What is an Early Access, Compassionate Use or Medical Need Program?
Early access programs (also named Compassionate Use, Expanded Access, Named Patient, Medical Need Programs) provide a way for patients with life-threatening diseases to access drugs before they are approved for market use.
These programs are designed for patients who have no other treatment options, including those who do not qualify for clinical trials, or have completed a trial and still need the drug before it is officially authorized.
The process is ethical, controlled, and compliant with regulations, ensuring that patients can benefit from these treatments in a safe manner.
Since 2014 in Belgium two types of early access programs exist:
- Compassionate Use program (CUP): for a non-authorized product in Belgium
- Medical Need Program (MNP): for a product that is already authorized for another indication in Belgium
The New Belgian Framework: Early & Equitable Fast Access (EEFA)
Since March 2026, Belgium has introduced a revised framework called Early & Equitable Fast Access (EEFA). This procedure allows patients to access innovative medicines more quickly, without waiting for lengthy price negotiations.
Types of program:
- Early Access: supports medicines still under Compassionate Use Programs (CUP) or Medical Need Programs (MNP)
- Fast Access: accelerates availability once a medicine has received marketing authorization but is still waiting for formal reimbursement.
Medicines that obtain early access reimbursement automatically flow through the fast access procedure.
Key features of the EEFA framework:
- Faster Access: Patients can start treatment immediately, even before a positive opinion from the European Medicines Agency (EMA).
- Temporary Reimbursement: The Belgian compulsory health insurance provides temporary reimbursement to companies per patient, covering the cost of therapy during the early phase.
- Continuity of Treatment: Patients already on treatment continue to have access under the same conditions, regardless of the final reimbursement outcome.
- Regulated Under Royal Decree: The EEFA system is established under the Royal Decree of 14 February 2026, which defines procedures, timelines, and reimbursement conditions.
What sets LIVV apart in supporting pharmaceutical companies with Early Access Programs?
At LIVV, our dedicated in-house experts provide a unique combination of strategic and operational support to pharmaceutical companies. What distinguishes us is our ability to approach Early Access Programs from multiple critical angles:
- Patient-Centric Approach: At the heart of LIVV’s mission is our unwavering commitment to patients. We design and execute Early Access Programs that prioritize patient safety, timely access to potentially life-saving therapies, and clear communication. By deeply understanding patient needs, we ensure that our services also deliver tangible, meaningful benefits to patients and their families.
- Our team offers protocol authoring that integrates market access considerations, ensuring the program is designed with both patient needs and commercial goals in mind.
- We facilitate early dialogue with Health Technology Assessment (HTA) bodies, helping to align your program with market access pathways and future reimbursement strategies.
- Comprehensive regulatory guidance, including guiding you through the submission of applications to health authorities, preparing detailed dossiers, and liaising with regulators to ensure all requirements are met for approval.
- LIVV’s operational support extends to every detail, from budget management to ensuring smooth distribution of medicinal products.
With extensive experience in managing Early Access Programs, LIVV is uniquely positioned to navigate the complex landscape of EAPs with a dual focus on regulatory compliance and market success, while keeping the patients needs at the center.
Our experience
Set-up and management of Early Access Program for Johnson & Johnson
Our team has been involved in a Global Early Access Program from Johnson & Johnson in the hematology field. Our expertise encompassed:
- Defining market access strategies for EU countries
- Provide guidance for program design in collaboration with key stakeholders
- Writing of application dossier for submission to Health Authorities
- Set-up of the patient and HCP flow to ensure a smooth and efficient program process
- Vendor selection and management for medicinal product distribution
- Set-up and management of global program budget
Want to Learn More? Contact Us Today!
If you want to learn how LIVV can support your Early & Fast Access Programs under the new Belgian EEFA framework, our team is here to help. We provide tailored solutions for program design, regulatory submissions, and operational execution, all while keeping patient needs at the center.
Reach out today to explore how we can help bring innovative therapies to patients faster.
