Q&A Dossier sperm donation

• The sperm of this Danish donor was used in Belgium between 2007 and 2017.
• In 2020, a suspected genetic mutation (TP53 gene) was reported. The gametes of the donor were quarantined, then released after investigation, as no abnormalities were detected.
• In 2023, new suspicions led to a new quarantine (5 October 2023). This time, a genetic mutation was confirmed. The donor was permanently blocked on 30 October 2023, and a European Rapid Alert was issued on 8 November 2023.
• Belgian reaction: on 8 November 2023 (the date of the European Rapid Alert), the FAMHP contacted the competent Danish authority to identify which Belgian fertility centres had received material from this donor. The response received on 13 November 2023 showed that 14 centres had used it. On the same day, the FAMHP carried out a retroactive investigation and verified all biovigilance notifications linked to this donor. The centres that had not yet notified were sent an e-mail to do so as soon as possible.
   

• National quota exceeded: the checks of biovigilance notifications and inspections showed that this donor's sperm was used for the conception of 53 children in 38 families. This is a violation of the law of 2007 on medically assisted reproduction, which limits the donor to 6 different families.
• Quota exceeded within a centre: the maximum number of authorised conceptions, i.e. a total of 6 different families per donor, was exceeded within a single fertility centre. Nine women were inseminated, with 11 children being conceived.
   

• Since 1 January 2024, Belgium has had a centralised donor register, called Fertidata. This application was set up by the FAMHP to structurally improve compliance with the so-called ‘6 women’ rule. Each fertility centre must register donor and recipient data before any use, to ensure that the donor's sperm has not already been used in 6 women.
• Official reports were drawn up and forwarded to the public prosecutor's office following the identified infringements.
• Inspection reports of the fertility centres from 2020 onwards are now available on our website.
•  A draft law is being prepared. It provides for abolishing donor anonymity and   setting up a new institute. This institute, which has the power to report irregularities, will be a point of contact for donors, donor children and families.
• Strengthened obligations for fertility centres are also planned.

Unfortunately, as in the case with natural reproduction, it is not possible to completely rule out the possibility of a genetic defect being passed on through gamete donations (egg cells or sperm). Even with current technologies, it remains difficult to correctly identify and interpret certain rare or as yet unknown genetic variants. If a mutation has not yet been associated with a disease, it is scientifically impossible to predict the effects.
Moreover, from an ethical perspective, complete genome sequencing is not authorised. The law only provides for genetic testing to detect certain hereditary (autosomal recessive) diseases that are more common in the donor's ethnic profile or according to family history (e.g. breast cancer - BRCA).
Limiting the number of children per donor, and therefore enforcing the 6-woman rule, significantly reduces the risk of large-scale transmission of an unknown genetic defect.

The case evolved gradually, with elements of it coming to light over time. It was treated from a technical and regulatory perspective, without any assessment of its political sensitivity. The FAMHP acknowledges that information about the concerned donor and the exceedance of the quota should have been communicated to a political level sooner. The audit also highlighted this lack of proactive communication. Corrective action will be taken to avoid similar situations in the future.

As a federal administration, we  apply legal measures proportionally. That means that we first have to apply the least restrictive tools before considering criminal prosecution. These tools may be an action plan with corrective or preventive measures, or a warning.

Criminal prosecution is only initiated in certain cases:

• if the infringement was committed intentionally (bad faith/fraud);
• if the same infringement has already been identified;
• if the infringement is very serious or flagrant and endangers public health.
• In the case of the Danish donor who carried the TP53 mutation, the infringement of the rule limiting donors to 6 female recipients was not identified until after the legal deadline for prosecution had expired. It was therefore no longer possible to subject the fertility centre in question to criminal prosecution. However, an official report was issued in June 2025. In the meantime, the centre had already taken corrective measures, which were evaluated and deemed sufficient by the FAMHP. This point was verified during the routine inspection.

The FAMHP welcomes constructive feedback. For each recommendation made in the audit report, a concrete action plan has been drawn up. This will form an integral part of the remediation plan requested by the Minister. We are committed to actively work on these actions, and implement them in time. Our aim is to continuously improve the quality of our services and to strengthen the trust of the public.

Questions regarding your personal file should be addressed exclusively to your fertility centre. If you have a more general question, or would like to notify something, please send it to the FAMHP at: icm@fagg-afmps.be

The 6-woman rule is a legal provision included in articles 26 and 55 of the Belgian law of 2007 on medically assisted reproduction. It stipulates that the same donor of gametes (sperm or oocytes) or embryos cannot be used for the conception in more than 6 different women. 
Note: when a female couple plan to become parents together, they are regarded as one woman for the application of this rule.
This rule is intended to limit the number of families conceiving with the same donor, for reasons of public health.

• Exceedance of the quota in a centre: this means that for the same fertility centre,  the gametes of a donor (from the centre or a foreign bank) have enabled more than 6 women to conceive, thereby exceeding the legal limit. This type of exceedance can be identified during an inspection or through a biovigilance notification. In this case, the centre had access to the information but did not comply with the rules.
• Exceedance of the national quota: the quota is exceeded when the FAMHP adds up the figures for all the Belgian centres working with the same European donor. This may be the case, for example, when a Rapid Alert is sent by the country responsible for the gamete bank.

The oldest case known to the FAMHP concerning a violation of the 6-woman rule dates back to 2011.

 

Since then, the FAMHP has occasionally recorded exceedances of the quota, via biovigilance notifications or following inspections. The FAMHP does not have a complete overview of all exceedances since the law of 2007. Thanks to this database, centres wishing to register future use of donor gametes or embryos are informed that the limit of six women has been reached, which ensures better compliance with the regulations.

The proper functioning of Fertidata partly relies on it being used correctly by the fertility centres. However, this system does not yet provide a complete overview of exceedances before 2024. The FAMHP is therefore currently working on a legislative and technical solution to collect all historical data, to ensure complete transparency for the families concerned.

It is currently already possible to find out which exceedances of the quota have been reported to the FAMHP via Rapid Alert since 2022. Since then, the agency has received several Rapid Alerts notifying that the quota has been exceeded. These exceedances vary between 7 and 38 women per donor, as detailed in this table.
These figures are based on data supplied by the fertility centres.

No, not from a biovigilance perspective. However, fertility centres are required by law to report any serious incident or adverse reaction to the FAMHP related to the use of human body material. This obligation is stipulated in a Royal Decree of 2009.

 

The fact that the use of a donor exceeds the authorised limit of 6 women is not considered a reportable incident in this context. However, this is an infringement of the law on medically assisted reproduction (law of 6 July 2007). Nevertheless, even without being obliged to, some centres inform the FAMHP directly when the quota is exceeded, which is appreciated.

To date, quota exceedances have been identified through biovigilance notifications or inspections. 

• In cases where a fertility centre has exceeded the quota and the FAMHP is aware of this based on biovigilance declarations, the relevant public prosecutor's offices were notified. Official reports were also drawn up due to misuse or non-use of Fertidata by certain centres. Since 2020, the FAMHP has drafted 8 official reports in the context of the rule of the quota of 6 women being exceeded and a fine for misuse of Fertidata. These were transferred to the public prosecutor's office.
• Before Fertidata, the FAMHP had few tools at its disposal to deal with cases of exceedances of the quota at the national level. These exceedances are always identified when the data from all the centres is compiled if there is a Rapid Alert. In this context, it is not possible to take action against a specific centre. 

Biovigilance is the systematic monitoring (alert, management and prevention) of risks (serious adverse events and reactions) from the selection of the donor to the follow-up of the recipient. The aim is to put in place the necessary public health measures in a collaborative manner, to ensure that the use of various substances of human origin (cells, tissues, etc.) is safer and more effective.

A Rapid Alert is a notification sent at European level via the platform Rapid Alert for Tissues and Cells (RATC). It is issued by a competent authority in European Union member states, in order to inform all parties and/or request additional information in the event of a serious health risk linked to the cross-border transfer of tissues and cells for use in humans.

 

These alerts may also involve 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 allows the competent authorities in the Member States to rapidly assess the risks and take the appropriate measures in good time.

When a sperm donor is the subject of a Rapid Alert, he is permanently blocked and his sperm can no longer be used to for the treatment of a new patient.

A biovigilance notification is all information sent to the FAMHP’s Biovigilance and Haemovigilance Entity by a Belgian establishment for human body material or hospital following a suspected incident or serious adverse reaction (donor or recipient). This information pertains to the quality and safety of cells and tissues of human origin at their own institution.

Healthcare professionals (managers of human body material or chief medical officers) report serious adverse events and serious adverse reactions to the FAMHP in two consecutive phases.

 

• As soon as possible after detection, a declaration is drawn up using a specific notification form. This contains as much information as possible, as well as the actions to be taken immediately.
• After investigation, a confirmation is sent via a specific confirmation form, with the results of the in-depth analysis. This investigation makes it possible to confirm or rule out a link between the incident/adverse reaction and a possible quality or safety defect that could affect the quality of life of patients.

When a notification is received, a file is created. The FAMHP then carries out the administrative processing and scientific evaluation of the dossier. All information received via the form is analysed to determine whether there is a link between the notified event or adverse reaction and the quality or safety of the cells and tissues.
The evaluation also takes into account the corrective and preventive measures implemented by the institution to avoid the incident or reaction recurring. If necessary, the FAMHP may request additional information. When required by the report, the data collected is forwarded to other competent departments of the FAMHP (inspection, medical devices, etc.) for further follow-up.

Follow-up of affected families is essential. However, in order to respect privacy and data protection legislation (GDPR), the FAMHP does not have access to the identity of patients and their place of residence: only the fertility centres have this information. 

 

When a donor risk is identified (e.g. via a Rapid Alert), the fertility centres are responsible for informing the persons concerned as part of the corrective and preventive measures. The FAMHP ensures that this procedure is followed, even if this cannot be confirmed for each individual case.

In early April 2020, the fertility centres were informed by the European Sperm Bank (ESB) that the donor had been temporarily blocked (quarantined) because a conceived child from this donor had developed a form of leukaemia. A mutation in the TP53 gene had been identified in the child.

 

At the end of April 2020, a sample of the donor's sperm was tested for this specific mutation and the result was negative. The ESB informed the fertility centres that donor sperm was being released for use. At the time, 7 centres had notified the FAMHP, but no further action was taken based on the information received.

In 2023, the FAMHP took various measures after receiving reports about the Danish donor and the associated genetic problem.
Timeline

• On 5 October 2023, the fertility centres were informed by the ESB that donor X had been quarantined again, because a child conceived with his sperm had a likely pathogenic mutation of the TP53 gene. The next day, the FAMHP’s Biovigilance Entity received an initial notification from a Belgian fertility centre, followed by notifications from 7 other centres.
• On 30 October 2023, ESB confirmed that the donor had been definitively blocked.
• On 8 November 2023, the FAMHP received an official notification from the Danish authorities via the European Rapid Alert system. This notification confirmed that the TP53 variant was present in the donor's sperm, and that the gametes had to be permanently blocked on account of the increased risk to children conceived via his sperm. The FAMHP immediately requested further information from the Danish authorities to ascertain which Belgian centres were involved.
• On 13 November 2023, the FAMHP received a list of 14 Belgian fertility centres that had received sperm from this donor. On the same day, the centres that had not yet reported the situation were contacted, with a request to report the incident promptly, and confirm the number of women and children involved.
• On 20 December 2023, the FAMHP received a notification from one of the centres involved confirming that the 6-woman quota had been exceeded in their fertility centre, with 9 women and 11 children implicated. The centre confirmed it had taken corrective and preventive measures to avoid such exceedances.
• In the weeks that followed, the Biovigilance Entity and inspection services of the FAMHP continued to follow up this case. The last notification was received on 22 July 2024.

A total of 38 families and 53 children were implicated (counted in December 2025). Babies were conceived in 11 of the 14 centres that used sperm from this donor.

Centre	Women	Children
Centre 1	4 Women	5 Children
Centre 2	4 Women	5 Children
Centre 3	5 Women	8 Children
Centre 4	1 Women	2 Children
Centre 5	1 Women	2 Children
Centre 6	2 Women	3 Children
Centre 7	1 Women	2 Children
Centre 8	5 Women	7 Children
Centre 9	5 Women	6 Children
Centre 10	9 Women	12 Children
Centre 11	1 Women	1 Child
Total	38 Women	53 children

A new mutation of unknown significance in the TP53 gene was identified in a mosaic form. Mosaicism is a genetic phenomenon in which an individual has two populations of cells: normal cells and abnormal cells. In this case, only 10 to 19 % of gametes are affected. This is one of the possible reasons for the negative results of the tests carried out in 2020.

Among other things, the mutation is linked to leukaemia and non-Hodgkin's lymphoma. Certain variants of the TP53 gene can lead to Li-Fraumeni syndrome, a hereditary predisposition to various types of cancer. Li-Fraumeni syndrome is autosomal dominant, which means that a person can become ill if they have inherited the gene from their mother or father. The disease can appear as early as childhood.

According to the information available to the FAMHP, this donor's sperm was used between 2007 and 2017. After this period, it was no longer used in Belgium. The Danish sperm bank permanently blocked the donor on 30 October 2023.

When the ESB blocked the Danish donor, it passed on the information to its competent authority (Danish Patient Safety Authority). A European Rapid Alert was then sent via the RATC platform. This platform allows health authorities in European countries to rapidly share important information. All countries involved were then informed. It is still not known how many children have been affected in total worldwide, as we have not received any information from other countries.

When the donor was permanently blocked in 2023, the fertility centres involved indicated that they would contact the parents to inform them. Most of them also indicated that genetic support would be offered.
In 2025, at the request of the Minister of Health, the FAMHP contacted each Belgian centre again to check whether patients had correctly been informed, both regarding the genetic mutation and the fact that the authorised number of families from the same donor had been exceeded.

 

Among the 38 families with at least one successful pregnancy, the centres tried to contact them using the most recent contact information. Currently, we know that 35 families have been informed regarding both the genetic mutation and the fact that the quota was exceeded. The three remaining families have not confirmed that they have received the information, suggesting that they may not be aware of the genetic mutation or the exceedance of the quota.

According to information received in June 2025 from the centres, 37 families live in Europe (18 in France, 15 in Belgium, 2 in the Netherlands, 1 in Germany and 1 in Italy) and one in South America.
These women were informed by their fertility centre, as were the Belgian women. But given the seriousness of the situation, the FAMHP also contacted health authorities in several countries (Germany, Netherlands, France and Italy and Peru). These authorities were informed that one or more of their citizens had conceived a child using sperm from this donor. The FAMHP asked them to take the necessary measures according to their own rules, and to inform the parents concerned.

 

This collaboration between countries is essential, as gamete donation is often cross-border. 

In any given case, the FAMHP never has direct contact with sperm banks. The ESB is under the responsibility of the Danish competent authority, to which it forwards information. In special cases, such as during an investigation, the inspectors of the FAMHP may contact the sperm bank directly to obtain information. The FAMHP has been in contact with the ESB, among other things, in the context of the exceedance of the quota during its investigations in the TP53 case. It is also in contact with the Danish authority responsible for monitoring the ESB.

The Danish authority has replied to letters from the FAMHP and announced that it would conduct an inspection of the ESB in autumn 2025.However, it pointed out that compliance with the Belgian quota does not fall within its remit.

As the competent Belgian authority, the FAMHP oversees the fertility centres mainly via biovigilance and inspections. The FAMHP is competent for granting recognition as a ‘human body material bank’ to the centres, and carries out regular checks and inspections, both planned and unannounced, to ensure that all activities comply with current legislation.

 

When violations are identified (for example, the limit on the number of women inseminated by the same donor is exceeded), the inspectors of the FAMHP can take the necessary and proportionate measures. For example, the FAMHP can issue warnings, draw up an official report and refer the matter to the public prosecutor's office for legal prosecution.

In terms of biovigilance, the fertility centres have to identify and report any risk (possible incidents and serious adverse reactions) that may occur at any stage, from donor selection to the use of human body material. By identifying and investigating the cause, preventive and corrective measures can be taken to prevent the incident or reaction recurring.

The fertility centres have several important responsibilities, including:

 

• managing medical records: they store medical information and can share it with other healthcare professionals or with the sperm bank, subject to compliance with medical secrecy and privacy rules;
• informing and obtaining consent: they clearly explain the procedures to donors and recipients, who must give their consent;
• complying with the legal limits: they must comply with the rules regarding the number of authorised donations;
• drawing up contracts: they draw up a contract with the sperm banks and written declarations for Belgian donors;
• reporting incidents: in the event of a serious problem or undesirable outcome, they must notify the FAMHP’s Biovigilance Entity;
• guaranteeing traceability: they must have access to gamete data and associated information, and be able to make these available. They must also be able to locate and identify the material, at every stage of the process, from obtaining human body material to its distribution or use.
• guaranteeing quality and safety: they must have a robust quality system in place to ensure that everything runs smoothly.

Each European competent authority is responsible for the centres located within its territory. Each centre is responsible for the donors who donate at their facility.
A distinction must therefore be made according to the origin of the donor.

 

If the donor comes from a foreign sperm bank:

• the foreign bank is responsible for its donors. It selects them in accordance with the relevant legislation, and is responsible for releasing gametes for human medical application, i.e. when these can be placed on the market and used in other national and international establishments;
• the fertility centre is also responsible for: human body material can only be transferred from another EU member state if it complies with the provisions of the Royal Decree on quality and safety standards. The manager of the human body material (HBM) must ensure that this is the case this before using gametes or embryos.

If the donor makes a donation in a Belgian fertility centre:

• the centre is fully responsible, from donor selection to the use of gametes for fertility treatment.

However, by law, donors are not subject to systematic genetic screening. Donor selection is based on an in-depth medical history. The law only provides for genetic testing to detect certain hereditary (autosomal recessive) diseases that are more frequent in the donor's ethnic profile or according to family history (e.g. breast cancer - BRCA). The centres or banks can only be held responsible if there is an error in donor selection. They cannot be held responsible if a genetic defect is discovered by chance after the donor selection.

Gamete donation is regulated by strict laws to guarantee the quality and safety of gametes and, consequently, public health.

 

• The donors are selected according to their age, health and medical history, via a questionnaire and an interview with a healthcare professional.
• The aim is to identify and exclude individuals for whom donation could present a risk:
  • to others (e.g. risk of transmitting a viral infection);
  • to the donor (e.g. side effects or psychological impact).
• Mandatory medical tests are carried out (HIV, hepatitis C, etc.). Other tests may be added depending on the donor's profile.
• If the donor does not meet the criteria, he or she is excluded from the donation process.

Fertility centres are recognised by the FAMHP as human body material banks.
In addition, under hospital legislation (outside the FAMHP's powers), they are recognised as type A or B reproductive medicine care programmes.

 

Type B centres are the only ones authorised to store gametes (eggs and sperm) and perform in vitro fertilisation. These are the only centres that potentially have their own sperm banks, but some also procure sperm from abroad. 

Type A fertility centres (15 centres) 

• Imelda Ziekenhuis (Bonheiden) 
• Clinique Saint-Pierre (Ottignies) 
• Chirec DELTA Hospital (Brussels) 
• CHU Helora (Mons) 
• AZ Groeninge (Kortrijk) 
• AZ Sint-Lucas (Ghent) 
• CHWAPI (Tournai) 
• Vitaz (Sint-Niklaas) 
•  AZ Delta (Roeselare) 
• Virga Jesseziekenhuis (Hasselt) 
• ZAS Sint-Augustinus (Wilrijk)  
• Kliniek Sint-Jan (Brussels)  
• CHU Charleroi (Charleroi) 
•  AZ Klina (Brasschaat) 
•  AZ Turnhout (Turnhout)

 
Type B fertility centres (18 centres) 

• UZ Brussel (Brussels)
• Erasmus Hospital (Brussels) 
• CHU Saint-Pierre (Brussels) 
• Cliniques universitaires Saint-Luc (Brussels) 
• CHR Namur (Namur)
• Grand Hôpital de Charleroi (Charleroi)
• UZ Leuven (Leuven)
• UZ Gent (Ghent)
• AZ Jan Palfijn (Ghent) 
• CHC MontLégia (Liège) 
• CHR de la Citadelle (Liège) 
• Centre Hospitalier de l'Ardenne (Libramont) 
• ZAS Middelheim (Antwerp) 
• Universitair Ziekenhuis Antwerpen (Edegem) 
• AZ Sint-Jan Brugge (Bruges) 
• Chirec Braine-l'Alleud (Braine-l'Alleud)
• Ziekenhuis Oost-Limburg (Genk) 
• Heilig Hart Ziekenhuis (Leuven) 

Centres with their own sperm banks (from their own donors) 

• UZ Brussel (Brussels)
• Erasmus Hospital (Brussels) 
• CHU Saint-Pierre (Brussels) 
• Grand Hôpital de Charleroi (Charleroi)
• UZ Leuven (Leuven)
• UZ Gent (Ghent)
• AZ Jan Palfijn (Ghent) 
• CHC MontLégia (Liège)
• Centre Hospitalier de l'Ardenne (Libramont) 
• ZAS Middelheim (Antwerp) 
• Universitair Ziekenhuis Antwerpen (Edegem) 
• Chirec Braine-l'Alleud (Braine-l'Alleud)
• Ziekenhuis Oost-Limburg (Genk) 
• Heilig Hart Ziekenhuis (Leuven) 

No exact figures are available. However, the fertility centres report that, on average, around 85 % of the sperm used comes from foreign banks.

This is a political decision that goes beyond the remit of the FAMHP. Currently, a child born of a donation cannot know the identity of their donor, except in the specific case of a 'directed donation' (when the donor is known to the family). However, on 26 September 2024, the Belgian Constitutional Court ruled that this strict anonymity was contrary to fundamental rights, and gave the legislator until 30 June 2027 to adapt the legislation. The agreement of the federal government of February 2025 provides for abolishing anonymity, and a draft law provides for the creation of a centralised institute and gradual access to data. Pending the adoption and entry into force of the new legislation, anonymity is still the rule.

Prior to January 2024, there was no central register to track gamete donations in Belgium. A distinction had to be made between two situations.

 

• Belgian donors: the centres could not verify whether a donor had donated at another centre. The donor was asked to confirm this information at the time of selection, and to sign a sworn declaration (exclusivity clause with the centre).
• Foreign donors (sperm banks): contracts were signed between the banks and the Belgian centres. These contracts stipulated that the legal quotas had to be complied with, but there was no exclusivity clause with the Belgian centre.

Since January 2024 - Fertidata

• .The Fertidata register now allows the fertility centres to verify that the legal limit of 6 women per donor has not been exceeded, before using a donation. This verification applies to both Belgian and foreign donors.
  Fertidata complements the checks that existed prior to 2024.

It is not prohibited for a foreign donor to supply multiple centres, but the centres must ensure that the quota is not exceeded.

 

Prior to Fertidata (before January 2024)
There was no national register to track donations. During routine inspections, the FAMHP carried out checks based on sampling.

• The contracts between the centres and foreign sperm banks, which included commitments to comply with the quotas.
• The measures taken by the centre to ensure that the donor does not donate to another Belgian centre, for example based on a sworn declaration signed during the donor selection.
• Compliance with the quota within each centre.

However, these checks did not guarantee that a donor had not also donated at another Belgian centre. And this check was not feasible during an inspection without a centralised database.

Since Fertidata
Fertidata is a platform that makes it possible to register donations before use, and since 2024 to track the number of families involved. During inspections based on sampling, the FAMHP checks that the centres are using the platform and associated procedures correctly.

The risk of a genetic defect being transmitted during medically assisted reproduction (MAR) with gamete donation is comparable to that of natural conception. The only difference is that the same donor can be used for up to six families. If an undetected defect is present, one (or more) child(ren) in one (or more) family(ies) could be affected. Gamete donors undergo a rigorous medical assessment, including genetic testing. However, excluding all risk is not possible: some mutations cannot be detected at the time of donation, and full genetic screening is not possible.

For ethical, scientific and financial reasons, systematic full genetic screening is not performed. Nevertheless, the legislation provides for certain checks, in particular:

 

• screening for frequent recessive genes depending on the donor's ethnic origin;
• an evaluation of the hereditary risk based on family history.

These examinations are carried out with the donor's consent, and the recipients receive clear information regarding the risks and the measures taken to limit them.

The aim of the inspections of the fertility centres is to check whether the inspected establishments comply with current legislation and the quality requirements arising from this legislation. The inspections are carried out within the framework of Belgian and European regulations on human body material. Random checks are used to assess the extent to which the processes, procedures and practices comply with the established standards, and whether the necessary measures have been taken to guarantee the quality, safety and traceability of the human body material used. In addition to the monitoring and corrective role, these inspections also raise awareness: they help centres to better understand legal expectations, identify areas for improvement and make their practices safer. The main purpose of an inspection is therefore to ensure that any identified shortcomings are remediated by the centre as quickly as possible, and that appropriate measures are taken to prevent recurrence in the future.
To achieve this objective, several types of inspection are carried out.

 

• Approval inspections: as part of the process for granting or renewing approval.
• Routine inspections: periodic checks based on a risk analysis.
• Inspections after important changes: such as a relocation or a new process.
• Targeted inspections (for cause): for example, following a biovigilance notification or complaint.
• Re-inspections: additional inspections deemed necessary according to the procedure following a previous inspection.
• Thematic inspections: these are carried out in several approved centres and focus on specific subjects with a limited scope, with the aim of taking an in-depth look at a specific aspect of activities or regulations, and assessing whether it is being correctly applied. Inspections are carried out according to a schedule established on the basis of a risk analysis and the available resources.

For further details on this subject, please consult our guide.

Fertidata, launched in January 2024, is a centralised database developed by the FAMHP to facilitate the exchange of information between Belgian fertility centres. It is a donor register with the aim of ensuring that gametes or embryos from the same donor are not used in the conception of children in more than 6 different women. If both parents are women, they are considered one and the same woman for the purposes of the quota.

 

The application automatically calculates the current quota based on data supplied by the fertility centres, including inseminations, distributions and implantations recorded for each donor (Belgian and foreign). The data is encrypted to uniquely identify a donor at a centre, without disclosing his identity.

Fertidata is exclusively used by Belgian fertility centres. The FAMHP has no insight into or access to the data stored in the application. As de-pseudonymisation of personal data in Fertidata is prohibited, the FAMHP can only request statistics on the number of registrations over a given period.

In 2007, when the law on medically assisted reproduction came into force, the proportion of Belgian donors in gamete donation was much higher. For Belgian donors, the 6-woman rule was easy to control thanks to exclusivity clauses between the donor and his centre. But given the rise in donations from foreign sperm banks, this rule quickly became difficult for individual centres to apply.

 

In 2013, work started on a donor register, initially via the e-Health platform, later via the BELRAP project (Belgian Register for Assisted Procreation), but this was not realised.
A legislative amendment initiative was also prepared in 2012-2013 to strengthen the legal framework for gamete donation. Since August 2015, the law on medically assisted reproduction explicitly provides the legal basis for setting up a central register to ensure the quota of six women by Royal Decree.

Although the register was not retained as a policy priority in the FAMHP operational plan in 2015, it was reprised in the FAMHP operational plans in 2018-2019 and again in 2020-2021, with a feasibility study and a draft implementing decree.

Despite delays, due in part to the COVID-19 crisis and the fall of the government, the project was restarted in 2022 with:

• validation of the framework/scope of the register by the policy unit;
• the register being made a political priority, with a deadline set for the end of 2023.

The various steps can be found in the timeline below. 

 
As Fertidata was developed, there was consultation with the various stakeholders and a revision of the legal basis. Fertidata was launched in January 2024.

Fertidata is designed in such a way that a donor cannot be linked to more than six women. If Fertidata is completed correctly by the fertility centres, an exceedance of the quota by a new donor used for the first time after 2024 is not possible. During inspections at the centres, checks are carried out to ensure that these births are correctly registered per donor. This is only possible for treatments registered since the introduction of Fertidata.
To ensure more transparency of past data and strengthen the checks of the FAMHP, the register will need to be further modified in the future. This will include:

 

• adding retroactive data (donation history);
• new functionalities for certain FAMHP staff, such as biovigilance and inspections.

The mandatory integration of all historical data into Fertidata is currently not possible due to the legal and technical limitations of the system.

 

In response to recent developments and the demand for transparency from families, the FAMHP is currently investigating how to adapt Fertidata to include historical data in the future (from prior to 2024).

This is checked during routine inspections, based on a sampling of donor/recipient files. The procedure in place for using Fertidata is also checked during inspections.

Up until October 2025, the following had been identified:

 

• during a routine inspection of a centre, it was found that an oocyte donor had not been accurately registered in Fertidata. A significant shortcoming was recorded in this regard;
• during a routine inspection at another centre, it was found that known donors had not been registered in Fertidata prior to using them. A warning was issued in this regard;
• an official report was sent to the public prosecutor's office for one centre, for failing to register a donor in Fertidata prior to using them.