Under the Funding Microscope

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The temperatures may be high, but the investment climate is staying cool. Nowhere is this reality more evident than in the life sciences and biopharmaceutical industries. In March, Delve’s Life Sciences Outlook 2023 explored why the post-pandemic operating environment is starkly different than the one in 2020 and 2021, and as the year unfolds, the headwinds continue to grow. That reality has implications for a range of industries.

While venture capital and private equity firms have plenty of capital, they are being highly judicious in deploying it. Economic indicators and rising interest rates are certainly part of their calculation, but when it comes to life sciences – and a number of other sectors – the policy direction from Washington is also putting many early-stage firms under a more rigorous microscope as investors increasingly consider not only where and when to invest, but even if. Here’s what public affairs professionals need to know to help their organizations stand firm amidst the economic and political headwinds.

An “Investment Plateau” Has Early-Stage Firms Scrambling For Viability

The life sciences and biopharma boom brought on by COVID-19 saw outsized valuations and unprecedented investment in the industry. While there is still good news related to long-term and sustainable growth, industry experts see an “investment plateau.” More cautious investments, combined with ramped-up regulatory oversight, has resulted in a 40% drop in early-stage investments and a 30% drop in venture capital funding. The decline in early-stage investments has meant layoffs and shifted firms’ focus on “nearest-term value drivers” rather than long-term innovation. As SVB’s Healthcare Industry Trends Mid-Year 2023 Update notes, “valuations are being recalibrated to align with current market conditions, rooted in fundamentals such as clinical assets and paths to profitability.”

For public affairs and government relations professionals, this shift in the funding environment requires an increased focus on effectively communicating your firm’s value proposition and path to profits. Investors, now more than ever, want – and expect – to hear where the market opportunity lies and the unique scientific offering provided before writing a check. To secure funding, companies must be able to articulate how they will navigate FDA approval, Medicare/Medicaid reimbursement schedules, and FTC scrutiny in the post-Dobbs Decision, post-COVID world. As our Life Sciences Outlook 2023 notes, that includes “building a robust bank of knowledge” to “illustrate the market value and scientific rigor in a communications-ready format,” as well as “survey[ing] the landscape for where meaningful wins can be achieved and where serious political and reputational blows are likely to come.”

Policymakers vs. Profits Takes Center Stage

While the Inflation Reduction Act is a boon for clean energy investments, it is a major dampener for life sciences, as the bill made the long-sought goal of Medicare drug price negotiations a reality. Getting added to the Medicare reimbursement schedule is a key milestone for early-stage drug and device developers, which makes the Centers for Medicare and Medicaid Services (CMS) plan to target the first ten drugs to be negotiated by September 1st a worrisome prospect for firms and investors alike.

Already, big firms like Bristol Myers Squibb and Merck, as well as several Washington trade groups, have filed suit to stop CMS’ plan. Meanwhile, one cancer treatment innovator is weighing “slow-walking” new treatments to avoid the anticipated Medicare price pressures. Even as it complicates life sciences innovation, a new study questions whether these negotiations will actually save patients or the government any money.

Beyond the IRA’s impact, the drug pricing debate has not been put to bed. The White House continues to call for price caps and attacks pharmaceutical companies for making a profit, while some on Capitol Hill question their patent protections. Being “proactive in making the case for the unmet need you are addressing and the clinical and technological efficacy your product or technology offers” is crucial to weathering this storm.

The Pressure Won’t Stop At Price

While who pays how much for which drugs remains a fraught debate, it is not the only scrutiny from Washington and beyond. Both established and early-stage life sciences firms face new or heightened scrutiny from across the political spectrum on a range of other issues, including drug shortages and supply chain difficulties that could soon be exacerbated by pharmaceuticals’ dependency on China amidst fraying economic relations between the U.S., the EU, and China.

Life science firms must also consider regulators’ impact on strategic acquisitions, with both Washington and Brussels taking a more active approach to anti-trust enforcement. Federal Trade Commission Chair Lina Khan said the commission’s focus is cracking down on acquisitions of companies with drugs that are already on the market, such as the body’s recent lawsuit to block Amgen’s takeover of Horizon Therapeutics, but claimed the FTC recognizes newer drugs or treatments may need M&A to reach full commercialization. This view, however, did not stop the FTC from working with their European counterparts to block Illumina’s acquisition of early-stage cancer diagnostics developer Grail.

Firms also have to contend with new areas of political scrutiny driven by the twin tides of populism and progressivism, both of which are skeptical if not hostile to business. On the Left, healthcare companies have drawn ire from climate activists over greenhouse gas emissions in their supply chains and single-use plastics. On the Right, even former champions of public health research funding are now calling for those budgets to be slashed and for Congress to increase scrutiny of the industry in the wake of the politicized COVID-19 vaccine debate. In addition, lines are beginning to be drawn in the sand over the industry’s adoption of artificial intelligence. These new fronts of debate each carry serious reputational risk requiring firms to be well-versed with the full spectrum of policymakers and outside stakeholders shaping the battlefield. debates.

To Thrive, Research Can’t Just Be Relegated to the Lab

Economic concerns and increased scrutiny from regulators are leading to a tighter funding environment. To ensure life sciences firms can survive and thrive this new reality, public affairs professionals must have the right insights to avoid the regulatory and reputational roadblocks to commercial success. That means understanding the risk environment and which stakeholders and policymakers are shaping it in what ways, then diving deep to understand those actors – who can be an ally and whose efforts will your firm have to overcome? At Delve, we use this proven playbook to help firms navigate the headwinds in life sciences and beyond to further innovation and ensure commercial success.

What Goes Up, Must Come Under Scrutiny

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After being thrust into the limelight during the pandemic, it is not surprising that life sciences firms – particularly the innovative early-stage firms advancing new cures, treatments, diagnostics, and other health technology – experienced banner years for investment in 2020 and 2021. As the cost of capital spiked with interest rates last year even as the public markets crashed, life sciences firms and their investors find themselves in a very different environment in 2023, and the challenges they face offer lessons and insights for a range of industries.

With investors more hesitant to deploy funding and life sciences exits declining in frequency and volume, early-stage biotechnology and biopharmaceutical firms that raised initial funding in the heyday of 2020 and 2021 face a funding cliff. Adding further pressure, Washington is waking up to just how expensive increasingly customized and sophisticated life science products can get while policymakers and other stakeholders are raising sharp questions for the industry about health equity, environmental justice, and a range of other concerns in an increasingly politicized operating environment.

To help life sciences firms push past these financial, political, and reputational headwinds, Delve has put together our Life Sciences Outlook 2023 to offer a playbook for advancing innovation no matter how uncertain the environment. Here’s what public affairs professionals need to know to help life science innovators navigate the headwinds of 2023.

Washington Questions The Cost Of Innovation

Policymakers Have Drug Prices In Their Sights. It’s not surprising that in Washington, questions about cost and access drive the debate over healthcare policy. Firms should prepare for political scrutiny of every pricing and access decision they make, especially for expensive and exclusive products, because politicians and regulators are increasingly questioning the logic that profit drives innovation. Last year’s Inflation Reduction Act added another arrow to the quiver of regulatory pressure on drug prices, allowing Medicare to begin negotiating prices on certain drugs, which many believe will hurt innovation by limiting the resources available to develop new drugs. The politics of drug pricing are even adding pressure to the drug approval process, with Biogen’s new Alzheimer’s drug Aduhelm becoming a poster child for how pricing decisions can upend the FDA approval process, draw the ire of Congress, and impact approvals for other lifesaving treatments.

Politicians Hope Trust-Busting Makes The Prices Go Down. Washington’s push for lower costs and broader access is also making it more complicated for early-stage firms to find the exit their investors need to keep advancing innovation, with more policymakers and regulators blaming industry consolidation for rising costs in the healthcare sector. That is leading to more antitrust action. Congress and President Biden have given the Federal Trade Commission even more resources to grow its trust-busting portfolio that already includes efforts against hospital mergers, private-equity acquisitions, and pharmacy benefit managers. Some in Congress are pressing for even more action.

Life Sciences Faces Its Stakeholder Capitalism Moment

Life Sciences Not Immune To Social Change. Widening the lens of scrutiny beyond Washington, a broad mix of social and cultural movements are increasingly expecting companies – including those in the life sciences sector – to re-think how they interact with and impact their communities and the world. In healthcare, stakeholders are focused on health equity and diversity, with firms under pressure to take action on issues like boardroom diversity and the ethnic composition of clinical trials. At the same time, the fallout from the Dobbs v. Jackson decision is complicating the life sciences space as elected officials and activists on both sides of the debate square off over telehealth services, patient privacy, and access to medicines.

Environmental Activists Expect Healthcare To Get Greener. These social movements are also linking up with environmental activists to scrutinize how a wide range of sectors impact our environment. Life sciences firms face pressure to address carbon emissions and manufacturing waste, as well as its (often vital) use of single-use plastics. As more and more firms adapt to the demands of the environmental movement, companies throughout the life sciences supply chain will face increased pressure to conform.

Geopolitical Winds Buffet The Industry

Replacing ‘Made In China’ With Domestic Supply Chains. For many biotechnology and biopharmaceutical companies, environmental impact is a global question since their supply chains crisscross the planet. That crisscrossing is also its own challenge brought into greater focus by the pandemic. The industry, politicians, and stakeholders are concerned about the vulnerability of a highly interconnected global supply chain with a heavy reliance on China. With supply chain issues still driving shortages for popular drugs, there are sustained calls for Washington and Europe to incentivize if not force reshoring of the biotechnology and pharmaceutical supply chain.

Patent System Under Attack From Newly Empowered Activists. The drug shortages experiences in the U.S. and Europe, along with vaccine politics and debates over drug prices, have added fuel to ongoing activism against the global patent system. What was a disparate collection of local and regional patent activists coalesced during the pandemic to demand the United States and European nations allow intellectual property rights to be waived for COVID-19 vaccines and other COVID-related technologies. Now more powerful, coordinated, and motivated anti-patent activists are leveraging that win to push for re-making or dismantling the patent system entirely, making it critical for life sciences firms to understand the patent debate and prepare for any changes to patent protections.

Your Playbook for Surviving The Uncertainty

During the pandemic, biotechnology and biopharmaceutical companies, especially early-stage firms, proved how important innovation is for sustaining and saving lives. Now those companies face complicated financial, political, and reputational headwinds, and they need a plan for confronting those challenges. Delve’s newly-released Life Sciences Outlook 2023 provides a playbook for life sciences firms to navigate the risks and opportunities of 2023 and beyond, but the trends and insights also apply to any firm in a range of industries trying to understand and navigate their own challenges.

Biden Goes Global

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It is the grand tradition of presidents who lose control of Congress to lean into foreign policy matters in which they can act with fewer legislative constraints. President Joe Biden wasted no time following this tradition, heading around the world before the votes were fully counted. His itinerary provided a glimpse into where his administration will focus abroad, spanning the 27th United Nations Climate Change Conference (COP27) in Egypt, G-20 Summit in Indonesia, and ASEAN Summit in Cambodia, the last of which included a high-profile meeting with Chinese President Xi Jinping.

While The White House’s recently released National Security Strategy “leaves more questions than answers about the White House’s approach to global crises,” in this era of heightened geopolitics, public affairs professionals cannot wait to see how Biden tackles foreign policy in the next two years. Biden will be under pressure from a GOP-controlled House regarding assistance to Ukraine and U.S.-China relations, but countless other international debates garnering less attention will impact a wide range of industries. Here is what public affairs professionals need to know as they prepare for Biden going global.

From Climate to Covid, Biden Can Use the Multilateral Stage to Advance His Agenda

Delivering Climate Aid to Developing Countries. At COP27 last month, Biden renewed his pledge of $11 billion to assist developing countries in the energy transition, even after these funds were left out of the Inflation Reduction Act this summer. A Republican-led House is unlikely to provide any funding, but Administration officials hope to leverage federal development agencies like the Export-Import Bank and the International Development Finance Corporation and a carbon credit system U.S. climate envoy John Kerry unveiled at COP27 to circumvent Congressional opposition.

Negotiating the WHO Pandemic Accords. Biden recently appointed Ambassador Pamela Hamamoto, who served as President Obama’s envoy to U.N. agencies in Geneva, to represent the U.S. in negotiations of the WHO’s proposed Pandemic Treaty. The accord – which the WHO is looking to have finalized by May 2024 – seeks to more effectively respond to future global health emergencies, and is likely to include several provisions impacting the pharmaceutical industry and other health innovation, as it could include intellectual property waivers, mechanisms to transfer technologies, and disclosure requirements in public procurement contracts.

Pressuring Countries to Enact a Global Minimum Tax. Having secured a 15% corporate minimum tax on many large firms in the Inflation Reduction Act, expect Treasury Secretary Janet Yellen to pressure other nations to keep their commitment to enacting their own minimum tax on multinational corporations – an early Administration ‘win’ on the global stage.

Great Wall of Congress May Force Biden to Stay Tough on China with a Little Help from Some Friends

Warming up to Xi, but not recoupling. Biden’s G20 meeting with Xi highlighted his desire “to find ways to work together on urgent global issues,” but the President has shown little sign of slowing efforts to disentangle critical American industries from Chinese supply chains. His administration recently announced new export control measures restricting China’s access to chips and chip-manufacturing equipment, and the Commerce Department will soon release preliminary finding in a prominent Chinese solar panel dumping case that could spur tariffs on imports when the President’s two-year moratorium ends.

Transforming Trump’s Tariffs into Biden’s Tariffs. The Biden Administration has so far maintained the Section 301 Tariffs that levied duties of up to 25% on hundreds of Chinese imports for national security reasons. However, the statutorily required four-year review of these duties, as well as ongoing legal actions and the December 31 expiration of several product exclusions, gives the Administration the opportunity  to reassess which products should remain protected. The comment period for the four-year review is open until January 17. With strong pressure from Biden’s base to maintain protectionist policies and both parties keeping the heat on China, expect firms to increase their lobbying efforts as decision time approaches.

Coupling With Taiwan. This month, the U.S. began talks with Taiwan aimed at strengthening trade and economic ties, with hopes for a pact as soon as next year. China has condemned the trade initiative,  which would be a boon to the U.S. agriculture and technology sectors, as Taiwan is the sixth-largest export market for U.S. food and agricultural products and the number one manufacturer and exporter of semiconductor chips in the world. The pact has the potential to ease the ongoing chip shortage.

Strengthening Indo-Pacific Ties. In the wake of the historic and encompassing Regional Comprehensive Economic Partnership (RCEP) trade agreement between the ten ASEAN countries and their six regional trading partners, including China, the Biden Administration will need to consider how it approaches trade liberalization in the Indo-Pacific. The recent Indo-Pacific Economic Framework may be a start, but it is far from a full-fledged free trade deal and India, a major player in the region, hasn’t signed on to its trade pillar, despite a recent visit by Treasury Secretary Janet Yellen. Biden has also been pushing for a digital trade agreement in the Indo-Pacific. Such an agreement would signal the U.S.’s commitment to strengthening ties in the region, especially economically, with an industry that is of strategic interest and commercial value.

Balancing Climate and Energy Security in European Relations

Boosting LNG Shipments to Europe…Or Retracting? Biden is trying to thread the needle between assuaging European allies who seek more LNG imports to supplant their reliance on Russian natural gas and the environmental justice advocates in his political base who disapprove of additional fossil fuel infrastructure. Biden has pledged to expand LNG exports to the EU to 50 billion cubic meters by 2030, though members of Congress from his own party are objecting, and some European officials are becoming perturbed by American “profiteering.”

Carbon Border Tax and Cleantech Subsidies Could End Biden’s Transatlantic Climate Camaraderie. Biden came into office hopeful for a Transatlantic alliance in climate policy, but it could become a climate clash as the EU enters the final stages of adopting a tax on carbon-intensive imports from countries – including the U.S. – that do not meet their imposed carbon emissions standards, starting in 2026. The tax will impact U.S. manufacturers of aluminum, steel, electricity, cement, and fertilizers that export to the EU. Here at home, Biden has indicated support for a carbon border tax of our own, and Senator Sheldon Whitehouse (D-RI) introduced legislation to do so in June. Meanwhile, European officials are becoming increasingly incensed by the domestic cleantech manufacturing subsidies and incentives embedded in Biden’s Inflation Reduction Act.

As Latin America Goes Left, Will Biden Go Along?

Navigating a Tricky Relationship with Mexico. Even if the border crisis headlines the bilateral relationship with Mexico, the country is also the United States’ third largest trading partner. Mexican President Andrés Manuel López Obrador (AMLO) has rocked the USMCA boat with some of his recent protectionist moves, including talk of nationalizing energy production and restricting GMO corn. While possibility of an all-out trade war seems unlikely, the Administration will have to choose how hard to push back against potential violations of the USMCA, and whether to prosecute potential treaty violations through relatively untested official channels, or keep things unofficial.

Freeing Hydrocarbons Even If the People Aren’t Free. The Biden Administration recently allowed Chevron to resume operations in Maduro-controlled Venezuela even as Senator Marco Rubio (R-FL) claims the Administration tried to oppose an Inter-American Development Bank loan supporting Guyana’s development of its energy infrastructure. As Congress shifts hands, expect more scrutiny of how Biden approaches energy production in the region.

Ensuring Access to Present and Future Resources. Newly elected leftist governments mean access to natural resources may be less certain: Colombia’s Petro seeks to leave oil behind; Peru’s Castillo has pushed to increase taxes on mining companies; Brazil’s Lula promised, in contrast to his opponent, to keep Brazil’s state oil company public; and Chile’s Boric contemplated a public lithium company. Indeed, Argentina, Bolivia, and Chile are discussing a “Lithium OPEC.” The Biden Administration has signaled its commitment to free enterprise in the region, but how willing it is to push back on these policy shifts is unclear, and ensuring access to these resources could conflict with Biden’s climate agenda in the region. While Biden has unveiled a framework for regional economic cooperation similar to its Indo-Pacific proposal, his administration has yet to demonstrate real enthusiasm for new or strengthened trade agreements in either region.

Biden’s Middle East Dilemmas

Pressuring Saudi Arabia on Oil Supply. After Saudi Arabia announced its support for OPEC’s cuts in oil production by two million barrels per day despite Biden’s attempt at mending ties with the de facto Saudi ruler, Biden declared there would be consequences. Potential repercussions could include military support reductions, arms sales cancellations, and enacting the “NOPEC” bill, which would classify OPEC as an illegal cartel and subject its members to U.S. antitrust enforcement. With mixed signals on whether OPEC will increase production soon, expect this relationship to remain as volatile as oil prices.

Reengaging In Nuclear Talks with Iran. With the U.S. condemning Iran’s brutal attacks on human rights protestors, Biden faces a challenging new dilemma: how can he continue his efforts to revive the Obama-era nuclear deal amidst some of the most widespread protests against the regime’s brutality in ten years? There are indications he has put the deal on the shelf for now, but a renewed deal was a key campaign pledge eagerly sought by many of his advisers.

Responding To Netanyahu’s Return. With Benjamin Netanyahu returning as Prime Minister of Israel, Biden will be working with a new (again) leader of the U.S.’s most important Middle East ally. The relationship between Biden and Netanyahu is decades-old and fraught with disagreements, including over the aforementioned 2015 nuclear deal with Iran, the necessity for a two-state solution, and the status of Israeli’s disputed territories. Now, as Netanyahu works to form a government, Biden’s Justice Department has launched “a rare, if not unprecedented” probe into a Palestinian-American journalist’s death, despite an already concluded inquiry by the State Department that found no intentional wrongdoing. Biden and Bibi are also likely to disagree over the value of the Abraham Accords, which the latter negotiated and views as the key to regional security. Yet the Biden Administration has displayed skepticism if not hostility to the Accords and their value in the region, even as they open trade and economic development between key countries in the region.

Critical Industries Have a Lot at Stake

Facing a divided Congress, President Biden will go his own way a lot more in the next two years, wielding the “phone and pen” of executive action on domestic policy and spending more time on foreign policy matters in which he has more autonomy to act. To advance and protect their organizations’ business and policy objectives, public affairs professionals should be prepared for the impact that Biden’s actions abroad may have for their industry, and how different interests and stakeholders can shape and influence those actions.

Regulatory Pain Relief

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Thousands of complex regulations were set aside when the U.S. Department of Health & Human Services (HHS) declared COVID-19 a public health emergency (PHE) in early 2020, thanks to waivers by HHS, Centers for Medicare & Medicaid Services (CMS), Food & Drug Administration (FDA), and other agencies to get care to those in need during what became a global pandemic. Freed of these constraints, America’s healthcare sector adopted new, innovative approaches to access and care provision. While HHS recently extended the PHE declaration through October 13, 2022, it will ultimately end, along with much of this regulatory flexibility.

The Biden Administration has promised to provide states 60 days’ notice before ending the PHE to allow sufficient time to prepare for changes to certain programs and regulatory authorities, but public affairs professionals in the healthcare industry cannot wait until the last minute to protect the advancements made in these challenging times. Here’s what you need to know to make the case.

Flexibility That Allowed Innovation

The waivers enacted under the PHE offered flexibility to a wide range of industry participants – from manufacturers to hospital systems to care providers and others  – to deliver technologies, testing, and treatments to as many patients as quickly as possible. The future of this regulatory relief remains uncertain after the PHE lapses.

Emergency Use Authorizations (EUAs) Brought Vaccines, Treatments, Diagnostic Tests, and Medical Supplies at Warp Speed. Based on the PHE, the FDA allowed manufacturers to bring COVID-19 countermeasures to market under EUAs. Firms whose products remain under EUA will have to seek full FDA approval to keep their products on the market after the PHE expires. During the pandemic, EUAs got medicines, tests, vaccines, and other lifesaving technologies to patients at a far quicker rate than under the typical FDA approval process. A study published in JAMA Internal Medicine found that over the past decade the median FDA clinical development period (from trial to approval) for a vaccine was just over eight years. By comparison, the Pfizer COVID-19 vaccine was granted an EUA in seven months.

Expanded Telehealth Coverage Connected Millions of Patients in Underserved Populations with Healthcare Professionals. Under the PHE, CMS enacted a waiver granting more Medicare and Medicaid beneficiaries much broader access to telehealth services. The waiver was especially important for both urban and rural underserved communities facing impediments to accessing healthcare. Once the PHE ends, so does the authority for these flexibilities. While Congress has extended telehealth access for five months following the end of the PHE, it is still considering whether to make it permanent. About half of states have passed their own telehealth legislation, but many have yet to do so, leaving patients, providers, and insurers to navigate a patchwork of rules. As these debates continue, the recent Supreme Court abortion decision and heightened scrutiny over possible overprescribing by telehealth providers, particularly healthtech startups, could complicate advancing those measures in a timely fashion.

Liability Protections Ensured Health Systems Could Focus on Caregiving and Not Court Cases. The PHE provides liability protections to developers, manufacturers, and providers of COVID-19 countermeasures, unless the plaintiff can prove gross negligence, willful misconduct, or failure to comply with public health orders, depending on the standard specified in each state’s law. Without them, medical manufacturers and providers would face greater exposure to litigation, and it may inhibit them from providing that care. It also could make it more difficult for to recruit and retain caregivers concerned with incurring litigation.

Common Sense Waivers Ensured Providers Could Secure Needed Staffing. To address the urgent need for qualified medical practitioners, HHS waived state licensure requirements to allow healthcare personnel to serve where they are most needed. With hospitals across the country still grappling with staffing shortages, the expiration of the PHE will create an additional headache, particularly since hospitals would also lose a number of CMS waivers related to workforce flexibilities, home care programs, and reporting. The added strain would come just as states lose the extra Medicaid funding provided by the CARES Act in exchange for not removing anyone from their Medicaid rolls during the PHE. Up to 14 million patients could lose their Medicaid coverage when the PHE ends, sending more uninsured patients to emergency rooms for care.

A Push To Make the ‘New’ Normal a Permanent Normal

As we wrote in April 2020, “While the country of course needs some degree of regulation to safeguard our people and our economy, the pandemic pause of regulations offers the promise of sanity and simplification in the future.” The practices listed above, enabled by the PHE, were not permitted in the regulatory landscape that existed pre-COVID and won’t last after the PHE lapses unless policymakers act to permanently adopt them. As public affairs professionals in the healthcare sector work to secure these industry-shifting changes, they must understand which policymakers and stakeholders will engage in the debate shaping the post-PHE regulatory environment and how that engagement will help or hurt their advocacy efforts. That’s the information advantage public affairs professionals will need to ensure success and reduce surprises along the way.

The Future Is In WTO Hands

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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.

Patents Were Never the Cause of Vaccine Inequity

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.”

So Who Does the Waiver Really Benefit?

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.

The Future of Intellectual Property Rights Is at Stake

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.

Pulling Back the Curtain

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?

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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

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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

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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.

The Chain Drain: Rethinking Pharmaceuticals After COVID

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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

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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.