BIOPHARMA + BIOETHICS EXPLAINED
What is biopharmaceutical bioethics?
Bioethics is the application of ethics concepts and principles to the life sciences, individual patient care, and public health. Bioethics provides guidance for the development of public and private policies, aids the comprehension of and compliance with established policy, and provides guidance when a policy is ambiguous or when no policy exists.
Biopharmaceutical bioethics is the application of bioethics concepts and principles to the research, development, commercialization, and clinical use of biopharmaceutical healthcare products.
Biopharmaceutical bioethics topics are varied but include:
| Expanded access to investigational medicines |
| Continued access to investigational medicines for research participants |
| International research |
| Research with vulnerable populations, such as children, underprivileged populations, and patients with rare diseases |
| Storage and use of human biological samples |
| Providing research results to patients |
| Gene editing |
Why does it matter?
Because PATIENTS matter…and we ALL are patients.
We all have been, are, or will be patients who need to trust healthcare practicioners and medicines.
Trust in healthcare is dependent on patient well-being, and patient well-being is central to bioethics.
Living up to stated values contributes to patient and healthcare practicioner trust.
To build and maintain trust, values must be incorporated into action.
To consistently move values to action, biopharmaceutical leaders need to be agile with bioethics and organizational ethics.
Patients TRUST their lives to medicines. Medicines must be worthy of that trust.
– LUANN VAN CAMPEN
CURRENT STATE:
The application of bioethics to biopharmaceutical issues has been developing since the late 1990s. However, there is not widespread understanding of what biopharmaceutical bioethics is or how it can be used to guide daily decision-making in the research, development, commercialization, and clinical use of healthcare products.
SOLUTION:
EthicsMatters LLC bioethics and organizational ethics consulting and training tailored to the contextual needs of biopharmaceutical leaders.
What is your current state?