Zenner, Florian

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1/6“Fair and Equitable Sharing of Benefits” – also inVaccine Development?jean-monnet-saar.eu/15.09.2021An article written by Florian Zenner*IntroductionWhen the search for a vaccine against SARS-CoV-2 began in 2020, Latin America stoodout as a central testing area for the newly developed vaccines. The reasons for this areobvious: Due to poor hygienic conditions, tight housing, and the economic impossibility ofgoing into quarantine, there was a massive increase in the number of infections.  It wasexactly these infections that were needed to conduct meaningful studies.While the pharmaceutical companies could assume that Latin Americans would continueto become infected and thus test the efficiency of their vaccines against SARS-CoV-2,these same Latin Americans were hoping to receive a piece of the pie when they weresuccessful. But while the companies‘ expectations were fulfilled, those of the people inLatin America were disappointed. Today, we are faced with the peculiar situation that athird injection of the vaccine is already being discussed in the European Union and theUnited States,  while in the countries that have tested the vaccine, not even 20% of thepeople enjoy full protection.  Even these vaccinations do not credit their European orAmerican partners to a large extent. Most of the vaccines against SARS-CoV-2 used inLatin America instead come from Russia or China.These developments give rise to the question of whether and in which mannerpreferential access to new pharmaceutical products for people in testing regions is, or atleast should be, enshrined in international law. Thereby it is not about the generalquestion of access to vaccines, since availability and accessibility of scientific progress isalready guaranteed by Art. 12 (1) of the International Covenant on Economic, Social andCultural Rights (ICESCR). Instead, it is a question of international distribution that arisesmost acutely in the phase of a pandemic when the demand for vaccines still far exceedsthe supply. This issue was only very sporadically addressed prior to the SARS-CoV-2pandemic.  However, it could gain new momentum since the countries, whose highinfection rates made the development of safe vaccines against SARS-CoV-2 possible,ended up being left behind in the distribution of those same vaccines.This article aims to shed light on two questions and to stimulate their discussion: Firstly,the question on which legal basis a preferential access for the countries concerned couldbe established. And secondly, the ensuing problem of who is the direct addressee of apossible obligation under international law and what could be the concrete legalconsequences resulting from such an obligation.[i][ii][iii][iv][v][vi][vii]2/6A legal basis for preferential or equal access?As a legal basis, human rights, especially those from the ICESCR, would first come tomind. This is in line with the idea of the Office of the United Nations High Commissionerfor Human Rights (OHCHR), which published a paper entitled „Human Rights and Accessto Covid-19 Vaccines“  shortly before the first vaccines against SARS-CoV-2 wereapproved in the EU.  The publication mainly emphasizes the responsibility of countriesand companies in the context of the pandemic and presents the legal bases, such asArt. 12 ICESCR, under which all people worldwide must have access to the vaccines.The OHCHR recognizes that there is a massive distribution problem with vaccines andcondemns the hoarding of them as a violation of international law. Nevertheless, not aword is said about the timeframe over which the vaccines are to be distributed.Developed countries are asked to provide support. However, the question of the extent towhich the worst-affected countries, which have contributed to the development of thevaccines, should be given preferential or at least equal access is left out. If an answer tothis question cannot be found in the ICESCR, it should be examined whether generalprinciples of international law or customary law can provide a satisfactory solution. Thefocus of this paper is thereby on the concept of fair and equitable sharing of benefits.The concept of benefit-sharing is familiar to most lawyers from the field of internationalenvironmental law. There it forms one of the three pillars of the Convention on BiologicalDiversity (CBD),  concretized in the Nagoya Protocol on Access to Genetic Resourcesand the Fair and Equitable Sharing of Benefits Arising from their Utilization. However,the basic idea behind this concept is much older: Art. 27 (1) of the 1948 UniversalDeclaration of Human Rights (UDHR)  already refers to everyone’s right to share in thebenefits of scientific advancement, and Art. 2 (3) of the 1986 UN Declaration on the Rightto Development stresses the States‘ duty to ensure the “active, free and meaningfulparticipation in development and in the fair distribution of the benefits resulting therefrom”.Furthermore, a number of international documents also make use of this as aninstrument.  A prominent example is the deep-seabed mining regime of the 1982 UNConvention on the Law of the Sea (UNCLOS).  The dissemination of this formula hasled to individual academic attempts to derive a general principle according to whichparticipation rights could be established in certain situations that are characterizedespecially by an imbalance of power between the parties.  The following will focus onhow this principle can be justified and whether it is applicable to vaccine distribution.Indeed, it is not easy to construct a legally binding effect from the concept of fair andequitable sharing of benefits. While it has already been recognized as customary law insome sectors,  the question of whether this also applies across sectors still requiresfurther legal research.  Such work cannot be done within the scope of this brief article.However, attention should be drawn to one argument in particular: On several occasions,the UN General Assembly has given special emphasis to the concept of fair and equitablesharing of benefits.  Legal scholars have drawn from this a core of elements that arereflected also in other areas of international law.  Therefore, at least the essence ofbenefit-sharing should be considered a general principle of international law.  Thiscould be formulated as follows: If the people of a country make a special contribution to[viii][ix][x][xi][xii][xiii][xiv][xv][xvi][xvii][xviii][xix][xx][xxi][xxii]3/6the development of knowledge by making their natural resources available or in someother way, they should be enabled to participate fairly and equitably in the progress if theyhave not been able to achieve this on their own for socio-economic reasons.If we use this definition as a benchmark, we can see a parallel to the problem outlined atthe beginning: The people of Latin America have made it possible to develop safevaccines against SARS-CoV-2 because of their high infection rates. While European andAmerican pharmaceutical companies brought the scientific know-how, the countries ofLatin America made themselves available as a testing area. Both contributions wereessential in the fight against the SARS-CoV-2. Therefore, all parties involved shouldbenefit equally from the outcome. The way in which this could be ensured will beanalyzed in the final sectionPossible ways to implement the right to equitable participationThe easiest way to enforce the participation rights of local people would be to grant theman enforceable right directly against the pharmaceutical companies concerned. However,this would require recognition that companies can be direct addressees of obligationsunder international law. Such a legal obligation for private companies is indeed beingdiscussed, especially in human rights protection. The prevailing view, however, stillrejects this.  Another question worth considering is whether the massive statesubsidies for vaccine development  might not result in companies being bound byinternational law. However, state support can at most lead to the attribution of thebehavior of private parties to the state,  but not to an attribution of the state’s status toprivate parties.The remaining option, therefore, is to hold those states responsible from which thecorporations operate and which support their research. In this context, it is certainly notpossible to derive concrete obligations under international law from the vague concept of“benefit-sharing”, for example, to agree to the much-discussed waiver of intellectualproperty rights under the World Trade Organization (WTO) Agreement on Trade-relatedIntellectual Property Rights (TRIPS).  Nevertheless, it must be excluded that statesblock the export of vaccines against SARS-CoV-2 or hoard them to an extent thatexceeds what is necessary for their population. In its application, the concept of “fair andequitable sharing of benefits” can therefore only oblige states to meet a minimum ofrequirements due to its vagueness. Unfortunately, we have seen that even this minimumstandard was not always met during the SARS-CoV-2 pandemic.ConclusionThis paper has attempted to show that there is a generalizable principle that fairparticipation in jointly-created scientific progress is required under international law. Thisprinciple can be deduced from various sources of international law and applied to thedistribution of vaccines against SARS-CoV-2. However, it has also been shown that, asthings are standing right now, companies are not directly bound by this principle. Evenstates have only the obligation to observe and implement a minimum standard.Theseresults may be unsatisfactory and it is the public debate about global vaccine distribution[xxiii][xxiv][xxv][xxvi][xxvii]4/6that seems to call for a more concrete framework than the voluntary commitments in theCovid-19 Vaccines Global Access (COVAX) program. However, the results can also beseen as an opportunity to establish a more solid legal framework in vaccine distributionand to strengthen international collaboration in the field of health policy. Because whetherwe like it or not, the SARS-CoV-2 pandemic is unlikely to be the last of its  Dipl.-Jur. Florian Zenner is a research associate and doctoral candidate at the chair ofProf. Dr. Jan Henrik Klement at the Albert Ludwig University of Freiburg. Gurk, Vom Hotspot zum Hoffnungsträger – Wie die Pharmaindustrie Lateinamerika zumExperimentierfeld gegen Sars-CoV-2 macht, Süddeutsche Zeitung, 3 August 2020, p. 2. Brühwiller, Das Corona-Labor, Frankfurter Allgemeine Zeitung, 17 September 2020,p. 7. While this article was being written, the so-called „booster vaccinations“ have alreadystarted in Germany, see Geinitz/Stahnke, Runde Drei, Frankfurter Allgemeine Zeitung,21 August 2021, p. 6. A good and updated overview is available at https://ourworldindata.org/covid-vaccinations?country=OWID_WRL (last visited 29 August 2021). Gurk, Profiteure der Armut, Süddeutsche Zeitung, 11 May 2021, p. 2. Committee on Economic Social and Cultural Rights (CESCR), General CommentNo. 25 (2020) on science and economic, social and cultural rights (article 15 (1) (b), (2),(3) and (4) of the International Covenant on Economic, Social and Cultural Rights),para. 70. Mira Chang, for instance, proposed a legal standard under which people would havepreferential access to pharmaceutical products tested in their country, quotedfrom Beyerle, Erst kommt der Test, dann die Moral, MaxPlanckForschung 1/2011, p. 34–41, 39. OHCHR, Human Rights and Access to Covid-19 Vaccines, 17 December 2020,available at https://www.ohchr.org/Documents/Events/COVID-19_AccessVaccines_Guidance.pdf (last visited 29 August 2021). After the OHCHR paper was published on 17 December 2020, the EuropeanMedicines Agency (EMA) announced its recommendation for approval of the first vaccineon 21 December 2020, see https://www.ema.europa.eu/en/news/ema-recommends-first-covid-19-vaccine-authorisation-eu (last visited 29 August 2021). This approach is not entirely new. The World Health Organization (WHO) 2011Pandemic Influenza Preparedness Framework (PIP Framework) embodies a multilateralsystem for sharing samples of pandemic influenza viruses and benefits arising from it,especially the sharing of vaccines produced from research on the virus, see World Health*[i][ii][iii][iv][v][vi][vii][viii][ix][x]5/6Organization (WHO), Pandemic Influenza Preparedness Framework for the Sharing ofInfluenza Viruses and Access to Vaccines and Other Benefits, WHO Doc. WHA64.5,24 May 2011. Convention on Biological Diversity (CBD), adopted on 5 June 1992. Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharingof Benefits Arising from their Utilization to the Convention on Biological Diversity, adoptedon 29 October 2010; a constantly updated overview of the states that have ratified theprotocol can be found at https://www.cbd.int/abs/nagoya-protocol/signatories/ (last visited29 August 2021). Universal Declaration on Human Rights, UN Doc. A/810 (1948). UN Declaration on the Right to Development, GA Res 41/128, 4 December 1986. A detailed overview is provided by Morgera, Fair and equitable benefit-sharing: history,normative content and status in international law, BENELEX Working Paper N. 12 (April2017; REV June 2018), p. 2 et seqq. United Nations Convention on the Law of the Sea (UNCLOS), adopted on10 December 1982. Morgera, Fair and equitable benefit-sharing: history, normative content and status ininternational law, BENELEX Working Paper N. 12 (April 2017; REV June 2018),p. 6; Morgera, The Need for an International Legal Concept of Fair and Equitable BenefitSharing, EJIL Vol. 27 No. 2 (2016), p. 253–383. With regard to bioprospecting, see Pavoni, Biodiversity and Biotechnology:Consolidation and Strains in the Emerging International Legal Regimes, inFrancioni/Scovazzi (eds.), Biotechnology and International Law, 2006, p. 29–58, 41et seq; with regard to the deep-seabed mining regime Harrison, The SustainableDevelopment of Mineral Resources of the International Seabed Area: The Role of theAuthority in Balancing Economic Development and Environmental Protection, 2014, p. 7et seq; for a differentiated overview, see Morgera, Fair and equitable benefit-sharing:history, normative content and status in international law, BENELEX Working Paper N. 12(April 2017; REV June 2018), p. 9 et seq. Morgera, The Need for an International Legal Concept of Fair and Equitable BenefitSharing, EJIL Vol. 27 No. 2 (2016), p. 253–383, 383. UNGA Res. 63/230, 17 March 2009, Second United Nations Decade for theEradication of Poverty (2008–2017), para. 12; UNGA Res. 29/3281, 12 December 1974,Charter of Economic Rights and Duties of States, Art. 10. Morgera, Fair and equitable benefit-sharing: history, normative content and status ininternational law, BENELEX Working Paper N. 12 (April 2017; REV June 2018), p. 6 etseqq.[xi][xii][xiii][xiv][xv][xvi][xvii][xviii][xix][xx][xxi]6/6 Morgera, Fair and equitable benefit-sharing: history, normative content and status ininternational law, BENELEX Working Paper N. 12 (April 2017; REV June 2018), p. 10; forthe difference between customary law and general principles of international law,see Lepard, Customary International Law – A new Theory with Practical Applications,2010, p. 162 et seqq. Von Arnauld, Völkerrecht, 4  ed. 2019, para. 632; a good overview of the state ofdiscussion is provided by Herdegen, Völkerrecht, 20  ed. 2021, § 13.  According to „Tagesschau“, Germany and the USA have invested by far the mostmoney in vaccine development, available at https://www.tagesschau.de/wirtschaft/corona-impfstoffe-investoren-101.html (last visited 29 August 2021); therefore, critical andadvocating a waiver of the World Trade Organization (WTO) Agreement on Trade-relatedIntellectual Property Rights (TRIPS) Arnold, Was öffentlich finanziert wird, sollte auchöffentlich zugänglich sein, Cicero, 1 February 2021. On the attribution of conduct to a state, see Chapter Two of the Draft articles onResponsibility of States for Internationally Wrongful Acts, adopted by the InternationalLaw Commission at its fifty-third session, in 2001, and accepted by the UN GeneralAssembly (Res. 56/83 of 12 December 2001). See Arnold, Was öffentlich finanziert wird, sollte auch öffentlich zugänglich sein,Cicero, 1 February 2021. On export restrictions and vaccine hoarding, see for examplehttps://www.tagesschau.de/ausland/usa-exportverbot-impfstoff-101.html (last visited29 August 2021).[xxii][xxiii] thth[xxiv][xxv][xxvi][xxvii]

“Fair and Equitable Sharing of Benefits”: also in Vaccine Development?

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“Fair and Equitable Sharing of Benefits”: also in Vaccine Development?

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