2007/01/16 - Pl. ÚS 36/05: Reimbursement of Medications

16 January 2007

HEADNOTES


According

to Art. 1 para. 1 of the Constitution, the Czech Republic is a

sovereign, unitary, and democratic state governed by the rule of law,

founded on respect for the rights and freedoms of man and of citizens. 

All state authority emanates from the people; they exercise it through

legislative, executive, and judicial bodies (Art. 2 para. 1 of the

Constitution). The fundamental rights and basic freedoms shall enjoy the

protection of judicial bodies (Art. 4 of the Constitution).  According

to Art. 36 para. 1 of the Charter of Fundamental Rights and Basic

Freedoms, everyone may assert, through the legally prescribed procedure,

his rights before an independent and impartial court or, in specified

cases, before another body.  The second paragraph of the same Article

provides to everyone who claims that her rights have been curtailed by a

decision of a public administrative authority the possibility, unless a

law provides otherwise, to submit the matter to a court for review of

the legality of that decision.  However, judicial review of decisions

affecting the fundamental rights and basic freedoms, the protection of

which is enshrined in the constitutional order of the Czech Republic,

may not be excluded from the jurisdiction of courts.

The decision on the inclusion of medicinal preparations into the list

of medications covered by public health insurance funds results in an

interference with the rights of their producers and distributors and,

for that reason, it is necessary to see to it that the principles of

fair process are consistently observed.  Within the framework of

abstract norm control, the Constitutional Court must adjudge whether the

statutory framework creates conditions such that any interference would

be balanced by such rights so as to eliminate, in a satisfactory

manner, any room for arbitrariness in each concrete decision on the

inclusion of medicinal agents into the list of medicines covered by

public health insurance funds.  Section 15 para. 10 of the Act on Public

Health Insurance does not meet this requirement, as it does not

guarantee the applicant that the decision on his application will be

based on objective and verifiable criteria, be subject to judicial

review, and be issued without unnecessary delay.  The Ministry decides

on the inclusion of a specific medication into the set of medicines

fully covered by health insurance and into the set or medications only

partially covered, as well as on the specific level or reimbursement,

not in an administrative proceeding, but within the boundaries of the

law-making process.  It is therefore incompatible with the principle of

the law-based state and, thus, in conflict with Art. 36 para. 1 of the

Charter of Fundamental Rights and Basic Freedoms.


 

CZECH REPUBLIC

CONSTITUTIONAL COURT

JUDGMENT


IN THE NAME OF THE CZECH REPUBLIC


The

Constitutional Court Plenum, composed of judges Stanislav Balík,

František Duchoň, Vlasta Formánková, Vojen Güttler, Ivana Janů, Vladimír

Kůrka, Dagmar Lastovecká, Jan Musil, Jiří Nykodým, Pavel Rychetský,

Miloslav Výborný, Eliška Wagnerová and Michaela, Židlická, in the matter

of the petition of a group of Senators of the Senate of the Czech

Parliament, represented by advocate, JUDr. Ing. V. J., proposing the

annulment of the provisions of § 15 para. 10 of Act No. 48/1997 Coll.,

on Public Health Insurance and on Amendments and Additions to certain

Related Enactments, as subsequently amended, and the annulment of

Regulation of the Ministry of Health No. 589/2004 Coll., on the

Reimbursement of Medications and Foodstuffs for Special Medical

Purposes, as amended, with the participation of 1) the Assembly of

Deputies of the Parliament of the Czech Republic, 2) the Senate of the

Parliament of the Czech Republic, and 3) the Ministry of Health of the

Czech Republic, as parties to the proceedings, decided as follows:

 

Section

15 para. 10 and that portion of the final sentence of § 15 para. 5 of

the Act on Public Health Insurance which follows the semicolon, reading,

„the level of their reimbursement from health insurance shall be laid

down in an implementing regulation,“ of Act No. 48/1997 Coll., on Public

Health Insurance and on Amendments and Additions to certain Related

Enactments, as subsequently amended, is annulled as of 31 December

2007.  On the same day Regulation of the Ministry of Health No. 532/2005

Coll., on the Reimbursement of Medications and Foodstuffs for Special

Medical Purposes, as subsequently amended, shall lose validity.

The proceeding on the petition proposing the annulment of Regulation of

the Ministry of Health No. 589/2004 Coll., on the Reimbursement of

Medications and Foodstuffs for Special Medical Purposes, as subsequently

amended, is dismissed.

 


REASONING

 

I.
Definition of the Matter and Summary of the Petition
 

1.

On 4 July 2005, the Constitutional Court received the petition of a

group of 29 Senators of the Senate of the Czech Republic proposing the

annulment of the provision of the Act on Public Health Insurance

designated in the heading, as well as the ministerial regulation

implementing it, due to their conflict with the Czech Republic’s

obligations resulting from Community law and from Article 36 para. 1 of

the Charter of Fundamental Rights and Basic Freedoms (hereinafter

„Charter“).  The petitioners are of the view that, under the current

legal scheme, authorized persons are not entitled to make a claim, in an

administrative proceeding, regarding the setting of the level of

reimbursement from public health insurance for medicinal preparations

and that they are denied the right to judicial and other protection

against measures of the Ministry of Health of the Czech Republic

(hereinafter „Ministry“) issued in this area.
 

2.

The petitioners then described the manner in which the Czech Republic

regulates by law the reimbursement of human medicines, as a component of

the covered health care.  It is contained in Act No. 48/1997 Coll., on

Public Health Insurance and on Amendments and Additions to certain

Related Enactments, as subsequently amended (hereinafter „Act on Public

Health Insurance“).
 

3. As

part of the provision of health care, certain medicinal preparations and

foodstuffs for special medical purposes (hereinafter „medications“) are

covered from health insurance funds.  They are the medications which

contain substances from groups of medicinal substances listed in the

Annex (Annex No. 2) to the Act on Public Health Insurance.  Each group

of medicinal substances listed in the Annex must contain at least one

medicinal preparation or foodstuff for special medical purposes which is

fully covered by health insurance.  As a prerequisite for health

insurance to reimburse medications, they must be entered into the list

of medicinal preparations and foodstuffs for special medical purposes

which is kept by the Ministry.  The request to enter them into the list

is submitted by the holder of a decision, issued by the State Institute

for the Supervision of Medications, on the registration of a medication

in accordance with Act No. 79/1997 Coll., on Medications and on

Amendments and Additions to certain Related Enactments.  The decision

not to enter into the list a particular medicinal preparation or

foodstuff for special medical purposes, as well as the decision to

remove it from the list, is made by the Ministry in an administrative

proceeding.
 

4. If the State

Authority for the Supervision of Medications has decided to register a

medication, the Ministry of Finance of the Czech Republic sets, in

conformity with Act No. 526/1990 Coll., on Prices, as subsequently

amended, its maximum price, and the holder of the registration decision

may request the Ministry to enter the medication into the list and can

submit to the Ministry a proposal to set the level of reimbursement for

the medication from public health insurance funds.  Without the Ministry

having any obligation to follow such proposals, the Ministry issues a

regulation in which it enumerates the medications which are fully

reimbursed from health insurance, as well as the level of reimbursement

for individual medicinal substances.  Proposals to set the level of

reimbursement are submitted to the Ministry, which then refers them to

the Classification Commission, an advisory body of the Ministry of

Health.  The Classification Commission discusses individual proposals

and recommends the level of reimbursement; the Commission’s

recommendations are then published on the Ministry’s web site.  The

appropriate division of the Ministry subsequently draws up a proposed

regulation and, together with comments on the recommended level of

reimbursement, refers it once again to the Classification Commission. 

Before work on the draft implementing regulation is completed, those

submitting proposals are one again afforded the opportunity to give

their views on the classification process, albeit to a significantly

restricted scope.  The resulting draft legal enactment is then sent to

the Ministry of Health, which, after the completion of the comment

proceeding, submits it to the Government Legislative Council.  If the

Council adopts a positive position on the legal enactment, it is then

promulgated.
 

5. A listing of

fully covered medications is then drawn up, and the amount of

reimbursement of medicinal substances is set in a legislative process. 

Participation in this process by the holders of a registration for a

medication and other interested persons, thus also their opportunity to

affect the form of the regulation, depends solely on the will of the

Ministry to inform them that it is under preparation and to heed their

proposal and observations on it.  It works similarly for the initiative

to revise the content of the regulation.  In addition, the empowering

provision of the Act on Public Health Insurance does not contain any

more detailed criteria for setting the level of reimbursement of

medications, and the resulting content of the regulation is not based on

objective and verifiable criteria.  As it is a legal enactment, the

regulation also does not contain any substantiation.
 

6.

The setting of the level of reimbursement of medications from health

insurance funds does not occur in the context of individual

administrative proceedings with the participations of

proposers-registration holders endowed with procedural rights.  Persons

are not entitled to claim rights relating to the level of reimbursement

before an independent and impartial court.
 

7.

Decisions on the reimbursement of medications in the Czech Republic are

thus not founded on objective criteria, are not substantiated, and are

not subject to judicial review.  These defects are not cured even by the

fact that the medications are integrated into the system of health

insurance in a proceeding on the inclusion of medications into the list

of medicinal preparations and foodstuffs for special medical purposes,

which is in essence an administrative proceeding.  While the inclusion

of a medication into the list is a pre-condition of their inclusion into

the system of repayment, still it does not have even the least

influence on the level of reimbursement for specific medications.
 

8.

The petitioners draw attention to the fact that the setting of prices

for human medications and their integration into the system of public

health insurance is regulated for the Member States of the European

Union, by Council Directive No 89/105/EEC relating to the transparency

of measures regulating the prices of medicinal products for human use

and their inclusion in the scope of national health insurance systems

(hereinafter “the Directive”).  Article 1 of the Directive imposes upon

Member States the obligation to ensure that all legal or administrative

measures to control the prices of medicinal products for human use or to

restrict the range of medicinal products covered by their national

health insurance systems complies with the requirements of the

Directive.  According to Article 6 para. 2 of the Directive, a decision

not to include a medicinal product in the list must contain a statement

of reasons based upon objective and verifiable criteria, including,

where necessary, any expert opinions or recommendations on which the

decision is based.  In such cases, the applicant should be informed of

remedies available to her.  In the petitioners‘ view Article 6 must be

interpreted in conjunction with Article 1.  The mere inclusion of a

medication into the system of public health insurance by means of a list

has no practical effect, to the extent that a decision is not made at

the same time on the level of reimbursement for the medication from

public health insurance.  The principles of Article 6 must be applied

not only to decisions to include a medication into the list, but also to

Ministry’s decisions on the actual level of reimbursement from health

insurance.
 

9. The

petitioners are of the view that the Czech Republic’s accession to the

European Union on 1 May 2004 resulted in the inclusion of Community law

into the Czech legal order.  This has direct impact also on the

perception of the concept of the constitutional order.  The norms of

primary law of the European Community now also constitute a component

thereof.  The principle of applicational precedence follows therefrom,

as does the duty duly to implement into the national legal order

obligations arising from European law.  The petitioners regard the

Constitutional Court as the body which oversees the respect for these

principles, so that it is empowered to review the conformity of relevant

domestic legal norms with the norms of Community law; in this regard,

then, it is endowed with the competence to derogate domestic norms.

According to the petitioners, the respect for, and supervision of, the

observance of the duty duly to implement domestically the obligations

under European law represents the effectuation of the attributes of a

law-based state in accordance with Art. 1 para. 1 of the Constitution of

the Czech Republic, and this obligation extends to the plane of the

constitutional order.
 

10.

Subsidiarily, the petitioners then add, without more detailed

constitutional arguments, that, if holders of a decision to register

medications are denied the right to claim their right „before an

independent and impartial administrative body or court“, then the

contested legal scheme in relation thereto violates the right to

judicial and other protection under Article 36 para. 1 of the Charter.
 


II. A)

Summary of the Significant Portions of the Statements of Views of Parties to the Proceeding
 

11.

In conformity with § 69 of Act No. 182/1993 Coll., on the

Constitutional Court, as subsequently amended (hereinafter „the Act on

the Constitutional Court“), the Constitutional Court sent the petition

initiating the proceeding to the parties to the proceeding – the

Assembly of Deputies and the Senate of the Parliament of the Czech

Republic, the Ministry of Health of the Czech Republic, and the Public

Defender of Rights.
 

12. As

regards the content of the petition, the Assembly of Deputies stated

that the petition is premised on the legal situation existing prior to

the adoption of two amendments to the Act on Public Health Insurance,

introduced by Act No. 438/2004 Coll. (which amends Act No. 551/1991

Coll., on the General Health Insurance Company of the Czech Republic, as

subsequently amended, Act No. 280/1992 Coll., on Departmental, Trade

Union, Enterprise and other Health Insurance Companies, as subsequently

amended, Act No. 592/1992 Coll., on Insurance Premiums for the General

Health Insurance Company, as subsequently amended, and Act No. 48/1997

Coll., on Public Health Insurance and on Amendments and Additions to

certain Related Enactments, as subsequently amended), which entered into

force on 1 August 2004, and Act No. 123/2005 Coll. (which amends Act

No. 48/1997 Coll., on Public Health Insurance and on Amendments and

Additions to certain Related Enactments, as subsequently amended, and

Act No. 592/1992 Coll., on Insurance Premiums for the General Health

Insurance Company, as subsequently amended), which entered into force on

30 March 2005.  The first of the mentioned acts incorporated the

substance of Council Directive No. 89/105/EEC into the Act on Public

Health Insurance in the sense that § 15 para. 8 of that Act now allows

for the review, in accordance with the Administrative Code, of a

decision to remove a medication from the list of medicinal preparations

or foodstuffs for special medical purposes, and the holder of a decision

to register a medication is also ensured legal protection before „an

independent administrative body“.  The second of the mentioned acts

introduced the same manner of proceeding into § 15 para. 6 of the Act on

Public Health Insurance for decisions not to include a medication into

the list of medicinal preparations or foodstuffs for special medical

purposes.  The Assembly of Deputies is thus of the view that the

contested provision is no longer in conflict with the mentioned

Directive.  The Assembly of Deputies did not, however, express any view

on the objection that the legal scheme conflicts with the principle of

the right to judicial protection.
 

13.

First of all the Senate observed that, on 20 May 2004, it debated the

bill to amend the Act on Public Health Insurance (subsequently

promulgated as No. 438/2004 Coll.), which introduced the contested

provision, and decided at that time to return it to the Assembly of

Deputies with proposed amendments.  No objections were raised to the

currently contested provision, and the Senate considered it as

corresponding to the right of citizens to be provided health care, in

the sense of Art. 31 of the Charter.  In the version approved by the

Senate, the bill was then adopted by the Assembly of Deputies.  The

Senate then draws attention to the fact that the petitioners are

themselves, as they assert, aware of the fact that the petition is of a

non-standard character, to the extent that a statutory provision is

contested primarily due to its conflict with Community law.  According

to the Senate, however, the ascertainment of whether domestic law is in

conformity with Community law cannot be within the competence of a

domestic body.  It is solely the European Court of Justice which is

competent in this respect.  The principle of applicational precedence of

Community law speaks in favor of this conclusion, as does the institute

of the preliminary questions, in which national courts refer matters to

the European Court of Justice; if the Constitutional Court could annul

statutes or individual provisions thereof due to their conflict with

Community Law, it would also be authorized to respond to preliminary

questions.  Naturally that is not the case.  The protection of rights

arising from Community law is ensured by other means, primarily by the

responsibility of Member States for the violation thereof.  The Senate

leaves it to the Constitutional Court to make the assessment of the

asserted conflict between the contested provision of the Act on Public

Health Insurance and Article 36 para. 1 of the Charter.
 

14.

In reaction to a specific query by the Justice Rapporteur, the then

Minister Milada Emmerová on behalf of the Ministry of Health, gave its

views on the process of adopting the contested regulation.  She asserted

that the norm-making process corresponded to the general manner of

adopting regulations.  In conformity with the Legislative Rules of the

Government, the proposed regulation was received by all bodies required

to give comments.  After the comments were incorporated into it, it was

discussed by the Government Legislative Council, which certified its

conformity with the constitutional order and statutes.  The regulation

was signed by the Minister and was subsequently promulgated in the

Collection of Laws.  As far as concerns the process of preparing the

regulation’s substantive content, it was governed by the Ministry’s

internal regulations, namely Minister’s Order No. 3/1992, for Ensuring

Legislative Activity at the Ministry of Health of the Czech Republic,

Order No. 12/2003, on the Principles for the Distribution of Materials

of the Ministry of Health of the Czech Republic for Internal and

External Comment Proceedings, and Order No. 6/2004, on the Statute and

Rules of Procedure of the Commission of the Ministry of Health of the

Czech Republic for the Classification of Medications and Foodstuffs for

Special Medical Purposes.  The transparency, representativeness, and

impartiality of the setting of the level of reimbursement is ensured by

the composition of the Classification Commission, whose members are

appointed and removed by the Minister.  The Ministry gives as examples

the representatives of the Czech Jan Evanglista Purkyně Medical Society,

the Czech Medical Chamber, the Czech Pharmaceutical Chamber, the Czech

Dental Chamber, organizations of patients and health insurance

companies, and the State Institute for the Supervision of Medications. 

In its work, the Classification Commission observes the prescribed rules

and abides by the principle of transparency when drafting and

evaluating proposals and complaints of proposers, and the principle of

objectivity and quality of provided evaluations of proposals and

analyses of objections.
 

15.

The Ministry rejects the petitioners‘ arguments regarding the

transposition of the Directive into the Act on Public Health Insurance. 

In the Ministry’s view, the Directive distinguishes, on the one hand,

the decision on the inclusion of medications into the list of medicinal

preparations or foodstuffs for special medical purposes and, on the

other, the setting of the price of a specific medication.  If the

Directive speaks of „decisions on price“, then it is merely reacting to

the various systems found in the Member States for the setting of

prices, without thereby imposing an obligation to set the price of

medications through an administrative proceeding.  Thus the petitioners

have joined, without justification, two separate processes, that is, the

decision on the inclusion into the list of medications covered by

health insurance funds and the approval of the price of this

medication.  The Directive neither regulates the setting of the price of

medications nor requires that decisions on it be in the context of an

administrative proceeding.  The obligations from the Directive have thus

been properly and fully implemented.
 

16.

The Ministry considers as a mere general assertion the petitioners‘

objection relating to the violation of the rights, arising from Art. 36

para. 1 of the Charter, of the holders of a decision to register a

medication.  It is of the view that the pre-condition for this objection

to be successful would be a „violation of a specific right prescribed

by a legal enactment“, and that the petitioner „would have to

specifically designate which legal enactment laid down the right they

cite and in what specifically the violation thereof consists“.  The

Ministry further observes that a medication can be introduced onto the

market without regard to whether it is at least partially covered from

public health insurance funds and that manufacturers and distributors

need not undergo the process of setting the reimbursement.  It considers

the petition as manifestly unfounded and, as such, proposes it be

rejected on preliminary grounds.
 

17.

The Public Defender of Rights informed the Justice Rapporteur, in his

29 July 2005 letter, that he would not intervene into the proceedings to

review the petition.
 


II. B)

The Positions of Further Affected Subjects and Experts
 

18.

In the endeavor to obtain the most complete information possible

concerning the process of creating the catalogue of medications

reimbursed from public health insurance funds, the Constitutional Court

also requested other interested institutions to inform it of their

positions on the petition of the group of Senators before the Court.  In

addition, the Czech Medical Chamber spoke to this matter, as did the

Czech Pharmaceutical Chamber, the General Health Insurance Company of

the Czech Republic, and the Federation of Health Insurance Companies, in

which are affiliated all other insurance companies operating in the

Czech Republic in the area of public health insurance, specifically the

Czech National Health Insurance Company, the Metallurgical Employee

Insurance Company, the Departmental Health Insurance Bank, Insurance

Company and Building Company, the Mining Fraternal Treasury, the

Military Health Insurance Company, the Employee Insurance Company –

Škoda, the Health Insurance Company - METAL-ALIANCE, and the Health

Insurance Company of the Czech Ministry of Interior.
 

19.

In its statement of position, the Czech Medical Chamber fully supported

the petition and also agreed with the grounds which led the petitioner

to submit it.  It considers it as undesirable for the setting of the

prices of medications, as defined in the contested statutory provision,

to take place in a system into which persons who should take part in

that task do not have the opportunity to intervene; it named as examples

doctors‘ professional organizations, representatives of health

insurance companies, scientific institutions and manufacturers of

medications.  It acknowledged that although its representatives number

among the members of the Commission for the Classification of

Medications, however, that Commission has not been convened for the last

six months, so that the Commission was not consulted at all with regard

to the most recent amendment to the contested regulation.  The Czech

Medical Chamber confirms that regulations are adopted in a thoroughly

informal manner, without an objective assessment of all viewpoints; for

example, its comments on the draft of the most recent amendment of this

regulation was not in any respect taken into consideration.  Under the

existing situation, the rights of producers of medications, as well as

of patients themselves, can be harmed.  The General Health Insurance

Company of the Czech Republic also agrees with the grounds which led the

group of Senators to submit this petition.  The empowering provision of

the Act on Public Health Insurance does not contain more detailed

criteria for setting the level of reimbursement of individual

medications.  In consequence the Ministry is afforded extensive

opportunity to decide in a subjective fashion, both as regards the

medications that will be fully covered by the system of public health

insurance and the level of partial reimbursement.  In contrast, other

interested persons are de facto excluded from this process, which they

cannot actively influence.  In addition, these persons cannot seek the

protection of their rights before an independent and impartial court. 

The existing legal arrangement for setting the prices of medications

does not correspond to the requirements of the Directive, which the

Czech Republic has not properly implemented.  The Czech Pharmaceutical

Chamber stated that it has repeatedly in the past criticized the current

form of the process of classification (that is, the inclusion of

medications among those which are covered by public health insurance

funds), citing a whole host of non-transparent steps, which in its view

seriously threatens the effective functioning of the whole system of the

reimbursement of medications.  It is, on the one hand, a fact that the

level of reimbursement of medications is set, taking into account their

maximum administrative price, as of a specific date when it will still

be a long time before stocks of the medication on the market will be

sold out.  In practice however, quite commonly the situation arises

where insurance companies refuse to reimburse that part of the price of

medications, declared to be covered in full, exceeding the newly set

maximum price.  The Czech Pharmaceutical Chamber further considers as

non-transparent the role of the Classification Commission in the process

of drafting the regulation.  It has the status of a mere advisory body,

and it has occurred in the past that, after interventions by the

Ministry, the resulting form of the regulation diverged from the form of

the draft discussed by the Classification Commission.  Affected persons

may submit comments on the results of its action only during a very

short time interval, which allows no opportunity for consideration of

the most fundamental possibilities of repercussions of the proposed

changes.  In the past, the time elapsing between the drafting, issuance

and coming into force of a relevant amendment has been much shorter than

required for the health care field to be prepared or for expert

discussion.  It is only in the period of time between the completion of

drafting the regulation and its coming into force that the General

Health Insurance Company of the Czech Republic prepares the „Number

Book“, and not before they have access to this aid does the public, and

even health care professionals, comprehend how this or that specific

medication will be reimbursed.  This Number Book is often issued only at

the moment a new regulation comes into effect, if not later.  Imprecise

information on the level of surcharges then burdens patients and

results in financial harm to pharmacies.  The Czech Pharmaceutical

Chamber would welcome it if a clear and binding deadline were set for

the drafting, issuance, and entry into force of the reimbursement

regulation, which would guarantee sufficient extra time for doctors,

pharmacists, and patients to prepare themselves for the new system of

reimbursement.  The Federation of Health Insurance Companies did not

inform the Constitutional Court of its position on the petition under

consideration.
 

20. In view

of the discussion currently being held in the expert literature on the

question of the constitutionality of Czech Republic legal enactments

which are considered to be in conflict with Community law, in which

divergent positions have been taken, the Justice Rapporteur requested

from the centers of scholarship, that is the relevant departments of

individual law faculties in the Czech Republic to give their expert

views on this issue.
 

21. The

views expressed in their responses fall into three basic groups.  The

first proceeds strictly from the conclusion that, since it does not form

a part of the constitutional order, Community law cannot be a

referential criteria for the adjudication of the constitutionality of

domestic statutes.  The second takes the position that the adjudication

of whether statutes of the Czech Republic are in conformity with primary

and secondary law of the European Community cannot be ruled out,

namely, where apart from their conflict with Community law, they also

come into conflict with the principles of the Czech Republic’s

constitutional order.  The third group distinguishes the case of proper

transposition of Community law into the Czech legal order, which

unequivocally eludes review of its constitutionality from the case of

defective transposition, which is subject to the abstract review of

constitutionality, as in such a case the legislature has not acted

within the confines of its delegated competence.  It can be deduced

therefrom that, even if the Constitutional Court cannot, within the

context of abstract norm control, annul a legal enactment due to its

conflict with Community law, in order for it to be possible to assess in

specific cases its competence to annul such an enactment, it must

always reach a conclusion on the enactment’s conformity or conflict with

this law.  The Constitutional Court reveals in advance that it has

itself, below in the reasoning, taken a position on the possibilities of

reviewing implemented Community law.
 


III.

The Wording of the Contested Provisions
 

A)
22.

Sec. 15 para. 10 of Act No. 48/1997 Coll., on Public Health Insurance

and on Amendments and Additions to certain Related Enactments, as

subsequently amended, reads as follows:
 „ The Ministry of Health shall lay down in a regulation
a) the medicinal preparations and foodstuffs for special medical purposes which are compensated in full by health insurance;
b)

the level of compensation of individual medicinal substances belonging

to the group of medicinal substances according to Appendix No. 2;
c)

the level of compensation for foodstuffs for special medical purposes

containing medicinal substances from the group of medicinal substances

according to Appendix No. 2;
d) the level of compensation from health

insurance of individually prepared medicinal preparations,

radiopharmaceuticals and transfusion preparations;
e) restrictions

and symbols fixing the conditions prescribed for medicinal preparation

and foodstuffs for special medical purposes reimbursed from health

insurance, including restrictions and symbols for the use of medicinal

preparation and foodstuffs for special medical purposes for the

provision of health care at specialized facilities.“

23. Sec. 15

para. 5, the last sentence after the semi-colon, of Act No. 48/1997

Coll., on Public Health Insurance and on Amendments and Additions to

certain Related Enactments, as subsequently amended, reads as follows:
„The level of their reimbursement from health insurance shall be laid down in an implementing regulation.“

B)
24.

Regulation of the Ministry of Health No. 532/2005 Coll., on the

Reimbursement of Medications and Foodstuffs for Special Medical

Purposes, as amended by Regulation of the Ministry of Health No. 37/2006

Coll., Regulation of the Ministry of Health No. 368/2006 Coll.,

Regulation of the Ministry of Health No. 387/2006 Coll., and Regulation

of the Ministry of Health No. 621/2006 Coll., reads as follows:
 „The

Ministry of Health shall lay down pursuant to § 15 para. 10 Act No.

48/1997 Coll., on Public Health Insurance and on Amendments and

Additions to certain Related Enactments, as amended by Act No. 438/2004

Coll., (hereinafter the ‘Act’):
§ 1
This Regulation lays down:
 

a) the medicinal preparations and foodstuffs for special medical

purposes which are reimbursed in full from public health insurance funds

(hereinafter „health insurance“), which are listed in Appendix No. 1 to

this Regulation;
  b) the level of reimbursement for individual

medicinal substances belonging to the groups of medicinal substances

under Appendix No. 2 to the Act, which are listed in Appendix No. 1 to

this Regulation;
  c) the level of reimbursement for foodstuffs for

special medical purposes, containing medicinal substances from the group

of medicinal substances under Appendix No. 2 to the Act, which are

listed in Appendix No. 1 to this Regulation;
  d) the level of

reimbursement from health insurance of individually prepared medicinal

preparations, radiopharmaceuticals and transfusion preparations which

are listed in Appendix No. 1 to this Regulation;
  e) restrictions

and symbols fixing the conditions prescribed for medicinal preparation

and foodstuffs for special medical purposes reimbursed from health

insurance, including restrictions and symbols for the use of medicinal

preparation and foodstuffs for special medical purposes for the

provision of health care at specialized facilities, which are listed in

Appendix No. 2 to this Regulation.

§ 2
The following are repealed:
  Regulation No. 589/2004 Coll., on the Reimbursement of Medications and Foodstuffs for Special Medical Purposes.
 

Regulation No. 225/2005 Coll., which amends Regulation No. 589/2004

Coll., on the Reimbursement of Medications and Foodstuffs for Special

Medical Purposes.
  Regulation No. 337/2005 Coll., which amends

Regulation No. 589/2004 Coll., on the Reimbursement of Medications and

Foodstuffs for Special Medical Purposes.

§ 3
This Regulation shall come into effect on 1 January 2006.
Minister: MUDr. Rath (signature).“
 


IV.
Conditions for Petitioners‘ Standing
 

25.

The petition proposing the annulment of § 15 para. 10 of the Act on

Public Health Insurance and on Amendments and Additions to certain

Related Enactments, as subsequently amended, and the annulment of

Regulation of the Ministry of Health, No. 589/2004 Coll., on the

Reimbursement of Medications and Foodstuffs for Special Medical

Purposes, as subsequently amended, was submitted by a group of

twenty-nine Senators of the Senate of the Czech Parliament, thus in

conformity with the conditions contained in § 64 para. 2, lit. b) of Act

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

amended.  In the current matter, it can be affirmed that the petitioners

have satisfied the standing conditions.
 


V.

The Constitutional Conformity of the Legislative Process
 

26.

In conformity with § 68 para. 1 of the Act, in proceedings on the

review of statutes or other legal enactment, the Constitutional Court is

obliged to assess whether the contested legal enactment was adopted and

issued in the constitutionally-prescribed manner.
 

27.

It was ascertained from the relevant internet sites that the bill to

amend the Act on Public Health Insurance was submitted to the Assembly

of Deputies by the Government of the Czech Republic on 8 September

2003.  By its resolution No. 1035 of 6 April 2004, the lower chamber

approved the bill by a majority of 87 Deputies from the 170 present,

while 79 Deputies voted against the bill.
 

28.

The Senate debated the transmitted bill on 20 May 2004, and by its

resolution No. 450, with a majority of 56 of the 57 present Senators,

pronounced its decision to return the bill, with proposed amendments, to

the Assembly of Deputies.
 

29.

The Assembly of Deputies debated the returned bill on 24 June 2004 and,

by its resolution No. 1199, expressed its approval of the bill in the

wording adopted by the Senate.  Of the 189 Deputies present, 119 voted

in favor and 36 against the bill.
 

30. The President of the Republic signed the law on 14 July 2004, as did the Prime Minister on 16 July 2004.
 

31. On 26 July 2004 the Act was promulgated in the Collection of Laws, Part 144, No. 438/2004 Coll.
 

32.

The authority of the Ministry to issue legal enactments for the

implementation of statutes is based on Art. 79 para. 3 of the

Constitution of the Czech Republic.  The prerequisite therefor is the

existence of an explicit statutory empowerment.  In the given case, this

empowerment was given precisely in § 15 para. 10 of the Act on Public

Health Insurance.  The regulation indicated in the petition was signed

by the Minister of Health and duly promulgated in Part 202 of the

Collection of Laws, as No. 589/2004.  The regulation currently in force

was also signed by the Minister of Health and was duly promulgated in

Part 181 of the Collection of Laws, as No. 532/2005.
 

33.

The Constitutional Court has thus established that the adoption and

issuance of the legal enactment, which are the subject of review, were

adopted and issued in the prescribed manner.
 


VI.

Actual Review
 

34.

The petitioners contest the empowering provisions of the Act on Public

Health Insurance on two independent grounds.  In their view it

conflicts, on the one hand, with the fundamental attributes of the

law-based state, that is, the State‘s obligation to respect Community

Law (Art. 6 of the Transparency Directive), with which it conflicts,

and, on the other hand, it neglects the guarantee of judicial

protection, as it is enshrined in Art. 36 of the Charter.
 

35.

In its Judgment No Pl. US 50/04 (No. 154/2006 of the Collection of

Laws), the Constitutional Court explained that Community law could not

serve as a referential criterion for its adjudication of the

constitutionality of domestic enactments.  On the other hand, the

European Communities, just the same as is the Czech Republic, are

law-based communities.  The European Communities are constructed on the

respect and esteem for the essential attributes of a law-based state. 

As can be deduced from the jurisprudence of the European Court of

Justice, its interpretation of general legal principles corresponding to

the fundamental rights contained in national constitutional catalogues,

is quite similar to the Constitutional Court’s approach.  Moreover, the

issue under adjudication concerns the establishment and functioning of

the internal market including interferences with the free movement of

goods, one of the four fundamental freedoms, or the very foundations of

the European Communities; it is therefore necessary to pay careful

attention as to whether the adopted restrictions are balanced by a

sufficient guarantee of the participating subjects‘ fundamental rights,

in the case under adjudication, above all the right to due process and

fair proceedings.  The Constitutional Court also dealt, in this spirit,

with the petitioners‘ objection that the contested provision of the Act

on Public Health Insurance is in conflict with the directive.  Even were

such conflict actually to be ascertained, that could not, in and of

itself, result in the derogation either of the statutory provision at

issue or of the regulations implementing it; nonetheless, the arguments

justifying one in ascertaining conflict with the directive could support

the substantiation of unconstitutionality.
 

36.

According to Art. 1 para. 1 of the Constitution, the Czech Republic is a

sovereign, unitary, and democratic state governed by the rule of law,

founded on respect for the rights and freedoms of man and of citizens. 

All state authority emanates from the people; they exercise it through

legislative, executive, and judicial bodies. (Art. 2 para. 1 of the

Constitution).  The fundamental rights and basic freedoms shall enjoy

the protection of judicial bodies (Art. 4 of the Constitution). 

According to Art. 36 para. 1 of the Charter, everyone may assert,

through the legally prescribed procedure, his rights before an

independent and impartial court or, in specified cases, before another

body.  The second paragraph of the same Article provides to everyone who

claims that her rights have been curtailed by a decision of a public

administrative authority the possibility, unless a law provides

otherwise, to submit the matter to a court for review of the legality of

that decision.  However, judicial review of decisions affecting the

fundamental rights and basic freedoms, the protection of which is

enshrined in the constitutional order of the Czech Republic, may not be

excluded from the jurisdiction of courts.
 

37.

In the Czech legal order, the system for the regulation of the market

in medical preparations is divided into four distinct steps:  the

registration of a medication (approval of its introduction onto market),

the setting of it maximum price, the decision on its inclusion on the

list of reimbursable medications, and the setting of the level of

reimbursement from public health insurance funds.  The State Institute

for the Supervision of Medications makes the decision on the

registration of a medication pursuant to § 26 of Act No. 79/1997 Coll.,

on Medications and on Amendments and Additions to certain Related

Enactments; the Administrative Procedure Code (see § 66 of the mentioned

Act) applies to such decisions.  The Ministry of Finance sets the

maximum price in conformity with § 10 of Act No. 526/1990 Coll., on

Prices, as subsequently amended, and it publishes, in the Bulletin of

Prices, an official notice containing a list of goods with regulated

prices.  The significance of the third step consists in the fact that a

medication can only be reimbursed from public health insurance funds if

it is entered into the list, kept by the Ministry, of medicinal

preparations or foodstuffs for special medical purposes.  If the

Ministry does not grant the application of a producer or distributor of a

medication to enter a certain medication into this list, the

Administrative Procedure Code applies to such decision.  The

Administrative Procedure Code also applies to decisions to remove

medications from the list.  The first and third steps then are conducted

in accordance with the rules of the Administrative Procedure Code,

where the issuance of an individual decision is proceeded by a

proceeding ensuring to the parties the possibility to assert their

procedural rights; in view of the subject of the proceeding, the

particular regime for the regulation of the prices of medications are

left aside.  In contrast thereto, the last step no longer provides for a

decision in the form of an individual administrative act.  It is in the

form of a ministerial regulation, but in its essence it is not a

general norm, rather „a bundle of individual decisions“; therefore, it

would be appropriate to apply to it the regime foreseen in Art. 36 para.

1 or alternatively para. 2 of the Charter.
 

38.

At the same time, the setting of a specific level of reimbursement

holds basic significance for the demand of any given medication, namely

according to the principle, the higher the share of reimbursement from

public health insurance, the higher is the demand.  The Ministry’s

decision on the concrete level of reimbursement of any given medication,

alternatively, as in our case, its decision regarding in what form it

prepares and promulgates the regulation at issue, is then reflected in

the economic performance and the success of the respective producer or

distributor.  In its own way, the creation of unequal conditions for

engaging in business deforms the free competition on the market in

medications for human use.  The conditions for engaging in business must

naturally be the same for all participants, even as far as concerns the

limitation thereof by the given Act.  All producers and distributors of

medicinal preparations can engage in business on the domestic market

only if they satisfy the prescribed statutory conditions, which,

however, must be the same for all.  To the extent that, as a result of

the inclusion of certain preparations into the list of medications

covered from public health insurance funds, their producers or

distributors gain an advantage, all the more thoroughly must care be

taken that this inequality is balanced by the opportunity to scrutinize

the transparency of the creation of these conditions, moreover, in each

case individually.
 

39. This

is otherwise also the objective of the Directive recalled by the

petitioners.  Article 6 thereof states that it applies “. . . if a

medicinal product is covered by the national health insurance system

only after the competent authorities have decided to include the

medicinal product concerned in a positive list”.  The terms of the

Article require that all such decisions be taken in the form of an

individualized administrative decision (in other words, that the

applicant be given a statement of reasons based upon objective and

verifiable criteria), that decisions be given within 90 or 180 days, and

that decisions be subject to judicial review (stated in a comprehensive

manner, it formulates a certain set of procedural rights for the

protection of parties).  As is clear from its wording, § 15 para. 10 of

the Act on Public Health Insurance does not require these guarantees.
 

40.

For the reasons analyzed in greater detail in the already cited

judgment, Judgment No. Pl. US 50/04, the Constitutional Court construes

Art. 36 para. 1 and para. 2 of the Charter while taking into account the

jurisprudence of the European Court of Justice relating to the

principle of fair process.  The European Court of Justice has already

twice resolved analogous issues, specifically in relation to the

Austrian and Finnish systems for the reimbursement of human

medications.  As appears from the case, Commission v. Finland, (Case

C-229/00, Commission v. Finland, [2003] ECR I-5727), Finland had a

system for the reimbursement of medicinal preparations from public

health insurance similar to that of the Czech Republic.  According to

Finnish law, as a result of the decision on pricing, medicines were

automatically entered onto the list of reimbursable medicines, which

meant that a claim arose to the reimbursement from public insurance of

50 % of their price.  Finnish law thus called for a bifurcated

decision-making process only in cases concerning those medicines which

were reimbursed from the public health insurance system at a rate higher

than 50 %.  For that purpose the Council of Ministers formulated, by

decree, a list of “certain active ingredients” which enjoy higher rates

of reimbursement.  The actual decision about higher reimbursement for

specific medicines was issued by experts in individual cases, but such

decision were simply a pro forma confirmation that particular medicines

contained an active ingredient included in the Council of Minister’s

list.  With reference to the mentioned structure of decision-making, the

Finnish government argued that Art. 6 of the Directive did not apply to

the enactment issued by the government because, in and of itself, it

“does not result in a medicinal product being entered on the list of

medicinal products qualifying for higher-rate cover, but refers to

certain active ingredients” (Id., para. 30)  The European Court of

Justice rejected this rather formalistic contention as it found that the

Council of Ministers’ decree (even though indirectly) predetermines

certain medications to qualify for a higher-rate of reimbursement and

that, although in the form of a general legal act, in fact “the Council

of Ministers' decision constitutes a bundle of individual decisions on

the inclusion of certain medicinal products in one of the social

security schemes, so as to bring it within the provisions of Article 6

of the directive.” (Id., para. 34).
 

The

case of the Commission v. Austria (Case C-424/99, Commission v.

Austria, [2001] ECR I-9285) presented a similar problem.  In the

Austrian system there was a register of medicinal preparations for the

purposes of their reimbursement, but it represented merely a “working

tool”, and the decision on the reimbursement of particular medicines

from the system of health insurance scheme was made in individual

instances.  In individual cases doctors could decide, on the basis of

the patient’s need, that medicines included on the register would not be

reimbursed and those not on the register would be.  Accordingly, the

Austrian government maintained that its register did not qualify as a

precise list in the sense of Art. 6 of the Directive.  The European

Court of Justice stated that the purpose of the Directive is to ensure

that any “measure to control the prices of medicinal products . . . or

to restrict the range of medicinal products covered by their national

health insurance systems complies with the requirements of the

directive” (para. 30).  Therefore, in order to bring the system within

the application of Art. 6 of the Directive, the European Court of

Justice concluded that, regardless of the merely guidance function of

the register, it was sufficient that “inclusion of a medicinal product

on the register normally means that its cost will automatically be borne

by the scheme”.  Therefore, the European Court of Justice has twice

clearly held that decisions concerning the level of reimbursement of

cost of medicines by the national health insurance system, even if

formally separated from decisions on inclusion in a list, are covered by

Art. 6, so that they must be accompanied by the procedural safeguards

contained therein.
 

41. As

was already explained above, the way in which the European Court of

Justice construes the principles corresponding to the fundamental rights

and freedoms necessarily has repercussions when domestic law and its

conformity with constitutionally protected rights are construed.  Art. 1

of the Charter bestows special protection upon fundamental rights.  If

then that Court concluded that the decision on the inclusion of

medicinal preparations into the list of medications covered by public

health insurance funds results in an interference with the rights of

their producers and distributors and, for that reason, it is necessary

to see to it that the principles of fair process are consistently

observed, then the Constitutional Court must take this line of argument

into account when interpreting Art. 36 para. 1 or para. 2 of the

Charter.  Within the framework of abstract norm control, it is necessary

to adjudge whether the statutory framework creates conditions such that

any interference would be balanced by such rights so as to eliminate,

in a satisfactory manner, any room for arbitrariness in each concrete

decision on the inclusion of medicinal agents into the list of medicines

covered by public health insurance funds.  Section 15 para. 10 of the

Act on Public Health Insurance does not meet this requirement, as it

does not guarantee the applicant that the decision on his application

will be based on objective and verifiable criteria, be subject to

judicial review, and be issued without unnecessary delay.  The Ministry

decides on the inclusion of a specific medication into the set of

medicines fully covered by health insurance and into the set or

medications only partially covered, as well as on the specific level or

reimbursement, not in an administrative proceeding, but within the

boundaries of the law-making process.
 

42.

On the strength of the empowerment contained in the provisions of the

Act on Public Health Insurance, the Ministry regulates by means of a

regulation, that is, a generally binding legal enactment, the rights and

obligations of precisely individually defined persons, which is

typically accomplished through the application of law.  The existing

practice thereby departs from one of the foundational substantive

characteristics of the concept of a statute (legal enactment), which is

its general character.
 

43.

The Constitutional Court has already in the past repeatedly given its

views on the requirements that legal enactments be of a general

character.  In this context, it stated in its Judgment No. Pl. US

55/2000, The Collection of Judgments and Rulings of the Constitutional

Court, Vol. 22, p. 55 and foll.:  „Among the foundational principles of

the material law-based state belongs the maxim that legal rules be of a

general character (the requirement of the generality of statutes,

alternatively of the generality of legal enactments).  The general

character of the content is an ideal, typical, and essential

characteristic of a statute (alternatively, of legal enactments in

general), as distinct from court judgments and governmental and

administrative acts.  The purpose of the division of state power into

legislative, executive and judicial powers is to entrust the state‘s

general and primary power of regulation to legislation, its derived

general power of regulation, as well as decision-making in individual

cases, to administration, and exclusively decision-making of individual

cases to the judiciary.  From the stated demarcation of the definitional

characteristics of the concept of a statute (alternatively, of a legal

enactment), is then deduced the concept of the statute (legal enactment)

in the substantive sense, from which must be distinguished statutes

(legal enactments) in the formal sense.“  The Constitutional Court has

subsequently affirmed this conclusion, for ex., in its 28 June 2005

Judgment No. Pl. US 24/04.
 

44.

In the matter of the proceedings on the petition proposing the

annulment of § 7 of Act No. 2/1991 Coll., on Collective Bargaining, the

Constitutional Court also decided on the basis of the requirement that

statutes be of a general character (Judgment No. Pl. US 40/02, The

Collection of Judgments and Rulings of the Constitutional Court, Vol.

30, p. 327 and foll.).  The supporting points of the argumentation apply

to this case as well.  In that case, the Constitutional Court recalled

the arguments in favor of the general character of statutes,

alternatively of legal enactments, which are the following: the

separation of powers, equality, and the right to one’s own, independent

judge.
 

45. The first of the

reservations to statutes, legal enactments relating to singular cases is

the principle of the separation of powers, or the division of the

legislative, executive and judicial powers in a democratic, law-based

State:  „It is the field of law application which presents the greatest

obstacles to the adoption of statutes relating to singular cases.  The

claim to one’s lawful judge and the independence of legal protection

exclude the legislature from issuing individual commands, also in fields

not protected by means of the principle, nulla poena sine lege (in this

respect lex can be a meaningful manner only if it is a written legal

sentence of a general nature).“ (H. Schneider, Gesetzgebung

[Legislation], 2nd ed., Heidelberg 1991, p. 32).
 

46.

Under the existing legal situation, the interested persons also cannot

obtain judicial protection.  Regarding the issue of the exclusion from

judicial review in the case of an individualized legal regulation, the

Constitutional Court stated, in its above-cited Judgment No. Pl. US

40/02:  “An individualized regulation contained in a legal enactment

which deprives its addressees of any opportunity to seek judicial review

as to whether a particular person has satisfied the general conditions

of a normative framework and which lacks transparent and acceptable

justification in relation to the possibility to regulate the matter

generally, must be considered to be in conflict with the principle of

the law-based state (Art. 1 of the Constitution), of which the

separation of powers and judicial protection of rights constitutes an

immanent component (Art. 81, Art. 90 of the Constitution).”
 

47.

As regards the availability of procedural protections, the European

Court of Justice adopted, in the mentioned cases, a similar approach. 

As regards the issue of the availability of legal remedies against the

decision, the text of the Directive merely provides that applicants

should be informed of the legal remedies available.  The European Court

of Justice deduced therefrom that the applicant must have the

possibility to avail itself of remedies ensuring effective legal

protection of its rights.  Moreover, it did not consider an

administrative remedy to be sufficient, rather, it should have the

character of judicial review.  The Constitutional Court entirely concurs

with that interpretation, as it also fully corresponds to the

requirements enshrined in Art. 36 para. 2 of the Charter.
 

48.

The same deficiencies of which the European Court of Justice were

critical in relation to the Directive are also evident in the provisions

under review, § 15 para. 10 of the Act on Public Health Insurance, in

relation to the Charter of Fundamental Rights and Basic Freedoms. 

Setting the specific level at which a medication will be reimbursed by

means of a regulation de facto rules out the participation of interested

persons in this process, and it weakens the transparency of particular

stages and, thereby, the trustworthiness of the entire process.  The

appropriateness of the specific level of reimbursement for one or

another medication should be ensured in the course of an administrative

process on the basis of a weighing of the various particular interests,

with the opportunity to consider all dissenting views and observations. 

Above all, the decision on one or another medication should then be

reasoned, so that it would be evident why prerequisites for its

inclusion into the system of reimbursement from health insurance are

better then the prerequisites for some other medications, and how the

deciding body dealt with the basic arguments.
 

49.

While it is true that the amendment to the Act on Public Health

Insurance, recalled by the Assembly of Deputies in its statement (Act

No. 438/2004 Coll. and No. 123/2005 Coll.), introduced into § 15 of the

Act, some elements of procedural protection.  That still does not mean,

however, that such a measure is sufficient in and of itself.  After all,

it relates solely to the Ministry’s decisions on the inclusion of

medicinal preparations onto the list, which for any medicinal

preparation is a prerequisite to its being reimbursed from the system of

public health insurance (and apparently indicates all medicines on the

list will be reimbursed, at least partially), but which is not a

decision of direct significance for determining whether a particular

medicinal preparation will be fully reimbursed or only in part.  It is

only at the second step that the decision is made as to the concrete

amount by which medicines will be reimbursed from public health

insurance.  It is an entirely separate measure, separate

decision-making, in the case of which the statute does not provide for

the guarantee of procedural rights, as is required by Art. 36 paras. 1

and 2 of the Charter.
 

50.

The empowering provision of § 15 para. 10 of the Act on Public Health

Insurance infringes the principles described above, and is therefore

incompatible with the principles of the law-based state, and thus in

conflict with Art. 36 of the Charter.  In this circumstance, the

Constitutional Court observes this it is no longer necessary to concern

itself with the impact upon the designated legal rules of further

constitutionally protected rights, such as, for ex., the right to

property, since the above-stated finding, and the conclusion of

unconstitutionality corresponding thereto, suffices to derogate the

contested provision of the Act on Public Health Insurance.
 


VII.
 

51.

The Constitutional Court cannot overlook the fact that in the event it

annuls § 15 para. 10 of the Act on Public Health Insurance, that portion

of the final sentence of § 15 para. 5 of the Act on Public Health

Insurance which follows the semicolon and reads, „the level of their

reimbursement from health insurance shall be laid down in an

implementing regulation,“ would also lose any sort of foundation.  Both

provisions are so closely connected to each other that the one cannot

stand independently of the other.
 

52.

In consideration of the above-stated arguments, the Constitutional

Court has, in accordance with § 70 para. 1 of the Act on the

Constitutional Court, annulled the provisions of § 15 para. 10 and the

final sentence of its para. 5 which follows the semicolon and reads,

„the level of their reimbursement from health insurance shall be laid

down in an implementing regulation“.
 

53.

In conformity with § 70 para. 3 of the Act on the Constitutional Court,

the Constitutional Court also declared, that simultaneously with the

annulled statutory provision, the Regulation of the Ministry of Health

issued on the basis of the empowerment contained therein lost its

validity.  At the point in time when the Court decided on the petition,

it was Regulation of the Ministry of Health No. 532/2005 Coll.  The

Constitutional Court has dismissed the proceeding on the petition

seeking the annulment of Regulation of the Minister of Health No.

589/2004 Coll., as it lost its validity in the interval between the

submission of the petition and the conclusion of the proceeding (§ 67

para. 1 of the Act on the Constitutional Court).
 

54.

Rectification of the existing situation requires a change in the

legislative scheme currently in force.  The legislature must elaborate

an entirely new regime for the compensation of medications from public

health insurance funds, one which would also correspond to the

principles adumbrated in the reasoning of this judgment.  The

Constitutional Court is aware of the fact that it is necessary to

provide the legislature with sufficient time in which to form and adopt

the new legal framework.  It therefore decided to postpone, until 31

December 2007, the coming into effect of its annulling judgment.

Notice: Judgments of the Constitutional Court may not be appealed.
 

Brno, 16 January 2007