The Tick-Tock of the EMA Clock
July 31st marks the final date for submission of proposals by member states to host the European Medicines Agency. Last month, at the EU summit in Brussels, the European Council endorsed a procedure to determine the final location of the EMA, which should be decided by November 2017. To date only a handful of member states have not submitted proposals to host the EMA.
Here we outline how this process will work. Subsequent to 31st July, submitted proposals will be assessed by the Commission accord to specific objective criteria. This assessment will serve the decision making process by the member states.
The main criteria for hosting the EMA are as follows:
1. 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
2. The accessibility of the location
3. The existence of adequate education facilities for the children of agency staff
4. Appropriate access to the labour market, social security and medical care for both children and spouses
5. Business continuity
6. Geographical spread
By 30th September 2017 at the latest, the Commission will submit its assessment of the offers to the Secretary-General of the Council for distribution to the Member States and will also make it publicly available. In October, a political discussion will take place among representatives of the member states on the basis of the commission’s assessment. Decision making will finally take place in November, in the margins of the General Affairs Council. Here, each of the member states can choose their top three preferences, with 3 points for first preference, 2 points for second preference, and 1 point for third preference. A member states that secures 14 first preference votes, and hence a majority, will be considered the selected offer. If not, second or even third round voting will take place to decide a winner. It is noteworthy to mention that both the EMA and the European Banking Authority (EBA) will be adjudicated according to the above process. Crucially, both agencies cannot be awarded to the same member state. A degree of ‘hedge-betting’ may therefore be involved in member states who particularly want one agency over the other. Member states may submit offers for one or both agencies.
Read more about Brexit and its implications for regulatory affairs and pharmacovigilance here.