founding the group, Cravens has attracted like-minded conservatives from across the country who have credibility with their side of the political spectrum – which Snopes, PolitiFact, or Media Matters for America may not – to take a discerning view of the facts and context of articles and news shared online, lead where they may, and push back on misinformation by sharing credibly-sourced links. Besides demonstrating a way to curb fake news online without federal regulation, which ultimately stifles competition and benefits entrenched incumbents, another aspect highlighted by Unfakery’s work is that credibility is an integral aspect of leveraging facts to gain a competitive advantage. 


The Executive Office of the President’s (EOP) Spring 2018 Unified Agenda of Regulatory and Deregulatory Actions was recently released, and to help you better prepare for what comes next, here is where you can review by agency the proposed deregulatory measures on deck. The “steady, bit-by-bit” deregulation by the Administration has continued persistently despite all of the noise, confusion, scandals, and unforced errors that undermine The White House’s work on a near-daily basis, and will likely have a profound impact on the regulatory landscape beyond the life of this Administration. While the President was ridiculed when he wanted last year’s tax reform law to be called the “Cut Cut Cut Act,” given the Administration’s continuing work to cut regulations, might we propose a simpler name: the “Cut Cut Cut” List.