Letter to Public attorney Dr. Gertrude Brinek

Mrs. Dr. Gertrude Brinek,
Public attorney (Ombudsman)
PO Box 20
1015 Vienna

Vienna, March 5, 2010

Dear Dr. Brinek,

UKRAIN is a medicament for the treatment of cancer, which is produced from two registered initial products. It is effective against cancer and at the same time more than 300 times less toxic than the initial products, as has been proved in numerous studies.

The application for registration of UKRAIN has been filed with the competent authority on July 27, 1981. Unfortunately a decision is still pending, despite the fact that the Republic of Austria has been convicted by the European Court of Human Rights due to the delaying of the registration, by the ‘Decision in the case No 34983/02’, dated February 24, 2005 (Att. 1).

In the matter of registration of UKRAIN during 30 years, I have been represented and advised by more than 10 attorneys. None of them has called my attention to the fact my application should have been granted in accordance with the law prevailing at that time, i.e §8, No 2 and 3 of the Speciality Regulation of 1947 (Att 2).

This paragraph states:  ‘Not eligible for registration are especially such preparations:

No. 2:.…that are obvious copies or repetitions specialities registered in Austria, unless they represent an evidenced  improvement in technical or therapeutic direction. That means that such ‘repetitions’  a r e  eligible for registration if they represent an improvement in technical or therapeutic direction. For UKRAIN, a clear therapeutic improvement could be documented as it is effective against cancer and more than 300 times less toxic than the starting materials (Att. 3).

§8 No. 3:…’if their manufacturing prescription is contained in the last or an earlier issue of the Pharmacopoea Austriaca VIII and the German Pharmacopoeia, 6th issue…’This clearly applies to UKRAIN, because thiotepa as well as alcaloids of Chelidonium majus have been contained in the Pharmacopoea Austriaca and the German Pharmacopoeia already much earlier than the date of application.

All preconditions for the registration were fulfilled (see letter to Dr. Hauer, attorney at law, dated Feb 10, 2010; Att. 4). But instead of granting the registration, the public officers have requested new conditions again. Having fulfilled these, I was confronted with new conditions (see my complaint to the Administratve Court; Att. 5).

The damage caused by the public officers by not granting the registration to the anti-cancer drug UKRAIN hurts not so much me, but the cancer patients, because the costs for the therapy will not be reimbursed by the social insurance institutions (see letter to Dr. Kurt Grünwald, MoP) Att. 6, (case Jakob) Att 6.

As described in an article in the weekly magazine ‘profil’ dated Feb 8, 2010 (Att. 7),
the results achieved with conventional chemotherpy are not satisfactory. UKRAIN however is not only effective in all tested cancer cell lines (see results in the National Cancer Institute, Bethesda, USA, Att. 8), but it also helps in cases, where no other therapy is available. (http….) (Att 9, Att 10, Att 11, Att 12). Its efficiency, safety and quality have been verified in laboratory tests as well as in clinical application. (Att. 13a, Att. 13b)

During all international medical conventions I am being asked, with lack of understanding (Att. 14), why UKRAIN is still not registered to date, and – in view of such astonishing successes – I receive no support at all from the Austrian government. Doctors and scientists, who continuously work with my preparation and receive impressive confirmation of its effectiveness can not hold back their lack of understanding this (see the book ‘Anticancer Pharmaceutical Ukrain: Criminal Story of a Prevention”, by Dr. Eleonore Thun-Hohenstein, Molden Publishing company, Att. 15).

In a constitutional state, public officers shall not have any other priority than to adhere to the law. In this case, however, there is a clear contravention to this rule: a medicinal speciality, which should have been registered already 30 years ago, is still not registered, and this despite the fact that the Republic of Austria has been convicted by the European Court of Human Rights due to the delaying of the registration by the Decision in the case No. 34983/02 dated February 24, 2005 (Att. 16). I fail to understand whose interests are being protected by the public officers – but definitely not these of the patients, nor the State of Austria.

My letter to the lawyer is still unanswered, therefore I kindly ask you, dear Dr. Brinek, to assist me juridically and advise me, which steps I should undertake to achieve my rights. Austria is a constitutional state.

As this is a matter of public interest, I will take the liberty to publish this letter and your esteemed reply in the Internet.

Yours sincerely

Dr Wassil Nowicky