INCEPTUA PHARMA ACCESS TO MEDICINES POLICY
The Inceptua Group is a forward-thinking, modern, ethical pharmaceutical company, and pharmaceutical services provider. ‘Helping Pharma. Helping Patients.’ is the mission we work to every day.
Inceptua Pharma is one of the 3 business units of the Inceptua Group. Inceptua Pharma holds the marketing authorizations to a number of prescription medicines. These medicines are marketed by Inceptua Pharma, and are available in certain countries on a commercial basis. Inceptua Pharma understands that demand for access to its medicines may come from physicians and patients resident in countries where its medicines are not commercially-available.
Outside of the commercial route of access, other routes exist to allow physicians to access a medicine which is not available in their country of residence. Inceptua refers to these routes as ‘pre-approval’ access, or ‘medicines access’, but such routes of access are also known by other terms, such as: expanded access, early access, named patient supply, managed access etc.
Whilst Inceptua is keenly aware of the unmet need that exists for some of its medicines, and the demand that exists for access outside of the countries where its products are marketed, it is not possible for Inceptua to grant widespread access outside of those markets where its medicines are commercially available.
However, Inceptua Pharma will consider requests for access to its medicines from countries where it is not making them available commercially, on a case-by-case basis. Inceptua Pharma will base its decision on whether or not to provide access to one of its medicines outside of its countries of commercialization based on the following criteria:
- Is there a regulatory pathway through which the medicine could be provided into the country in question?
- Does the patient have a condition for which the medicine has a marketing authorization, or for which it is undergoing clinical trials?
- Is the patient eligible for any ongoing clinical trial in their country of residence?
- Has the patient exhausted all other treatments available in their country of residence?
- Does Inceptua Pharma believe that the potential benefits to the patient outweigh the potential risks?
- Would providing the medicine affect Inceptua’s ability to operate and serve its existing customers and patients?
To enquire about access to any of the medicines within the Inceptua Pharma portfolio, please send an email to the following address: firstname.lastname@example.org
We will respond to your enquiry within 5 working days. Consideration of a request for access does not constitute an obligation by Inceptua Pharma to grant access to a medicine.
Please note that Inceptua can only respond to enquiries from qualified healthcare practitioners.
LAST UPDATED: September 2020