What is a biovigilance report?
A biovigilance report is a notification sent to the Federal Agency for Medicines and Health Products (FAMHP) by an establishment for human body material or a hospital following a suspected serious adverse event or a serious adverse reaction (in the donor or the patient/recipient).
Definitions
- A serious adverse event is an unwanted medical event that may have serious consequences for the donor or patient, such as:
- infection with a communicable disease;
- life-threatening situation or death;
- permanent disability or incapacity for work;
- hospitalisation;
- contracting a disease or prolongation of a disease.
- A serious adverse reaction is an adverse reaction, including a communicable disease, in the donor or recipient that:
- is fatal;
- is life-threatening;
- causes disability or incapacity for work;
- results in hospitalisation;
- causes or prolongs an illness.
In the specific case of gamete donation, where the donor is a carrier of a particular genetic mutation, there is a serious adverse reaction if a child born from this donor is a carrier of the mutation or suffers from the disease. However, the human body material of this donor is defective in quality and safety, which in itself makes it a serious adverse event.
What is a rapid alert?
A rapid alert is a warning message issued by the competent authorities of European member states to inform each other and/or request additional information in the event of serious health risks linked to tissues and cells circulating across borders. These warnings may also apply to other products, such as medical devices, medicines or human organs intended for transplantation, if they present a risk to the quality and safety of tissues or cells. This helps the competent authorities in the member states to assess the risks quickly and take appropriate measures in good time.
There are four types of rapid alert.
- Quality and safety defects are warnings that require corrective measures, such as the recall or quarantine of the tissues/cells concerned.
- Information messages are warnings about corrective measures taken in other sectors, such as medical devices or medicinal products, which may be important for tissues and cells and which may affect patient safety in other member states.
- Warnings of potential illegal or fraudulent activities in the supply, testing, processing, packaging, distribution, labelling, import/export or promotion of tissues or cells.
- Epidemiological notifications concerning major epidemiological situations (e.g. epidemics) that may have cross-border consequences for tissues and cells.
Each competent authority assesses the content of the warning, takes the necessary measures and communicates, if necessary, with the parties concerned.
Notification requirement
Hospitals and establishments of human body material must notify the FAMHP of any suspected serious adverse event or serious adverse reaction. When they receive information from a foreign gamete bank concerning, amongst other things, the quarantine or blocking of donors, they must also inform the FAMHP immediately. This notification requirement applies to the chief physician of the hospital where the human body material is used and applied to a human being, as well as to the human body material manager of the establishment concerned.
How does the notification process work?
The notification process consists of two stages.
- At the time of the initial notification, the hospital or establishment of human body material concerned will provide all the information available and the measures already taken.
- In the second stage, the hospital or establishment of human body material concerned submits a confirmation form containing the results of a thorough investigation, which confirms or refutes the link between the event or adverse reaction and a possible quality or safety defect in the human material concerned. This confirmation also includes an analysis of the causes and the corrective measures taken.
Role of the FAMHP
After receiving a biovigilance report (initial notification and confirmation form) from a hospital or establishment for human body material, the FAMHP assesses, on the basis of the results received, whether there is a link between the event or adverse reaction and the quality and safety of tissues and cells. In its assessment, the agency also takes into account the corrective and preventive measures already taken by the hospital or establishment. If necessary, additional questions can be addressed to the establishment concerned. Depending on the nature of the event or adverse reaction, the information is also passed on to other relevant divisions within the agency (such as the relevant inspection service) for further follow-up.
In addition, the FAMHP receives information via rapid alerts from the competent authorities in other member states. The FAMHP then contacts the competent authority (which issued the rapid alert) to ask which centres have received material from the donor concerned. The agency then contacts the fertility centres concerned so that they can pass on all the relevant information to the agency as soon as possible. Fertility centres that have used this donor must then submit a biovigilance report as soon as possible.
This involves the following biovigilance reports:
- a report of a serious adverse event concerning a donor's material, if they are not aware of a serious adverse reaction in a child;
- a report of a serious adverse reaction if there is a suspicion of a serious adverse reaction in a child born from this donor.
It is possible that after the parents have been informed by the fertility centres, these centres submit a new report to the FAMHP because the parents have subsequently informed them of a possible problem in their child (this is then a serious adverse reaction). The subsequent investigation may then determine a possible link with the donor.
The FAMHP does not directly receive official information from foreign gamete banks concerning, amongst other things, the quarantine or blocking of donors. This information is only exchanged between these banks and the fertility centres. It is only when a donor is confirmed to be a carrier of a disease or is permanently or conditionally blocked that the agency is officially informed via a rapid alert issued by the competent authority of the foreign gamete bank. However, as mentioned above, fertility clinics must inform the FAMHP immediately as soon as they become aware of or receive information about a serious adverse event or reaction.
In addition to receiving and assessing biovigilance reports and rapid alerts, the FAMHP also monitors compliance with the obligation to notify during routine inspections and checks the follow-up of biovigilance reports by fertility centres and their procedures in this respect. These checks include the following actions (non-exhaustive list):
- analysis of causes;
- risk analysis;
- impact analysis;
- corrective and preventive actions;
- notification requirement;
- ...
Communication with recipients and future parents
Fertility centres are responsible for informing the future parent(s) of serious adverse events and serious adverse reactions.
The FAMHP does not know the identity of the recipients or their descendants.