Safeguarding the Human Right of Informed Consent: Corporate Accountability in State-Private Partnerships and Responsibility for Violations of International Law

Joel Slawotsky

IDC Herzliya, Israel

2021.07.31

1. The role of large global corporations in promoting international law is a pivotal issue given the overwhelming power of corporate actors. Indeed, the complexities of state and corporate power - including the balance of power between them and their interrelationship - is being increasingly scrutinized, evaluated and criticized within the context of global governance. Recent years have brought a substantially increased focus on human rights abuses conducted by global corporations (either directly or by aiding and abetting the state) as well as the absence of safeguards ensuring corporate compliance with international law and human rights.

2. The global trend to make corporations responsible for human rights abuses is manifestly clear. In the United States, corporations have been held to be liable for violations of international law under the Alien Tort Statute (“ATS”). While the U.S. Supreme Court based a recent ATS dismissal in Nestle (https://www.supremecourt.gov/opinions/20pdf/19-416_i4dj.pdf) on the presumption against extraterritoriality, a plurality of Justices indicated that corporations are not inherently immune from liability for violations of international law. The U.S. Supreme Court’s implicit recognition of corporate liability comports with recent global trends. Last year, the Canadian Supreme Court ruled in Nevsun (Nevsun Resources Ltd. v. Araya, 2020 SCC 5 (Can.)) that Canadian corporations may be liable in Canadian courts for human rights violations committed in foreign countries. Enlightened jurisdictions everywhere are increasingly focusing on preventing corporate complicity in human rights abuses committed “away from home” (See Modern Slavery Act of 2015, § 54(1)).

3. International legal responsibility of states and businesses to uphold human rights gained traction and was mainstreamed by the landmark “Guiding Principles” (https://www.ohchr.org/documents/publications/guidingprinciplesbusinesshr_en.pdf). The classic understanding of the responsibility of states and businesses views corporations as entities which need to be monitored by states so as to ensure the obligation to protect human rights is fulfilled. However, in the context of government procurement – such as the acquisition of vaccines in a pandemic, focusing on the enforcement of global norms through the lens of state monitoring of corporations may be outdated. The Guiding Principles place responsibilities on the corporate actor which potentially encompasses sovereigns as a business partner or in the context of a business relationship, linked to the corporation’s product or service.

For the purpose of these Guiding Principles a business enterprise’s “activities” are understood to include both actions and omissions; and its “business relationships” are understood to include relationships with business partners, entities in its value chain, and any other non-State or State entity directly linked to its business operations, products or services. (https://www.ohchr.org/documents/publications/guidingprinciplesbusinesshr_en.pdf at page 15.)

Thus, corporations are under an obligation to ensure their partners – which might include sovereigns in the context of vaccination programs – protect human rights.

4. Accordingly, rather than examining the obligations via a framework of governments imposing (or enforcing) the international law norm on the corporation; the corporation’s obligations can be enforced through proactive corporate oversight of governmental compliance. In the context of vaccinations and partnering with pharmaceutical corporations, unquestionably, governments need to comport with human rights obligations in implementing mass vaccination programs. The obligation encompasses the duty to perform due diligence “to identify, prevent, mitigate and account for how they address their impacts on human rights” and “to enable the remediation of any adverse human rights impacts they cause or to which they contribute.” (https://www.ohchr.org/documents/publications/guidingprinciplesbusinesshr_en.pdf at page 16.) 

Informed Consent and Pharmaceutical Corporations

5. One such right is the right to informed consent – held by some as a jus cogens norm – which obligates a medical provider to fully inform the patient or treatment recipient of the risks involved. Voluntary consent is of utmost importance prior to administering medical treatment. (See The Nuremberg Code; Article 7 of the ICCPR; the Declaration of Helsinki; the Convention on Human Rights and Biomedicine; the Universal Declaration on Bioethics and Human Rights, etc.) 

6. The paramount importance of defending human rights is particularly acute in the context of global health emergencies given the past misconduct of pharmaceutical corporations. The example of U.S. pharmaceutical Merck is illustrative. Merck sold Vioxx as a safe drug but after several years, Merck withdrew the drug and settled with thousands of plaintiffs for billions of dollars for death and serious injuries arising from Vioxx. While initially professing disappointment over the adverse health effects, internal documents demonstrated that Merck was well-aware of Vioxx’s dangers in 1997, but despite the fact of this knowledge commenced selling Vioxx in 1999. Merck’s Chief Scientist stated that he did not trust the FDA. Indeed, Merck’s salesforce was instructed to “dodge” questions relating to Vioxx’s dangers when marketing the product (https://www.wsj.com/articles/SB110038946760273330).

7. In a further example, U.S. pharmaceutical Pfizer admitted in 2005 that it was aware in 1999 of dangers associated with Celebrex despite denying for years allegations that Celebrex posed dangerous risks (https://www.nytimes.com/2005/02/01/business/pfizer-says-1999-trials-revealed-risks-with-celebrex.html).

8. In yet another exemplar, the Second Circuit Court of Appeals in the U.S. upheld the right of plaintiffs to file ATS claims against Pfizer for failing to provide informed consent in Nigeria to children many of whom needlessly died from an experimental treatment when a free and safe treatment was available at the same location the Pfizer corporation performed its experiments on children. The court ruled there was sufficient evidence that Pfizer failed to disclose any risks, hid the experimental nature of the drug and failed to comply with the informed consent requirement (Abdullahi v. Pfizer, 562 F.3d 163 (2d Cir. 2009)). Indeed, numerous pharmaceutical entities stand accused of lackluster compliance with ethics in overseas testing (Stichting Onderzoek Multinationale Ondernemingen, SOMO Briefing Paper on Ethics in Clinical Trials #1: Examples of Unethical Trials (Dec. 2006), available at https://www.somo.nl/wp-content/uploads/2008/02/Examples-of-unethical-trials.pdf).

9. With respect to global governance, vaccines are a potentially important tool to fight pandemics and private sector corporations may be a vital and effective tool to advance public health. However, human rights must be protected as rights not strictly enforced risk fall down the proverbial “slippery slope”. The international law norm—some would argue jus cogens obligations—of obtaining informed consent is a crucial issue and must be safeguarded. Given we are discussing human lives and health as opposed to economic loss, pharmaceutical misconduct limited to a specific jurisdiction is sufficiently outrageous. However, in the framework of a global pandemic, malfeasance might have dire results.

Pfizer’s Experimental mRNA Vaccine and Partnership with the Israeli Government

10. In terms of the Covid-19 pandemic, the question of informed consent takes on great relevancy. Noteworthy is that given the scope of the pandemic, the U.S. FDA had insufficient data to grant full approval but decided to grant a more limited authorization for emergency use. The FDA reports that Pfizer’s mRNA vaccine “is an investigational vaccine not licensed for any indication.” (https://www.fda.gov/media/144412/download.) Indeed, plainly stated in the FDA Fact Sheet is that Pfizer’s vaccine may have adverse risks and remains in clinical trials. (https://www.fda.gov/media/144414/download.) While hopefully no adverse long-term effects will be actualized, as an experimental treatment, the possibility cannot be eliminated. Corporate profits may impact on the practical incentive of corporate obligations to safeguard human rights, including ensuring that government vaccination programs do not violate law norms. Pfizer’s mRNA vaccine is expected to generate revenues in 2021 to the tune of $15 Billion (https://s21.q4cdn.com/317678438/files/doc_financials/2020/q4/Q4-2020-PFE-Earnings-Release.pdf at page 4.) It would be naïve to believe that such immense profits play no role in corporate decision-making.

11. What is the corporate responsibility in ensuring state compliance with the informed consent requirement? Given the propensity of pharmaceutical misconduct in overseas testing, the issue of informed consent is vital. State-private sector partnerships raise interesting issues with respect to the corporation’s obligations to ensure the safeguarding of human rights norms in implementing a national vaccination program. The Israeli national vaccination program, and the government’s collaboration agreement with Pfizer is illustrative. Noteworthy is the fact that large segments of the Israel-Pfizer partnership agreement describing “The Project” are blacked-out and unavailable for public discourse (https://govextra.gov.il/media/30806/11221-moh-pfizer-collaboration-agreement-redacted.pdf).   

12. Pfizer’s CEO tacitly (if not expressly) conceded that Israel is the world’s laboratory for Pfizer’s mRNA vaccine which further corroborates that the Israeli program is in essence a clinical trial. Corroborating the Pfizer CEOs statements, the former Israeli Prime Minister stated “Israel will act as a large world testing laboratory.” While the understanding between Pfizer and the Israeli government was arguably a commitment to embark on a campaign to vaccinate every Israeli citizen, it is an open question whether Israeli citizens understand that they have been recruited for a clinical trial, “The Project”.

13. The Israeli governmental declaration of its intent to vaccinate the entire population is a potentially significant factor inasmuch as it might incentivize an overly-zealous implementation of the “Project” not comporting with informed consent. As the FDA Fact Sheet explicitly advises, adverse effects are unknown and the vaccine remains in clinical trials. (https://www.fda.gov/media/144414/download (emphasis added).) This fact is seemingly omitted in the governmental push to vaccinate every Israeli as it apparently committed to Pfizer that every Israeli citizen would indeed be vaccinated. State sponsored ads featured the former Israeli Prime Minister as mocking individuals for questioning the safety of Pfizer’s experimental mRNA vaccines as “clowns” (https://www.youtube.com/watch?v=0hS9TEDULgs&feature=youtu.be, (at second 19) claiming the vaccine was “FDA approved” which gives the false impression that the drug received “full approval”).

14. Another question is whether Pfizer’s mRNA was falsely portrayed as “the only cure” as opposed to competing vaccines such as ones produced by Chinese pharmaceuticals SinoPharm and SinoVac. For example, according to the Israeli HMO Leumit’s internet information site, there is no reference to any possible adverse long-term effects, no indication that the Pfizer vaccine was in clinical trial and the misleading impression is given that Pfizer’s mRNA is “the only option”. According to the HMOs site,  

The vaccination has undergone intensive testing phases, and health officials both in Israel and worldwide have determined that the vaccine is safe for use, with an efficiency rate of 95% against the Covid19 virus.…

Operation “Vaccinating for Life” is the only way that will allow us to resume our normal lives and much welcomed daily routine, including family gatherings and celebrations, cultural events, vacations and more.  (https://www.leumit.co.il/eng/Life/FamilyHealth/familyhealth/coronavirus/articlegalleryitem,5171/.) 

15. There is no mention of the unknowable potential longer-term adverse effects. There is no mention that non-mRNA alternative vaccines do exist. Based upon the author’s conversation with vaccine-takers, there was no written information provided at the vaccination centers regarding unknown risks and often no information at all.  At other times, a brochure was provided stating Pfizer’s mRNA vaccine was safe and “FDA approved”. Does the omission of crucial information creating the false perception that it is fully “FDA approved” and completely safe, erode consent from being truly informed? Furthermore, claims that the vaccine are “the only way out” might prompt going down a slippery slope of persuasion based on negative pressure.

16. While the Israeli government evidently entered into a partnership with Pfizer and pushed the Pfizer vaccine, geo-strategic considerations may also have played a role as the U.S. Pfizer mRNA was aggressively marketed “as the only option” and one that is “FDA approved”. It is an open question whether the Israeli government entertained discussions with Chinese pharmaceuticals to procure Chinese vaccines. This is important because numerous Israelis refused to take the mRNA vaccine because of the untested mRNA technology and absence of long-term safety studies. Presumably some mRNA opponents would have preferred a more traditional vaccine such as the vaccines offered by Chinese pharmaceutical corporations. Yet Israeli citizens were not provided this option and were pressured into taking the Pfizer mRNA vaccine marketed as the sole option, further raising the possibility of a lack of informed consent. 

17. An important question is whether Pfizer insisted the Israeli government comply with the informed consent requirement and if so whether Pfizer implemented any effective control mechanism to ensure informed consent was obtained. Nowhere in the heavily redacted collaboration agreement does Pfizer insist on its partner’s obligation to obtain informed consent although Pfizer is quite aware of other regulatory oversight responsibilities such as compliance with the Foreign Corrupt Practices Act which is specifically noted in the agreement. Having an obligation to Pfizer or even “an unwritten understanding” between the Israeli government and Pfizer’s CEO (and perhaps other Pfizer corporate officers and/or directors) that the sovereign would endeavor to vaccinate every citizen might trigger a conflict of interest between the government and its citizens whereby risks are downplayed (or not mentioned) while only strongly positive comments are declared. Moreover, Pfizer would also be in favor of the marketing campaign that Pfizer’s mRNA is “FDA approved” and the Israeli government lack of offering alternatives.

Conclusion

18. The Pfizer mRNA vaccine is essentially experimental and the knife-edge dilemma is balancing the recruitment of citizens in a corporate collaboration with full disclosure to obtain meaningful informed consent. Both human rights and governmental efforts at combatting a pandemic are of paramount importance. The challenge in such situations is ensuring the state provides sufficient information to comply with the informed consent requirement.

19. To be sure, the covid-19 virus is highly contagious; but it is not a virus which kills a high percentage of all infected individuals such as Ebola, the Spanish Flu or the Black Plague. Covid-19 infects many people who do not even know that their immune systems defeated the virus as they had no or very minor common cold symptoms. The virus, while potentially deadly, only kills a small percentage of infected and that percentage might be even less than currently believed because of the possibility that many more individuals were infected but never tested as there was no reason to do so. While more dangerous to select segments of the population, it is almost innocuous to other segments. Yet the facts may take second-place when other interests exist and full disclosure would impede the overriding goal of the partnership agreement.        

20. Notwithstanding governmental and corporate interests, to comply with the informed consent requirement, governments must convey the truth and do so with transparency even if that constitutes admitting there is real lack of understanding of long-term risks associated with a novel treatment. Of course factors such as a very high (or low) death rate need to be balanced into the equation. Another element is positive and negative pressure and whether and to what extent governments can exercise social and economic pressures. Surely a pandemic provides some latitude to sovereigns but perhaps not enough as some governments seem to think. Moreover, it is of paramount importance that international law norms be respected. During times of crisis, the safeguarding of human rights and jus cogens norms in particular must be sacredly guarded.

21. Corporations must take a pro-active approach to monitoring governmental compliance in national vaccination programs. This argument is particularly compelling when the pharmaceutical entity enters into some collaborative agreement with the sovereign. Financial self-interest as well as an overzealous drive to obtain data which could be advantageous to the corporation in securing full approval may dis-incentivize effective corporate oversight of its sovereign customer (partner). Yet this obligation is vital to ensure compliance with international law and must be viewed as an integral component of ensuring that both states and corporations protect human rights and uphold international law.

***

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 the 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; Hong Kong Law Journal; Chinese Journal of Comparative Law; Georgetown Journal of International Law; Journal of World Trade; Tsinghua China Law Review; Fordham International Law Journal; 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 jslawotsky@idc.ac.il.