Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Analysis of the EMA relocation decision - regulatory reasoning and impact on regulatory functionality of the EMA
Dr. Lasse Reefschläger (Abschlußjahr: 2018)
Summary
Language: English
In November 2017, the Council of the European Union voted for Amsterdam as new hosting city for the EMA due to leave of the UK from the EU. As this decision was taken by politicians, it remained unclear, if the decision for Amsterdam was indeed the best alternative for the new host of the EMA. Therefore, a decision analysis was performed to evaluate, which submitted offer is objectively the best alternative to host the EMA. In a first step, required criteria are described. These criteria are distinguished into ‘Must Criteria’, which definitely need to be met by the candidate cities, and ‘Want Criteria’, which are desired and for which it was assessed, how good or bad alternatives fulfil these criteria. In addition, these criteria were also weighted by their importance to ensure functionality of the EMA during and after relocation. It is shown that 2 criteria are most crucial for ensuring EMA’s functionality:
- Availability of the proposed facility.
- Amount of EMA staff willing to relocate to a specific alternative
The alternatives are then ranked for each single criterion, how good this specific criterion us fulfilled. The better a candidate city fulfils a criterion, the higher is the ranking of this city. The ranking of the city is then multiplied with the weighting of the specific criterion. In the end, the scores of a city for each criterion is summed up. By this approach, it is shown that Amsterdam is indeed the best alternative to host the EMA. This is mainly based on the fact that Amsterdam is ranked among the top 3 alternatives for the criteria with the highest weighting. It is further discussed, how the result of the decision analysis affects the functionality of the EMA. It is shown that the decision for Amsterdam could indeed have a negative effect on the functionality since the permanent building for the EMA will not be ready in time and a temporary facility is necessary. However, about 81 % of EMA staff expressed their willingness to relocate to Amsterdam. Therefore, Amsterdam is the city with the least risk of negative influence on the functionality of the EMA due to loss of human resources.
As the decision by the European Council for Amsterdam was in the end taken by coin decision between Amsterdam and Milan, a comparison between the result of the decision analysis and Milan is also discussed. It is shown that for Milan, no temporary building is necessary. However, the Amsterdam offer provides more detailed information on specific requirements with regards to the facility. In addition, more EMA staff expressed their willingness to relocate to Amsterdam than to Milan. Hence, it is shown that Amsterdam is indeed the best choice to host the EMA.
Pages: 74