This article is part of: MEB Annual Report 2019

Board, organisation and financial affairs

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Board

The Medicines Evaluation Board (MEB) is an independent administrative body. The Board decides on the market authorisation of medicinal products in the Netherlands and is responsible for the pharmacovigilance of all medicinal products that have been granted market authorisation in the Netherlands. The political responsibility for the Board lies with the Minister of Health, Welfare and Sport (VWS).

The Board is supported by the Medicines Evaluation Board agency (MEBa). The agency prepares the decisions of the Board and executes these. The agency also carries out the pharmacovigilance in the Netherlands. The agency is part of the Ministry of VWS.

More information can be found here.

The Advisory Board

The task of the Advisory Board is to advise the MEB and the agency independently and critically about the MEB's main policy themes and other aspects of the MEB's tasks. The Advisory Board advises by focusing strategically on the environment in which the MEB operates.

The Advisory Board convened twice in 2019. Topics that were discussed included the consequences of Brexit, regulatory science, the MEB's strategy, shortages of medicinal products and patient involvement in the assessment of medicinal products.

in 2019, the Advisory Board paid farewell to its first chair, Professor D.D. Breimer, and the Advisory Board member, Professor J.M. Van Ree. They will be succeeded in 2020 by Professor P.A.B.M. Smits (Radboud UMC) and Professor J.T. van Dissel (RIVM).

More information about the Advisory Board can be found here.

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Organisation

As an independent administrative body, the Medicines Evaluation Board (MEB) wishes to make decisions in a well-substantiated and transparent manner. That is why the MEB provides an opportunity, in relation to decisions, for an opinion to be submitted and for a hearing. It is also possible to object to a decision by the MEB and then to lodge a legal appeal.

Integrity

Independence demands integrity. To ensure this, the MEB has a code of conduct and an integrity policy. Board members, employees and external experts fill in a 'Conflict of Interest Declaration'. This takes place when employment starts 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 2019 the Policy, Regulatory and International Affairs Unit of the MEB frequently issued advice about reported interests, additional 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 interest can lead to limitations being set for a Board Member or employee, which means that he or she cannot be involved in certain activities or can only be involved to a limited extent.

Objection and appeal procedures

Various objection and appeal procedures took place in 2019 as well. These procedures could be divided roughly into two main categories: procedures in which renewal decisions or procedures in which the refusal of a market authorisation were contested and procedures about decisions to disclose information pursuant to the Government Information (Public Access) Act [Wet openbaarheid van bestuur] (Wob). Competition interests of pharmaceutical companies play an important role in both types of procedures.

Objection and appeal procedures

Objection and appeal procedures
Objection and appeal procedures
201625
201743
201834
201930
Source table as .csv (70 bytes)

Government Information (Public Access) Act requests

The MEB received 37 requests based on the Wob in 2019. In most cases, Wob requests are made by or on behalf of a pharmaceutical company. By far most of the requests concerned information about current marketing authorisation applications at the MEB. The MEB also received more extensive requests, in which documents were requested such as assessment reports. Documents that have been made available to the MEB often contain confidential information, for example 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.

Government Information (Public Access) Act requests

Government Information (Public Access) Act requests
Number of requests
201670
201756
201847
201937
Source table as .csv (57 bytes)

Opinion procedure

Before the MEB takes a decision on an application for a market authorisation, companies who have an interest in the matter (such as the requesting party) must be given the opportunity to give their opinion. Companies made use of this possibility 19 times in 2019. A hearing was organised 4 times at the request of a company; the opinion was submitted in writing in the other cases.

Opinion procedures

Opinion procedures
Hearings and written opinions
201617
201712
201823
201919
Source table as .csv (68 bytes)

Successful recruitment

The Human Resources Management and Training department worked on recruiting new employees for the Information Provision Unit (IV) in 2019. By making use of the services of a recruiter, who actively approached candidates, we succeeded in filling nearly all the vacancies with new colleagues. A good result in view of the tight employment market, certainly where positions such as (enterprise) architects and experts in the field of IT infrastructure are concerned. Good secondary employment benefits such as flexible working hours and the role of the MEB's work in society resulted in a number of enthusiastic new IV colleagues.

Participation of all target groups

The Dutch Central Government and thus also the MEB profile themselves as an attractive employer with a diverse range of positions. These positions must also be accessible for people with a disadvantage on the labour market. The statutory framework for this has been laid down in the Participation Act and the Jobs and Jobs Quota (Work Disabled Persons) Act.

The MEB has made an extra effort in the past year to help people who experience a threshold when accessing the job market, for example due to an occupational disability. This is line with the MEB's ambition to be an inclusive employer; all employees should feel actively involved and accepted. In 2019, it was the MEB's aim to realise in total 10.3 FTEs in jobs for people with a disadvantage on the labour market. This aim was ultimately not realised: 8.9 FTEs were realised in 2019.

Facts and figures

The MEB employed on average 378 employees in 2019, together they accounted on average for 341.6 FTEs. Nearly two-thirds of the MEB employees (65.5%) were women in 2019, compared to 34.5% men. The average MEB employee is 44.5 years old, works with a part-time factor of 89.8% and has been in MEB's employment for 8.9 years.

Absenteeism due to illness amounted to 1.0% for long-term absenteeism (ill for longer than 42 days) and 1.2% for short-term absenteeism.

New departments and employees

The Information Provision Unit (IV) was established on 1 January 2019, with the aim of providing high quality, accessible, secure and efficient information to MEB employees. The unit's focus is to clarify the demand for IT services and to ensure that this support is made available at the lowest possible costs. An important spear point for 2019 was the recruitment of internal staff instead of external staff.

Information security and privacy

Information Security and Privacy (IS&P) received the necessary attention within the MEB in the past year. The processing register - in which all processing of personal data of the MEB is registered - was completed and published in 2019. The privacy statement on the MEB's website was also completely revised. The MEB is now demonstrably in control with regard to the requirements of the General Data Protection Regulation (GDPR).

In addition, a number of assessments have been carried out to actively identify and handle security risks, including penetration tests and business impact assessments. More awareness was created internally by means of mystery guests and tests with phishing mails. In addition, various policy frameworks were finalised, for instance with regard to physical access, cryptography, account and access management.

Outsourcing ICT infrastructure

The MEB concluded in 2018 that a large part of the existing IT infrastructure was outdated and that the hardware needed to be replaced urgently. The choice was then made to outsource the ICT infrastructure. This project was further implemented in 2019 by formulating a sourcing strategy, launching a tender and completing the specifications. Besides the technical changes, the outsourcing of the complete ICT infrastructure also demands an organisational change from the IV unit itself and the development of a professional contractors role. In order to ensure that the department is well-prepared for this, its whole demand and supply process was elaborated in 2019.

European cooperation in the area of information provision

Within the European information provision network, the IV unit is working on flexible, innovative and supporting services for information exchange, harmonisation and collaboration. The largest project that was started in 2019 is EU-SRS, a European substance database. The EU-SRS database, a project with a three-year term that is financed by the Ministry of Health, Welfare and Sport and the European Commission, will contribute to patient safety in Europe. The MEB supervised a Proof of Concept process for EU-SRS in 2019, including a study into whether specific software which is already being used by the US Food and Drug Administration (FDA), can also be used in a European setting.

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 verifiable manner. This promotes confidence. External certification provides additional assurance. The audit certification of 2019 shows that the MEB still meets the standard.

Complaints

12 complaints were received in 2019. Of these 11 were well-founded and 1 was declared non-admissible. 6 of the well-founded complaints concerned exceeding the response period of three weeks for questions that were asked via the contact form ‘Ask your question’ on the website. For 3 well-founded complaints, the MEB had failed to respond to questions concerning the status of a case. Furthermore, 1 complaint concerned a question that was received through Twitter for which the response time was too long and another complaint concerned an incorrect payment demand of an annual fee. All the complaints have now been resolved.

The number of complaints that were declared well-founded in 2019 (11 complaints) decreased compared to 2018 when 16 complaints were declared well-founded. The decrease could possibly be attributed to the improvement measures that were taken in the past year to improve the MEB's service. After handling the complaint, the cause of each complaint is determined. In 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.

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Financial affairs

Following the financial deficit of € 4.0 million in 2018, the Dutch Central Government Audit Service (ADR) performed an audit of the (financial) management within the Medicines Evaluation Board agency (MEBa) and prepared a public report with seven important recommendations. A number of these recommendations were already followed up in the course of 2018.

We continued to work on this in 2019 and also followed up on the other recommendations. For instance, the reporting cycle was tightened in 2019, in which each department prepares a forecast every two months of the development of costs, and an integral accountability reporting per department is prepared every four months. These progress reports are discussed at the board level and decisions that are taken in these meetings are documented and monitored. Furthermore, we started developing revenue forecast models in 2019 and continued to develop a cost price calculation model to substantiate our tariff proposals. The MEBa will also be using this cost price calculation model for internal management purposes. In addition, we also worked on increasing the financial awareness of the whole organisation in 2019.

Result

The MEB Agency realised a positive result of € 3.4 million in 2019. This was due to € 1.5 million higher revenues and € 1.9 million lower costs than budgeted. The higher revenues concern a large number of non-recurring items, including the realisation of the residual value of the MEBa's inventory and additional financing that the MEBa received from the Ministry of VWS for various projects and for processing a higher number of notifications of medicine shortages.

On the other hand, the revenues from applications for new marketing authorisations were lower than budgeted. At the time the 2019 budget was prepared, the MEBa expected substantially higher revenues than in the previous years. However, it became clear well before the beginning of 2019 that our revenue forecast had to be adjusted downwards. In anticipation of this expected decrease in revenues, the MEBa took cost-saving measures and monitored expenses critically during the year.

In the last quarter of 2019, revenues turned out to be higher which resulted in a strong improvement of the result to be expected. This means that in spite of the measures taken based on the ADR report of 2018, the MEBa still has insufficient insight into the development of its revenues. The MEBa is currently still insufficiently flexible in up- or downscaling its activities if the result - as expected based on the agency requirements - does not ultimately amount to € 0. The negative result in 2018 and the downward adjustment of the revenue forecast for 2019 caused the MEBa to be too critical and too cautious with expenses across the board during the year 2019. As a result, the costs for the various units were lower than budgeted.

Two important measures were taken in 2019 to reduce the recent considerable negative and positive fluctuations in the result:

  • Further strengthening of the forecast models.
  • Preparing scenarios, so that activities can be upscaled or downscaled better and quicker during the year.

More financial details and a further clarification can be found in the annual accounts. annual accounts.