2009/01/08 - II. ÚS 1009/08: Preliminary Question to ECJ

08 January 2009

HEADNOTES

The

constitutional complaint thus represents a specific procedural means,

the purpose of which is to ensure the respect of, alternatively afford

protection to, the fundamental rights and freedoms guaranteed by the

constitutional order. The complaint does not qualify as an ordinary or

extraordinary remedial procedure relating to the subject of the specific

proceeding before ordinary courts. The differentiation of the functions

of ordinary and administrative courts, on the one hand, and the

Constitutional Court on the other, is entirely within the competence of

the national legislature. According to the provisions of the Treaties on

the European Community and on the European Union relating to the

division of competences, as well as the ECJ jurisprudence, it is in

principle a matter for the Member States to lay down detailed procedural

rules (cf. ECJ judgment of 13 March 2007, C-432/05, headnote, marginal

number 39-42).

Although the referral of a preliminary question is

a Community law matter, the failure, in conflict with Community law, to

make a reference may, in certain circumstances, also entrain a

violation of the constitutionally-guaranteed right to one’s statutory

judge. After all, one must bear in mind the fact that the prerequisite

for the entitlement to submit a constitutional complaint is the

exhaustion of all procedures afforded him by law for the protection of

rights. A violation of the right to one’s statutory judge comes about in

the case where a Czech court (the decision of which may no longer be

contested through further remedial procedures afforded by

sub-constitutional law) applies Community law but fails, in an arbitrary

manner, that is, in conflict with the principle of the law-based state

(Art. 1 para. 1 of the Constitution of the Czech Republic), to refer a

preliminary question to the ECJ.

The Constitutional Court asserts

that it deems as arbitrary action such conduct by a court of last

instance applying a norm of Community law where that court has entirely

omitted to deal with the issue whether it should refer a preliminary

question to the ECJ and has not duly substantiated its failure to refer,

including the assessment of the exceptions which the ECJ has elaborated

in its jurisprudence. In other words, it is a case where the court

entirely fails to take into consideration the existence of the

peremptory rule, which is binding on it, contained in Article 234 of the

Treaty establishing the European Community.

 


CZECH REPUBLIC

CONSTITUTIONAL COURT

JUDGMENT


IN THE NAME OF THE CZECH REPUBLIC

 


On

8 January 2009, a panel of the Constitutional Court, composed of its

Chairwoman, Dagmar Lastovecká, and Justices František Duchoň and Eliška

Wagnerová (Justice Rapporteur), in the matter of the constitutional

complaint of the commercial company, Pfizer, spol. s r. o., whose

headquarters is at Stroupežnický 17, 150 00 Prague 5, represented by

JUDr. Jan Matějka, an attorney of the law offices of Čermák, Hořejší,

Matějka a spol., with its headquarters at Národní 32, 110 00, Prague 1,

against the 6 October 2005 decision of the Ministry of Health of the

Czech Republic, No. FAR - 165/1656, 32397/2005, the 28 March 2007

judgment of the Prague Municipal Court, No. 12 Ca 144/2005-137, and the

23 January 2008 judgment of the Supreme Administrative Court, No. 3 Ads

71/2007-183, decided as follows:

I. By proceeding in a

manner violative of Art. 2 para. 3 of the Constitution of the Czech

Republic in conjunction with Art. 4 para. 4 of the Charter of

Fundamental Rights and Freedoms, the 23 January 2008 judgment of the

Supreme Administrative Court, No. 3 Ads 71/2007-183, resulted in the

violation of the complainant’s fundamental right guaranteed by Art. 38

para. 1 of the Charter of Fundamental Rights and Freedoms.

II. Accordingly, that decision is quashed.

III. In other respects, the constitutional complaint is rejected on preliminary grounds.



 


REASONING

 

I.
 

1.

In its constitutional complaint, consigned for postal delivery on 21

April 2008 and supplemented by a submission on 1 September 2008, the

complainant has asked that the above-mentioned decisions be quashed, as

they resulted in a violation of its fundamental rights guaranteed by

Art. 11 para. 1 and Art. 36 para. 1 of the Charter of Fundamental Rights

and Freedoms (hereinafter „Charter“).

2. The constitutional

complaint is admissible (§ 75 para. 1 a contrario of Act No. 182/1993

Sb., on the Constitutional Court, as subsequently amended, (hereinafter

"Act on the Constitutional Court")), was timely submitted and, following

the curing of defects as so requested, fulfills the other requirements

demanded by law [§ 30 para. 1, § 72 para. 1, lit. a) Act on the

Constitutional Court].

3. In its constitutional complaint, the

complainant objects that several of its fundamental rights have been

violated, in particular, its right to fair process under Art. 36 para. 1

of the Charter. This violation consisted in the fact that it was denied

the opportunity to be a party to the administrative proceeding on the

registration of the medicinal product, TORVACARD 40 por. tbl. flm., of

the firm Zentiva, which was registered pursuant to a decision of the

State Institute for the Supervision of Medications, File No. 5260/04,

Reg. No. 31/206/04-C. This medicinal product was registered by making

reference to the complainant‘s registration data for the medicinal

product SORTIS 40. In the complainant’s view, the denial of the

opportunity to be a party to the administrative proceeding constituted a

denial of the right to fair process, which can be effectuated only and

solely in the case where a person claiming her rights is given the

opportunity to take part in a proceeding to assert and defend her

rights. In the complainant’s view, sincethe Supreme Administrative Court

(hereinafter „SAC“), in contrast to the Municipal Court, reached the

conclusion that the Act on Medications valid at that time (No. 79/1997

Sb., which regulated the process of the registration of medicinal

products) did not define a special class of parties to that proceeding,

meaning that the issue of participation had to be assessed according to §

14 para. 1 of the then valid Act No. 71/1969 Sb., the Administrative

Procedure Code, the SAC should have quashed the contested judgment of

the Municipal Court, in accord with Constitutional Court Judgment No.

Pl. ÚS 547/02 (however, the complainant meant Judgment I. ÚS 547/02, N

170/35 SbNU 301), which provides that „in order for a legal or natural

person to have the status as a party to an administrative proceeding, it

is sufficient that there be a mere supposition that they have rights,

legally protected interests or obligations which should be considered in

the matter.“

4. According to the complainant, the violation of

its right to fair process also occurred in view of the 9th paragraph of

the Preamble to Directive 2001/83/EC (hereinafter „the Directive“),

which emphasized the protection of innovative firms from being

disadvantaged. Nonetheless, it was not possible to effectuate this

protection since the administrative office denied the innovative firm

participation in the proceeding. While it is true that para. 10 of the

Preamble to the Directive provides that it is in the public interest

that tests on humans and animals not be performed repeatedly, unless it

were urgently needed, the complainant’s participation in the proceeding

should not, however, lead to the necessity of repeating those tests.

5.

That the complainant should be a party to the administrative proceeding

follows from the fact that it is the owner of the information and data

of pre-clinical and clinical tests which the complainant provided the

registrar, thus it has an interest in seeing that its property is used

in comformity with law. Since it was denied its right to fair process,

its right to own property guaranteed by Art. 11 of the Charter was also

restricted. The complainant was not able, within the registration

proceeding, to ensure the proper use of its own registration and other

data, and thus its property rights were restricted beyond the limits of

the law, as the law does not restrict the protection of property in

information provided and in pharmacological and toxicological tests. Its

property rights were restricted entirely without respect for the

principle of proportionality. Moreover, the SAC denied the complainant

its right to the protection of acquired rights and the protection of

property by the fact that the complainant was not able to effectuate the

protection of data for the duration of the protective period for data

on medicinal products which were registered before the coming into

effect of Act No. 149/2000 Sb. (and Act No. 129/2003 Sb.), which amended

the Act on Medications that was at that time valid. In the

complainant’s view, this was a clear case of genuine retroactivity (the

time period was shortened while it was still running), which is not

permissible. In accord with Judgment Pl. ÚS 21/96 (63/1997 Sb., N 13/7

SbNU 87), the legal norm which is valid and in force at the time the

claim came into being must be applied to the start and the running of

the protective period for data on the product SORTIS 40.

6.

Therefore, in view of what has been stated above, the petitioner

proposed that, in its judgment, the Constitutional Court quash the

decisions cited in the heading.

7. At the Constitutional Court’s

request, the Prague Municipal Court and the SAC gave their views on the

constitutional complaint. One party, the Ministry of Health, did not

gives its views on the petition. In relation to the secondary party,

Zentiva, a.s., the Constitutional Court proceeded as required by the

proposition of law expressed in its Judgment I. ÚS 642/03 and did not

request the secondary party to give its views, as the protection of its

rights and interests were not at stake in this proceeding on a

constitutional complaint.

8. In its statement of views, the

Prague Municipal Court, represented by Mgr. Jiří Tichý, panel chairman,

referred to the reasoning of its 28 March 2007 judgment, No. 12 Ca

144/2005-137. In its view, in the complainant’s matter, there was no

denial of the right to its statutory judge consisting in the failure to

refer a question to the European Court of Justice. There were no grounds

for so doing, as Act No. 79/1997 Sb. speaks clearly to the point of

participation in an administrative proceeding.

9. In the opinion

of JUDr. Jaroslav Vlašín, Chairman of Panel 3 of the SAC, the arguments

that the complainant makes in its constitutional complaint are

essentially identical to those it made in its cassational complaint. The

SAC points out that in the adjudicated case, it dealt only with the

issue of participation by the firm, Zentiva, a.s., in the proceeding on

the registration of medicinal products and not on the merits of matter

itself. No grounds were adduced for referring a preliminary question.

Panel 3 did not find any provision in EU Directive No. 2001/93/EC [Note

of translator: correctly No. 2001/83/EC] which would be necessary to

interpret for the purposes of adjudicating the complainant’s

participation in the registration proceeding. The Chairman of Panel 3

then analyzed Art. 10 of the Directive, which delineates the cases where

the results of toxicological and pharmacological tests or the results

of clinical assessments of the original medicinal products can be used

for registration of generic products. The purpose of that article is to

lay down which data the competent body is not obliged to demand within

the framework of the proceeding for the registration of generic

medicinal products. That provision does not serve to protect the rights

of industrial and commercial property of the producers of the original

medicinal products, which are not assessed within the framework of the

registration proceeding. There is thus nothing establishing its right to

participation.

10. According to § 44 para. 2 of the Act on the

Constitutional Court, the Constitutional Court may, with the consent of

the parties, dispense with an oral hearing if further clarification of

the matter cannot be expected from such a hearing. The parties granted

their consent, and an oral hearing was dispensed with.
 


II.
 

11.

In order to assess the complainant‘s objections and assertions, the

Constitutional Court also requested from the Prague Municipal Court case

file No. 12 Ca 144/2005, from which it ascertained the following facts.

12.

On 13 December 2005 the complainant contested before the Prague

Municipal Court the 6 October 2005 decision of the Ministry of Health,

No. FAR-165/1656, 32397/2005, which had rejected as inadmissible the

appeal against the 29 December 2004 decision of the State Institute for

the Supervision of Medicines, No. 5260/04, on the registration of the

medicinal product TORVACARD 40. The appeal was based on the

complainant’s assertion that it should have been a party to the

administrative proceeding, however, it was not dealt with in the

proceeding on registration, even though the decision on registration

significantly affected both its rights and its commercial interests.

According to the opinion of the Ministry of Health, this appeal cannot

be considered as an ordinary remedial procedure against this decision,

as it was not submitted by a person who was a party to this proceeding

according to § 30 para. 2 of the Act on Medications, which is lex

specialis in relation to the general regulation in the Administrative

Procedure Code. The purpose of this provision is to exclude the

possibility that some person other than the applicant for registration

could be a party to the proceeding. There is another reason why the

complainant cannot be considered a party to the administrative

proceeding, namely that in a proceeding on registration only the rights

of holders are founded in the decision on registration.

13. It

appears from the 28 March 2007 decision of the Prague Municipal Court,

No. 12 Ca 144/2005, that the court concerned itself primarily with the

issue of whether the complainant was a party to the registration

proceeding (which the complainant substantiated with reference to Art.

10 of the Treaty establishing the European Community and Art. 234 of the

same Treaty, laying down the principle of legal protection, which would

be violated were the complainant not to be admitted as a party to the

proceeding). In the Municipal Court’s view, the group of parties is

specially defined in § 30 para. 2 of Act No. 79/1997 Sb., on

Medications, the purpose of which is to restrict the possibility that

any other legal subject which sought participation in the registration

proceeding would gain access to all data relating to the medicinal

products submitted by the applicant for registration within the

framework of the registration proceeding. The rejection of the appeal on

the merits was thus well-founded because the fact that the complainant

could not be a party to the proceeding also results in the outcomes that

neither could it submit an appeal against the registration of the

medicinal product. According to the court’s view, the complainant’s

rights are in no way affected by the registration. If the complainant

makes arguments based on EU Directive No. 2001/83/EC, it is solely the

laying down of a protective period which serves to protect the producers

of original medications, after which cannot be registered derivative,

„generic“ medicinal products, but it does not follow from any enactment

that the holder of a decision on the registration of medicinal products

would be a party to the proceeding on the registration of other

medicinal products, albeit generic ones. On the contrary, according to

the Municipal Court, Art. 19 of the Directive provides (sic!) that it is

unacceptable for one competitor on the market to be entitled to

adjudicate the products and performances of another competitor,

alternatively for it to be entitled to participate in a proceeding in

which the rights, legally protected interests, and obligations of

another competitor are decided. The Municipal Court is then in no way

bound by the decisions of the Supreme Administrative Court in Stockholm

(according to whose opinion the producer of the original medicinal

product has such an interest in the issue of registration that it has

the right to appeal from the registration of generic copies) or those of

the Supreme Administrative Court in Sweden, to which the complainant

referred. That case concerned the registration of a „generic“ medicinal

product, and that medicinal product was registered only after the

statutory protective period had expired.

14. In its 14 May 2007

cassational complaint, the complainant contested the Municipal Court’s

judgment before the SAC. Although the SAC did not concur with the

Municipal Court’s opinion that § 30 para. 2 of the Act on Medications

does not specially define the parties to the registration proceeding, it

did concur with it on the point that the registration procedure

concerns solely the rights and obligations of the registration. The fact

that the State Institute for the Supervision of Medicines is authorized

to make use of data submitted by the producer of the original product

(and the applicant is thus not obliged to submit the results of

pharmacological and toxicological tests) does not affect the rights to

the protection of industrial and commercial property. It is only the

applicant for registration who is a party to the proceeding, as the

subject of the proceeding is not the protection of data or the

protection of the holder’s industrial and commercial property (for the

protection of its rights, the holder is referred to civil judicial

proceedings). The SAC gave its views only obiter dictum on the issue of

the length of the protective period for the data on medicinal products.

It was entirely correct that the Municipal Court did not adjudicate the

issue whether the conditions were fulfilled for the registration of the

medicinal product (the issue of the similarity or dissimilarity of the

intended medical use), as the crucial issue was that of participation in

the proceeding.
 


III.
 

15. The Constitutional Court has reached the conclusion that the constitutional complaint is well-founded.

16.

As follows from the Constitutional Court’s constant jurisprudence, the

Constitutional Court is bound only by the petit [requested relief] in a

submitted petition and not by its legal reasoning. The Constitutional

Court can entertain the possibility of reviewing even in terms of other

fundamental rights and freedoms than those which are mentioned in the

petition. In this case what appears crucial is the issue whether the

complainant’s right to its statutory judge, guaranteed by Art. 38 para. 1

of the Charter, was violated. The primary, not however the sole,

purpose of the right to one’s statutory judge is to exclude arbitrary

manipulation in the assignment of cases to individual judges. In other

words, the purpose of this right is to ensure impartial decision-making

by an independent judge. As the Constitutional Court has already ruled,

it is fitting that the constitutional imperative that no one may be

removed from the jurisdiction of his statutory judge (Art. 38 para. 1,

first sentence, of the Charter), „be deemed an entirely indispensable

condition of the due performance of that part of public power which has

been constitutionally entrusted to courts; after all, on the one hand it

completes and strengthens judicial independence, and on the other hand

it represents for each party to a proceeding the equally valuable

guarantee that courts and judges have been enlisted to decide in his

matter in accordance with principles (procedural rules) that have been

previously laid down, so as to preserve the principle of the fixed

assignment of the court’s business and so as to exclude – for various

reasons and sundry aims – the selection of courts and judges „ad hoc“.

Accordingly, the constitutional principle of the statutory judge cannot

be circumvented, whatever be the grounds therefor; even less can its

circumvention be masked with reference to a decision issued in conflict

therewith being „otherwise correct on the merits“, as not only

historical experience, but even experience from the recent period of the

totalitarian regime persuasively demonstrate how dangerous it is for

the individual and damaging to the entire society to enlist courts and

judges in the administration of justice in accordance with opportunistic

perspectives or through selection“ (III. ÚS 232/95, N 15/5 SbNU 101).

17.

Whereas the purpose of the manipulative assignment of cases distinctive

for totalitarianism is to carry out the will of the assignor (generally

party organs), in a liberal democracy the purpose of the right to one’s

statutory judge is to ensure impartial and independent decision-making,

that is, the discovery of the intent and purpose of the legal norm, or

of the statute, which should be applied, such that it would be possible

to decide fairly. Further, where a Community law component is present,

the purpose of the right to one’s statutory judge is to ensure the

unitary interpretation of legal norms of Community law so as to make it

possible, throughout the entire European Union, to fulfill the maxim of

equality before the law through individual interpretations of the

objective of legal norms contained in Community law. At the same time,

the requirement of the foreseeability of the law (see, for ex., I.ÚS

287/04, N 174/35 SbNU 331, I.ÚS 431/04, N 31/36 SbNU 347, IV.ÚS 167/05, N

94/37 SbNU 277, Pl.ÚS 38/04, 409/2006 Sb., N 125/41 SbNU 551), which

makes up a component of the demands arising from the requirement of the

principle of a law-based state, is thereby ensured.

18. In

consequence of the Czech Republic‘s accession to the European Union,

Czech courts acquired the entitlement, and in certain circumstances also

become subject to the obligation, to address the European Court of

Justice (hereinafter „ECJ“) with preliminary questions. On the basis of

the third sub-paragraph of Article 234 of the Treaty establishing the

European Community, a Member State court, against whose decisions there

is no judicial remedy under national law, is obliged to refer a

preliminary question to the ECJ
(the ECJ, in its decision C-283/81,

Srl CILFIT and Lanificio di Tabardo SpA v. Ministry of Health, [1982]

3415, then elaborated the aggregate of exceptions to the obligation to

refer a preliminary question). The purpose of the proceeding on a

preliminary question is above all to ensure the uniform application of

Community norms by the national courts of Member States and [the purpose

of the third paragraph of Article 234 is] „to prevent a body of

national case-law not in accord with the rules of Community law from

coming into existence“ (107/76 Hoffmann-La Roche v. Centrafarm, [1977]).

19.

The Constitutional Court has repeatedly held that it does not form a

part of the system of ordinary courts. The Constitutional Court’s

yardstick is constitutionality, in other words the review of conformity

with the normative and value categories of the Constitution (cf.

Klokočka, V.: The Task of the Constitutional Court in the Supervision of

the Constitutionality of Judicial Action, Legal Advisor, No. 9/1998,

suppl., p. V). The constitutional complaint thus represents a specific

procedural means, the purpose of which is to ensure the respect of,

alternatively afford protection to, the fundamental rights and freedoms

guaranteed by the constitutional order (cf. analogously Šimíček, V., The

Constitutional Complaint, Prague, Linde, 2005, p. 76). The complaint

does not qualify as an ordinary or extraordinary remedial procedure

relating to the subject of the specific proceeding before ordinary

courts. The differentiation of the functions of ordinary and

administrative courts, on the one hand, and the Constitutional Court on

the other, is entirely within the competence of the national

legislature. According to the provisions of the Treaties on the European

Community and on the European Union relating to the division of

competences, as well as the ECJ jurisprudence, it is in principle a

matter for the Member States to lay down detailed procedural rules (cf.

ECJ judgment of 13 March 2007, C-432/05, headnote, marginal number

39-42).

20. The normative framework for Constitutional Court

review remains, even after 1 May 2004, the norms of the constitutional

order of the Czech Republic (Pl. ÚS 50/04, 154/2006 Sb., N 50/40 SbNU

443, Pl.ÚS 36/05, 57/2007 Sb.), as the function of the Constitutional

Court is the protection of constitutionality (Art. 83 of the

Constitution of the Czech Republic), moreover in both its aspects, that

is, both the protection of objective constitutional law, and of

individual, that is fundamental, rights. Community law does not form a

part of the constitutional order, therefore, the Constitutional Court is

not competent to interpret that law. Nonetheless, the Constitutional

Court cannot entirely overlook the impact of Community law on the

formation, application, and interpretation of national law, all the more

so in a field of law where the creation, operation, and aim of its

provisions is immediately bound up with Community law (Pl. ÚS 50/04,

154/2006 Sb., N50/40 SbNU 443). It is, however, both supreme courts

belonging to the system of ordinary courts which ensure the unity of

jurisprudence within the Czech Republic, moreover within the compass of

their statutorily-defined jurisdiction (competence). Since, as declared

above, Community law belongs among the mass of sub-constitutional law,

it is in principle a matter for the ordinary courts to review the

application of Community law and in certain cases falling within the

purview of Art. 234 of the Treaty establishing the European Community to

refer to the ECJ questions concerning the interpretation or validity of

Community law. It is an obligation in the case of supreme courts,

against the decisions of which the procedural enactments provide for no

remedial procedures resolvable within the framework of the system of

ordinary and administrative courts. A similar doctrine has been

embraced, for ex., by the German Federal Constitutional Court (see BvR

2419/06).

21. Although the referral of a preliminary question is a

Community law matter, the failure, in conflict with Community law, to

make a reference may, in certain circumstances, also entrain a violation

of the constitutionally-guaranteed right to one’s statutory judge.

After all, one must bear in mind the fact that the prerequisite for the

entitlement to submit a constitutional complaint is the exhaustion of

all procedures afforded the complainant by law for the protection of

rights (§ 75 para. 1 of the Act on the Constitutional Court, interpreted

in the Constitutional Court’s jurisprudence such that by, those

„procedures“, is meant any sort of procedure – that is, not only a court

action, etc., not only a purely procedurally understood remedial means

within the framework of a specific proceeding – see, for ex., II. ÚS

722/05, I. ÚS 575/06, II. ÚS 1036/07 accessible at

nalus.usoud.cz). A violation of the right to one’s statutory

judge comes about in the case where a Czech court (against whose

decision there is no longer any further remedy afforded by

sub-constitutional law) applies Community law but fails, in an arbitrary

manner, that is, in conflict with the principle of the law-based state

(Art. 1 para. 1 of the Constitution of the Czech Republic), to refer a

preliminary question to the ECJ. As follows from the conjunction of Art.

2 para. 3 of the Constitution and Art. 4 para. 4 of the Charter, state

power must be asserted only in cases, within the bounds, and in the

manner provided for by law, while at the same time preserving the

essence and significance of the fundamental rights and freedoms. Should

it be otherwise, then that action or act of state power would constitute

arbitrary conduct. As the Constitutional Court has repeatedly

emphasized, it is not every violation of the norms of ordinary law, in

their application or interpretation, which entails a violation of an

individual’s fundamental rights. Nevertheless, the violation of certain

of the norms of ordinary law in consequence of arbitrary conduct

(carried out, for ex., by the failure to respect a peremptory norm) or

in consequence of interpretation which is in extreme conflict with the

principle of justice, might be capable of encroaching upon an

individual‘s fundamental rights or freedoms (cf., for ex., III. ÚS

346/01, N 30/25 SbNU 237).

22. The Constitutional Court asserts

that it deems as arbitrary action such conduct by a court of last

instance applying a norm of Community law where that court has entirely

omitted to deal with the issue whether it should refer a preliminary

question to the ECJ and has not duly substantiated its failure to refer,

including the assessment of the exceptions which the ECJ has elaborated

in its jurisprudence. In other words, it is a case where the court

entirely fails to take into consideration the existence of the

peremptory rule, which is binding on it, contained in Article 234 of the

Treaty establishing the European Community. The bare opinion of a

court, that it considers the interpretation of the given problem to be

obvious, cannot be considered as due substantiation; such an assertion

does not suffice, particularly in a situation where the court’s opinion

has been contested by a party to the proceeding. The substantiation is

insufficient also where it fails duly to explain how and why the

solution chosen comports with the purpose of the Community legal norm.

This is a case where the court omitted to construe the peremptory rule

contained in Article 234 of the Treaty establishing the European

Community, thereby denying specific parties the right to their statutory

judge guaranteed by Art. 38 para. 1 of the Charter.

23. For the

sake of comparison and information, the Constitutional Court would

allude to the fact that the concept of arbitrariness leading to a

violation of the right to one’s statutory judge was defined primarily in

the jurisprudence of the German Federal Constitutional Court. In its

conception „it constitutes arbitrary conduct, if: (1) a fundamental

violation of the obligation to refer a preliminary question has

occurred; one can speak of a fundamental violation in the moment when

the deciding court of last instance itself had doubts concerning the

correct interpretation of Community law, yet failed to bring the matter

before the ECJ; (2) the deciding court intentionally departed from the

ECJ’s settled interpretation of a given issue, but it failed nonetheless

to institute a proceeding on a preliminary question; and (3) there did

not exist (or does not as yet exist) ECJ constant jurisprudence on the

given issue or this jurisprudence does not cover the entire range of

questions. The Federal Constitutional Court deduces the non-existence of

constant jurisprudence from the fact that the given issue can be

interpreted in a manner differing from the interpretation made by the

court applying Community law in the given case“ (Bobek, M.: The

Violation of the Obligation to Institute a Proceeding on a Preliminary

Question pursuant to Article 234 (3) of the EC Treaty, Prague, C.H.

Beck, 2004, p. 49).



IV.
 

24.

As follows from what is stated above, the pivotal issue appears to the

Constitutional Court to be whether the final instance court has acted in

an arbitrary manner, that is, the issue of whether and how the final

instance court reasoned that it considered the interpretation of the

given issue of Community law to be so obvious that there is no reason

for applying the peremptory norm contained in Art. 234 of the Treaty

establishing the European Community and it is, therefore, not necessary

to refer a preliminary question to the ECJ.

25. By the Czech

Republic‘s acceptance into the European Union, all rules contained in

Community law thereby became binding, with all consequences, at the

moment of its acceptance. Also Directive No. 2001/83/EC thereby became

binding, and was implemented domestically, that is, transposed into a

national enactment, specifically into the Act on Medications. The

provisions of the Act on Medications are crucial in the given matter, in

particular § 24 para. 6, lit. c), which provides, among other things,

that [without the separate legal enactments on the protection of

industrial and commercial property being affected] applicants seeking

registration are not obliged to submit either the results of

pharmacological and toxicological tests or the results of clinical

evaluations, insofar as they can demonstrate that the medicinal product

is essentially similar to a medicial product which has been registered

in the Czech Republic for a period of at least 6 years; however, if such

medicinal product had already, prior to the issuance of a decision on

registration, been registered in certain Community Member States, than

the six-year time period would begin to run on the day of such

registration. This provision resulted from the transposition of the

Directive into the national legal order, namely its Article 10, which

reflects the principles expressed in paragraphs 9 and 10 of the Preamble

to the Directive. The SAC was, after all, entirely aware of this, as it

itself stated this fact in its decision. Nevertheless, in the

Constitutional Court’s opinion, the SAC did not deal in a sufficient

manner with the interpretation of the aims pursued by the given

Directive, an act of secondary Community law, the respect and

implementation of which should also have actually been ensured by the

Czech Republic. The issue of the purposes of a Directive is otherwise

pivotal for the given issue, as the teleological and systematic

interpretation is far more common than grammatical interpretation in

Community law and, as a rule, is of greater relevance (cf. Bobek, M.,

Komárek, J., Passer, J., Gillis, M., Preliminary References in Community

Law, Prague, Linde, 2005, p. 230, and Tichý, L., Arnold, R., Svoboda,

P., Zemánek, J., Král, R., European Law, Prague, C.H. Beck, 2006, p. 228

and the jurisprudence mentioned therein). It follows from the legal

character of the Directive that the national measures implementing it

must ensure the objectives pursued by the Directive, whereas the choice

of means remains on the national level.

26. In the Constitutional

Court’s view, the SAC’s fundamental error was the fact that, in

interpreting Community law, it shed no light on the jurisprudence of the

ECJ, that is, the body with the authority to make the final and

unifying interpretation of Community law, as follows from the

conjunction of Arts. 220, 234, and 292 of the Treaty establishing the

European Community (cf., analogously, Bobek, M.: The Violation of the

Obligation to Institute a Proceeding on a Preliminary Question pursuant

to Article 234 (3) of the EC Treaty, Prague, C.H. Beck, 2004, p. 60). As

is seen from the SAC’s decision, it did not in any way ascertain

whether or how the ECJ has held on the given issue. The SAC’s decision

does not have so much as a reference to any ECJ decision whatsoever

which would relate to the given issue. The SAC did not concern itself in

the least with ECJ jurisprudence, therefore the SAC’s decision can

scarcely be considered as properly substantiated. Despite the fact that

the complainant did not, in its cassational complaint, propose that a

preliminary question be referred, it nonetheless appears alone from its

submission instituting cassational proceedings that, for the reason of

preserving the principle of legal protection, the complainant was

alluding to a preliminary question. The complainant stated in its

submission, among other things, that „the State Institute for the

Supervision of Medicines does not come within the term, ‘court‘, in the

sense of Article 234 of the Treaty of Rome, so that it could not itself

refer to the ECJ a preliminary question on the interpretation of the

relevant provisions of Directive No. 2001/83/EC.“ The subject of the

dispute is connected with the issue of the proper interpretation of

Community law, decision on which the ECJ alone is entitled to render, a

fact which the SAC has entirely overlooked. On the one hand, the SAC was

well aware of the importance of the issue of interpretation of

Community law, nonetheless it resolved the issue of participation in the

proceeding by the citation of the pertinent provisions of the Directive

and their implementation, without attempting to interpret them, much

less seek out their intent.

27. The SAC’s decision contains no

reference to the exceptions which the ECJ has elaborated on the

obligation of courts of last instance to refer preliminary questions, if

they must apply a norm of Community law, although that obligation is

laid down for it in the peremptory norm of Art. 234 of the Treaty

establishing the European Community. The decision does not contain a

reference of any kind to the criterion laid down in the ECJ‘s decision

C-283/81, Srl CILFIT and Lanificio di Tabardo SpA v. Ministry of Health,

[1982] 3415, in which the ECJ laid down specific exceptions which

relieve courts of last instance of the obligation to refer a preliminary

question on the interpretation of legal norms of Community law which

should be applied in a concrete case. As follows from the SAC’s

statement of views, it found no grounds for referring a preliminary

question to the ECJ, as it had no doubts concerning the interpretation

of particular provisions. In other words, in its decision the SAC

considered the interpretation of Community law to be obvious and clear

(moreover, without the necessity of making reference to any ECJ

precedents whatsoever). In making that finding, it did not even take

into consideration the argument the complainant made before the Prague

Municipal Court which drew attention to the fact that the jurisprudence

of the Swedish Supreme Court in Stockholm resolving the issue of

participation speaks in favor of the complainant’s interpretation.

Namely, the Swedish court came to the conclusion that producer of the

original medicinal product had such an interest in the issue of

registration as to entitle it to appeal the registration of generic

copies. The SAC’s conviction, that its interpretation of the Community

law norm is entirely clear and obvious, is not persuasive also for the

reason that is has not properly come to terms with the objection that in

other Members States the given enactment is interpreted and applied in a

divergent fashion. If the decisional practice of the Swedish Supreme

Court is to remain different, the SAC’s conviction would thus be founded

on nothing that is well-founded, the undesirable variance in

interpretation of the intent of the Community norm at issue within the

EU area, which is in conflict with the principle of legal certainty,

from which follows also the requirement of the foreseeability of law

throughout the entire territory in which it should be applied. This fact

should have been of interest to the SAC.

28. The fact, that the

SAC cannot be considered to have made due substantiation, follows also

from the fact that the SAC merely transcribed certain aims contained in

the Directive‘s Preamble in conjunction with the Act on Medications,

without embarking on a more in-depth interpretation of them, all the

while ignoring the other aims to which the complainant drew its

attention. The SAC did not ask in more depth what consequences are

ushered in by the further aims pursued by para. 9 of the Directive’s

Preamble, that is, the requirement that innovative firms not be

disadvantaged, and further contained in Art. 10 of the Directive,

according to which the registration of generic products should not

affect the legal protection of industrial and commercial property.

Preferring only certain aims leads to the outcome that the SAC’s

conclusion [namely that „only the applicant for registration is a party

to the registration proceeding. The rights or obligations of the holder

of the decision on registration of the original medicinal product cannot

be affected by the decision on the registration“] follows from its

selective choice. The SAC has not dealt with the interpretive

alternatives, which would be to take into account also the other

above-designated aims. Acknowledged participation could thus be a

preventive and effective protection against possible encroachments upon

the rights of the holder of the decision on the registration of the

original medicinal product, that is, participation would pursue, in the

form of a preventive defense, a restriction in the intensity of a

possible encroachment into the property rights of the holder of the

decision on the registration of the original medicinal product. Since

this interpretive alternative also suggests itself, supported by Swedish

jurisprudence, it would be appropriate to become acquainted with the

ECJ’s jurisprudence, and should it not prove possible to find a response

therein, it would be necessary to refer a preliminary question to the

ECJ.

29. In this context, we must also pause to consider the

practice of our courts, which have rarely addressed themselves to the

ECJ with a preliminary question. As appears from the statistics

contained in the ECJ Annual Report for 2007 (p. 99nn.), neither the

Supreme Court nor the Supreme Administrative Court have ever yet

addressed itself to the ECJ with a preliminary question, although our

limited experience with Communitary law should, on the contrary, make

for a larger number of references. The Municipal Court’s work in this

matter is also indicative of our limited experience with Community law.

This court is wholely mistaken on the content of Art. 19 of the

Directive at issue if it asserts that this provision lays down that „it

is unacceptable for one competitor on the market to be authorized to

adjudicate the products and performance of another competitor, or for it

to be authorized to take part in a proceeding in which the rights,

legally protected interests, and obligations of other competitors are

decided upon.“ This reference served the Municipal Court as a subsidiary

argument for excluding the possibility for the complainant to

participate in the proceeding, even though Article 19 lays down nothing

of the kind. The court took the citation from an assertion made by the

secondary party, without having checked it.

30. Since the

complainant has the right to the exhaustion of all remedies which the

legal order envisages for the protection of its rights, the SAC, as the

court of last instance, has violated its right to its statutory judge,

which is guaranteed by Art. 38 para. 1 of the Charter, when it

arbitrarily (that is, in conflict with Art. 2 para. 3 of the

Constitution of the Czech Republic in conjunction with Art. 4 para. 4 of

the Charter) failed to address itself to the ECJ with a preliminary

question regarding the complainant’s participation in the given

proceeding. The SAC also failed both to explain or to substantiate, with

regard to the existence of the peremptory rule contained in Art. 234 of

the Treaty establishing the European Community, why its interpretation

of the pertinent norms of Community law is quite obvious and why its

chosen solution, consisting in the refusal to accord participation in

the registration proceeding, comports with the intent of the Community

norm.

31. For the above-stated reasons, the Constitutional Court

has granted the complaint and, in accordance with § 82 para. 3 of Act

No. 182/1993 Sb., on the Constitutional Court, as subsequently amended,

quashed the SAC’s decision. In did so based upon the fact that the SAC,

as a court of last instance, is obligated, in the sense of Article 234

of the Treaty establishing the European Community, to refer a

preliminary question, whereas lower courts are merely given the

possibility, however do not have that obligation, and administrative

bodies do not have the possibility to refer a preliminary question.

Accordingly, the Constitutional Court rejected, as an inadmissible

petition (§ 43 para. 1 lit. e) of the Act on the Constitutional Court),

the constitutional complaint against the decision of the Ministry of

Health of the Czech Republic, as well as against the judgment of the

Prague Municipal Court.


Notice: A Constitutional Court decision may not be appealed (§ 54 para. 2 of the Act on the Constitutional Court).

Brno, 8 January 2009

 

 

 

Dissenting Opinion

of Justice Dagmar Lastovecká

I

have adopted this separate opinion in relation to the statement of

judgment I and part of the reasoning of the judgment, that is, to the

conclusion reached that the Supreme Administrative Court‘s „arbitrary“

means of proceeding (described primarily in points 25 to 28 of the

reasoning) resulted in a violation of the petitioner’s right to his

statutory judge, guaranteed in Art. 38 para. 1 of the Charter of

Fundamental Rights and Freedoms.

In a situation where a court of

last instance applying a norm of Community law has entirely omitted to

deal with the question whether it should refer a preliminary question to

the ECJ and has not duly substantiated its failure to refer (see point

22 of the reasoning), and where the issue of the statutory judge has,

thus, not been duly answered by the court, one cannot at that point

reach a conclusion on the violation of Art. 38 para. 1 of the Charter of

Fundamental Rights and Freedoms. Such conduct by the court constitutes a

violation of the rules of fair process, and thereby also an

encroachment upon the right guaranteed by Art. 36 para. 1 of the Charter

of Fundamental Rights and Freedoms (cf. analogously, for ex., also the

decisions of the Constitutional Court in the matters No. I. ÚS 74/06,

and No. III. ÚS 521/05).