- VACCINATIONS AND VARIANTS
Herd Immunity. Many States in the world are continuing their race to vaccinate as many people as possible. The prize of the race is reaching herd immunity, i.e., "the indirect protection from an infectious disease that happens when a population is immune either through vaccination or immunity developed through previous infection"1. Herd immunity is currently the dream of any government on the planet: once such level of protection is obtained, any healthcare system would return to normalcy, and any sector of the economy would be able to freely reopen: Covid-19 would be officially over.
Vaccinations. As in many other areas, the Covid-19 pandemic has emphasized previously existing inequalities between citizens and between States. While certain States have been able to have access to large quantities of vaccines' doses, others have lagged behind. At the time this article is being written2, the US has fully vaccinated 59,6% of its population having 18 years or more, while 68,3% of the same population received at least one dose3. In the EU, 51.3 % of its 18+ population is fully vaccinated, while 67.3% has received at least one dose of vaccine4. In stark contrast, the African continent has fully vaccinated only 1.37% of its global population, while 3.19% has received at least one dose5.
Variants. The pace of vaccinations is incredibly important to prevent further Covid-19 variants from emerging6. New variants, such as the B.1.1.7/Alpha variant (first reported in the United Kingdom), the B.1.351/Beta variant (first reported in South Africa), the P.1/Gamma variant (first reported in the United States), the P.1/Gamma (first reported in Japan and Brazil) and the B.1.617.2Delta (first reported in India)7 and have spread in many countries and have proven to be more transmissible than the original strain. The variants carry multiple mutations and may erode the efficacy of the current vaccines. Hence the saying "no one is safe until everyone is safe" actually reflects a hard truth.
- PATENTS ON VACCINES: RIGHTS OF THE PATENT HOLDER
Patents on Covid-19: Patents vs Public Health? Thanks to unprecedented cooperation between scientists across the globe and between private firms and governments, all strongly motivated by the severity of the pandemic, Covid-19 vaccines have been developed at record speed. All of the current vaccines are, or will be, covered by patents since they are based on one or more inventions that meet the patentability requirements. Some argue8 that this proves the inherent value of the patent system, which affords strong incentives to the inventor and was able to mobilize tremendous resources in the vaccine research. Others9, instead, believe that patents are an obstacle to public health because the use of patents on Covid-19 vaccines is reserved to the inventor rather than accessible to all.
WTO AND TRIPS. Most countries in the world have agreed to protect intellectual property, including patents on pharmaceutical products. Such international agreement has been reached under the World Trade Organization ("WTO", an organization between States that promotes free trade, settles trade disputes and sets forth a system of trade rules, with more than 164 States as members). In particular, specific arrangements on intellectual property have been reached under the "TRIPS" agreements, an acronym for "Trade Related Aspects of Intellectual Property Rights", aimed at setting certain minimum standards on intellectual property rights for all States that are members of the WTO. In light of specific healthcare emergencies (HIV/AIDS, tuberculosis, malaria and other epidemics) TRIPS were amended in 2001 by the "Declaration on the TRIPS agreement and public health" signed in Doha10.
Patents under TRIPS. According to article 27 of TRIPS11, inventions are patentable if they (i) are new, (ii) entail an inventive step, and (iii) are capable of industrial application. If such requirements are met, in case the patent is on a product, for 20 years the patent holder is granted the right to "prevent third parties not having the owner's consent from the acts of: making, using, offering for sale, selling, or importing for these purposes that product"12.
The Balance Inherent in the Patent System. The patent holder is thus rewarded with a long monopoly on the use of its invention in exchange for a description of the invention with sufficient detail that would allow an expert in the field to reproduce it. The patent system has been conceived as a balance between private and public interests: while the rights granted to the patent holder constitute an incentive to innovate and a reward for the inventor, the general public gains access to knowledge that would otherwise remain secret, allowing for further progress of research13.
- COMPULSORY LICENCE OF COVID -19 PATENTS
Compulsory License of Patents. Article 31 of the TRIPS agreement provides for an exception to the patent holder rights. Subject to several conditions14, which render the compulsory license far from easy to activate, the use of a patented invention can occur without the consent of the patent holder, who will in any case be receiving adequate remuneration for such use (the adequacy of such remuneration should be subject to review by a judicial or other independent higher authority). The rationale was to mitigate the patent system in case of a national emergency or extreme urgency, by giving the possibility to obtain a limited license to use a patented invention.
Obstacles to Compulsory Licenses. Many scholars15 have pointed out that the instrument of compulsory license has proven to be difficult to use and that so called "flexibilities" of the patent system are more theoretical than effective. In fact, not only a compulsory license requires a national law allowing for it, but also domestic capabilities to reproduce the patented invention within the borders of the concerned State. If the State does not have sufficient know-how to do so, then article 31-bis of TRIPS, providing for an even more complex mechanism allowing a third party State to manufacture the patented product and the concerned State to import it, should be used16.
- THE PROPOSED WAIVER TO PATENT RIGHTS
Proposal of Waiver to Patent Rights. On October 2, 2020 India and South Africa presented a proposal17 to waive patent rights altogether. Although the waiver would be limited to sections 1, 4, 5 and 7 of part II of the TRIPS Agreement (inclusive of rights to patents) and to a certain duration in relation to the Covid-19 pandemic, the proposal was clearly going beyond compulsory licenses. The proposal, however, was struck down in March 2021 by the WTO.
Support for the Proposal by the US and the EU Parliament. On May 5, 2021 the United States, however, completely reversed its stance when Trade Representative, Ms. Katherine Tai, announced the Biden administration's support to the waiver18. The price of stocks of vaccine manufacturers Moderna Inc. Novavax Inc. and Pfizer Inc. dropped after the announcement. The European Union's position has changed in the last months: the latest news is the June 10, 2021 resolution of the EU Parliament proposing a temporary (not indefinite) waiver of TRIPS on patents, a boost to voluntary licensing and technology transfer to countries with vaccine-producing industries and an elimination of export bans by the US and the UK19. The European Commission, instead, is still resisting the patent waiver, while proposing alternative measures20, but its position is currently viewed as "isolated"21.
How a Waiver Should be Approved. Even if political support has shifted dramatically in favour of the vaccine waiver after the US announcement, achieving the waiver will neither be quick nor easy. In fact, pursuant to article IX of the Agreement Establishing the World Health Organization, waiver of obligations imposed under the Treaty itself or other multilateral agreements (such as TRIPS) may only be reached by consensus (as per common international practice). If consensus cannot be reached, then the decision must be approved by three-fourths of the members of the WTO.
- ARE COMPULSORY LICENSES OR WAIVERS THE SOLUTION TO VACCINE SHORTAGES? PROBABLY NOT
Health vs Profit, Patients vs Patents. The debate on the waiver has shown, once again, that the pros and cons of patents on pharmaceutical products are still subject to a heated discussion. Even in the wake of one of the biggest success stories for "big pharma", the stereotype of greedy corporations, who have more power than States and interests that run against collective interests to healthcare, has quickly emerged22.
Problems Unsolved by the Compulsory License or by the Waiver. While a temporary waiver to Covid-19 vaccine patents may be of help in the short term, there are several issues that would continue to be unresolved in case of compulsory license or waiver of patent rights:
- Some of the vaccines (especially those based on mRNA technology) are extremely recent, very difficult to manufacture and not based on long standing know-how. The cooperation of the patent-holder, who invented the vaccine, is of paramount importance.
- There is an objective scarcity of raw materials to manufacture vaccines: reportedly23, even patent-holders are having trouble purchasing such materials.
- As the pharmaceutical sector is regulated in all aspects, production facilities need to be certified prior to being deployed for vaccine production, a process that greatly lengthens the process of vaccine manufacturing.
Export Bans Also a Critical Barrier. In the wake of the Covid-19 pandemic, many States have closed their borders, thus rendering more difficult the flow of devices, medicines and raw materials that were necessary for the cure of Covid-19, as well as for the development and manufacturing of Covid-19 vaccines. This has created great problems to States that depend on imports of such products and has proven to be a barrier as crucial, or more, than intellectual property protection of vaccines. Stopping international supply chains is a threat to the health of citizens worldwide24.
Conclusions. The debate in favor or against patents is largely political. Some25 argue that insisting on patent protection during a pandemic is short-sighted, since this leaves most of the world's citizens unprotected by vaccines, thus leaving greater room for variants to evolve. Others26 fear that diminishing incentives to produce new vaccines could decrease efforts in the development of vaccines for new variants in the future. In any case, the current shortage of vaccines is rooted in many causes, and - even if compulsory licenses or waivers would "eliminate" patents – this would not, alone, trigger vaccine abundance for the world population.
1 Source: World Health Organization
2 The following data refers to July 21, 2021.
3 Centers for Disease Control and Prevention: https://covid.cdc.gov/covid-data-tracker/#vaccinations
4 European Centre for Disease Prevention and Control: https://vaccinetracker.ecdc.europa.eu/public/extensions/COVID-19/vaccine-tracker.html#uptake-tab.
5African Centers for Disease Control and Prevention: https://africacdc.org/covid-19-vaccination/. Additionally, the same source shows that over 72.75% of available vaccines have been inoculated, showing that the issue is directly linked to the scarcity of vaccines rather than to the vaccination campaign.
6 See "Accelerated vaccine rollout is imperative to mitigate highly transmissible COVID-19 variants" by P. Sah, T. Vilches, et al. published on April 24, 2021, by EClinicalMedicine published by THE LANCET ( https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(21)00145-0/fulltext)
7 The above mentioned are the so-called "variants of concern". According to the World Health Organization, those are variants associated with, alternatively: (i) increase in transmissibility or detrimental change in COVID-19 epidemiology; (ii) increase in virulence or change in clinical disease presentation; or (iii) decrease in the effectiveness of public health and social measures or available diagnostics, vaccines, therapeutics. Other variants, called "variants of interest", exist (more on https://www.who.int/en/activities/tracking-SARS-CoV-2-variants/).
8 See "Vaccini, brevetti e big pharma tra profitto, sostenibilità e diritto alla salute" by Fausto Massimino published on "Il Diritto Industriale" 3, 2021; "The Roles Of Patents And Research And Development Incentives In Biopharmaceutical Innovation" by Henry G. Grabowski, Joseph A. Dimasi, Genia Long published in Health Affairs, vol. 34, n. 2.
9 See "Pandemic and Vaccines. The unsolvable
antagonism between open science and intellectual
property" by Roberto Caso published on Trento Law and
Technology Research Group – Research Paper n. 44;
"Ensuring Vaccine Equity, Erasing Vaccine Nationalism:
Upholding the Human Rights and Justice Framework" by
Shalu Nigam, Independent Researcher Corresponding" by Shalu
11 Article 27 - Patentable Subject Matter "1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application".
12 Such 20-year term is sometimes extended by national legislation in order to take into account the length of the regulatory process required to access the market.
13 Additionally, as pointed out by several scholars (e.g., on page 25 of "Pandemic and Vaccines. The unsolvable antagonism between open science and intellectual property" by Roberto Caso published on Trento Law and Technology Research Group – Research Paper n. 44), many patents – especially in the pharmaceutical sector – are granted even without an accurate description of the invention allowing third parties to reproduce the invention. With regard to Covid-19 vaccines, in particular, there appears to be substantial know-how that may be necessary to reproduce the vaccine, which cannot be easily derived from the description of the invention alone.
14 See Article 31 - Other Use Without Authorization of the Right Holder: https://www.wto.org/english/docs_e/legal_e/27-trips_04c_e.htm .
15 E.g., Study 4C commissioned by the Commission on Intellectual Property Rights "The Use of Flexibilities in TRIPS by Developing Countries" by Sisule F. Musungu and Cecilia Oh https://www.who.int/intellectualproperty/studies/TRIPSFLEXI.pdf
16 Italy has recently enacted a national law (no. 108 of July 29, 2021) that allows for compulsory licensing also in case of declared state of national emergency due to health reasons, in relation to patents connected to the production of specific pharmaceutical products or medical devices. Such compulsory license applies to the supply of the Italian domestic market and cannot last longer than 12 months after the end of the state of emergency.
18 An excerpt of the press release reads: "This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures. The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines." ( https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/may/statement-ambassador-katherine-tai-covid-19-trips-waiver).
24 In its July 7, 2021 resolution, the EU Parliament "23. Stresses that global supply chains for raw materials and the production and distribution of vaccines must benefit from open trade relations; underlines that protectionism in the production and distribution of vaccines can hinder the response to the global pandemic; emphasises, in this connection, the detrimental effects of unilateral measures such as export restrictions and bans, the lack of transparency of global stocks and the subsequent price speculation with regard to scarce essential goods, not least for low- and middle-income countries; [...]".
26 "A waiver of IP protection could leave the society vulnerable to such emerging variants of Covid-19 if the current IP holders/vaccine developers abandoned research efforts as a result of such a waiver" in "Covid-19 and the Role of Intellectual Property, Position Paper of the Max Planck Institute for Innovation and Competition" by Reto M. Hilty, Pedro Henrique D. Batista, Suelen Carls, Daria Kim, Matthias Lamping, Peter R. Slowinski, 2021.
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