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European Union corruption knows no shame

The latest scandal over former European Health Commissioner John Dalli beggars belief, even by the standards of Brussels

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John Dalli: a little bit of this, a little bit of that...
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David Atherton
On 11 February 2013 12:32

This week saw the EU agree a budget, although the nearest analogy would be that they are just adjusting the prices for renting a deckchair on the Titanic. 

Over the next seven years, the EU budget will be €908.4 billion, and most of us have not had the opportunity to light a candle in a brown bottle to it let alone shine a torch on the previous €942.8 of follies. However, out of sight, out of mind an ongoing scandal of Biblical proportions has now come into the public domain.

Let me enlighten you on one small item which should stir rage and clenched fists from even the most strung out on mogadon.

First, some necessary detail. There is a genetically inherited liver condition where infants and children are unable to produce bile acids. Thankfully, it is very rare affecting 0.06 per 10,000. There are two ways of treating the condition, either via a liver transplant or through the use of the drug Orphacol. It is produced by the French company, Laboratoires CTRS, and it has been used to great effect since 1993.

Permission for the full marketing rights for the drug began in October 2009 with agreement from the European Medicines Agency (EMA). The EMA passed the drug on three separate occasions and concluded:

“Based on the Committee for Medicinal Products for Human Use (CHMP) review of data on quality, safety and efficacy, the CHMP considered by consensus.. that the risk-benefit balance of Orphacol was favourable in the treatment of inborn errors in infants, children and adolescents aged 1 month to 18 years and adults and therefore recommended the granting of the marketing authorisation under exceptional circumstances.”

All twenty seven member states have approved the drug too. However, the then European Health Commissioner John ”backhander” Dalli refused Orphacol a licence. His conduit was Dr. Patricia Brunko,  Head of the Unit for Pharmaceuticals whose spokesperson said:

“Marketing authorisations for medicines can only be granted in the EU if the efficacy and safety of the product has been demonstrated according to strict standards. Orphacol did not comply because the applicant tried to short-circuit the requirements needed for obtaining a marketing authorisation”.

If you look at the EMA review again, that is plainly untrue. So, what is going on?

Get this. An American pharmaceutical company, Asklepion Pharmaceuticals, which produces a rival drug called Xebam, which is at the Phase 3 stage and not yet allowed to be generally prescribed, wrote to the Health Commission objecting to its release.  

Some MEPs are rightly apoplectic. Marc Tarabella, the Belgium MEP, in written questions on the 10th January 2013  in response to Asklepion Pharmaceuticals' letter  wrote:

“Is it normal practice for one firm to attempt to lobby officially the direct or indirect decision‐makers at the Commission against another firm?  …would it not be in the interest of the EU institutions, the firms mentioned and, in the end, the patient, to refer the whole matter to the European Anti-Fraud Office (OLAF)?”

French MEP Gilles Pargneaux is on record as stating that: “All the clinical arguments are developed word for word by the competitor,” and spoke of, “…evidence that the Commission contacted the competitor directly….I do not want to believe in a conflict of interests in the Commission, but I have strong suspicions”

The next stage is an appeal to the European Court of Justice.

For those who may not be fully in the picture, John Dalli was sacked in October last year amid suspicions over complicity in, or at least awareness of, a  €60 million bribe from Swedish Match who make snus, a smokeless tobacco product. HIs sacking came after an investigation by the European Anti-Fraud Office (OLAF.)

Back to the pharmaceuticals scandal, it is my understanding that Asklepion’s drug Xebam is being fast tracked by the EMA. Is Dalli in any way involved? We are surely entitled to ask.

If Orphacol remains banned, Asklepion may get a 10 year monopoly. Unlike Orphacol, Xebam is unproven.

If this is the case, the level of dishonour resting on the shoulders of our Lords and Masters in Brussels is beyond adjective and description.

Licensing Orphacol would, without doubt, save lives. In my opinion, failure to do so would be tantamount to corporate manslaughter.

David Atherton is Chairman of Freedom2Choose, which seeks to protect the informed choices of consenting adults on the issues of smoking. Follow him on Twitter: @DaveAtherton20

Read more on: SNUS, Match, Xebam, Laboratoires CTRS, Orphacol, pharmaceuticals, Asklepion Pharmaceuticals, John Dalli, and European Commission
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