Lexploria

AS TO THE ADMISSIBILITY OF

Application No. 26988/95

by OSTEO Deutschland GmbH

against Germany

The European Commission of Human Rights (First Chamber) sitting

in private on 14 January 1998, the following members being present:

MM M.P. PELLONPÄÄ, President

N. BRATZA

E. BUSUTTIL

A. WEITZEL

C.L. ROZAKIS

Mrs J. LIDDY

MM L. LOUCAIDES

B. MARXER

B. CONFORTI

I. BÉKÉS

G. RESS

A. PERENIC

C. BÎRSAN

K. HERNDL

M. VILA AMIGÓ

Mrs M. HION

Mr R. NICOLINI

Mrs M.F. BUQUICCHIO, Secretary to the Chamber

Having regard to Article 25 of the Convention for the Protection

of Human Rights and Fundamental Freedoms;

Having regard to the application introduced on 14 March 1995 by

OSTEO Deutschland GmbH against Germany and registered on 6 April 1995

under file No. 26988/95;

Having regard to:

- the reports provided for in Rule 47 of the Rules of Procedure of

the Commission;

- the observations submitted by the respondent Government on

21 June 1996 and their further submissions of 5 December 1996;

and the observations in reply submitted by the applicant company

on 18 July 1996 and its further submissions of 13 November,

11 December 1996 and of 4 August and 22 September 1997;

Having deliberated;

Decides as follows:

THE FACTS

The applicant company is a limited company with its seat in

Freiburg. It produces pharmaceuticals and other medical products.

Before the Commission the company, represented by Mr. B. Leu, its

managing director, is represented by Mr. H. Kroitzsch, a lawyer

practising in Karlsruhe.

A. Particular circumstances of the case

The facts of the case, as they have been submitted by the

parties, may be summarised as follows.

On 21 January 1988 the applicant company requested the Federal

Health Office (Bundesgesundheitsamt) for an authorisation to produce,

as a medical product, a bone substitute product, pursuant to the

Pharmaceutical Act (Arzneimittelgesetz).

In July 1991, in the absence of any decision on their request,

the applicant company instituted proceedings with the Berlin

Administrative Court (Verwaltungsgericht) complaining about the

inactivity of the Federal Health Office. On 13 December 1991 the

Administrative Court ordered the defendant to decide on the applicant

company's request.

On 4 December 1992 the applicant company lodged an official

liability action before the Berlin Regional Court (Landgericht) against

the Federal Health Office, claiming damages due to the failure to

decide upon their request of 1988. These submissions were received at

the Court Registry on 13 January 1993.

Moreover, on 16 December 1992 the applicant applied to the Berlin

Administrative Court for measures in execution of the decision of

13 December 1991. On 11 January 1993 the Administrative Court,

pursuant to S. 172 of the Code of Administrative Procedure

(Verwaltungsprozeßordnung), fixed a fine of DEM 2,000 in case the

Office should not decide within one month. The Office appealed, but,

on the basis of its appeal statements, the applicant company submitted

that the matter was disposed of. The proceedings were thereupon

discontinued.

On 18 March 1993 the Regional Court, referring to S. 148 of the

Code of Civil Procedure (Zivilprozeßordnung), stayed (Aussetzung) the

proceedings in order to await the decision by the Federal Health Office

on the applicant company's request. The Regional Court considered that

the outcome of the proceedings regarding the compensation claims

depended upon the question whether or not the product concerned could

be authorised.

On 17 May 1993 the Regional Court declined to entertain ("wird

nicht abgeholfen") the applicant company's appeal. It referred the

applicant company inter alia to the possibility of applying for

executive measures under the Administrative Court decision of

13 December 1991.

On 26 November 1993 the Berlin Court of Appeal (Kammergericht)

dismissed the applicant company's appeal against the decision of

18 March 1993. The Court of Appeal argued that the stay of the

proceedings was necessary within the meaning of S. 148 of the Code of

Civil Procedure. The Court noted that the officials of the Federal

Health Office had failed in their duty to decide speedily on the

applicant's request, in particular after a decision rendered by the

Berlin Administrative Court (Verwaltungsgericht) on 13 December 1991,

ordering the Office to decide without further delay. However, the

award of damages depended on the question whether the production of the

medical product concerned could be authorised under the Pharmaceutical

Act, and the decision of the Federal Health Office had to be awaited

in order to avoid conflicting decisions.

On 29 December 1993 the applicant company lodged a constitutional

complaint with the Federal Constitutional Court, complaining that the

decision to stay the official liability proceedings violated its right

to have its compensation claims decided within a reasonable time. On

2 March 1995 the applicant company's representative Mr. Kroitzsch, upon

his inquiry with the Federal Constitutional Court, was informed that

no date for the Court's deliberations on the complaint of December 1993

had been fixed.

On 12 April 1996 the Federal Institute for Pharmaceutical and

Medical Products (Bundesinstitut für Arzneimittel und Medizinprodukte),

the successor of the Federal Health Office, dismissed the applicant

company's request. The Institute noted that in its report of

13 July 1995 it had drawn the applicant company's attention to

shortcomings in its application for authorisation, i.e. questions of

clinical research. The Institute found that the applicant company's

further submissions of 31 October 1995 had not remedied these

shortcomings. The decision was served upon the applicant company on

15 April 1996.

On 8 May 1996 the applicant company lodged an administrative

appeal (Widerspruch) with the Institute. In the appeal reasons of

26 June 1996 it was submitted that the alleged shortcomings had been

fully remedied and attached a private medical opinion. These

proceedings are pending.

On 20 May 1996 the Rapporteur of the First Division (Senat) of

the Federal Constitutional Court inquired with Mr. Kroitzsch as to

whether, following the Institute's decision of April 1996, steps had

been taken with a view to resuming the adjourned proceedings pending

before the Berlin Regional Court as well as about the state of these

proceedings. The Rapporteur further warned that in the event that the

Regional Court had set aside its earlier decision to adjourn, the

constitutional complaint could be inadmissible. By letter of

4 June 1996, Mr. Kroitzsch replied that no decision had been taken by

the Regional Court and that appeal proceedings were pending before the

Institute for Pharmaceutical and Medical Products.

On 31 October 1996 the Second Section (Kammer) of the

First Division of the Federal Constitutional Court refused to entertain

the applicant company's constitutional complaint. The decision was

served on the applicant company's representative on 13 November 1996.

According to information provided by the applicant company on

22 September 1997, no further decisions have been taken.

Meanwhile, on 28 February 1996 the applicant company obtained a

certificate under the 1994 Medical Devices Act (Medizinproduktegesetz)

and can sell its bone substitute product in Germany.

B. Relevant domestic law

As regards preliminary issues giving rise to separate proceedings

still pending, S. 148 of the Code of Civil Procedure (Zivilprozeß-

ordnung) provides as follows:

"Where the determination of a dispute depends wholly or in part

on the existence or non-existence of a legal relationship, which

is the subject of other legal proceedings pending or which is to

be established by an administrative authority, the court may stay

the main proceedings until such time as a final decision has been

given in the other legal proceedings or the decision by the

administrative authority has been given."

"Das Gericht kann, wenn die Entscheidung des Rechtsstreits ganz

oder teilweise von dem Bestehen oder Nichtbestehen eines

Rechtsverhältnisses abhängt, das den Gegenstand eines anderen

anhängigen Rechtsstreits bildet oder von einer Verwaltungsbehörde

festzustellen ist, anordnen, daß die Verhandlung bis zur

Erledigung des anderen Rechtsstreits oder bis zur Entscheidung

der Verwaltungsbehörde auszusetzen ist."

According to S. 150 of the Code of Civil Procedure, the court may

at any time amend (aufheben) its decisions on, inter alia, the stay of

the main proceedings.

S. 250 of the Code of Civil Procedure provides that stayed or

suspended proceedings are resumed (Aufnahme) in filing written

submissions with the court.

Decisions to stay main proceedings are subject to appeal (S. 252

of the Code of Civil Procedure).

COMPLAINTS

The applicant company complains under Article 6 para. 1 of the

Convention about the length of the official liability proceedings and

in particular about the delay in the Constitutional Court proceedings.

PROCEEDINGS BEFORE THE COMMISSION

The application was introduced on 14 March and registered on

16 April 1995.

On 12 April 1996 the Commission decided to communicate the

application to the respondent Government.

The Government's written observations were submitted on

21 June 1996. The applicant company replied on 18 July 1996. It made

further submissions on 13 November 1996. The Government filed

supplementary observations on 5 December 1996. The applicant company

also made submissions on 11 December 1996, on 4 August and

22 September 1997.

THE LAW

The applicant company complains under Article 6 para. 1

(Art. 6-1) of the Convention about the length of the compensation

proceedings pending before the Berlin Regional Court.

This provision, as far as relevant, provides:

"In the determination of his civil rights and obligations ...,

everyone is entitled to a ... hearing within a reasonable time

by [a] ... tribunal ...".

The Commission notes that the applicant instituted the said

proceedings with the Berlin Regional Court on 13 January 1993 and that

these proceedings are still pending.

The Government submit that the application is manifestly ill-

founded. They consider that, following the decision given by the

Institute for Pharmaceutical and Medical Products in April 1996, the

applicant company can request that the proceedings pending before the

Berlin Regional Court be resumed. In their view, the stay of these

proceedings in March 1993 was appropriate in the circumstances, thereby

avoiding the taking of specialist expert evidence on a complex question

in the civil proceedings. The applicant company could have pursued the

administrative execution proceedings regarding the Administrative Court

decision of 13 December 1991. The Government further submit that

Article 6 para. 1 (Art. 6-1) of the Convention does not apply to the

proceedings before the Federal Constitutional Court. In any event, the

Constitutional Court decided within a reasonable time, other more

urgent cases had prevented it from deciding upon the applicant

company's complaint earlier.

The applicant company complains that the continuation of the

compensation proceedings is completely left to the discretion of the

defendant public authority. Moreover, it was not required to apply

repeatedly for executive measures against a public authority. In any

event, such measures were not effective in the circumstances.

The Commission has taken cognizance of both parties' submissions.

After a preliminary examination thereof the Commission has reached the

conclusion that the case raises serious issues as to the interpretation

and application of Article 6 (Art. 6) of the Convention and that these

issues can only be determined after a full examination of their merits.

It follows that the application cannot be regarded as manifestly

ill-founded within the meaning of Article 27 para. 2 (Art. 27-2) of the

Convention. No other ground for declaring it inadmissible has been

established.

For these reasons, unanimously, the Commission

DECLARES THE APPLICATION ADMISSIBLE, without prejudging the

merits of the case.

M.F. BUQUICCHIO M. PELLONPÄÄ

Secretary President

to the First Chamber of the First Chamber

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OSTEO DEUTSCHLAND GmbH v. GERMANY

OSTEO DEUTSCHLAND GmbH v. GERMANY

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