Regulatory and policy environment
The Policy, Regulatory and International Affairs (BRI) ) is charged with the administrative organisation, decision-making processes, strategic developments, legal procedures and representation of the MEB on the national and international levels.
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.
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.