November 22, 2013
Guest post by Daniel Guéguen, chairman of PACT European Affairs, and visiting professor at the College of Europe (Bruges).
Orphacol is the tale of a 1,000-day battle between the European Commission and CTRS, a small laboratory. It will take you into the obscure labyrinth of EU comitology, with two court judgments, an exciting media saga, a mysterious American competitor and an amazing finale. The case poses fundamental questions about the EU decision-making process.
A product of joint French-American research in the 1990s, Orphacol is an orphan medicine that cures a rare liver disease in young children. In 2007, CTRS, a specialised French laboratory, was selected to bring the product onto the European market. To do so, CTRS first had to apply for a marketing authorisation (MA) at the European Medicines Agency (EMA) in London.
The Commission disregarded two EMA opinions and two Member State votes
The EMA experts delivered two unanimous positive opinions in favour of MA for Orphacol: first in December 2010 and again in April 2011. In defiance of the two opinions however, DG SANCO – the Commission’s Directorate-General for Health and Consumer Affairs – submitted to the Examination Committee of Member State officials (the “comitology committee”) a draft decision refusing MA for Orphacol.
In October 2011, the Member States voted by qualified majority (QMV) against the Commission’s draft, i.e. in favour of MA for Orphacol. However, DG SANCO retained its text, submitting it to the Appeal Committee – composed of higher ranking national officials – who also voted by QMV against the Commission. But DG SANCO still refused to budge.
Left with no other choice, CTRS stood up for its rights and took action
CTRS responded by taking the case to the EU General Court in January 2012, claiming that the Commission should have conformed to the Member States’ position on Orphacol. Three months later, while the court case was still pending, DG SANCO decided to submit to the Examination Committee a draft that was basically the same text twice rejected by the Member States!
This time, the Member States could not reach the qualified majority needed to block the draft, so the Commission adopted a decision on 25 May 2012 refusing MA for Orphacol. CTRS was now unable to market its medicine at European level and the General Court was unable to rule on the initial case. Nonetheless, CTRS immediately filed a new action to annul the decision, alleging violation of the post-Lisbon comitology procedures.
The legal dimension supplemented by lobbying action in Brussels
CTRS also launched a lobbying campaign in Brussels aimed at conveying its message to the Member State Perm Reps, MEPs and Commission officials. Meetings were combined with communication: articles published in the European press helped to raise awareness of the Orphacol affair. One controversial article by a French journalist proved to be a bombshell, putting real pressure on the Commission.
The EU Institutions, particularly the Parliament, began to get involved. At a hearing in June 2012, MEPs put questions to DG SANCO officials. Important facts came to light at this event, e.g. the presence of a competing American laboratory called Asklepion Pharmaceuticals, which had been in contact with DG SANCO from an early stage.
The Court judgment and Member State vote: a knock-out blow for the Commission
On 4 July 2013, the General Court annulled the refusal to grant MA to Orphacol, finding the Commission’s scientific analysis to be fundamentally flawed (although it did not address the comitology angle). In response, the Commission committed itself to draft a pro-Orphacol text and submit it for Member State approval via a fast-track written procedure.
Despite a nervous final stretch, when there was a risk that the vote might be postponed, the finale was truly remarkable: on 11 September 2013, twenty-eight Member States voted unanimously in favour of Orphacol.
Despite the result, important questions remain unanswered:
- Why did DG SANCO ignore two EMA opinions and two Member State votes so blatantly?
- Why did this file generate such hostility throughout the Commission, from the lower levels right up to the top where the excesses of the case seemed to be condoned?
- Why did certain civil servants flout the codes of conduct and publicly make erroneous statements to MEPs?
The case highlights a number of loopholes and uncertainties in the post-Lisbon system:
- Post-Lisbon comitology is a kind of murky trench warfare, where the hidden power is firmly in the hands of the low-level civil servant.
- Lobbying in the EU is now more procedural and legal than before. The Orphacol affair underlines the major role of the media, both national and European, in putting pressure on an opponent.
- Finally, Orphacol reinforces the case for regulation of EU lobbying that is stronger than the current Transparency Register.
If you wish to read a more detailed analysis of the case, I am very pleased to share with you the full booklet – “The Orphacol Saga” – at this link.
The article has been circulated very widely so far and I have received many positive comments.
Do not hesitate to contact me if you have any comment or feedback.