Our position

For appropriate patients with serious, life-threatening diseases unable to participate in a clinical trial, our compassionate use programs is designed to potentially provide access to selected medications before they complete the full regulatory review process. Our patient access programs include compassionate use programs for groups of patients with a condition that Boehringer Ingelheim is researching, single patient use requests outside our current scope of investigation, and in some countries such as the United States, Expanded Access Programs where groups of patients with a particular condition are enrolled in a treatment protocol. Country-specific variations may exist depending on local laws and regulations. Some rules permit compassionate supplies in only limited circumstances, and this means that Boehringer Ingelheim will not be able to fulfill all requests.

Requests on behalf of patients with serious, life threatening diseases can only be considered for compassionate use if the patient has exhausted all available treatments and is not eligible for an ongoing clinical trial. Boehringer Ingelheim will consider requests from patients in a fair, compassionate and thoughtful manner. We endeavor to respond to all requests with appropriate urgency. We aim to use our best efforts to respond to most requests within 7 days of receipt of a fully completed request. However, complicated requests may require additional consultation and discussion and this may mean we need more time.

For patients with serious, life threatening diseases participating in Boehringer Ingelheim sponsored trials, we strive to make the investigational product available as clinically appropriate until access is available in the participant's country.

Boehringer Ingelheim is committed to the safe use of our products, whether approved or investigational. Requests on behalf of seriously ill patients can only be considered when the patient is under the care of a licensed physician experienced in the treatment of disease with which the patient suffers and able to assess the benefit and risk of the investigational treatment. Boehringer Ingelheim will consider requests that have a valid scientific and clinical rationale even if outside the clinical indications we are currently researching through our clinical trial programs. 

We reserve the option to consult an external multidisciplinary advisory panel to provide an external opinion regarding compassionate use requests. We may also require that an Institutional Review Board or Ethics Committee reviews the request and provides approval before the investigational therapy can be provided. Where required, local government and/or health authority approvals must also be obtained. There is no guarantee that the Institutional Review Board or Ethics Committee will support the request, or that relevant authority will permit Boehringer Ingelheim to supply the product.

Only therapies that are under active clinical development will be considered for compassionate use requests. There should be sufficient data to allow for proposing a dose and treatment regimen as well as a reasonable assessment of potential benefits and risks by the treating physician and Boehringer Ingelheim. In general, this will be during phase II clinical trials or later during the development. For patients in the United States, only therapies with an active Investigational New Drug (IND) application will be available for compassionate use requests, including Right to try (RTT) requests. Boehringer Ingelheim may not be able to provide the product if it does not consider that it will be effective, if it could harm the patient, or if its risks are likely to outweigh its benefits.

Boehringer Ingelheim is committed to bringing promising therapies to the maximum number of appropriate patients and therefore when an investigational drug is in limited supply, clinical trials will have priority. Furthermore, the complexity of distribution of some investigational therapies may prevent access in some countries for patients in the pre-approval setting. Boehringer Ingelheim will only be able to make compassionate supplies available through appropriate distribution channels. Depending on the jurisdiction, this may mean we can only supply through authorized manufacturers, authorized distributors, pharmacies, hospitals or clinics.

In general, Boehringer Ingelheim will only use its compassionate use programs to supply products that have not been approved for marketing. In all circumstances, Boehringer Ingelheim retains the final decision-making authority regarding compassionate use requests.

Boehringer Ingelheim commits to seek registration of new pharmaceutical products in all countries where clinical trials for this compound were performed after approval of the pharmaceutical product by either the US FDA or the EMA.

For details regarding any variation of these principles in your country based on local laws or regulations, please consult the web page for the local Boehringer Ingelheim affiliate in your country or region.