Organisation and governance

Regulatory and policy environment

European aspects again played a role in legal procedures related to the authorisation of medicines in 2016. For example, in the case of the parallel import marketing authorisation for the medicinal product D-Cure. The administrative court concluded that the MEB properly implemented the law and the policy document concerning parallel import. The MEB rightly took the position that D-Cure is equivalent, or virtually equivalent, to the reference medicinal product D-Cura.

The MEB was also involved in a procedure on the patented indication of generic pregabalin products in 2016. The MEB aims to inform medicine users as completely as possible and therefore publishes all approved indications of a medicinal product on its website, even if an indication is still subject to a patent. There are differing opinions on this approach. The patent holder (a pharmaceutical company) that did not agree with this initiated proceedings. The provisional relief court agreed in part with the pharmaceutical company. In view of its interest in informing patients as completely as possible, the MEB lodged an appeal.

In 2016, 17 hearings were organised as part of the application procedure (for example, for a proposed refusal of a marketing authorisation application).

Freedom of Information Act (Wob) requests

In 2016, the MEB received 70 requests on the basis of the Wob, substantially more than in previous years. Most of the requests concerned data about current marketing authorisation applications to the MEB. The MEB also received more extensive requests. Ten requests involved the retrieval of data from the authorisation dossier of a medicinal product, such as an assessment report, risk management plan or clinical overview. In most cases, Wob requests are made by a competing pharmaceutical company.

In response to the public unrest concerning the impending shortage of Thyrax, the media requested information relating to the communication and monitoring of this medicinal product. Furthermore, a citizen requested information on the number of FTE, the organisation chart and the wage costs of the organisation.
 

Integrity

Independence demands integrity. To ensure this, the MEB has a code of conduct and integrity policy. Employees, external experts and MEB members complete a ‘Conflict of Interest Declaration’. This is done when commencing employment or when entering into a contract, and annually after that. In the meantime, new interests must be reported. On the basis of the code of conduct and the integrity policy, a total of 112 fundamental assessments were conducted in 2016. As a result of an assessment, restrictions may be imposed on an employee concerning the cases he or she may be involved in. In 2016, restrictions were imposed on 30 employees and 7 MEB members.
 

European expert meeting ‘Innovation for the patient’

As part of the EU presidency, the MEB, the Ministry of Health, Welfare and Sport and the National Health Care Institute organised the meeting ‘Innovation for the Patient’ on 1 and 2 March 2016, with experts on marketing authorisation, reimbursement and pricing policy. During this meeting, the participants examined the possibilities and preconditions for flexible marketing authorisation with early agreements on the pricing of innovative medicines. It was stressed that new agreements should be made at a future European meeting to ensure that patients gain access to innovative medicinal products, such as medicines that would not be eligible for authorisation or reimbursement in the current system.
 

Organisation, quality and finances

Advisory Board

The Advisory Board advises the MEB independently and critically about the major policy themes and other aspects of the MEB’s tasks.

The Advisory Board met with representatives of the MEB three times in 2016. The meetings focused on attracting new MEB members and the EU presidency. The other topics discussed were:

• Brexit; the future of the EMA, the Netherlands as a place of business and the role of the MEB.
• Faster access to innovative medicinal products.
• Information function of the MEB.
• Clarity in variety; innovative treatment methods versus existing authorisations.
• The Board’s contribution to the MEB annual plan for 2017.

The approved minutes of the meetings of the Board have been published on the MEB website.

In 2016, the Board and the MEB considered the functioning of the Advisory Board. The usefulness and necessity of the Board are recognised.
The Board and the MEB conclude that the Board’s recommendations could be formulated more succinctly and more precisely. The recommendations should be usable and be implemented more easily in the organisation. The varied composition of the Board is regarded as positive.

The Board issued its first written recommendation in 2016, concerning the information function of the MEB. The Board advises the MEB to provide the most extensive information possible, within formal frameworks, on medicines, the proper use thereof and the risks involved in using these medicines. The MEB welcomed this recommendation. This recommendation fits within the developments of the MEB in accordance with the Strategic Business Plan.

The Advisory Board consists of 6 members. The members originate from different social sectors and have specific expertise in the MEB’s areas of expertise. The position, tasks and working procedure of the Advisory Board are documented in the ‘MEB Advisory Board administrative regulations 2013’. These regulations can be found on the MEB website.
 

Members of the Advisory Board

Prof. D.D. Breimer (Chairman)
Prof. J.M. van Ree
Dr. G.W.M. van Odijk
Prof. dr. H.A. Büller
Prof. dr. J.E.W. Broerse
Dr. J.A.M. Hulshof

Finances

The MEB Agency posted a positive result of approx. €5.9 million in 2016. Revenue was once again high. Revenue from both centralised and decentralised procedures was higher than expected. Accordingly, part of the positive annual result for the 2015 financial year was passed on to 2016. This was used partly to fund IT work and activities related to the EU presidency.

Necessary adjustments in IT were started in 2016. The focus is on increasing the level of automation and efficiency in addition to connecting to international systems. This will take several years to implement and will also require substantial investments in the coming years.

In the context of the Dutch EU presidency, the MEB Agency organised and financed meetings on the subject of medicines and pharmacovigilance.

The MEB Agency has a strong and solid financial position, and excellent liquidity. Equity satisfies the maximum criteria for agencies, and can be used to absorb any disappointing results in the future.

More financial details and clarification can be found in the 2016 annual accounts.
 

Human Resource Management and Organisation

The new MEB organisation was formally launched on 1 February 2016. The changes to the organisation are described in detail in the Organisation and Staffing Report ‘Towards a communicative organisation’. The greatest change concerns the formation of a Quality unit and a Pharmacology, Toxicology and Kinetics (FTK) unit. In addition, the Communications unit was expanded and several of the unit's profiles were re-evaluated. The HRM&O unit was further professionalised in 2016. The service level was maintained and the department has taken on a recognisable position within the MEB. HRM is a reliable discussion partner for the managers. More and more employees are turning to HRM for information.

In 2015, the MEB concluded an agreement with the Netherlands Health Care Inspectorate (IGZ) to hire and share knowledge and expertise.
The collaboration was evaluated and terminated in 2016. As a result, the MEB has had its own HRM&O unit head since September 2016.

Vitality, working conditions and workload management received explicit attention in 2016. In order to make the workload manageable, employees are trained in efficient working and meeting practices. Thanks in part to feedback from the MEB, many employees participated in training programmes by the Denkacademie in 2016, where they learned to write assessment reports and supplementary memoranda more efficiently.
 

Quality Control Committee

The Quality Control Committee assesses whether the MEB has responded adequately to identified errors and issues on the basis of notifications and reports. If prompted by the signals reported, the Quality Control Committee formulates suggestions for improvement and monitors the follow-up. The Quality Control Committee is independent and reports to the Executive of the MEB and to the Board.

The Committee met twice in the past year. The Quality Control Committee considered the following:

• An objection to registered parallel import products
• Evaluation of the process revealed that it concerned an isolated incident and that the parallel procedure was properly described
• The settlement of the shortage of thyroid medication Thyrax

This led to actions implemented by the Medicinal Product Shortages Working Group of which the MEB is a member.

The Quality Control Committee concluded that reports were handled adequately, that opportunities for improvement were identified and that action will be taken.

The Quality Control Committee was established by the Board in 2013. The Quality Control Committee will evaluate its activities in 2017.
 

Quality

The MEB has had ISO certification for many years. ISO 9001 is the internationally accepted standard for quality management systems. It presents the criteria for a quality management system that can be used by an organisation to improve customer satisfaction by meeting the customer’s requirements and conforming to the relevant legislation. The European authorisation agencies make use of each other’s findings within the EMA via mutual examination of joint quality audits.
 

Complaints Committee

22 complaints were received in 2016, of which 19 were legitimate, 2 were partly legitimate and 1 was unfounded. The number of complaints remained virtually unchanged from 2015.

• Appendix G: Organisation and finances 2016