Criminal Story of a Prevention - Ukrainian Anti Cancer Institute

So once again Nowicky went to the ministry. What then happened is described by
Nowicky, who was in the habit of recording his experiences in writing. ‘I was handed a
document which I had to sign to confirm receipt. I assumed that I would then be given the
whole document but I was mistaken. Without further ado it was taken from my hands and I
was given only the appended letter – signed on behalf of the Federal Minister. The letter
contained a rejection of Nowicky’s application on the grounds that the Ministry of Health,
‘neither knows whether the company Solvay Pharmaceuticals from The Netherlands has
approval to produce cytostatica such as Ukrain, nor is there any proof that the production of
the drug is carried out by this company’.
The certification from the Dutch Ministry of Health stating that Solvay was an
approved producer of human medicines and that the company actually did this in accordance
with GMP regulations had been handed back as unnecessary at the time of the application. –
Along with the documentation covering the second point of the rejection.
There was stated: ‘The manufacture of Ukrain is said to be contracted out. It should be
emphasised that the company Nowicky Pharma has neither a trade licence nor approval in
accordance with paragraph 63 for the production of parenteral drugs and can therefore cannot
appear as the contractor in relation to such drugs. The existing patents and trade licence cover
only the manufacture of the effective substance.’
Apart from the fact that it was intended that Solvay fill the ampoules, Nowicky had a
‘concession decree’ from 1988 giving him permission for ‘the manufacture of substances and
preparations for medicinal use.’
His company, Nowicky Pharma, is entered on the register of companies. The height of
this absurdity is the fact that in 1994 Nowicky had already received such a ‘Certificate of a
Pharmaceutical Product’ rubber-stamped by the Ministry of Health without any objection.
If so much is ‘unknown’ to the ministry, it could be due to the fact that so much of the
documentation was repeatedly handed back at the time of the application since it was deemed
unnecessary.
Nowicky once again experienced how unhelpful information from civil servants at the
Ministry of Health was, when in a letter of 25 November 1998, addressed to the Minister of
Health, Eleonore Hostasch, he asked for the information: ‘What formalities are necessary to
set up my own production of Ukrain according to the regulations of Good Manufacturing
Practice here in Vienna?’ Since his letter was still unanswered in the middle of January 1999,
he wrote an urgent letter to the minister on 22 January in which he referred to what he had
been told by one of her civil servants. This passage is certainly worth quoting:
‘In reply to a brief enquiry to one of your civil servants I received the answer that I
should first have the facilities built and then it would be considered whether I would be
granted approval for GMP production. Please understand that I cannot spend around €
500,000 if it is possible that I would not receive approval for production in accordance with
the regulations.’
After once again referring to the fact that that his anti-cancer drug Ukrain was
registered in two countries (Ukraine and Belarus) and that its efficacy had been sufficiently
proven, he summarised his frustration in one sentence with an exclamation mark. ‘I applied
for registration in Austria in 1978 and I am still waiting today!’ He continued: ‘If the same
delaying tactics are used in this matter, i.e. the GMP certification, as in my application for
registration, for which I have been waiting for more than twenty years, I will finally be left
with no option but to take the production and distribution of Ukrain abroad, where my efforts
are supported. I would therefore URGENTLY ask you to give me a clear answer to my
question as quickly as possible.’
The answer arrived before four weeks had gone by, dated 19 February 1999 and
signed by the civil servant Michtner who was responsible for registration. In just two
sentences he managed to avoid the clear answer Nowicky had asked for. ‘With reference to
49