ABOUT EARLY ACCESS
Ipsen defines “Early Access”1 as access to:
- Unapproved medicine for the requested indication in the country where the request comes from
- For life-threatening or serious medical conditions
- Where there is no satisfactory alternative therapy available for the given medical condition
- Where there is no alternative option for the patient to participate in an ongoing clinical trial in the given indication
- Where the medicine has reasonable medical evidence of the positive balance of benefits/risks in the given indication and the medicinal product has started the regulatory process of approval in the US and/or the EU
Early Access can only take place if it is allowed within the local laws, rules and regulations or specifically approved in writing by local authorities.
The physician and the patient should discuss the expected benefits, known and potential unknown risks before seeking Early Access to a medicinal product.
In some cases, Ipsen may set up a program designed to provide Early Access to several patients in defined countries.
The list of Ipsen’s Early Access Programs in the United States is available on www.clinicaltrials.gov.
1Other terms commonly used: Compassionate Use, Early Access, Expanded Access Program, Managed Access Program, Patient Access Program, Special Access Program, Scheme Access Program, Temporary Use Authorization and Pre-approval access.
Request for Early Access to an Ipsen Product
Only qualified Physicians can make requests for Early Access to an Ipsen Product once they have exhausted all other appropriate and available options to treat the medical condition of their patient, including enrollment in a clinical trial.
When the request is received by Ipsen, Ipsen will send an acknowledgement of receipt of the request within 48 business hours. The request will be assessed by Ipsen medical affairs fairly, as promptly as possible and after a thorough discussion with the Physician as necessary.
The decision will be based on at least the following criteria:
- The conditions for Early Access are met
- Patient’s individual medical conditions
- Ipsen product availability
- Regulatory and health system environment where the request has come from (e.g. to make sure a Pharmacovigilance structure is in place)
If the request for Early Access is approved by Ipsen, the Physician must collect and complete all necessary documents to comply with appropriate rules and regulations – as quickly as possible. Once collected, Ipsen will send the Physician the requested Ipsen Product for Early Access to treat their patient.
The physician must commit to the regulatory obligations including reporting of adverse events during the entirety of the Early Access.
Ipsen is committed to Early Access but the company cannot guarantee approval and regrets that there are occasions where it is not appropriate for the company to provide Early Access to its medicine or where the request does not fall within the definition of Early Access. In these circumstances we commit to provide a timely response and clear rationale for the decision.