BREXIT Chance und Herausforderung 13. September 2017 Dr. Christa Wirthumer-Hoche AGES Medizinmarktaufsicht, BASG
Brexit With the trigger of Art 50 a 2 years transitional period started, Art 50 was triggered on 29 March 2017 transitional period will expire 29 March 2019, and EMA needs to prepare and is working on the assumption that the UK will become a third country as of 30 March 2019. This is without prejudice to the outcome of the withdrawal negotiations. Nowadays the only thing which is certain is uncertainty. The UK fully participates in the activities of EMA &EU-network; it continues to participate in all formal meetings and retains its speaking and voting rights.
Relocation of the EMA
Criteria for relocation The assurance that the agency can be set up on site and take up its functions at the date of the United Kingdom s withdrawal from the Union the availability of appropriate office premises The accessibility of the location The existence of adequate education facilities for the children of agency staff Appropriate access to the labour market, social security and medical care for both children and spouses Business continuity Geographical spread
EMAzing Vienna
Building The assurance that the agency can be set up on site and take up its functions at the date of the UK s withdrawal from the Union - availability of appropriate office premises with the necessary logistics and sufficient space for offices, meeting rooms and off-site archiving, high-performing telecommunication and data storage networks as well as appropriate physical and IT security standards.
The accessibility of the location This criterion concerns the availability, frequency and duration of flight connections from the capitals of all EU Member States to the airports close to the location, the availability, frequency and duration of public transportation connections from these airports to the location, as well as the quality and quantity of accommodation facilities. In particular, the criterion implies the capacity to allow for the continuation of the volume and intensity of current meeting activities of the Agency.
The existence of adequate education facilities for the children of agency staff This criterion concerns the availability of multi-lingual, European-oriented schooling that can meet the needs for education facilities for the children of the current staff as well as the capacity to meet also the future education needs
Business continuity This criterion, which complements the previous criteria, concerns amongst other things the ability to allow the Agencies to maintain and attract highly qualified staff from the relevant sectors, notably in case not all current staff should choose to relocate.
Appropriate access to the labour market, social security and medical care for both children and spouses This criterion concerns the capacity to meet the needs of the children and spouses of the current as well as of future staff for social security and medical care as well as the availability to offer job opportunities for these
http://europa.eu/rapid/pressrelease_ip-17-2202_en.htm
12.9.2017 Government ministers and diplomats from across the EU27 will make a decision on November 20, at a General Affairs Council meeting, about where to base EMA and EBA after Brexit, the Council of the EU has confirmed. With barely two months left before that decision, countries in the running for the EMA are intensifying their lobbying in Brussels. Austria held an event Monday (11 Sept. 2017), complete with Sachertorte, potato salad and snow globes. Germany s is on Thursday, Bulgaria and Poland next week, and Spain, Italy and Romania in the week of September 25.
There is a need for the remaining 27 MSs to focus on increasing assessment capacity on the basis of a very good analysis. Development of the Business continuity Plan
Relocation preparedness Development of prerequisites for a new location /city for EMA to ensure EMA continuity of operation, there are a lot of visits to the EMA and EMA vistis candidate sites which want to host the Agency Enabling scientific experts from all EU MSs to meet at EMA Retaining recruiting staff and enabling staff to relocate with their families Staff survey s performed 3% won t move ~ 50% will move, rest depeding on the choice of the city, Information welcomes form MSs who want to host the EMA, staff member want to know how to build up their new life Providing an efficient working environment
Operational and financial preparedness Impact assessment on the consequences for the operation of the EMA On applications, regulatory procedures Survey on how the EU 27 agencies are preparing themselves increasing number of staff, in which discipline? On EMA scientific Committees, WPs and experts 2 WGs on operation of Committees have been set up (hum and vet) On all staff irrespective of their nationality, impact on staff with UK nationality IT contractors, contracts and procurement
HR related matters Once the city is decided language training, teleworking from abroad,
Politico - Brexit A temporary British membership of the European Economic Area (EEA) post Brexit would be challenging and costly, Norwegian Prime Minister Erna Solberg said Monday, according to Reuters. Britain rejoining the internal market from outside the EU the so-called Norway model is EU chief negotiator Michel Barnier s favored option for a transitional arrangement. Brexit might lead to shortages of medicines across Ireland and cause drug prices to rise, Medicines for Ireland, which represents the generic drugs industry, warned at a health care seminar in Dublin. Britain s departure from the single market and customs union will force drugmakers to juggle the demands of two different regulatory systems, increasing paperwork and costs, and slowing down supply chains.
Danke! Fragen? Christa Wirthumer-Hoche 22