O. M. A.

Obesity Management Association
6 Victoria Crescent Road, Glasgow, G12 9DB
TEL: 0141 357 1991   FAX: 0141 357 3322


January 13 2003

European Court overturns European Commission (EU) decision to withdraw marketing authorisations on anorectics

  • Small UK companies success in overturning an EU decision on Diethylpropion and Phentermine.
  • Anti-obesity Drug monopoly broken
  • Costs awarded against EU.

In a landmark test case in which Sixteen European companies contested the decisions of the CPMP to withdraw the marketing authorisation for five established anorectics the European Court of First Instance annulled these decisions and awarded costs to the applicants.

The court stated;

The commission was not competent to take these decisions and even if they were the decisions are invalid because they were not based on new data.

Competence means that the EU has no power to remove Diethylpropion and Phentermine from the UK market because these authorisations were issued originally by the United Kingdom's Medical Control Agency (MCA) and not by EU.

The court found that the EU had not proven their allegation of lack of efficacy. Efficacy had been proven when the MCA originally registered these medicines.

The court also found that no new safety concerns had been proven since the EU review of the safety data in 1996.

The importance of these decisions cannot be overstated because they establish:- 

  1. That Diethylpropion and Phentermine are safe in normal use.
  2. That Diethylpropion and Phentermine are effective in normal use.
  3. That Diethylpropion and Phentermine are a low cost, safe and effective alternative to the more expensive Orlistat and Sibutramine thus removing an artificial monopoly of these products.
  4. That the British National Formulary, B.N.F (a joint RPS / GMC publication on medicines) should now re-state its position on the use of Diethylpropion and Phentermine by Physicians.
  5. That the NHS should add Diethylpropion and Phentermine to its list of anorectics so that they are available to more obese patients resulting in large savings to the NHS budget. NHS could then support the prescribing of Phentermine through OMA accredited private clinics
  6. That Medical Indemnity Insurance for the use of Phentermine and Diethylpropion should be restored and offer the same terms which are offered for the use of Orlistat and Sibutramine.

 
NOTE TO EDITORS

The pharmaceutical companies are located in the United Kingdom, France, Spain, Portugal, Italy, Belgium, Austria and Germany. The United Kingdom companies were; Cambridge Healthcare Supplies Ltd, Essential Nutrition, and Hoechst Marion Roussel Limited. 

  1.  
    • The anorectics included in the judgement are; Phentermine, Amfepramone, Clobenzorex, Fenproporex, and Norpseudoephedrine
       
    • The Judges were R M Moura Ramos, President, V Tiili, J Pirrung, P Mengozzi and A W H Meij
       
  2.  
    • The judgement was delivered by the Court of First Instance on the 26th November 2002.

 

Further Information:

OMA

Tony Meehan +44 141 357 1991 - 07768 850 855

Dr. Tom Chapman - Essential Nutrition +44 1482 66 76 34

 

European Court

For further information please contact Isabelle Guibal:

Tel: (00 352) 4303 3355      Fax: (00 352) 4303 2731.

For full text of the judgement, please consult the internet page http://www.curia.eu.int/

 

 

 

 

 

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