“Orphacol Saga” reveals loopholes within Lisbon Treaty
11/23/2013

Senior EU Lobbyist and Visiting Professor at the College of Europe for comitology, Daniel Guéguen, provides insight into the lobbying efforts behind the market authorisation of the orphan drug “Orphacol”. He shows that loopholes within the Lisbon Treaty are exploited ...

Online PR News – 23-November-2013 – Brussels/Belgium – “Orphacol Saga” reveals loopholes within Lisbon Treaty

Senior EU Lobbyist calls for closing of black holes in EU decision making

Senior EU Lobbyist and Visiting Professor at the College of Europe for comitology, Daniel Guéguen, provides insight into the lobbying efforts behind the market authorisation of the orphan drug “Orphacol”. He shows that loopholes within the Lisbon Treaty are exploited at the expense of a transparent and democratic European Union. Mr. Guéguen calls for more social, legal and media pressure to plug the remaining holes.

“The problem lies within the new rules of comitology (delegated & implementing acts). The Lisbon Treaty created complexity, uncertainty and opacity within the EU decision making system. Post Lisbon comitology changed the balance of power between the Parliament, the Council and the Commission, in favour of the latter. As if politicians were abandoning their responsibility, leaving it instead to bureaucrats”, says Daniel Guéguen.

Orphacol is an orphan drug, created to treat an extremely rare liver enzyme deficiency in young children in order to avoid an otherwise inevitable liver transplant. Its market authorisation has been blocked by the European Commission for several years despite overwhelming support by the European Medicines Agency (EMA) and experts of most European Member States.

“The Commission ignored the EMA and the Member States several times. The problem was that it could! The European Commission currently enjoys a degree of freedom within the new comitology structure that is worrisome. More legal security, increased transparency and supervision by the other EU institutions are needed, but to achieve change, we have to stop turning a blind eye to comitology”, demands Guéguen.

[LINK to the case study "The Orphacol Saga": http://www.pacteurope.eu/pact/wp-content/uploads/2013/10/SagaOrphacolUK.pdf]