Early access program services
What is an early access program?
An early access program, also known as an expanded access program, is a regulatory pathway that enables companies to widen potentially lifesaving access to investigational and pre-approval medication. By allowing a broader patient population to receive promising treatments before full approval, early access programs can result in accelerating adoption and generating diverse real-world data. In these cases, the patient does not have comparable or satisfactory alternative therapies available and cannot participate in a clinical trial.
For rare disease patients, early access programs are a crucial lifeline, providing access to innovative therapies that may not yet be available in their home country.
Early access programs can be launched at any stage of the product lifecycle, including:
- Before full regulatory approval to help generate real-world data
- After a product is discontinued to maintain patient access
Different types of early access programs
Early access programs can generally be categorised into two main types:
- Named Patient Programs (NPP) – Designed to provide access to a specific, unapproved drug for an individual patient, often on a case-by-case basis
- Compassionate Use Programs (CUP) – Broader initiatives that allow access to investigational drugs for a group of patients facing serious or life-threatening conditions
Faster access to new global markets
Network building with clinicians and PAGs
Collection of valuable real-world data
Expanded access program vs. clinical trials
Clinical trials for rare disease therapies, as well as more prevalent speciality care illnesses can be infrequent and challenging for several practical and ethical reasons. Early access programs can be an attractive alternative for companies who wish to widen potentially lifesaving access for patients who are not eligible for a clinical trial. Unlike clinical trials, early access programs:
- Do not have strict eligibility criteria, making access easier for a broader population
- Allow patients to live their daily lives while receiving treatment
- Still involve monitoring for safety and efficacy but in a real-world setting
Early access programs in Europe: challenges and solutions
Gaining approval for an early access program in Europe can be challenging and costly, with multiple complex regulatory landscapes and different healthcare systems to negotiate across the many member states.
- Regulatory complexity – Each country has different EAP rules and approval processes
- Strict promotion restrictions – Unlicensed medicines cannot be actively marketed, so all requests must be unsolicited
- Potential risks – Adverse events or poor patient adherence could impact future commercialisation
Key challenges:
- Regulatory complexity – Each country has different EAP rules and approval processes
- Strict promotion restrictions – Unlicensed medicines cannot be actively marketed, so all requests must be unsolicited
- Potential risks – Adverse events or poor patient adherence could impact future commercialisation
Sciensus’ solution:
- Country-specific regulatory expertise – We handle approvals across Europe
- Compliance-first approach – Ensuring all interactions align with promotional restrictions
- Risk mitigation strategies – Implementing safety monitoring & adherence programs
Accelerate your biotech strategy – unlock early access in Europe today
Our fully integrated expanded access services
A comprehensive regulatory assessment
We will support you with a regulatory assessment of the countries where you are interested in running an early access program. This will include advice on the most suitable program type, whether it can be charged for, and the data you may be able to collect.
A digital platform for clinicians
We will ensure healthcare professionals are properly validated and given access to our online ordering portals: Sciensus Axcess and Sciensus Connect Registered HCPs will be able to view documentation for the access program including product information and any relevant training materials.
An established supply chain
We operate a GDP-certified medical warehouse hub in the Netherlands, equipped for all temperature regimes, facilitating delivery to most European sites within 24 to 48 hours. In the UK we have 2 GDP-certified warehouses, with 15 national hubs. We will ensure there is full track-and-trace capability to allow auditing of all activity.
Digitally enabled Patient Support Programs
We deliver global Patient Support Programs (PSP), both face-to-face and remotely, through highly qualified HCPs. We understand regulatory frameworks and can mobilise our clinical workforce to assess needs, research conditions, and develop tailored PSPs for your product.
A dedicated account manager
We provide a personal touch thanks to a dedicated account manager, a bespoke solution tailored to your specific needs, a strategy developed by our Director of Early Access Programs or Business Development Director with therapy specialism, supported by a dedicated team that will implement it for you.
How to get started
Step 1: Schedule a consultation with our EAP regulatory experts.
Step 2: Define the program scope, including eligibility, distribution, and safety monitoring.
Step 3: Sciensus handles logistics, compliance, and patient engagement.
Step 4: Monitor real-world data and refine access strategies.
Streamlined regulatory approval
Faster patient access
End-to-end EAP management
Data-driven insights
Meet our EAP expert
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