Board, organisation and financial affairs

Board

Organisational structure

Board

The Board has a maximum of 17 members, including the chair. There was one vacant position in 2021 and there were no changes in composition. The members are all medical specialists, hospital pharmacists, professors or experts in other fields. Members of the Board are appointed by the Minister of Health, Welfare and Sports for a period of 4 years. The term of office can be extended twice through reappointment. Ton de Boer was reappointed Chairman of the Board in 2021. This marks the start of his second four-year term as MEB Chairman.

A meeting attended by all Board members takes place in principal once a month, while another monthly meeting is attended by a smaller group of members. The chair and vice-chairs also meet every week to discuss specific questions about medicine dossiers. The members of the Medicines Evaluation Board met for an additional morning session at the end of 2021 to discuss strategic issues.

Agency

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

Administrative consultation

The Director of the agency is also the Secretary of the Board. During administrative consultations, the Chairman of the Board and the Director of the agency discuss all matters that affect both the Board and the agency, together with their deputies where applicable.

European representation

The Dutch members of the EMA’s scientific committees are members in a personal capacity and are not bound by any mandate or instructions. The Board gives the EU committee members advice on European assessment procedures.

The Advisory Board

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

Two online meetings of the Advisory Board were held in 2021. Topics of discussion included the MEB's role within the COVID-19 pandemic and the MEB’s long-term strategy.

Organisation

Transparency, independence and integrity

Independence demands integrity. To ensure this the MEB has a Code of Conduct and an integrity policy. Board members, MEB employees and external experts fill in a ‘Conflict of Interest Declaration’. This takes place when employment commences or when entering into a contract, and then annually. New interests must be reported in the interim.

Based on the Code of Conduct and the integrity policy, in 2021, the MEB Agency’s Policy, Regulatory and International Affairs Unit (PRI) frequently issued advice about reported interests, ancillary activities and participation in events, seminars and collaborations. Some interests and activities are deemed to be incompatible with activities carried out for the MEB; other interests can lead to limitations being set for a Board Member or employee. These limitations mean that he or she may not be involved in certain activities, or can only be involved to a limited extent.

Objection and appeal procedures

In 2021, there were 32 different objection and appeal procedures. These procedures could be divided roughly into two main categories. Procedures in which decisions to grant or refuse a marketing authorisation were contested, and procedures about decisions to disclose information under the Public Access to Government Information Act (Wet openbaarheid bestuur, WOB). Competition interests of pharmaceutical companies play an important role in both types of procedures.

Freedom of Information Act requests

The MEB received 52 requests under the Public Access to Government Information Act in 2021. In most cases, WOB requests are made by or on behalf of a competing pharmaceutical company. The vast majority of requests concerned ongoing applications for marketing authorisation at the MEB. The MEB also received more extensive requests, in which documents such as assessment reports were requested.

A new development in 2021 was a number of extensive WOB requests for documents relating to the COVID-19 vaccines. Documents that have been made available to 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 these can be provided to the party who requested this information.

As a result of a change in the mandate in December 2019, the MEB agency has also handled WOB requests about veterinary medicinal products since 2020. We do this on behalf of the Minister of Agriculture, Nature and Food Quality.

Opinion procedure

Before the MEB takes a decision on an application for a marketing authorisation, companies that have an interest in the matter (such as the requesting party) must have had the opportunity to give their opinion. In 2021, 15 companies made use of this opportunity. Of these 15 opinions, a hearing was organised at the request of a company in 8 cases. In the other cases, the opinion was submitted in writing. Due to the coronavirus pandemic, all hearings were conducted online via a video link rather than physically at the MEB office.

Quality management

The MEB has been ISO-9001 certified since 2006. With this certificate, the MEB demonstrates that it meets this international quality management standard for the execution of its statutory tasks.

For the statutory tasks with regard to pharmacovigilance, the MEB is obliged to have a quality system in place by virtue of European regulations. Although the regulation does not actually specify that external certification is obligatory, the MEB considers it important to operate in a transparent and, where possible, verifiable manner. This promotes confidence. External certification provides additional assurance. The audit certification of 2021 shows that the MEB still meets the standard.

Complaints

A total of 20 complaints were received from external parties in 2021. Of these, 9 were well-founded, 4 were unfounded, 1 was partially founded and 6 were non-admissible. The well-founded complaints mainly concerned exceeding the statutory time limit for marketing authorisation assessments, the handling of WOB requests and exceeding the time limit for responding to questions submitted via the contact form.

After handling the complaint, the cause of each 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 wants to be an inclusive employer: all employees should feel actively involved and accepted. This ambition is reflected in a diverse range of positions and accessibility for people with a disadvantage on the labour market. The statutory framework for this has been laid down in the Participation Act (Participatiewet) and the Jobs Quota (Work Disabled Persons) Act (Wet banenafspraak en quotum arbeidsbeperkten). In 2021, it was the MEB's aim to realise in total 14.3 FTEs in jobs for people with a disadvantage on the labour market. This number was successfully achieved. In order to further lower the threshold for people with a disadvantage on the labour market, the MEB aims to realise 15.5 FTEs in 2022.

The MEB joined the Ministry of Health, Welfare and Sports’ Working Group for Diversity and Inclusion in 2020. The MEB is placing a greater internal focus on diversity and inclusion and raising awareness by organising activities and sharing watching and listening tips.

Facts and figures

The MEB had an average of 421 employees in 2021, together accounting for an average of 387 FTEs. Nearly two-thirds of the MEB employees (65.4%) in 2021 were female, compared to 34.6% male. The average MEB employee is 44.4 years old, works with a part-time factor of 90.6% and has been in MEB's employment for 8.5 years.

On 31 December 2021, the MEB had 428 employees (395 FTEs).

Sickness absence in 2021 was 4.1%. This was an increase compared to the previous year.

Organisational development

For the MEB Agency, the focus is on optimal performance of its statutory tasks; the assessment of medicinal products and vaccines to determine whether they can be marketed, monitoring adverse reactions and risks, and encouraging proper use of medicines. In addition, the MEB Agency adds value to the national and international chain of organisations involved in the authorisation of medicinal products. This can be done by offering patients reliable, clear and easy-to-read information to encourage correct use of medicines, or by improving the notification centre for shortages for all stakeholders. We also participate in international initiatives to facilitate our work, for example by developing a medicine information database, for medicinal products for human use as well as veterinary medicinal products.

The performance of key tasks has come under pressure in recent years. On the one hand, this pressure is caused by growth of the organisation, complexity of procedures and an increase in activities besides the legal tasks, and on the other hand by pressure on the system of regulating medicines, technological developments and questions from society. Without letting go of our connection to the organisations around us, we had to focus on improving our own organisation in order to be well-equipped to perform our tasks now and in the future.

For the future design of the MEB Agency, the Board opted for a model with three divisions into which the units are grouped. The three division managers and one managing director together form the senior management team. Drafting of the Organisation and Staffing Report for the senior management structure started at the end of 2021. This will be completed in 2022. The further structuring of the remaining organisation will follow.

Employee representation

The composition of the Works Council changed in 2021 as two Council members were no longer able to combine their Council membership with their normal activities. Following an interim election, the Council continued with the maximum number of nine members.

The retirement of the Director meant that a new Director was appointed. The Council issued a recommendation on this appointment as described in Article 30 of the Works Councils Act (Wet op de ondernemingsraden, WOR). The Council also agreed to look for a new business operations manager. This decision was reached in anticipation of the reorganisation in order to address vulnerabilities in the senior management structure.

The COVID-19 pandemic once again generated more work for the MEB in 2021. This included adapted working methods due to accelerated procedures. Staff were also directly and indirectly impacted by COVID-19. The result was a considerable increase in sickness absence. The combination of more work and more absenteeism led to a consistently high workload within the organisation. A number of actions were implemented in 2021 aimed at reducing the workload, however the effect of such measures can only be felt over time.

Workload and absenteeism were important topics for the Works Council. We also drew attention to staff well-being and the impact of COVID-19 measures on job satisfaction. Other topics on the Council’s agenda in 2021 were the organisational development process (including the reorganisation of the senior management structure), the perception of social safety within the organisation and the upcoming relocation.

Information provision

The central theme of this annual report, ‘Looking forward’, also applies to the MEB’s Information Provision Unit (IPU). In a number of areas, the foundations have been laid behind the scenes for plans that will bear fruit in the years to come.

Alongside normal activities, the COVID-19 pandemic also had an impact on the work. The digital workplace has been adapted to better suit the large amount of time spent working from home, colleagues were given access to new information provision resources, and faults were eliminated from the system as much as possible.

Outsourcing ICT infrastructure

The start of 2021 saw the completion of the extensive migration of the MEB’s ICT infrastructure to a government data centre and the transition to the new ICT services provider Solvinity. The rest of 2021 was all about fine-tuning this service provision. This is the first step in a long-term plan to level up the MEB’s information provision service and to allow the unit to grow into a demand-supply organisation. Preparations for the replacement of the organisation's case management system also started in 2021.

Information security and privacy

Information security is becoming increasingly important. This was demonstrated at global level by multiple successful hacks of companies and institutions. One of the reasons behind the hacks was the Log4j vulnerability. The MEB is affiliated with the central government National Cyber Security Centre (NCSC). Reported threats have increased in both severity and number.

The threat is therefore growing, however protective measures have proven their worth in 2021. The MEB has worked to structurally improve digital resilience. The previously mentioned transition to Solvinity has also contributed positively to this.

New Veterinary Medicinal Products Regulation

The introduction of the new Veterinary Medicinal Products Regulation also generated a lot of work within the Information Provision Unit in terms of European data exchange. One of its tasks was to establish connections between various new databases for the veterinary medicinal products authorised in Europe, such as the European Union Product Database (UPD). Member states must ensure that all information about veterinary medicinal products is available in this database.

All in all, the MEB’s Information Provision Unit therefore made progress in a wide range of areas in 2021. This included improving and levelling up digital services and resilience.

Financial affairs

Financial control

The volume of work was not only higher, but there was also considerable pressure to accelerate the assessment process. This had a major impact on how the vaccine assessments took place and therefore also on the workload of MEB Agency staff. Additional staff were recruited during the course of 2021 to reduce the workload. Changes to the MEB Agency’s senior management structure also pressed ahead in 2021, and the first steps were taken towards replacing the primary process system. Carrying out all necessary activities required additional expenditure by the MEB Agency and, as a result, it started out with a €2 million budget deficit. Against the backdrop of these developments, financial management was a challenge in 2021.

In both spring and autumn the MEB received additional funding from the Ministry of Health, Welfare and Sports for extra activities in relation to COVID-19, totalling €1.4 million. It became clear during 2021 that the additional efforts dedicated to COVID-19 were having a negative impact on the replacement of the primary process system. One of the reasons for this was difficulty in recruiting the necessary personnel. Other programmes and projects were also able to carry out fewer activities than budgeted. This meant that, after the summer, the budget deficit turned into an anticipated surplus. Better-than-expected revenue from centralised procedures increased this surplus to €1.2 million.

Performance

The MEB Agency posted a positive result of €1.2 million in 2021. This was due to €3.4 million higher profit and €2.2 million higher costs than budgeted. These differences are explained in further detail below.

The €3.4 million higher profit is attributable mainly to higher third-party revenue of €2.4 million. The main reason for this is another sharp increase in the inflow of centralised procedures: an increase of €1.4 million compared to 2020 and €2.6 million more than budgeted.

In addition, the turnover of the parent department was substantially higher than budgeted in 2021. This was due, among other things, to additional contributions towards COVID-19 related costs (€1.4 million) and towards adjustments to the Medicine Shortages and Defects Notification Centre (€0.2 million). The sums included in the budget for contributions to the Better Use Programme were lower than expected due in part to re-prioritisation in the deployment of people and resources.

Lower non-staff costs and higher staff costs led to the higher equipment costs of €2.4 million. Staff costs were €3.6 million higher than budgeted. This is almost entirely due to the increase in the costs of the MEB’s own staff.

The increase in demand for labour, a trend that started in 2020, the persistently high workload and the restructuring of the senior management structure have led to growth in the organisation. The expansion of the workforce is clearly visible in 2021 in financial terms. On the other hand, the higher workload meant that the budgeted costs for training and development were lower than expected (€0.4 million). The additional costs arising from the CLA (including the homeworking allowance) were offset by the lower commuting costs. The costs of hiring third parties slightly exceeded the budget. Part of the increase in capacity was temporarily dealt with by employing external staff.

The other non-staff costs were €2.4 million lower than budgeted, where the common thread is that the focus on COVID-19-related activities resulted in fewer project and research activities than budgeted. The increase in the number of employees since mid-2020 and the proven vulnerability of systems and the connections between them have led to higher automation costs than budgeted (€1.2 million), with a limited increase compared to 2020 (€0.1 million).

More financial details and a further clarification can be found in the financial statements (in Dutch).

A look ahead to 2022

A great deal of additional work due to COVID-19 is anticipated once again in 2022. The MEB Agency received an additional contribution from the Ministry of Health, Welfare and Sports to cover the costs of extra activities in 2021. This additional contribution will continue in 2022. The shift in the number of national applications to applications via the EMA will also continue in 2022. This will place additional pressure on the operation of the MEB.

The effect of not starting to replace the primary process system in 2021 is that these costs will be deferred to subsequent years. Additional costs must be incurred to keep the current system running.

The MEB will therefore start 2022 with an unbalanced budget. The expectation is that 2022 will end on a deficit and the MEB Agency will need to use a large proportion of its general reserve to cover the deficit.

Financial affairs

Financial control

Against the backdrop of these developments, financial management was a challenge in 2020. Until halfway through the year, the MEB appeared to be on course for a financial surplus. In the second half of the year, additional staff were recruited to handle the high volume of work related to COVID-19 and to help reduce the existing workload. This is reflected in the increase in personnel costs and the number of FTEs. The work related to COVID-19 did not have any effect on revenue in 2020. This effect is not expected until 2021.

Result

The MEB ultimately closed 2020 with a loss of €0.7 million. This was due to €3.5 million higher profit and €4.2 million higher expenses than budgeted. The higher profit relates to increases in revenue of €2.3 million for procedures through the EMA, €0.4 million for National applications and €0.6 million for annual fees. Revenue from DCPs was €1.1 million lower than budgeted. Subsidy income was also €0.4 million higher due to the implementation of a number of additional projects.

The higher expenditure is attributable mainly to higher costs of the MEB’s own staff (€2.8 million) to relieve the high workload, more staff for activities related to COVID-19 activities, and to higher costs of external hiring (€1 million), such as for the Techniek Buiten de Deur project (‘Technology Outside the Office’). The higher costs for the MEB's own staff include a €0.9 million addition to the provision for leave hours. The decrease in other personnel costs (€0.3 million) was caused by less commuting due to the coronavirus measures. In addition, the ICT overhead costs were €1.8 million higher than budgeted due to the relocation of the ICT hardware, including the technical application management (Techniek Buiten de Deur project). Because there was little investment in 2020, depreciation charges were €0.4 million lower than budgeted. The item of €0.2 million for allocations to provisions concerns an increase in the provision for doubtful debts. Due to the increase in outstanding payments, the balance of accounts receivable has increased and a larger provision must be maintained.

More financial details and a further clarification can be found in the financial statements (in Dutch).