PROCEDURE

The case originated in an application (no. 34983/02) against the Republic of Austria lodged with the Court under Article 34 of the Convention for the Protection of Human Rights and Fundamental Freedoms (“the Convention”) by an Austrian national, Mr W. Nowicky (“the applicant”), on 28 March 2002.

The applicant was represented by Schönherr OEG, a company of lawyers practising in Vienna. The Austrian Government (“the Government”) were represented by their Agent, Ambassador H. Winkler, Head of the International Law Departement at the Federal Ministry for Foreign Affairs.

On 21 October 2003 the Court decided to communicate the application. Applying Article 29 § 3 of the Convention, it decided to rule on the admissibility and merits of the application at the same time.

THE FACTS

The applicant was born in 1937 and lives in Vienna.

On 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 ).

On 27 July 1981 the applicant requested the Minister for Health and Environmental Protection to authorise “Ukrain” under the Austrian pharmacopeia.

By letter of 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.

On 29 August 1988 the applicant submitted a copy of his licence to produce “Ukrain” which had been issued on 15 May 1988.

On 31 August 1988 the then competent authority, namely the Federal Chancellor’s Office (Bundeskanzleramt), ordered the Federal Institute for chemical and pharmacological examinations (FICP, Bundesanstalt für chemische und pharmazeutische Untersuchungen) and the Federal Institute for experimental pharmacological and balneological examinations (FICB, Bundesstaatliche Anstalt für experimentell- pharmakologische und balneologische Untersuchungen) to submit expert opinions.

On 23 December 1988 the FICB submitted an expert opinion. It noted that the documentation submitted by the applicant suffered from severe shortcomings. On 26 January 1989 the applicant was informed about the expert opinion and invited him to make the necessary amendments to his request within twelve months.

Between 1990 and 1995 the applicant submitted more documentation, which, however, was found to be insufficient in some twelve expert opinions issued by the FICB and the FICP.

On 1 February 1995 the applicant lodged an application against the administration’s failure to decide (Säumnisbeschwerde) with the Administrative Court (Verwaltungsgerichtshof).

On 13 February 1995 the Administrative Court ordered the Federal Minister to decide upon the applicant’s request, following which the then Federal Minister of Health and Consumer Protection (Bundesminister für Gesundheit und Konsumentenschutz) dismissed the applicant’s request for authorisation on 2 June 1995. He found that the applicant had failed to establish the necessary quality, effectiveness and harmlessness of “Ukrain”.

On 13 July 1995 the applicant filed a complaint with the Administrative Court. He complained inter alia about shortcomings in the proceedings in that the Federal Minister had not duly taken account of his arguments.

On 26 February 1996 the Administrative Court quashed the Federal Minister’s decision and remitted the case. It found that the Federal Minister had not given sufficient reasons for his decision and had not duly taken account of the applicant’s arguments.

Meanwhile, in July 1995 the applicant had submitted new documents to the Federal Minister. He had, in particular, altered the indication as to the type of cancer against which “Ukrain” should be used.

In two expert opinions of May and June 1996 the FICP and the FICB found that the documentation suffered from severe shortcomings and “Ukrain” should, therefore, not be authorised.

On 29 August 1996, 24 October 1996, 16 May 1997 and 17 and 23 July 1997 the applicant submitted further documentation including two opinions of private experts.

On 29 August 1997 the Federal Ministry appointed a further expert, E. who submitted his opinion on 25 November 1997. He found that “Ukrain” should not be authorised. On 8 January 1998 an expert opinion by the FICP came to the same conclusion.

In May and June 1998 the applicant commented on these opinions and submitted a further private expert opinion. This documentation was found to be still insufficient in an expert opinion submitted by E. on 13 August 1998.

After having discussed the matter with the Federal Ministry in April and May 1999, the applicant, on 12 May 1999 limited his request for authorisation of “Ukrain” to one particular type of cancer. In a meeting with an official of the Ministry on 19 May 1999 the applicant discussed a study scheme concerning a clinical test to be carried out in Moscow which, however, concerned another type of cancer than the one indicated in his request of 12 May 1999.

On 24 February 2000 the applicant requested the Federal Minister to indicate which documents were still missing. On 17 July 2000 the Federal Minister complied with this request and ordered the applicant to file his submissions by 15 January 2001.

Between 2000 and 2002 the applicant submitted more documentation, which, however, was found to be insufficient in nine expert opinions issued. During this time, namely on 3 August and on 7 December 2000, the applicant again altered the indications as to the types of cancer against which “Ukrain” should be used.

On 5 March 2001, the applicant limited his request to authorise “Ukrain” as a medicament to be used exclusively where the usual treatment had failed.

On 27 September 2001 the applicant lodged another application against the administration’s failure to decide (Säumnisbeschwerde) with the Administrative Court.

On 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 amended request for authorisation on 5 March 2001. His complaint about the administration’s failure do decide was therefore premature.

On 25 April 2002 the Minister for Social Security and Generations (Bundesminister für soziale Sicherheit und Generationen) dismissed the applicant’s request for authorisation.

On 7 June 2002 the applicant lodged a complaint with the Administrative Court. He submitted inter alia that the proceedings suffered from shortcomings in that the Federal Minister had not sufficiently investigated the facts. On 25 June 2002 the Administrative Court commenced preliminary proceedings. On 2 September 2002 and on 13 December 2002 the parties submitted their respective submissions.

The proceedings are currently pending before the Administrative Court.
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CODE
DIRECT
34983/02
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ORG
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Republic of Austria
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Austrian
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PERSON
DIRECT
Mr W. Nowicky
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28 March 2002
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Schönherr OEG
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LOC
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Vienna
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Austrian Government
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PERSON
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H. Winkler
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International Law Departement
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Federal Ministry for Foreign Affairs
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QUASI
21 October 2003
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1937
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Vienna
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28 June
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QUASI
Ukrain
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NO_MASK
Ministry of Health and Environmental Protection (Bundesministerium für Gesundheit und Umweltschutz )
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27 July 1981
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NO_MASK
Minister for Health and Environmental Protection
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MISC
QUASI
Ukrain
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NO_MASK
Austrian
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14 August 1981
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DATETIME
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29 August 1988
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Ukrain
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15 May 1988
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31 August 1988
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ORG
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Federal Chancellor’s Office (Bundeskanzleramt)
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NO_MASK
Federal Institute for chemical and pharmacological examinations (FICP, Bundesanstalt für chemische und pharmazeutische Untersuchungen)
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001-68396_a8_em29
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NO_MASK
Federal Institute for experimental pharmacological and balneological examinations (FICB, Bundesstaatliche Anstalt für experimentell- pharmakologische und balneologische Untersuchungen)
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001-68396_a8_e26
001-68396_a8_em30
DATETIME
QUASI
23 December 1988
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ORG
NO_MASK
FICB
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DATETIME
QUASI
26 January 1989
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NO_MASK
twelve months
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QUASI
1990
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1995
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NO_MASK
FICB
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NO_MASK
FICP
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DATETIME
QUASI
1 February 1995
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NO_MASK
Administrative Court (Verwaltungsgerichtshof)
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DATETIME
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13 February 1995
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NO_MASK
Administrative Court
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NO_MASK
Federal Minister of Health and Consumer Protection (Bundesminister für Gesundheit und Konsumentenschutz)
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DATETIME
QUASI
2 June 1995
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MISC
QUASI
Ukrain
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QUASI
13 July 1995
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NO_MASK
Administrative Court
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QUASI
26 February 1996
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NO_MASK
Administrative Court
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July 1995
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MISC
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Ukrain
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DATETIME
QUASI
May and June 1996
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NO_MASK
FICP
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NO_MASK
FICB
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MISC
QUASI
Ukrain
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29 August 1996
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24 October 1996
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16 May 1997
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17 and 23 July 1997
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29 August 1997
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Federal Ministry
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E.
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25 November 1997
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Ukrain
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8 January 1998
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NO_MASK
FICP
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May and June 1998
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E.
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QUASI
13 August 1998
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NO_MASK
Federal Ministry
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April
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May 1999
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12 May 1999
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Ukrain
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19 May 1999
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Moscow
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12 May 1999
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24 February 2000
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17 July 2000
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15 January 2001
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2000
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2002
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3 August
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7 December 2000
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Ukrain
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5 March 2001
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Ukrain
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27 September 2001
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NO_MASK
Administrative Court
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QUASI
18 February 2002
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NO_MASK
Administrative Court
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NO_MASK
two years
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5 March 2001
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QUASI
25 April 2002
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ORG
NO_MASK
Minister for Social Security and Generations (Bundesminister für soziale Sicherheit und Generationen)
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DATETIME
QUASI
7 June 2002
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NO_MASK
Administrative Court
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QUASI
25 June 2002
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Administrative Court
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QUASI
2 September 2002
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QUASI
13 December 2002
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NO_MASK
Administrative Court
W. Nowicky
AUT
CHAMBER
Task: Annotate the document to anonymise the following person: W. Nowicky