Vaccines, patents and the commons in the age of Covid-19

In the pharmaceutical field, intellectual property, and in particular patents, have been the subject of much discussion for decades. While some argue that patents are indispensable incentives for pharmaceutical research, others emphasize that they are responsible for the exorbitant prices of certain treatments (cancers, rare diseases, hepatitis C) that are unsustainable for health insurance systems, or for problems of access to essential treatments in certain countries. 20 years after the fight for access to HIV treatment in the South⁽¹⁾, the current health crisis is once again bringing the issue of patents to the forefront⁽²⁾.

In recent months, dozens of analyses in favor of a relaxation of intellectual property law have been reported in the press. These publications have reported on numerous proposals and initiatives taken around the world expressing a demand, both from civil society and from certain States, for adjustments to intellectual property protection regimes in various forms⁽³⁾. This demand for greater flexibility in intellectual property has existed for several decades, but it used to come mainly from actors whose interests were not met by intellectual property protection regimes (developing or emerging countries, NGOs). Nevertheless, in 2001, the Doha Declaration on the TRIPS Agreement and Public Health was adopted, which (relatively speaking) facilitates the granting of compulsory licences. However, between March and July, this demand for changes also seemed to come from more powerful actors, traditionally in favour of strengthening intellectual property, such as France, for example, whose president raised the idea that the Covid-19 vaccine should be a global public good available, accessible and affordable to all⁽⁴⁾or like Germany and Canada, which, according to MSF, have changed their legislation to facilitate compulsory licensing⁽⁵⁾.

One can therefore legitimately wonder: is this demand real on the part of countries traditionally in favour of strong intellectual property regimes, or is it just communication? Is this request likely to succeed and benefit all countries, communities, research and health actors, and patients? Will it have temporary implications limited to the Covid-19 crisis or long-term implications for intellectual property protection that could benefit other pharmaceutical or medical research, or even other sectors? Is there hope for patients, for health insurance systems, for developing countries?

The return of the common?

Between March and August 2020, there did indeed seem to be hope, as there were also a number of publications in the press portraying the health system as  » an essential common « , the drug as the philosophy of the commons as a« common good « , the « a pandemic survival strategy, » the theme of the commons as « a a central theme in the reflections on the world after « , the coronavirus crisis as having  » putback in the foreground the obligations of the common « , etc. Well beyond simple adjustments to intellectual property protection regimes, the authors of these publications called for the construction of commons that escape private appropriation and exploitation, for the political institution of global commons that are democratically managed, for the recreation of genuine public services based on solidarity, but also for citizen cooperation to « awaken » and strengthen the failing social state.

The view of WIPO (World Intellectual Property Organization), however, differs from these « idealist » projects. The Director General of WIPO believes that at this stage, in a context where, according to him, almost 70% of research and development is funded and conducted by the private sector as opposed to about 30% by the state, the main policy issue is to obtain treatments for covid-19 rather than access to treatments (since these would not yet exist), to support innovations that contribute to the management of the crisis (e.g., the development of tracking applications), and to improve vital medical equipment. Therefore, what governments should focus on are incentives for innovation, including intellectual property⁽⁶⁾.

As for the obstacles to accessing essential innovations at affordable prices, there are, according to him, many: lack of means of production, obstacles to free movement, transport, health and digital infrastructures, etc. But  » none of this has to do with intellectual property issues. While he notes that intellectual property can also act as a barrier to access, mechanisms already exist to address this potential situation: compulsory licensing and outright licensing of patented technologies incorporated into medical supplies and essential medicines, as well as the use of exceptions for cultural and educational works. But the possible use of these mechanisms, if it takes place, must be targeted and temporary so as not to undermine innovation. WIPO’s No. 1 continues, « Initiatives already exist in relation to covid-19: innovative licensing agreements, publication of open access scientific data, publication of technical specifications of essential equipment (such as respirators) to allow their manufacture by third parties, waiver of the application of certain patents. Governments can also take measures, such as « requisitioning production capacity, using public procurement or injecting capital and easing credit for start-ups and small and medium-sized enterprises to ensure the survival of innovation. »

For WIPO, the existing measures would therefore be sufficient, the main thing being to stimulate innovation through intellectual property rights. But make no mistake: WIPO’s voice is really the voice of those states that have an interest in preserving strong intellectual property protection systems. These States are introducing (or pretending to introduce) adjustments, because it is in their interest at this particular time, but their guiding principle remains that of respect for intellectual property rights.

What can we say to WIPO? Firstly, the statement that nearly 70% of R&D is financed and conducted by the private sector, as opposed to approximately 30% by the State, seems to need to be qualified with regard to the public money received, in normal circumstances, by the private sector in the form of subsidies, loan guarantees, tax incentives, reimbursements by the social security system, or even with regard to the tax evasion of the pharmaceutical giants⁽⁷⁾. And this claim is even more questionable in the context of the Covid-19 crisis, which has seen states fund private pharmaceutical research to the tune of billions.

Secondly, if the treatments are not known, this does not mean that they do not already exist in the immense pharmacopoeia available to humanity, some of which is in the public domain. We have thus witnessed a highly mediatized episode where a widespread and cheap drug, which a well-known doctor and researcher claimed, based on his practice, could accelerate the recovery of Covid-19, was banned by virtue of demonstrations that were sometimes not very scientific. Without taking a position in this debate, it cannot be denied that, in general, it is more attractive for the pharmaceutical sector to benefit from R&D support and incentives than to discover that a remedy is already in the public domain and would be easy and cheap to produce.

Status quo versus beneficial upheaval 

And thirdly, one could, contrary to WIPO, argue that the real political, social and health issues would rather be to finance or refinance (depending on the country) the health sector (hospitals, health workers) and health insurance systems; to protect people at risk and to properly care for the elderly⁽⁸⁾; to develop prevention (strengthening the immune system through a diet and lifestyle conducive to better health and resistance); to learn from our mistakes by questioning all the practices that may be at the source of the emergence of this epidemic; and to reexamine our relationship with life and death, as well as with the younger generations, whose vital needs are currently denied and sacrificed and who will find themselves deprived in a devastated economic, social and cultural landscape.

Between these two antagonistic visions (the one that plans to develop global commons or at least to relax intellectual property norms, and the one of a strict respect of these norms), in which direction are things evolving concretely? Unsurprisingly, what we see today is a global situation unfavorable to a relaxation of intellectual property.

This is evidenced, for a start, by the waltz of patent filings on candidate vaccines that has already begun. In the midst of a global health crisis, some people are not hesitating to advocate the need to extend the duration of patent protection beyond the 20 years provided for by the law, on the pretext of encouraging research into a vaccine⁽⁹⁾.

When asked about the statements of E. Macron equating the Covid-19 vaccine with a common good, Nathalie Coutinet⁽¹⁰⁾, a health economist, reminds us that international (and even bilateral) agreements are, on the contrary, moving in the direction of a permanent reinforcement of intellectual property rights, which the French president cannot ignore. The WTO did provide for compulsory licensing mechanisms, but these have proven to be a virtual failure in the face of threats from certain companies and in the face of US Special 301, which authorizes retaliatory measures in the event of infringement of its intellectual property rights.

As some analysts rightly note⁽¹¹⁾, in order to negotiate the prices of vaccines or treatments, there should be an obligation to be transparent about the public funds that have contributed to the development of these vaccines or treatments, but this is not the case. Conditions, such as patenting and price caps, should be imposed on research programs funded, even partially, by public money. It is entirely possible, with political will, to include in public-private contracts clauses on the licensing of future treatments, clauses on the transparency of trial data, or on the accessibility of drugs. But the programs launched by the European Union do not seem to make clear mention of these guarantees. The European Commission supports voluntary licensing of Covid-19 treatments and vaccines. However, it is not yet clear whether this commitment will be sufficient to guarantee universal access⁽¹²⁾. And as far as compulsory licences are concerned, they are not applicable everywhere: the country wishing to benefit from them must have production capacity⁽¹³⁾.

An article inAlternatives économiques takes stock of the situation⁽¹⁴⁾. It usually takes 7 to 10 years to bring a vaccine to market (when it is discovered). In the current situation, in order to save time, the different stages of the research are carried out simultaneously. The development phase also runs in parallel with the research: production is started before the final results and marketing authorization, in the hope that these will be positive. This novel (and unorthodox) procedure is extremely costly, especially since the doses produced will have to be destroyed if the results are negative. And although most of the money invested (financing and pre-orders) is public, the total amounts invested are not precisely known, even if we know that they are in the billions. 

Rich countries reserve millions of doses for themselves, while poor countries depend on the Covax program to reserve doses of vaccine and make them available to these countries, some free of charge and others at affordable prices. Despite these public subsidies, the patents will be private, confirms Nathalie Coutinet, although there has been no private risk-taking on the part of the companies themselves. Indeed, it is increasingly clear that vaccines will not be a global public good, as intellectual property rights will not be relinquished: companies are already negotiating bilateral agreements with other producers to increase production capacity⁽¹⁵⁾.

On October 16, 2020, in the framework of the WTO, the United States, the EU, Norway, the United Kingdom, Switzerland, Canada and Australia rejected the request for waivers to certain provisions of the TRIPS Agreement for the prevention, control and treatment of Covid-19, a request that was submitted by South Africa, India and other countries of the « South » and supported by the WHO⁽¹⁶⁾. And even UNESCO’s recent draft recommendation on open science⁽¹⁷⁾ admits that if  » Open Science criticizes and transforms the limits of intellectual property to improve access to knowledge for all, » the open approach does not call into question the use of intellectual property as a means of leveraging the private exploitation and use of knowledge to create new competitive products or services that can generate tangible economic benefits  » (Article 14). There is therefore no change in the foundations of intellectual property law, before which life, health and knowledge seem to have to bend, again and again.

A few other findings are worth mentioning before concluding. First of all, it should be remembered that in 1953 Jonas Salk refused to patent the polio vaccine he had discovered: such ethical conduct does not seem to be considered today. Many observers note that the patent incentive is leading Big Pharma to focus on growth markets and reduce its investment in critical medical areas, including bacterial or viral infections⁽¹⁸⁾.

Prior to the Covid-19 epidemic, leading analyses predicted a sharp slowdown in the growth rate of the drug industry due to the upcoming expiration of market exclusivity periods for many drugs⁽¹⁹⁾. In this context, the Covid-19 vaccine appears to be the new Eldorado for the pharmaceutical industry.

Finally, in a news report, Marie-Paule Kieny, director of the Medicines Patent Pool, acknowledges that it may not be prudent to vaccinate too many people in the first few months of vaccine availability, as safety data are still lacking⁽²⁰⁾. Despite this admission, she insists that the population will have to be « convinced » to be vaccinated, and acknowledges that in France, she contributed to the movement that led to making vaccination mandatory because of growing opposition to vaccination. She does not hesitate to make the future vaccination against Covid-19 an ethical issue⁽²¹⁾ and individual responsibility ». saturated emergency rooms to avoid and deaths in Ehpad « , whereas these two situations are obviously the result of failing health policies that could (with political will) be rectified in the future, independently of vaccination.

What can we conclude from the above? There have been numerous calls in recent months from civil society and several states for a relaxation of intellectual property regimes, with some actors even calling for all covid-19 research results, including any vaccines that may be discovered, to be placed in the public domain. However, we have seen that the reality was quite different and did not meet these demands and proposals at all: the laboratories do indeed intend to claim their intellectual property, despite the massive public investment that has been granted to them. Will these intellectual property rights result in excessive prices and/or difficulties in accessing vaccines for certain populations? It is still too early to say, but we can at least fear that the countries that have already invested billions in private research will have to finance or reimburse the purchase of these vaccines, once again pouring a flood of public money into these private actors that they will have to do without for other societal projects. It is also possible that some poorer countries may also have to disburse sums commensurate with their financial capacities.

But the most worrying thing, apart from the billions of public money literally siphoned off when public investment is more essential than ever to strengthen the health care and social protection systems, is that social, economic, cultural, educational, relational, family life and democratic process be stopped manu militari until the vaccines arrive. Can we consider as a good vaccines obtained at such an economic and social cost, and for which nothing, except declarations that do not commit anyone, guarantees that they will be safe and effective, given the speed of their development and the brevity of their test phases? Indeed, in the event of deleterious side effects, laboratories will not be held responsible or prosecuted in several countries⁽²²⁾.

Moreover, to repeat several scientific questions, is there no risk in being vaccinated after having contracted the disease? What is the point of looking for a vaccine for a disease that is not immunizing, or not for very long, unless one is vaccinated again and again, which would be a real jackpot for the laboratory(ies) that would have such a principle accepted? Couldn’t the mutations of the virus render useless the vaccines that have been developed or even already inoculated? Interview with a Moderna manager: « We hope that with messenger RNA, it will be possible to administer repeated doses and continue to boost the immune response over time, if necessary. » What if the virus mutates? « It is a possibility, but again we would have the means to react quickly⁽²³⁾ ». Comments confirmed by E. André who adds that other vaccines could complete the immunity of those who will have received the RNA vaccines⁽²⁴⁾. It is therefore not one, but several vaccines (some of them, like RNA vaccines, of a type never before experienced) that we should be inoculated with.

Despite the objections related to the real interest and safety of these hastily designed vaccines, it is to be expected that the rich countries have invested far too much in research and pre-orders (1.4 billion doses ordered so far by the EU for 446 million European citizens)⁽²⁵⁾ to give us the freedom to vaccinate⁽²⁶⁾. A French publication already reminds us « that if each person has the right to refuse the care proposed to him in the name of the respect of the private life and the physical integrity, the obligation of vaccination is one of the exceptions, because it has a public health objective (…) A 12th vaccination before 18 months? It is in this context that the possibility of vaccination against covid-19 will be situated.

But what is the point of vaccinating populations that are not at risk (if not to make more profits) if the people at risk, who are responsible for their health, protect themselves or take the decision to be vaccinated if they wish, or accept the risk of contracting the virus one day (just as they have lived up to now with the risk of contracting the flu)? Because what we have to understand is that once the principle of compulsory vaccination is accepted, the door will be wide open for the repetition of the same scenario (masks, distancing, confinement… or compulsory periodic vaccination) for the flu for example, and then for the panoply of vaccines available on the market (and which, given the prospects of profits, will not fail to multiply at full speed). The propagandist justification is a chimerical ideal of eradicating pathogenic viruses.

Faced with this unprecedented race for profit, the ins and outs of which we do not even suspect, faced with the gobbling up and privatization of huge public investments whose impact on the future we do not yet dare to imagine, faced with the obvious conflicts of interest of certain national experts, certain politicians and the media mainstream in many countries⁽²⁷⁾in the face of the alarming censorship exercised by way of public discredit on wise people who try to bring other enlightenment⁽²⁸⁾In the face of suspicions of inaccuracies in the counting of positive cases and deaths actually attributable to Covid-19 and in the face of unprecedented and already irreparable societal upheavals and impacts that a majority of people do not yet seem to realize⁽²⁹⁾Each of us, young and old, should ask ourselves if the search for vaccines for Covid-19, in the current conditions of their elaboration, is really worth such damage which amounts to a societal, and perhaps even civilizational suicide.