The Constitutional Court found no 75 / 2019 Coll.
The Constitutional Court found of 29 January 2019 sp. zn.
Valid
The Constitutional Tribunal found
Text versions:
19.03.2019
Contents
I.
II.
III.
IV.
V.
VI.
VII.
VIII.
IX.
IX. A. Ústavní východiska
IX. B. Napadené ustanovení v kontextu zákona o veřejném zdravotním pojištění
IX. C. Závazek zajistit dostupnost léčivého přípravku
IX. D. Zkoumání dostupnosti léčivého přípravku v době následující poté, co byl určen plně hrazený léčivý přípravek z veřejného zdravotního pojištění
IX. E. K argumentaci městského soudu o snášení léčivého přípravku pacienty
X.
75
FIND
The Constitutional Court
On behalf of the Republic
On 29 January 2019, the Constitutional Court decided under sp. zn. such medicinal products are always considered available on the market in the Czech Republic, "with the participation of the Chamber of Deputies of the Parliament of the Czech Republic and the Senate of the Parliament of the Czech Republic as parties,
as follows:
Motion denied.
Reasons
Recap of the proposal and recap of the present proceedings
1. The applicant - Municipal Court in Prague (hereinafter referred to as the "Municipal Court") - requested, pursuant to Article 95 (2) of the Constitution of the Czech Republic (hereinafter referred to as the "Constitution") and Article 64 et seq. of Act No. 182 / 1993 Coll., on the Constitutional Court, as amended, (hereinafter referred to as the "Law on the Constitutional Court"), that the Constitutional Court annul part of the provisions of § 39c (2) (a) of Act No. 48 / 1997 Coll., on Public Health Insurance and the amendment and amendment of certain related laws, as amended, (hereinafter referred to as the "Public Health Insurance Act" or a medicinal product whose highest price of the producer or reimbursement has been concluded; such medicinal products are always considered available on the market in the Czech Republic, '.
2. In the proposal, he stated that he was discussing an action against an administrative decision by which the Ministry of Health partially annulled the primary administrative decision of the State Institute for Drug Control (SÚKL) and partially confirmed that decision. The administrative procedure was decided under the Public Health Insurance Act. The City Court also examined the application of Paragraph 39c (2) (a) of that Law when assessing the case and considers that the contested part of it is contradictory to Article 31 of the Charter of Fundamental Rights and Freedoms (hereinafter referred to as the Charter).
3. In this context, the municipal court pointed out that the legal conditions (in accordance with Article 31 of the Charter) which specify the right to free health care must be laid down in a sufficiently clear and comprehensible manner. The law cannot push a substantial part of it into an area which it itself cannot regulate anymore. In practice, however, the specific conditions are determined in practice by the health insurance company and the distributor of medicinal products in a contract concluded, the content of which is not affected by public authorities. The requirement for a closer definition of legal conditions is not fulfilled. It is a contract which, although it itself declares that it is concluded in the public interest pursuant to Article 17 (2) of the Public Health Insurance Act, was assessed by the administrative authorities in the present case in the light of the relevant provisions of the contract, but a more detailed legal regulation of the fundamental rights and obligations of such a contract does not exist (e.g. in terms of the obligation to deliver a certain quantity of the medicinal product to the pharmacy network and thus to ensure its actual availability).
4. The Municipal Court recalled that § 39c (2) (a) of the Public Health Insurance Act lays down the basic rule that the medicinal products concerned must be available on the market in the Czech Republic for the purposes of determining the basic remuneration in the reference group. According to the basic rule, a medicinal product is available on the market in the Czech Republic, with a total sales volume of at least 3% of the same medicinal product containing the same active substance in the relevant period. However, the basic rule provides for a derogation in Section 39c (2) (a) of the Public Health Insurance Act, which the Municipal Court proposes to abolish, concerning a medicinal product for which a written agreement is concluded on the highest price of the manufacturer or remuneration. Then the general rule of availability does not apply and the law determines that such a medicinal product is always considered to be available, although according to the municipal court the content of the relevant written agreement is not defined by law or by law and without the availability being factual or real, or without the legal and non-contractual condition forcing the competent bodies to make the medicinal product available on the market. In summary, as a result of the contested legislation, the medicinal product may not actually be available, although the Public Health Insurance Act declares its availability and is based on it.
5. According to the City Court, the determination of the availability assumption allows for a de facto denial of the basic rule and the requirement of respect for the public interest, which it considers to be the quality and availability of the services covered under Section 17 (2) of the Public Health Insurance Act. Therefore, a medicinal product for which a written arrangement has been concluded under the contested provision may not be effectively available, or its share in the market is almost negligible. Even so, such a medicinal product is fully covered in the relevant group of active substances, which has a significant impact on the annual allowance limit applicable to medicinal products (Section 16b (1) of the Public Health Insurance Act). It is by determining the basic remuneration for a product which is actually unavailable, even if it was to be fully covered by public health insurance, that the remuneration for other medicinal products that are no longer fully covered will be reduced. None of these medicinal products can be made available on the market as a fully funded medicinal product. While public health insurance funds are spared, the definition of the availability of a medicinal product is meaningless. It is not ensured that, in each reference group, at least one truly available medicinal product fully covered by public health insurance. In its summary, the general principle of public health insurance, which the municipal court sees as being that a medicinal product fully covered by health insurance must be available and its availability must be based on a real finding, not on a legal presumption based on a written agreement, which in essence does not have to regulate this availability.
6. In the application for the annulment of Section 39c (2) (a) of the Public Health Insurance Act, the Municipal Court mentioned that a medicinal product which was not available on the market in the Czech Republic at the time of the decision of the administration would not normally have sufficient experience of prescribing it and information on patient tolerability.
7. The municipal court considers that the contested legal provision cannot be interpreted in a constitutional manner. This is a clear and understandable provision in the sense that if the relevant written arrangement is concluded, the medicinal product is considered to be available. In view of the fact that the written arrangement is governed by a private law agreement, the content of which is not defined by public law, the presummation of the availability of the medicinal product is based on a private law agreement, not a law. In the view of the Municipal Court, the legislation is a contradiction with Article 31, second sentence, of the Charter, since the Charter required a condition for free health care is not governed by a law but by a private law.
Dedication of the contested provision and its systematic classification
8. Due to the link between the part of the law which the municipal court proposes to abolish to § 39c (1) and (2) of the Public Health Insurance Act, the Constitutional Court cites § 39c (1) and (2) of that law, with the contested part of the law being marked in bold (quoted as effective from 1 July 2017):
(1) The Institute shall include the medicinal product in the procedure referred to in Paragraph 39g in the reference group unless it is established during the procedure that it does not belong to that reference group. The reimbursement of the medicinal product shall be determined on the basis of the basic remuneration of the reference group to which the medicinal product was included. The basic payment is payment for the usual daily therapeutic dose of active substances contained in medicinal products and is the same for the whole reference group. The reference groups are groups of medicinal products essentially interchangeable with similar or close efficacy and safety and similar clinical use. The list of reference groups shall be established by the Ministry of Health by implementing legislation.
(2) The basic remuneration in the reference groups is set at
(a) the lowest producer prices for the daily therapeutic dose of a medicinal product or a food for special medical purposes included in the reference group established in any country of the European Union for a medicinal product or a food for special medical purposes available in the Czech Republic; the medicinal product or food for special medical purposes available on the market in the Czech Republic means a medicinal product or food for special medical purposes whose share in the total volume of sales, in principle, of therapeutically interchangeable medicinal products or special medical food containing the same active substance, during the relevant period, was at least 3%, except for the first to third like product in the medicinal product in the order of the application for the level and conditions of reimbursement, or a medicinal product for which the highest price of the manufacturer or reimbursement was concluded; such medicinal products are always considered available on the market in the Czech Republic,
(b) the daily costs of other therapy reduced by trade surcharges and value added tax applied, where it is comparable and cost-effective compared to the use of the medicinal product or food for special medical purposes referred to in point (a), and these facts are known to the Institute when determining the basic remuneration, taking into account the required duration of treatment with the medicinal product or food for special medical purposes and the need for comparable treatment;
(c) the highest producer prices contained in the written arrangement referred to in Article 39a (2) (b), if the price is lower than the payment calculated in accordance with points (a) and (b), if the holder of the marketing authorisation for the medicinal product, importer or domestic food producer for special medical purposes, the importer or the promoter of a specific treatment programme has not committed an infringement under Article 39q (1) (b) in the last 2 years;
(d) the remuneration contained in a written arrangement concluded in the public interest by all health insurance undertakings with a marketing authorisation holder of a medicinal product, an importer or a domestic manufacturer of a food for special medical purposes, unless it has been committed within the last 2 years by an infringement pursuant to Paragraph 39q (1) (c) for all supplies of a medicinal product or a food for special medical purposes on the Czech Republic market, and the obligation that the medicinal product or food for special medical purposes will be available on the Czech Republic market for at least 1 year and the final consumer price of such medicinal product or food for special medical purposes does not exceed the highest remuneration for the final consumer.
9. The provision cited is included in Part Six of the Public Health Insurance Act entitled "Regulation of the Prices and Reimbursements of Medicinal Products and Food for Special Medical Purposes," in the group of provisions (Section 39b et seq.), marked "Principles of establishing or amending the amount and conditions of reimbursement of medicinal products and foodstuffs for special medical purposes."
Observations of the parties
10. The Constitutional Court, pursuant to Article 69 of the Law on the Constitutional Court, sent the proposal to the Chamber of Deputies of the Parliament of the Czech Republic (hereinafter referred to as the Chamber of Deputies) and to the Senate of the Parliament of the Czech Republic (hereinafter referred to as the Senate) as parties to the proceedings, to the Government of the Czech Republic (hereinafter referred to as the Government) and to the Ombudsman as authorities authorised to intervene as interveners.
11. The Chamber of Deputies stated in its observations, signed by President Mgr. Radek Vondráček, that the amendment to the Act on Public Health Insurance, which contained the contested provisions, was published in the Collection of Laws as Act No. 298 / 2011 Coll., amending Act No. 48 / 1997 Coll., on Public Health Insurance and amending and supplementing certain related laws, as amended, and other related laws ("Act No. 298 / 2011 Coll."). The bill submitted by the Government was replaced by the text of Mr Leoš Heger's amendment in a later approved text. The proposal was approved at the third reading on 21 June 2011, because of the 180 Members present, 104 Members voted in favour and 75 Members opposed. Furthermore, the Chamber of Deputies informed that the proposal was forwarded to the Senate, which discussed and approved it. After signature by the relevant constitutional authorities, the Act was published in the Collection of Laws on 14 October 2011. Finally, it stated that, in accordance with established constitutional practice, it was limited to a description of the course of the legislative process.
12. The Senate, signed by its President Milan Štěm, focused on the course of the legislative process. He referred to the fact that the proposal was referred to him by the Chamber of Deputies on 30 June 2011 and rejected it at the 10th meeting of the 8th term of office on 21 July 2011. The motion to dismiss was approved by 48 senators out of 75 present, 27 senators opposed. The Senate also informed that the Chamber of Deputies had discussed the bill on 6 September 2011 at its 21st session in the 6th parliamentary term and insisted on its original proposal. Finally, the President of the Senate stated that he was sending observations, knowing that it was entirely up to the Constitutional Court to examine and rule on the application for annulment of the contested legal provision.
13. The conflict between the observations of the Chamber of Deputies and the Senate has been verified by the Constitutional Court from publicly available sources (http: / / www.psp.cz). He found that the communication by the Chamber of Deputies did not reflect the course of the legislative process, as the Chamber of Deputies discussed the bill previously rejected by the Senate on 6 September 2011, and adopted Resolution No 668, for which 103 Members voted (68 were opposed) of which he maintained his original proposal (see also paragraph 41).
14. The Government and the Ombudsman have indicated that they will not exercise their right to intervene.
Statement by the Ministry of Health and Trade of LEK Pharmaceuticals d. d.
15. The Constitutional Court pursuant to § 48 (2) of Act No. 182 / 1993 Coll., on the Constitutional Court, asked the Ministry of Health for an opinion on the submitted proposal. In its detailed opinion, the Ministry of Health stated that Section 39c (2) (a) of the Public Health Insurance Act, which the Municipal Court proposes to abolish, introduced a presumption of the availability of the medicinal product. The presumption of availability shall apply to a medicinal product for which the highest producer price agreement has been concluded [as provided for in Section 39a (2) (b) of the Public Health Insurance Act] or the reimbursement agreement [as provided for in Section 39c (2) (d) of the Public Health Insurance Act].
16. Under Section 39c (2) (d) of the Public Health Insurance Act, an obligation to ensure the availability of a medicinal product or food for special medical purposes on the market in the Czech Republic must be included in the reimbursement agreement for the duration of the arrangement. That undertaking shall be accepted by the marketing authorisation holder of the medicinal product, importer or domestic food manufacturer for special medical purposes. The agreement on the highest producer price is concluded in the public interest pursuant to § 39a (2) (b) of the Public Health Insurance Act under § 17 (2) of the Act, where the legislative abbreviation "public interest 'is introduced. It also includes an interest in ensuring the availability of paid services. According to the Ministry of Health, even the highest price agreement is required to ensure the availability of the medicinal product. The Ministry of Health also imports from the definition of the terms of the agreement on the highest price of the manufacturer that the arrangement is to be concluded for all supplies of the medicinal product on the Czech market [§ 39a (2) (b) of the Public Health Insurance Act]. The Ministry of Health therefore does not agree with the view of the municipal court that the Public Health Insurance Act underpins the presumption that the medicinal product is available only by private law arrangements, but not by law.
17. The purpose of the presumption of availability in § 39c (2) (a) of the Public Health Insurance Act is, according to the Ministry of Health, the inclusion of medicinal products with the agreement on the highest price of the manufacturer or the reimbursement agreement in the price reference regardless of the availability of the medicinal product established by 3% of the market share. The availability under that provision is not to be examined at all in the procedure for determining the remuneration. The purpose of the absence of a 3% market share availability requirement is a certain "benefit 'of the medicinal products covered by the above agreement when determining the basic remuneration. By concluding an agreement on the highest price of the manufacturer, the medicinal product is placed on the" positive list' of public health insurance companies and increased consumption. The presumption of availability of a medicinal product allows the market share of cheaper competing medicinal products to be introduced or increased. The need to ensure availability by 3% of the market share of a new cheaper and unpaid medicinal product before entering the reimbursement system could often be insurmountable, as it is not usually the cheapest product for a patient who pays the full price, compared to a competing product where the patient pays only the difference between the price and payment from the insurance company. The placing on the market of a medicinal product before its entry into the reimbursement system without the conclusion of the highest-price agreement of the manufacturer poses certain risks to the marketing authorisation holder, e.g. in the form of uncertainty as to the total consumption of the medicinal product. The highest-price agreements of the manufacturer and reimbursement agreements are measures aimed at promoting the functioning of the market for medicinal products and competition.
18. In addition, the Ministry of Health pointed out a number of legal provisions which allow a response to a breach of the obligation to ensure the availability of the medicinal product taken into account in the manufacturer's highest price agreement or the reimbursement agreement on the basis of which the basic remuneration of the reference group was determined. It pointed out the facts of the infringement according to § 39q (1) (b) and (c) of the Act on Public Health Insurance, for which a fine of up to CZK 10 000 000 can be imposed. A further agreement with the perpetrator of the infringement cannot be concluded in the following two years under § 39c (2) (c) and (d) of the Public Health Insurance Act. Infringement of the agreement leads to the initiation of a shortened revision pursuant to § 39p (4) of the Act on Public Health Insurance and the selection of another medicinal product, according to which the basic remuneration is set in the reference group. The implementation of the agreement is also provided by non-legal mechanisms, namely an increase in profits resulting from the conclusion of an agreement which leads to an increase in market share. On the contrary, a breach of the agreement can seriously reduce the reputation of the contra-hent.
19. The Ministry of Health does not agree with the view of the Municipal Court that Article 39c (2) of the Public Health Insurance Act is a provision which is intended to directly ensure the full reimbursement of a medicinal product within the meaning of the right to free health care based on public health insurance under Article 31 of the Charter. Section 15 (5), § 39c (5), § 39p (2) and (4) of the Act on Public Health Insurance considers legal provisions directly providing for free health care in the area of payments for outpatient medicinal products.
20. On its own initiative, the submission of 27 April 2018 on the submitted proposal was addressed by LEK Pharmaceuticals d. d., referring to the key aspects of the contested provision, and at the same time politely asked the Constitutional Court to comment on the alleged inconstitutionality of § 39h (4) of the Public Health Insurance Act, which rules out the suspensive effect of the appeal against price and remuneration decisions. The Constitutional Court sent the statement by LEK Pharmaceuticals d. to the Municipal Court, which mentioned that § 39h (4) of the Public Health Insurance Act did not consider it unconstitutional. The Chamber of Deputies and the Senate and the opinion of the Ministry of Health were not heard by the municipal court.
Findings of the municipal court and administrative file
21. The Municipal Court, together with the proposal, forwarded to the Constitutional Court three files in joined cases sp. zn. 6 Ad 23 / 2014, sp. zn. 6 Ad 25 / 2014 and sp. zn. 6 Ad 26 / 2014, from which the following facts are submitted.
22. The actions were brought by three commercial corporations (Apotex Europe b. v.; Krka d. d., Novo City; and LEK Pharmaceuticals d. d.), which stated in the actions that they hold marketing authorisations for specific medicinal products for which the conditions for reimbursement of public health insurance have been modified in administrative proceedings. All actions are directed against the third operative part of the decision of the Ministry of Health of 31 July 2014 No. MZDR35012 / 2013, sp. zn. FAR: L137 / 2013 confirming the SÚKL decision of 30.8.2013 sp. zn. In the appeal procedure, the 1st opinion of the SÚKL decision to determine the basic remuneration of CZK 1,4000 for the usual daily therapeutic dose for reference group No. 28 / 1 (hypolipidemic, statins, p.) was confirmed. This was a conditional statement (within the meaning of Sections 140 (2) and (7) of Act No. 500 / 2004 Coll., the Administrative Rules) for subsequent statements which included specified medicinal products in reference group No 28 / 1 and which amended the amount of the public health insurance compensation for those products. A large number of successive statements were also confirmed in the appeal proceedings.
23. In determining the basic remuneration of the SÚKL, the SÚKL first selected the lowest price product for the usual daily therapeutic dose in any EU country under Section 39c (2) (a) of the Public Health Insurance Act. In particular, ATORVASTATIN ACTAVIS 20 MG POR TBL FLM 100X20MG (hereinafter "ATORVASTATIN '), traded in Sweden. Subsequently, it compared the lowest price in terms of the normal daily therapeutic dose established in any country of the European Union against the average of the second and third lowest prices of the same medicinal product and found that the lowest price of the manufacturer found in Sweden was 33,25% lower than the average of the second and third lowest prices of the manufacturer of the same product found in other countries. Since the condition laid down in § 16 (2) of Decree No. 376 / 2011 Coll., implementing certain provisions of the Public Health Insurance Act (" Decree No. 376 / 2011 Coll.') was met, the SÚKL increased the basic remuneration of the reference group No. 28 / 1 in the public interest up to the average of the second and third lowest price of the product. The basic remuneration after the increase calculated from the average of the second and third lowest prices of the manufacturer was CZK 0.5850 for the usual daily therapeutic dose. However, after determining the basic remuneration in accordance with that procedure, at least one fully paid available medicinal product with a force within the interval included in group 53 (hypolipidemic from the group of statins) of Annex 2 to the Public Health Insurance Act would not be secured. SÚKL therefore found, in accordance with § 39c (5) of the Public Health Insurance Act, the least expensive preparation of the group of products under consideration, which was the ZOCOR FORTE 40 MG POR TBL FLM 98X40MG (hereinafter referred to as "ZOCOR '), according to which the resulting basic remuneration of CZK 1,4000 was determined. This basic remuneration was set at the level corresponding to the highest price of the manufacturer agreed in the written arrangement (contracts agreed on the highest prices of the manufacturer of medicinal products based in the file). It was the agreed highest producer price of CZK 274.40 for ZOCOR and a pack of 98 tablets containing 40 mg of the active substance simvastatin, which represented 196 of the usual daily therapeutic doses, which led to a basic remuneration of CZK 1,4000 (as 274.40 divided by 196).
24. In the decision on appeal, the Ministry of Health stated that ZOCOR was included in the price reference under the agreement on the agreed highest producer price under § 39c (2) (a) of the Public Health Insurance Act. It pointed out that according to this provision, products whose highest producer price or reimbursement has been made in writing are always considered available on the market in the Czech Republic. They are included in the price reference regardless of the availability defined by the 3% market share and the availability of the product with the highest price contract should not be investigated at all. The Ministry did not agree with the appellants' claim that the agreement on the agreed highest price of the manufacturer would not include the obligation of the marketing authorisation holder of ZOCOR to make this product available in the Czech Republic. It assessed that the contract was concluded in accordance with § 39c (2) (c) and § 39a (2) (b) of the Public Health Insurance Act.
25. In the actions which the municipal court assesses, it was argued, inter alia, that the agreement on the highest producer price had not been concluded in the public interest, as provided for in Article 17 (2) of the Public Health Insurance Act, and that the agreement did not contain any form of commitment by the marketing authorisation holder to keep the product on the market in any quantity, there is therefore no guarantee that the medicinal product will be present on the market in the Czech Republic. The applicants see a breach of the law in that SÚKL did not actually examine the availability of the product under which the basic payment was established.
Abandonment of oral proceedings
26. The Constitutional Court concluded that further clarification of the case cannot be expected from oral proceedings and therefore, in accordance with Article 44 of the Law on the Constitutional Court, it decided on the case without its regulation.
Procedural assumptions of the annulment procedure
27. Pursuant to Article 95 (2) of the Constitution, if the court concludes that the law to be applied in the resolution of the case is contrary to constitutional order, it shall bring the matter before the Constitutional Court. The General Court is entitled to make a proposal when proposing the repeal of the law or of its individual provision, the application of which is to be immediate or necessary, is not sufficient only for hypothetical use or other broader context (order of the Constitutional Court of 23.10.2000 sp. zn. Pl. ÚS 39 / 2000 (U 39 / 20 CollNU 353); the decisions of the Constitutional Court are available from http: / / nalus.ujud.cz]. It follows from the purpose and purpose of the specific control of the constitutionality of legal standards that the law (or its provision) to be applied in the resolution of the case is only one which obstructs the achievement of the desired, i.e. a constitutional consensus; If not removed, the outcome of the present proceedings would be different [finding of 6.3.2007 sp. zn.
28. The assessment of the necessity of the application of the contested provision, of the nature of the case, is primarily for the general court which leads the initial proceedings. These are usually questions of sub-constitutional law, for which the Constitutional Court, as a judicial body for the protection of constitutionality, is consistently held in restraint [finding of 25.9.2007 sp. zn. ÚS 85 / 06 (N 148 / 46 SbNU 471)]. The conclusion that the use of the contested provision is not necessary for the referring court may be made by the Constitutional Court in particular if the applicant's conclusion is manifestly unsustainable [the finding of 27 June 2017 sp. zn. Pl. ÚS 22 / 16 (N 111 / 85 SbNU 817; 268 / 2017 Coll.), paragraph 20; or the finding of 8 August 2017 sp. zn. Pl. ÚS 9 / 15 (338 / 2017 Sb.), paragraph 21].
29. The Constitutional Court found that the municipal court was actively procedural to file an application for annulment of Section 39c (2) (a) of the Public Health Insurance Act in the form in which it submitted it.
30. As can be seen from the recap in point 23, SÚKL first ascertained the lowest price of the manufacturer per daily therapeutic dose of the medicinal product included in the reference group found in any European Union country for the medicinal product available in the Czech Republic under Section 39c (2) (a) of the Public Health Insurance Act. As a result of its findings, the selection of ATORVASTATIIN and the price for the usual daily therapeutic dose was made after all adjustments of CZK 0.5850. However, according to this preparation, the basic remuneration was not finally established and no objections were raised to the choice of ATORVASTIN or its price in the actions. Consequently, the requirement that the municipal court apply the part of § 39c (2) (a) of the Public Health Insurance Act which it proposed to abolish cannot be fulfilled.
31. The basic payment for the usual daily therapeutic dose was set at CZK 1,4000 according to ZOCOR and was determined primarily on the basis of Section 39c (5) of the Public Health Insurance Act. The selection of ZOCOR shall be subject to an objection which shall be examined by the municipal court. In the application of Paragraph 39c (5) of the SÚKL's Law, the SÚKL also made use of § 39c (2) (a) of the Public Health Insurance Act, which was expressly noted in its decision (on page 214), as it mentioned here that the basic remuneration was determined on the basis of § 39c (5) following § 39c (2) (a) of the Public Health Insurance Act.
32. In accordance with Section 39c (5) of the Public Health Insurance Act, if, when determining the remuneration under Sections 39b to 39e, at least one medicinal product has not been fully covered in one of the groups of active substances listed in Annex 2 to that Act, SÚKL shall adjust the decision of remuneration to ensure that the least expensive medicinal product from the group of medicinal products under consideration is fully covered.
33. In its decision (on page 217), the group of investigational medicinal products under Section 39c (5) of the SÚKL Act included "available products, i.e. having at least a 3% share of sales within the same active substance and of products with a valid DNC [highest price agreement, notes the Constitutional Court] or with a remuneration agreement and a first to third like product to the active substance regardless of market share '. It is therefore clear that, in order to define the group of medicinal products under assessment under Section 39c (5) of the Public Health Insurance Act, the SÚKL has benefited from an amendment in that section of Section 39c (2) (a) of the Public Health Insurance Act which the Municipal Court proposes to abolish. Similarly, point 6.9.1 of the methodology for determining the basic remuneration of the reference group / active substance and the fully paid medicinal product (edition 11, effective date 13.3.2017) is expressed in order to define the group of products under assessment under Section 39c (5) of the Public Health Insurance Act; the methodology is available from the SUKL website at http: / / www.sukul.cz).
34. In its proposal, the Municipal Court implicates itself in the consideration of linking the definition of a group of medicinal products under Article 39c (5) of the Act on Public Health Insurance with the adaptation in § 39c (2) (a) of the Act in those cases where SÚKL first, for the purposes of determining the basic remuneration in the reference group, ascertained the lowest price of the producer for the daily therapeutic benefit [§ 39c (2) (a) of the Public Health Insurance Act], which was subsequently adjusted in accordance with § 39c (5) of that Act. The Constitutional Court, in the context of its stated discretion (see paragraph 28), does not intend to intervene in the assessment of procedural assumptions. It also notes that, in the circumstances of the case under assessment, it does not consider the conclusion of the Municipal Court on the need to apply Section 39c (2) (a) of the Public Health Insurance Act, which the Municipal Court proposed to abolish. On that provision, the actions under examination by the municipal court raised pleas in law (cf. Recapitulation in paragraph 25).
35. The Constitutional Court has in that context failed to see that the relationship between § 39c (5) and § 39c (2) (a) of the Public Health Insurance Act was previously pronounced by the Supreme Administrative Court in paragraph 31 of judgment of 27.11.2013 No 4 Ads 52 / 2013-41 (the decision of the Supreme Administrative Court is available from www.nsjud.cz). The Supreme Administrative Court found here that "Paragraph 39c (5) of the Public Health Insurance Act does not provide for the Constitution to seek a medicinal product available on the market in the Czech Republic in terms of § 39c (2) (a) of the same Act, i.e. whose share of the total volume of sales of essentially interchangeable medicinal products was at least 3% in the last calendar quarter '. The Supreme Administrative Court therefore, in the decision cited, refused to rely on certain links between § 39c (5) and § 39c (2) (a) of the Public Health Insurance Act. The Constitutional Court notes that the judgment cited by the Supreme Administrative Court deals with an amendment effective until 30 November 2011 (cf. paragraphs 23 and 24 of that judgment by the Supreme Administrative Court), whereas for the Municipal Court, the law is relevant at the date of the administrative decision (§ 75 (1) of Act No. 150 / 2002 Coll., the administrative order). The Ministry of Health decided on 31 July 2014.
36. By 30 November 2011, Paragraph 39c (5) of the Act on Public Health Insurance was worded as follows: "Where, after determining the remuneration under Sections 39b to 39e, at least 1 of the medicinal product is not fully covered in one of the groups of active substances listed in Annex 2, the Institute shall adjust the reimbursement decision so that the least expensive medicinal product belonging to that group is fully covered." (Marked by the Constitutional Court) From 1 December 2011 (the effectiveness of Act No. 298 / 2011 Coll.), Paragraph 39c (5) of the Act on Public Health Insurance has been amended to the following form: "If, when determining the remuneration pursuant to Sections 39b to 39e, in one of the groups of active substances listed in Annex 2 to this Act, regardless of the therapeutic interchangeability of at least 1 medicinal product, the Institute will adjust the decision of reimbursement in such a way that the least expensive medicinal product from the group of medicinal products under consideration is fully covered. 'The explanatory note to amending Act No 298 / 2011 Coll. explicitly states that the amendment of the text from the original words" to this group' (according to the context of the provisions, meaning certain groups of active substances listed in Annex 2 to the Act) to the text "from the group of medicinal products under consideration 'is intended to mark the content shift in legal regulation. The explanatory memorandum notes that the change from previous legislation occurs in a situation where no medicinal product is fully covered in Annex 2. In that case, the SÚKL will detect the least expensive medicinal product from the group of medicinal products under consideration (according to the previous modification it sought the least expensive in the whole group of Annex 2) and adapt the decision so that the least expensive medicinal product from the group of medicinal products under consideration is fully covered. The explanatory memorandum is available from http: / / www.psp.cz.
37. The Constitutional Court thus notes that the amendment described has been newly incorporated into Section 39c (5) of the Public Health Insurance Act since 1 December 2011 by the concept of "group of medicinal products under consideration ', to which the Supreme Administrative Court did not express itself in the judgment in sp. zn. 4 Ads 52 / 2013, but which is of great importance in the case under assessment by the Municipal Court. As a result of the change in legislation, it cannot be said that the City Court's reasoning concerning the association of the definition of a group of medicinal products under assessment within the meaning of § 39c (5) of the Public Health Insurance Act, with the provisions of § 39c (2) (a) of that Act, runs against the conclusions of the Supreme Administrative Court expressed in sp. zn. 4 Ads 52 / 2013. In other words, the Constitutional Court is not in a situation where the conclusion of the court which put forward a proposal for annulment of the law on the need to apply the contested provision is that it must be applied in contravention of the case law of the Supreme Court, which unites the caselaw. Thus, the Constitutional Court does not need to assess whether, at all or under what conditions, even in such a situation, the condition of the inevitable application of the legal provision proposed for annulment would be fulfilled.
38. The Constitutional Court summarises that it considers it a requirement that the municipal court must inevitably apply the provisions of the law which it proposes to abolish. Other procedural conditions for the application for annulment are also fulfilled.
Constitutional conformity of the legislative process
39. The text of the contested legislation was incorporated into the Act on Public Health Insurance by Act No. 298 / 2011 Coll. The draft amendment to the Act on Public Health Insurance (later published under No. 298 / 2011 Coll.) was submitted by the Government to the Chamber of Deputies on 13 April 2011 (House Press 325). The draft law submitted by the Government also contained a draft new version of § 39c (2) (a) of the Act on Public Health Insurance, which was replaced by the text of the approved parliamentary amendment in the later approved Act No 298 / 2011 Coll..
40. The first reading of the draft law took place on 27 April 2011 and 3 May 2011, on which the draft law was ordered to be discussed by Resolution 472. The second reading took place on 10 June 2011 and the amendment here to draft a new version of Paragraph 39c (2) (a) of the Public Health Insurance Act was made by Mr Leoš Heger, as is apparent from the House Press 325 / 2. By order No 592 of 21 June 2011, The Chamber of Deputies approved the proposal by a majority of 105 Members out of 180 who voted against it.
41. The Senate discussed the proposal referred to it on 30 June 2011 and, in Resolution 281, the majority of the 75 senators present spoke for its rejection. The Chamber of Deputies of the Chamber of Deputies discussed the rejected bill on 6 September 2011 (resolution 668), and the bill was approved by a majority of 103 Members out of 177 present. 68 Members voted against. The law was delivered to the President of the Republic on 15 September 2011 and signed by the President on 29 September 2011. The Act was published in the Collection of Laws on 14. 10. 2011 in the amount of 105 under No. 298 / 2011 Coll.
42. The Constitutional Court notes that the adoption and issue of the legislation under review took place in a constitutional manner. It can be recalled that the same result was expressed on the procedure for the adoption of Act No. 298 / 2011 Coll. in the Found of 20.6.2013 sp. zn. Pl. ÚS 36 / 11 (N 111 / 69 CollNU 765; 238 / 2013 Coll.), paragraphs 29 to 32, in the Found of 30.5.2017 sp. zn. Pl. ÚS 3 / 15 (N 89 / 85 SbNU 503; 231 / 2017 Coll.), paragraphs 77 and 80, and in the Found of 4.9.2018 sp.
Substantial assessment of the proposal
43. The Municipal Court contests the non-compliance of the contested provision with the fundamental right of citizens to health care free of charge and to public health benefits under the second Charter of Article 31.
44. Rights to health care free of charge and to health care based on public health insurance may only be claimed under Article 41 (1) of the Charter within the limits of the laws implementing such law. Article 31 of the Charter also refers to the conditions for the exercise of that right laid down by law. The legislature shall adopt the legal arrangements provided for in Article 31 of the Charter, the implementing act being required to examine the substance and meaning of the fundamental law in question.
45. The nature and meaning of the fundamental right to health care free of charge and to public health care is in the obligation of the State to establish a public health insurance system and to provide citizens with a fair way of access to health care and medical facilities of adequate quality (see the finding of 30 May 2017 sp. zn. The nature of the right to health care free of charge and to health-care facilities based on public health insurance requires citizens to be guaranteed the free provision of health care and medical supplies needed to improve or maintain their health or to alleviate their suffering, in the form of treatment and treatment which corresponds objectively to the requirements of the appropriate level and ethics [cf. úS 19 / 13 (N 178 / 71 SbNU 105; 396 / 2013 Sb.), paragraph 52].
46. In the context of access to health care, it can also be pointed out that the Convention for the Protection of Human Rights and the Dignity of Human Being in the Application of Biology and Medicine: the Convention on Human Rights and Biomedicine (published under No 96 / 2001 Coll.), in which Article 3 of which the Parties have committed themselves, bearing in mind the health needs and available resources, to take appropriate measures to ensure equal access to health care of appropriate quality within their jurisdiction.
47. In the case of the fundamental right of citizens to health care free of charge and medical supplies pursuant to Article 31 (2) of the Second Charter, the legislator is obliged to determine the conditions for its implementation, including the definition which healthcare and medical supplies must be provided to citizens free of charge, that is, without requiring citizens to pay them directly. The fulfilment of the right to health care free of charge and to medical devices based on public insurance pursuant to Article 31 (2) of the Second Charter assumes that the payment of public health insurance will cover not only the individual performance of the health service provider, but also the medicinal products and medical devices needed to achieve the desired therapeutic effect [the finding of 30.5.2017 sp. zn. Pl. ÚS 3 / 15 (N 89 / 85 SbNU 503; 231 / 2017 Coll.], paragraph 137; the finding of 17.4.2018 sp. ÚS 2332 / 16, paragraph 44].
48. The right to health care free of charge and to public health insurance medical devices shall also apply to medicinal products which are necessary to achieve a medicinal effect. The State is obliged to build a public insurance system in order to ensure equal access to those medicines. This is linked not only to their invalidity, but also to the actual availability in terms of ensuring the quantity needed for the health care of the rightholder guaranteed in Article 31 of the Second Charter. In this respect, by the nature and meaning of the fundamental right guaranteed by Article 31 of the second Charter, a constitutional requirement may be imposed to regulate the process of selecting medicinal products to be free of charge on the basis of health insurance where, at the time of that determination, it is justified that they are not available to citizens in the Czech Republic to the extent necessary from a medical point of view. In addition, it may be requested that the health care adjustment system allow adequate response to situations where a particular medicinal product, which has been included under the implementing act under the free health care heading, has become unavailable during the period of time in the Czech Republic if it interferes with such a state of health care provision to the extent foreseen in Article 31 of the Second Act free of charge on the basis of public health insurance. The constitutional requirement for an implementing act for such cases is the establishment of a mechanism that allows, within a reasonable time, the selection of another medicinal product provided free of charge on the basis of public health insurance or other means of providing the health care needed to achieve the desired therapeutic effect free of charge on the basis of public health insurance.
49. The Municipal Court proposes to abolish part of § 39c (2) (a) of the Public Health Insurance Act, which introduces an irrefutable presumption of the availability of a medicinal product, the highest price of which the manufacturer has concluded a written arrangement.
50. In order to assess the city court's proposal to abolish part of the law, it is first necessary to analyse certain aspects of the regulation of reimbursement of medicinal products in the Public Health Insurance Act. Article 39c (5) of the Act on Public Health Insurance provides for a correction mechanism defined as follows: "In the event that, when determining the reimbursement under Sections 39b to 39e, a group of substances listed in Annex No 2 to this Act does not fully cover the therapeutic interchangeability of at least one medicinal product, the Constitution [i.e. the SÚKL, notes, the Constitutional Court] shall adjust the decision of the reimbursement in such a way that the least expensive medicinal product from the group of medicinal products under consideration is fully covered. 'This is a provision forming part of the statutory provision for the provision of free health care on the basis of public health insurance.
51. The application of the provision is subject to consideration only after the amount of the remuneration determined in accordance with § 39b to 39e of the Act on Public Health Insurance, which includes the determination of the basic remuneration according to § 39c (2) (a) of the Act. It can therefore be concluded that § 39c (5) of the Act on Public Health Insurance follows the prior determination of the remuneration under § 39b to 39e, which under the conditions laid down it commands to modify. When fulfilling the hypothesis set out in Section 39c (5) of the Public Health Insurance Act, the level of remuneration must be adjusted so that the least expensive medicinal product from the group of medicinal products under consideration is fully covered. There was no dispute over the fulfilment of this hypothesis in the proceedings before the municipal court. It is therefore possible to focus on the available standards in Section 39b (5) of the Public Health Insurance Act and, in particular, the term "group of medicinal products under consideration ', among which it is chosen which will be fully covered. From a constitutional point of view, at least 1. the requirement that only therapeutically interchangeable products should be included in this group, and 2. the negative requirement that medicinal products from which a fully funded product is selected should not fall in the group of medicinal products for which there is a real presumption that they are not actually available on the market in the Czech Republic.
52. For the requirement for therapeutic interchangeability, reference should be made to the finding of 17 April 2018 sp. zn. III. ÚS 2332 / 16, paragraph 47. The Constitutional Court found here that the legal rule under which at least one medicinal product from a particular group of drugs is to be fully covered by public insurance must be interpreted in a constitutional manner in such a way that only medicinal products that are therapeutically interchangeable must be taken into account in order to avoid unjustified differentiation between different patient groups. Another procedure would be contrary to Article 4 (3) and (4) of the Charter.
53. The negative requirement that a fully paid medicinal product should not be selected among medicinal products for which there is a real presumption that it will not be available on the market in the Czech Republic arises from the second Charter of Article 31 (see paragraph 48). The right to free health care on the basis of public health insurance would become illusory in a situation where, among all essentially therapeutically interchangeable medicines, one fully covered by public health insurance would be identified, but for which there would be a reasonable assumption that it would not be available to citizens on the market in the Czech Republic.
54. Therefore, the availability of a medicinal product which is fully covered by public health insurance is of no constitutional significance. As availability is a factual condition, which can be changed over time, the availability of a fully paid medicinal product is reflected in two levels. Firstly, in a process leading to the future identification of a medicinal product fully covered by public health insurance, which relates to the selection of a medicinal product for which there is no reasonable assumption that it will not be available to citizens on the market in the Czech Republic (this is an assessment which relates to the future status of such a medicinal product after it has been determined, i.e. a certain prediction made at the time of the selection of the medicinal product fully paid). Secondly, the issue is expressed at the time following the determination of a medicinal product fully covered by public health insurance, which is related to whether the medicinal product is actually available (this is an assessment which relates to the current situation at the time when such an assessment is made) and to the remedy in the event of its unavailability. The Act on Public Health Insurance contains an adjustment which, to a certain extent, relates to both indicated levels of the issue (see paragraphs 62 to 75 for the first level, see paragraphs 76 to 87 for the second). The City Court's proposal to abolish part of Section 39c (2) (a) of the Public Health Insurance Act mainly concerns the plane of the issue of the selection of a medicinal product fully covered by public health insurance.
55. The question of the availability of the medicinal product is regulated in § 39c (2) (a) of the Public Health Insurance Act, which concerns the process of determining the basic remuneration in the reference groups. Reference groups are groups of medicinal products which are essentially interchangeable with similar or close efficacy and safety and similar clinical use. The list of reference groups is established by the Ministry of Health by implementing legislation, which is currently Decree No. 384 / 2007 Coll., on the list of reference groups, as amended.
56. As already stated in paragraph 34 above, the Constitutional Court does not intend to interfere with the conclusion of the Municipal Court on the association of the definition of a group of medicinal products under Section 39c (5) of the Act on Public Health Insurance with the provisions of Section 39c (2) (a) of the Act in those cases where SÚKL, in order to determine the basic remuneration in the reference group, first ascertains the lowest price of the producer belonging to the daily therapeutic benefit [§ 39c (2) (a) of the Public Health Insurance Act], which it subsequently adjusted in accordance with Section 39c (5) of that Act, and thus established the basic remuneration of the reference group. The conclusion of the City Court on continuity is that the definition of the availability of a medicinal product in § 39c (2) (a) of the Public Health Insurance Act is also intended to be used by that court in relation to § 39c (5) of that law, which is intended to ensure that, in certain cases, a medicinal product fully covered by public health insurance is selected. The Constitutional Court notes that this is an interpretation of the sub-constitutional law that allows the text of the law.
57. Paragraph 39c (2) (a) of the Public Health Insurance Act provides for general arrangements for the availability of a medicinal product or food for special medical purposes, by requiring effective availability, representing at least 3% of the total volume of sales, in principle, of therapeutically interchangeable medicinal products containing the same active substance. A special availability adjustment, which depends on the irrefutable presumption of availability for a medicinal product, the highest price of which has been made by the manufacturer or the payment of which has been made in writing. The assumption is that the presumption of availability is based on the accepted commitment to ensure availability (see paragraphs 62 to 75) and the presumption of compliance. Inrefundability is indicated by the treatment according to which such medicinal products are always considered available. It is also stated in the explanatory memorandum to Act No 298 / 2011 Coll. that the intention of the legislator was to establish an irrefutable presumption: "An irrefutable presumption then arises when assessing the availability and presence of a medicinal product... the price of which for the final consumer or the reimbursement of which has been made in writing..."
58. Paragraph 39c (2) (a) of the Public Health Insurance Act also provides that a first to third like product in the active substance is always considered available on the market in the Czech Republic in the order of the time of the application for the level and conditions of reimbursement. The provision of the availability of the first to third similar product is not the subject of a proposal by the municipal court, therefore the Constitutional Court no longer deals with it in the next text.
59. The use of the availability adjustment in Section 39c (2) (a) of the Public Health Insurance Act in adjusting the basic remuneration in the reference group so that there is a medicinal product fully covered by public health insurance (Section 39c (5) of the Act) has a different approach to the requirement that medicinal products which are not available to citizens on the market in the Czech Republic should not be included in the group of products between which full payment is made (see paragraphs 48 and 53). For the general adjustment of availability through a 3% market share, in principle, therapeutically interchangeable medicinal products containing the same active substance, it is assumed that in the past the medicinal product has reached at least a legally established market share. The presumption of the availability of a medicinal product for which the highest price of the manufacturer or reimbursement has been made is based on the fact that an undertaking has to be made to ensure its availability on the market in the Czech Republic (see paragraphs 62 to 75). In both cases, it is an adjustment that helps to prevent a certain degree of unintended condition where a fully paid public health care product is not available to citizens on the market in the Czech Republic.
60. However, even at the selection stage of a fully-paid medicinal product, it is practically unfeasible to ensure that, in future, an undesirable situation linked to the actual unavailability of the intended medicinal product cannot occur. However, the legislator offers the possibility of responding through legal institutes which would be activated in the event of non-availability and through which another fully paid product would be identified, the lack of availability or otherwise the situation resolved (see paragraphs 76 to 87).
61. The importance of the presumption of availability for medicinal products for which the highest price of the manufacturer or payment has been made is seen by the Constitutional Court in the creation of an area for the possibility of faster saving the total cost of health care compared to a procedure whereby the basic remuneration in the reference groups is determined using the general availability adjustment provided for in Section 39c (2) (a) of the Public Health Insurance Act. The general treatment is considered to be available for a medicinal product with a proportion of the total sales volume of, in principle, therapeutically interchangeable medicinal products containing the same active substance of at least 3% during the relevant period. The relevant period is determined by the Ministry of Health by implementing legislation [§ 39a (3) (b) of the Act on Public Health Insurance]. According to Article 13 (1) of Decree No. 376 / 2011 Coll., the relevant period for assessing the availability of the medicinal product is the calendar quarter preceding the calendar quarter in which the administrative procedure was initiated. The Constitutional Court thus notes that if the actual availability determined by a 3% market share is assessed, this is the case for a defined period of 3 calendar months preceding the initiation of the administrative procedure as defined. In cases where the sale of a medicinal product has reached at least 3% of the total sales volume, in principle, interchangeable products only during the administrative procedure, but not in the preceding calendar quarter under which the relevant period is determined, it will not be an available medicinal product within the meaning of Article 39c (2) (a) of the Public Health Insurance Act for the purpose of such administrative proceedings, having regard to the definition of the relevant period in which the availability was examined. Using the presumption of the availability of the medicinal product for which the highest price of the manufacturer or reimbursement has been made, prior consideration may be given to those medicinal products which are deemed to be concerned when determining the basic remuneration, and it is not necessary to wait until they have reached a market share of 3% in principle of therapeutic, interchangeable medicinal products containing the same active substance during the relevant period, but it can be assumed that availability is covered by a contractual obligation. This practice may be practical if the entity accepting the commitment to ensure availability is prepared to place on the market in the Czech Republic in sufficient quantities such a medicinal product through which the healthcare financing system can achieve savings.
62. As mentioned above, the presumption of availability of the medicinal product is based on an undertaking to ensure its availability.
63. Pursuant to Article 39b (2) (d) of the Act on Public Health Insurance when determining the amount and conditions of reimbursement of a medicinal product, the administrative authority assesses, inter alia, the public interest under Article 17 (2) of the Act, where the legislative abbreviation "public interest" is introduced. Under this abbreviation according to the legal definition there is an interest in ensuring the quality and availability of the services paid, the functioning of the health system and its stability within the financial possibilities of the public health insurance system. The services covered include the provision of medicinal products [Paragraph 13 (2) (b) 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. 369 / 2011 Coll.]. The finding of all the circumstances relevant to the protection of the public interest is a general obligation of the administrative authority provided for in Paragraph 50 (3) of the Administrative Regulation. The Constitutional Court thus finds that when determining the level of remuneration for a medicinal product, the administrative authority also examines the question of the availability of the medicinal product as one of the public interest elements.
64. The legal obligation to assess the public interest [§ 39b (2) (d) of the Public Health Insurance Act, § 50 (3) of the Administrative Code] leads to the need to verify whether the written agreement on the highest price of the manufacturer or remuneration contains an obligation to ensure the availability of the medicinal product on the market in the Czech Republic, in the process of determining the basic remuneration, is based on the presumption of the availability of the medicinal product linked to the above written arrangements. The fulfilment of this obligation is all the more urgent in the light of Article 31, sentence, of the second Charter, in those cases where the adjustment of the amount of the basic remuneration in the reference groups under Section 39c (5) of the Public Health Insurance Act is made in such a way that the least expensive product from the group of medicinal products under consideration is fully covered.
65. The written settlement arrangement is further specified in § 39c (2) (d) of the Public Health Insurance Act. There is also an obligation among the elements of such an arrangement that the medicinal product or food for special medical purposes will be available on the Czech market for the duration of the arrangement. The undertaking shall be accepted by the marketing authorisation holder of the medicinal product, the importer or the domestic food manufacturer for special medical purposes.
66. The written agreement on the highest price of the manufacturer is specified in Section 39a (2) (b) of the Public Health Insurance Act, which states that it is a public-interest arrangement under Section 17 (2) of that Act. One of the elements of public interest under that provision is also an interest in ensuring the availability of the services covered, where the provision of medicinal products also includes. The Constitutional Court finds that, through a requirement to enter into an arrangement in the public interest, one component of which is to ensure the availability of the services covered, the Public Health Insurance Act considers the obligation to ensure the availability of the medicinal product as part of a written agreement on the highest price of the manufacturer. The obligation to ensure availability shall be accepted by the marketing authorisation holder of the medicinal product, the importer or the domestic food manufacturer for special medical purposes or by the promoter of a specific treatment programme.
67. The Constitutional Court may make a partial summary of the fact that both for the written agreement on the highest price of the manufacturer and for the written arrangement on reimbursement, the law provides that the obligation to ensure the availability of the medicinal product to which the arrangements relate is to be included during the period of effectiveness of the arrangement.
68. In the context of an examination of the public interest, which also includes an interest in ensuring the availability of the services paid in determining the level and conditions of reimbursement of the medicinal product [§ 39b (2) (d) of the Public Health Insurance Act, § 50 (3) of the Administrative Code], it is the duty of the administrative authority to verify whether the undertaking to ensure the availability of the medicinal product on the market of the Czech Republic has been properly negotiated in the agreement on the highest price of the producer or reimbursement agreement, if these arrangements are of relevance to its decision. If such an undertaking has not been properly agreed, it is not possible to make an irrefutable presumption of the availability of a medicinal product the highest price of which has been concluded by a written arrangement [Paragraph 39c (2) (a) of the Public Health Insurance Act]. That presumption of availability is based on an obligation to ensure the availability of a medicinal product without which it cannot be properly negotiated.
69. It can be added that the performance of the obligations arising from the written agreement on the highest price of the manufacturer or remuneration is sanctioned by the fact that, under these arrangements, the basic remuneration of the reference group has been determined in accordance with § 39q (1) (b) and (c) of the Public Health Insurance Act. This offence shall be committed by a natural or legal person who infringes a written agreement on the highest price of the manufacturer on the basis of which the basic remuneration of the reference group [§ 39q (1) (b) of the Public Health Insurance Act] has been determined, or infringes a written payment arrangement on the basis of which the basic remuneration of the reference group [§ 39q (1) (c) of the Public Health Insurance Act] was established. This is an offence for which a fine of up to CZK 10 million can be imposed. The Constitutional Court notes that the basic remuneration of the reference group, which was established on the basis of a written agreement on the highest price of the producer or remuneration, must also be regarded as a basic remuneration, the determination of which made use of the presumption of the availability of the medicinal product of which the highest price of the producer or of which a written arrangement was concluded [§ 39c (2) (a) of the Public Health Insurance Act].
70. The modification of the infringement in § 39q (1) (b) and (c) of the Public Health Insurance Act is of relevance for the application of the presumption of the availability of a medicinal product whose highest price of the manufacturer or payment has been made in writing from a further perspective. In order to be able to apply the presumption of availability described, the condition that he has not committed an infringement under § 39q (1) (b) of the Public Health Insurance Act, if it is an arrangement on the highest price of the manufacturer or an infringement under [§ 39q (1) (c), in the last two years shall be satisfied on the part of the entity that undertakes to ensure the availability of the medicinal product. The conditions for not committing those offences are set out in Section 39c (2) (c) and (d) of the Public Health Insurance Act. The application of these conditions for the application of the presumption of availability of a medicinal product, the highest price of which has been the subject of a written arrangement, is based on the internal scheme of § 39c (2) of the Public Health Insurance Act. Paragraph 39c (2) (a) of the Public Health Insurance Act mentions a written arrangement on the highest price of the manufacturer or remuneration without providing for any further legislation relating to them. Further provisions relating to these arrangements can be found in § 39c (2) (c) following § 39a (2) (b) and § 39c (2) (d) of the Act. Therefore, the adjustment contained in the provisions mentioned above must also be based on a reference to the written agreement on the highest producer price or remuneration contained in Section 39c (2) (a) of the Public Health Insurance Act, to the extent that this is appropriate to establish the presumption of availability. The quality of the presumption of availability is enhanced by the fact that only those arrangements on the highest producer price or remuneration in which the undertaking to ensure availability has been taken over by an entity which has not committed an infringement in the last two years, the nature of which is to violate such agreements, provided that the basic remuneration of the reference group has been determined on their basis.
71. The Constitutional Court notes that the irrefutable presumption of the availability of a medicinal product, the highest price of which has been concluded by a written arrangement [Paragraph 39c (2) (a) of the Public Health Insurance Act], does not give room for the competent authority to examine the market share of the medicinal product in the Czech Republic for the purposes of determining the basic remuneration in the reference groups or for adjusting that basic remuneration in accordance with the procedure laid down in Section 39c (5) of the Public Health Insurance Act, so that at least one of the group of medicinal products under consideration is covered. This is the intention of the legislator, motivated by an attempt to provide greater scope for the more cost-effective use of funds intended to cover health care. The explanatory note to Act No 298 / 2011 Coll. mentions that, in order to reduce the expenditure of public health insurance funds (cf. 61), the amended version of Section 39c (2) (a) of the Public Health Insurance Act extends to cases where the availability of specific medicinal products is not detected and their price is always included in the price reference. This applies to medicinal products for which a written arrangement has been concluded for the highest price of the manufacturer or reimbursement. The examination of the availability defined by 3% of the market share, in principle, of therapeutically interchangeable medicinal products containing the same active substance, is superseded by the administrative authority's obligation to determine the basic remuneration in reference groups (and, where appropriate, to modify its amount under Section 39c (5) of the Public Health Insurance Act) to verify whether all the legal conditions for applying the presumption of availability of the medicinal product have been fulfilled. This presumption can only be made if all the legal conditions have been met. In the case of a medicinal product for which the highest price of the manufacturer or payment has been made, these conditions include the acceptance of an obligation to ensure the availability of the medicinal product on the market in the Czech Republic and the fact that the entity which has committed an undertaking to ensure the availability of the medicinal product has not committed an infringement pursuant to § 39q (1) (b) or (c) of the Public Health Insurance Act in the last two years, following the type of such an arrangement which is concerned.
72. The Municipal Court, as it describes in its proposal, concluded that the Act provides for a presumption of availability, which depends on the written arrangements for the highest price of the manufacturer or reimbursement, without further specifying the content of such written arrangements and without specifying the specific quantity of medicinal product to be supplied to the pharmacy network. The Constitutional Court finds that, in view of the presumption of the availability of a medicinal product, the obligation to ensure the availability of a medicinal product is relevant, which under the legislation is to be part of a written agreement on the highest price of the manufacturer or reimbursement (see paragraphs 65 and 66). At the same time, it did not find it possible to deduce the normative scope of the concept of "availability 'within the meaning of § 39a (2) (b), in conjunction with § 17 (2) of the Public Health Insurance Act or the concept of" available medicinal product' within the meaning of § 39c (2) (d) of the Public Health Insurance Act. These concepts constitute the central point of the commitment to ensuring availability and are characterised by a degree of uncertainty. The indeterminity of legal concepts is not unusual in the rule of law and, in essence, results from the abstract and regulatory nature of legal standards. It does not, in itself, create unconstitutionality. However, as a contradiction with the requirement of legal certainty, which is one of the requirements of the rule of law (Article 1 (1) of the Constitution), it could be considered that its intensity would exclude the possibility of determining the normative content of legislation by means of the usual interpretative procedures [e.g. the findings of 5.4.2005 sp. zn. Pl. ÚS 44 / 03 (N 73 / 37 SbNU 33; 249 / 2005 Sb.), of 13.3.2007 sp. zn. Pl. ÚS 10 / 06 (N 47 / 44 SbNU 603; 163 / 2007 Sb.), of 27.3.2018 sp. Pl. ÚS 7 / 17 (81 / 2018 Sb.), paragraph 71].
73. In order to determine exactly what the obligation to ensure availability in a written agreement on the highest price of the manufacturer or on the remuneration cannot be determined only from Section 39c (2) (a) of the Public Health Insurance Act, taking into account the interpretative rule lex specialis derogat legi generali (special legislation excludes general rules). According to that provision, the general definition of availability by means of a 3% market share does not apply to medicinal products whose highest price of the producer or payment has been made by a written arrangement, as a special provision is provided for in Section 39c (2) (a) of the Public Health Insurance Act in the form of a presumption of availability. However, using the presumption of availability (a medicinal product of which the highest price of the manufacturer or payment has been made by a written arrangement is always considered to be available), it is not meaningful to determine exactly what the content of the undertaking is to ensure availability in those arrangements. Even if reference is made to the interpretative rule lex specialis derogat legi generali, it cannot be overlooked that the definition of availability by 3% of the market share is related to the relevant period in the past in § 39c (2) (a) of the Public Health Insurance Act (cf. this part of the provision: "at least 3% in the relevant period '). However, the obligation to ensure the availability of the medicinal product in the written agreement on the highest price or remuneration must be respected throughout the period of effectiveness of the arrangement, its relationship to the previous period would make no sense, for this purpose, see Section 39c (2) (c) of the Public Health Insurance Act, according to which the written agreement on reimbursement should include an obligation to make the medicinal product available on the market in the Czech Republic during the period of effectiveness of the arrangement. In the case of a written agreement on the highest price of the manufacturer, the obligation to ensure the availability of the medicinal product throughout the period of effectiveness of the written arrangement from a requirement of public interest to ensure the availability of the services to be paid [Paragraph 39a (2) (a), following § 17 (2) of the Public Health Insurance Act] may be assumed.
74. What is to be the content of the obligation to ensure the availability of the medicinal product accepted in a written agreement on the highest price of the manufacturer or on the remuneration can be derived from the interpretation of the word availability or accessible. The Constitutional Court notes that the commitment to ensure the availability of the medicinal product is aimed at ensuring, to an acceptable extent, that, in terms of quantitative medical reasons, justified demand for the medicinal product in the Czech Republic is met, subject to the price requirements and, where appropriate, the reimbursement provided for by the legal order. The commitment to ensure the availability of the medicinal product is aimed at achieving and maintaining the required factual status, generally reflected in the fact that, on the market in the Czech Republic, the medicinal product will be available to patients, i.e. that there will be no significant problems with its quantitative supply to the market and covering the demand of patients in compliance with the legal requirements for price or remuneration. Thus, the Constitutional Court does not see the uncertainty that would prevent the establishment of the regulatory scope of the obligation to ensure the availability of the medicinal product which is part of the written agreement on the highest price or remuneration. From a constitutional point of view, it is not necessary for the legislative regulation of the obligation to ensure the availability of a medicinal product to be provided for a specific quantity of medicinal product to be delivered to the pharmacy network, as indicated by the municipal court. In other words, the commitment to ensure availability is defined by the state to be achieved (simply put, by saturation of medically justified patient demand), without the availability to which the commitment is directed being defined, for example, by some market share of the medicinal product concerned on the market or certain quantities supplied.
75. The Constitutional Court may summarise that the presumption of the availability of a medicinal product, the highest price of which has been concluded by a written arrangement, is based on an obligation to ensure the availability of a medicinal product which is legally included in those arrangements. In order to be able to apply the presumption of availability when determining the amount of remuneration, the administrative authority must verify that the commitment to ensure availability has been properly negotiated. The fulfilment of this obligation is sanctioned by the facts of the infringement where, under these arrangements, the basic remuneration of the reference group has been determined, which in addition to the private liability institutions, the compulsory body is motivated to properly fulfil the obligation to ensure the availability of the medicinal product. At the same time, the application of that presumption of availability is subject to the condition that the body which has undertaken to ensure the availability of the medicinal product has not committed an infringement under § 39q (1) (b) or (c) of the Public Health Insurance Act in the last two years, which relates to a breach of the written agreement on the highest price of the manufacturer or remuneration on the basis of which the basic remuneration of the reference group has been determined. According to the Constitutional Court's assessment, therefore, it is not contrary to Article 31 (2) (a) of the Second Charter to modify the presumption of the availability of a medicinal product, the highest price of which has been concluded by a written arrangement in § 39c (2) (a) of the Public Health Insurance Act. In cases where a fully paid medicinal product under Section 39c (5) of the Act on Public Health Insurance is determined in accordance with Section 39c (2) of the same Act, using this presumption of availability, there is no unacceptable condition in the light of Article 31 of the Second Charter, i.e. the selection of a fully paid medicinal product between those products for which, at the time of its selection, it would be reasonable to assume that they would not be available to citizens on the market in the Czech Republic. On the contrary, the provision described above in the Public Health Insurance Act, which provides for the continuity of the presumption of the availability of a medicinal product, the highest price of which has been concluded by the manufacturer or the payment of a written arrangement, to ensure availability, leads to the conclusion that the fully paid product is chosen among those for which the legal regulation by means of the commitment to ensure availability creates the conditions for it to be available.
IX. D. Zkoumání dostupnosti léčivého přípravku v době následující poté, co byl určen plně hrazený léčivý přípravek z veřejného zdravotního pojištění
76. In paragraph 54, the Constitutional Court pointed out that the issue of availability with regard to a medicinal product which is fully covered by public health insurance is reflected in two levels. Firstly, when determining the medicinal product fully covered by public health insurance, which concerned the treatise on the obligation to ensure the availability of the medicinal product in points 62 to 75. First, at the time following the identification of a medicinal product fully covered by public health insurance. The Constitutional Court considers it necessary to comment on the presumption of the availability of the medicinal product and on a situation where a fully paid medicinal product has already been designated. The legislation is hardly able to fully prevent the choice of a fully paid medicinal product from being made available on the market in the Czech Republic in the future, whether it was determined by the presumption of availability or by the determination of its market share. According to the explanatory memorandum to Act No. 298 / 2011 Coll., the legal institute of the abbreviated revision is supposed to respond to the undesirable situation associated with the factual lack of availability, which is designed to provide the system with the necessary flexibility for situations of failure of the availability of the medicinal product or withdrawal from the market for the medicinal product on which the reimbursement system is based. The Constitutional Court has verified that the presumption of the availability of a medicinal product, the highest price of which has been concluded by the manufacturer or the payment of a written arrangement, does not make it impossible to respond to a possible adverse situation associated with the actual unavailability of the medicinal product. Therefore, the presumption that the medicinal product is available does not conflict with the second Charter of Article 31.
77. In cases where not one medicinal product is fully covered by the law, a short revision under Section 39p (2) of the Public Health Insurance Act is responded to. In the case where, when determining the basic remuneration in the reference group (adjusted, where appropriate, in accordance with Section 39c (5) of the Public Health Insurance Act, so that at least one of the medicinal products under consideration is fully covered), the presumption of availability of a medicinal product, the highest price of which of the manufacturer or of the remuneration has been concluded by a written arrangement, is of relevance to Section 39p (4) of the Public Health Insurance Act. The Constitutional Court will therefore focus on that provision.
78. SÚKL pursuant to § 33 (2) of Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (the Law on Medicines), as amended, (hereinafter referred to as "the Law on Medicines") receives electronically information on the volume of supplies of medicinal products placed on the market in the Czech Republic which are fully and correctly required to be provided by the marketing authorisation holders of the medicinal product. The dispenser of pharmaceuticals according to § 77 (1) (f) of the Drug Act also has a similar obligation. The SÚKL is to receive on a regular basis from the drug distributor complete and correct data on the volume of medicinal products that the distributor has distributed to pharmacies and other health service providers, other distributors, dealers of reserved medicinal products and veterinary medicinal products, and on the volume of advertising samples supplied to marketing authorisation holders or sales agents.
79. SÚKL thus regularly receives information on the volume of supplies of medicinal products. In accordance with Section 42 of the Administrative Regulation, it also accepts initiatives to initiate proceedings ex officio. In both cases, it is a source of information which can be used to initiate a shortened revision of payments under Section 39p (4) of the Public Health Insurance Act. In the short and in-depth review, the basic remuneration of the reference group is determined (Section 39c (7) of the Public Health Insurance Act). According to Section 39p (4) of the Public Health Insurance Act: "The Institute shall immediately initiate a shortened revision in the event of
(a) infringement of a written arrangement under Paragraph 39c (2) (c) [i.e. the highest producer price arrangement, note of the Constitutional Court] where the basic remuneration of the reference group has been set at the level of such a written arrangement; or
(b) infringement of a written arrangement under Paragraph 39c (2) (d) [i.e. a settlement arrangement, note to the Constitutional Court] where the basic remuneration of the reference group has been determined under such a written arrangement. ';
80. Although there is talk of a shortened revision in Section 39p (4) of the Public Health Insurance Act, in the event that a first revision of the reimbursement system has not taken place for the group in principle, the SÚKL, under the conditions mentioned in Section 39p (4) of the Public Health Insurance Act, will initiate an in-depth revision (§ 39l), as defined in Section 39p (5) of the fourth law. However, the interpretation of the conditions in Section 39p (4) of the Public Health Insurance Act is the same as for the opening of a shortened and in-depth revision. Furthermore, the Constitutional Court refers only to a shortened revision.
81. The Constitutional Court notes that one of the conditions for initiating the shortened revision under Paragraph 39p (4) (a) of the Public Health Insurance Act is that the basic remuneration of the reference group was set at the level of the written agreement on the highest price of the producer. It is not only those cases where the basic remuneration has been determined in accordance with § 39c (2) (c) of the Public Health Insurance Act, but also all cases where the basic payment has been determined in accordance with the medicinal product, the highest price of which the manufacturer has concluded a written arrangement and the availability of which in the procedure for determining the basic remuneration has been deemed to be available under § 39c (2) (a) of the Public Health Insurance Act. The basic remuneration of the reference group does not need to be set at the level of the highest price arrangement of the manufacturer only in accordance with the procedure laid down in Section 39c (2) (c) of the Public Health Insurance Act, but can be determined in practice with the use of Section 39c (2) (a) of the Act. It can be pointed out, for example, that the case examined by the Municipal Court where the basic remuneration at the level of the highest-price arrangement was determined on the basis of Paragraph 39c (5) following the provisions of Section 39c (2) (a) of the Public Health Insurance Act (see recital 23).
82. The Constitutional Court considers it necessary to add that the written agreement on the manufacturer's highest price already requires, according to its name, only a restriction on the producer's price so that its amount may not exceed the agreed highest price, but may be lower. Therefore, if the basic remuneration would have been determined according to this lower (de facto charged) price according to the product for which a written arrangement was concluded and the availability of which in the procedure for determining the basic remuneration was deemed to be available under § 39c (2) (a) of the Public Health Insurance Act, it would still be a remuneration set at the level of the written agreement on the highest agreed producer price pursuant to § 39p (4) (a) of the same law. If the manufacturer's price is limited by a written agreement on the highest agreed price of the manufacturer, this should also be taken into account in the interpretation of Section 39p (4) (a) of the Public Health Insurance Act. Therefore, the wording "at the level of such a written arrangement 'should be understood as meaning a price interval limited to the highest producer price above. In other words, if the basic remuneration in the reference group was determined using the presumption of availability, it is determined from the point of view of § 39p (4) (a) of the Law that the basic remuneration was determined according to the product for which the presumption of availability associated with the medicinal product, the highest price of which was the conclusion of a written arrangement, not whether it was set precisely at the agreed highest price of the manufacturer or at the lower (de facto charged) level.
83. A similar consideration can be made in relation to § 39p (4) (b) of the Act on Public Health Insurance and the Payment Agreement. Therefore, it is not only those cases where the basic remuneration has been determined in accordance with § 39c (2) (d) of the Public Health Insurance Act, but also all cases where the basic payment has been determined in accordance with a medicinal product whose payment has been made in writing and the availability of which in the procedure for determining the basic remuneration has been deemed to be available in accordance with § 39c (2) (a) of that Act. The wording "under such a written arrangement 'should be understood to mean the price interval limited to the above-mentioned remuneration agreed in the written remuneration arrangement. Here, too, the price restriction, this time for the final consumer, is made by setting the maximum price, since part of the reimbursement agreement is an obligation that the price for the final consumer of the medicinal product does not exceed the maximum possible remuneration for the final consumer [§ 39c (2) (d) in fine public health insurance law].
84. According to Section 39p (4) of the Public Health Insurance Act, the SÚKL is obliged to initiate a short review without delay in the event of a breach of the written agreement on the highest price of the manufacturer or the written arrangement on the remuneration, provided that the basic remuneration of the reference group has been set at the level of the highest price arrangement or under the arrangement on the remuneration. As explained above (paragraphs 81 to 83), that provision is aimed at cases where the basic remuneration was determined according to a medicinal product for which the presumption of availability associated with the concluded written agreement on the highest producer price or remuneration [§ 39c (2) (a) of the Public Health Insurance Act was used in the procedure for determining the basic remuneration]. The infringement of the highest price or remuneration arrangement is also a breach of the obligation to ensure the availability of the medicinal product covered by those written arrangements. This commitment must be part of them in order to allow for the presumption of availability when determining the basic remuneration (see paragraph 67). Therefore, on the basis of Section 39c (4) of the Public Health Insurance Act, it is possible to respond to a situation where the commitment to ensure availability is not fulfilled by establishing a new basic remuneration in a reduced revision.
85. The Constitutional Court notes that when assessing whether a written agreement on the highest producer price or remuneration has been infringed, if the basic remuneration of the reference group has been established on their basis, it must be made in the event of an examination of compliance with the obligation to ensure the availability of the medicinal product for the examination of the actual availability contained in that undertaking (see paragraph 74). If the irrefutable presumption of availability were to apply to Section 39p (4) of the Public Health Insurance Act, it would make it completely impossible to examine whether the written arrangements on the highest price of the manufacturer or the remuneration were infringed in those parts of them concerning the commitment to ensure availability. The irrefutable presumption of availability under Section 39c (2) (a) of the Public Health Insurance Act cannot be applied here as this would lead to absurd consequences and to a denial of the meaning of the regulation in Section 39p (4) of the same Act, which is to ensure the flexibility of the system for situations of failure of the availability of the medicinal product, as stated in the explanatory report to Act No 298 / 2011 Coll.
86. At the same time, if the reason for initiating a shortened revision of the infringement was to ensure the availability of the medicinal product accepted in the written agreement on the highest price of the manufacturer or remuneration, it cannot be based on the presumption of availability in the context of this reduced revision when determining the basic remuneration, namely when adjusting the remuneration in the groups of medicinal products in which at least one of them is to be fully covered (Section 39c (5) of the Public Health Insurance Act) for the product for which the obligation to ensure availability has been infringed. The opposite approach would often make it impossible to remove the defect which led to the introduction of a shortened revision under § 39c (4) of the Public Health Insurance Act.
87. It can be concluded that the presumption of the availability of a medicinal product for which the highest price of the manufacturer or payment has been made is not an obstacle to a legally foreseeable reaction (usually a different treatment of payments in reference groups) to the actual unavailability of the medicinal product under Section 39p (4) of the Public Health Insurance Act. Even from this point of view, the Constitutional Court therefore did not find any contradiction in the presumption of availability with Article 31 (2) of the Second Charter. The Constitutional Court points out that, in its assessment, it was limited to verifying that the contested presumption of availability did not prevent a shortened revision (possibly in-depth revision), initiated under Section 39p (4) of the Public Health Insurance Act, and that the presumption of availability here did not prevent the removal of the malfunctioning. Other aspects of the legislation relating to the shortened revision (possibly in-depth revision) initiated under Section 39p (4) of the Public Health Insurance Act, but not directly related to the presumption of availability of the medicinal product, were not addressed by the Constitutional Court. The purpose of its assessment in this procedure is merely the constitutionality of the presumption of the availability of a medicinal product, the highest price of which has been concluded by a written agreement [Paragraph 39c (2) (a) of the Public Health Insurance Act].
88. As part of the additional argument in its proposal, the municipal court expressed doubts as to whether a medicinal product which was not available on the market in the Czech Republic at the time of decision of the administration will have sufficient experience of prescribing it and information on patient tolerability.
89. The Constitutional Court finds that questions about the effect of a medicinal product on patients are not subject to the regulation of the presumption of the availability of a medicinal product, the highest price of which has been concluded by a written agreement between the manufacturer and the reimbursement. Therefore, this question does not need to be addressed on the basis of the application for annulment of the contested section of Section 39c (2) (a) of the Public Health Insurance Act.
90. In short, it can be noted that an amendment to the issue covered by the additional arguments of the Municipal Court can be found, for example, in the Drug Act. The medicinal product referred to in Article 25 (1) of Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (Law on Medicines), as amended by Act No. 75 / 2011 Coll., may not be placed on the market in the Czech Republic until SÚKL has granted it registration or the registration has been granted in accordance with the procedure laid down in the directly applicable European Union Regulation. Under the conditions laid down in the marketing authorisation procedure, the assessment of the effectiveness, safety and quality of medicinal products (cf. Article 31 (5) (a) of Act No 378 / 2007 Coll., on medicinal products and on amendments to certain related laws (the Law on medicinal products), as amended by Act No 75 / 2011 Coll., Article 37 (1) (a) of Regulation (EC) No 726 / 2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency). The registration process also includes, under specified conditions, the requirement to submit the results of physical, chemical, biological or microbiological tests, toxicological and pharmacological tests and clinical trials [Article 26 (5) (j) of Act No. 378 / 2007 Coll., on Medicines and on amendments to certain related laws (Law on Medicines), as amended by Act No. 70 / 2013 Coll., Article 6 (1) of that Regulation, in connection with Article 8 (3) (i) of Directive 2001 / 83 / EC of the European Parliament and of the Council of 6.11.2001 on the Community code relating to medicinal products for human use].
Conclusion
91. For the reasons set out above, the Constitutional Court concludes that the provisions of § 39c (2) (a) of the Public Health Insurance Act in words' or of a medicinal product whose highest producer price or remuneration has been agreed upon in writing; such medicinal products are always considered available on the market in the Czech Republic, "is not contrary to constitutional order. The City Court's proposal to abolish this provision of the Act therefore rejected, pursuant to Paragraph 70 (2) of Act No. 182 / 1993 Coll., on the Constitutional Court.
92. The Constitutional Court did not take into account the request of LEK Pharmaceuticals d. d., to comment in its obiter dictum decision on compliance with § 39h (4) of the Public Health Insurance Act on the exclusion of suspensive effect against a decision in an in-depth review, shortened revision and other proceedings. That company, which is the applicant in the proceedings before the municipal court, is not entitled in the present procedural situation to file an application for annulment of the law or its individual provisions. Paragraph 39h (4) of the Public Health Insurance Act had no impact on the examination by the Constitutional Court of the application of the Municipal Court.
President of the Constitutional Court:
JUDr. Rychetský v. r.
Contents
I.
II.
III.
IV.
V.
VI.
VII.
VIII.
IX.
IX. A. Ústavní východiska
IX. B. Napadené ustanovení v kontextu zákona o veřejném zdravotním pojištění
IX. C. Závazek zajistit dostupnost léčivého přípravku
IX. D. Zkoumání dostupnosti léčivého přípravku v době následující poté, co byl určen plně hrazený léčivý přípravek z veřejného zdravotního pojištění
IX. E. K argumentaci městského soudu o snášení léčivého přípravku pacienty
X.
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Regulation Information
| Citation | The Constitutional Court found No 75 / 2019 Coll., on the application for annulment of Section 39c (2) (a) of Act No. 48 / 1997 Coll., on Public Health Insurance and on the amendment and addition of certain related laws, as amended |
|---|---|
| Regulation Type | The Constitutional Tribunal found |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 19.03.2019 |
|---|---|
| Effective from | - |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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