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