On The Proposal That Repeal Of § 15 Para. 10 Of Law No. 48/1997.

Original Language Title: On The Proposal To Repeal § 15 Para. 10 Of Law No. 48/1997.

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now

Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=64651&nr=57~2F2007~20Sb.&ft=txt

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laws, as amended, are hereby repealed on 31 December. 12.2007.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.