The rapid development of highly effective COVID mRNA vaccines was enabled by decades of international collaborative research. The failure of the vaccines to be treated as global public goods is a result of the substantial public contribution.
Only 20% of people in low-income countries have had a first shot at the vaccine. Most people in low- and middle-income countries don't have access to the most effective mRNA vaccines because their production and distribution are under the control of BioNTech/Pfizer and Moderna, companies that have been granted many patents and other intellectual property protections. Many people in the Global South still suffer from the Pandemic with no vaccines at all, despite the fact that shots and boosters of mRNA vaccines are easily available to people in wealthy nations.
Even though governments are eager to be done with COVID, continued infections around the world mean a more deadly global variant could be just a few genes away.
Despite the importance of access to vaccines, attention has shifted to testing and treatment for a variety of reasons. Global policy makers need to change their approach to how they control intellectual property for both vaccines and COVID treatments. The moral and epidemiological failures that led to vaccine apartheid will happen again if not treated and diagnosed.
Consider that in clinical trials Paxlovid reduced COVID mortality by 89 percent, and that the treatment is effective among people who are unvaccinated. In the United States, anyone who needs Paxlovid can get it. Many people have benefited from the drug. Hundreds of thousands of people will die unnecessarily if intellectual property rules surrounding this and other treatments are not changed. The Omicron variant that evades vaccine immunity can lead to infections.
It is an economic imperative to keep people alive and out of hospitals. Billions of people in the developing world depend on treatments and vaccines for their survival. People who don't work do not eat. That is it. There are global economic ramifications. Supply chain problems have worsened due to the spread of the new variant to China.
Ensuring global access to COVID treatments and tests is something that needs to be done. The mistakes that led to vaccine apartheid can't be repeated. A temporary waiver of the WTO's Agreement on TRIPS, a pact that requires governments to ensure holders of patents and other intellectual property grant have monopoly control over production of protected products, was vital for saving lives. The European Union, U.K. and Switzerland blocked it despite the request from South Africa, India and 100 other WTO member nations.
Compulsory licenses, used by the WTO to make sure critical medicines are available in the midst of an epidemic,proved useless in the case of vaccines. A compulsory license comes from a government, unlike a company's voluntary license. It means that a patent holder will be compensated by other firms that produce its patented medicine, but it can't deny licensing in order to limit supply and keep prices high. There are too many intellectual property barriers to be made in a timely fashion using compulsory licenses. The lipids that are a key component are made in just a few locations and are locked behind a web of intellectual property protection.
There is evidence that some producers around the world would have entered if there had been an intellectual property exemption for vaccine production. There would be no downside for the drug companies if no one could make the drugs. Governments that gave a lot of money for the development of the vaccine could have pressured the companies to give up their key patents. Despite evidence of vaccine shortages and supply shortages, a WTO ministerial declaration issued in June failed to waive any intellectual property barriers.
It is possible to avoid treatment apartheid.
There is a chance that using compulsory licenses for effective treatments like Paxlovid can avoid the kind of discrimination that marked vaccine availability Paxlovid has less intellectual property barriers than vaccines. Technology transfer from Pfizer is not necessary because it is easier to make. There are hundreds of generic manufacturers around the world.
What is the problem since the agreement allows compulsory licenses? The pharmaceutical companies don't like compulsory licenses and are doing everything they can to make them useless.
Two problems are present. Compulsory licenses were not provided for the production of generic medicines that can be exported for use in other countries. Small countries like Costa Rica or Jamaica are denied generic imports because they don't have enough demand at home. Drug companies and governments have a history of threatening each other.
There was one meaningful provision in the June WTO Ministerial Decision. If only compulsory licenses could be used to produce vaccines, it would be easier to export generic vaccines. Increasing access to treatments and tests could be made easier with the extension of that permission.
Wealthy countries pre- purchased the Paxlovid supply. The same will happen under the current pharmaceutical intellectual property regime. The flow of COVID-19 antivirals to low- and middle-income areas is restricted by limited supplies and high costs. Demand for Paxlovid has been crushed by a lack of supply and high prices in poor countries.
Pfizer made a deal with the UN Medicines Patent Pool to license 35 firms to make generic Paxlovid, which can be sold in 96 nations. The other 100 countries of the world with 47 percent of the world's population have been barred from selling those generics.
Pfizer has banned sales in countries where it has a license. The Dominican Republic firm has a license but can't sell it at home. Pfizer only allows sales in the poor countries. In the Americas, that means only six countries. African, Middle Eastern and Asian nations are not included. It is important for companies all over the world to be able to make the treatment using a compulsory license.
Over the opposition of most other WTO nations, the U.S. insisted the June WTO COVID deal only covered vaccines. The June Declaration included a six-month time frame to decide whether to extend the export permission to treatments. South Africa is one of the countries pushing for the extension. Switzerland is one of only a few countries that oppose it.
The decision will be made by immediate U.S. support. A large coalition of U.S. health, faith, consumer, human rights and labor organizations called on President Biden to support broadening the WTO deal to treatments and tests and to publicly declare that no country using compulsory licenses to produce Covidien will face U.S. threats. The U.S. government issued the most licenses related to COVID. The US government has attacked countries that use this mechanism to improve access to affordable medicine.
The Biden administration should work with the partners of the dozens of U.S. free trade agreements and bilateral investment treaties to suspend the terms of these pacts. The lawyers can award the corporations unlimited sums to be paid by the country's taxpayers, including for the loss of future profits. A pharmaceutical corporation needs to convince the lawyers that a compulsory license or related policy is in violation of an investor right. Lawyers decisions are not subject to appeal and the amount awarded has no limit. Governments have been ordered to pay billions of dollars in compensation.
This is something that could happen. In the Americas, applications for Paxlovid compulsory licenses have been filed in several countries that have free trade agreements with the U.S. Pfizer, which holds the monopoly patents on the treatment, is fighting to preserve its monopoly and pricing.
There is a moment of hope and frustration as the world transitions from vaccinations to testing and treatment. If the international community insists on a WTO deal to ease exports of compulsorily licensed medicines that goes beyond vaccines, the era of vaccine apartheid will be avoided. It won't happen without U.S. support. It is possible for the U.S. to lead the way in agreeing to a trade Ceasefire. Many countries will be able to produce treatments and tests, but they need to be able to sell them to other countries that can't afford Pfizer's prices.
Millions of people rely on it. The moral authority of the West is also affected. In contrast to authoritarian regimes, global democracies put profits over lives during the Pandemic. We have the opportunity to redeem ourselves.
The views expressed by the author or authors are not necessarily those ofScientific American.