The demand for earlier patient access
Every day we provide a critical lifeline for people who have run out of treatment options, a safe route for patients to access the medicine they need. We effectively manage the complexity and delivery challenges involved in sourcing and providing the right medicine to the right person at the right time.
But through all the legal and regulatory challenges, the frameworks and agreements, customs checks and ethical considerations, we never lose sight of the fact that behind it all there is a patient in need.
We connect you with pharmaceutical and biotech companies who have medicines that could meet this need and deliver medicine to the patient ethically, safely, and efficiently.
Accessing unlicensed or unavailable medicines?
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are not licensed in the country in which the patient is being treated (though licensed elsewhere), or have been withdrawn from that country. Access programs are a way of supplying medicines to patients with an ‘unmet medical need’ – that is, to people who have no other way of obtaining treatment.
How do access programs work?
They enable you to access medicines that are not licensed in your country when you consider that they are the best possible treatment for your patients. Access programs are often instigated by healthcare professionals contacting the manufacturer or distributor of a medicine to ask about access.
The programs themselves can take many forms. An 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 a group of patients who have taken part in clinical trials of a medicine that is not yet licensed for use.
Access to unlicensed medicines can include:
Early access programs:
Including Named Patient, Compassionate Use, and Expanded Access programs, which enable patients to access medicines while they are still in clinical trials, or when trials have been completed but the medicine has yet to be commercially launched.
Extended access programs:
Which provide access to medicines in countries where they are not licensed because they have not been launched.
Mature access programs:
Which make withdrawn, discontinued or end-of-lifecycle medicines available to patients with unmet medical needs.
How can Clinigen help?
We have a detailed understanding of the complex regulatory structures governing the supply of licensed and unlicensed medicines all over the world, as well as a commitment to logistical excellence that ensures that medicines supplied through our programs are delivered to you and your patients rapidly and in perfect condition. We are also a truly international business, with offices in the UK, US and the AAA region, and our customer services teams can answer enquiries in 25 languages.
What do I do next?
We are a unique business that does this in many ways. In partnership with pharmaceuticals and biotechnology companies, Idis Managed Access enables early access to products that are still in clinical development through our Managed Access Programs. Through Idis Global Access, we provide a 'go-to' solution for healthcare professionals to access commercial medicines that are currently unlicensed or unavailable in their home country. Our Clinigen Specialty Pharmaceuticals team acquires the rights to and then revitalizes essential niche medicines to maintain access for patients in need.
To contact us for more information about accessing a medicine for your patients in need, use the form to the right.