Access to medicines that are not licensed in your country
It may still be in clinical trial development, or have finished clinical trials but yet to be commercially launched; the manufacturer may not have proceeded with licensing in your country or the medicine may have been discontinued or withdrawn. Such medicines are described as ‘unlicensed’, though they may be licensed in other countries. Under certain circumstances, physicians and other healthcare professionals may consider that unlicensed medicines are the best treatment for a patient who would otherwise have what is called an ‘unmet medical need’. Access Programs run by businesses like Clinigen Group enable physicians to access such medicines for their patients. If you are a patient or are visiting this site on behalf of a patient, you should discuss treatment with your physician or healthcare professional.
What is a managed access program?
These medicines may be unavailable because they are still in clinical development, are not licensed in the country in which the patient is being treated (though licensed elsewhere), or have been withdrawn from that country. Managed Access Programs are a way of supplying medicines to physicians treating patients with an ‘unmet medical need’ – that is, to people who have no other way of obtaining treatment and have already exhausted the available medicinal options. Managed Access Programs are generally initiated by healthcare professionals contacting the manufacturer or distributor of a medicine to ask about access for their patient. The programs themselves can take many forms. A Managed Access Program can involve a complex logistical operation to deliver a niche medicine to a remote region for a single patient; it could equally describe providing continuing access to patients who have taken part in clinical trials of a medicine that is not yet licensed for use. If you are a patient or are visiting this site on behalf of a patient, you should discuss treatment with your physician or healthcare professional.
What do I do next?
If you are a patient or are visiting this site on behalf of a patient, you should discuss treatment with your physician or healthcare professional.
As an organization committed to delivering the right medicine, to the right patient, at the right time, Clinigen Group can assist patient organizations to ensure they are providing the best information possible to their communities about obtaining ethical and compliant access to unlicensed medicines.
Patient organizations that we proudly support:
Interested in talking with Clinigen Group? For more information, please contact firstname.lastname@example.org.