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Injury related to a medicinal product
Verified 15 May 2020 - Directorate for Legal and Administrative Information (Prime Minister)
The Ministry of Health has taken measures to ensure medical care and compensation for the victims of certain medicines, and to strengthen the prevention of risks related to the use of these medicines as well as precautionary measures.
What applies to you ?
If you notice any side effects on your health (even if these are mentioned in the package leaflet or because of an error on your part), after taking a medicine, you can report them on the portal "Health reporting":
In the event of a dispute with a health facility (public or private), involving the care of patients, it is possible to refer the case to the Users' Commission (CDU). It is present in every establishment.
In case of damage related to a health product (medicine, cosmetic product, medical device...) you can obtain compensation with the group action procedure. Several users of the health system must be affected by similar harm. Such a procedure shall be initiated by an association of users of the health system approved at regional or national level.
Benfluorex was withdrawn from the market on 30 November 2009 following reports of heart valve damage. It was indicated for the management of type 2 diabetes but prescribed for weight loss. There have been reports of pleural fibrosis (thickening of the lung membrane) since then.
The request for compensation must be sent by registered letter with a request for notice of receipt or filed with theOniam: titleContent by means of a form against receipt.
Who shall I contact
This is an amicable and optional procedure. During this period, the victim has the opportunity to be accompanied by any person of his choice: association representative, lawyer, medical adviser... This procedure is an alternative to referring the case to the court.
L'Oniam: titleContent is responsible for investigating claims for compensation. If a medical examination needs to be done, it is free of charge.
Those found liable for the damage suffered by the victim will be required to make an offer of compensation within three months. In the event of their refusal, the victim may ask Oniam: titleContent to submit an offer in their place.
Exposure to valproic acid (Depakine®)
Valproic acid (or sodium valproate) is used to treat epilepsy. It is also prescribed to treat bipolar disorder. When taken by pregnant women, it can cause birth defects in children (neural tube defects, autism or related disorders).
You can enter Oniam: titleContent if you feel you have been harmed by one or more malformations or developmental problems caused by the prescription of valproate sodium or any of its derivatives. This prescription should have been made before 31 December 2015 and during pregnancy.
The application shall specify the names of the medicinal products which have been administered and the particulars which may establish the administration of sodium valproate or any of its derivatives.
Who shall I contact
Referral to the Office shall suspend the limitation period and the time-limits for bringing proceedings.
The application shall be lodged with Oniam: titleContent by any means capable of attesting to the date on which it was sent.
Who shall I contact
The claim is established with the claim form from Oniam: titleContent, accompanied by the documents necessary for the admissibility of the file:
- Document of affiliation to a social security scheme
- Contact details of the social security body
- Family booklet
- Any evidence justifying legal benefits and medical-social assistance received or to be received from other third-party payers (such as general advice, insurance ...)
- Documents for establishing the period of pregnancy concerned (medical certificate, health booklet, etc.)
- Documents relating to the proof of prescription of sodium valproate and derivatives (prescription, certificate of dispensing of the pharmacist, reimbursement slips of social security ...)
- Documents to establish the existence and extent of the damage (medical certificate, testimony(s), neuropsychological or speech therapy evaluation...)
Where the file is complete, the Office shall send the applicant a receipt indicating the date of receipt of all the documents. The college of experts attached to Oniam: titleContent make its assessment within 6 months of the date of receipt of the file.
It is on the basis of the opinion of the expert group that persons found liable for the damage suffered by the victim will be required to make an offer of compensation within one month. In the event of their refusal, the victim may ask Oniam: titleContent to submit an offer in their place.
the request may also be made by the legal representative of the victim or an heir, in which case additional documents will be requested.
PIP breast implants
All women who have been implanted during the period from 1 June 2004 to 29 March 2010, can submit a claim to the Service d'aide aux Recoveries des Victimes d'Infractions (Sarvi).
If you don't have a lawyer, go to the Sarvi website and download the form:
Fill it out, attach the requested parts:
- Copy of the criminal decision, bearing the order for enforcement, awarding you damages
- Copy of the certificate of non-appeal or of non-opposition or of non-appeal, stating the date and method
- Copy of one of the following valid identity documents: identity card, passport, booklet
- family, birth certificate, residence permit of service
- Additional information on the author's assets, income, employer, to be provided on free paper
- If you have filed a case with CIVI, a copy of the decision and its notification
- Bank Identity Statement (BIR)
Send the complete file (completed form and requested documents) to the Sarvi Guarantee Fund.
Who shall I contact
The victim who has not been paid by the convicted person may take the matter to the Sarvi. As a substitute for the person responsible, Sarvi pays the victim all damages up to €1000. Beyond that, he pays an advance of 30% of the sum, up to a maximum of €3,000.
the appeal to the Sarvi must be lodged between two months and one year from the day on which the decision on damages becomes final (no further appeal possible).