I N T E R N A L M E M O R A N D U Mt H I S M E M O R An D U M S U B ✓ Solved
I N T E R N A L M E M O R A N D U M T H I S M E M O R AN D U M S U B J E C T T O AT T O R N E Y - C L I E N T P R I V I L E GE TO: OFFICE OF THE CHIEF ETHICS OFFICER FROM: OFFICE OF THE CHIEF EXECUTIVE OFFICER AND PRESIDENT SUBJECT: REQUEST FOR GUIDANCE DATE: MARCH 14, 2021 CC: OFFICE OF THE GENERAL COUNSEL Our company’s vaccine to the COVID-19 virus is entering the production and distribution stage. The vaccine presents some limited potential adverse impacts to end-users. Our regulatory filings present this information and statistical analysis. Our filings do not advocate for authorization. The Company has no formal position on these decisions.
Our role in the response to the COVID-19 pandemic is vaccine design and manufacture only. We believe, however, that the benefits of our product will mitigate governments to sua sponte initiate emergency use authorizations. Such risk/benefit analysis must be the sole responsibility of nation-states/purchasers. The company will not solicit any continuing emergency use authorizations. Purchasers will be required to address any suspension of an authorization internally.
Once a nation- state grants initial emergency use authorization, our obligations concerning data collection, analysis, and reporting shall terminate. We will not provide access to any internal scientific or anecdotal information collected by the Company after an emergency use authorization is granted. These policies were adopted at a meeting of the Board of Directors on February 1, 2021. We anticipate achieving full production capacity within the fiscal next quarter (Q2) providing supply-chain issues can be resolved. Internal Memorandum Subject to Attorney-Client Privilege March 14, of 4 Pre-existing orders are significant.
Our purchasers are a wide variety of nation-states. We also anticipate sales to, or through, the COVAX initiative, WHO, and other transnational entities. Forward guidance suggests our satisfaction of these orders will positively impact our top, and bottom, line financial positions. To preserve the monetary gain of this scientific effort, we will require that nation-state and transnational purchasers guaranty immunity from civil suit or indemnification. We will also require immunity/pre-emptive pardon regarding any form of potential criminal liability.
In-house counsel has opined that such legal/political demands are not inconsistent with our legal obligations, especially vis-à -vis the United States’ Foreign Corrupt Practices Act of 1977 (FCPA) (15 U.S.C. § 78dd-1, et seq.). The world applauds our current medical progress and inoculation efforts. The Board believes that this supportive atmosphere will dissipate with remarkable alacrity. The Board notes increasing export licensing restrictions, excessive bulk purchases, and a reluctance by economically secure nation-states to cooperate in the distribution of vaccine to economically compromised nation-states. These actions have the potential to reflect adversely on the Company as these political decisions manifest themselves in medical implications, i.e., morbidity and mortality.
The Board desires to pre-emptively address this anticipated deflection toward our manufacturing and distribution efforts. Each sales venue presents unique legal and ethical issues. In-house counsel does not foresee significant civil or criminal liability from third and fourth world nations given the continuing internal tensions present in those venues. First and second world nation-states present not insignificant concerns. Criminal and civil immunity and indemnification protections could be rescinded by any, or all, of these political groupings.
Further, second-party sales to nation-states identified as state sponsors of terrorism present a unique set of issues. For these reasons, the development, distribution, and monetization of our vaccine could produce a variety of ethical and legal issues in all these venues. Unlike legal issues which typically are contained within a given country and are quantifiable, ethical issues could become transnational and risk becoming financially uncontrollable. The legal department is already mobilizing internally, including the retention of outside counsel, in preparation for litigation in those jurisdictions identified as most concerning. The Board of Directors vested the Office of General Counsel with plenary control over vaccine-related litigation at its February 1, 2021 meeting.
At that same meeting, your Office was vested with plenary control over the resolution of ethical issues. The Board of Directors also established a policy that your Office shall communicate only with, and to, Internal Memorandum Subject to Attorney-Client Privilege March 14, of 4 the Board of Directors in connection with vaccine-related matters. No communication of any form is to occur with your Office and any other subdivision of the Company. On April 1, 2021 commencing at 9:00AM the Board of Directors will meet to discuss the status of the Company’s vaccine roll-out program. This meeting will last at least three days.
All corporate departments will present confidential, internal guidance at this meeting. Your staff is to present regarding the known and potentially unknown ethical challenges and opportunities. Your Office is also expected to identify any unknown unknowns to the best of their ability. Each member of your staff will be allotted no more than 10 minutes to present on an ethical opportunity they identify. The Board will not ask any questions following a presentation.
The Board is seeking at least the following information concerning any identified ethical challenge/opportunity: 1. Identification of stakeholders. 2. Identification of opportunities/challenges and their classification. 3.
Any relevant facts of which the Board should be aware regarding the noted challenge/opportunity. 4. Compliance opportunities and potential liabilities. 5. Suggested resolutions (including normative approaches).
6. Suggested training, police, and audit infrastructure. 7. Suggestion for how the vaccine distribution effort can be integrated into the Company’s sustainability plan. The Board does not desire to have a presentation read to them.
There is already a vast amount of objective data to be presented at the meeting from the finance, supply, and operations management divisions. Your staff is urged to diversify its subjective presentations using charts, graphs, pictures, etc. My staff will incorporate your staffs’ slides into a larger presentation. We do not require a cover slide as a result. Your staffs’ slides must be received by March 19, 2021 so that this inclusion process can be completed.
We only require the substantive slide stack from each presenter. In addition, a slide with any references should also be provided. We will consolidate the reference slide into the larger stack. At the current time only a slide stack is required. Your staff does not need to provide their oral presentations.
Internal Memorandum Subject to Attorney-Client Privilege March 14, of 4 Your staff members must present a visual format their slides. The marketing department is addressing other issues and cannot allot time to internal aesthetic matters. We will select the best visual configuration for universal application. Please note that the audience numbers approximately 50 and social distancing will require that the presentations be made in the 750-seat corporate amphitheater. I look forward to receiving your staffs’ slide stacks.
Feel free to contact my office if you have questions. TO: OFFICE OF THE CHIEF ETHICS OFFICER FROM: OFFICE OF THE CHIEF EXECUTIVE OFFICER AND PRESIDENT SUBJECT: REQUEST FOR GUIDANCE DATE: MARCH 14, 2021 CC: OFFICE OF THE GENERAL COUNSEL
Paper for above instructions
Introduction
The COVID-19 pandemic has presented unprecedented challenges to the global community, particularly in the realm of public health. As our company prepares to enter the production and distribution stage of our COVID-19 vaccine, it is crucial to identify and address the various ethical challenges and opportunities that may arise (Paltiel et al., 2021). This memorandum aims to provide guidance on these issues as outlined in the request from the Chief Executive Officer (CEO). The crucial points discussed will highlight stakeholder identification, classification of challenges and opportunities, relevant facts, legal compliance, suggested resolutions, training and policy recommendations, and alignment with the company's sustainability plan.
Stakeholder Identification
In the context of our vaccine distribution efforts, stakeholders can be broadly categorized into the following groups:
1. Direct Stakeholders: This includes government entities, regulatory authorities, healthcare providers, and our company's personnel directly involved in vaccine production and distribution.
2. End-users: This group encompasses patients and populations receiving the vaccine, which may vary across different nation-states and communities.
3. Investor and Financial Stakeholders: Shareholders, financial institutions, and venture capitalists invested in the company have a significant interest in the financial returns from the vaccine distribution.
4. Global Health Organizations: Bodies such as the World Health Organization (WHO) and COVAX play a critical role in ensuring equitable distribution of vaccines.
5. Legal Stakeholders: Legal counsel, both in-house and external, will be essential in navigating the ethical and legal implications surrounding vaccine distribution (Shapiro et al., 2021).
Opportunities and Challenges
Opportunities
1. Global Health Impact: The distribution of the vaccine holds the potential for considerable public health benefits by mitigating the pandemic's spread and saving lives (Kraus et al., 2021).
2. Strengthening Corporate Reputation: Being at the forefront of the fight against COVID-19 can enhance the company’s reputation as a leader in biotechnology and public health.
3. Innovation in Vaccine Technology: The challenges posed by the pandemic have accelerated advancements in mRNA technology, which could lead to further opportunities in different therapeutic areas (Maruggi et al., 2021).
Challenges
1. Public Trust: Vaccine hesitancy, fueled by misinformation and skepticism regarding vaccine safety and efficacy, may hinder distribution efforts (Larson et al., 2021).
2. Ethical Allocation: Deciding which populations and nation-states receive the vaccine first raises ethical questions regarding equity and justice (Jansen et al., 2021).
3. Legal Liability: Demanding immunity and indemnification from government purchasers may face scrutiny and potential pushback from various legal perspectives (Hoffman et al., 2021).
Relevant Facts
1. Regulatory Environment: Emergency use authorizations (EUAs) are activated only when the benefits outweigh the risks (U.S. Food and Drug Administration, 2021). Regulatory bodies will assess these before authorizing the vaccine.
2. Immunity Considerations: The concept of liability protection during public health emergencies varies between jurisdictions, affecting how civil suits against the company may arise.
3. Global Vaccine Disparities: There is a noted disparity in vaccine access worldwide, with lower-income countries facing challenges in obtaining sufficient supplies (Bollyky et al., 2021).
Compliance Opportunities and Potential Liabilities
Compliance necessitates vigilance regarding the legal frameworks governing pharmaceutical products, particularly concerning public health emergencies. Potential liabilities may also arise from:
1. Regulatory Breaches: Compliance with the conditions of emergency use can mitigate legal exposure.
2. Negligence Claims: Failure to provide adequate safety data could expose the company to negligence lawsuits.
3. Political Risks: We must consider local political climates when engaging with nation-states, particularly with those categorized as state sponsors of terrorism (Bardos et al., 2021).
Suggested Resolutions
1. Transparent Communication: Actively engage with communities to provide clear and accurate information about vaccine safety and efficacy to build public trust.
2. Equitable Allocation framework: Collaborate with global health entities to develop an equitable distribution strategy that prioritizes vulnerable populations (Orenstein et al., 2021).
3. Legal Safeguards: Establish a robust legal framework within contractual agreements to minimize liability while remaining ethical in our business practices.
Suggested Training, Policies, and Audit Infrastructure
1. Ethical Training Programs: Mandatory training about ethical considerations in vaccine distribution for all employees involved in the process.
2. Policy Development: Draft comprehensive ethical guidelines that address issues like equity, transparency, and accountability.
3. Internal Audits: Regular audits of vaccine distribution processes to ensure adherence to ethical and legal standards.
Integration into Company’s Sustainability Plan
To align our vaccine distribution effort with the company’s sustainability plan, we should:
1. Promote Environmental Sustainability: Ensure that production methods minimize environmental impacts by employing sustainable practices and responsible sourcing.
2. Social Responsibility Initiatives: Partner with global health organizations to support vaccination programs in lower-income regions as part of corporate social responsibility efforts (Poteat et al., 2021).
3. Long-term Commitment: Commit to ongoing research and development to address emerging infectious diseases and contribute to global health solutions beyond COVID-19.
Conclusion
The deployment of our COVID-19 vaccine is not only a scientific achievement but also an ethical responsibility that demands careful navigation of complex legal and ethical landscapes. By identifying stakeholders, recognizing challenges and opportunities, and developing comprehensive policies and procedures, we can ensure that our efforts align with the principles of equity, transparency, and accountability while contributing positively to public health.
References
1. Bardos, H. N., et al. (2021). "The Ethical Dimensions of Vaccine Distribution During a Global Pandemic." International Journal of Health Governance, 26(3), 285-300.
2. Bollyky, T. J., et al. (2021). "The Global Health Infrastructure: Disparities in Vaccine Distribution." Health Affairs, 40(1), 123-130.
3. Hoffman, S. J., et al. (2021). "Legal Liability and Vaccine Distribution." Vaccine, 39(16), 2249-2251.
4. Jansen, K. U., et al. (2021). "Ethical Allocation of Vaccines: A Global Perspective." Journal of Global Health, 11, 1-4.
5. Kraus, A., et al. (2021). "Public Health Benefits of Vaccination: A Review." Health Policy and Planning, 36(4), 465-473.
6. Larson, H. J., et al. (2021). "Vaccine Hesitancy: Causes and Consequences." The Lancet, 397(10269), 1148-1150.
7. Maruggi, G., et al. (2021). "mRNA as a Novel Therapeutic Approach for Infectious Diseases." Nature Reviews Drug Discovery, 20(7), 503-520.
8. Orenstein, W. A., et al. (2021). "Health Equity and Vaccine Distribution." American Journal of Public Health, 111(2), 257-261.
9. Paltiel, A. D., Zheng, A., & Zheng, F. (2021). "Assessment of COVID-19 Vaccine Distribution Strategies." New England Journal of Medicine, 384(18), 1726-1728.
10. Poteat, T., et al. (2021). "Corporate Social Responsibility and Vaccine Distribution." Global Health Action, 14(1), 1-3.