Access to investigational therapies
- Types of access
- How to request access
At Biogen, our expanded access programs (EAPs) and single patient access are guided by a set of principles that reflect our commitment to providing ethical access to investigational therapies. When developing an EAP, we:
Listen to those who represent the community affected by the disease
When designing an EAP, we speak with patient groups and physicians to clearly understand the experiences and needs of patients affected by the disease.
Identify eligibility criteria that are reasonable and clearly understood
We consult with physicians, patient groups and medical experts to help determine the eligibility criteria for an EAP. They are based, in part, on what we have learned about the potential risks and benefits of the investigational therapy.
Allocate investigational therapies in an ethical manner
We consult with key individuals, including bioethicists, to ensure that the distribution of investigational therapies is done in an ethical manner. We recognize that not everyone who wants access to an investigational therapy will receive it; therefore we make our decisions with an effort to be fair and just to the entire patient population.
Honor our responsibility to patients participating in our placebo-controlled clinical trials
Patients who participate in placebo-controlled clinical trials often do so with the understanding that the only benefit they may receive is their contribution to improving medical knowledge. At Biogen, we respect the sacrifice of those participating in our placebo-controlled clinical trials and will not allow access to an investigational therapy until the Phase III placebo-controlled trial(s) are closed.