With Patents on Coronavirus Medicines, International Drug Companies Will Decide Whether Brazilians Live or Die

Jonas Sena, suspected of contracting Covid-19, waits on a stretcher to be allowed in the 28 de Agosto Hospital in Manaus in Amazonas state, Brazil on April 16, 2020.

As Brazil confronts the coronavirus pandemic, it is hard to imagine how things could get any worse. At least 8,500 people have died as new infections continue to climb. Meanwhile, Brazilian President Jair Bolsonaro refuses to take the crisis seriously and is battling his own administration. He has opposed plans to shut down the economy, fired his health minister, and endangered citizens by encouraging public meetings. The explosive resignation of his justice minister, Sergio Moro, led to calls for his impeachment. Now, the Supreme Court has approved an investigation into Bolsonaro on multiple violations, including obstruction of justice.

In the middle of a global health crisis, a handful of companies in the U.S. and Europe will decide whether we should live or die.

In all this chaos, it is reasonable to hope that the crisis will ease when coronavirus treatments emerge. Unfortunately, the crisis may only get worse for Brazil when we finally have medicine and vaccines for the coronavirus — unless the National Congress acts immediately.

A majority of the potential treatments for Covid-19 and all the vaccines under development will be brought to market by big pharmaceutical corporations who hold monopoly power over them through patents, which are temporary monopolies granted by national law. This power will result in an outrageous situation: In the middle of a global health crisis, a handful of companies in the U.S. and Europe will decide whether we should live or die.

This problem is not Brazil’s alone. In the last three decades, millions of people from poor countries have died because they could not afford the medicines they needed to live. But, as a “middle-income” country in a long recession, Brazil faces a unique and immediate threat: the inability of the public health system  — Sistema Único de Saúde, or SUS — to do its job and keep people alive.

In 2016, Brazil’s Constitutional Amendment 95 froze federal budgets for 20 years, including for public health. In this environment of austerity, with no wiggle room and SUS straining to accommodate growing health demands, the absurd cost of monopoly medicine has the potential to break the system.

While the threat is supercharged in the current coronavirus pandemic, monopoly medicines have been threatening the viability of SUS over the last three decades. Two cases stand out.

In 1996, Brazil made history by providing universal treatment for HIV/AIDS, becoming the first developing country in the world to do so. Less known is that this victory was almost undermined by monopoly medicine prices. Of the cocktail of medicine required to treat HIV/AIDS, some were being manufactured in Brazil, including by Farmanguinhos, the government-owned medicine producer located at Fiocruz in Rio de Janeiro. But other medicines were available only under monopoly from big pharmaceutical corporations — and their price made the HIV/AIDS treatment program unviable. Brazil threatened to issue compulsory licenses, which would have suspended the patents and allowed cheaper, local production. The corporations responded by caving and lowered their prices. In 2007, the HIV/AIDS treatment program was again threatened by Merck’s monopoly price on efavirenz, a key medicine in the program. When Merck refused to lower prices, then-President Luiz Inácio Lula da Silva issued a compulsory license on the advice of his health minister, José Gomes Temporão. As a result, over the next five years, SUS saved nearly $500 million reals in expenses by buying generic versions of efavirenz for use in the country.

Related

Coronavirus Treatment Developed by Gilead Sciences Granted “Rare Disease” Status, Potentially Limiting Affordability

In contrast, Brazil’s experience with sofosbuvir, the first effective treatment for hepatitis C, is tragic. When the medicine first came to market in 2013, it promised to be a lifeline for the more than a million Brazilians suffering from a debilitating and fatal disease with no cure. There was just one problem: The full course of sofosbuvir cost $84,000 in the U.S. and the pharmaceutical giant Gilead Sciences owned the monopoly on the medicine. Gilead offered a discount to SUS, but at $6,000 per course, the price was still 60 times more than the cheapest generic version of the medicine. After a long tussle over the validity of Gilead’s patents — they were challenged multiple times — the corporation eventually won and immediately increased the price of the medicine by 1,421 percent — no, that’s not a mistake. As a result, in the last six years, SUS could only afford to treat a minuscule number of people who have the disease, even as several thousands of others died from it.

Our only access to the one existing treatment for Covid-19 will be entirely dependent on the compassion of a giant multinational pharmaceutical corporation that has shown no sign it has any.

How is this relevant? Consider the antiviral medicine remdesivir, also brought to market by Gilead and originally targeted at Ebola. The U.S. Food and Drug Administration just certified remdesivir for use against Covid-19; it is the first treatment to have been approved. Gilead has multiple patents over remdesivir in 70 countries around the world, including Brazil. These patent monopolies last until the year 2038. Apart from one vague statement, Gilead has not committed to making this medicine affordable or available in sufficient quantity. Instead, early in March, Gilead sought “orphan drug” incentives in the U.S. for the use of remdesivir against Covid-19, which would have given them additional monopolies and tax benefits of $40 million. The word “orphan” in the designation refers to rare diseases that affect less than 200,000 people. Over 3 million people have been infected with the coronavirus. When this was pointed out, Gilead backtracked.

To recap: As things stand, for the next 18 years, our only access to the one existing treatment for Covid-19 will be entirely dependent on the compassion of a giant multinational pharmaceutical corporation that has shown no sign it has any.

We have two ways out of the monopoly trap. The first is a multilateral solution, which depends on a proposal by the World Health Organization coming to fruition. Prompted by Costa Rica, WHO is exploring the creation of a Covid-19 technology “patent pool”: a mechanism by which monopoly producers of protective equipment, tests, medicines, and vaccines could voluntarily suspend their monopolies for global public use. The proposal is gaining steam. However, Brazil’s middle-income status — a senseless category that confuses the needs of a poor majority with the wealth of a rich minority — has meant that it is excluded from a similar arrangement offered by the Medicines Patent Pool, whose benefits only extend to poor countries, regardless of where the disease they are trying to solve is prevalent. A new global patent-pooling solution will only work if it explicitly includes middle-income countries like Brazil.

The second way is a national solution. In this moment, an assertion of sovereignty is the only solution that is guaranteed to work. Countries as diverse as Canada, Germany, Israel, Chile, Peru, and Ecuador have taken swift action in the last few weeks, either suspending key patents or enacting legislation to suspend all monopolies on technologies related to the coronavirus pandemic. Brazil must join them.

Last month, a multiparty group of 11 members of Brazil’s Congress introduced a bill to amend the Industrial Property Law. The proposal builds on existing provisions in Brazilian patent law to respond to the crisis. It would create  a fast, simple, and legal process by which the government can deal with the coronavirus pandemic (as well as any other health emergency) by suspending monopolies that affect the lives of its citizens, whether on equipment and tests or medicines and vaccines. The National Health Council — Conselho Nacional de Saúde, or CNS — immediately came out in favor of the bill. Strong international support followed. However, despite a request made in Congress to debate the bill with urgency, hearings have not yet begun.

Pedro Villardi, speaking for Grupo de Trabalho sobre Propriedade Intelectual, one of the civil society organizations that advocated for the bill, explained its purpose: “The point is to increase the government purchase options, with the agility for distribution that a health emergency requires.” Noting the delay, he added, “The approval of this bill is urgent. We need to ensure maximum responsiveness to save lives. Any delay or high prices during times like these is inconceivable.”

This is a time for solidarity, a time for cooperation and care. In order to survive the coronavirus pandemic, Brazil must take decisive steps to protect SUS. We can secure our future by learning from the past. When we have confronted medicine monopolies, we have saved lives, saved money, and improved the human and financial health of the country. And when we have succumbed to pharmaceutical corporations, we have lost lives and damaged the fabric of society. In the long term, there is much more we can do to save our SUS. In the short term, we have a pandemic and a path that leads us out of it. We must take it.