Compassionate Use Program («Identification») for Individual
Patient Supply of «Product Name» for the treatment of «Indication»
1. PURPOSE OF THIS DOCUMENT
This document:
1. Describes the conditions of the Compassionate Use Program (identification) set up by
«Company Name», under which «Product Name» will be made available by
«Company Name» free of charge following an unsolicited request from Belgian
physicians to receive the product for the treatment of an individual patient.
2. Defines the patients eligibility criteria for this Compassionate Use Program.
3. Defines the procedures for each individual initial and repeated request for «Product
Name» will be handled.
4. Provides instructions on how to report safety events and discontinuations occurring in
the program.
2. RATIONALE FOR THE COMPASSIONATE USE PROGRAM
«Describe rationale».
3. SCOPE OF THE COMPASSIONATE USE PROGRAM
The aim of this Compassionate Use Program is to make, on an individual patient basis,
«Product Name» available to patients who suffer from «Indication» and, in the opinion and
the clinical judgement of the treating physician, would benefit from a treatment with the
product, that does not have a marketing authorization yet. The disease for which the drug is
requested is a chronic disease or severely affects patient’s health or is life-threatening and
cannot be satisfactorily treated by the drugs currently marketed in Belgium and approved for
the treatment in this indication.
«Product Name» will only be made available after approval by appropriate «Company
Name» staff of an individual request submitted by the treating physician. The initiation and
conduct of the treatment with «Product Name» for a particular patient will fall under the full
and only responsibility of the treating physician.
4. DRUG ELIGIBILITY CRITERIA FOR THIS COMPASSIONATE USE PROGRAM
Options
-
Drug should be under central EMEA registration procedure in the given indication or
Drug should be under clinical investigation in that given indication.
Template protocol Compassionate Use Program (pharma.be – 09/2008)
This document contains information that is confidential and proprietary to «Product name»
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5. PATIENTS ELIGIBILITY CRITERIA FOR THIS COMPASSIONATE USE PROGRAM
«Describe criteria».
Patients should have been clearly and completely informed by the requesting physician and
provided written consent, before the start of the treatment.
6. AMENDMENT TO THE COMPASSIONATE USE PROGRAM
Decision is with the company.
Different options
«Company Name» has the possibility to review the Compassionate Use Program
-
whenever new information becomes available.
when the risk/benefit ratio has changed.
when there are problems with product availability.
due to changing regulatory environment.
7. DURATION OF THE COMPASSIONATE USE PROGRAM AND FREE DRUG SUPPLY
«Product Name» will be provided free of charge by «Company Name» on an individual
patient basis for
Different options (and/or)
- maximum “time limit e.g. 1 year” or
- until the product will be commercially available in Belgium,
- until, in the clinical judgement of the treating physician, the patient is not longer
benefiting from continuation of the treatment, whichever is sooner.
8. DRUG REQUEST PROCEDURES (initial and repeated)
Description of procedure of this particular program, “this should minimally include the
following in any kind of written documentation”:
- Unsolicited request by physician for individual patient supply of «Product Name» will
be collected in writing (PDF, letter or fax).
- Signed physician declaration including the following:
o He/she is personally responsible for the use of a drug that is not (yet) registered in
this indication, or that is approved but not yet commercially available in this
indication.
o The disease for which the drug is requested is a chronic disease or severely affects
patient’s health or is life-threatening and cannot be satisfactorily treated by the
Template protocol Compassionate Use Program (pharma.be – 09/2008)
This document contains information that is confidential and proprietary to «Product name»
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drugs currently marketed in Europe and approved for the treatment in this
indication. The requesting physician should include a description of the disease.
o He/she will inform the patient of all aspects of the Compassionate Use Program in
a clear and complete manner and will obtain informed consent from the patient, at
the latest before the start of the treatment with the drug received within the
modalities of a Compassionate Use Program.
- «Company/product specific procedures»
- Forms to be completed
All documents related to this Compassionate Use Program (program description,
physician request forms, unsolicited written requests, discontinuation of drug forms,
…) will be archived by «Company Name» and requesting physician in Belgium for at
least 10 years.
o Physicians request form (initial-repeated)
This form will be signed by the requesting physician and returned to «Company
Name».
o Patient consent form
Patient must accept participation in Compassionate Use Program and provide a
written informed consent.
o Notification end of treatment form
 This form should be used to document and report any patient discontinuation
from the Compassionate Use Program.
 Information regarding the reason for discontinuation is requested.
9. SAFETY REPORTING
In the context of a Compassionate Use Program, regular post marketing pharmacovigilance rules are applicable; only spontaneously mentioned safety events should be
reported as required by the post-marketing pharmacovigilance regulations. The methods for
reporting spontaneously mentioned safety events are described below.
Reporting of spontaneously mentioned adverse drug reactions
With regards to the reporting of Adverse Drug Reactions (ADRs) observed in patients
participating in this Compassionate Use Program, ADRs will be reported by the treating
physician for purposes of pharmacovigilance as per local regulatory requirements:
Different options
1. the FAMHP by means of the dedicated yellow form:
o in paper copy to:
Template protocol Compassionate Use Program (pharma.be – 09/2008)
This document contains information that is confidential and proprietary to «Product name»
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Centre National de Pharmacovigilance/Nationaal Centrum voor
Geneesmiddelenbewaking
Eurostation II (8° étage/verdiep)
Victor Hortaplein 40 B10
1060 Bruxelles-Brussel
OR
o electronic version to:
adversedrugreactions@healthfgov.be
Both, the paper version and the electronic version of the yellow form can be downloaded
from the following website link: https://portal.health.fgov.be
French: Médicaments /Usage humain/vigilance /pharmacovigilance /formulaire)
Dutch: Geneesmiddelen /Humaan gebruik /Vigilantie /farmacovigilantie / formulier)
2. «Company Name», fill instructions.
10. MEDICATION
Add Investigator brochure and specific recommendations
Description product form and presentation
Storage conditions
Drug administration
Handling of unused medication
Any unused medication needs to be returned to «Company Name» or destroyed in an
appropriate facility as soon as possible after the patient’s discontinuation from the
Compassionate Use Program. The medication delivered for an individual patient request in
the context of a Compassionate Use Program can only be used for that particular patient.
11. FINANCIAL ASPECTS
No financial compensation of reimbursement is foreseen for the requesting physician and/or
the hospital pharmacist. Freight costs for drug shipment, can be eventually considered / will
be covered by «Company Name».
12. EMERGENCY CONTACTS
In case of emergency, please contact «Local Company Contact Names».
13. NOTIFICATION TO CA AND ETHICS COMMITTEE (EC)
The Compassionate Use Program can only start after having obtained a positive EC
opinion. Once a positive EC opinion obtained, the program should be submitted for approval
Template protocol Compassionate Use Program (pharma.be – 09/2008)
This document contains information that is confidential and proprietary to «Product name»
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to the FAMHP (Dpt R&D) for authorization. If no objection is received within 2 weeks, the
program can start.
This dossier has been submitted to the FAMHP and the following EC:
Name
Address
E-mail/contact
APPENDICES
- Patient IC form proposal
- Individual Drug request form
- End of treatment form
Template protocol Compassionate Use Program (pharma.be – 09/2008)
This document contains information that is confidential and proprietary to «Product name»
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