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Who Benefits from UKRAIN not Being Registered?

Who Benefits from Ukrain not Being Registered?

The first application for the registration of UKRAIN was made in 1976 after is was proved that it has a selective effect, i.e. this medicament kills only cancer cells while leaving healthy cells undamaged (Brüller). Under the law in force at the time this anti-cancer drug should have been registered immediately because UKRAIN is far less toxic than its registered starting substances (http://www.ukrin.com/docs/1981-07-27-brief-zulassung-1981.pdf).  However, registration has still not been granted until now. The application was rejected by the Ministry of Health, whereby this rejection was declared invalid in 1996 by the Administrative Court, Vienna due to unlawfulness and a breach of procedural regulations (http://www.ukrin.com/docs/im_namen_der_republik-1996.pdf).

In 2005 the European Court of Human Rights also found against the Republic of Austria for not dealing with the application for the registration of UKRAIN (http://www.ukrin.com/docs/case_nowicky_austria.pdf).

In 1993 the ministry demanded that comparative clinical studies be carried out. A palliative study was carried out in accordance with the protocol approved by the ministry (http://www.ukrin.com/docs/Arrouas.1993.pdf). The results of this study showed that the survival rate (after 21 months) of non-metastasizing colonic cancer patients was 78.6% in the group treated with UKRAIN and 33.3% in the control group (http://www.ukrin.com/docs/Susak_1996.pdf). The results of this treatment were published in 1996.

In Austria approx. 3,000 people per year die of colorectal cancer, which is one of the most dangerous forms of the disease. It is therefore rather difficult to understand why, after such positive results of the treatment of patients with UKRAIN, this medicament was not registered and still has not been registered.

In this context it should be emphasised that in 1993 the company Bristol Myers applied for the registration of their anti-cancer medicament TAXOL in Austria. Registration was granted only five months after application although Austria was not its country of origin and no comparative studies were carried out. It was only proved that this medicament was highly toxic (http://www.ukrin.com.docs/Taxol_de_93.pdf).

Furthermore, instead of granting registration to UKRAIN new demands have continually been made, which have actually always been fulfilled.

Nevertheless UKRAIN has still not been granted registration in Austria, although Austria is the country of origin of this medicament and one is left with the feeling that registration is being deliberately prevented although the efficacy, safety and quality of the preparation have been confirmed (http://ukrin.com/en/efficacy).