Governance, organisation and financial affairs

Governance and organisation

Organisational structure

The Medicines Evaluation Board is an independent administrative body within central government. The Board makes decisions regarding the authorisation of medicines for human use on the Dutch market and the classification of medicines (legal status of supply). In doing so, the Board assesses the balance between efficacy and risks. The Board’s other responsibilities include pharmacovigilance, issuing scientific advice and providing advice on medicinal products that have been integrated into a medical device. The Board is supported by the Agency.

Board

The Board has a maximum of 17 members, including the chair. The members are all medical specialists, hospital pharmacists, professors or experts in other fields. Members of the Board are appointed by the Minister for Health, Welfare and Sport for a four-year term. This term may be extended twice through reappointment.

In 2022, a vacancy was advertised for a Board member/hospital pharmacist with expertise in the area of ATMPs and biotechnology. This vacancy is expected to be filled in 2023. In late 2022, a position became vacant due to the departure of Annemiek van Rensen, who had served as a Board member since 2015 with a focus on the patient and consumer perspective.

In theory, a meeting attended by all Board members is held once a month, while another monthly meeting is attended by a smaller group of members. The chair and vice-chairs meet every week to discuss specific questions about medicine dossiers. Board members are also increasingly being consulted in relation to assessments on an ad hoc basis. In addition, Board members met several times in 2022 to discuss strategic issues.

Agency

The Board is supported by an agency, the MEB Agency. The Agency is under the control of the Ministry of Health, Welfare and Sports and its activities are under the authority of the Board (with the exception of centralised procedures). The Agency is responsible for preparing and implementing decisions by the Board and handles around 20,000 cases each year. These cases vary from administrative changes to assessments of medicine dossiers with new active substances.

European representation

The Netherlands is represented in the scientific committees of the EMA. The Dutch committee members are staff of the Agency. More information about the various committees is provided below.

In the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC), member states join forces in the assessment of medicinal products for human use within the framework of the European centralised procedure. These committees comprise representatives from all EU countries. The committees meet every month at the EMA in Amsterdam.

When the Netherlands serves as a rapporteur, the dossier is assessed by a team of MEB staff. The composition of the team depends on the medicinal product and the topics to be addressed in the assessment. The outcome of the assessment is presented to the Board. The Board then consults with the European committee members and recommends a proposal, on the basis of which the Dutch CHMP or PRAC members will engage in discussions in their respective committees.

The EMA has criteria in place for assigning rapporteurships and co-rapporteurships, to ensure assignments are based on the best available expertise in the member states. There is also scope for the assignment of countries that have not often served as rapporteurs in the past.

The assignment of co-rapporteurships by the PRAC is different from the process followed by the CHMP: whichever country is assigned as CHMP Rapporteur automatically becomes the PRAC co-rapporteur.

Alongside the CHMP and PRAC, there are four other scientific committees that deal with medicinal products for human use in the centralised procedure at the EMA:

• The Committee for Orphan Medicinal Products (COMP);
• The Paediatric Committee (PDCO);
• The Herbal Medicinal Products Committee (HMPC); and
• The Committee on Advanced Therapies (CAT).

Various working groups are active in each scientific committee of the EMA. One example is the Scientific Advice Working Party (SAWP).

The coordination of the European work in connection with the decentralised and mutual recognition procedures has been delegated to the Coordination Group for Mutual Recognition and Decentralised Procedures human (CMDh). The CMDh is a scientific committee of the member states but, like the other committees, meets at the EMA head office and is also supported by the EMA.

The Committee on Herbal Medicinal Products (HMPC) of the European Medicines Agency (EMA) assesses the scientific data of herbal medicinal products and draws up European herbal monographs.

The Committee for Medicinal Products for Veterinary Use (CVMP) is the scientific committee for veterinary medicinal products of the European Medicines Agency (EMA). All EU member states are represented in this committee.

Coordination of the European work connected with the decentralised and the mutual recognition procedures is carried out by the Coordination Group for Mutual Recognition and Decentralised Procedures veterinary (CMDv). The CMDv is a scientific committee of the member states but, like the other committees, meets at the EMA head office. The committee is also supported by the EMA. The Dutch representatives on both the CVMP and the CMDv work in the VMPU.

The Advisory Board

The task of the Advisory Board is to provide the MEB with independent and critical advice on the major policy themes and other aspects of our tasks. The Advisory Board provides advice by focusing strategically on the environment in which the MEB operates.

One online meeting of the Advisory Board was held in 2022. Topics of discussion included the development of the MEB’s long-term strategy and the review of the EU’s medicinal product legislation.

Organisation

Transparency, independence and integrity

As an independent administrative body, the MEB aims to make decisions in a substantiated and transparent manner. It therefore provides an opportunity for an opinion to be submitted and for a hearing to be held before it makes a decision. It is also possible to lodge an objection to an MEB decision and to appeal to the courts.

Independence demands integrity. To ensure this, the MEB has a Code of Conduct and an Integrity Policy. Board members, MEB staff and external experts complete a ‘Conflict of Interest Declaration’ when commencing employment or entering into a contract, and annually from then on. New interests that arise in the interim must be reported.

Objection and appeal procedures

In 2022, there were 30 separate objection and appeal procedures. These procedures can broadly be divided into two main categories. The first category concerns procedures in which decisions to grant or refuse a marketing authorisation were contested. The second category comprises procedures about decisions to disclose information under the Government Information (Public Access) Act (WOB), which was replaced on 1 May 2022 by the Open Government Act (WOO). The competition interests of pharmaceutical companies play an important role in both types of procedures.

Requests under the Open Government Act (WOO) (previously the Government Information (Public Access) Act (WOB))

On 1 May 2022, the Government Information (Public Access) Act (WOB) was replaced with the Open Government Act (WOO). The MEB received a total of 53 information requests in 2022 under the Government Information (Public Access) Act or Open Government Act, according to which was in force at the time. In most cases, such requests were made by or on behalf of a competing pharmaceutical company. The vast majority of requests concerned pending applications for marketing authorisation from the MEB.

The MEB also received more extensive requests pertaining to documents such as assessment reports. In 2022, a number of extensive information requests were made for documents relating to COVID-19 vaccines. Documents held by the MEB often contain confidential information. This includes personal data or confidential commercial information. This confidential information has to be removed from the documents before they can be provided to the requesting party.

Following an amendment to the mandate regulations in December 2019, since 2020 the MEB Agency has handled WOB requests concerning veterinary medicinal products on behalf of the Minister of Agriculture, Nature and Food Quality.

Opinion procedure

If the MEB intends to make a negative decision, companies with an interest in the matter (such as the requesting party) must have had the opportunity to give their opinion. In 2022, 24 companies made use of this opportunity. Of these 24 opinions, a hearing was organised at the request of a company in 4 cases. In the other cases, the opinion was submitted in writing.

Quality management

The MEB has been ISO-9001 certified since 2006. This certification shows that the MEB meets this international quality management standard for the execution of its statutory tasks.

For the statutory tasks relating to pharmacovigilance, the European regulations require the MEB to have a quality system in place. Although strictly speaking external certification is not mandatory under the regulations, the MEB considers it important to operate in a transparent and, where possible, verifiable manner. This creates confidence, and external certification provides additional assurance. The 2022 audit certification shows that the MEB still meets the standard.

Complaints

A total of 12 complaints were received from external parties in 2022. Of these, 8 were found to be justified, 2 were unfounded, 1 was partially justified and 1 was inadmissible. The justified complaints mainly related to delays in the processing of pending procedures for marketing authorisations, and failing to respond in a timely manner to questions about the status of these procedures.

Once a complaint has been processed, the cause of the complaint is determined. During the annual complaints analysis, the cause is discussed with the head of the department to which the complaint pertained. The aim of this discussion is to identify trends and take suitable improvement measures to avoid repetition in the future.

Diversity and inclusion

The MEB has an ambition to be an inclusive employer and to be accessible for people with a disadvantage on the labour market. The associated statutory frameworks are laid down in the Participation Act and the Jobs Agreement and Quota for People with Occupational Disabilities Act. For 2022, the MEB had set a target of creating a total of 15.7 jobs for people with a disadvantage on the labour market. We partially achieved this target (8.3 jobs).

In 2023, the MEB is aiming to increase the intake of employees covered by the Jobs Agreement. We will achieve this aim by holding a ‘job carving’ workshop, and through more intensive collaboration with the Ministry of Health, Welfare and Sports in the area of recruitment.

Two MEB staff members are members of the Ministry of Health, Welfare and Sports’ Working Group for Diversity and Inclusion. The MEB also has an internal Diversity and Inclusion working group and an internal focus on diversity and inclusion. We raise awareness by organising activities and sharing watching and listening tips.

Facts and figures

At the end of December 2022, the MEB had 460 employees. Together, they accounted for an average of 423.5 FTEs. In 2022, two-thirds of MEB employees (67.2%) were women, compared to 32.8% men. The average MEB employee is 44.4 years old, works at a part-time factor of 92% and has been working for the MEB for 8.7 years.

The annual average rate of absences due to illness in 2022 was 4.6%, which is increasing.

Restructure

The organisational structure of the agency has been modified. The restructure was prompted by a desire for a greater focus on the core tasks that have come under pressure in recent years. This pressure resulted in part from the growth of the organisation, the complexity of procedures and an increase in work outside of the statutory tasks. It also resulted from pressure on the system for the regulation of medicinal products, technological developments and societal issues. The first step was to adjust the senior management structure. Instead of two directors managing all departments, from 1 May 2022 we are formally working with a divisional model. There are three divisions into which the departments are grouped:

• Assessment & Granting of Authorisations;
• Europe, Medicine Use & Veterinary;
• Operations, Legal Affairs & Communication.

The three division heads plus the Managing Director form the Management Team. This model provides greater clarity with regard to leadership, and the span of control from the top of the organisation is better distributed. The second step in the restructure was to spread the departments among the three divisions. We completed the restructuring on 1 February 2023, and we began to officially work under the new organisational structure.

Accommodation

In late 2022, the Deputy Secretary-General decided that the MEB Agency would not move to the Utrecht Science Park with the RIVM. The construction of the new building has experienced significant delays, and in the meantime the RIVM has grown so much that it will require the entirety of the new building. As a result, suitable alternative accommodation is being sought for the MEB Agency. At this point, it is unclear where the Agency will be accommodated and when it will move there.

Provision of information

In the area of ICT/provision of information, continuity of the current system for the assessment of medicinal products and preparations for a new system were the central concerns in 2022. We made significant progress on both counts. The number of disruptions to the current system has decreased considerably. Preparations for the procurement of a new system progressed so well in 2022 that the selection phase for potential suppliers was able to begin in late February 2023.

Finances

Preliminary notes

In 2022, the COVID-19 pandemic continued to have a major impact on the amount of work within the MEB Agency. The additional work consisted mainly of assessing new and adjusted products to fight the coronavirus, and providing information to the general public about the efficacy, safety and quality of these products. The MEB Agency received a contribution of €1.1 million from the Ministry of Health, Welfare and Sports in 2022 for extra activities relating to COVID-19.

The RIVM has decided to charge the MEB Agency for costs that were specifically incurred on behalf of the Agency in relation to the new building at the Utrecht Science Park. Because these costs originated in 2022, the Agency has included an item of €0.9 million under extraordinary expenses.

Result

The MEB Agency posted a positive result of €0.1 million in 2022. This was due to the income being €0.3 million lower and the expenses being €0.4 million lower than budgeted. These differences are explained in further detail below.

Income

The €0.3 million shortfall in income can mainly be explained by a €2 million reduction in contributions from the Ministry of Health, Welfare and Sport. The budget included a Ministry contribution of €3.4 million for public tasks. This contribution was ultimately only €1.4 million. The budgeted contribution from the Controlling Information Management (IoO) programme was also less than budgeted: €0.7 million instead of €2 million. This was offset by a contribution of €1.2 million that the MEB received as part of the Werk aan Uitvoering (WaU – Working on implementation) project. These activities were not included in the budget.

The revenue from procedures and annual fees was €1.3 million more than budgeted. This was mainly due to the influx of procedures submitted via the European Medicines Agency returning to its usual high level, and increasing by €2.1 million from the budgeted figure. The revenue from other procedures was lower than budgeted.

The revenue from other departments was €0.3 million higher, due to an increased contribution from the Ministry of Agriculture, Nature and Food Quality for the New Veterinary Regulation programme.

Expenses

Labour market shortages meant that the MEB Agency had difficulty attracting staff, including contractors, which in turn led to staffing costs being €1.1 million lower. The cost of external contractors was also lower (€0.7 million). To comply with the guidelines on the classification of staffing costs, some external contracting costs have been reclassified as internal staffing costs. The comparative figures – the budgeted figures for 2022 and the actual figures for 2021 – have been adjusted accordingly. These lower costs were offset by the €0.9 million exit fee for the Utrecht Science Park building. This fee was not budgeted.

Equipment costs were approximately the same as the budgeted costs. However, ICT costs were €0.4 million higher and other equipment costs €0.4 million lower than budgeted. The higher ICT costs were caused by a shift away from external contractors in relation to ICT hardware, because performance contracts were signed to replace the contracts based on staffing. The lower ‘other equipment costs’ were due to a number of small changes.

More financial details and clarification can be found in the annual financial statements.

Looking ahead to 2023

Labour market shortages will continue to affect the scale of the MEB Agency’s activities in 2023. By engaging two recruiters, the Agency hopes to be able to fill the outstanding vacancies with employees, thus reducing the use of contractors. However, the Agency will continue to use contractors for the implementation of programmes and projects.

In 2022, work began on replacing the ICT system used for the primary process. The tendering procedure for the new system will begin in 2023, and implementation will start in 2023. The cost of the new system is covered by the funds allocated under the WaU project.

The WaU funds will also be used to develop activities to strengthen ICT security at the Agency.

In 2023, further work will be done as part of the Controlling Information Management (IoO) programme to ensure the Agency complies with the Open Government Act (WOO). Additional funding has been made available for this programme through the Ministry of Health, Welfare and Sport.