Among the 15 page document, the following 2 key topics can be highlighted:
Brexit is discussed in 3 main sections: “B.1 Programming 2017-2020” on the financial point of view and also in 2 paragraphs of the “B.2 Highlights of the Executive Director” (Brexit preparedness & EMA preparedness following the UK referendum on membership of the EU).
On the financial side, it should be noted that “following the budgetary authority decision to cut EMA’s EU contribution by €8,350,000, the Agency will not be able to create a proposed ‘Brexit provision’ of €6.4 million, and €2.2 million for IT project activity will need to be covered by further cross budget savings and by closely following the Euro –GBP exchange rate developments”.
On the operational side, “The Agency is conducting impact assessments and general preparedness activities to identify the possible impact of loss of UK expertise, loss of current staff and currency volatility”.
“A first set of information was prepared by the Agency’s Operation and Relocation Task Force (ORP) looking at the impact of a Brexit on the operation and functioning of EMA & was presented to the board. Based on gathered information, including results of an EMA staff readiness survey, it is estimated that in a worst case scenario, up to 50% of staff members may decide not to relocate, and that this decision is largely dependent on the future location of the Agency”.
The current uncertainty of Brexit will impact planned work programmes, the Agency priorities & the increase of activities of the EMA (“Workload evolution trends indicate continuous growth in procedure volume, as well as in complexity of procedures, as more innovative products enter the Agency’s portfolio”). A second aspect of Brexit is related to the impact assessment for the scenario in which the UK were to leave the Union without joining the EEA. This could have more serious implications.
Implementation of the Clinical Trials Regulation & EU Portal and Database:
Some good news about the implementation on Regulation N° 536/2014.
Work on the legal obligations is on track as several Implementing and Delegated acts will be adopted by April 2017.
The Board noted a status update on the development of the Clinical Trial EU Portal and Database, which is on schedule to deliver the auditable version in July 2017. Key enhancements for sponsor and Member States (MS) functionality are being prioritised for post audit implementation and their specification will be finalised in Q2 of 2017.
Nevertheless, “Some members pointed out that much work still needs to be done, at the Agency in the development of the Portal and Database, and in the MSs who have to prepare on the basis of clear definitions and information on the systems”. Implementation at the national level seems considered at risk by some Member States.
The clinical trials facilitation group (CTFG) proposed to hold a workshop on the implementation of the Clinical Trial Regulation on 14 FEB 2017 with representatives of all Member States, the Commission and the EMA. The objective of the workshop will be to provide the status update of all work streams of the implementation. A mix of experts representing business and IT, but also members of the board and heads of agencies should be invited, to achieve alignment at all levels, including the national level.
In addition, the impact of the “Revised EU Telematics governance model” (B.9), and the proposition to create a new governance body, on the IT aspects linked to Implementation of the Clinical Trials Regulation are difficult to evaluate.
More information can be found here