Transversal Support

with the general support services of the agency which fall directly under the Chief Executive Officer

Management Support
ICT
Budget and Management Control
Communication
Legislation and Litigation
Personnel and Organisation
Quality
Facility
International Relations
Project and Portfolio Management Office Coordination​

Management Support

Organised meetings

Parliamentary questions answered

Trend

Due to the coronavirus crisis the FAMHP received many parliamentary questions, as in 2020. The questions were mainly about the COVID-19 vaccines and medicines, (self-)testing and testing materials, and the side effects of the vaccines.

 

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ICT Division

Projects and Development Entity

Distribution by activity (in number of hours)

Operations Entity

Service Desk Team

Tickets closed by the Service Desk

Infrastructure Team

Activity
Number of hours
Management of ICT applications
5 986,8
Existing ICT service
1,2
New ICT service
1 735,6
Moving/Redesign project
1 093,9
Other
10,7

*ICT        Information and Communication Technology

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Budget and Management Control Division

Expenses
Budget 2021 (in KEUR)
Implementation 2021 (in KEUR)
Personnel expenses
46 395
42 062
Other personnel costs
596
489
Expertise
8 614
5 651
Non-ICT expenses
6 270
4 786
ICT expenses
9 556
9 672
Non-ICT capital expenses
156
0
ICT capital expenses
221
129
Subsidies for NAT* blood tests
7 727
7 727
Other expenses and subsidies
11 019
10 356
Reimbursements to the Federal State
7 146
7 975

*ICT        Information and Communication Technology

*NAT Nucleic Acid Amplification Test – Blood test using the nucleic acid amplification technique

Revenues

Revenues
Implementation 2021 (in KEUR)
Taxes of 30 and 15 centimes
9 261
Registration fees
9 070
Taxes on medical devices
9 927
EMA fees
7 638
Clinical trial fees
3576
Taxes of 50 centimes
3 048
PSUR fees
800
Other fees
15 738
Dotations
29 789

*EMA European Medicines Agency
**PSUR Periodic Safety Update Report

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Communication Division

928
press questions answered

865 of which related to COVID-19

155
news items on the website
289
internal newsletters
> 40000
interactions (reactions, likes, shares ...) on our social media channels

New

Since the FAMHP, the RIZIV-INAMI (national institute for health and disability insurance) and the FPS Public Health moved to the shared Galilee building in Brussels, digital screens have been used as additional visual support for communication activities. The screens are mainly used to spread internal messages to our employees. Read more about this project.

Trend

Due to the coronavirus crisis, the Communication Division answered almost 20 % more press questions in 2021 than in 2020 and almost twice as many as in 2019.

Due to our move to the Galilee building, the Communication Division also sent a quarter more internal newsletters to staff in 2021 than in the previous year.

 

COVID-19

In 2021, the Communication Division received 865 press questions about COVID-19. The questions were mainly related to the COVID-19 vaccines (supplies, side effects, vaccination materials) and to self-testing.

In 2021 the FAMHP published a weekly cumulative overview of the side effects reported after the administration of a COVID-19 vaccine in Belgium. By being fully transparent, the FAMHP wishes to increase confidence in COVID-19 vaccines. The overview is compiled by the Vigilance Division in collaboration with the Communication Division. Since the end of 2021, the overview has been published on a monthly basis.

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Legislation and Litigation Division

Publication of legislation

81
requests relating to the public nature of administration

COVID-19

During the COVID-19 crisis, requests for passive disclosure tripled. The trend over one year is not significant, but over four years we can see the effect of the health crisis on this procedure.

We received 28 requests in 2018, 21 in 2019, 82 in 2020 and 81 in 2021.

 

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Personnel and Organisation Division

Distribution by language

Distribution by working regime

Distribution by level

Staff turnover

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Quality Division

Internal audits

3
internal audits conducted by the FAMHP

Non-conformities in internal audits

3
internal audits conducted by the Federal Internal Audit Service

Non-conformities identified by the Federal Internal Audit Service

External complaints

Received complaints

Status of the received complaints

Distribution of complaints by entity

Quality documents

Trend

The number of non-conformities identified following an internal audit doubled in 2021 compared to 2020.

Trend

The Executive Council decided to restrict the internal audit planning for 2021 to three internal audits. This decision was taken in order to reduce the workload for the teams during the fight against COVID-19 and to be able to continue to guarantee business continuity.

COVID-19

The number of external complaints related to the COVID-19 crisis continued to rise, accounting for almost half (45 %) of the complaints filed in 2020 and for more than half (60 %) of the complaints filed in 2021. The number of external complaints on other topics remained the same.

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Facility unit

In March 2021, the FAMHP, the RIZIV-INAMI (national institute for health and disability insurance) and the FPS Public Health moved to the shared Galilee building in Brussels. From then on, most of the tasks of the Facility Unit have been carried out by the joint Facility Service 1FM.

An overview of the services of 1FM.

  • Procurement for contract management and legal and administrative support for public procurement contracts.
  • Support services
    • Events for the reception of visitors and employees and support in the organisation of meetings and events.
    • Mobility for support in domestic and international missions and travel as well as the management of the car park and the service bicycles and cars.
    • Document centre for the management of incoming and outgoing mail, the management of the media lounge, the archives and the execution of print jobs.
  • Service desk for the management of ServiceNow, the office supplies catalogue and requests for office materials and the lockers.
  • Real estate for the management of the building assets, the maintenance and cleaning of the buildings.
  • Translation service for translation and interpretation assignments.

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International Relations Unit

Belgium-Luxemburg cooperation

1
meeting

Pharmaceutical Committee

4
meetings

Joint meeting of the Directors for Pharmaceutical Policy and Pharmaceutical Committee of the European Union

1
meeting

Workshops on the revision of the general pharmaceutical legislation of the European Union

7
meetings

Management Board of the European Medicines Agency

4
meetings

Network of the Heads of Medicines Agencies

4
meetings

European Task Force for Industrial Scale-up of COVID-19 vaccines

7
meetings

Conclusies van de Raad betreffende geneesmiddelen en medische hulpmiddelen

2
sets of conclusions adopted

New

2021 was marked by several new events.

  • The negotiation and adoption of a regulation extending the mandate of the European Medicines Agency, including the creation of the European Shortages Monitoring Platform, to be launched by early 2025.
  • The implementation of the Pharmaceutical Strategy for Europe.
  • The launch of a development cooperation initiative.

 

The unit ensured strengthened and improved the transversality and information exchange of the FAMHP entities through dynamic distribution lists per dossier and a quarterly report to the Extended Executive Council.

Trend

Cooperation between competent national authorities has significantly increased with the launch of four joint actions in 2021, under the European funding programme EU4Health, in which the FAMHP will actively take part.

The number of important transversal files for the FAMHP is also growing, specifically with the proposal of a legislation on artificial intelligence and the NIS2 Directive proposal about cybersecurity in the European Union.

COVID-19

The International Relations Unit continuously informed the FAMHP entities of relevant international information

The unit coordinated the Belgian position and participated actively in the seven meetings of the Task Force for Industrial Scale-up of COVID-19 vaccines that took place with the European member states in 2021.

The unit also played an active role in working out Belgium’s position on the European Health Emergency Preparedness and Response Authority (HERA) by participating in:

The International Relations Unit also ensured the FAMHP was represented in the Structured dialogue on security of medicines supply.

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Project and Portfolio Management Office Coordination

24
projects supported by our experts

DThe Project and Portfolio Management Office (PPMO) Coordination supported several projects with different objectives selected by the Executive Council.

The main objective of these projects was to comply with legal requirements. Many projects prepared our agency for new European legislations such as Regulation (EU) 2019/6 on veterinary medicinal products, Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

Other projects have been launched purely on the initiative of our agency and aim to improve our services to the public. An example of such a project is the FarmaStatus platform, which informs citizens of the availability of medicinal products in Belgium. It also allows those involved in the medicinal product circuit (from the producer to the pharmacist) to inform the FAMHP of the availability of products. Another project is the plan to allow patients or healthcare professionals to report adverse reactions during vaccination campaigns against COVID-19. Various projects have also been set up on the evolution of technologies and the improvement of digitalisation of our activities. However, it is difficult to categorise individual PPMO projects according to these objectives as the vast majority of them address more than one objective.

New

In 2021, the Executive Council decided to participate on a regularly basis in the European Commission’s initiatives of the EU4Health 2021-2027 programme.

The FAMHP would now actively participate in the European Joint Actions in order to:

  • strengthen the collaboration of our agency with the other member states,
  • develop our activities more actively in line with the European Commission’s guidelines,
  • benefit from active funding from the European Commission (our expenses are financed up to 80 % by Europe for these activities).

Trend

In order to support these new projects in 2021, the PPMO team was reinforced with an additional employee (a reinforcement that should be recurrent).

The vision of the Executive Council is to continue to be part of the European Commission’s initiatives beyond the current 2021-2027 programme.

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