Vladimir HACEK, M.D., Member of Legislative Committee of the Slovak Medical Chamber

Krupina, 25 May 2010                              

Mr. Martin TERBERGER, Head of the Pharmaceuticals Unit

HEALTH AND CONSUMERS DIRECTORATE-GENERAL

EUROPEAN COMMISSION, B-1049 BRUSSELS, BELGIUM 

 

Dear Mr. Martin Terberger,

Head of the Pharmaceutical Unit,

Thank you for your letter dated 19 May 2010 in Case Exelon transdermal patch. I also thank Mr. Dalli Commissioner for his thanks to me.

As an EU citizen I am deeply disappointed from the passive attitude towards the reporting of suspected breaches of the regulations of the European Union, especially in such area as the safety of treatment of patients is. Registration of drugs for the treatment of neurodegenerative diseases is the sovereign domain of the European Union. I think that Member States must respect this fact without exception.

I think that is unlawful by defining the terms of payment for drugs, if the decision of the Member State (in this case by the Slovak Republic), expands the using of drug rivastigmine in conflict with the central approval indications. Although (as you wrote in your letter) that EU legislation does not affect the powers of Member States – I mean that also „setting of prices“ must accept the EU authorized indication.

EMA (Mr. Juan Garcia Burgos, MD) sent my report of suspected handled to the State Institute for Drug Control of the Slovak Republic, but this Institute is completely subordinated to the Ministry of Health of the Slovak Republic. The Minister appoints and dismisses the Director of the State Institute for Drug Control at any time and without giving reasons.

The response from the State Institute for Drug Control is exactly corresponding to this subordinated position of this Institute. State Institute for Drug Control wrote about „misunderstanding of doctors and insurance companies“, wrote about the Initiative of the Ministry of Health (strictly separating indications for Exelon oral forms, and Exelon transdermal patch). What, what, what?! I emphasize that I was the first who pointed to this problem (workshop at the Ministry of Health of the Slovak Republic on 18 March 2010)!

Nearly two years has been rivastigmine transdermal patch illegally used in Slovak Republic to treatment patients with Parkinson's dementia. How many patients have been unlawful treated? There was even some death in connection with this unlawful using of the drug rivastigmine transdermal patch? Answers on these questions are for the EMA probably uninteresting.

My experience is that the work in the EMA is moving documents from table to table respectively from the e-mail box to the other e-mail box. Mr. Dr. Burgos forward me an exact copy of the e-mail of the State Institute for Drug Control of the Slovak Republic as an answer to my report for EMA on suspect activities of Ministry of Health of the Slovak Republic. Sapienti satis.

Sincerely, Vladimir Hacek