Staff at the Medicines Evaluation Board have always worked hard. But in 2016 it really was ‘all hands on deck’, explains MEB Executive Director Hugo Hurts. Internationally, the MEB made its voice heard in a positive and powerful manner, not only during and after the Netherlands’ EU presidency, but also with regard to Brexit.
The MEB hosted or organised 18 European meetings during the first half of 2016. "That was really hard work, while the regular work carried on as well. In 2015, there was a surge in the number of procedures we processed, and this growth continued in 2016. Our role during the EU presidency cost a considerable amount of extra effort, but gave us a lot of positive energy in return," explains Hurts. "And we were able to provide substantive direction to the activities, which is something not all EU presidencies do."
In addition, the MEB sought a different approach and cooperation. Members of several scientific committees consulted with one another on the initiative of the MEB. Hurts: "Areas of common ground were emphasised. For example, there were meetings with the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Orphan Medicinal Products (COMP). And the Committee for Medicinal Products for Veterinary Use (CVMP) and the Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv). These provided real eye openers." And during the human stakeholder meeting, there was a change from the usual procedure of each umbrella organisation of companies presenting its own story. For the first time there was a joint response from the pharmaceutical industry with regard to Regulatory Efficiency. "They coordinated this together at our request. It was one of the best stakeholder meetings in recent years."
Unique European Work Plan
Hurts is proud of the fact that the Heads of Medicines Agencies (HMA) established a Multi-Annual Work Plan (MAWP) 2016-2020 during the Netherlands’ EU presidency. This plan comprises 11 strategic priorities with regard to medicinal products for humans, for animals and the link between them. "It is the first time that pharmaceutical agencies in Europe have formulated something like that. The entire European network has developed its – often abstract – strategic objectives into concrete priorities. And those have been developed into a number of activities. Our EU presidency enabled us to set a timeframe within which decisions were made. But a plan alone is not enough. From now on, progress of the implementation of the plans will be considered at all HMA meetings. This is exciting for the Netherlands because, as a lead Member State, we took on by far the greatest and most significant of all of those priorities, namely optimisation of the regulatory operations of the network." This includes 21 of the 63 concrete actions from the whole MAWP.
Connection between necessity and possibilities
With the MAWP the European pharmaceutical authorities are critically assessing their procedures, explains Hurts. "Do we have to do everything in the way we were accustomed to? Or is there a simpler way of achieving a better result? There is a lot involved in this. For the first time, we are making connections between what is necessary based on our business, the IT facilities needed for this and what is possible from a regulatory perspective. Our field of work is full of rules and regulations. And now you force everyone to take a look: can it be done differently, better, more efficiently? We have to ask the questions that are most important for patients and the availability of medicinal products. But we never lose sight of our primary task: the critical assessment of efficacy, quality and safety of medicinal products."
Consequences of Brexit
Brexit made 2016 a decisive year for the European medicines authorities. “You see that only 5 to 7 countries play a major role in Europe. The Netherlands is one of those countries. Those countries do 70-80% of all the work, and that percentage is not going to decrease. How can we absorb the work that the UK does now and might no longer do after Brexit? That will have to be done by the countries that do it now, but doing so will increase the imbalance between the European medicines authorities, which is not desirable. For the countries that currently do less, we will have to develop programmes, and train and educate them. This was necessary even before Brexit, but due to Brexit we need to accelerate and hone the process.
The Dutch offer to house the EMA states that we are committed to ensuring the continuity of the whole network. We will do this by being ready, and taking on additional work if necessary. We will also play a role in expanding the capacity in countries that are not yet able to do so. It would be downright dangerous if continuity with regard to the authorisation and monitoring of medicinal products were threatened. This also applies to the EMA itself. The Netherlands is situated close to London and has a lot to offer in terms of ensuring the continuity of the EMA. Not everyone can offer the same."
Linchpin for innovative medicinal products
In addition to the MEB’s many international activities in 2016, the organisation was also actively involved in various developments in the Netherlands. For example, the MEB is participating in initiatives related to accelerating the availability of innovative medicinal products and preventing and resolving medicinal product shortages. This is done in cooperation with partners from the Dutch medicinal products chain. Hurts: "It is also important for us to talk to one another at the earliest possible stage. The MEB is the linchpin in this respect. But we have to take care not to go beyond our authority; we are not concerned with the reimbursement of medicinal products, for example. However, in order to benefit optimally from the work we do, we must not rely only on our own responsibility, but also interact with others. We have to talk to one another as early on as possible and ask the right questions. 2016 has been an important year in that respect."