May 10, 2016
In the not too distant past, we communicated a lot about the Orphacol case, involving the authorisation of an orphan medicine via an implementing decision. The affair made great waves. We told the story in a booklet called ‘The Orphacol Saga.’
One of the many bombshells in this case occurred when a Member State interrupted the written procedure, initially started by the Commission to enable a quasi-automatic approval of the medicine. The cancella on of the written procedure brought even more turbulence for Orphacol!
The written procedure allows the Commission to adopt a draft measure without debate (although a debate might have taken place at an earlier phase). This automatism of decision-making can be stopped by a Member State, giving the committee the chance to meet, vote and potentially oppose. Stopping the written procedure is therefore not a neutral act: it constitutes an important lobbying ac on in terms of taking back control of the situation.
Under Article 3 of Regulation 182/2011, which sets down the details of the examination procedure, the written procedure for an implementing act can be immediately terminated if a Member State so requests (no justification on being necessary).
In this case, the Commission has to convene an Examination Committee composed of one representative per Member State. The Commission submits the draft to the committee, and the committee votes. Depending on the vote, it may result in adoption, amendments to the draft or recourse to the Appeal Committee.
But Regulation on 182/2011 also states that there can be exceptions to this principle of stopping the written procedure.
Exceptions reducing the scope for lobbying
We have two recent examples of this. First, the Tobacco Products Directive (2014/40/EU). This legislation stipulates that cancellation on of the written procedure cannot happen unless it has the support of a simple majority of Member States in the committee (i.e. 15 out of 28). Thus, the termination becomes all but virtual, given the tight deadlines used in this procedure.
But it gets worse than this: the 2013 Regulation on the Union Customs Code provides that only the Commission can terminate the written procedure for an implementing act. This clause is completely unfair as it basically authorises the Commission to stop a procedure that it has itself started in its own favor.
The legislative phase is where delegated and implementing acts have to be framed
There is a general trend among European lobbyists to neglect any in-depth analysis of the procedural articles in each basic act. The result? You find out too late about the margins of influence you have granted to the Commission, due to not paying enough a en on to legal details.
This can lead to delegated acts with excessively broad mandates, allowing the Commission total freedom on vital issues, or giving the Commission the advantage in the written procedure.
In all of these cases, the damage has been done and it is almost impossible to go back and turn it around. This is why technical analysis of legislative proposals must always go hand in hand with a procedural analysis. A procedural analysis aiming to identify exceptions and derogations reinforcing the Commission’s power at the expense of civil society and industry is generally not done.
More than ever, lobbying has a legal dimension. What is the point of mastering every technical detail of a le if the very processes for adopting technical measures escape your understanding?
These developments confirm that the nature of European lobbying has changed. Failing to realise this means accepting paralysis of ac on, which is most o en the case.