Ensuring EMA a seamless transition
The Dutch government is prepared to engage in a long-term commitment regarding cooperation with the EMA, beginning with the seamless relocation for the Agency and its staff. We will provide support on both sides of the Channel immediately after the decision regarding relocation has been made. An intensive expat service will be available throughout the process, providing support with finding housing, registration at international schools, selecting health insurance, supporting job-seeking opportunities for partners and assisting with the administrative procedures that go along with moving to another country.
Relocation plan for EMA
The Dutch government and the City of Amsterdam are committed to ensuring business continuity to EMA by presenting a comprehensive relocation programme for EMA headquarters, as well as for the Agency’s employees and their families. This will be achieved via two defined trajectories. The first, is aimed at fully supporting the preparation, relocation and after-care of the relocation of EMA’s headquarters from London to Amsterdam. The second, concerns the complete support and unburdening of the relocation of EMA staff and their families. A dedicated team of experts, covering all aspects of the potential relocation, has already been assembled. This EMA Transition Team (ETT) will be coordinated by the Ministry of Health and will act as the focal point for EMA regarding all aspects of the transition process. The aim of the Netherlands is to provide 360-degree support and to unburden the Agency and its staff.
In order to be able to take immediate action once the decision regarding the new host country has been made, the Netherlands is already taking the necessary preparatory steps. The CGREA is working together with the Amsterdam Metropolitan Area to expedite all the legal, planning and other arrangements regarding the building proposed in this bid.
As part of the overall approach to ensuring business continuity, the Dutch government wishes to support the Agency in retaining essential staff by providing support throughout the entire relocation process and by unburdening families through a tailored relocation process. This will be done by establishing a temporary service desk at the EMA premises in London to answer initial questions and provide information. Furthermore, monthly information sessions will be held for EMA employees and families in London. Throughout the entire relocation process, EMA employees will receive personal assistance to ensure a soft landing. This includes assistance with finding accommodation and schooling, municipality registration, permits, applications for government incentives and taxation.
The EMA Transition Team will also conduct an inventory of educational needs and preferences among the EMA families including the type of school that is preferred, current curriculum followed, preferred school locations, education levels, school fees and potential special needs. Throughout the transition phase, information sessions and study visits will be arranged for parents who wish to acquaint themselves with specific schools.
Seat Agreement, privileges and immunities
The Netherlands offers EMA a Seat Agreement that includes the full privileges and immunities as stipulated by Protocol No.7 to the Treaty on the Functioning of the European Union, as well as additional privileges and immunities comparable to those enjoyed by the European organisations that are currently located in the Netherlands.
The aim of the Netherlands is to fully support and unburden the EMA and its staff in this process.
The Netherlands Medicines Evaluation Board
EMA will benefit significantly from being located in a country with a robust and stable national regulatory environment. The Netherlands is home to one of the strongest national regulatory agencies in the European Union in the field of medicinal products. The Netherlands Medicines Evaluation Board (MEB) operates both quantitatively as well as qualitatively at the forefront of European medicines regulation.
In absolute numbers, the UK and the Netherlands are currently responsible for more decentralised procedures than any other individual member state. The MEB is one of the top European regulators for central and pharmacovigilance procedures. The Netherlands maintains its position at the forefront of innovation by concentrating on a growing number of complex and ground-breaking scientific advice procedures and by participating in state-of-the-art initiatives such as PRIME and European cooperation between HTA (Health Technology Assessment) and pricing authorities. Be it in central, decentral, pharmacovigilance or scientific advice procedures, the MEB has made a significant contribution over the years, and continues to standby to safeguard the continuity of European medicines regulation in the future. The Dutch Medicines Evaluation Board is able to provide a similar level of service to EMA in the event of its relocation to the Netherlands.
The Government of the Netherlands will invest in bolstering the EU medicines regulatory system over the next few years.
This will be done by strengthening the regulatory capacity of the Dutch Medicines Evaluation Board. In the short term, 2 million euros has been allocated so that a greater share of the European regulatory procedures can be covered by the Dutch Agency.
Furthermore, by investing in EU cooperation within the EU network of National Competent Authorities: 8 million euros will be allocated to support the development of expertise and IT cooperation within the network. This will be facilitated by setting up – together with EMA and the Heads of Medicines Agency – an in-depth training programme for developing expertise and assessment capacity in those EU Member States that are keen to expand their role in taking up assessment procedures.
“The MEB understands the need to secure the continued performance of the European assessment of medicines. Therefore, we have undertaken to invest in additional staff – preparing ourselves to take over part of the work, if necessary. We are also ready and willing to help other countries to take on additional assessment work. The European network is important – together we must ensure continuity.”
Hugo Hurts – Director Medicines Evaluation Board Agency