The Corporate Responsibility To Respect Human Rights: The Exemplar of Pfizer’s Failure In The Israel-Pfizer COVID-19 Vaccination Collaboration
Reichman University, Israel
The Corporate Responsibility To Respect Human Rights
1. Corporate accountability for human rights abuses has become a significant focus of both academic attention and increasing State scrutiny. States have commenced establishing mechanisms to subject corporations to more intensive regulations particularly regarding corporate subsidiaries, supply-chains, and business partners. Doing so is in accord with the United Nations Guiding Principles on Business and Human Rights (Guiding Principles) which tasks States with protecting, and businesses with respecting, human rights (Guiding Principles on Business and Human Rights: Implementing the United Nations “Protect, Respect and Remedy” Framework, A/HRC/17/31 (21 March 2011) https://www.ohchr.org/documents/publications/guidingprinciplesbusinesshr_en.pdf).
2. While the State’s duty to protect is essential, the need for corporations to respect human rights might be a potentially under-utilized conceptual framework to advance human rights. Specifically, the Guiding Principles reference a business responsibility to perform due diligence on business partners (including State-linked entities), to respect human rights in connection with a business contract’s performance. This responsibility has generally been understood as engaging in due diligence over subsidiaries and supply chain partners. However, it is not always private actors that are the business partners of corporations. States are often contract parties in commercial relationships and these partnerships or collaborations may indeed increase in the future. Perhaps an enhanced focus on corporate responsibilities to respect human rights can offer a beneficial tool to promote human rights.
3. The context of this essay is the Pfizer-Israel Collaboration and Data-Sharing Agreement which formed the basis of the Pfizer mRNA vaccination program in Israel. The question this essay examines is whether Pfizer fulfilled its responsibility to protect, i.e., to endeavor to ensure the Israeli government satisfied its State duty to protect the right of Israeli citizens to informed consent. The issue of informed consent during a pandemic is crucial as the failure to safeguard human rights is a slippery slope – once human rights are not respected or protected, additional violations of human rights beyond informed consent are at-risk. Indeed, this topic is of vital import not just for informed consent but other rights such as freedom of movement (Fernando Dias Simões, Protecting International Travelers During Pandemics: Charting the Way Forward, (2022) 31 Minnesota Journal of International Law 41, 54 (“If international law does not implement efficient therapies, human rights – including freedom of movement – will continue to fall victim to future pandemic outbreaks”) and even government censorship. Illustrative, a United States District Court found sufficient evidence of U.S. governmental coordination with social media and technology businesses with respect to censoring the internet on dissenting opinions related to the safety of COVID-19 vaccines to grant a preliminary injunction against parts of the U.S. Federal government (https://www.documentcloud.org/documents/23867317-missouri-v-biden-memorandum-ruling-on-request-for-preliminary-injunction?responsive=1&title=1). This essay analyzes the corporate responsibility to respect in the context of the COVID-19 pandemic and the collaboration between U.S.-based Pfizer corporation and the Israeli government.
The Pfizer-Israel Collaboration and Data-Sharing Agreement
4. The Covid-19 global pandemic swept the globe in early 2020 incentivizing expedited development of novel treatments such as Pfizer’s mRNA vaccine. In or around December 2020, the Israeli government entered into a procurement contract titled “Epidemiological Evidence Collaboration Agreement” (referred to in the Contract as “the Project”), for the supply of Pfizer’s mRNA vaccines to Israel as well as comprehensive data sharing. According to Pfizer CEO Bourla, he and Prime Minister Netanyahu had 30 discussions prior to signing the contract (https://www.timesofisrael.com/pfizer-ceo-obsessive-netanyahu-called-30-times-in-effort-to-seal-vaccine-deal/). The Israeli government initially adamantly refused to provide the Israeli public with the Contract insisting on complete secrecy. Israeli officials claimed disclosing the contents of the Pfizer-Israel Contract would be criminal (https://www.haaretz.com/israel-news/israel-reveals-what-patient-s-data-it-gives-pfizer-as-part-of-covid-vaccine-deal-1.9459439).
5. Eventually, immense media and public pressure led the Israeli government to reluctantly publish a heavily censored version of the Contract which was recently removed from the Ministry of Health website but is available on non-governmental sites at https://govextra.gov.il/media/30806/11221-moh-pfizer-collaboration-agreement-redacted.pdf (removed by the Israel Ministry of Health without explanation, but available here https://www.keionline.org/misc-docs/IsraelMOH-Pfizer-Collaboration-Agreement-6Jan2021.pdf). Entire contractual provisions related to indemnification, damages, liability, dispute resolution, along with isolated sentences are completely blacked-out in the redacted version made public. The Pfizer-Israel Contract obligated Israel to transfer an exhaustive amount of data to Pfizer, and both parties “agreed to cooperate on a reasonable basis to share information… including to track its benefits”.
The Israeli Government’s Aggressive Marketing Campaign To Vaccinate All Israelis
6. The campaign to vaccinate was ensconced in Israeli governmental claims that the U.S. Food and Drug Administration (FDA) had definitively found the vaccine as safe with no side-effects. For example, in an effort to convince Israeli citizens of the vaccine’s complete safety, the Israeli government and Health Maintenance Organizations (HMOs) commenced marketing the vaccine as safe and effective. In one example, an ad featured the Israeli Prime Minister mocking anyone questioning the safety of the Pfizer mRNA vaccine describing those asking questions as “clowns” and claiming the Pfizer vaccine had already been “approved by the Americans” (https://www.youtube.com/watch?v=0hS9TEDULgs). However, when the Israeli vaccination program commenced, the FDA had only provided Emergency Use Approval (EUA) pending further testing. EUA is fundamentally different than full approval and is based on a reasonable belief of effectiveness and an express concession that there is a dearth of information regarding risks (https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19). Accordingly, due to the unique circumstances associated with an EUA approval, the FDA provides a Fact Sheet for EUA approved products to ensure recipients are informed of the risks (https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained). Indeed, the first FDA Fact Sheet explicitly advised, adverse effects are unknown and the vaccine remains in clinical trials (https://www.federalregister.gov/documents/2021/01/19/2021-01022/authorizations-of-emergency-use-of-two-biological-products-during-the-covid-19-pandemic-availability).
7. However, the intensive Israeli governmental marketing campaign failed to disclose that the FDA approval was not full approval but rather an EUA and that the Pfizer mRNA vaccine was still undergoing testing. Indeed, the Israeli vaccination drive was part of the testing and constituted a “sort of a ‘Phase 4’ study”. David Gurwitz, COVID-19 vaccine hesitancy: Lessons from Israel (2021), 39 Vaccine 3785). These facts were not noted in the marketing efforts nor was it widely communicated (if at all). Indeed, the FDA Fact Sheet was not provided to the Israeli vaccine recipients in either Hebrew or English.
8. The fact that risks existed, the Israeli vaccination drive constituted a Phase 4 Trial, and the fact there was only an EUA, militate compellingly to the conclusion that informed consent was lacking. As one commentator noted:
The timely COVID-19 vaccine supply in Israel, unparalleled by other countries, was possible thanks to an agreement between its government and Pfizer, according to which Israel agreed to serve as a real-world testing ground (sort of a “Phase 4” study) for the vaccine, in return for sharing with Pfizer aggregated information on COVID-19 vaccination and infection rates. However, at time of writing, details of this agreement remain undisclosed. This lack of transparency, along with the fact that Israeli citizens eligible and willing to receive COVID-19 vaccination were not offered alternative (non-mRNA based) COVID-19 vaccines, and were not asked to sign an informed consent to be vaccinated, contributed to public mistrust in the Israeli vaccination drive (David Gurwitz, COVID-19 vaccine hesitancy: Lessons from Israel, (2021) 39 Vaccine 3785).
Moreover, based upon the author’s conversations with hundreds of Israeli Pfizer vaccine-takers, including University students who were vaccinated in widely diverse locations throughout Israel, and adults working in various sectors, no written information and no disclosure was provided at the Israeli vaccination centers informing recipients that the FDA had only issued an EUA approval. No consent forms were provided and there was no mention of potential risks.
9. In a further exemplar of a lack of transparency, Israel’s HMOs emphasized only the positive touting Pfizer’s mRNA vaccine as “safe” and the “only way” to return to normal life. As has been noted:
The vaccination has undergone intensive testing phases, and health officials both in Israel and worldwide have determined that the vaccine is safe for use….Operation “Vaccinating for Life” is the only way that will allow us to resume our normal lives (https://www.leumit.co.il/eng/Life/FamilyHealth/familyhealth/coronavirus/articlegalleryitem,5171/).
But citizens were not informed that risks existed. Nor were they informed of alternative options such as Chinese non-mRNA vaccines. Furthermore, public messages and announcements from some Israeli government officials denounced individuals who were reluctant to take part in “the Project” (https://www.nytimes.com/2021/02/18/world/middleeast/israel-covid-vaccine-reopen.html).
Many Israelis were hesitant but substantial pressure was imposed to be vaccinated (https://www.yahoo.com/news/israels-unvaccinated-fear-exclusion-152649526.html). Citizens were implicitly threatened that the Israeli Welfare Department would contact parents and ask why their children remained unvaccinated (https://news.yahoo.com/israel-turns-carrots-maybe-sticks-165838959.html) which could lead to abuse claims and removal of children which the Welfare Department has been criticized as being excessively willing to remove children from homes based on anonymous reports (https://www.israelhayom.co.il/article/142317) and would therefore serve as a great pressure for parents to vaccinate their families. Based on the above-referenced facts, a relatively compelling argument can be made that there was no informed consent in the implementation of the Pfizer-Israel mRNA vaccination program.
The State’s Obligation To Protect The Right To Informed Consent
10. Informed consent is fundamental to human rights, and is specifically articulated in the International Conference on Civil and Political Rights (ICCPR). The ICCPR is addressed to State actors, and established informed consent for medical experimentation as a critical human right and jus cogens principle of international law. As described above, at the time of the vaccination program the Pfizer mRNA vaccine had only received EUA approval and likely constituted a Phase 4 trial. Furthermore, in light of Pfizer CEO Bourla’s explicit reference to Israel serving as a “world laboratory” (https://www.nbcnews.com/nightly-news/video/pfizer-ceo-albert-bourla-on-covid-vaccine-extended-interview-101616709754?fbclid=IwAR36WYfS6XV6P7l1aCip63zXP8Xrjn49Eh-eVq3d1T2C9dKlrZnK7XQro6s), it is quite reasonable to conclude the “Project” was indeed a medical experiment. Accordingly, it is likely that the Israeli government was obligated to obtain informed consent before vaccinating Israeli citizens.
11. However, whether or not the mass vaccination program fulfilled the technical strictures of an experiment, informed consent is also mandated when medical treatment is offered. The International Covenant on Economic, Social and Cultural Rights (CESCR) states that informed consent encompasses medical treatment as well as medical experimentation (CESCR Art. 12). Moreover, in 2005, the General Conference of the United Nations Educational, Scientific and Cultural Organization (UNESCO) adopted the Universal Declaration on Bioethics and Human Rights, mandating “the prior, free, express and informed consent of the person concerned” for research-oriented treatments which at a minimum the Pfizer-Israel program encompassed (Art. 6). In another exemplar of informed consent’s crucial importance, the Universal Declaration on Human Genome and Human Rights states regarding treatment or diagnosis, “In all cases, the prior, free and informed consent of the person concerned shall be obtained” (Art. 5).
12. Further underscoring the importance of informed consent, even in the non-medical experimental context, as enumerated in the WHO International Health Regulations (‘IHR’), a global health crisis does not outweigh the obligation to obtain informed consent even for ordinary vaccinations. The IHR states:
No medical examination, vaccination, prophylaxis or health measure under these Regulations shall be carried out on travellers without their prior express informed consent or that of their parents or guardians….Travellers to be vaccinated or offered prophylaxis pursuant to these Regulations, or their parents or guardians, shall be informed of any risk associated with vaccination https://www.who.int/publications/i/item/9789241580410 Art. 23).
The Israeli Government Failed To Obtain Informed Consent
13. As discussed above, informed consent is enshrined in international law and the Israeli government was obligated to obtain informed consent before vaccinating Israeli citizens. Yet in contrast to other States (Deirdre T. Little, Elvis Seman, I. & Anna L. Walsh, COVID-19 Vaccination: Guidance for Ethical, Informed Consent in a National Context, (2021) 36 Issues L. & MED. 127 (arguing the consent form used by the Australian Government was inadequate)), the Israeli government never provided a consent form. Full disclosure and transparency are crucial in determining whether one should receive a particular medical treatment. Risks being downplayed (or not mentioned) while only strongly positive comments are declared, fails to comport with informed consent. The omission of crucial information in the Israeli government’s marketing campaign created the perception that the Pfizer mRNA vaccine was fully “FDA approved and completely safe” and “the only way out”; this failed to disclose other options such as Chinese non-mRNA vaccines or herd immunity. Anyone questioning the vaccination campaign was criticized and was labeled a clown. However, an absence of pressure or coercion is essential to an informed decision. The Israeli government’s intensive marketing campaign which failed to cite potential risks, disclose that the vaccine remained in trial, provide the FDA Sheet, and failed to provide an adequate consent form, convincingly raise substantial doubt regarding informed consent.
14. While this essay does not opine that the Pfizer mRNA is dangerous in the long-term, in parallel, at this juncture, one cannot claim it is absolutely safe. Interestingly, since the rollout of Covid-19 vaccines, there have been acknowledgements based on the science of adverse effects and risks. Illustrative, the most recent FDA Fact Sheet discloses a low, but elevated risk for cardiac problems particularly in young males taking the Pfizer mRNA vaccine https://www.fda.gov/media/167212/download). Moreover, it cannot be seriously contested that risks may be discovered and injuries linked to the Pfizer mRNA vaccine over the next few years. Indeed, the potential adverse effects are unknowable and are currently being researched (https://www.nbcnews.com/health/health-news/myocarditis-covid-vaccine-research-long-term-effects-rcna55666 ).
15. Significantly, some governments have decided against vaccinating certain groups as the risks have been deemed by the science to outweigh the benefits (https://www.forbes.com/sites/roberthart/2021/11/10/germany-france-restrict-modernas-covid-vaccine-for-under-30s-over-rare-heart-risk-despite-surging-cases/?sh=4d263e3e2a8a). Therefore, notwithstanding the Israeli government’s marketing campaign which created a false impression the Pfizer vaccine was “absolutely safe”, short-term and long-term risks were unknown (and indeed unknowable) since it takes years to definitively determine the existence and extent of health risks (Philip R. Krause and Marion F. Gruber, Emergency Use Authorization of Covid Vaccines-Safety and Efficacy Follow-up Considerations, (2020) N. Engl. J. Med. 2020; 383:e107). Surely, many Israeli recipients within any “at risk” demographic groups might have elected not to take the risk of cardiac damage had they been informed that risks were unknown rather than being told it was safe and “had been approved by the Americans”.
Pfizer’s Failure To Respect Human Rights: How Pfizer Could Have Fulfilled Its Responsibility
16. Does Pfizer have responsibility for the failure of the Israeli government to obtain informed consent? To answer the question, the Guiding Principles are instructive. In the context of a procurement contract, the responsibility on a State to protect human rights – and engage in oversight of corporations is well-accepted. Under the Guiding Principles, States should exercise adequate oversight over businesses when commercial relationships such as contracts “may impact upon the enjoyment of human rights” (Guiding Principle 5). But the reverse is also equally true; businesses can use contracts to respect human rights – particularly when a business relationship such as “The Project” may impact upon the enjoyment of a human right such as informed consent.
17. Corroborating the logic of this approach, the Guiding Principles conceptualize the corporate responsibility to respect human rights holistically to encompass human rights violations arising from the business relationship even if the corporation might not have engaged directly in the misconduct. Businesses must: “(a) [a]void causing or contributing to adverse human rights impacts through their own activities, and address such impacts when they occur”, and “(b) [s]eek to prevent or mitigate adverse human rights impacts that are directly linked to their operations, products or services by their business relationships, even if they have not contributed to those impacts”. Guiding Principle 13.
18. While monitoring business partners is often understood in the contexts of parent-subsidiary and/or supply-chain partners, such partners can also include States (Commentary to Guiding Principle 13). Specifically, the Guiding Principles envision partners as encompassing a “State entity directly linked to its business operations”. While this conceptualization is described as a partnership between a business and a State-linked entity, there is no reason to narrowly restrict the understanding of a partner to a state-linked or state-owned enterprise as opposed to the State itself.
19. In the context of government procurement contracts, corporations have a unique opportunity to prevent human rights abuses committed by State partners. Pursuant to the Guiding Principles, corporations should engage in due diligence from the inception of contract negotiations to determine whether human rights might be implicated in the performance of the contract (Guiding Principle 17). After such due diligence, the business should endeavor to use leverage to place human rights as a focus of the which is key and The Commentary to Guiding Principle 19 emphasizes how business can marshal their economic strength to incentivize the protection of human rights by its partners.
20. Pfizer’s enormous leverage with the Israeli government was extensive. Indeed, Pfizer was the first manufacturer to receive an EUA. Furthermore, CEO Bourla described the Prime Minister’s incessant calling which provided great leverage for Pfizer to insist on informed consent being part of the contract. Therefore, Pfizer had the opportunity, from the earliest stage of negotiation, to discuss informed consent. In addition, during all of these discussions, Pfizer could have offered to provide advice regarding informed consent to build the Israeli government’s capacity to comply with their duty to obtain informed consent. By engaging directly with the Israeli Prime Minister, Pfizer could have “short-listed” the issue of informed consent. Pfizer could have used their leverage at each stage of the public procurement process, from the Netanyahu-Bourla consultations, contract negotiations, and execution to insert informed consent into the Contract.
21. Therefore, as a first step, Pfizer should have conducted due diligence “as early as possible in the development of a new activity or relationship, given that human rights risks can be increased or mitigated already at the stage of structuring contracts or other agreements” (Guiding Principle 17). Ideally, Pfizer would have identified the Israeli government’s duty to obtain informed consent from Israeli citizens prior to vaccination. However, nowhere in the heavily redacted Pfizer-Israel Contract does Pfizer insist on (let alone mention) an obligation to obtain informed consent. This omission stands in stark contrast to other legal obligations that Pfizer specifically enumerated in the Contract such as compliance with the Foreign Corrupt Practices Act as well as various other “Regulatory Requirements” such as “Privacy Protection …Pharmacist regulations… [and] Global Trade Control Laws”.
22. Pfizer should have capitalized on its enormous leverage and insisted that the Israeli government comply with informed consent from the outset. Moreover, as this was a data sharing collaboration, it would have been relatively easy for Pfizer to insert into the contract some clause to the effect that along with the data to be transferred to Pfizer such as age, sex, and other criteria, an additional data point could have been added, i.e., confirmation that informed consent was obtained. Moreover, while absolutely a vital first step, merely performing the initial assessment is insufficient. Pfizer had a continuous responsibility to perform due diligence and to assess potential human rights problems associated with the procurement contract (Commentary to Guiding Principle 18). Furthermore, Pfizer could have utilized its leverage in various additional ways to fulfill its responsibility to respect human rights: as a large pharmaceutical business providing advice to the Israeli government on informed consent, reaching out to Israeli human rights organizations to ascertain whether informed consent was being obtained, working with the Israeli government to develop an informed consent form. Yet Pfizer evidently had no interest in ensuring that the human right to informed consent was respected. This perspective yields substantial promise since a corporation can use its commercial leverage to incentivize States to comply with human rights obligations. Doing so also comports with the recognition that ignoring State conduct arising from the performance of the contract which conflicts with human rights compliance is inadequate to fulfill the corporate responsibility to respect. While this essay does not opine that the Pfizer mRNA is dangerous in the long-term, in parallel, at this juncture, one cannot claim it is absolutely safe. Moreover, global corporations are powerful actors with economic leverage and human rights compliance language can be inserted into commercial arrangements with States. Furthermore, large corporations can use their global experience and in-house expertise to enhance both awareness and compliance with human rights responsibilities.
23. Businesses must be proactive in fulfilling their responsibilities to respect human rights rather than ignore whether or not their State business partners protect human rights: “The responsibility of business enterprises to respect human rights … exists independently of States” abilities and/or willingness to fulfil their own human rights obligations and does not diminish those obligations… Therefore, it is not enough for companies to monitor developments and follow the measures States take; they have an individual responsibility” (Friends of the Earth, paras 4.4.13–4.4.14). In light of the Pfizer-Israel Contract, there are lessons to be learned from the Pfizer-Israel experience with respect to the corporate responsibility to respect human rights applicable to future global pandemics or other emergencies.
24. Once Pfizer decided to engage in a business relationship with the Israeli government, Pfizer should have performed due diligence to identify potential human rights issues arising from the Pfizer-Israel business relationship such as the Israeli government’s duty to obtain informed consent. In addition, Pfizer should have discussed and negotiated contractual language addressing informed consent, and established an oversight mechanism to ensure compliance so violations would be flagged and subsequently remedied. Particularly during times of crisis, the safeguarding of human rights must be sacredly defended. Utilizing contracts is a potentially important mechanism to promote the safeguarding of human rights.
25. Pursuant to the Guiding Principles, Pfizer’s obligatory due diligence should have raised informed consent as a potential human rights issue arising from the contract’s performance. Utilizing Pfizer’s leverage which existed from the initial consultations, through negotiations, and ultimate contract execution, Pfizer should have inserted language into the contract regarding the Israeli government’s duty to obtain informed consent. Yet despite ample opportunity, there is no reference to informed consent in the redacted contract. By failing to undertake these measures, Pfizer failed to fulfill its responsibility to respect human rights.
26. Finally, while the corporate responsibility to respect human rights exists even with routine procurement contracts, in the context of actual collaborations, such as the Pfizer-Israel Contract, this responsibility to respect is even more compelling. A holistic examination of the relationship suggests a more extensive connection than a mere procurement contract. Pfizer’s CEO conceded in an NBC interview that Israel serves as Pfizer’s global laboratory for the mRNA vaccine suggesting that the Israeli program constitutes more than an ordinary procurement contract. Yet the Israeli government’s obligation to obtain informed consent was seemingly of no import to Pfizer. Pfizer’s failure to fulfill its responsibility to perform due diligence as well as the failure to insert contractual language regarding informed consent, is a glaring exemplar of a missed business opportunity to respect human rights.
Notes about the author:
Joel Slawotsky is a former law clerk to the Hon. Charles H. Tenney, (U.S.D.J., S.D.N.Y.) and AV peer-review rated (pre-eminent rating) litigator at Dentons. Joel teaches at Reichman University (IDC Herzliya, Israel) where his primary areas of research and teaching focus on corporate and economic governance; international economic law; national security and global governance. He has taught, lectured and presented at conferences in Asia, Europe, and both North and South America. Joel has published over 50 journal articles and book chapters. Recent publication venues include the Chinese Journal of International Law (SSCI); Law Science (CSSCI) Hong Kong Law Journal (SSCI); Asia Pacific Law Review (SSCI); Journal of World Trade (SSCI); Chinese Journal of Comparative Law (ESCI); Tsinghua China Law Review (ESCI); Georgetown Journal of International Law; Fordham International Law Journal; Virginia Law and Business Review; Duke Journal of Comparative and International Law; Virginia Journal of International Law; Review of Banking and Financial Law; Delaware Journal of Corporate Law and U.Penn. Business Law Journal. He may be reached at firstname.lastname@example.org.