We strive to maintain the highest ethical, scientific, and clinical standards in all our research activities and to comply with all national and international standards. Actelion regularly reviews its research policies to align them with its corporate values and goals, and with the evolving values and goals of its stakeholders.
Regulatory authorities around the world require pharmaceutical companies to test all new drugs before they are launched, and there is no alternative to including some animal testing as part of this process. It is essential both for scientific reasons and to safeguard the volunteers and patients who take part in subsequent clinical trials.
As a fundamental principle we support the ‘three R’s’ in relation to animal testing - the reduction of the number of tests undertaken; the refinement of those tests; and, ultimately, the replacement of animal testing by other methods. The number of animals used in drug development has dropped dramatically over the past three decades as a result of industry initiatives like this. Actelion revised and strengthened its policy on the care, welfare and treatment of animals in 2010 and we conduct regular audits to make sure that our expectations are being met, whether the studies are being conducted in-house or outsourced.
Regulatory authorities around the world require drugs to be thoroughly evaluated before they are used in human studies. Animal testing remains an essential part of this process – both for scientific reasons and to safeguard the volunteers and patients who take part in subsequent clinical trials.
Actelion’s policies and standards for the use of laboratory animals are based on the 3R principle:
In addition, we ensure that the use and care of all laboratory animals meets or exceeds relevant local, national and international regulations. Our programs and facilities are subject to unannounced regulatory review and inspections. For sponsored work at contract research organizations, our animal welfare oversight activities include regular on-site evaluations by our veterinary staff. Actelion has never used great apes (gorillas, chimpanzees, orangutans and bonobos) in its research, and in 2013 our animal welfare policy was expanded to explicitly prohibit any such use.
Actelion is also a signatory to the Interpharma Animal Welfare Charter, in which Swiss research-based pharmaceutical companies outline their commitment to applying the highest possible standards in animal studies.
Clinical trials are essential to the development of innovative medicines. Actelion is committed to the highest standards of quality and ethical conduct in all our clinical research. Our trials are performed in accordance with internationally accepted guidelines, and protocols are evaluated by independent review boards and ethics committees prior to study initiation. We are also dedicated to improving public health through responsible clinical trial data transparency which – as well as complying with applicable regulations – respects our proprietary information and patients’ privacy. In addition to our existing clinical trial disclosure activities, we are committed to implementing the EFPIA/PhRMA Principles for Responsible Clinical Trial Data Sharing.