e-Medical Need Programs (MNP)

Enabling early access with compassion. Powered by precision.

In the face of life-threatening or chronic conditions, waiting for full market authorization can mean lost time—and lost lives. e-Medical Need Programs (MNPs), including early access programs and compassionate use programs, provide a critical bridge: allowing eligible patients to receive innovative treatments when no other options are available.

These programs are more than just access—they are an essential part of chronic care management solutions and rare disease management strategies.

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What is a Medical Need Program (MNP)?

A Medical Need Program allows pharmaceutical and biotech companies to provide non-commercial access to investigational or not-yet-commercialized therapies for patients with serious, long-term, or rare diseases.

These programs are typically initiated when:

A therapy shows promise in clinical trials
No comparable alternative treatments exist
Patients are not eligible for ongoing trials
The therapy has not yet received full reimbursement or market authorization

Types of MNPs include:

Early Access Programs (EAP)
Compassionate Use Programs (CUP)
Named Patient Programs (NPP)

Each is governed by national regulations and must balance access, safety, ethical responsibility, and regulatory compliance.

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Local execution. Global standards.

Deploying a Medical Need Program in countries like Belgium, the Netherlands or Eastern European countries requires a trusted partner who understands:

Regulatory frameworks (FAGG, EMA etc.)
Healthcare compliance
Healthcare data management
Pharmacovigilance and reporting obligations
Patient communication and consent flows

At Novellas Healthcare, we support sponsors to manage the end-to-end implementation of MNPs, providing remote therapy management, logistics and communication management to support patients and HCPs throughout the journey.

We provide an integrated solution, tailored for the life sciences industry and HCPs.

1. Program enrollment & onboarding

2. Supply chain & documentation

3. Digital tool for follow-up and reporting

4. HCP support & education

Learn more about Medical Need Programs

Why use an MNP

A Medical Need Program (MNP):

Saves lives by offering early access to critical therapies.

Strengthens patient relationships & brand trust.

Provides real-world insights to complement clinical data.

Prepares the market ahead of commercial launch.

How do we make your Medical Need Program better?

Easy to access

Dynamic

Structured

Compliant

Key features of our Medical Need Program:

Medical Officer access
Online patient registrations
Live supply overview per patients
View of upcoming supply requests
Online access to patient’s letter of agreements
View of upcoming /expired supply requests
Online statistics

Benefits of our E-Medical Need Program tool

Easy Tracking & Monitoring

Logistical monitoring, tracking, and follow-up processes are seamless now more than ever with Novellas Healthcare’s e-MNP tool. Get a clear overview of current activities and upcoming steps, and thus ensure a smooth workflow.

Easy Market Introduction

Introducing life-changing treatments at an earlier stage not only enables healthcare professionals to gain experience sooner, but also allows patients to experience the benefits sooner. This sums up the essence of healthcare: improving patient’s quality of life.

Online Patient Approval Process

❓Frequently Asked Questions

What is the difference between an Early Access Program and a Compassionate Use Program?

Early Access Programs typically apply to therapies already submitted for approval.

Compassionate Use Programs may provide access earlier in the development process for patients with no alternatives.

What medicines can patients receive in a Medical Need Program (MNP)?

The law from 1964, March 25, outlines conditions for providing unapproved medicinal products in Belgium, either for compassionate use or medical need programs. Compassionate use is allowed for non-authorized products undergoing clinical trials or seeking marketing authorization. Medical need programs apply to authorized products when other treatments are inadequate. Additional conditions include ongoing authorization processes, unavailability in the market, ongoing trials, or demonstrated relevance in the intended use. As long as eligibility criteria are met, the same company can submit a marketing notification for one indication while reimbursement procedures for another indication are underway for the same medicine.

Who authorizes the MNP?

Each country’s health authority must approve the MNP.

In Belgium, this is managed by AFMPS/FAGG. In the Netherlands, by the Medicines Evaluation Board (MEB).

Can you collect data in a Medical Need Program (MNP)?

Patients should always be considered for inclusion in clinical trials before being offered inclusion into a CUP or MNP. Clinical data collection in MNP/CUP is NOT POSSIBLE. MNP/CUP cannot replace clinical trials for investigational purposes. However, data collected during a CUP or MNP that are necessary to conduct the program (e.g. to check inclusion / exclusion criteria, to follow-up the benefit / risk of a patient, pharmacovigilance data) could be used to increase the understanding of the treatment. Processing of data collected (e.g. AE information) can only happen to evaluate the dossier with focus on quality and cost of the medicine. It is not possible to collect more data than strictly needed for the conduct and evaluation of the program.

Is the medication free?

Yes. Under compassionate use and early access programs, medications are typically provided free of charge to patients.

What are the components of a Medical Need Program (MNP)?

There are 4 main components in a Medical Need Program: – Patient Eligibility Assessment – Consent & Letter of Agreement – Medication Provision – Monitoring Supplies.

Let's build your next program together

When standard options fall short, early access can be the key to hope. Partner with Novellas Healthcare to implement a reliable, compliant, and patient-centered MNP—from design to daily execution.

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Not looking for Medical Need Programs?

We also offer Patient Support Programs and Clinical solutions to support your business needs. Whether you’re seeking short-term expertise or project-based assistance, we have you covered.

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