Shire believes that biotechnology can provide significant benefits to life and that these technologies carry with them responsibilities. Any Shire decision to commercialize a biotechnology-derived product or therapy will receive careful consideration of the risks and the benefits of the technology in light of the information available. The ability to perform an activity will not automatically justify the activity. As a company, these principles and processes govern our efforts to research, develop, and provide products for critical therapies for patients worldwide.
The purpose of this policy is to outline the principles, processes and ethical standards governing bioethics in the development and registration of new medicines at Shire.
This policy applies to all activities related to the development and registration of new medicines at Shire that have bioethics implications within Shire’s own laboratories and to those outsourced to external laboratories.
This bioethics standard applies to Research and Development work performed by, or at the direction of Shire, by external contract research organizations, consultants, and third-party vendors. Where Shire performs as a third-party vendor, Shire will take into account the bioethical conduct of the contracting organization in determining whether or not to take on the work.
Bioethics Guiding Principles
Shire places the highest priority on the safety and efficacy of our products, and we support government agencies in safeguarding health and wellbeing throughout the world.
Shire listens to and considers feedback from the public and responds to concerns about the social, ethical, and technical application of biotechnology in the research, development, manufacture, and sale of our therapies and products. Shire's response to these concerns will be based on ethical considerations and scientifically sound hypotheses, theories, and data.
Shire actively participates in public discussions and professional forums encouraging science-based policies and regulations that serve the public interest as an ethical priority.
Shire will determine the potential benefit of our applied biotechnology.
Shire will ensure that any research undertaken by Shire or at its direction is designed to produce valued health enhancements for patients and healthcare providers or advancement of scientific knowledge while seeking to identify and minimize relevant risks.
Shire complies with applicable legislation and regulatory requirements, and supports accepted ethical and professional standards in the research, development, manufacture, and sale of its products. Specifically, Shire is sensitive and responsive to concerns related to the conduct of all research on humans. Shire is committed to protecting the life, health, privacy and dignity of those participating in clinical trials, as well as to protecting the integrity of the data obtained from these studies. These standards are found in, but are not limited to, the following documents:
- Guidelines for Good Clinical Practice (GCP), edited by the International Conference on Harmonization (ICH), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP)
- Declaration of Helsinki
- International Ethical Guidelines for Biomedical Research Involving Human Subjects
- Applicable privacy and data protection standards
Shire supports the conscientious use of animals in research when no other valid scientific alternatives exist.
Shire recognizes that protecting the environment and maintaining the biological diversity of our planet is of vital importance to human life.
Gene cloning, molecular cloning, and cell cloning techniques are used routinely in the discovery and development of new drugs. Shire is not engaged in cloning of animals or humans.
Shire is exploring somatic gene therapy as a potential treatment for genetic diseases with unmet medical needs. Shire follows the ICH guideline “General Principles to Address the Risk of Inadvertent Germline Integration of Gene Therapy Vectors” to minimize the risk of germline transmission occurring with our potential therapies.
Research using human stem cells is advancing rapidly, and the technology offers exciting opportunities for the discovery and development of new medical treatments. Unspecialised induced pluripotent cells (IPSCs) can be selectively stimulated to differentiate into many different cell types. Shire supports research using adult stem cells as guided by published ethical principles, including the International Society for Stem Cell Research Guidelines1. Shire does not support the use of human embryo-derived stem cells in research.
Genetically Modified Organisms
The ability to genetically-modify organisms (GMOs) has revolutionized pharmaceutical research and development, contributing to many new drug treatments. For example, GMOs have improved the ability to identify and validate novel drug targets, and resulted in new in vitro and in vivo preclinical test systems with improved translatability for human drug responses.
Shire is engaged in the ethical production and use of genetically-modified organisms (GMO) for the discovery, development and manufacture of important new medicines. All work with GMOs is conducted in facilities that have the required levels of biosafety containment and in compliance with relevant environmental, health and safety laws and regulations. GMOs include genetically-modified micro-organisms, plants, mammalian cells and animals. The following precautions apply to use of GMOs in Shire studies:
- A risk assessment is conducted prior to generation, and appropriate precautions are implemented adopting a precautionary approach to uncertainty.
- Studies are conducted in facilities that have been designed to provide the necessary containment.
- Waste from GMO studies is treated to prevent discharge into the environment.
Waste from GMO studies is treated using accepted methods prior to offsite disposal or approved discharge into the environment.
Shire tracks the types of genetically modified animals (i.e. transgenic mice) used in animal experimentation.
On occasion, Shire collects genetic information to understand the diseases we seek to treat. Shire complies with local and international regulations protecting personal genetic information and patenting of genetic sequences. Shire seeks to share genetic information in an appropriate manner to improve the treatment of patients by physicians and advance disease understanding.
Xenotransplantation and Xenografting
Shire is engaged in utilizing animal models to evaluate human cell-derived, human tissue-derived and humanized biologic therapies for safety, efficacy and mechanism of action studies. Where possible, immunocompromised rodent models will be used to avoid host-donor immune reactions. The use of immunocompetent animals may however be essential in some circumstances, for example to model specific disease conditions. Under all circumstances, Shire will conduct such studies in accordance with the standard guidelines for animal welfare and bioethics provided in this policy.
Use of Human Fetal and Embryonic Tissue
Shire recognizes and respects the intrinsic distinctiveness of human embryos. Any cell lines or primary cells used by Shire or under its direction will utilize cells derived from human adults or cells and tissues that were either obtained from human cord blood or as a result of a confirmed, naturally occurring event negatively affecting the continued viability of the fetus. In the event that cell lines or tissues derived from sources other than those described above (human embryonic and fetal tissue/cell lines) are the only option for experiments of a safe and effective therapy, Shire’s Head of Research and Development, the Chief Medical Officer and the Chief Executive Officer must evaluate and unanimously affirm the use of such cell line. In making the decision, the Head of Research and Development, the Chief Medical Officer and the Chief Executive Officer must give consideration to the following criteria:
- Viability of alternative technologies or alternative sources of cells
- Potential benefits to be realized from such use
- Probability of success for the proposed use
- Compliance with Shire’s bioethics standard
http://www.isscr.org/docs/default-source/clin-trans-guidelines/isscrglclinicaltrans.pdf: ISSCR Guidelines for the Clinical Translation of Stem Cells