If a COVID-19 vaccine or some other game-changing treatment becomes available, will governments suspend their own long-established global rules restricting access to medicines?
Big Pharma has successfully fought fair-pricing clauses in recent COVID-19 relief bills. Republicans in the Senate led by Ben Sasse, Republican of Nebraska, even proposed extending already overzealous drug monopolies by another decade.
Perhaps, but only if a global campaign to push back against what is known as “extreme patenting,” prevails. This refers to the far-ranging protections of drug monopolies that maximize profits by putting prices out of reach for all but the affluent.
The World Health Assembly is hoping to push through a resolution, prompted by the current pandemic, that refers to immunization as a public good. The World Health Organization’s forthcoming collective statement on COVID-19 calls for “unhindered timely access” to treatments, patented or not.
In March, Costa Rica proposed the creation of an emergency “Technology Intellectual Property Pool,” ideally overseen by the WHO, that would share otherwise proprietary information about the pandemic, allowing knowledge to accumulate faster. Every member state could affordably license resulting medicines. This would be one step in the fight to dismantle the right to own life-saving drugs.
In February, forty-six Democrats in Congress sent a letter to President Donald Trump that opposed letting for-profit companies decide drug prices.
“We write to ask you to ensure that any vaccine or treatment developed with U.S. taxpayer dollars be accessible, available, and affordable,” the lawmakers wrote. “That goal cannot be met if pharmaceutical corporations are given authority to set prices and determine distribution, putting profit-making interests ahead of public health priorities,”
On May 4, a European-led vaccine conference broached the idea of information sharing and open access, with powerful statements from rich countries that produce brand drugs. But the United States was conspicuously absent from this gathering. The Trump Administration, it seems, is intent on trying to corner the market on a future vaccine, threatening to hold the world hostage to price gouging.
The biopharmaceutical research company Gilead Sciences tried asserting patent rights over Remdesivir, a treatment that may hasten recovery from COVID-19, before backing down under public pressure led by U.S. Senator Bernie Sanders, Independent of Vermont. The company evoked trade rules to retain sole licensing power, which could have been a prelude to a bidding war.
Big Pharma has successfully fought fair-pricing clauses in recent COVID-19 relief bills. Republicans in the Senate led by Ben Sasse, Republican of Nebraska, even proposed extending already overzealous drug monopolies by another decade.
A report by South Centre, an intergovernmental organization of developing nations, warns that, if the drug companies get their way, “high-income countries will likely put in large orders for vaccine doses to meet the needs of their populations and may be willing to pay high prices,” driving up costs worldwide. Without strict controls over supplies and prices, the report warned, “an unprecedented humanitarian catastrophe will arise.”
In 2001, amid the AIDS crisis, poor countries won modifications to WTO rules at a conference in Doha, Qatar. These now allow countries to duplicate drugs in an emergency, if they have the capability. And, if not, a parallel importing exemption frees them to shop for the lowest prices on the world market.
Fighting COVID-19 is a matter of health, not trade.
Ecuador’s legislature is considering issuing compulsory licenses on COVID-19 treatments that would set a compelling precedent for other developing countries.
But countries that seek to invoke these exemptions face stiff resistance from multinational pharmaceutical firms. In the most famous case in 2001, the United States slapped South Africa with trade sanctions and suspended aid as it tried scaling up AIDS treatments (the Clinton Administration relented amid the horrendous optics).
In 2016, the United States pressured Columbia not to issue a compulsory license for an anti-cancer drug. The WHO sided with Columbia, concluding that exorbitant costs were “a legitimate reason for issuing a compulsory license” for the Novartis-produced drug. The United States put similar retaliatory pressure on Brazil, Ecuador, and Thailand.
These threats don’t work in every case, but they do cause governments to proceed cautiously. Developing countries issued two dozen compulsory licenses in the first two decades after the WTO’s patent laws went into effect, according to a figure reported by Global Health Watch. Most of these licenses were for HIV/AIDS treatments, to the neglect of everything else.
To ward off bad publicity, drug firms trumpet “voluntary licensure” programs as alternatives to compulsory licensing. This leaves them with the power to negotiate terms with Southern governments. By contrast, compulsory licensing happens without any assent from patent owners.
India was the world’s single most important generic drug manufacturer during the HIV/AIDS epidemic. It was the Indian firm Cipla that used the country’s then-unique patent laws to make generic, simplified regimens. This new competition—not Big Pharma’s loudly touted voluntary licensing programs—drove prices down on AIDS treatments, including for brand drugs.
Despite stiff resistance from Gilead, India also managed to keep domestic costs relatively low for the Hepatitis-C cure. It now charges $4 for one pill that costs $1,000 in the United States (the pill costs $1 to manufacture).
On the other hand, Gilead retained enormous influence over pricing for Hepatitis-C drugs, negotiating voluntary licenses with poor countries. India distributed HIV/AIDS treatments for little to nothing worldwide, but did not do so for Hepatitis-C. Overall, the country issued just one compulsory license since its exemption from WTO patent law expired in 2005.
With loopholes at the WTO, high-income countries are pressing for bilateral and regional agreements with more extreme patent protections. These provisions go beyond the twenty-year monopoly allowed by the WTO. Fully one-quarter of new trade agreements undermined exemptions for poor countries, reported Global Health Watch.
Trump’s NAFTA 2.0 broadens the definition of what knowledge can be owned. As one analysis put it, the agreement “represents a significant success” for the pharmaceutical lobby.
As I write this, the Unites States and United Kingdom have successfully watered the WHA resolution down, blocking a global patent pool along the lines of that proposed by Costa Rica—and called for by 140 policymakers and experts—that would make the search for a vaccine a true international effort with the results freely available to every country.
The draft resolution reflects changing times. Noting that COVID-19 “disproportionately affects the poor and the most vulnerable people,” it references the Doha Declaration. It calls for the “distribution of all quality, safe, efficacious, and affordable essential health technologies” and “ the urgent removal of unjustified obstacles” to affordable access.
Meanwhile, the WHO, Costa Rica, and now Chile are moving forward with a voluntary patent pool for COVID-19 later this month, regardless of the resolution’s outcome.
In the end, fighting COVID-19 is a matter of health, not trade. The WHO has long argued for modifying patent rules in favor of access, despite intense pressure from pharmaceutical giants.
WHO Director General Tedros Adhanom Ghebreyesus called for universal access to any successful COVID-19 vaccines, and challenged the idea that poor patients in the Global South should be used as guinea pigs to test unproven medicines they may never be able to afford.
WHO Emergencies Director Mike Ryan suggested that the pandemic may persist indefinitely even with a vaccine, noting that perfectly eradicable diseases linger for decades. In short, the barriers are political as much as scientific or logistical.
When Jonas Salk refused to patent his revolutionary polio vaccine in 1955, he famously remarked that to do so would be like patenting the sun. If we don’t heed his message, vaccines and treatments will mean nothing to those who can’t afford them.