Complex procedures as hurdle to accountability: verticalization of pharmaceutical enforcement

In 2015, the European Medicines Agency (EMA) celebrated its 20th anniversary, coinciding with the 50 years of pharmaceutical regulation in the European Union (EU). In the EU, pharmaceuticals are legislated at the EU level, but the enforcement of this legislation is typically left to the Member States. Yet also in this area we can see a trend of verticalization. This development has resulted in too complex procedures, with potential negative effects on accountability.

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Illicit but admissible evidence

Imagine that a person records a telephone conversation without the knowledge and consent of her interlocutor, nor any legitimate authorisation. What if those records are found by a public authority conducting an administrative investigation? Can this authority use the content of those conversation to prove its case? If the authority is a EU enforcement authority, these questions are far from being self-evident, given the lack of clear exclusionary rules.

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Mind the trend! Direct enforcement of EU law and policies is moving to ‘Brussels’

A sealed sign with the EU flag does not automatically mean ‘sealed by the EU Commission’ anymore. The number of EU entities acquiring direct enforcement powers has grown from one to eight recently. The first post of this blog puts on the map and raises awareness of an ongoing development in the EU law and governance – proliferation of EU enforcement authorities (EEAs) – which so far has been unnoticed. The aim is to launch a discussion of the aims, means and challenges of this development to understand and contribute to shaping of effective and secure law enforcement in the EU.

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