30 April 2020
Coronavirus is undermining capitalism grounds globally, so it is time to rethink not only health system models but also how research and development are conducted, in a context in which patents generate barriers to access, and facilitate speculation and overpricing. Are there any tools that help guarantee access to medical technologies? What are compulsory licenses? Where have they been used or intended to be used and how do they serve countries, even after the pandemic?
After the collapse of health systems caused by coronavirus SARS-Cov-2, the whole world is under alert and the State’s role is being reconsidered. The present challenge posed by this pandemic is not only to guarantee the availability of emergency rooms or to improve the working conditions of health staff. It is also essential to guarantee access to medicines and supplies which are difficult and even impossible to procure, not only in middle income and low-income countries, but also in the so-called developed countries. Why? Because they are considered commodities and are commercialized under the domain of intellectual property rights, which follow market rules, and aim to favor big companies’ profits over people.
In this context, there are many international and governmental organizations, political and non-political leaders and activists from different parts of the world proposing initiatives or taking measures intended to avoid that, once more, the benefits of these medical technologies are diluted in market rules and never get to the people who really need them.
That’s the case of a group of public, private, civil and social organizations, which created a Coalition for Epidemic Preparedness Innovations (CEPI), seeking to finance and coordinate the development of vaccines against emerging infectious diseases. There is also the case of SARS-CoV-2 Diagnostic Pipeline, that collates information on all SARS-CoV-2 tests commercially available or in development for the diagnosis of COVID-19.
There are also more than 70 researchers from almost 30 countries which created a global coalition that promotes the use of collaborative principles to accelerate research and its scope, particularly in low and middle income countries. Even the Bill & Melinda Gates Foundation that triggers an initiative called Therapeutics Accelerator to speed development of drugs to treat COVID-19, meanwhile the World Health Organization (WHO) carries out an international clinical trial, “Solidarity” with the aim of generating solid data on which therapies are the most effective (Argentina was one of the first countries to become part of it).
In order to treat critical clinical cases and to avoid others to become critical, different drugs and therapies are currently under clinical trial. Some of them are already being used to treat other diseases, like chloroquine and hydroxychloroquine, commonly used for malaria, rheumatic and autoimmune diseases like lupus; the combination of antiretrovirals lopinavir/ritonavir, used to treat HIV; Interferon Beta 1-Alpha, used to treat multiple sclerosis; monoclonal antibodies like Tocilizumab; and plasma from recovering patients, that in Argentina has been successfully used in reducing the mortality of the so-called “stubble disease” (Argentine hemorrhagic fever), among many others.
The efficacy of remdesivir, an antiretroviral of broad spectrum that inhibits virus replication in the body, is currently under clinical trial, and is one of the most promising options. It was originally developed to treat infections caused by the Ebolavirus, although it has not been approved yet. It has also been tested in animal trials to treat other coronavirus, like Middle East respiratory syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS).
Remdesivir has been developed by Gilead Sciences, a holding company that counts big global financial groups such as Blackrock PLC, Vanguard Group and Capital Research Global Investors among its shareholders. In the context of the COVID-19 crisis, Gilead made efforts to obtain the U.S. Food and Drug Administration (FDA) status of “orphan drug” for remdesivir, which implies that the company owns a monopoly and other tax benefits for seven years. But the company had to decline that benefit due to the pressure of civil society and political representatives. Nevertheless, Gilead Sciences already has the monopoly of the product, since it has patents over remdesivir in more than 70 countries.
A patent is an intellectual property right that implies, in practical terms, that those who hold it can exclude others from producing, commercializing, and import of the patented product for a minimum of 20 years in every country with valid patents. In this case, the expiration date would be 2035. That is why, in case the drug’s efficacy to treat of COVID-19 patients is proven, the access to the treatment for millions of people around the world would be jeopardized.
¿Which countries will have a priority to buy remdesivir and which will have real chances of getting it? ¿How would the company be controlled for it not to impose abusive prices to an essential lifesaving medicine? Most probably, developed countries will be willing to pay more to get the necessary doses for their populations. At the same time, there are no instruments to guarantee procurement of these products at affordable prices to developing and less developed countries.
Gilead has already proved to have abusive behaviour with States regarding the sale of its products. Such was the case of sofosbuvir, a drug that cures hepatitis C, sold at an average price of 1,000 dollars per pill – which meant a total cost of 84,000 dollars for the whole treatment-. In Argentina, due to the work of civil society organizations, the company reduced the price to 6,000 dollars for the first purchase by the Ministry of Health.
Back then, Fundación GEP filed an opposition to Gilead’s patent applications in Argentina through a legal mechanism by which Patent Law allows third parties to contribute to the process of examination of these applications, submitting arguments that prove that the applications do not meet the requirements of novelty, inventive step and industrial application for the patent to be granted. Thanks to these arguments, also exposed by local producers, the National Institute of Industrial Property (INPI) analyzed the application and rejected the patents for lack of compliance with the legal conditions.
Once the barriers were removed, it was possible to have price competition in the Argentinian market, and at least 5 local producers obtained the health registration to commercialize sofosbuvir in the country, and in the following purchases of the Ministry of Health, the price was reduced to 350 dollars.
Even though from the point of view of patent law the case of remdesivir is different, it shares two essential characteristics with sofosbuvir: it has the potential to save lives and the price companies intend to impose over medicines is abusive and very distant from its cost of production. In order to avoid this kind of abusive behaviour, 150 social organizations and activists worldwide, amongst which is Fundación GEP, have already sent a joint letter to Gilead Sciences, to cease the claim of exclusive rights on the drug.
A recent study published in the Journal of Virus Eradication shows that a 14-day treatment of lopinavir/ritonavir, for example, reaches maximum prices of 503 dollars in the market, though its cost of production is barely 4 dollars. There’s also the case of chloroquine, with a cost of production of 0.30 dollars, also for a 14-day treatment, that has reached a price of 93 dollars. Remdesivir is not yet available in the market, but its cost of production is estimated in 9 dollars (for a 10-day treatment).
The good news is that there are legal instruments that countries can use to avoid this kind of situation, to make access to these commodities more affordable, and to guarantee its provision to whomever might need them.
Barriers to access to medicines and health technologies have to do with an agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), stipulated by the World Trade Organization (WTO) during the Uruguay round (1986-1994). This agreement, subscribed by Argentina in 1994, sets global rules on intellectual property and sets down minimum standards of protection, mostly in areas of technology, biotechnology and medicines.
The aim of this regulation is to stimulate innovation and encourage investment in the development of health technologies, but what really happened is that it delegated in the market the definition of “Health Needs” (because development is centred in what’s profitable rather than in priorities). Besides, it boosted power concentration in the few companies that patent their products and paused industrial development in less developed countries, even though TRIPS establishes that every State, in exercise of its sovereignty, “shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice”.
In order to do so, States can make use of Health flexibilities. Opposition to patents is one of them, and it is the instrument to reject the patent over sofosbuvir, thanks to the support of civil society organizations like Fundación GEP, and the support of local industry. They played a fundamental role in the use of this flexibility, by contributing with arguments and proof that Gilead’s patent applications did not meet the legal requirements to obtain the rights over the patent.
Also, there are compulsory licenses that allow countries to limit the patent holders’ exclusive rights, in case of emergency and public health’s needs, to allow access to affordable generic versions; and licenses of public non-commercial use -or governmental use- which, as inferred by its name, serve governments to use the patented object for a non-profitable purpose or for non-commercial purpose, such as public research. In none of these cases it is necessary to negotiate previously with the patent owner, and they do not prevent the owner to continue exploding the invention as long as the license is in force.
Compulsory licensing find its way when a government allows someone else to import, produce and commercialize the patented products. Compulsory licensing also allows governments to produce, import, and locally purchase diagnosis equipment, vaccines or patented medicines, especially when they are products that cannot be substituted (it would be the case of remdesivir). In Argentina, these flexibilities can be issued not only in cases like the current health emergency. National patent law 24.481 allows this as well, to counteract anticompetitive commercial behaviour, or to do research.
Compulsory licensing is contemplated in most developed countries. It has been used to control anticompetitive behaviour in the United States, for example. It has also been implemented due to public health needs in Germany and Italy, mostly for antiretrovirals and HIV drugs, but also for cancer treatments and anticoagulants, among others.
Developing countries have also used these flexibilities, despite the oppositions and pressure from governments and industries. In Latin America, for example, Brazil used this flexibility in 2007 on antiretroviral efavirenz, what led to reduce the price more than 60% of the price of the original version of the company owner of the patent.
In only four months, global pandemic of COVID-19 has reached more than 2.8 million people and killed almost 200,000 people around the world, uncovering the need to stop looking at Health and medicines through the market glass. It is in this respect that the role of States is essential to guarantee access to Health as a right, and not as a privilege of those who can afford it. Many countries are already issuing (or trying to) compulsory licenses to procure access to medicines, vaccines, and diagnosis equipment necessary to fight the disease.
For instance, Israel has authorized compulsory licenses to allow the import of generic versions of the antiretroviral combination lopinavir/ritonavir, a product protected by patents in this country (AbbVie is the patent owner, and commercializes the product with the name Kaletra). Also in Brazil, the opposition party has submitted a draft supported by civil society to automatically cancel the exclusivity of exploitation of patented products, and the Chilean parliament has submitted a draft resolution for the granting of compulsory licenses, and other countries like Argentina, Canada, Colombia and Ecuador, are also in the list of countries taking this kind of legislative measures to ease the quick access to the right technologies to restrain the pandemic.
In Argentina, Patent Law 24.481 allows the use of compulsory licensing. Besides, law 27.541, in force since December 23rd, 2019, declares a public national emergency and establishes compulsory licensing as essential instrument for the country, in the eventual “possible problems of availability or unreasonable or unjustifiable raise” in the prices of medicines and inputs in the Health sector.
With the entry into force of this law, National Congress has granted the Ministry of Health the right to resolve around the use of compulsory licenses whenever it finds it convenient, which means a big step in terms of political will, which can be applied to the health emergency that included COVID-19 in a presidential decree 260/2020, from March 12th.
Argentina has been one of the first countries to react to COVID-19 pandemic, by implementing measures of compulsory social distancing to prevent the exponential increase of contagion. Since compulsory quarantine was imposed on March 19th, the national government is taking a series of measures so the Health sector is better prepared with facilities and input to take care of infected persons. Civil society also has great expectations for the government to also use this kind of legal instruments to avoid speculations from pharmaceutical and biotechnological companies regarding COVID-19 pandemic.
Fundación GEP claims that Health is not merchandise. That is why it makes a call to the Executive Power in Argentina: to issue compulsory licenses to guarantee the access to medicines, inputs and technology of all the people who might need it, in order to guarantee availability and access in a situation of patent monopoly.