Ethics in R&D

How to request access to investigational medicines

 

At Bayer, we are committed to making medicinal products available as quickly and safely as possible. We encourage patients to participate in a clinical trial to get access to a promising but not yet authorized investigational medicine for the treatment of a serious, chronic, or life-threatening disease. However, in rare cases when a patient does not qualify for a clinical trial and has exhausted all available therapies, Bayer may be able to provide treatment through one of our early single patient access programs.

Access via clinical trials

Bayer encourages patients to first speak with their treating physicians to determine if a clinical trial is appropriate for them. Information on Bayer’s clinical trials can be found on the publicly funded website www.ClinicalTrials.gov. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies conducted around the world. This website allows the viewer to search by company, disease or medicinal product. Clinical Trial Registry information on Bayer trials is also provided in the Bayer Trial Finder application on our website. Requests for participation in a clinical trial must be made by a treating physician.

Prerequisites for early single patient access

An investigational medicine may only be eligible for early single patient access if sufficient clinical safety and efficacy data suggest a favorable benefit/risk profile for the proposed use. Local laws and regulations may govern the availability, administration, distribution and/or use of medicinal products prior to receiving marketing authorization.

Requests for access to investigational medicines must be made by a treating physician. Please note that Bayer will not accept requests directly from patients. The following criteria must be fulfilled to be considered for early access to an investigational medicine.

The patient:

  • Is suffering from a severely debilitating or life-threatening disease which cannot be treated satisfactorily by an authorized drug in the country where the request has originated.
  • Has received appropriate standard treatment without success (or no standard treatment exists for the patient’s condition) and no satisfactory alternative drug is available.
  • Is ineligible or, due to geographical limitations, cannot participate in any ongoing clinical study.

In the USA, there is a specific program called the ‘Expanded Access Program’ (EAP). Expanded access is designed for patients who may not meet the inclusion criteria for a clinical trial. For patients who cannot participate in a clinical trial of an investigational medicine but have a serious disease or condition that may benefit from treatment with the drug, FDA regulations allow manufacturers of such drugs to provide those patients with access to the drug under certain situations, known as “expanded access”.

Request for early access

Patients with questions regarding access to one of our investigational medicines through clinical trials or single patient early access should speak with their treating physician. Requests for access must be made by a treating physician who must follow all applicable safety-reporting regulations of the respective country. We will respect patient privacy. We will consider each request carefully and acknowledge receipt of your request within two business days. Once we have all the necessary information, we will strive to provide our decision as quickly as possible, within five to ten business days.

Bayer, where permitted by local regulations and laws, may provide access to medicinal products prior to the marketing authorization. If required by local regulations, the country Regulatory Authorities must also approve the use of the investigational medicine. Bayer’s acceptance and processing of a request does not guarantee that access to an investigational medicine will be provided.

Treating physicians who wish to discuss access to investigational medicines for their patients may contact the Bayer medical information team in your country. A list of all affiliates can be found on www.bayer.com. Alternatively, the treating physician can contact trialinfo.MIS@Bayer.com or +1-888-842-2937.