The Constitutional Court found No 57 / 2007 Coll.
The Constitutional Court's finding of 16 January 2007 on the application for annulment of Article 15 (10) of Act No. 48 / 1997 Coll., on Public Health Insurance and amending and supplementing certain related laws, as amended, and the application for annulment of Decree No. 589 / 2004 Coll., on the reimbursement of medicinal products and foodstuffs for special medical purposes, as amended
Valid
The Constitutional Tribunal found
Text versions:
23.03.2007
57
FIND
The Constitutional Court
On behalf of the Czech Republic
The Constitutional Court decided on 16 January 2007 in plenary in the composition of Stanislav Balík, František Duchoň, Vlasta Formánková, Vojen Güttler, Ivana Jan, Vladimir Krůk, Dagmar Lastovecká, Jan Musil, Jiří Nykodým, Pavel Rychetský, Miloslav Excellent, Eliška Wagner and Michaela Židlická on the proposal of a group of 29 senators of the Senate of the Parliament of the Czech Republic on the abolition of the provisions of § 15 paragraph 10 of Act No. 48 / 1997 Coll., on public health insurance and the amendment and the amendment of certain related laws, as amended, and the Decree of the Ministry of Health No. 589 / 2004 Coll.
as follows:
Paragraph 15 (10) and Paragraph 15 (5) of the last sentence of the last sentence with a semicolon sounding "; the amount of their reimbursement from health insurance is laid down in the implementing legislation 'of Act No 48 / 1997 Coll., on Public Health Insurance and amending and supplementing certain related laws, as amended, shall be repealed on 31 December 2007.
On the same day the Decree of the Ministry of Health No. 532 / 2005 Coll., on the reimbursement of medicines and food for special medical purposes, as amended, will expire.
The procedure for the annulment of the Decree of the Ministry of Health No. 589 / 2004 Coll., on the reimbursement of medicines and foodstuffs for special medical purposes, as amended, is hereby terminated.
Reasons
Definition and recap of the proposal
1. On 4 July 2005, the Constitutional Court received a proposal from a group of 29 senators of the Senate of the Czech Republic for annulment in the heading of the marked provision of the Act on Public Health Insurance and its implementing ministerial decree for their contradiction with the obligations of the Czech Republic under Community law and Article 36 (1) of the Charter of Fundamental Rights and Freedoms (hereinafter referred to as "the Charter"). The appellants consider that, under the current legislation, beneficiaries cannot claim the amount of compensation for public health insurance medicinal products in administrative proceedings and are also denied the right to judicial and other protection against measures of the Ministry of Health ("the Ministry ') issued in this field.
2. The applicants then describe the way in which the reimbursement of human medicines as part of the covered health care is legally regulated in the Czech Republic. This is contained in Act No. 48 / 1997 Coll., on Public Health Insurance and on the amendment and addition of certain related laws, as amended, ("the Act on Public Health Insurance ').
3. In the provision of healthcare, certain medicinal products and food for special medical purposes (in the next text also referred to as "medicines') are covered by health insurance. They are medicines containing substances from groups of active substances listed in the Annex (Annex 2) to the Public Health Insurance Act. There shall be at least one medicinal product or food for special medical purposes within each group of active substances listed in the Annex which is fully covered by health insurance. The reimbursement of the medical insurance medicinal product shall be subject to registration in the Ministry's list of medicinal products and foodstuffs for special medical purposes. Applications for registration shall be submitted by the marketing authorisation holders of a medicinal product issued by the State Office for Drug Control pursuant to Act No. 79 / 1997 Coll., on Medicines and on amendments and additions to certain related laws. The Ministry shall decide on the non-inclusion of medicinal products and food for special medical purposes and its withdrawal from the list.
4. In accordance with Act No. 526 / 1990 Coll., on Prices, as amended, its maximum price and the MAH requested the Ministry to register the medicinal product, the Ministry may submit a proposal to the Ministry to determine the amount of reimbursement of the drug from public health insurance. Without the obligation to reflect such proposals, the Ministry shall issue a decree calculating the health insurance medicines fully paid and the level of reimbursement of the individual active substances. Proposals for setting the amount of remuneration shall be submitted to the Ministry, which shall proceed them to the categorisation commission as the advisory body of the Minister for Health. The categorisation board shall discuss individual proposals and recommend the amount of remuneration; the recommendations of the commission are then published on the Ministry's website. The competent department of the Ministry will then draw up a draft decree and forward it to the categorisation commission, together with comments on the recommended remuneration levels. Prior to the complete completion of the draft implementing decree, the appellants are given the opportunity to comment on the categorisation process, but in a very limited space. The final draft legislation is then referred to the Minister for Health who will submit it to the legislative board of the Government after the end of the comment procedure. In the case of a positive statement, the legislation is declared.
5. The list of fully paid medicines is thus compiled and the level of reimbursement of the active substances is laid down in the legislative process. The participation of the marketing authorisation holder of the medicinal product and other interested parties in this process, and thus their ability to influence the form of the decree, depends solely on the Ministry's will to inform and hear proposals and comments on it. The same applies to the initiation of changes to the content of the decree. Moreover, the law on public health insurance does not contain any more detailed criteria for determining the level of reimbursement of medicines and the resulting content of the decree is not based on objective and verifiable criteria. The Decree as a law also does not contain a justification.
6. The level of reimbursement of medical insurance drugs is not determined in individual administrative procedures involving applicants - holders of a marketing authorisation awarded by procedural rights. The rights of the bodies relating to the level of remuneration cannot be invoked by an independent and impartial court.
7. The decisions on reimbursement of medicines in the Czech Republic are therefore not based on objective criteria, are not justified and are not subject to judicial review. This fact is not resolved by the fact that medicinal products are incorporated into the health insurance system in the procedure for the inclusion of medicinal products and food for special medical purposes, which is essentially administrative. Although the inclusion of a drug in the list is a condition for inclusion in the reimbursement system, it does not have a minimal impact on the level of reimbursement of a particular drug.
8. The applicants draw attention to the fact that the setting of prices for medicinal products for human use and their integration into the public health insurance system is regulated by Council Directive 89 / 105 / EEC on the transparency of pricing measures for medicinal products for human use and their inclusion in the scope of national health insurance schemes (hereinafter referred to as the "Directive ') for Member States of the European Union. Article 1 of the Directive obliges Member States to ensure that all legal or administrative measures to control the prices of medicinal products for human use or to limit the range of medicines covered by health insurance schemes comply with the requirements of the Directive. According to Article 6 (2) of the Directive, the non-listing decision must be justified on the basis of objective and verifiable criteria, including, where necessary, expert opinions or recommendations on which the decision is based. In such cases, the applicant should be informed of appeals. According to the applicants, Article 6 should be interpreted in the context of Article 1. The mere inclusion of a medicinal product in the public health insurance system through the list shall not have practical effect unless a decision is taken at the same time on the level of reimbursement of the public health insurance medicinal product. The principles of Article 6 must be applied not only to the decision on the listing of the medicinal product, but also to the decision of the Ministry on the specific amount of the health insurance payment.
9. The applicants consider that the access of the Czech Republic to the European Union on 1 May 2004 has been integrated into the Czech legal order. This also has a direct impact on the perception of constitutional order. It also includes the standards of primary European Community law. These are also based on the principle of application priority and the obligation to properly implement the obligations arising from European law into national law. The appellants of the Constitutional Court consider as a body which oversees respect for these principles and is therefore entitled to review the compliance of the relevant national legislation with the Community law and which is in this context endowed with derogatory powers. Respect for and supervision of compliance with the obligation of proper national implementation of the obligations of European law is, according to the applicants, the fulfilment of the attributes of the rule of law according to Article 1 (1) of the Constitution of the Czech Republic (hereinafter referred to as the Constitution), with this obligation reaching the level of constitutional order.
10. In the alternative, without any closer constitutional argument, the appellants add that, if the marketing authorisation holders are denied the right to claim their rights "from an independent and impartial administration and court ', the contested legislation in relation to them infringes the right to judicial and other protection under Article 36 (1) of the Charter.
Recital of the essential parts of the observations of the parties
11. The Constitutional Court sent a motion to initiate proceedings in accordance with the provisions of Section 69 of Act No. 182 / 1993 Coll., on the Constitutional Court, as amended, to the parties to proceedings - Chamber of Deputies and Senate of the Parliament of the Czech Republic, the Ministry of Health and the Ombudsman.
12. The Chamber of Deputies stated on the content of the proposal that the proposal is based on the legal status before the adoption of two amendments to the Act on Public Health Insurance implemented by Act No. 438 / 2004 Coll. (amending Act No. 551 / 1991 Coll., on the General Health Insurance Company of the Czech Republic, as amended, Act No. 280 / 1992 Coll., on departmental, occupational, corporate and other health insurance companies, as amended, Act No. 592 / 1992 Coll., on Insurance against General Health Insurance, as amended, and Act No. 48 / 1997 Coll., on Public Health Insurance and on the Amendment and Addition of Certain Related Acts, as amended), Act No. 592 / 1992 Coll., on General Health Insurance, as amended, Act No. 123 / 2005 Coll., which amended Act No. 48 / 1997 Coll., on Public Health Insurance and on the Amendment of certain Related Acts, as amended, and Act No. 592 / 1992 Coll. The first of those laws reflected the content of Council Directive 89 / 105 / EEC in the Public Health Insurance Act by allowing its Article 15 (8) to review the decision on the withdrawal of a medicinal product from the list of medicinal products and foodstuffs for special medical purposes under the Administrative Code and thus allowing the marketing authorisation holder to have legal protection with the "independent administration '. The second of these laws enshrined in Section 15 (6) of the Public Health Insurance Act the same procedure for decisions not to register medicinal products and food for special medical purposes. The Chamber of Deputies therefore considers that the contested provision is no longer contrary to that Directive. The Chamber of Deputies did not comment on the contested infringement of legislation with the principle of the right to judicial protection.
13. The Senate first recalled that the draft amendment to the Act on Public Health Insurance (published later under No 438 / 2004 Coll.), which brought the contested provision, was discussed by the Senate on 20 May 2004 and decided to return it to the Chamber of Deputies with amendments. No objections were raised at the time and the Senate considered them appropriate to the right of a citizen to provide health care as referred to in Article 31 of the Charter. The Senate approved the bill and the Chamber of Deputies. The Senate then points out that the plaintiffs themselves are, as they claim, aware of the non-standard nature of the proposal if the designated legal provisions are primarily challenged for a conflict with Community law. However, according to the Senate, the finding of compliance or non-compliance of national law with the law of a Community body cannot be considered as a national. Only the European Court of Justice is competent in this regard. For this conclusion, the principle of the priority application of Community law as well as of the preliminary questions with which the national courts refer to the European Court of Justice is demonstrated; If the Constitutional Court could abolish the laws or their individual provisions for a conflict with Community law, it would also be entitled to answer the questions referred for a preliminary ruling. That is not the case. Protection of rights under Community law is ensured in other ways, in particular by the responsibility of the Member State for its infringement. The examination of the alleged contradiction of the contested provision of the Act on Public Health Insurance with Article 36 (1) of the Charter leaves the Senate to consider the Constitutional Court.
14. In response to a specific question from the Judge-Rapporteur, the Ministry of Health first commented on the process of adopting the contested decree. The normative process was said to be consistent with the general way of adopting decrees. The proposal received comments in accordance with the legislative rules of the Government. After incorporating the comments, it was discussed by the legislative council of the Government, which found compliance with constitutional order and laws. The decree was signed by the Minister and subsequently published in the Collection of Laws. As regards the process of preparing the material content of the decree, it is regulated by the Ministry's internal regulations, by order of Minister No. 3 / 1992 to ensure legislative activity at the Ministry of Health of the Czech Republic, by order No. 12 / 2003 on the principles for the distribution of materials of the Ministry of Health into internal and external comment proceedings, and by order No. 6 / 2004 on the Statute and Rules of Procedure of the Commission for the categorisation of medicines and foodstuffs for special medical purposes of the Ministry of Health. Transparency, representativeness and impartiality of setting the level of remuneration shall ensure the composition of a categorisation commission, the members of which shall be appointed and withdrawn by the Minister. Examples include representatives of the Czech Medical Society Jan Evangelist Purkyně, Czech Medical Chamber, Czech Pharmacy Chamber, Czech Dental Chamber, patient organization, health insurance companies, State Institute for Drug Control. The categorisation board shall respect the rules laid down in its activities and shall follow the principle of transparency in the processing of the evaluation of proposals and complaints by the applicants and the principle of objectivity and quality of the evaluation of proposals and analyses provided on objections.
15. The Ministry rejects the appellants' arguments regarding the poorly transposed directive into the Public Health Insurance Act. According to the Ministry's view, the directive distinguishes between decisions on the inclusion of a medicinal product in the list of medicinal products and food for special medical purposes and the fixing of the price of a particular medicinal product on the other hand. If the 'price decision' directive talks, it simply responds to the various pricing systems in the Member States without imposing an obligation on them to set the price of medicines by administrative procedure. Thus, the applicants unreasonably combined two separate processes, namely the decision to add to the list of medicines covered by health insurance, with the approval of the price of the medicine. The Directive does not regulate the pricing of medicines or impose administrative decisions. The obligations under the directive are therefore implemented properly and completely.
16. The Ministry considers the appellants' objection to the infringement of the rights of marketing authorisation holders under Article 36 (1) of the Charter to be a mere general statement. It considers that a precondition for the success of this objection would be a "breach of a specific right laid down by law ', whereby the appellants" would have to indicate precisely which legislation their law was laid down and what specifically constituted its infringement'. The Ministry further notes that the medicinal product can be placed on the market, whether or not it is at least partially covered by public health insurance, and that the reimbursement process by manufacturers and distributors need not be undertaken. It considers the proposal to be manifestly unfounded and proposes to reject it as such.
17. The Ombudsman informed the Judge-Rapporteur by letter dated 29.7.2005 that he did not intervene in the proceedings under consideration.
Opinion of other stakeholders and experts
18. The Constitutional Court, led by an attempt to obtain the fullest possible information about the process of establishing a catalogue of medicinal products covered by public health insurance, has requested the communication of an opinion on the proposed draft of a group of senators by other institutions concerned. He also addressed the Czech Medical Chamber, the Czech Pharmacy Chamber, the General Health Insurance Company of the Czech Republic and the Association of Health Insurance Companies, bringing together all other insurance companies in the Czech Republic in the field of public health insurance, namely the Czech National Health Insurance Company, the Hutnik Employee Insurance Company, the Commercial Insurance Company of banks, insurance companies and construction companies, the Regional Brotherhood Fund, the Military Insurance Company, the Škoda Employee Insurance Company, the Health Insurance Company METAL-ALIANCE and the Health Insurance Office of the Ministry of the Interior of the Czech Republic.
19. The Czech Medical Chamber fully supported the proposal in its opinion and agreed with the reasons which led the applicant to submit it. It considers it undesirable that the pricing of pharmaceuticals as defined in the contested legal provision takes place in a system in which they are not allowed to interfere with the entities to participate in it; appoint an exemplary professional organisation of doctors, representatives of health insurance companies, scientific institutions and drug manufacturers. It admits that their representatives are included among the members of the Commission for the categorisation of pharmaceuticals, but they have not been convened for six months, so the last amendment to the contested decree has not been consulted with the members of the Commission at all. The Czech Chamber of Medicine confirms the informal way of adopting the Order without an objective assessment of all the opinions, for example, its comments on the draft last amendment to the Order in question were not taken into account. In the current situation, the rights of both drug manufacturers and patients may be damaged. The General Health Insurance Company of the Czech Republic also agrees with the reasons which led the group of senators to submit the proposal. The Law on Public Health Insurance does not contain any more detailed criteria for determining the level of reimbursement of individual medicines. As a result, the Ministry's extensive ability to decide subjectively on medicines fully covered by the public health insurance system and on the amount of partial payments. On the contrary, other stakeholders who cannot actively influence it are de facto excluded from this process. Moreover, these entities cannot seek the protection of their rights before an independent and impartial court. The current regulation on drug pricing does not comply with the requirements of the directive, which was implemented inconsistently by the Czech Republic. The Czech Chamber of Pharmacy stated that the current form of the categorisation process, namely the inclusion of pharmaceuticals among those covered by public health insurance, has repeatedly cited a number of non-transparent steps in the past which, in its view, seriously jeopardise the effective functioning of the entire system of reimbursement of medicines. This is, firstly, the fact that, in order to determine the level of the reimbursement of the drug, taking into account its maximum administrative price, there is a certain specific date when the market can be accompanied for a long time after the supply of medicines. In practice, there is often a situation where pharmaceuticals, declared fully paid, refuse to pay in excess of the newly set maximum prices. Furthermore, the Czech Pharmacy Chamber considers the categorisation commission to be an untransparent role in the preparation process of the Decree. It is a mere advisory body, and in the past it has already happened that the resulting form of the decree deviated from the draft discussed by the categorisation commission after the State Department intervened. The results of its deliberations may only be mentioned by the parties concerned within very short time limits, which do not give the discretion of the most fundamental eventual impact of the proposed changes. The deadlines between the preparation, publication and effectiveness of the relevant amendments were much shorter in the past than required by the preparation of medical terrain and expert discussion. It is only during the period between the completion of the preparation of the decree and its effectiveness that the General Health Insurance Company of the Czech Republic is preparing a code list, and only from this aid will the public and health care professionals understand how the specific medicine will be covered. This code list is often issued only at the time of the entry into force of the new decree, or even later. Inaccurate information about the amount of additional payments then burden patients and lead to economic damage to pharmacies. The Czech Pharmacy Chamber would welcome a clear and binding setting of deadlines for the preparation, issue and effectiveness of the reimbursement order, which would guarantee a sufficient time reserve for the preparation of doctors, pharmacists and patients for a new reimbursement system. The association of health insurance companies did not give its opinion on the present proposal to the Constitutional Court.
20. In view of the discussion that took place in the expert press on the issue of the unconstitutionality of the legislation of the Czech Republic, which was seen in contravention of Community law, in which different opinions were taken, the Judge-Rapporteur asked the scientific institutes, namely the respective departments of the various faculties in the Czech Republic, to express their expert opinion on this issue.
21. The opinions expressed in the replies can be divided into three basic groups. The first is strictly based on the conclusion that Community law, because it is not part of constitutional order, cannot be a reference criterion for assessing the constitutionality of national law. The second is that it cannot be ruled out that an assessment of the question of compliance of the laws of the Czech Republic with the primary and secondary law of the European Community can be ruled out, at the same time as it goes against the principles of constitutional order of the Czech Republic. The third distinguishes between cases of proper transposition of Community law into Czech law, which clearly escape constitutional control, and cases of defective transposition which are subject to abstract control of constitutionality, since in such case the legislator does not act within the limits of delegated powers. It then concludes that, even if, in the context of abstract control of the standard, the legislation for a conflict with Community law cannot be repealed, it must always be concluded, in a particular case, that the law is compatible or contrary to that law in order to assess the power to revoke it. The Constitutional Court foresees that it itself takes an opinion on the possibilities for a review of the implemented Community law, as set out below.
Derogation of the contested provisions
(A)
22. Paragraph 15 (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 determine by decree:
(a) medicinal products and foodstuffs for special medical purposes fully covered by health insurance;
(b) the level of reimbursement of each active substance belonging to the groups of active substances referred to in Annex 2;
(c) the amount of food payments for special medical purposes, containing active substances from groups of active substances as referred to in Annex 2;
(d) the level of reimbursement of individually prepared medicinal products, radiopharmaceuticals and transfusion products from health insurance;
(e) restrictions and symbols setting out the conditions for the prescription of medicinal products and foodstuffs for special medical purposes covered by health insurance, including restrictions and symbols for the use of medicinal products and foodstuffs for special medical purposes when providing healthcare at specialised workplaces. "
23. Paragraph 15 (5) of the last sentence behind the semicolon of Act No. 48 / 1997 Coll., on Public Health Insurance and on the amendment and addition of certain related laws, as amended, reads:
"the amount of their reimbursement from health insurance shall be determined by implementing legislation '.
(B)
24. Decree of the Ministry of Health No. 532 / 2005 Coll., on the reimbursement of medicines and foodstuffs for special medical purposes, as amended by Decree of the Ministry of Health No. 37 / 2006 Coll., Decree of the Ministry of Health No. 368 / 2006 Coll., Decree of the Ministry of Health No. 387 / 2006 Coll. and Decree of the Ministry of Health No. 621 / 2006 Coll., reads:
"The Ministry of Health provides pursuant to § 15 (10) of Act No. 48 / 1997 Coll., on Public Health Insurance and on the amendment and addition of certain related laws, as amended by Act No. 438 / 2004 Coll., (hereinafter referred to as" the Act "):
This decree provides:
(a) medicinal products and foodstuffs for special medical purposes, fully covered by public health insurance (hereinafter referred to as "health insurance"), listed in Annex 1 thereto,
(b) the amount of the reimbursement of each active substance belonging to the groups of active substances referred to in Annex 2 to the Act, as set out in Annex 1 to this Decree;
(c) the amount of food payments for special medical purposes, containing active substances from groups of active substances as listed in Annex 2 to the Act, as listed in Annex 1 to this Decree;
(d) the level of reimbursement of individually prepared medicinal products, radiopharmaceuticals and transfusions of health insurance products listed in Annex 1 thereto;
(e) restrictions and symbols setting out the conditions for the prescription of medicinal products and foodstuffs for special medical purposes covered by health insurance, including restrictions and symbols for the use of medicinal products and foodstuffs for special medical purposes in the provision of healthcare at specialised centres listed in Annex 2 to this Regulation.
The following shall be deleted:
1. Decree No. 589 / 2004 Coll., on the reimbursement of medicines and foodstuffs for special medical purposes.
2. Decree No. 225 / 2005 Coll., amending Decree No. 589 / 2004 Coll., on the reimbursement of medicinal products and foodstuffs for special medical purposes.
3. Decree No. 337 / 2005 Coll., amending Decree No. 589 / 2004 Coll., on the reimbursement of medicines and foodstuffs for special medical purposes.
This Decree shall take effect on 1 January 2006.
Minister:
MUDr. Rath v. r. '
Conditions for the applicant's active legitimacy
25. The proposal to abolish the provisions of Paragraph 15 (10) of Act No. 48 / 1997 Coll., on Public Health Insurance and to amend and supplement certain related laws, as amended, and on the abolition of the Decree of the Ministry of Health No. 589 / 2004 Coll., on the reimbursement of medicinal products and foodstuffs for special medical purposes, as amended, was submitted by a group of twenty-nine senators of the Senate of the Parliament of the Czech Republic and thus in accordance with the conditions contained in the provisions of § 64 (2) (b) of Act No. 182 / 1993 Coll. In the present case, it can therefore be concluded that the conditions of active legitimacy on the part of the applicant are met.
Constitutional conformity of the legislative process
26. The Constitutional Court is required, in accordance with the provisions of Paragraph 68 (1) of the Law on the Constitutional Court in proceedings for the control of laws or other legislation, to assess whether the contested legislation has been adopted and issued in a constitutional manner.
27. From the relevant website it was found that the draft amendment to the Public Health Insurance Act was submitted to the Chamber of Deputies by the Government of the Czech Republic on 8 September 2003. By resolution No 1035 of 6 April 2004, the Lower House approved the proposal by a majority of 87 out of 170 Members present, with 79 votes against it.
28. The Senate discussed the proposal referred to it on 20 May 2004 and in Resolution 450, the majority of 56 of the 57 senators present spoke in favour of returning it to the Chamber of Deputies with amendments.
29. The Chamber of Deputies, which returned the bill, discussed the bill on 24 June 2004 and agreed with it by Resolution 1199, as approved by the Senate. Of the 189 Members present, 119 voted in favour and 36 against the proposal.
30. The President of the Republic signed the Act on 14.7.2004 and the Prime Minister on 16.7.2004.
31. On 26.7.2004 the law was published in the Collection of Laws in the amount of 144 under the number 438 / 2004 Coll.
32. The power of the Ministry to legislate for the implementation of the Act is based on Article 79 (3) of the Constitution. Its precondition is the existence of explicit legal authorisation. In the present case, the provision of Section 15 (10) of the Public Health Insurance Act is this authorisation. The decree marked in the proposal was signed by the Minister for Health and published properly in 202 under the number 589 / 2004 Collection of Laws. The current decree was signed by the Minister for Health and was properly published in 181 under number 532 / 2005.
33. The Constitutional Court notes that the adoption and issue of legislation under review took place in the prescribed manner.
Own review
34. The appellants challenge the authorising provisions of the Public Health Insurance Act for two separate reasons. First, it contradicts the fundamental attribute of the rule of law, namely its obligation to respect Community law (Article 6 of the Transparency Directive), with which it is contrary, and, secondly, for omission of the guarantee of judicial protection, as enshrined in Article 36 of the Charter).
35. The Constitutional Court in the Found sp. zn. Pl. ÚS 50 / 04 (published under No 154 / 2006 Coll.) stated that Community law cannot be the reference criterion for assessing the constitutionality of a national regulation. On the other hand, the European Communities, like the Czech Republic, are legal communities. The European Communities are built on respect and respect for the essential elements of the rule of law. It can be concluded from the case law of the European Court of Justice that its interpretation of the general principles of law corresponding to the fundamental rights contained in the domestic constitutional catalogues is close to that of the Constitutional Court. Moreover, the issue in question concerns the creation and functioning of the internal market, including interference in the free movement of goods as one of the four fundamental freedoms, namely the very essence of the European Communities, and it is therefore necessary to take greater care to ensure that the restrictions adopted are balanced by a sufficient guarantee of the fundamental rights of the stakeholders, in particular the right to sound and fair management in the case at hand. In this spirit, the Constitutional Court also worked with the appellants' objection that the contested provision of the Public Health Insurance Act is contrary to the Directive; Nor could the de facto found contradiction in itself lead to the deregation of the legislative provision in question and its implementing decree, but the arguments justifying such a finding can be supported by the justification of inconstitutionality.
36. Article 1 (1) The Constitution is a sovereign, unified and democratic rule of law based on respect for human and citizen rights. The source of all state power is the people and is exercised through the authorities of power legislative, executive and judicial (Article 2 (1) of the Constitution). Fundamental rights and freedoms are protected by judicial authority (Article 4 of the Constitution). Article 36 (1) The Charter may be invoked by any person in accordance with the procedure laid down in his or her right in an independent and impartial court and in specified cases by another authority. The second paragraph of that article gives anyone who claims to have been shortened on his rights by a decision of a public authority the opportunity to refer to a court to examine the legality of such a decision, unless otherwise provided for by the law. However, decisions concerning fundamental rights and freedoms, the protection of which is enshrined in the constitutional order of the Czech Republic, must not be excluded from the judicial review.
37. The Czech legal system distinguishes between four different steps in the regulation of the market for medicinal products: the registration of a medicinal product (consent to its placing on the market), the setting of its maximum price, the decision to be included in the list of medicines to be paid and the setting of the amount of remuneration from public health insurance. The registration of medicinal products is decided by § 26 of Act No. 79 / 1997 Coll., on Medicines, and on amendments and additions to certain other laws, the State Institute for Drug Control; the administrative rules apply to this decision (see Section 66 of that Act). The maximum price is set in accordance with Section 10 of Act No. 526 / 1990 Coll., on Prices, as amended, by the Ministry of Finance, which issues a list of goods with regulated prices by means of an opinion published in the Price Bulletin. The third step is that only those medicines that are listed in the Ministry-maintained list of medicinal products and food for special medical purposes can be covered by public health insurance. If the Ministry does not comply with the request of the manufacturer or distributor for the entry of a medicinal product in that list, its decision shall be subject to the administrative rules. The administrative rules shall also apply to the decision to remove the medicinal product from the list. The first and third steps therefore take place under the administrative system, where the issue of an individual decision is preceded by a procedure ensuring that its participants can exercise their procedural rights; The Constitutional Court, in view of the subject matter of the proceedings, leaves its attention to the specific regime governing the regulation of pharmaceutical prices. By contrast, the final step in the decision as an individual administrative act does not count. It takes the form of a ministerial regulation, but in essence it is not a general standard but a "set of individual decisions', and it would therefore be appropriate to apply the scheme foreseen in Article 36 (1), possibly Article 36 (2) of the Charter.
38. The determination of the specific amount of remuneration is essential for the demand for which drug, according to the principle that demand is greater, the higher the proportion of the public health insurance remuneration. This decision by the Ministry on the specific amount of the reimbursement of the medicinal product or, in our case, the form in which it prepares and publishes the decree in question also reflects the economic result and benefit of the producer or distributor concerned. Creating unequal conditions for entrepreneurs in a way will distort their free competition in the market for human medicines. However, the conditions for entrepreneurship must be the same for all its participants, including as regards its restrictions imposed by law. All manufacturers and distributors of medicinal products may only do business on the national market for the fulfilment of statutory conditions, which must be the same for all. If, by including a product in the list of medicines paid out by public health insurance, its producer or distributor benefits against other producers or distributors, it must be more closely ensured that this inequality balances the possibility of checking the transparency of the creation of these conditions, in any individual case.
39. This is, moreover, the aim of the proposed directive. Article 6 states that it shall apply if...... "if the medicinal product is covered by a national health insurance scheme after the competent authority has decided on its listing." The provisions of the Article require that all such decisions are taken in the form of individual administrative decisions (in other words, the applicant is to be given a decision, the justification of which is based on objective and verifiable criteria), that the decision is given within 90 possibly 180 days and that the decision can be subject to judicial review (in summary terms, it formates a set of procedural rights to protect the participant). Paragraph 15 (10) of the Public Health Insurance Act does not require these guarantees, as is clear from its text.
40. The Constitutional Court, for the reasons detailed in the above mentioned finding, sp. zn. Pl. ÚS 50 / 04 sets out the provisions of Article 36 (1) and (2) of the Charter, taking into account the case law of the European Court of Justice relating to the principle of fair trial. The European Court of Justice has already dealt with a similar problem twice in the case of the Austrian and Finnish reimbursement systems for human medicines. The Commission's case against Finland [Case C-229 / 00, Commission against Finland (2003), ECD I-5727] shows that Finland had a similar system of reimbursement of public health insurance medicinal products as the Czech Republic. According to Finnish law, the medicinal product was included in the list of medicines to be paid as a result of the decision to fix its price, which automatically meant that 50% of its public insurance price was entitled to reimbursement. Thus, Finnish law only required two-stage decision-making in cases relating to those drugs that were covered by the public insurance scheme in the range of more than 50%. To this end, the Finnish Government has established by law a list of "certain active substances' which have received higher rates of remuneration. The actual decision on the level of reimbursement for a particular drug was made by experts on a case-by-case basis, but such decisions were merely a form of confirmation that the individual drugs contained these active substances included in the list. With reference to that decision-making structure, the Finnish Government argued that Article 6 of the Directive does not apply to a regulation issued by the Government because" it did not in itself result in a specific drug being included in the list of medicines that benefit from a higher coverage of the public health insurance system but merely refers to certain active substances' (paragraph 30). The European Court of Justice rejected this argument as too formalistic, stating that a government regulation (albeit indirectly) determines certain medicines for inclusion in a higher level of remuneration and that, although it takes the form of a general regulation, "the Government's decision" constitutes a set of individual decisions on the inclusion of certain medicinal products in one of the social security systems and therefore falls under the scheme of Article 6 of the Directive (id, paragraph 34) '.
In the case of the Commission against Austria (Case C-424 / 99 Commission v Austria, (2001) ECD I-9285), there was a similar problem. There was a register of medicinal products in the Austrian system for the purposes of their reimbursement, but it was only a kind of guidance, and the reimbursement of individual medicines from the health insurance system was decided in individual cases. In individual cases, doctors could decide on the basis of the patient's need that the medicine entered into the registry would not be paid for, and vice versa, the medicine did not. Therefore, the Austrian Government considered that the register could not be qualified as an accurate list within the meaning of Article 6 of the Directive. The European Court of Justice stated that the purpose of the Directive is to ensure that "measures to control the prices of medicinal products... or to limit the scope of medicinal products covered by health insurance comply with the requirements of the Directive '(paragraph 30). The European Court of Justice therefore concluded that, notwithstanding the merely indicative function of the register, it is sufficient for the system to fall under the scheme of Article 6 of the Directive that" the inclusion of a medicinal product in the register usually means that the amount of its reimbursement will also be created in the system. "The European Court of Justice has therefore stated twice clearly that the decision concerning the amount of the reimbursement of a medicinal product from public health insurance, even if it is formally separated from the list decision, falls within the scope of Article 6 of the Directive and must therefore be accompanied by the guarantee of procedural rights contained therein.
41. As has already been explained above, the interpretation by the European Court of Justice of principles corresponding to fundamental rights and freedoms cannot go unanswered in the interpretation of national law and its consistency with constitutionally guaranteed rights. The Charter in Article 1 grants special protection to fundamental rights. Therefore, if that court has concluded that the decision to include medicinal products on the list of medicinal products covered by public health insurance is to interfere with the rights of their producers and distributors, and therefore to ensure that the principles of the fair process are respected, the Constitutional Court must take this argument into account when interpreting Article 36 (1) and (2) of the Charter. As part of the abstract control of the standard, it must assess whether legal regulation creates conditions such that intervention is balanced by such rights as to sufficiently eliminate the margin of pleasure in any specific decision to include medicinal products in the list of medicinal products covered by public health insurance. Paragraph 15 (10) of the Act on Public Health Insurance does not comply with such a requirement because it does not guarantee the applicant that the decision on its application is based on objective and verifiable criteria, that it is judicial and that it is issued without undue delay. However, the Ministry decides on the inclusion of a particular drug in a set of health insurance drugs paid in full and in a set of medicines paid only partially, as well as on the specific amount of remuneration, not in administrative proceedings but in the framework of the normative process.
42. On the basis of the authorisation contained in Section 15 (10) of the Public Health Insurance Act, the Ministry regulates the Decree, i.e. by means of a generally binding law, rights and obligations of specifically individualised entities, which is typical of law-enforcement acts. The current practice thus deviates from one of the fundamental material characteristics of the concept of law (legislation), which is its generality.
43. The Constitutional Court has repeatedly expressed itself in the past on the requirement of the universality of the law. In the decision sp. zn. Pl. ÚS 55 / 2000 (Collection of finds and orders of the Constitutional Court, Volume 22, Found No 62, p. 55 et seq.; Declared under No. 241 / 2001 Coll.) in this connection: "The fundamental principles of the material rule of law are the maximum of the universality of legal regulation (requirement of the universality of the law or of the general law). The universality of content is an ideal, typical and essential feature of the law (or even of the law at all), in relation to judicial judgments, governmental and administrative acts. The purpose of the division of state power into legislative, executive and judicial power is to entrust universal and initial power regulation to the state of legislature, based on universal power regulation and decision-making on individual cases of administration and exclusively on individual cases of the judiciary. The definition of the definition of the concept of a law (or of a law) then depends on the concept of a law (legislation) in a material sense, from which laws (legislation) must be distinguished in the sense of formal. 'This conclusion was confirmed by the Constitutional Court at a later date, for example, in the decision of 28.6.2005 sp. zn. Pl. ÚS 24 / 04 (Collection of finds and orders of the Constitutional Court, Volume 37, Found No. 130; published under No. 327 / 2005 Coll.).
44. The Constitutional Court also based on the requirement of the universality of the Act on the application for annulment of the provisions of § 7 of Act No. 2 / 1991 Coll., on collective bargaining (the finding sp. zn. The points of argument also affect the case under assessment. The Constitutional Court referred here to the arguments in favour of the universality of the law or the law, which are: division of power, equality and the right to an independent judge.
45. The first of the reservations against the laws, the laws relating to unique cases, is the principle of division of power, i.e. separation of legislative, executive and judicial powers in a democratic rule of law: "The adoption of laws concerning unique cases is the most hindered by the area of application of law. The right to legal judge and the independence of legal protection are also excluded by the legislature in areas which are not protected by the principle of nulla poena sine, (the lex can only be a general and written legal sentence here)." (H. Schneider, Gesetzgebung, 2 Auflage, Heidelberg 1991, p. 32).
46. The parties concerned are also unable to obtain judicial protection under the current legal situation. On the issue of the exclusion of judicial review in the case of individual legal regulation, the Constitutional Court in the above mentioned finding of sp. zn. Pl. ÚS 40 / 02 stated: "Individual regulation contained in the law, depriving the addressees of the possibility of judicial review of the fulfilment of the general conditions of the regulatory regulation of a particular body lacking a transparent and acceptable justification in relation to the possibility of regulation of general regulation, must be regarded as a contradiction with the principle of the rule of law (Article 1 of the Constitution), to which is an independent division of power and judicial protection of rights (Articles 81 and 90 of the Constitution)."
47. Similarly, the European Court of Justice, in the cases referred to above, has accepted the possibility of procedural protection. As regards the possibility of recourse to appeals against decisions, the text of the directive only provides that the applicant is to be informed of the possibility of appeal. Consequently, the European Court of Justice concluded that the applicant must be able to exercise an appeal effectively ensuring the protection of its rights. Moreover, it does not consider that an administrative appeal is sufficient, it should be of the nature of judicial review. The Constitutional Court fully agrees with this interpretation as it fully complies with the requirement laid down in Article 36 (2) of the Charter.
48. The same shortcomings that the European Court of Justice has set out in relation to the Directive are also reflected in the provision under examination under Paragraph 15 (10) of the Public Health Insurance Act in relation to the Charter of Fundamental Rights and Freedoms. The determination of the specific amount to which the drug will be covered by the decree effectively excludes the full participation of stakeholders in this process, weakens the transparency of individual actions and thus the credibility of the whole process. The appropriateness of the specific amount of reimbursement of which medicinal products should be ascertained during the administrative procedure on the basis of a measure of various specific interests, with the possibility of considering all discrepancies and comments. In particular, a decision on which drug should be justified should be made in order to make it clear why its assumptions for inclusion in the health insurance scheme are better than those of other medicines and how the determining authority has settled with substantial arguments.
49. While it is true that the amendments to the Act on Public Health Insurance mentioned by the Chamber of Deputies in its observations (Acts No. 438 / 2004 Coll. and No. 123 / 2005 Coll.) introduced into its § 15 elements of procedural protection. But that does not mean that such a move is sufficient in itself. This applies only to the Ministry's decision to register a medicinal product as a precondition for any medicinal product to be reimbursed from the public health insurance system (and it appears to suggest that all the medicinal products on the list will be paid at least partially), which is not a decision of immediate importance for determining whether or not each medicinal product will be paid in full or in part. It is only in the second stage that the specific amount paid for the medicine from public health insurance is decided. This is a completely separate measure, a separate decision, for which the law does not provide for the guarantee of procedural rights, as required by Article 36 (1) and (2) of the Charter.
50. Paragraph 15 (10) of the Public Health Insurance Act infringes the principles described above and is therefore incompatible with the principles of the rule of law and therefore contrary to Article 36 of the Charter. In this context, the Constitutional Court notes that it was no longer necessary to deal with the effects of the labelled legislation on other constitutionally protected rights, such as the right to property, since the above findings and their corresponding conclusion on the non-constitutionality to derogate from the contested provision of the Public Health Insurance Act are sufficient.
51. The Constitutional Court could not overlook that, in the event of the annulment of the provisions of Paragraph 15 (10) of the Public Health Insurance Act, even part of the last sentence after the semicolon of the provision of Section 15 (5) of the Public Health Insurance Act, as amended by "the amount of their reimbursement from health insurance is laid down in implementing legislation." Both provisions are closely linked and cannot stand alone without each other.
52. In the light of the above arguments, the Constitutional Court has annulled the provisions of § 15 (10) and (5) of the last sentence with a semicolon in its wording '; the amount of their reimbursement from health insurance is laid down in the implementing law' of the Public Health Insurance Act pursuant to § 70 (1) of the Law on the Constitutional Court.
53. The Constitutional Court, in accordance with § 70 (3) of the Law on the Constitutional Court, has also stated that, at the same time as the annulled statutory provision, the Decree of the Ministry of Health issued on the basis of the authorisation given here will cease to apply. At the time of the decision on the draft Decree of the Ministry of Health No. 532 / 2005 Coll. Procedure for the application for annulment of Decree No. 589 / 2004 Coll. The Constitutional Court stopped because, in the meantime, between the filing of the application and the termination of the proceedings expired (Paragraph 67 (1) of the Constitutional Court Act).
54. The correction of the existing situation requires a change to the very nature of the legislation in force. The legislator will have to work through a whole new system of reimbursement of medicines from public health insurance, which will also correspond to the principles outlined in the justification for this finding. The Constitutional Court is aware that legislators therefore need to provide sufficient time for the creation and adoption of new legislation. It therefore decided to postpone the enforceability of the cancelling decision until 31 December 2007.
President of the Constitutional Court:
JUDr. Rychetský v. r.
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Regulation Information
| Citation | The Constitutional Court found no. 57 / 2007 Coll., on the application for annulment of § 15 paragraph 10 of Act No. 48 / 1997 Coll., on Public Health Insurance and on the amendment and addition of certain related laws, as amended, and the application for annulment of Decree No. 589 / 2004 Coll., on the reimbursement of medicines and food for special medical purposes, as amended |
|---|---|
| Regulation Type | The Constitutional Tribunal found |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 23.03.2007 |
|---|---|
| Effective from | - |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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