Ethical Framework for Decision-Making During the COVID-19 Pandemic
Johnson & Johnson Office of the Chief Medical Officer
The values that guide our decision-making at Johnson & Johnson are spelled out in Our Credo. Put simply, Our Credo challenges us to put the needs and well-being of the people we serve first. In times of pandemic, we are unwavering in our belief that we have an obligation to allocate our resources fairly and responsibly and in seeking to do so, we aim to save as many lives as possible. We also are committed to standing by those patients who are already using our medicines and products and receiving important, sometimes life-saving benefits. We also believe that we have a moral obligation to collaborate, contribute, learn and share as much, as quickly and as broadly as possible, to inform the ongoing public health response against COVID-19.
We and others are currently evaluating a variety of medicines for treatment and prevention of COVID-19, the disease caused by sars-cov-2. In the face of the pandemic but the absence of controlled clinical trial data, we have an obligation to manage the supply of our medicines in an ethical, transparent, and fair manner. To this end, we engaged with internal and external experts in medicine, epidemiology, and bioethics to create an ethics-based framework, consistent with our Credo, that guides how we will allocate supply of our products with the following general principles:
- To support efficient use of finite resources and streamline activities, we should encourage global scientific cooperation and engagement.
- Decision-making should be driven by medical, scientific and epidemiological evidence, as well as ethics, with an emphasis on reducing suffering, saving the greatest number of lives, and supporting those who are working the frontlines of the pandemic.
- In some cases, decision-making on allocation and challenges related to access may benefit from the guidance of an internal but independent body of medical experts, epidemiologists, and those with expertise in bioethics. In addition, external experts may also provide guidance.
- Activity against sars-cov-2 should be explored and confirmed through appropriate testing and clinical trials for use in treating COVID-19.
- For medicines currently approved and on the market for other uses, special consideration needs to be given to allocation of supplies for both treatment and research.
- The first priority should be consideration of maintaining supply for patients who currently rely on the treatment for approved uses.
- The next priority is supply for well-designed randomized, controlled clinical trials (RCTs) that will provide important safety and efficacy data to inform clinical practice.
- The next priority is to supply studies or registries that are not designed as RCTs, but may collect and share valuable information on the efficacy and safety of medicines.
- If there is further supply available after allocation is given to the groups above, it should be allocated as fairly as possible. There may be a variety of manufacturers or sources available for any one medicine, and there may also be other similar medicines to choose from within the same class. National and international health authorities and regulatory bodies can perform an important role in assessing and guiding the study and supply efforts and can help coordinate and guide these globally.
- In the absence of national or international allocation guidance, we will be guided by our Ethical Framework and our internal group of medical, ethical, and epidemiological experts will guide allocation as fairly as possible based on the best available information about the pandemic and with the aim to save as many lives as possible.