An endless story
28 June 1976 the applicant filed a request with the Federal Chancellor (Bundeskanzler) to examine a product developed by him, namely “Ukrain”, a medicine for the treatment of cancer. The request was transmitted to the Ministry of Health and Environmental Protection (Bundesministerium für Gesundheit und Umweltschutz).
27 July 1981 the applicant requested the Ministry of Health and Environmental Protection to authorise “Ukrain” under the Austrian pharmakopeia.
14 August 1981 the Minister informed the applicant that, under the relevant legislation which was in force at that time, he did not meet the conditions to request such an authorisation as he was not in possession of a licence to produce the medicament in question.
Between 1984 and 1986 the applicant, upon his requests, was repeatedly informed about the conditions for requesting an authorisation, in particular the necessity to submit the relevant physical and chemical data and examinations.
30 August 1986 the applicant filed another request for the authorisation of “Ukrain”.
29 August 1988 the applicant submitted a copy of his licence to produce “Ukrain” which had been issued on 15 May 1988.
31 August 1988 the then competent authority, namely the Federal Chancellor’s Office (Bundeskanzleramt), ordered the Federal Institute for chemical and pharmacological examinations (FICP, Bundesstaatliche Anstalt für chemische und pharmazeutische Untersuchungen) and the Federal Institute for chemical and balneological examinations (FICB, Bundesstaatliche Anstalt für chemische und balneologische Untersuchungen) to submit expert opinions.
23 December 1988 the FICB submitted an expert opinion. It noted that the documentation submitted by the applicant, in particular the clinical examinations, suffered from severe shortcomings.
26 January 1989 the applicant was informed about the expert opinion and invited to make the necessary amendments to his request within twelve months.
3 October 1989 the FICP requested the applicant to submit further documents.
Between 11 Januar and 26 April 1990 the applicant submitted further documents.
29 May 1990 and 21 June 1990 the FICB, and on 4 July 1990 the FICP submitted further expert opinions. They found that the submitted documentation concerning “Ukrain” was still insufficient and that “Ukrain” should therefore not be authorised.
Between 1990 and 1995 the applicant submitted more documentation, which, however, was found to be insufficient in more than ten expert opinions issued by the FICB and the FICP.
8 March 1995 the applicant lodged an application against the administration’s failure to decide (Säumnisbeschwerde) with the Administrative Court (Verwaltungsgerichtshof).
2 June 1995 the then competent Federal Ministry of Health and Consumerism (Bundesministerium für Gesundheit und Konsumentenschutz) dismissed the applicant’s request for authorisation. It found that the documentation the applicant had submitted since 1976 had never been sufficient in order to establish the necessary quality, effectiveness and harmlessness of “Ukrain”.
26 February 1996 The Administrative Court quashed the Federal Ministry’s decision and remitted the case back. It found that the Federal Ministry had not given sufficient reasons for its decision.
17 December 1998 the applicant amended his request with the Federal Ministy. demanding in the alternative, to authorise “Ukrain” as a medicament to be used exclusively in cases where the usual treatment had failed.
5 March 2001 the applicant limited his request. He now only requested to authorise “Ukrain” as a medicament to be used exclusively where the usual treatment had failed.
27 September 2001 the applicant lodged another application against the administration’s failure to decide (Säumnisbeschwerde) with the Administrative Court.
18 February 2002 the Administrative Court dismissed the applicant’s request. It noted that according to the Pharmaceutical Act (Arzneimittelgesetz), a decision concerning a request for authorisation should be issued within two years after the request had been lodged. In the present case, the applicant had filed his amendment request for authorisation on 5 March 2001. His complaint about the administration’s failure do decide was therefore premature.
25 April 2002 the Ministry for Social Security and Generations (Bundesministerium für soziale Sicherheit und Generationen), after having taken further expert opinions, dismissed the applicant’s request for authorisation.
7 June 2002 the applicant lodged a complaint with the Administrative Court.
6 Septemer 2002 answer of the Administrative Court
12 September 2002 the applicant makes his statement to this answer
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