57/2007 Sb.
FIND
The Constitutional Court
On behalf of the United States
The Constitutional Court ruled on 16. January 2007 in plenary in the composition of Stanislav
Package, Francis Skinner, Vlasta Formankova, Turgut Güttler, Ivana Janů,
Vladimir Crust, Dagmar Lastovecká, Jan Musil, Jiří Nykodým, Pavel
Rychetský, Miloslav Výborný, Elisabeth Wagner and Michael on April
the design of a group of 29 Senators Senate of the Parliament of the Czech Republic for annulment of
the provisions of § 15 para. 10 of Act No. 48/1997 Coll., on public health
insurance and amending and supplementing certain related laws, as amended by
amended, and the cancellation of the Decree of the Ministry of health no.
589/2004 Coll., on transfers of medicines and foods for special medical purposes,
as amended,
as follows:
The provisions of § 15 para. 10 and the provisions of § 15 para. 5 the last sentence of section
After the semicolon-sounding "; the amount of reimbursement from health insurance
down detailed legal regulation "Act No. 48/1997 Coll., on public
health insurance and amending and supplementing certain related
laws, as amended, are hereby repealed on 31 December. 12.2007.
On the same date of expiry of the Decree of the Ministry of health.
532/2005 Coll., on transfers of medicines and foods for special medical purposes,
in the wording of later regulations.
Proceedings on the application for annulment of the Decree of the Ministry of health.
589/2004 Coll., on transfers of medicines and foods for special medical purposes,
as amended, is hereby terminated.
Justification
(I).
The definition of things and a recap of the proposal
1. The Constitutional Court was on 4 December 2002. July 2005 served group 29
Senators of the Senate of the Czech Republic for annulment in the header labeled
provisions of the Act on public health insurance, and its implementing
Ministerial Decree for their conflict with the obligations of the United States
arising out of Community law and from article. paragraph 36. 1 of the Charter
fundamental rights and freedoms ("the Charter"). The appellants consider that
that, according to existing legislation, the authorized persons cannot claim
reimbursement of medicinal products from public health
insurance in administrative proceedings, and whether or not they are denied their right to judicial and
Another measure of protection, the Ministry of health (
"the Ministry") published in this area.
2. The appellants then describe how that is legally in the Czech Republic
regulated the payment of human medicinal products as part of paid health care.
This is contained in Act No. 48/1997 Coll., on public health insurance
and amending and supplementing certain related laws, as amended by
amended (the "law on public health insurance").
3. When providing health care are certain medicinal products and
foods for special medical purposes (hereafter also referred to as
"pharmaceuticals") covered by the health insurance funds. These are pharmaceuticals,
that contain substances of groups of active substances referred to in annex
(annex # 2) of the Act on public health insurance. In each group
the active substances listed in the annex shall be at least one medicine
medicine or food for special medical purposes, which is fully
paid for by health insurance. A prerequisite for the payment of the drug from
health insurance is its entry on the list of medicinal products and
foods for special medical purposes held by the Ministry. The request for
write serves the marketing authorisation holders, issued by the State Drug Administration
the Office for drug control in accordance with Act No. 79/1997 Coll., on pharmaceuticals and on
changes and additions to certain related laws. About missing drugs
to the list of medicines and foods for special medical purposes,
as well as its delisting decisions in Administrative Department
control.
4. If the State Bureau for drug control on the registration of the drug,
The Ministry of Finance has established in accordance with Act No. 526/1990 Coll.
prices, as amended, the maximum price, and the holder of the
the Ministry asked the marketing authorisation for entry into medicine
list, you can submit a proposal to the Ministry of the reimbursement of the drug from
public health insurance funds. Without having the obligation to
such proposals reflect, the Ministry shall issue the sort order in which the
calculates drugs from health insurance fully paid, and the amount of payment
individual active substances. Suggestions for fixing the amount of remuneration
serves the Ministry, which is categorization Commission as follows
the advisory body of the Minister of health. Categorization Commission
discusses the various proposals and recommend the amount of the payment; recommendations of the Commission
they are then published on the website of the Ministry. The competent
the Department of the Ministry shall draw up a draft decree and subsequently together with
comments on the recommended size of the payment of the advance it again
categorization Commission. Before full implementation are refined design
the decree is still provided to the appellants the opportunity to
kategorizačnímu process, but in a very limited space. The resulting
the draft legislation is then sent to the Minister of health, who
After the end of it could submit to the Legislative Council of the Government.
In the event of a positive expression of the legislation is proclaimed.
5. the drug is so fully covered by compiled and the level of remuneration of the medicinal
substances laid down in the legislative process. The participation of the holder of the registration
pharmaceuticals and other stakeholders in the process, and thus their
the ability to affect the appearance of the Decree, only depends on the will of the Ministry of
to inform about its preparation and to hear suggestions and comments to it. Similar
also applies to initiate changes to the content of the Decree. The enabling provisions of the Act
on public health insurance plus does not contain any detailed
the criteria for determining the level of reimbursement of medicines and the resulting contents of the decree is not
based on objective and verifiable criteria. The Decree as a
the legislation also does not contain a statement of reasons.
6. To determine the amount of reimbursement of medicines from health insurance resources
does not occur in the individual administrative proceedings with the participation of the appellants-
holders of registration of gifted procedural rights. Subjects ' rights
relating to the amount of the payments is not possible to pursue an independent and
an impartial court.
7. Decision on the disbursement of drugs in the Czech Republic is therefore not based
on objective criteria, are not justified and are not subject to the Court
review. This fact is not cured by the or by the drug are in the system
health insurance rights in proceedings concerning the classification of medicinal products to a list
medicines and foods for special medical purposes, which is in the
essentially an administrative procedure. The classification of the drug to the list is
the condition for inclusion in the system of payment, however, does not even have the minimum
effect on the level of the remuneration of a specific drug.
8. The appellants draw attention to the fact that the fixing of prices for human
drugs and their integration into the public health insurance system
adjusts for the Member States of the European Union Council Directive 89/105/EEC on
the transparency of measures regulating the pricing of medicinal products for human
products and their inclusion in the scope of national
health insurance systems (hereinafter "the directive"). Article 1 of Directive
requires Member States to ensure that any laws, regulations or
administrative measures to control the prices of medicinal products or
restrict the range of medicinal products covered by the health insurance systems in the
accordance with the requirements of the directive. Pursuant to article 6 (1). 2 of Directive
the decision not to include medicinal products on the list shall be justified on the basis of the
objective and verifiable criteria, including, if necessary,
any expert opinions or recommendations on which the decision is based.
The applicant in such cases is to be informed of the remedies available.
According to the appellants, it should be article 6 be interpreted in connection with article
1. The mere inclusion of the drug into the system of public health insurance
the list has no practical effect unless at the same time to
the decision on the amount of reimbursement of medicines from public health insurance.
The principles of article 6 should be applied not only to the decision on the classification
drugs on the list, but also to the decision of the Ministry about the specific amount of the
reimbursement from health insurance.
9. The appellants take the view that the approach of the United States to the European
Union on 1 May 2004. 5.2004 to incorporate the Community law into the Czech
the rule of law. This has a direct impact on the perception of the concept of constitutional order.
His part make up the new standards primary law of the European
the community. One of those is based on whether or not the principle of the application of priority and
the obligation to properly implement obligations arising from European law to
the national legal order. For the authority, which oversees respect for these
principles, and is therefore entitled to review the compliance of the relevant
national rules with Community law, and that is in this
context endowed with powers, the appellants shall be deemed derogatory to the constitutional
the Court. Respect for and observance of the compliance with the requirements of sound
national implementation of the obligations of European law represents according to
the appellants ' populate the attributes of the rule of law pursuant to art. 1 (1). 1 of the Constitution
The Czech Republic (hereinafter referred to as "the Constitution"), and this obligation is achieved
the level of the constitutional order.
10. in the alternative, without further constitutional argument, then the appellants
added that if the marketing authorisation holders drug denied to
the right to claim their rights before an independent and impartial administrative
the authority and the Tribunal ", challenged the legislation in relation to them violates the law
on the judicial and other protection. paragraph 36. 1 of the Charter.
II. A)
Recap the essential parts of the representation of the parties
11. the constitutional court proceedings in accordance with the
the provisions of section 69 of Act No. 182/1993 Coll., on the Constitutional Court, as amended by
amended, the parties-the Chamber of Deputies and the Senate
Parliament of the Czech Republic, the Ministry of health and the public
the Ombudsman.
12. The Chamber of deputies to the content of the proposal indicated that the proposal is based on the
the legal situation prior to the adoption of two amendments to the law on public health
insurance made by law No 438/2004 Coll. (the amending Act No.
551/1991 Coll., on General health insurance company in the Czech Republic
as amended, Act No. 280/1992 Coll., on departmental,
industry, business and other health insurance companies, as
amended, Act No. 592/1992 Coll., on premiums for General
health insurance, as subsequently amended, and Act No. 48/1997
Coll., on public health insurance and amending and supplementing certain
related laws, as amended), which took
effect on 1 May. in August 2004, and by Act No. 123/2005 Coll. (amending
Act No. 48/1997 Coll., on public health insurance and amending and
certain related laws, as amended,
and Act No. 592/1992 Coll., on premiums for general health insurance,
in the wording of later regulations), which came into force on 30 November. March
2005. The first of these laws reflected the content of Council Directive 89/105/EEC to
the Act on public health insurance, by its article 15, paragraph 2. 8
allows you to review the decision on decommissioning now medicines from the list of medicinal products
medicines and foods for special medical purposes according to the code of administrative procedure and
the marketing authorisation holder of the drug has so benefited from legal protection
the "independent administrative institution". The second of those laws enshrined in the
§ 15 para. 6 of the Act on public health insurance the same procedure for the
cases deciding not to register a drug on the list of medicinal products and
foods for special medical purposes. The Chamber of Deputies is therefore of
the view that the contested provision is already in breach of that directive is not.
Contrary to namítanému of the legislation with the principle of the right to judicial protection
the Chamber of Deputies did not comment.
13. He recalled that the first Senate amendment to the Act on public
health insurance (published later under no 438/2004 Coll.), which
the contested provision has brought, has addressed the Senate on 20 April. 5.2004, and decided to
then, about the return of the Chamber of Deputies with amendments. Against the
now the contested provisions were not if no objections are raised and the Senate
It is considered the appropriate law the citizen to the provision of health care,
How is the article has in mind. 31 of the Charter. In the version approved by the Senate, then
adopted the draft Bill and the House of Commons. The Senate then points out that the
the appellants themselves are, as alleged, aware of non-standard design
If the legal provisions indicated attack primarily for conflict with the
Community law. According to the Chamber, however, cannot belong to a finding of
consistent or inconsistent national law with Community law, the authority
the national. Competent in this direction, it is only the European Court of
Court of Auditors. For this conclusion suggests the principle of priority of the application of community
Law Institute of the questions with which the national courts on the
European Court of justice are turning; could the Constitutional Court to cancel or modify
laws or their individual provisions conflict with the community
the law, he would have been entitled to and answer questions. This, of course,
It is not. Protection of rights under Community law is ensured in other
methods, primarily the responsibility of the Member State for infringements.
The assessment of the contested provisions of the Act tempered conflict on public
health insurance with the article. paragraph 36. 1 of the Charter leaves it to the discretion of the Senate
Of the Constitutional Court.
14. The Ministry of health, through the mouth of the former Minister, Milady
Emmerové in response to a specific query, the judge-rapporteur expressed the
first to the adoption of the contested regulations. The legislative process is said to be
match the General method of adoption decrees. The proposal has received in accordance
with legislative rules of the Government request for space. After incorporating
the Legislative Council was pending observations of the Government that stated
compliance with the constitutional order and laws. The Minister signed a decree and
It was subsequently published in the statute book. As regards the process of preparing
the substantive content of the Decree, because it is modified the internal regulations
the Ministry of the Minister's command no. 3/1992 to ensure the legislative
the activities of the Ministry of health of the CZECH REPUBLIC, no. 12/2003 on
the principles for the distribution of materials to the Ministry of health
the inner and outer disagrees, and no 6/2004 on the
of the Statute and the rules of procedure of the Commission for the categorization of drugs and food for
Special medical purposes, the Department of health. Transparency,
the representativeness and impartiality of the determination of the amount of payments ensures that the composition of the
categorization Commission, with members appointed and recalled by the Minister.
Příkladmo lists the representatives of the Czech medical society
Evangelist Purkyne, Czech Medical Chamber, the Czech Chamber of pharmacists,
The Czech dental Chamber, patients ' organisations, health
insurance companies, State Institute for drug control. Categorization Commission
in its activities follows the rules and is governed by the principle of
transparency in the processing of the evaluation of proposals and complaints
the appellants and the principle of objectivity and quality of the provided reviews
design and analysis on the objections.
15. the Ministry of the appellants ' arguments about bad rejects
transponované directive into the law on public health insurance. According to the
Preview of the Ministry directive distinguishes between deciding on the inclusion of the drug
on the list of medicines and foods for special medical purposes
the one hand, and the determination of the prices of a particular drug, on the other.
Speak to the directive on the "decision on the price", then the only responds to the
the different pricing systems in the Member States, without
imposing the obligation to establish the price of the drug procedure in administrative proceedings.
The appellants thus nedůvodně two separate processes, therefore
deciding on the inclusion on the list of medicines covered by the resources of
health insurance with approving prices for this drug. Directive
does not regulate the pricing of medicines or store to make decisions about her in
administrative proceedings. The obligations from the directive are carried out properly and
completely.
16. the appellants ' Objection relating to the infringement of the rights accruing to the holders of
the decision on the registration of the drug from the article. paragraph 36. 1 of the Charter shall be considered
the Ministry is just a general statement. Considers that a prerequisite
the success of this objection, it would be "a violation of specific rights provided for
legal regulation ", the appellants ' having to exactly indicate
that legislation was their right, under what
is it a violation of ". The Ministry also suggests that the drug may be
placed on the market regardless of whether or not it is at least partly
be covered by the resources of public health insurance, and the process
determining the payments producers and distributors do not have to take. A proposal from the
considered as manifestly unfounded and, as such, it proposes to refuse.
17. The Ombudsman to query the judge-rapporteur, non dated
29.7. 2005 said that the question of control over the design
He does not enter.
II. B)
The opinion of other interested bodies and experts
18. The Constitutional Court, led the effort to obtain the most complete information about the
the process of creating a catalog of drugs financed by public funds
health insurance, has asked for opinions on the communication under consideration
the proposal of the Group of Senators still further the institutions concerned. Addressed in this
Yet the Czech Medical Chamber, the Czech pharmaceutical Chamber
General health insurance company in the Czech Republic and Association of health
insurance companies, bringing together all the other undertakings operating in the Czech
Republic in the field of public health insurance, specifically, the Czech
national health insurance, employee insurance, Metallurgical
Occupational health insurance banks, insurance companies and the construction industry, Golden Hill
brotherly cashier, Military health insurance, employment
insurance company Škoda, a health insurance company METAL-ALLIANCE and health
the insurance company of the Ministry of Interior of the Czech Republic.
19. the Czech Medical Chamber in its opinion on the proposal fully endorsed and
identifying the reasons which led to its filing of the claimant.
Considers it undesirable that the pricing of medicinal products, as defined in the contested
statutory provisions took place in the system to which they do not have the ability to
interfere with the bodies which contribute to; called příkladmo
a representative of the professional organization of physicians, health insurance companies, scientific
institutions and the manufacturer of the drug. He admits that their representatives are
included among the members of the Commission for the categorization of drugs, but it has not been already
six months convened, and so the last amendment of the contested Decree was not with
members of the Commission shall be consulted at all. Czech Medical Chamber confirming
entirely informal way of adopting the Ordinance without an objective assessment
all the opinions, its comments on the draft of the last amendment in question
the Decree, for example, were not taken into account. In the current situation may
experience a deterioration of the rights of drug manufacturers and patients themselves. Also
General health insurance company of the United States agrees with the reasons
a group of Senators has led to the submission of the proposal. The enabling
provisions of the Act on public health insurance does not contain any
more detailed criteria for determining the level of remuneration of the individual drugs.
As a result, the extensive ability to subjectively decide Ministry
fully covered on pharmaceuticals public health insurance system and
the amount of the partial reimbursement. And on the contrary are from this process of de facto
excluded other interested bodies that actively influence
they cannot. In addition, these bodies cannot seek the protection of his rights
an independent and impartial court. The existing legislation on pricing
of medicinal products does not match the requirements of the directive, which was the Czech Republic
carried out inadequately. United said the Chamber stated that the present form
the process of categorization, i.e. the incorporation of drugs between those that are paid from the
public health insurance resources, already in the past repeatedly
to complain of a variety of non-transparent steps, which in its opinion seriously
threaten the efficient functioning of the entire system of reimbursement of medicines. It is both
the fact that the reimbursement of the drug, taking into account its
the maximum administrative price occurs to a specific date,
When in the market for a long time then can doprodávat the drug out of the inventory. In
practice, often creates a situation where drugs, declared as a fully
to be paid by the insurance companies refuse to pay, in the excess of newly laid
the maximum prices. Further South, the Chamber said it considers
the role of the Commission in addition to the categorization process for the preparation of the Decree.
Has the status of a mere advisory body and in the past has already happened, that
the resulting appearance of the Decree of the Ministry after the intervention has departed from
the form of the proposal discussed categorization by the Commission. The results of its
negotiations can only comment on the operators concerned in a very short
the time limits, which do not give discretion to the most basic of probables
impact of the proposed changes. The period between the preparation, issuance and effect
the novels have been in the past, much shorter than required a
preparation of the medical field and support the discussion. Only in the period between the
the completion of the preparation of the decree and its efficiency in general health
insurance company of the United States is preparing a so-called. Spinner, taking up to this
the public and health care professionals understand AIDS, how will be about it that
specific drug to be covered by. This occurs often in the dial pad
the time of the entry into force of a new decree, or even later. Inaccurate
information on the amount of arrears then a burden on patients and lead to economic
damage of pharmacies. United said the Chamber would welcome clear and binding
determination of periods of preparation, Edition and the effectiveness of the reimbursement of the order, which would
guarantee a sufficient time for the preparation of reservu doctors, pharmacists
even patients on the new system of reimbursement. The Union of health insurance companies of their
opinion on the proposal, the Constitutional Court has not communicated.
20. In view of the discussion, which took place in the trade press to question
neústavnosti legislation of the Czech Republic, which was seen in
his conflict with Community law, in which it was zaujímána different
the opinion of the judge-rapporteur asked the scientific workplace, namely
the competent departments of the individual law schools in the Czech Republic,
to your expert opinion on this issue.
21. The views expressed in the replies can be divided into three basic
groups. The first is based on strictly from the conclusion that Community law, therefore,
that is not part of the constitutional order, cannot be a reference criterion
for the assessment of the constitutionality of the national law. The second is on
opinion, that assessment cannot be excluded questions souladnosti of the laws of the United
States with primary and secondary European Community law, and
It's at that level, when in addition to the breach of Community law is getting
at the same time contrary to the principles of the constitutional order of the Czech Republic. The third
distinguishes cases of proper transposition of Community law into Czech
legislation which clearly escapes the constitutionality, and
cases of faulty transposition of that abstract review of constitutionality
they are subject, as in this case, the legislature does not act within the
delegated powers. It then concludes that even if in the framework of the
abstract standards cannot be cancelled checks law conflict with the
Community law, must always be considered in the specific case of
compliance or contravention of this law, in order to assess the competence of
such a prescription. The constitutional court heralds that he occupies
opinion on the options the review implemented Community law
in the grounds below.
III.
The diction of the contested provisions
And)
22. the provisions of article 15, paragraph 2. 10 of Act No. 48/1997 Coll., on public
health insurance and amending and supplementing certain related
laws, as amended, reads as follows:
"The Ministry of health shall lay down by Decree
a) medicines and foods for special medical purposes fully
paid for by health insurance,
(b) the amount of payment) the individual active substances belonging to groups
the active substances referred to in annex 2,
(c) the amount of the reimbursement) of foods for special medical purposes, containing the active
the substance of the groups of active substances referred to in annex 2,
(d) the amount of the reimbursement) individually prepared medicines,
radiopharmaceuticals and transfusion products from health insurance,
e) restrictions and conditions prescribing symbols
medicines and foods for special medical purposes covered by the
health insurance, including restrictions on the use of symbols and
medicines and foods for special medical purposes, when providing
health care in specialised workplaces. "
23. the provisions of article 15, paragraph 2. 5, the last sentence with a semicolon to Act No.
48/1997 Coll., on public health insurance and amending and supplementing
some related laws, as amended, reads as follows:
"the amount of reimbursement from health insurance lays down detailed legal
prescription ".
(B))
24. The Ministry of health Decree No. 532/2005 Coll., on transfers
medicines and foods for special medical purposes, as amended by Decree
The Ministry of health no. 37/2006 Coll., Decree of the Ministry of
health care no 368/2006 Coll., Decree of the Ministry of health.
387/2006 Coll. and Decree of the Ministry of health no. 621/2006 Coll.
added:
"The Ministry of health shall lay down pursuant to § 15 para. 10 of law No.
48/1997 Coll., on public health insurance and amending and supplementing
some related laws, as amended by law No 438/2004 Coll. (hereinafter referred to
"the Act"):
§ 1
This Decree provides:
a) medicines and foods for special medical purposes fully
paid from the funds of the public health insurance (hereinafter referred to as
"health insurance"), referred to in annex 1 to this notice,
(b) the amount of payment) the individual active substances belonging to groups
the active substances referred to in annex No. 2 of the Act, referred to in annex 1 to the
This Decree,
(c) the amount of the reimbursement) of foods for special medical purposes, containing the active
the substance of the groups of active substances referred to in annex No. 2 of the Act, referred to in
Appendix No. 1 to this notice,
(d) the amount of the reimbursement) individually prepared medicines,
radiopharmaceuticals and transfusion products from health insurance, referred to
in annex 1 to this notice,
e) restrictions and conditions prescribing symbols
medicines and foods for special medical purposes covered by the
health insurance, including restrictions on the use of symbols and
medicines and foods for special medical purposes, when providing
health care in specialized sites, listed in annex No. 2
to this Decree.
§ 2
Shall be repealed:
1. Decree No. 585/2004 Coll., on transfers of medicines and foods for special
medical purposes.
2. Decree No. 225/2005 Coll., amending Decree No 585/2004 Coll., on
disbursement of medicines and foods for special medical purposes.
3. Decree No. 337/2005 Coll., amending Decree No 585/2004 Coll., on
disbursement of medicines and foods for special medical purposes.
§ 3
This Decree shall enter into force on 1 January 2000. January 1, 2006.
Minister:
Mudr. Rath v. r. "
IV.
The conditions of the locus standi of the applicant
25. The proposal to repeal the provisions of § 15 para. 10 of Act No. 48/1997 Coll., on
public health insurance and amending and supplementing certain
related laws, as amended, and on the abolition of
Decree of the Ministry of health no. 589/2004 Coll., on transfers of medicines and
foods for special medical purposes, as amended, was
filed by a group of twenty-nine senators of the Senate of the Czech
Republic, and therefore in accordance with the conditions contained in the provisions of § 64
paragraph. 2 (a). b) Act No. 182/1993 Coll., on the Constitutional Court, as amended by
amended. In the case in question can therefore fulfill
conditions of locus standi on the part of the claimant.
In the.
The constitutional conformity of the legislative process
26. The Constitutional Court is in accordance with the provisions of § 68 para. 1 of the law on
The Constitutional Court in proceedings for review of laws or other legislation
required to assess whether the legislation was adopted and issued
constitutionally prescribed way.
27. From their respective Web sites, it was found that the amendment
the Act on public health insurance has submitted to the Chamber of Deputies
the Government of the Czech Republic on 8 June 1998. 9.2003. Resolution No. 1035 6 May. 4.2004
the lower House approved the proposal by a majority of the 170 members of the present 87,
79 members voted against the proposal.
28. The Senate forwarded a proposal discussed on 20 April. 5.2004 and resolution No.
the majority of the 450 56 57 present senators called for his return
The House of representatives with amendments.
29. The Chamber of Deputies returned the Bill discussed on 24. 6.2004
and resolution No. 1199 agreed with him in the version approved
By the Senate. Of the 189 MPs 119 voted for them and 36 against
the proposal.
30. the President of the Republic signed the Act on 14 June 2005. 7.2004 and Prime Minister
16 December 2002. 7.2004.
31. On 26 April. 7.2004 was promulgated in the collection of laws on the amount of 144
under number 438/2004 Sb.
32. The competence of the Ministry of supply legislation for the implementation of the law
determined by article. paragraph 79. 3 of the Constitution. The prerequisite is the existence of
explicit legal authorization. In that case, the authorization right
the provisions of § 15 para. 10 of the law on public health insurance.
The Decree marked in the proposal was signed by the Minister for health and
duly published in amount 202 under number 588/2004 laws.
Also a valid decree signed by the Minister of health, and was
duly published in 181 amount under the number 532/2005 collection of laws.
33. The Constitutional Court notes that adoption legislation,
which are the subject of the review, there has been in the prescribed manner.
Vi.
Your own review
34. The appellants challenge the enabling provisions of the Act on public
health insurance for two separate reasons. According to them, on the one hand
contradicts the basic attribute of the rule of law, namely, the obligation to
respect Community law (article 6 of the transparenční directive), which
is in violation of, and, secondly, for the omission of the guarantee of judicial protection, as
enshrined in article. 36 of the Charter).
35. the Constitutional Court finding SP. zn. PL. ÚS 50/04 (promulgated under no.
154/2006 Coll.) He explained that Community law cannot be a reference
the criterion of assessment of the constitutionality of national regulation. On the other
side are the European Community, as the Czech Republic,
legal communities. To respect for and deference to a substantial
aspects of the rule of law are the European Community built. From
ECJ case-law can be inferred that its interpretation of the
the General principles of the laws of the relevant fundamental rights contained in the
domestic constitutional catalogues is close to approach the Constitutional Court. In addition, the
the issue in question refers to the creation and functioning of the internal market, including
interference with the free movement of goods as one of the four fundamental freedoms,
Thus, the essence of the European communities, and therefore it should be about it
more carefully to ensure that the restrictions are adopted balanced by sufficient guarantees
fundamental rights of stakeholders, particularly in the case under consideration
the right to a proper and fair trial. In this spirit, the Constitutional Court also
He worked with the appellants ' objection that the contested provisions of the law on
public health insurance is contrary to the directive; or actually
the observed discrepancy by itself could not result in the derogation of the
legal provisions and its implementing decrees, however, arguments
justifying such a finding can be supported by justification
neústavnosti.
36. According to the article. 1 (1). 1 the Constitution of the Czech Republic is a sovereign, unified
and the democratic rule of law based on respect for the rights of man and of the citizen.
The source of all State power is the people and is exercised through
authorities able to legislative, Executive and judicial (article 2, paragraph 1, of the Constitution).
The fundamental rights and freedoms are under the protection of the judiciary (article 4 of the Constitution).
According to the article. paragraph 36. 1 of the Charter, each can claim procedure set forth
their rights before an independent and impartial court and in specified
cases at another institution. The second paragraph of the same article gives each,
who claim that their rights was truncated by a decision of the public authority
management, the ability to apply to a court to review the legality of such
the decision, unless the law provides otherwise. The review of the jurisdiction of the Court, however,
must not be excluded decisions concerning fundamental rights and freedoms,
whose protection is embodied in the constitutional order of the Czech Republic.
37. The Czech legal order distinguishes in the system of regulation of the market in medicinal products
products in four different steps: registration of the drug (in agreement with its indication of the
on the market), the determination of the maximum prices, the decision to include on the list
financed by drugs and reimbursement from public funds
health insurance. On the registration of the drug pursuant to section 26 of the Act shall be decided by
No. 79/1997 Coll., on pharmaceuticals and on amendments and additions to some of the other
laws, State Institute for drug control; on this decision-making
covered by the administrative code (see section 66 of the Act). The maximum price
be determined in accordance with section 10 of Act No. 526/1990 Coll., on prices, as amended by
amended, the Ministry of finance, that assessment, published in
A price list item with a journal of regulated prices. The importance of the
the third step consists in the fact that the resources of public health
insurance can be paid for by the drug, which are written in
the Ministry maintained a list of medicines and food for
Special medical purposes. If the Ministry fails to comply with the request of the manufacturer or
the distributor of the drug for the registration of a particular drug, it refers to this list
in its decision the administrative code. The administrative code also applies to
the decision to exclude pharmaceuticals from the list. The first step, and the third way
taking place in the mode of the administrative code, when the release of the individual decision
precedes the control its participants the possibility to take advantage of their
procedural rights; pharmaceutical price regulation scheme-specific Constitutional Court
leaves due to the subject matter of the proceedings a party to their attention. On the other hand
This last step with the decision as an individual administrative act
does not count. Has the form of a ministerial regulation, but in its essence is not
the general norm, but rather "file of individual decisions", and it would be
Therefore, no need to apply the system envisioned in the article. paragraph 36. 1, possibly even
paragraph. 2 of the Charter.
38. While determining the specific amount of the payment is essential for
the demand for a different drug, and according to the principle that the demand is the
the larger, the higher the settled portion of public health insurance.
This decision of the Ministry about the specific level of the remuneration of the
Pharmaceuticals, or in our case, in what form it prepares and publishes the
the Ordinance in question, as reflected in the profit and
the benefit of the manufacturer or Distributor. Building uneven
the conditions for entrepreneurs in a way it distorts their free
competition on the market for human medicinal products. The conditions for doing business, however, must be
for all its participants equal, even if the constraints of the
by law. All manufacturers and distributors of medicinal products may, at
the national market a business only for the fulfilment of the statutory
the conditions, which must, however, be the same for all. If the inclusion of the
a specific product on the list of medicines covered by the resources of the public
health insurance its manufacturer or distributor receive against other
manufacturers or distributors to benefits, they must more strictly observe it on
that this inequality was offset by the ability to control transparency
the creation of these conditions in each individual case.
39. It is also the aim of the plaintiff the Court referred to the directive. Her article
6 says that the "... If the medicinal product is paid
the national health insurance system, after the competent authority of the
decides about his inclusion on the list ". The diction of the article requires that all
such decision was made within the individual administrative
the decision (in other words, the applicant has to reach a decision which
the reasoning is based on objective and verifiable criteria) to
the decision was made within 90 days and 180 respectively that a decision could
be subject to judicial review (in summary, formulates a specific
file to protect the procedural rights of the participant). The provisions of § 15 para. 10
the Act on public health insurance, these guarantees, as is evident from
its text is not required.
40. The Constitutional Court, for the reasons detailed in the already cited award
SP. zn. PL. ÚS 50/04 provisions art. paragraph 36. 1 and 2 of the Charter shall be interpreted with
taking into account the case law of the European Court of Justice relating to the
the principle of fair process. The European Court has already twice a similar problem
addressed, in the case of the Austrian and Finnish remittance system of human
pharmaceuticals. Of the Commission's case against Finland [case C-229/00, Commission v
Finland (2003), the ECJ I-5727] follows that Finland should have a similar system of payments
medicinal products from public health insurance as a United
Republic. According to the Finnish law was a consequence of the decision of the medicinal product
on the determination of the prices charged to appear on the list of medicinal products, which
automatically mean entitlement to the reimbursement of 50% of the price of the public
insurance. Finnish law therefore required the two-stage decision-making in
cases concerning those medicines from the system of public
insurance paid in the range of greater than 50%. To this end, it has created a
the Finnish Government legislation list "of certain active substances", which
have received higher levels of remuneration. Its own decision on the amount of payment for
specific medicine published experts in individual cases, but such
the decision was merely a pro forma confirmation that individual medicines
include these active substances included in the list. With reference to the
the structure of decision making the Finnish Government argued that article 6 of the directive
does not apply to prescription issued by the Government, because "this in itself did not
with the result that a particular drug is included in the list of medicinal products, which
enjoy higher protection of the public health insurance system, but
only refers to certain active substances "(para. 30). European Court of Justice
rejected this argument as too formalistickou with the fact that regulation
Government (albeit indirectly) predisposes certain medicines for inclusion in the higher
the level of remuneration, and that-as has the form of the General Regulation-in
really "represents the decision of the Government to the individual file,
a decision on the inclusion of certain medicinal products into one of the
of social security systems, and therefore falls under the provisions of article mode.
6 directive (id, para. 34).
In the case Commission v Austria [case C-424/99 Commission v Austria,
(2001) the ECJ I-9285] was a similar problem. In the Austrian system
There was a register of medicinal products for the purposes of their remuneration, but the
represented only a kind of guide and the individual payment of
the health insurance system are decided in the individual
cases. In individual cases, the doctors were able to decide on the
the basis of the patient's needs, that the drug will not be paid to the registry by registered,
and vice versa the cure unregistered Yes. Therefore, the Austrian Government took the view that
the registry cannot be regarded as an accurate list within the meaning of article 6 of the
directive. European Court of Justice has stated that the purpose of the directive is to ensure,
"that measures to control the prices of medicinal products ... or to limit the
the range of medicinal products covered by the health insurance
meet the requirements of the directive "(para. 30). The European Court of Justice
concluded that, regardless of the reference only the function of the registry is sufficient for
the system fell under the regime of article 6 of the directive, that the "inclusion of the drug
to the registry usually means that the system will be created also above its
remuneration. ". The European Court of Justice is therefore clearly expressed in it twice
the meaning of the decision concerning the level of remuneration of the medicinal product
resources for public health insurance, even if formally separated
from the decision on the inclusion in the list falls within article 6 of the directive, mode
and, therefore, must be accompanied by a guarantee of procedural rights contained herein.
41. As already explained above, that, as interpreted by the European Court of Justice
principles corresponding to the fundamental rights and freedoms, cannot remain without
the response when the interpretation of national law and its accordance with constitutionally
guaranteed rights. The Charter in article 6(2). 1 confers fundamental rights special
the protection. Therefore, if the court deduced that decisions on the classification of
medicinal products in the list of medicinal products covered by the resources of the public
health insurance you are experiencing interference with the rights of their producers and
distributors and, therefore, it is necessary to consistently ensure compliance with the principles of
fair process, then the Constitutional Court to this line of argument in the interpretation of article.
paragraph 36. 1 and 2 of the Charter into account. In the context of an abstract checks
standards must assess whether the legislation creates such conditions in order to
the intervention was offset by such rights which sufficiently eliminate
space for discretion each specific decisions on the classification of
medicines in the list of medicinal products covered by the resources of the public
health insurance. The provisions of § 15 para. 10 of the law on public
health insurance does not meet such a requirement, since it does not guarantee
to the applicant, that a decision on his application was based on objective and
verifiable criteria in order to be judicially reviewable and that
issued without undue delay. The inclusion of a particular drug to a
a set of medicines from health insurance fully paid and to the set
Pharmaceuticals paid only partially, as well as about the specific amount to be paid, however,
the Ministry shall be decided not in the administrative procedure, but in the context of the
the regulatory process.
42. On the basis of the mandate contained in the provisions of article 15, paragraph 2. 10 of the law on
the Ministry of public health insurance regulates the Decree, i.e..
generally binding legal regulation, the rights and obligations of exactly
personalised subjects, which is typical for the acts of the application of the law.
The existing practice that stray from the one of the base material
character of the concept of law (law), which is its universality.
43. The Constitutional Court has already in the past, to the requirement of universality of the legal
prescription repeatedly expressed. In finding SP. zn. PL. ÚS 55/2000 (collection
the findings and resolutions of the Constitutional Court, Volume 22, no. 62, p. 55 and
seq.; promulgated under no. 241/2001 Coll.) in this context, said: "to the
the basic principles of the rule of law in the material belong to the maxima
universality of legal regulation (requirement of universality of law, respectively.
the generality of legislation). Universality of the content is an ideal, typical
and the essential character of the law (and the law), and in
relation to the court decisions, Government and acts of the administration. The purpose of the distribution
State power in the legislative, Executive and judicial is entrusting the General
and initial power regulation of State legislation, derived General
power regulation and decisions on individual cases, manage and
exclusively only deciding individual cases, the judiciary. From
referred to the definition of the concept of the definition of the character of the law (or legal
prescription) is then based on the concept of law (law) in the material
the meaning of which differentiate laws (legislation) within the meaning of
formal. ". This conclusion is confirmed by the Constitutional Court later for example. in the award
of 28 June. 6.2005, SP. zn. PL. ÚS 24/04 (collection of findings and resolutions
The Constitutional Court, Volume 37, finding no 130; promulgated under no. 327/2005
SB.).
44. The requirement of the universality of the law was based on the Constitutional Court also on
proceedings on the application for annulment of the provision of section 7 of Act No. 2/1991 Coll., on the
collective bargaining (find SP. zn. PL. ÚS 40/02, a collection of awards and
the resolution of the Constitutional Court, volume 30, no. 88, p. 327 et seq.;
promulgated under no. 199/2003 Coll.). Carrier points of argument fall on
the case under consideration. The Constitutional Court here reminded of the arguments in favor of
universality of the law or legal regulation, namely: separation of powers,
equality and the right to own, an independent judge.
45. The first of the objections against the law, the legislation concerning the
unique cases, is the principle of the separation of powers, or the separation of the legislative,
Executive and judicial power in the democratic rule of law: "the adoption of laws
concerning the unique cases, most application area
rights. Entitled to the statutory independence of the judge and the legal protection of exclusive
individual regulation of the legislature also in areas that are not
protected by the principle of nulla poena sine lege (while here
Lex in a meaningful way can only be general and written legal
sentence). " (H. Schneider, Gesetzgebung, 2. Auflage, Heidelberg 1991, s.
32).
46. Those concerned cannot in the present legal status
obtain judicial protection. On the issue of the exclusion of judicial review in the case of
individual legal regulation of the Constitutional Court in the above-cited finding sp.
Zn. PL. ÚS 40/02 said: "Individual control that is contained in the legal
Regulation, depriving the addressees of the possibility of judicial review of the fulfillment
General terms and conditions for a specific body modifications normative, which meet
transparent and acceptable justification in relation to the regulation of
in General, should be regarded as rozpornou with the principle of the rule of law (article 1
The Constitution), which is the immanent power-sharing and judicial protection of rights (article 81,
article. 90 of the Constitution). ".
47. Similarly, he went to the procedural protection options and the European
the Court of Justice in the mentioned cases. As regards the possibility of using
appeals against the decision, the text of the directive lays down only
so much, that the applicant should be informed of the possibility to appeal.
Of the European Court of Justice deduced that the applicant must be able to take advantage of the
appeal, effectively ensuring the protection of its rights. In addition, the
administrative appeal is not considered sufficient, it should have a
the nature of judicial review. With this interpretation of the Constitutional Court shall be fully
identifies itself as fully complies with the requirement in article zakotvenému. paragraph 36. 2
Of the Charter.
48. the same deficiencies, that had denied the European Court of Justice in relation to the
directive, also considered the provisions of § 15 para. 10 of the law on
public health insurance in relation to the Charter of fundamental rights and
freedoms. The determination of the exact amount, to what will be paid for by the drug,
the Decree effectively excludes the full participation, stakeholder
entities in this process, weakens the transparency of individual steps,
and thus the credibility of the whole process. The suitability of a particular level of remuneration
the drug should be studied during the administrative procedure
based on the measurement of various vested interests, with the possibility of
consider all the contradictions and comments. In particular, it should be
the decision about which drug is justified to make it clear why his
prerequisites for inclusion in the system of payments from health insurance are
better than drugs other assumptions, and how the decision-making authority with the
the essential arguments.
49. While it is true that the amendments to the law on public health
insurance of the Court referred to the Chamber of deputies in its observations (laws No.
438/2004 Coll. and no 123/2005 Coll.) to its article 15, elements of procedural
the protection. But this does not mean that such a move is itself
pleasant. This applies only for entry of the decision of the Ministry
medicinal product in the list, which is for any medicinal product
the premise of his remuneration from the public health insurance system (and
appears to indicate that all medicinal products from the list will be covered by
at least in part) which is of direct relevance to the decision
the determination of whether the individual medicinal products will be covered fully or
partially. It was only in the second instance decides on the specific amount of the
paid for by the drug from public health insurance. Here it is a completely
a separate measure of decision making, which separated the law does not
guarantee of procedural rights, as required under article 3(2). paragraph 36. 1 and 2 of the Charter.
50. The enabling provisions of § 15 para. 10 of the law on public health
insurance violates the principles described above, it is therefore incompatible with the
the principles of the rule of law, and therefore in breach of article 88(3). 36 of the Charter. For this
the situation of the Constitutional Court notes that it was no longer necessary to address the effects of
labeled the legislation to other constitutionally protected rights, such as the.
the right to property, as the above findings and their corresponding
conclusion on neústavnosti to derogation of the contested provisions of the Act on public
health insurance is sufficient.
VII.
51. The Constitutional Court could not overlook that in case of cancellation the provisions of §
15 paragraph 1. 10 of the law on public health insurance is losing any
justification the last sentence of part after the semicolon the provisions of § 15 para. 5
the Act on public health insurance, as amended by the amount of their remuneration from "
health insurance lays down implementing legislation ". Both provisions
they are closely related, and one without the other can not stand alone.
52. with regard to the above arguments, the provisions of § 15 of the Constitutional Court
paragraph. 10 and para. 5 the last sentence after the semicolon in the version "; the amount of their
reimbursement from health insurance lays down implementing legislation "
the Act on public health insurance under the provisions of section 70 para. 1
the law on the Constitutional Court to annul it.
53. The Constitutional Court, in accordance with the provisions of section 70 para. 3 of the law on the constitutional
the Court at the same time expressed that at the same time with rušeným legal provisions
Decree of the Ministry of health shall cease issued on the basis
here referred to the mandate. That is, at the time of deciding on the draft decree
The Ministry of health no. 532/2005 Coll. the proceedings on the application for revocation
Decree of the Ministry of health no. 589/2004 Coll., Constitutional Court
He stopped, because in the intervening period between the filing of the application and the end of the trial
lapse (section 67, paragraph 1, of the law on the Constitutional Court).
54. the current state of the Axle requires to change the very nature of a valid
of the legislation. The legislature will have to work through a whole new mode
reimbursement of medicinal products from the resources of public health insurance, which will be
match also the principles outlined in the preamble of this finding. The constitutional
the Court is aware of the fact that the legislature is therefore the need
provide sufficient time for the development and adoption of new
of the legislation. Therefore, defer the enforceability of decided being exercised by
the operative part of the award until 31 December 2006. 12.2007.
The President of the Constitutional Court:
JUDr. Rychetský in r.
