Those seeking examples of successful European cooperation and the resulting benefits for the inhabitants of the Netherlands in this day and age can look at the system of marketing authorisation and monitoring of medicines in Europe. Not working together would be unthinkable. Without working together in Europe we certainly would not have the level of availability and safety of medicines that virtually everyone in the Netherlands takes for granted. The Dutch EU presidency in the first half of 2016 drew attention to the fact that there is always work to be done if you want to ensure that something so important remains so self-evident. Stronger connections with our European partners was a primary focus for the Medicines Evaluation Board (MEB) in 2016. During the Dutch EU presidency, the MEB had the opportunity to host more than 18 meetings of European committees and working groups. In 2016, the MEB was once again among the key players in Europe in the field of medicines, with a growing number of procedures and rapporteurships. The MEB played a leading role in Europe in over 500 procedures for medicinal products.
There was a strong impetus in 2016 to look critically at ourselves together in Europe and to review the system with which we regulate the market for medicines. Are there things we can organise better or more efficiently? Not only in order to balance the burden for ourselves or for pharmaceutical companies, but ultimately also regarding accessibility for users of medicines, whether they be humans or animals. Building on the joint Network Strategy to 2020 of the national and European medicines agencies (HMA and EMA) published at the end of 2015, the HMA adopted a Multi-Annual Work Plan, which focuses on the efficiency of the European medicines system. The MEB is one of the coordinators of this subject which will be of vital importance in the coming years.
New medicines are authorised each year, and the number of medicines is growing each year. For pharmaceutical authorities such as the MEB, this means that evaluation work is piling up. Because in addition to the authorisation of new products, monitoring the efficacy, risks and quality of the current medicinal products is a very important and extensive part of our work. From this perspective too, continuous attention for how we organise our work is essential.
Within the MEB, this starting point led to a lot of attention for training of employees in 2016, in terms of both substance and communication.
Connection between science and practice
Connection in and with Europe with regard to science was also a focal point. The MEB presented the Regulatory Science Programme for 2016 and beyond during the MEB Science Day in February. In addition, science in Europe featured prominently during the annual MEB Day.
In order to continue to effectively carry out its role as a pharmaceutical authority in Europe and at the national level, in the interest of Dutch patients, the MEB invested in its contacts and connections with science and with practice in 2016. Work on improving the relationships with the environment: the scientific community, healthcare practitioners, chain partners, patients/consumers and other stakeholders continued unabated as well.
The connecting term for much of what we describe here is adaptive regulation. While the rules provide direction in order to continue to provide patients with good medicinal products, the MEB always takes clinical practice into account. The MEB pays close attention to the patient groups that need particular medicines and careful considerations are made accordingly.* There is a lot of attention for this way of thinking, involving reasoning ‘from the outside in’, in the day-to-day activities of MEB employees.
* This was the theme of the in-depth interview with Bert Leufkens in the NRC Handelsblad (spring 2016).
Availability of medicines
In 2016, the MEB was closely involved in the issues concerning the availability of medicines to Dutch patients, such as the problems with the shortage of the thyroid medicinal product Thyrax. It was decided in 2016 to set up the Medicine shortages and defects notification centre. This notification centre is coordinated by the MEB and the Health Care Inspectorate (IGZ). The notification centre was commissioned by the Ministry of Health, Welfare and Sport (VWS). The establishment of the notification centre brings an end to the uncertainty faced by pharmaceutical companies concerning which shortages should be reported to which authorities. From 2017, all obligatory notifications will proceed via this notification centre. This will enable the Dutch government to have a better understanding of the market and supply situation for medicines, which should contribute to solutions being found swiftly when problems occur.
MEB and veterinary medicines
Throughout 2016, there was a lot of attention for the preparation of a new system of rules for veterinary medicines. The Veterinary Medicinal Products Unit has provided intensive support to the negotiations in the Council working groups in Brussels about new regulations for veterinary medicines. In addition, the intended transfer of decision-making powers for the marketing authorisation of veterinary medicines from the Ministry of Economic Affairs to the MEB was placed back on the agenda in 2016.
This preface concludes with the launch of Young MEB, an important development in 2016, with the aim of engaging young and outstanding talent in our work. Young MEB advises the MEB on request or otherwise. Young MEB consists of 14 young scientists with a broad scientific and clinical network. Is there any better reason to look to the future with confidence?
Bert Leufkens, Chairman
Hugo Hurts, Secretary/Director