The Constitutional Court found no 231 / 2017 Coll.
The Constitutional Court found of 30 May 2017 sp. zn.
Valid
The Constitutional Tribunal found
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231
FIND
The Constitutional Court
On behalf of the Republic
On 30 May 2017, the Constitutional Court decided under sp. zn. Pl. ÚS 3 / 15 in plenary composed of the President of the Court of Paul Rychetský (Judge) and the judges Louis David, Jaroslav Fenyk, Josef Fiale, Jan Filip, Jaromír Jirsa, Tomáš Lichovník, Jan Musil, Vladimir Sládeček, Radovan Sukánek, Catherine Šíšimková, Vojtěch Šimíček, Milady Tomková, David Uhlír and Jiří Zemánek on the motion of the Senate of the Czech Parliament of the Senate, represented by JUDr. Janá Marečková, a lawyer, with responsibility for the implementation of the minimum economic and seriousness; the cost of the least economically demanding execution of the medical device is ascertained by the health insurance company by market research 'and the provisions of Annex 3, Section C, of this Act, in parts where the symbols of the remuneration limits "A' and" B 'are defined and the amount of remuneration of individual types of medical devices is limited by these symbols, 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 to the proceedings and the Government of the Czech Republic, represented by the Minister of Health, as an intervener,
as follows:
I. Paragraph 15 (12) 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. 298 / 2011 Coll., in words "in the execution of the least economically demanding, depending on the extent and severity of the disability; The price of the least economically demanding medical device is determined by the health insurance company by market research 'shall be cancelled by 31 December 2018.
II. In Annex 3 to Act No 48 / 1997 Coll., on Public Health Insurance and amending and supplementing certain related acts, as amended, the parts of Section C, as defined by the letters "A" and "B," which limit the amount of reimbursement of individual types of medical devices, and the text which reads as follows:
"Payment limits symbols
A - Reimbursement at the level of the price for the final consumer of the medical device in the performance of the least economically demanding according to the degree and severity of the disability (hereinafter referred to as the least economically demanding option); the cost of the most economically demanding variant of the medical device is ascertained by the health insurance company by market research.
B - Reimbursement at the level of the cost of the least demanding economic variant of the entire system of medical devices of Group 3 of this Section. '
Reasons
Subject matter
1. On 23 January 2015, the Constitutional Court received a proposal from a group of 20 senators of the Senate of the Parliament of the Czech Republic ("the appellant ') on behalf of the Senator Prof. MUDr. Jan Žavoudík, CSc., on the abolition of Article 15 (12) of Act No. 48 / 1997 Coll., on Public Health Insurance and on the amendment and addition of certain related laws, as amended, (" the Act on Public Health Insurance') in words "in the execution of the least economically demanding, depending on the extent and severity of the disability; the cost of the least economically demanding execution of the medical device is ascertained by the health insurance company by market research 'and the provisions of Annex 3, Section C, to this law, in parts where the symbols of the remuneration limits" A' and "B 'are defined and the amount of remuneration of each type of medical device is limited by these symbols (hereinafter referred to as" the contested provisions').
2. The contested provisions lay down the criteria from which the reimbursement of certain public health insurance medical devices in the provision of outpatient health services depends. As is apparent from their classification, the health insurance company is limited to the price of those medical devices, which, taking into account the "degree and severity of the disability ', represents" implementation of the least economically difficult'. In doing so, its price is determined by "market research."
3. According to the appellant, the legal arrangements in question are so vague that they allow health insurance companies to determine, in fact, whether and to what extent they will cover a particular medical device. This situation affects, on the one hand, the rights of insured persons who may be restricted in access to certain - from the point of view of their disability - medical devices and, on the other hand, the rights of health-care providers and health-care providers who are unable to engage in a foreseeable environment. Moreover, health insurance companies decide on the reimbursement of medical devices without the individual bodies concerned being able to express themselves or subject them to control, or to judicial review.
4. These facts lead the appellants to the conclusion that the contested provisions do not comply with the principles of the rule of law contained in Articles 1 (1) and 2 (3) of the Constitution of the Czech Republic (hereinafter referred to as "the Constitution ') and Article 2 (2) and Article 4 (2) of the Charter of Fundamental Rights and Freedoms (hereinafter referred to as" the Charter'), in particular the principles of legality and the prohibition of libel. On the basis of these, there is to be an undue restriction on the right to own property pursuant to Article 11 (1) of the Charter, the right to do business pursuant to Article 26 (1) of the Charter, the right to free health care and to medical supplies under public insurance under the second sentence of Article 31 of the Charter and the right to a fair trial under Article 36 (1) of the Charter. Finally, the appellant sees non-compliance with Articles 11 and 13 of the European Social Charter, published under No 14 / 2000 Coll., according to which Member States are required to take measures aimed in particular at eliminating the causes of diseases as far as possible, as well as the obligation to ensure that any person who is without adequate resources and who is unable to provide such resources either through his own efforts or from other sources, is given adequate assistance and, in the case of sickness and care, necessary according to his condition.
Arguments of the appellant
5. As regards the various grounds for the application, the appellant considers that the contested provisions are not sufficiently understandable and specific. The Act on Public Health Insurance and other generally binding legislation do not define what is meant, in the case of medical devices, to "carry out the least economically demanding" or how the "degree and severity of disability" or to "market research" is to be taken into account in its determination. There is no timetable or procedural procedure to ensure transparency and protection of the rights of the parties concerned. Only the essential requirements for the effectiveness and safety of medical devices, originally contained in Act No. 123 / 2000 Coll., on medical devices and on the amendment of certain related laws, as amended, and now in Act No. 268 / 2014 Coll., on medical devices and amending Act No. 634 / 2004 Coll., on administrative fees, as amended, ("the Law on medical devices') shall apply with certainty.
6. The appellant considers that, in this situation, health insurance companies identify in their activities a variant of a medical device that is "the least economically demanding ', they do so necessarily in a manner and on the basis of qualitative and quantitative requirements that insurers, medical devices suppliers and health service providers cannot identify under the law using standard interpretation methods. It is intended to be a similar deficiency to the one that the Constitutional Court has in the past set out in the definition of a basic variant in the legislation of the so-called superstandards [finding of 20 June 2013 sp. zl. ÚS 36 / 11 (N 111 / 69 CollNU 765; 238 / 2013 Coll.), in particular points 42, 49 and 51]. The law does not lay down clear criteria for the classification of medical devices into individual payment groups, i.e. groups of such devices with similar effectiveness, safety and use (or therapeutically interchangeable products), although the requirement to take into account the degree and severity of disability implies that any further stratification of individual types of medical devices should be carried out for the purposes of determining the level and conditions of reimbursement. Instead, in each of these groups there is a whole range of products of completely different properties that cannot always be used interchangeably.
7. These deficiencies concern not only Article 15 (12) 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. 298 / 2011 Coll., which allows the reimbursement of some medical devices from public health insurance up to a maximum of 75%, but also the contested parts of Section C of Annex No. 3 thereto. In the case of the reimbursement groups listed here, although the law defines maximum payment limits, whether quantitative, volume, or financial, or percentage, they are only a ceiling which should not exceed. Under this limit, however, it can move to any position that corresponds to the arbitrarily selected variant of the medical device. For these reasons, the appellant considers that the contested provisions will not stand, in the light of the principles of the rule of law, in particular the principle of legal certainty and legality arising from Article 1 (1) of the Constitution, nor can it be seen that there is a sufficient guarantee of the right of insured persons to free health care and medical supplies on the basis of public insurance under Article 31 (2) of the Second Charter.
8. In practice, the uncertainty of the contested legislation has led to the creation of a system of so-called medical device code lists, namely the lists of medical devices publicly declared by health insurance companies as paid. It is only these dials that carry out the distribution of medical devices into individual payment groups, indicating for each of them the amount of the health insurance remuneration that the insurance company will assign to it under unchecked procedures. Without their knowledge, the level of medical compensation cannot be inferred at all. However, the appellant is of the opinion that the authorised health insurance companies so defined do not have the necessary legal basis to determine the amount of remuneration. According to his findings, only Decree No. 618 / 2006 Coll., which issues framework contracts, envisages the issue of code lists, but is to be a supporting contract document which the health insurance company is obliged to issue for its contractual partners, i.e. the health service provider, as a means of reporting and calculating the reimbursement of the paid health care. It is in no way a normative activity within the meaning of Article 79 (3) of the Constitution.
9. In the context of the so-called medical device code lists, the applicant further developed the practice that health insurance companies only pay from public health insurance medical devices listed in the current code list and only at the level and under the conditions specified therein. If the medical device is not included in the code list of the General Health Insurance Company of the Czech Republic (hereinafter referred to as "General Health Insurance Company" or "ZVP") or the Association of Health Insurance Companies of the Czech Republic (hereinafter referred to as "the Association of Health Insurance Companies"), this means that it does not have the so-called ZVP code assigned and therefore no doctor will prescribe it to the patient. The requirement to indicate the code under which the medical device is registered by the health insurance company was, in accordance with § 2 (1) (c) of Decree No. 100 / 2012 Coll., on the prescription and treatment of medical devices, a compulsory requirement for a voucher to be paid from public health insurance. Prescription only of medical devices listed in the code list of which health insurance company is also part of a contractual obligation between health service providers and health insurance companies. Moreover, it follows from the provisions of Article 3 (1) (a) of the individual annexes to the already mentioned Decree No 618 / 2006 Coll. that the parties are required to "comply with the agreed methodology when reporting and paying for the covered healthcare."
10. The applicant submits that the inclusion of a specific medical device in the code list is currently a prerequisite for it to be covered by the health insurance company. This is irrespective of whether the medical device otherwise meets the requirements of the Health Insurance Act. However, this is related to the other fundamental problem of the contested provisions, which is the absence of any adjustment to the process of including medical devices in the code list. Such classification is today a self-contained operation carried out by a health insurance company as one of the private legal entities involved in the health insurance system. To illustrate this, it can be pointed out that, according to the guidelines of the General Health Insurance Company, the application of an authorised body, usually a manufacturer of a medical device, can only be made on very limited dates, usually twice a year. In addition, a number of supporting documents and documentation are required to comply with the request, which often has absolutely no connection with the legal requirements for reimbursement of medical devices (e.g. data on their reimbursement from health insurance in other countries of the European Union in an officially certified translation into the Czech language). Any non-compliance with the requirements thus established results in the health insurance company refusing to enter the medical device in the code list, as a result of which it is not covered.
11. For the purpose of the practical implementation of the contested legal regulation, a parallel system for regulating the reimbursement of medical devices in excess of the legal criteria was therefore to be developed by the appellant. It is, however, a system that creates room for the arbitrary nature of health insurance companies. These can limit the entry of new medical devices into the code lists (and thus into the public health insurance reimbursement scheme) or change the data in the code lists. In this context, the appellant points out the case where the General Health Insurance Company suspended the receipt of applications for inclusion of medical devices in code lists in 2011 for several months, thereby effectively preventing new products from being marketed during the period. In January 2013, the absorption bases for incontinence were temporarily and unjustifiably removed from the remuneration system. It is also worth mentioning the October 2013 activity, when health insurance companies published on their website a call for medical devices suppliers and invited them to send applications to the General Health Insurance Agency for the continuation of the medical device in its reimbursement catalogue to a certain arbitrarily established date. According to this call, the medical devices for which the application would not have been lodged should have been removed from this catalogue.
12. Even the statutory "market research" provided for by health insurance companies did not leave the opposition side. The appellant sees nothing in it other than their authorisation for a direct and untouchable influence on the extent of the medical devices paid on the market. Its use can obviously lead to a reduction in the marketability and competitiveness of certain medical devices that will not be able to withstand without a public health insurance payment. This is because this remuneration has an immediate impact on the market position of the product and on the demand for it. The applicant considers the current practice of health insurance companies to be inadmissible in terms of constitutional principles of legality, equality, non-discrimination and free competition, as well as European principles guaranteeing the free movement of goods and services. It is also not consistent with patients' needs. The legal arrangements allowing such a broad and unlimited discretionary power of health insurance companies to disproportionately detract from the principle of equal status of the entities concerned or involved in the payment of medical devices for the benefit of health insurance companies.
13. The ability of bodies that are or may be affected by health insurance companies to seek protection against their arbitrary intervention is, according to the applicant, significantly limited. There is no formal procedure for this activity to ensure that there is no undue interference with their rights, and the possibility of applying the principles of administrative procedure as enshrined in the administrative order is questionable. The appellant considers that this makes this whole process untransparent and enhances the relevance of the criticisms expressed in the past by the Constitutional Court in relation to decisions on the reimbursement of medicinal products by a substatutory standard [cf. the finding of 16 January 2007 sp. zl. ÚS 36 / 05 (N 8 / 44 SbNU 83; 57 / 2007 Coll.)]. If the constitutional conformity of the limits on the right to free health care and on medical devices based on public insurance pursuant to Article 31 (2) of the Second Charter is not a substatutory standard, the more so cannot be in line with the constitutional principles of leaving those limits completely out of the legal regulation at the discretion of health insurance companies.
14. Under current legal arrangements, the patient does not have any procedural means by which he could actually (in court or otherwise) have the health insurance company to pay for a medical device not included in the code list. The doctor will not even prescribe such a device because he would act contrary to the health insurance methodology and thus risk sanctions. Therefore, according to Article 17 (7) of the Public Health Insurance Act, a health insurance company cannot be obliged to pay it. The motivation to go into such a conflict is zero on the part of patients and health service providers. As a result of this uncontrolled system, the health insurance company can effectively reimburse only part of the price of the medical device (or not at all), although the insured person should be entitled to full or higher remuneration due to his disability.
15. The only group that can have sufficient professional and material background to have such a dispute with the health insurance company are the suppliers of medical devices whose natural interest is to market and sell medical devices in a competitive and profitable manner, which may effectively impede the non-inclusion of the medical device in the code list or repeated or uncontrollable changes in the code list. However, since these suppliers have no direct claim from health insurance and the activities of the health insurance company in determining the level of reimbursement of the medical device do not, in the view of the courts, have the nature of administrative decisions (e.g. judgment of the Supreme Administrative Court of 17 October 2013 No 74 / 2013-30), their protection is also very limited. According to the appellant, their right to judicial protection under Article 36 (1) of the Charter is therefore denied. In addition, the fact that a health insurance undertaking may unilaterally change the level of payment of medical devices without clear criteria also affects their right to equal treatment and the right to do business in accordance with Article 26 (1) of the Charter, as the change in the conditions and extent of the reimbursement of healthcare means a change in the conditions for doing business in this area.
16. The fact that the determination of the reimbursement of the medical device under § 15 paragraphs 11 and 12 of Act No. 48 / 1997 Coll., on public health insurance and on the modification and addition of certain related laws, as amended by Act No. 298 / 2011 Coll., by the health insurance company, should be the nature of administrative decision-making, is also to be evidenced by the comparison of this activity with the right of the State Institute for Drug Control in the process of determining the level of reimbursement of medicinal products under Part Six of this Act, for which that nature is not disputed [cf. Resolution of the Constitutional Court of 30 March 2011 sp. In both cases, the payment of references to a particular product shall be determined. In the case of medicinal products, the so-called basic remuneration is established for the group of interchangeable products, which is based on the statutory procedure for determining the price of the reference product (Section 39c of the Public Health Insurance Act). The reference product is, in essence, the "least economically demanding option 'between therapeutically interchangeable products. According to this price, the National Institute for Drug Control then sets a remuneration for individual medicinal products, as if the" least difficult economic option "were to be derived from the reimbursement of other interchangeable medical devices.
17. The appellant does not in any way question the solution itself, according to which the amount of the payments is derived from a basic option, but such a solution can only be held provided that a verifiable determination process is established which is the basic option and which already exceeds that option. In this context, it points out that insufficient control can result in a waste of public funds, resulting not only in the violation of fundamental rights but also in the failure to ensure another legitimate objective of the contested provisions, which is to ensure the stability and sustainability of public health insurance costs. In conclusion, the appellant adds that in the current procedure of health insurance companies, the Ministry of Health should also have knowledge of it, which specifically pointed out it in the explanatory report on the government bill amending certain laws in connection with the adoption of the Law on Medical Devices (Chamber of Deputies, 7th Election, 2013- 2017, House Press 88 / 0; hereinafter referred to as "House Press 88 / 0 ').
18. In support of its argument, the appellant added a number of documents to prove the alleged facts. In particular, it is a code list (reimbursement catalogue) of the General Health Insurance Corporation medical devices and its methodology, as well as information on the details of the application for inclusion of a medical device and changes to that code list, the public invitation of the General Health Insurance Company and other health insurance companies of 18 September 2013 for manufacturers and suppliers of medical devices to send an application for the continuation of medical devices in that code list, and the opinion of the Ministry of Health on the exclusion of incontinent patients from reimbursement.
Proceedings before the Constitutional Court
19. The Constitutional Court pursuant to Article 69 (1), (2) and (3) of Act No 182 / 1993 Coll., on the Constitutional Court, as amended, (hereinafter referred to as "the Law on the Constitutional Court") sent the proposal to the chambers of Parliament as parties to the proceedings and to the Government and the Ombudsman as entitled to intervene as interveners.
Observation of Parliament's chambers
20. The Chamber of Deputies and the Senate, both in their observations of 25 February 2015 and 24 February 2015, signed by the Presidents of the individual chambers of Jan Hamakk and Milan Štěm, summarised the course of the legislative processes under which Law No 298 / 2011 Coll. and No 369 / 2011 Coll.
Government observations
21. On 25 February 2015, the Constitutional Court received, by the statutory deadline, the notification by the Government of the initiation of the procedure decided by Decree No 140 of 23 February 2015. It mandated the Minister for Human Rights, Equal Opportunities and Legislation, in cooperation with the Minister for Health, to draw up and submit observations on the draft Constitutional Court. It also mandated the Minister for Health to represent the Government in this proceedings before the Constitutional Court.
22. The Government's statement of 23 March 2015, signed by the Minister for Human Rights, Equal Opportunities and Legislation Mgr. Jiří Dienstbier, shows that the contested legislation constitutes a legitimate legal regulation of the legal relations in question. This adjustment responds to the limited amount of public health insurance funding, the need to ensure its functioning and to eliminate the risk of its collapse that its absence could lead to. In addition, the appellant does not in any way call into question the use of the concept of "performance of the least demanding economy 'in Sections 15 (4) and (5) and 30 (2) of the Public Health Insurance Act, although these provisions must necessarily apply to them.
23. The appellant's various objections are noted by the Government that, in the contested provisions, it does not see any inconsistency with the right to own property pursuant to Article 11 (1) of the Charter or to do business under Article 26 (1) of the Charter. The finding of the price of a medical device through market research is not a non-transparent procedure and can be carried out by any supplier of medical devices. In this way, everyone can find out the same facts that were or will be identified by health insurance companies when carrying out the same process and then adapt their business strategy to those findings. The contested legislation does not prevent suppliers of medical devices from doing business in this field. Its aim is only to maintain an entire public health insurance system which could be exhausted and brought to a collapse by unjustified and disproportionate payments, which would be in breach of Article 31 of the Charter, which expressly provides for its existence. The Public Health Insurance Act creates the preconditions for implementing this right.
24. Criticism of the contested provisions in respect of the right to judicial protection pursuant to Article 36 (1) In the Government's view, the Charter is rather an incentive for possible legislative proposals in the ordinary legislative process. The assumption that the patient will not initiate a lawsuit due to his financial and professional motivation is odd as he assumes a patient's zero interest in protecting his rights. It's just a hypothesis that doesn't have any basis in the proposal. Moreover, the Government states that the issue of so-called medical devices code lists is not an administrative procedure. Decisions shall not be taken here, shall not be modified, cancelled or established by the persons designated by them. This determination of the reimbursement of the medical device cannot lead to a breach of that right because it does not have the nature of a procedural decision.
25. As regards the alleged infringement of Articles 11 and 13 of the European Social Charter, the Government adds that, within the framework of the legal system set up for the functioning of health care, science, development and research in the field of medicine, various types and forms of healthcare are provided to all persons through health service providers as required by their individual status. They shall also be provided with medical devices if necessary.
26. In conclusion, the Government summarises that the application for annulment of the contested legislation is not justified and should be rejected. In the event that the Constitutional Court comes to a different conclusion, the Government proposes that it should proceed with the suspension of enforceability for at least 12 months. In fact, its immediate cancellation would result in a step-by-step increase in the remuneration of the said medical devices, which could jeopardise the financial sustainability of the public health insurance system.
Communication from the Ombudsman
27. The Ombudsman Mgr. Anna Shabatová, Ph.D., informed the Constitutional Court by letter of 3 February 2015 that she did not exercise her right to intervene in this proceedings.
Replication of the applicant
28. Those comments were sent to the appellant, who replied by reply of 23 April 2015. Nor does the appellant consider it questionable that the system of reimbursement of medical devices should be designed to respond to possible market changes. However, it is certainly not an acceptable mechanism to achieve this objective in the rule of law when determining a specific remuneration for a product without any transparent process. The necessary regulatory mechanisms can be set up (or even necessary) in a way that ensures a transparent, fair and objective determination of the amount of the health insurance remuneration for all concerned entities.
29. The interest in the economic balance and sustainability of the health insurance system is certainly desirable, but this does not mean that other constitutional principles and guarantees can be disregarded. It must not become the sole criterion for deciding on the extent to which and to which medical devices to pay. By transferring all responsibility for setting the specific amount of remuneration to health insurance companies whose natural interest is to minimise the costs of the health insurance system without setting rules and control mechanisms, it is precisely such an imbalance that ultimately results in a de facto reduction in the scope of medical devices paid and the availability of individual products on the market.
30. As regards the uncertainty of the use of the concept of "making it economically least demanding ', the proposal deals only with the rules governing the reimbursement of medical resources in Section 15 (11) and (12) of the Act on Public Health Insurance and Section C of Annex 3 thereof, which does not exclude that other provisions of that law which use it may be unconstitutional. The aim of the proposal was not to" capture "all these provisions. They are not relevant for the assessment of its rationality.
31. In relation to the Government's assertion of a transparent process of finding the least economically difficult execution, as well as the possibility for each entity concerned to conduct a market survey itself, the appellant refers to the argument in its proposal. It reiterates that, without knowledge of the code list, the amount of medical compensation cannot be ascertained. Their determination is effectively in the hands of health insurance companies. If the medical device is not included in the health insurance code list, then neither the patient nor the prescribing doctor will ever know about the payment of such a product. Neither can be required to monitor the potential supply of medical devices at present and to examine which other medical devices of those not included in the code list should still be covered by the law. Moreover, such a medical device could not even be prescribed because it would be contrary to the legislation and to the contractual obligations of the provider towards the health insurance company. However, even if this device was entered in the code list, the insured person has no possibility of verifying whether the medical device in question could be paid a higher amount. This limits the variability of the healthcare services offered through the code list without there being a mechanism to prevent this defecation of the patient's right to free health care and public health care.
32. The appellant formulated its proposal by ensuring the smooth functioning of the reimbursement system of the medical devices referred to, without delaying the enforceability of any satisfactory finding. By abolishing the contested provisions, only the power of health insurance companies to provide for the reimbursement of medical devices will be removed, not the maximum remuneration limits laid down in the law. However, any conclusion on the appropriateness of the postponement of enforceability will be respected by the appellant.
General Health Insurance Company of the Czech Republic
33. In the course of the proceedings, the Constitutional Court also received unsolicited comments from the General Health Insurance Company of the Czech Republic dated 18 June 2015, signed by its Director, Ing. Zdeněk Kabátek. It states that medical devices constitute one of the two basic commodities used in the provision of health care. In view of the fact that a large proportion of them are fully or partly covered by public health insurance, their adjustment is one of the particularly important elements of the public health insurance system. If the amount of remuneration were not to be derived from the medical device in "least economically demanding 'implementation, this would result in a substantial increase in expenditure. For example, in relation to the total cost of this insurance company for medical devices in 2014, amounting to approximately CZK 11,163 billion, this change would mean an increase of 24%, i.e. approximately CZK 2.7 billion. These data clearly show that the restriction in question significantly impedes destabilisation in the area of medical devices' reimbursement.
34. When identifying a medical device in the "least economically demanding implementation ', account should always be taken not only of the financial and economic aspect, but also of the patient's health status, the need for and availability of medical devices at a given time. Free competition in the field of medical devices is limited by at least two specificities. Firstly, these are goods which have no real equivalent and cannot be omitted or postponed. The second is the public health insurance payment. No manufacturer or supplier with a fully-paid medical device is motivated in any way to reduce the final prices, since in this case it would be completely unnecessarily concerned with guaranteed profit. The reduction would not give him any competitive advantage. From the patient's point of view, the product would still be at the same price. It is therefore not rational to fix the amount of remuneration directly in the law.
35. According to the health insurance company, the contested legislation is sufficiently specific. While the placing into circulation of medicinal products is subject to registration in accordance with the procedure of Act No. 378 / 2007 Coll., on Medicines and on amendments to certain related laws (the Law on Medicines), as amended, and for each of them an individual administrative act, there is no such procedure for medical devices. The Law on Medical Devices underlines their use to the general regime provided for by Act No. 22 / 1997 Coll., on technical requirements for products and amending and supplementing certain laws, as amended. Therefore, in the case of medical devices, the conclusions expressed in sp. zn.
36. With regard to the issue of code lists, the health insurance undertaking stated that their issue, which always takes place with effect from 1 January, 1 April, 1 July and 1 October, is certainly not an administrative procedure. The issue of code lists shall not give rise to, alter or revoke third parties' rights. This is only a certain methodology on the basis of which the reimbursement of medical devices is assessed to ensure, inter alia, adaptation to current developments. Otherwise, the health care system and its financing could not work. Furthermore, it cannot be overlooked that the Health Devices Act has brought about significant changes in the legislation of medical devices, including their definition, classification, clinical evaluation and performance assessment, distribution and sales. A fundamental step towards removing all duplicate and inefficient forms of regulation and replacing them with a new clear system of rules on the management of medical devices is to be the Register of Medical Devices administered by the State Institute for Drug Control.
37. Finally, it is not possible to identify with the claim that there is no judicial protection against the behaviour of health insurance companies. The appellant completely omits the possibility that all parties concerned may make use of on the contrary. If health insurance companies were to violate the equality of competitors, they would clearly have committed unfair competition within the meaning of Article 2976 (1) of the Civil Code. In such a case, an action could therefore be called upon to refrain from, or to eliminate, unfair competition from, the health insurance undertaking concerned, and to seek reasonable satisfaction, compensation or the issue of unjustified enrichment.
38. Although the General Health Insurance Company does not have the status of a party or intervener, the Constitutional Court took note of its observations and sent them to the applicant in case he wished to respond. The appellant did not make use of this possibility.
Additional observations by the appellant
39. On 6 April 2017, following an oral hearing order, the Constitutional Court received further observations from the appellant, adding his arguments and making proposals for evidence, including witness interviews. This statement was supplemented by a submission dated 2 May 2017 to the invitation of the Constitutional Court.
40. The appellant summarised in detail the procedure required by suppliers by the General Health Insurance Office for the inclusion of medical devices in the reimbursement catalogue. Among other things, the application must be submitted within the prescribed time limit and meet the requirements prescribed by the health insurance undertaking, which, however, have no basis in the legislation in force and, in some cases, even lack the importance in determining the remuneration. As an example, it indicated the obligation to submit "a list of ZP codes from the Reward Catalogue of SZP with a comparable therapeutic effect, if they are already included in the Reward Catalogue of SZP 'or" a written confirmation from a foreign health care payer or a confirmation from the State authority setting out the reimbursement of each ZP mentioned in the application from at least two Member States of the European Union, with the exception of Bulgaria, the Czech Republic, Estonia, Luxembourg, Germany, Austria, Romania, Cyprus and Malta, showing the amount of remuneration / price of the relevant ZP in these countries - a Czech officially certified translation'. Failure to comply with these requirements, which are assessed in a very non-transparent manner, results in the application being not transferred to the code list because of its incompleteness. The applicant is therefore referred to as a possible re-application within the next application deadline (i.e. about half a year). In addition, the general health insurance company, in its letters announcing the failure to comply with the formalities, is constructing a kind of fiction according to which the applicant, by picking up the file with the application, confirms a consensus with the stated conclusion.
41. If the application for inclusion of medical devices in the code list is valid in accordance with those formal requirements, it shall proceed to the next round where the "economic intensity" of medical devices is assessed in the form of an approval process. The rules of this assessment are not known to any of the participants except the General Health Insurance Company. Only from existing practice can some of its core principles be traced. Thus, the applicant applies for reimbursement at the required price, the level of the remuneration being set by the health insurance company itself. In fact, "market research 'is reduced to simply comparing the price of the medical device covered by the application against comparable medical devices already included in the code list. If the health insurance company concludes that the code list already contains a cheaper option, it calls on the applicant to submit a new price proposal. Without price adjustment, the medical device is not included in the code list at all. The applicant does not find in the law any authorisation of a health insurance company which would allow it to require the applicant to reduce the price or exclude the medical device from the possibility of reimbursement.
42. As already mentioned, according to the appellant, it is not clear at all which medical devices are compared in the search for "least economically demanding 'or considered to have comparable therapeutic effects. The available information indicates that the General Health Insurance Corporation completely resigns to the" degree and severity of disability' criterion when paying for medical devices. The specific (i.e. better quality) therapeutic characteristics of the medical device for which inclusion in the code list is requested are usually not taken into account.
43. The appellant points out that in the circles concerned, the notoriety is already the sudden and completely autonomous intervention of the General Health Insurance Company into the code list. In recent years, the so-called categorisation tree is used to classify medical devices for the purpose of determining public health insurance payments. The creation of categorisation, which includes some assessment of therapeutic interchangeability, was not preceded by any broader discussion. On the contrary, the professional public and the Ministry of Health opposed it. The documentation for this categorisation had to be supplied by individual manufacturers to the General Health Insurance Company by May 2014, otherwise it would have excluded them from the nearest code list. In autumn 2016, without any consultation, a new categorisation tree was introduced and a least economically demanding option was established within it. This change in categorisation led, for example, to the newly set up of 124 categories instead of the original 15 categories for absorption incontinence medical devices. Only some of these funds (at least one third of each category) are newly fully paid, while others are at most 75% of the price. This created an additional obligation which does not have any legal basis, but in a fundamental way affects individual market players and the level of health care covered by public health insurance. Taking into account the criticism of professional companies, at least the technical basis of this procedure is questionable.
44. In order to prove its claims, the appellant proposed the execution of 24 paper evidence, including a reasoned report on the draft law amending certain laws in the context of the adoption of the Law on Medical Devices (House Press 88 / 0), the current reimbursement catalogue of the General Health Insurance Company, the documentation for the inclusion of medical devices and for the implementation of changes in the remuneration catalogue and other documents containing in particular the expression or correspondence provided by the current practice of health insurance companies in determining the level of reimbursement of medical devices. The appellant further proposed to interview JUDr. Jakub Králové, Ph.D., an independent expert on pharmaceutical law issues, in particular to clarify the reasons which led to the preparation of this bill. In addition, he proposed an interview of representatives of suppliers, namely Ing. Stanislav Jančík, a representative of HARTMANN - RICO, a. s., Mgr. Monika Hradecká, a representative of SCA Hygiene Products, s. r. o., Mgr. Stanislav Šulák, a representative of Mölnlycke Health Care, s. r. o., Petr Vasek, a representative of Edwards Lifesciences AG, an organizational component, and Ing. Miroslav. Vázler, a representative of Kimberly-Clark, s. o.
Oral proceedings
45. The Constitutional Court has ordered oral proceedings under Paragraph 44 of the Constitutional Court Act in order to further clarify the case. The oral hearing took place on 10 May 2017 with the participation of the lawyer of the appellant, who, on the basis of the substitution power of Dr. Jakub Kadlec, was a lawyer, based in Prague 3, Luxembourg 1569 / 47, and in the presence of the Senators MUDr. Alena Derner, Mgr. Zdeňka Hamous, Božena Sekanova and Prof. MUDr Jan Žádík, CSc. Representatives of the Chamber of Deputies, Senate and Government did not participate in the oral proceedings. Although the absent representative of the government, the Minister for Health, entrusted his representation to the Deputy Minister, Dr. Radek Policar, he did so outside his own mandate to represent the government, which results from the relevant government resolution. For this reason, the Constitutional Court did not consider the Deputy Minister for Health present as a representative of the intervener.
46. The Constitutional Court called as witnesses to the General Health Insurance Company of the Czech Republic, the Association of Health Insurance Institutions of the Czech Republic, the Czech Association of Medical Devices Suppliers, the Association of Manufacturers and Suppliers of Medical Devices, the Czech Medical Society Jana Evangelist Purkyně, the Czech Society for Orthopedia and Trauma of the Musical Orchestra and the National Council of Persons with Disabilities of the Czech Republic, the National Council of the Czech Republic, the Czech Association of Medical Devices, each of these bodies was to ensure that an informed representative took part in the oral hearing to prove his authority to act on his behalf and to be able to give evidence of the current practice of health insurance companies in determining the amount of medical devices under the contested provisions.
Witness interviews
47. MUDr. JUDr. Petr Honěnek, Deputy Director of the General Health Insurance Company of the Czech Republic for Health Care, stated that the total expenses of the health insurance companies represented by him for medical devices are around CZK 12 billion per year. From this amount, the medical devices for the voucher are less than CZK 5 billion, the remaining volume of approximately CZK 7 billion is the so-called separately charged materials, i.e. materials charged when providing bed or outpatient health care. Spending on medical devices, which, pursuant to Article 15 (12) of Act No. 48 / 1997 Coll., on public health insurance and amending and supplementing certain related laws, as amended by Act No. 298 / 2011 Coll., are paid at the most at 75% of the price, amounts to approximately CZK 188 million per year. Compared to the total amount of payments, this is a relatively marginal part. Although the health insurance company has no knowledge of the total amount of premiums paid by insured persons, it can be assumed that, in view of a number of options for fully paid medical devices, these supplements are not essential. The immediate compliance of the application for annulment of the contested provisions would result in an increase in expenditure of approximately CZK 2 billion per year.
48. In order to identify a medical device in the "least economically demanding implementation, depending on the extent and severity of the disability ', the witness noted that the evaluation of the legal criteria thus defined was virtually very difficult. Medical devices are assigned to groups according to whether they fulfil the same purpose in terms of a particular disability, the latter being selected as" the least economically demanding option'. The fulfilment of the "degree and severity of disability 'criterion is ensured by the fact that there is a wide range of all possible options or sub-variants of medical devices that are fully covered. As an example, the witness refers to incontinence devices for which not only one type of diapers is fully covered, having a certain absorbency but several different types of diapers. The selection of one of the fully paid options can take into account the specific disability of each individual insured person. On the contrary, the possibility that the amount of his claim would only be ascertained retrospectively is hardly feasible. The distribution of medical resources into individual groups is based on discussions with specialist companies. The general health insurance company is in close contact with a number of them, such as cardiological, urological, orthopaedic or diabetic. They are also consulted on the uniqueness of a particular medical device.
49. According to the witness, the "market research" itself is carried out on the basis of the reporting data provided by the health insurance company from individual medical institutions. On the basis of these data, which indicate the actual remuneration, prices are checked once per quarter. However, there is only a change in remuneration if a significant difference is found between the prices shown in the remuneration catalogue and the prices reported. It also serves to "market research" compare with foreign prices, which is particularly important for new medical devices. Any comparability in the prices reported by health care establishments is very difficult to control. For practical control, health insurance companies lack the necessary competence, such as the possibility of looking at accounting.
50. The witness recognises that the legal arrangements for the reimbursement of health care benefits from public health insurance are very partial. The general health insurance company has issued a methodology for classifying medical devices and making changes to the remuneration catalogue precisely to ensure that the process of determining such payments is as transparent as possible. This is a certain technical tool for fulfilling the legal claim of the insured person. For the inclusion of a medical device, for example, a declaration of conformity, information on the distributor, instructions for use, definition of purpose shall be required. The required documentation is intended to prevent public health insurance from being covered by a medical device which would subsequently prove ineffective or dangerous. They are intended to demonstrate the medical effectiveness of a medical device which the health insurance company is unable to detect for capacity reasons itself. The supply of the necessary supporting documents is therefore in the interest of the applicant. The application shall also specify whether a similar medical device already exists or whether it concerns a completely new medical device and a draft price which is then confronted with the price of other medical devices already included in the reimbursement catalogue. High price reduces the chances of placing a medical device in the code list. The legal reason for non-inclusion is seen by the witness in the legal requirement for "least economically demanding execution." The long-term inclusion of higher-price medical devices could ultimately result in an increase in the price level needed for reimbursement as well as a possible increase in prices.
51. In those requirements, the witness does not match any impenetrable barrier to the entry of new medical devices into the market. In 2016, about 7% of applications were rejected due to administrative defects (typically absence of instructions or declarations of conformity) and about 20% were not included in the code list due to significant discrepancies between the price of the new medical device and the price of other comparable medical devices. The new medical device did not differ in any particular way, nor did it allow any special claim to be fulfilled by a group of insured persons that would not be covered by the current remuneration catalogue. In fact, the requirement for applicants to submit a written confirmation from a foreign health care payer or a confirmation of a state authority providing for the reimbursement of each medical device mentioned in the application from at least two selected Member States of the European Union is a kind of analogy of law with Part Six of the Public Health Insurance Act concerning the reimbursement of medicinal products. This requirement allows the health insurance company to have an overview of the prices of medical devices abroad. The limitation of the comparison to only some countries in the European Union is based on the fact that only countries with similar economic performance or similar size should be compared. The comparison also excluded countries for which there are no comprehensive databases of medical devices. However, failure to comply with an application due to non-compliance with this requirement is quite exceptional. In addition, the health insurance company accepts honest statements from applicants that they are unable to comply with it. Problems cannot be expected even in connection with the obligation to submit a list of codes of medical devices with a comparable therapeutic effect.
52. The inclusion in the remuneration catalogue takes place in total four times a year; However, it is only twice a year for a specific category of medical devices. Each application period shall be set taking into account the administrative complexity of the process. However, if a completely unique medical device appeared, the General Health Insurance Corporation would undoubtedly be able to respond, on the basis of its internal rules, and to advance its classification, as well as the possibility of a de facto remuneration associated with it. The duration of the inclusion process, which is about half a year or so, is comparable to other Western European countries, except perhaps Germany, where the process is significantly faster thanks to a very efficient economy and a rich health insurance system. A medical device is decided on the health care section, in addition to the Deputy Director, four other persons must sign the cover sheet to confirm its correctness. This is not an administrative procedure, so the unsuccessful applicant can reapply. Nor is the possibility of turning to court, but so far the courts have failed to comply with such an action. The applicant shall be informed in writing of non-compliance. Exceptionally, insured persons claim payment of certain medical devices directly.
53. Mgr. Václav Krása, Chairman of the National Council of Persons with Disabilities of the Czech Republic, first of all noted that the association represented by it brings together 98 organizations with direct membership and 7 or 8 organizations with associated membership. In essence, it brings together all groups of people with disabilities, including those with mental disabilities, physical disabilities, multiple sclerosis or various neurological disorders. The general health insurance company has the floor when deciding on the reimbursement of medical funds. Individual producers, for reasons of a strategy (in order not to provide information to competitors) do not declare in advance the prices of products, as a result of which the health insurance company itself ascertains them through its contacts, including from producers or suppliers. The finding of prices in markets in other European countries is problematic because it is based on an environment and context that may not be of much relevance in the Czech Republic. These markets may vary in size, resulting in various quantity discounts being applied to them with increased consumption of medical devices. At the same time, health policy and local health insurance systems are affected. For these reasons, the price based on these figures may not be well established.
54. The witness considers the impact of the current reimbursement system on specific patients to be most problematic. The identification of the "least economically demanding variant 'of a medical device often depends on the quality of the prescription issued by the doctor, in particular as regards the part where the need for medical compensation is justified. Here can be significant even very minor nuances. The witness considers that the vast majority of doctors cannot well justify the provision of an expensive medical device, which best compensates for the health status of the insured person, including any associated medical complications. For example, they shall state the social reasons, which are not relevant in the light of the Public Health Insurance Act and cannot be taken into account by the health insurance company. As a result of a poorly completed regulation, the health insurance company will approve the reimbursement of a completely different medical device of the same category, which is much cheaper. However, this variant, which represents the" least economically demanding execution', is comparable only at first sight, as it does not really meet all the needs of the insured person. The insurance guy's getting trapped. Many of the medical devices are approved for the so-called indicative period of use, during which it is virtually impossible to change the medical device and to get a new one also paid out of public health insurance, except for a dramatic change in health status, which, in the vast majority of cases, does not occur.
55. The current legal regulation leads, according to the witness, to excesses, and the solution could be to change it. In this context, he referred to cases where the health insurance company does not grant wheelchair rights to insured persons who have been prescribed a bed. The witness confirmed that the association represented by him was negotiating with health insurance companies to eliminate such excesses, while the General Health Insurance Company was generally helpful in these negotiations. Otherwise, this association is not involved in any decision on the level of remuneration.
56. Ing. Jan Beneš, Chairman of the Medical Device Commission of the Association of Health Insurance Companies of the Czech Republic, stated that employee health insurance companies take over the items from the reimbursement catalogue of the General Health Insurance Company into their common code list, issued by the association. This procedure was already agreed in 1992 and is intended to avoid complications which would arise in the case of the existence of two different dials. However, in addition to the payment catalogue, other medical devices may be added to the Union code list for health insurance companies, which takes place mainly in order to make them more readily available. This relates to about 250 items, which, with a total of around 12,000 items, represents a relatively marginal part. These different items are given in the so-called difference code list. On the contrary, it is not a situation where a particular medical device is listed only in the remuneration catalogue of the General Health Insurance Company. In some cases, approximately 0,5% of the items, there may be a slight difference in the amount of remuneration.
57. As was further apparent from the witness's interview, the Health Insurance Association has written down on its website a methodology according to which a new medical device may be added to its code list. No deadlines or time limits for submission shall be set compared to the remuneration catalogue; the application may be submitted at any time. The number of materials required is smaller. It is sufficient to declare the CE marking or the declaration of conformity, the instructions for use and the price details and the amount of remuneration proposed. If the request is granted, the inclusion shall be made when the code list, which normally occurs once a month, is updated. The inclusion shall be decided by a commission whose members, in addition to the witness, are representatives of each of the six employees. In case of a different opinion on the level of remuneration, the applicant is asked whether he would agree to the change. In this context, the witness does not recall a case where such an agreement would not have occurred. In assessing the effectiveness of the medical device, the Association of Health Insurance Companies relies on the written documents already mentioned. Items for which their effectiveness is evident are usually registered. However, if any ambiguities arise, the applicant shall be contacted to remove them; Exceptionally, some studies are added. The advisory body in the examination of applications shall be the review doctors who have a section within the Union of health insurance companies. The economic criterion is taken into account by comparing interchangeable medical devices within the appropriate remuneration group. It is based on a mutual consensus between health insurance companies, manufacturers and suppliers, which was achieved in the preparation of a government bill, constituting the House Press 88 / 0. The "market survey" is mainly used for the data contained in the code lists. However, medical devices that are actually no longer on the market are not taken into account.
58. MUDr. Miroslav Palát, MBA, President of the Czech Association of Suppliers of Medical Devices (abbreviated name "CzechMed"), summarized that the association represented by him was founded in 1998. There are currently 20 Czech and foreign companies that operate as manufacturers or importers of medical devices; Most of them operate outside the Czech market and one operates globally. Their total turnover in the Czech Republic, omitting the export turnover, is about CZK 7 billion, which is a third of the market for medical devices implemented in the Czech Republic.
59. First, the witness does not share the conclusion that medical devices are - for example, compared to medicinal products - an unregulated matter. Their regulation takes place today in four ways: 1. Price regulation, which takes the form of material price control, 2. The necessity to meet the hard-to-predict conditions for entering the code list, 3. Prescription restrictions for prescribers and 4. If suppliers wish to be used on the domestic market, they must have completed the procedure for the inclusion of a medical device in the General Health Insurance Code, as they will only be able to obtain reimbursement of the medical devices they supply from the public health insurance. The procedure can be characterised by the following concepts: opacity, inconsistency, inefficiency, anti-innovation and the inability to include medical devices in the same regime as medicinal products.
60. Opacity is due to the absence of any formalised procedure for the inclusion of a medical device in the reimbursement catalogue. The application of the medical device and the duration of the proceedings shall depend on the person of the officer assessing the application. The assessment of the application is often reduced to the question of the price of the medical device, i.e. whether it is too expensive, which will not result in its inclusion at all. There are no remedies against decisions by health insurance companies. This decision may take a written form, but the reasons for the non-inclusion are generally not known to the applicant except by oral communication or telephone. The applicant may oppose the procedure of the health insurance undertaking by completing the request for a new argument or by submitting a new application within a further deadline. As an example of incorrect practice, the witness refers to the case concerning products in the area of care for diabetes, when the applicant was first informed that the medical device did not meet the requirements of the Public Health Insurance Act, which was also factually wrong. This law does not lay down any requirements. It was then communicated in further mutual communication that the reason for the non-inclusion was sufficient similar medical resources paid in the payment catalogue. It is not unusual that the success of the whole procedure depends on the bravery and invention of a particular supplier's representative or on his ability to gain sympathy with his counterpart. In the past, the whole process was influenced by the long-term action of the relevant referees who had detailed information on products and suppliers forming their agenda. The process itself was then influenced by their personality. Some could be agreed, for example, on the sale of a product, and others were excluded from such behaviour. The outcome of the examination was always uncertain. Without the addition of the medical device to the code list, the promising value added product is not negotiable.
61. The inconsistency is seen by the witness in deciding the amount of the remuneration. In practice, individual medical devices may be paid to different levels (in full or in part), although they differ in different subjects and clinical views. The practice of the General Health Insurance Company is such that the inclusion of a medical device with a supplement is permitted only for some medical devices, while others are not. Another example of inconsistency is the way in which the General Health Insurance Corporation carried out a change in the classification of incontinence funds into remuneration groups in 2016. Originally it was supposed to be the reason for saving approximately CZK 200 million. Later, the reason was the attempt to change the conditions so that insured persons could receive a larger number of products. As a result of the change in question, a number of funds were subject to additional charges which put them at a disadvantage in competition. Although patients have been given more pieces, they lack what they would need and which were available before the introduction of this scheme. The financial limit is met annually by 12,000 incontinence patients who have to buy up additional funds. It is approximately 5% of all patients with incontinence. The remaining 95% is fully in line with the financial limit.
62. The ineconomy of the current system of public health insurance payments is, according to the witness, that only the price and not the collateral costs of the treatment are taken into account when finding the "least demanding economic option." By using an expensive device, we can often achieve the healing process better and faster. However, weighing all these aspects does not correspond to actual practice. The witness points out that each patient is different and that their problems may develop over time. It is important to always find the best solution for him. There is no sense that the more expensive the product, the better. For some patients, a cheaper product is preferable, for others the more expensive. This is also related to the problem of the anti-innovation of the current setting of the level of remuneration. New medical devices may have added value in the form of incremental or transformation innovations. Transformational innovation, for example, is an option in interventional cardiology to do heart interventions without opening the chest. Many products then bring in incremental innovations that affect even a certain parameter. The application of such innovation in the existing system is very difficult, because any subsequent product having a similar effect simply cannot apply this added value. The witness considers that, when assessing economy, attention should be paid not only to the overall expenditure but also to the health needs of insured persons. For example, wet wound healing in vascular insufficiency of lower limbs, ulcers, etc. These can be treated either in a classical way, i.e. by mechanical removal of impurities and covering the wound by passive covering, or in a modern way, which allows to adapt to the wound by its physiological abilities and assist in healing processes. While these resources are more expensive, if you count on the need for more bandages, longer treatment times and other related complications, it will be economically more efficient in the long term. Today, only some of the patients (about 10%) who would need it are getting this approach.
63. Although there is now a clear attempt to establish a similar regime for medical devices to those laid down for medicinal products and their reimbursement in accordance with the so-called transposition directive - Council Directive 89 / 105 / EEC of 21 December 1988 on the transparency of pricing measures for medicinal products for human use and their inclusion in the scope of national health insurance schemes - no international association or group of competent authorities is proposed. Instead, the European Commission has adopted a document according to which medical devices are such a different and diverse area that the directives do not apply to them. The witness also regards as an argument against the use of an international price reference between some countries the fact that the practice of medicine is fundamentally different in different countries. In Belgium and Germany, for example, a million inhabitants account for twice the number of implanted pacemaker than in Switzerland and Norway. There is no medical or economic rational explanation for this difference. It appears to be the result of different developments in care provision and health care in some countries, different traditions and emphasis on other treatments. The comparison of the price of a pacemaker with its prices in Germany or Norway is therefore completely odd.
64. Petr Kotík, a member of the Board of Directors of the Association of Manufacturers and Suppliers of Medical Devices, represents an association which has 105 members mainly from producers, importers and distributors of medical devices. However, the taking of its members' activities is wider. In total members of this association employ around 16000 people and have an annual turnover of approximately CZK 20 billion. Most members have decent export experience; they deliver their products not only on the Czech but also on the European and non-European markets. The witness confirmed that the General Health Insurance Company of the Czech Republic, when the medical device was included in the payment catalogue, preferred products with the lowest purchase price, which is not always interpreted as "economically least demanding option."
65. The members of the Association, according to the witness, are facing problems that have been indicated by other witnesses. It is particularly problematic to meet certain requirements for the inclusion of a medical device by which the health insurance company effectively shifts its obligation of market research to suppliers. For example, the obligation to submit a written confirmation from a foreign healthcare payer or a confirmation of a state authority providing for the reimbursement of each medical device mentioned in the application of at least two selected Member States of the European Union has no legal basis. Moreover, it is very difficult to meet, and the way it should be communicated is not even obvious. The application procedure itself otherwise takes place in a very simple way. All formalities shall be submitted in paper form to the General Health Insurance Corporation, which, after a certain period of time - without any conciliation procedure - shall declare whether or not the medical device has been classified. The inclusion of a medical device in the payment catalogue depends in practice on the decision of the relevant officer. The notice of whether it has occurred shall be signed by the head of the department. However, the applicant will no longer know the reasons for which his request was not granted, despite having complied with all the requirements laid down. This can only be further questioned. In conclusion, the witness points out that the health insurance company considers that another "economically less demanding 'execution of the medical device is no longer a reason for non-inclusion as well as the fact that another" less demanding' execution of the medical device is already included in the payment catalogue. However, this is not a legitimate reason. The health insurance company must include every medical device in the remuneration catalogue.
66. Prof. MUDr. Jan Švihovec, DrSc., Chairman of the Committee on Drug Policy and the categorisation of Medicines of the Czech Medical Society Jan Evangelist Purkyně, z. s., pointed out that a system of evaluation of health technologies is currently being introduced throughout Europe. There is a system of grouping health technologies everywhere. It is always sought which of them are comparable, or whether it is possible to include them in a certain same category where there are benefits for a particular group of patients or a certain exact diagnosis. This evaluation shall also include an assessment of the possibility of replacing them by other procedures. There must always be a clear definition of the benefits that that technology has for both the patient and the health care system. In general, the economic component of the evaluation is a problem. The criterion of "least economic difficulty" is relatively well defined in the case of medicines, but the question is how it is interpreted in the case of medical devices. In the case of medicinal products, even if there is a basic remuneration for a particular group, there are open options for determining an increased remuneration for individual patients if they have a much more expensive treatment. This is how the necessary individualisation is done. The witness believes that such a solution can also be chosen for medical devices. In relation to the economic assessment already mentioned, it notes that basic functions can be found for a number of medical devices that all must fulfil and are usually sufficient for 80 to 85% of patients. However, for some patient groups, benefits may be different from those in the baseline. In this respect, expert discussions must be held.
67. The witness also summarized that the Czech Medical Society Jana Evangelist Purkyně, h.s., is an umbrella organization for 130 professional companies with a total of around 35 000 members. Each of them has a relatively large degree of autonomy. In the field of pharmaceuticals, there is a commission, the activities of which include certain non-member professional companies. But otherwise, in the case of medical devices. The witness turned to the individual member specialist companies to see if their expert opinions were applied in the process of determining the reimbursement of medical devices. All the answers to this question were negative, which in the end also applies to the company represented by it. Although it set up a Medical Device Commission in 1992, it only worked in 2009-2014. This was on the basis of a request from the Ministry of Health to participate in the preparation of laws in the field of medical devices.
68. MUDr. Pavel Dupal, Head of the Committee on Insurance of the Czech Society for Orthopedia and Trauma of the Musculoskeletal Devices, confirmed that the represented company is not addressed by health insurance companies in connection with decisions on reimbursement of medical devices. However, it is addressed by individual applicants in an attempt to obtain a recommendation to strengthen their argument in favour of inclusion of the medical device in the code list. The field of trauma covers a large number of medical devices; includes thousands of items.
69. Finally, the Constitutional Court conducted an interview with JUDr. Radek Policar, but not as an intervener, but as a witness representing the Ministry of Health. With regard to possible legislative proposals on the reimbursement of medical devices, the witness considers the current system to be good, fair and guaranteeing what it is supposed to guarantee. This is true regardless of the fact that excesses can also occur in it. It is not, of course, a perfect system, but the effort to achieve the best possible and best care for all insured persons always faces the problem of a limited amount of funding. The contested provisions specify how to determine the amount to be paid by the patient. However legitimate health-care suppliers, however legitimate their interests are in this regard, cannot seek a guarantee of some of their profits or revenues. The objections concerning the constitutionality of the contested provisions are directed in particular towards patients. In the witness's view, patients can defend themselves against the procedure of health insurance companies who have refused to pay for a medical device. They may also oppose the procedure of a doctor who refused to prescribe this medical device. In general, the contested legal regulations do not see the problem. The introduction of the same system that works for medicines today would only lead to an increase in its costs. This system would only be fairer on paper.
Other evidence proposals
70. Since the Constitutional Court did not call any of the appellants of the designated witnesses, the appellant suggested that evidence be made at least by their affidavits, in which they give their opinion on the application under consideration.
71. The Constitutional Court rejected all the appellants' proposals for the interview of witnesses and documentary evidence (see paragraphs 18, 44 and 70) for their redundancy.
Final proposal of the appellant
72. At the end of the oral hearing, the appellant stated that the Deputy Minister for Health's statement did not contain any facts enabling real practice to be established, but merely an argument about how the whole system works. But the reality is different. Suppliers and patients do not have a real chance to defend themselves against health insurance. The general health insurance company fully resigns in its activities to the assessment of the degree and severity of the disability. The basic criterion under which it progresses is "performance of the least economically demanding ', with only the appearance of moderating the degree and severity of disability in general; in this respect, the contested legal regulation is not only unconstitutional but also factually incorrect. In addition, the Act does not give health insurance companies any space not to include medical devices that meet the requirements in their code lists. The appellant concludes that the practice of health insurance companies has been clearly identified by witness interviews: no one knows how they decide on the level of remuneration, no one knows in what process and no one knows on what criteria he would appeal. This decision-making takes place beyond any control. The appellant therefore persists in its proposal that the Constitutional Court should decide to repeal the contested provisions on the date of the publication of the finding in the Collection of Laws.
Presumption of proceedings before the Constitutional Court
73. The Constitutional Court notes that it is competent to discuss the application for annulment of the contested legal provisions and that the appellant's proposal fulfils all the formal requirements laid down by law and was submitted by a person entitled [Paragraph 64 (1) (b) of Act No. 182 / 1993 Coll., on the Constitutional Court]. At the same time, it finds none of the grounds for inadmissibility of the appellant's proposal or for the termination of the procedure. Therefore, the conditions for its substantive assessment are met.
Assessment of the competence and constitutional conformity of the procedure for the adoption of the contested legislative provisions
74. Pursuant to Article 68 (2) of Act No 182 / 1993 Coll., on the Constitutional Court, as amended by Act No 48 / 2002 Coll., the assessment of the constitutionality of the law with a constitutional order consists of answering three questions: whether it was adopted and issued within the limits of the Constitution, whether it was adopted in a constitutionally prescribed manner and whether its content is in accordance with constitutional law.
75. In Article 15 of the Act on Public Health Insurance, paragraph 12 was inserted by 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, with effect from 1 December 2011. He has not made any further changes during his term of validity.
76. As regards Section C of Annex 3 to the Act on Public Health Insurance, the symbols of the remuneration limits "A" and "B" by which, for each type of medical device, the limits on the amount of remuneration, as well as the definitions of these symbols have become part of the Act as a result of the amendment of Annex 3 to the Act No. 369 / 2011 Coll., amending Act No. 48 / 1997 Coll., on Public Health Insurance, and amending and supplementing certain related laws, as amended, and certain other laws. This amendment took effect on 1 April 2012. Before that date, Act No. 458 / 2011 Coll., on the amendment of laws related to the establishment of one collection post and other changes to tax and insurance laws, was replaced by the original version of Lot No. 3 of Section C of Annex 3 to the Public Health Insurance Act. Its new wording included a symbol of the "A 'payment limit. In this section, Act No. 458 / 2011 Coll. also became effective on 1 April 2012, as a result of which this item was never effective in the originally approved version, i.e. in the version of Act No. 369 / 2011 Coll...
77. The Constitutional Court notes that Parliament was competent to adopt the three acts within the meaning of Article 15 (1) of the Constitution. From the statements of his chambers and publicly available documents relating to the legislative process, he also found that the draft law amending Act No. 48 / 1997 Coll., on Public Health Insurance and amending and supplementing certain related laws, as amended, and other related laws (Chamber of Deputies, 6th Election, 2010- 2013, House Press 325 / 0) was submitted by the Government to the Chamber of Deputies on 13 April 2011. It was approved at its 19th meeting at its third reading on 21 June 2011 (Resolution 592), with 105 out of 180 Members voting in favour, 73 opposed and 2 abstentions. The Senate discussed and rejected the bill (Senate, 8th term, 2010- 2012, Senate Press 148 / 0) at its 10th meeting on 21 July 2011. 25 senators voted in favour, 47 opposed and 2 abstained. The Chamber of Deputies remained at its 21st meeting on 6 September 2011 at the original approved bill (Resolution No 668). 103 of the 177 Members present voted in favour, 68 opposed and 6 abstained. The Law adopted was delivered to the President of the Republic on 15 September 2011 and signed on 29 September 2011. His publication took place in the Collection of Laws on 14 October 2011 in the amount of 105 under No. 298 / 2011 Coll.
78. The draft law amending Act No. 48 / 1997 Coll., on Public Health Insurance, and amending and supplementing certain related laws, as amended, and certain other laws (Chamber of Deputies, 6th Election, 2010- 2013, House Press 409 / 0), was submitted by the Government to the Chamber of Deputies on 30 June 2011. It was approved at its 22nd meeting on 7 September 2011 at its third reading (Resolution No 682), with 95 of the 158 Members present voting, 61 opposed and 2 abstentions. The Senate discussed and rejected the bill (Senate, 8th term, 2010- 2012, Senate Press 187 / 0) at its 12th meeting on 12 October 2011 (Resolution 345). Of the 65 senators present, 40 voted in favour, 21 opposed and 4 abstained. The Chamber of Deputies, at its 25th meeting on 6 November 2011, remained on the original approved bill (Resolution No 832). 108 of the 178 Members were voted in favour and 70 opposed. The law adopted was delivered to the President of the Republic on 9 November 2011 and signed on 22 November 2011. His publication took place in the Collection of Laws on 6 December 2011 in the amount of 129 under No 369 / 2011 Coll.
79. The draft Act on the amendment of laws relating to the establishment of a single collection point and other changes to tax and insurance laws (Chamber of Deputies, 6th term, 2010- 2013, House Press 473 / 0) was submitted by the Government to the Chamber of Deputies on 8 September 2011. It was approved at the third reading on 9 November 2011 at its 30th meeting (Resolution 847), when 92 of the 160 Members present voted for it, 63 opposed and 5 abstained. The Senate discussed the bill (Senate, 8th term, 2010- 2012, Senate Press 240 / 0) at its 14th meeting on 8 December 2011 and returned it with amendments (Resolution 435). Of the 66 senators present voted in favour of his return 64, 1 was opposed and 1 abstained. On 20 December 2011, at its 32nd session, the Chamber of Deputies approved the bill as approved by the Senate (Resolution No 973). 98 out of 130 Members were voted in favour, 2 opposed and 30 abstained. The law adopted was still delivered to the President of the Republic that signed it on 27 December 2011. His publication took place in the Collection of Laws on 30 December 2011 in the amount of 158 under No. 458 / 2011 Coll.
80. Those findings are sufficient to conclude that all three laws have been adopted in a constitutional manner. Moreover, the appellant does not object to the procedure for their acceptance. It can only be recalled that, in the case of Law No 298 / 2011 Coll., the Constitutional Court reached the same conclusion in the sp. zn. Pl. ÚS 36 / 11 (see above). in the case of Act No. 369 / 2011 Coll. he did so in the case of Act No. 369 / 2011 Coll. in the case of Act No. 27 November 2012 sp. zn. In this situation, it was possible to assess the substantive compliance of the contested legal provisions with the constitutional order.
Text of the contested provisions and related legislation
81. In the introduction to the further part of the review of the provisions under appeal, the Constitutional Court considers it desirable to summarise the rules which are relevant for their interpretation and application. Firstly, the Act on Medical Devices, which regulates the treatment of medical devices, i.e. their production, including conformity assessment, placing on the market, import, distribution, putting into service, supply, sale, use in the provision of health services, service and disposal. The Act entered into force on 1 April 2015. The medical device defines in its § 2 (1):
(1) A medical device means the instrument, apparatus, equipment, software, including software intended by its manufacturer for specific use for diagnostic or therapeutic purposes and necessary for the correct use of the medical device, material or other object, as specified by the manufacturer for human use for the purpose of:
(a) diagnosis, prevention, monitoring, treatment or mitigation of disease;
(b) diagnosis, monitoring, treatment, mitigation or compensation of injury or disability;
(c) investigation, replacement or modification of the anatomical structure or physiological process; or
(d) checks on conception;
and which do not achieve their main intended function in or on the body by pharmacological, immunological or metabolic action; However, their function may be supported by such effects. ';
That definition is supplemented by paragraph 2, which provides a demonstration of what is meant by a medical device when the general definition referred to in paragraph 1 is fulfilled. The following paragraph 3 contains a negative definition of this concept when - in short - (although with some exceptions) it excludes its relationship with, for example, medicinal products, human blood and blood products, transplants, tissues or cells of human or animal origin, food supplements, cosmetic products and biocidal products.
82. The Law on Medical Devices provides in its Section 31 (1) that, in the case of any medical device placed on the market, its manufacturer or authorised representative established in the Czech Republic must submit an application for notification of the medical device to the State Institute for Drug Control no later than 15 days after its placing on the market. Following this request, a notification decision shall be taken. If it is satisfied, the State Institute for Drug Control will register the medical device in the Register of Medical Devices (Section 35 (1) of the Act cited). The previous legal regulation contained in Act No. 123 / 2000 Coll., on Medical Devices and on the amendment of certain related laws, did not foresee the obligation of notification or registration of all medical devices.
83. In particular, the arrangements contained in Sections 15 paragraphs 11 and 12 of Act No. 48 / 1997 Coll., on Public Health Insurance and on the amendment and amendment of certain related laws, as amended by Act No. 298 / 2011 Coll., against which the proposal is partly directed and which defines the basic rules for determining the amount of compensation for public health insurance in the provision of outpatient health care. The text of these provisions is as follows:
...
(11) The medical devices listed in Section B of Annex 3 to this Act are not covered by health insurance. The medical devices listed in Section C of Annex 3 to this Act shall be covered by health insurance at the level and under the conditions set out in this Annex.
(12) Medical devices other than those referred to in paragraph 11 shall be covered by health insurance at the rate of 75% of the price of the medical device in the performance of the least economically demanding, depending on the degree and severity of the disability; the price of the least economically difficult execution of the medical device is ascertained by the health insurance company by market research. Health insurance under this paragraph shall be covered by medical devices prescribed for the purpose of:
(a) continue the treatment process;
(b) to encourage or significantly improve the health of the insured person or to eliminate deterioration; or
(c) to compensate or mitigate the consequences of a medical defect, including replacement or modification of the anatomical structure or physiological process. "
The appellant seeks the annulment of Section 15 (12) of the cited Act, which is defined by the words "the least economically difficult implementation, depending on the extent and severity of the disability; the price of the least economically demanding medical device is ascertained by the health insurance company by market research '.
84. The proposal goes against some of the provisions of Annex 3 to the Public Health Insurance Act, which is entitled "List of Medical Devices." The list of medical devices covered by public health insurance for the provision of outpatient health services is set out in Section C thereof, consisting of 185 items classified in 17 groups marked with a number. The name of these groups is contained in Section A. Each item represents a type (type) of medical device which, depending on its nature, is specified by means of a "restriction '(e.g. in terms of size, weight or quantity, but also a voucher issued by a doctor of a particular specialisation or approval by a revision doctor), and a limit on its remuneration from public health insurance is set. This limit is expressed as a percentage in which a particular medical device is paid, and, where applicable, its maximum price (expressed in a specific amount) and the use of the A or B margin symbol, which results in the calculation of the remuneration not being based on the price of a particular variant of the medical device, but on the price of the" least economically demanding variant' of the medical device. Specific delimitation of individual items of the list of medical devices can be illustrated on the example of some of them:
| Položka | Skupina | Název druhu (typu) zdravotnického prostředku | Omezení | Limitace výše úhrady |
|---|---|---|---|---|
| 1 | 1 | prostředky pro klasické hojení ran | max. rozměr 10 x 10 cm | 100 %; max. 4 Kč za 1 ks; A |
| 21 | 3 | systémy kolostomické dvoudílné uzavřené -sáčky | max. 60 ks za měsíc | 100 %; max. 4 000 Kč za 60 ks; B |
| 76 | 7 | vozík mechanický - základní | max. 1 ks za 5 let; po předepsání REH, ORT, NEU, INT a po schválení revizním lékařem | 100 %; max. 9 000 Kč za 1 ks; A |
| 93 | 8 | sluchadlo pro vzdušné vedení - pro středně těžkou nedoslýchavost od 40 dB do 59 dB SRT | max. 1 ks za 5 let; od 18 let; po předepsání FON, OTO S3 | 100 %; max. 2 700 Kč za 1 ks; A |
| 164 | 14 | hůl bílá slepecká | max. 3 ks za rok; po předepsání OPH, PRL | 100 %; A |
The symbols for the remuneration limits A and B are defined at the end of this list as follows:
"Payment limits symbols
A - Reimbursement at the price of the final consumer of the medical device in the performance of the least economically demanding according to the degree and severity of the disability (hereinafter referred to as the least economically demanding variant); the cost of the most economically demanding variant of the medical device is ascertained by the health insurance company by market research.
B - Reimbursement at the level of the cost of the least demanding economic variant of the entire system of medical devices of Group 3 of this Section. '
According to the appellant, the definition, on the one hand, of remuneration symbols and, on the other hand, the symbols used for the various items in the list of medical devices should be deleted.
85. The term "implementation of the least economically demanding, depending on the extent and severity of the disability," in respect of which the law provides for a legislative abbreviation "least demanding economically," is not specified in the Public Health Insurance Act. However, it is part of the law in more of its places and, in connection with medical devices (formerly medical devices), even throughout its effectiveness. In particular, Article 15 (6) of the Act on Public Health Insurance, in its original version, i.e. the text which is effective until 11 December 2003, can be mentioned. According to this provision, the medical equipment was always paid for in the basic performance of the least economically demanding according to the extent and severity of the disability. The provision of this text remained part of the Act on Public Health Insurance until the effectiveness of Act No. 298 / 2011 Coll., although its location was changed during each period (the numerical description of the paragraph).
86. Furthermore, the term is contained in Section 15 (5) of the Act on Public Health Insurance, which is part of which since 1 January 2008 as a result of its amendment by Act No. 261 / 2007 Coll., on the stabilisation of public budgets. According to that provision, as amended, health insurance for the provision of bed care is fully covered by medicinal products and food for special medical purposes, individually prepared medicinal products, radiopharmaceuticals, transfusion products, medical products, advanced therapy medicinal products and tissues and cells, in the performance of the least economically demanding, depending on the extent and severity of the disease, and the insured does not participate in their reimbursement.
87. Paragraph 15 (4) of the Act on Public Health Insurance, which is part of it throughout its period of effectiveness, provides that medicinal products containing listed active substances (e.g. serum against staphylococci, diphtheria or rabies or immunoglobulin against tetanus or hepatitis B) are always fully covered by health insurance. By Act No 298 / 2011 Coll. this provision was amended with effect from 1 December 2011 so that these products will no longer be paid in full but in "the least economically demanding execution." At the same time, Article 30 (2) (b) of the Public Health Insurance Act was amended, according to which the care paid includes vaccination and reimbursement of medicinal products containing the listed vaccines in the "least economically demanding execution ', while the provision of vaccines was previously paid regardless of price.
88. In view of the interpretation of the concept of "implementation of the least economically demanding, depending on the extent and severity of the disability ', the definition of the concept of" variant of medical devices' contained in Section 3 (6) of the Medical Devices Act is relevant. This provision shall read as follows:
...
(6) The variant of a medical device means a closer identification of a particular model or packaging of a medical device. Individual variants of the medical device differ mainly in size, number of pieces in the package, colour design or power supply. The various variants of the medical device shall be identical in their trade name, intended purpose, risk class, material composition and production process. ';
That definition became part of the legal order only when the contested provision had been effective for several years. However, the term "least economically demanding execution 'refers to one of the variants of a medical device.
89. Medical devices wholly or partly covered by public health insurance shall be provided to insured persons by means of dispensers who are persons operating a pharmacy, medical devices or optics, as well as other persons with whom the health insurance company has concluded a contract of discharge [cf. § 5 (g) of the Medical Devices Act]. The medical device issued shall be covered to the extent specified by the health insurance company. If it is only partially covered by public health insurance, the remaining part will be paid by the insured person himself. Only a doctor or dental practitioner may prescribe the medical device to be covered in this way.
90. The relevant legislation also includes the price regulation of the Ministry of Health 3 / 2012 / FAR of 16 April 2012 on price regulation of medical devices (Communication No 251 / 2012 Coll.). It was issued according to § 2a (1) of Act No. 265 / 1991 Coll., on the competence of the Czech authorities in the field of prices, as amended, and § 1 (6) and § 10 of Act No. 526 / 1990 Coll., on prices, as amended; it was published in the Ministry of Health Bulletin 3 / 2012 and became effective on 1 May 2012.
91. With this price regulation, the Ministry of Health regulates prices for the final consumer in the case of medical devices for vouchers paid in full or in part from public health insurance and separately charged material. It does so in the form of a material price adjustment consisting of a binding procedure for the calculation and negotiation of the prices of goods, which concerns the producer's price, i.e. the wholesale selling price of the producer or other person who first places the goods on the European Union market (including the possibility of an annual increase in the price) and the maximum trade premium; the price for the final consumer includes value added tax. The Ministry of Health may deregulate their price for certain groups of medical devices if there is sufficient evidence of interchangeability between the elements and the competitive environment. At present, its price decision 2 / 13- FAR of 7 December 2012 establishing a list of groups of medical devices with deregulated producer prices is in force. This decision was published in the Ministry of Health Bulletin 10 / 2012 and came into effect on 1 January 2013.
92. The above-mentioned price regulation obliges the person who first places on the market the medical devices subject to price regulation of the Czech Republic the obligation to notify the health insurance companies of the highest price of the producer actually applied in the previous calendar year. For this purpose, the producer price shall be the wholesale selling price of the manufacturer or the person who first places the medical devices concerned on the European Union market, without any trade mark-up or value added tax.
General basis for the review
93. The Constitutional Court has dealt with the rules on the basis of which the amount of the public health insurance payment is determined several times. The contested provisions provide for the price to be paid to dispensers of medical devices to be entitled to the health insurance company if, subject to other legal conditions, one of the medical devices listed in Section C of Annex 3 to the Public Health Insurance Act which bears the symbols of the remuneration limits A or B, or not listed in Sections B and C of this Annex, has been issued by its insured persons. This price is specified by the insured person's right to this medical device. It is precisely because it depends on whether it will be given to it free of charge or whether it will be obliged to pay a supplement when it is issued. It also completes the conditions under which suppliers of medical devices can provide this medical device on the Czech market.
94. Although the Constitutional Court has in the past dealt with the legislation in question always in connection with the provision of health services and not medical devices, the substance of the issues it had to deal with was similar in many ways. In particular, it is about whether the contested provisions sufficiently clearly and predictably define the content of the basic right of citizens to health care free of charge and to medical devices on the basis of public insurance provided for in Article 31 (2) of the second Charter, whether they set limits in accordance with the provisions of the law referred to in Article 4 (2) of the Charter, and whether that basic right is not restricted by them in an inadmissible manner.
95. The second level of review of the contested provisions concerns the possibility of suppliers of medical devices, namely their producers, importers and distributors, to operate under equal and foreseeable market conditions, thereby exercising their right to engage in business and to operate other economic activities pursuant to Article 26 (1) of the Charter. The market for medical devices and business conditions are significantly affected by the existence of a public health insurance scheme, from which certain medical devices are paid to insured persons either in whole or in part. The Constitutional Court therefore examined the contested provisions also in the light of the fundamental right of their suppliers to do business.
96. Finally, the Constitutional Court examined whether the contested provisions, as a result, did not result in the impossibility of obtaining judicial protection under Article 36 (1) and (2) of the Charter for the two groups of parties concerned.
In general, the fundamental right to free health care and medical supplies based on public insurance under Article 31 of the Second Charter and the law's reservation
97. The appellant contests the non-compliance of the contested provisions with the fundamental right of citizens to health care free of charge and to medical supplies on the basis of public insurance under the second Charter of Article 31. The substance and purpose of this fundamental right lies in the obligation of the State to establish a public health insurance system and to ensure that citizens have a fair, i.e. the emergence of possible inequalities excluding access to health care and adequate quality medical supplies [cf. Resolution of 5 May 1999 sp. zn. ÚS 23 / 98 (U 33 / 14 CollNU 319)]. The concept of medical devices contained here clearly includes medical devices within the meaning of Section 2 of the Law on medical devices.
98. The fundamental right of citizens to health care free of charge and to health care under public insurance under Article 31 (2) of the Second Charter is a social right. The purpose of its constitutional establishment is not to define an area of individual freedom in which public authority is not entitled to intervene, but rather to guarantee that the State will act actively in certain cases to ensure the conditions for its decent life and equality of chances. This is also the case with Article 41 (1) of the Charter, according to which the economic, social and cultural rights contained in the listed provisions of Title Four of the Charter, including the fundamental rights referred to in Article 31 of the Charter, may be invoked only within the limits of the laws transposing those provisions.
99. The Constitutional Court refers here to its earlier conclusions [see, for example, the finding of 25 March 2014 sp. zn. Their content is the obligation of the State to adjust, at the level of the law, effective means to achieve a specific purpose, which constitutes the substance and meaning (or essential content) of social law, and subsequently to implement it through its institutions. It is the so-called sub-constitutional legislation that actually answers the question of what and under what conditions an individual can claim under this fundamental law, i.e. what are the limits of this fundamental law. Another solution would not even be possible in view of their general nature.
100. While the legislator is called upon to determine what an individual can do under his social law, his discretion in this respect is not unfettered. Its limits are based on the substance and meaning of the social law which must be investigated by law in accordance with Article 4 (4) of the Charter. The law must not deny or purge this right. Any interference with the very essence of social law must be sustained in terms of the principle of proportionality.
101. 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 nature and purpose of this fundamental right will be maintained if citizens are guaranteed the free provision of health care and medical supplies needed to improve or maintain their health status or to alleviate their suffering, in the form of such treatment and treatment as is compatible with objectively identified needs and requirements of the appropriate level and ethics [cf. ÚS 19 / 13 (N 178 / 71 SbNU 105; 396 / 2013 Sb.), paragraph 52]. The suitability and effectiveness of treatment must simply not depend on the financial possibilities of the citizen to be provided. However, if this requirement is fulfilled, it is up to the legislator to determine, beyond this necessary framework, whether and what other healthcare or medical facilities are to be provided free of charge, or for partial remuneration, and which are not.
102. The definition of the extent of health care or medical supplies which must be provided to citizens free of charge or for partial remuneration, as the case may be, requires the setting of conditions and, at the same time, the limits of the basic right to free health care and medical supplies on the basis of public insurance provided for in Article 31, sentence of the second Charter.
103. Article 4 (2) The Charter may be governed by law only under the conditions laid down in the Charter. The purpose of the legislature's exclusive mandate (or the reservations of the law) thus formulated is to make it impossible for executive powers to "realize their own ideas of how and how much fundamental rights can be reduced. By granting this power to a democratically legitimate parliament, it is to be ensured that the restriction of fundamental rights will take place only after a democratic parliamentary discourse, and in addition it will obtain a restriction of fundamental law and subsequent democratic feedback" (Wagner, E. in Wagner, E., Šiměl, V., Langášek, T., Pospíšil, I. and kol. Charter of Fundamental Rights and Freedoms. Comment. Praha: Wolters Kluwer ČR, a. s., 2012, p. 128).
104. Reservation of the Law pursuant to Article 4 (2) The Charter does not preclude the statutory definition of social law within which an individual may seek it from being further regulated by a statutory law issued pursuant to Article 78 of the Constitution or by a statutory authority pursuant to Article 79 (3) of the Constitution. In this way, however, it cannot be narrowed or extended by the legal regulation of the content resulting therefrom. The Constitutional Court has in the past stated that it is not a violation of the rule of law, if the law "specifies the issue, as laid down in the fundamental features of the law itself. The opposite conclusion, which would require the determination of any obligation directly and exclusively by law, would obviously lead to absurd consequences, namely the denial of the meaning of secondary (and in some cases primary) standards, since the conceptual part of each legal standard is the definition of certain rights and obligations of the addressees of the standard" [finding of 16 October 2001 sp. zn. What is understood by these essential features depends on the nature of the obligation in question, or the corresponding right.
105. The law, which lays down the limits of fundamental rights and freedoms so generally or vaguely that the determination of their content effectively leaves to the practice of state authorities or other bodies, is contrary to the rule of law provided for in Article 4 (2) of the Charter for the same reasons for which the determination of the limits of fundamental rights cannot be left to a statutory law.
106. In some cases, for the determination of the limits of the fundamental right, the legislator has provided for a special reservation of the law, which either has tightened up the general rules for adjusting the limits of fundamental rights by means of a statutory law, or even ruled out such an amendment [cf. the finding of 23 July 2013 sp. zn.
107. The law establishing the limits of fundamental rights and freedoms, like any other legislation, must comply with the fundamental requirements arising from the principle of democratic rule of law under Article 1 (1) of the Constitution. The principle of legal certainty, which is an inseparable part of which is a requirement for clarity and certainty of the law [finding of 24 May 1994 sp. zn. Pl. ÚS 16 / 93 (N 25 / 1 CollNU 189; 131 / 1994 Coll.)], for its predictability, clarity and internal inconsistencies [e.g. finding of 12 February 2002 sp. zn. Pl. ÚS 21 / 01 (N 14 / 25 SbNU 97; 95 / 2002 Coll.), for the finding of 15 February 2007 sp. The indeterminity of the law constitutes its inconsistency with the constitutional order if its intensity excludes the possibility of determining the normative content of the law by means of the usual interpretation procedures [e.g. the finding of 28 February 1996 sp. zn. Pl. ÚS 9 / 95 (N 16 / 5 SbNU 107; 107 / 1996 Coll.), the finding of 30 June 2004 sp. zn. Pl. ÚS 23 / 02 (N 89 / 33 SbNU 353; 476 / 2004 Coll.)].
Assessment of compliance of the contested provisions subject to the law referred to in Article 31 of the Charter
108. The legislature intended to devise the contested provisions in such a way that the amount of the public health insurance payment for the provision of outpatient medical care results directly from their wording and can thus be used without further delay in legal relations between insured persons, workers and health insurance companies.
109. The amount of payment of a medical device from public health insurance in the provision of outpatient care is limited by the price of the option of a medical device, which represents "performance of the least economically demanding, depending on the degree and severity of the disability '. The specific amount in which the insured person is entitled to reimbursement of this medical device shall be calculated in accordance with the rules contained for each individual item in Section C of Annex 3 to the Public Health Insurance Act, unless it is medical devices not listed in Sections B and C of this Annex, for which 75% of the" economically least demanding option "price is always paid under Section 15 (12) of Act No 48 / 1997 Coll., on Public Health Insurance and on the amendment and amendment of certain related laws, as amended by Act No 298 / 2011 Coll. The obligation to" determine "the price of a medical device in the least economically demanding execution, depending on the degree and severity of the disability," shall lie with the health insurance undertaking which carries out the "market research" for this purpose.
110. The basic question that the Constitutional Court had to answer in the present case is whether the contested provisions actually allow the health insurance company to "ascertain 'the extent to which the individual medical means of public health insurance are to be paid. More precisely, it had to assess whether these provisions were sufficiently specific in this respect and whether all the criteria from which the remuneration was based could be derived. Only in that case would it fulfil the requirement of a reservation of the law resulting from Article 31 of the Second Charter. This does not strictly preclude a health insurance undertaking from making certain necessary clarifications of these criteria in the application of the contested provisions, but it must not be substantially reflected in the amount of remuneration found.
111. Legal relationships between insured persons, dispensers and health insurance companies are designed in such a way that the amount of payment of the public health insurance medical device must be known to all participants before it is issued by the insured person on the basis of the voucher. The procedure of the health insurance company in determining the amount of this remuneration cannot lead to the insured being subsequently informed of the obligation to pay a supplement to the price of the medical device. In the same way, the transferee cannot only subsequently know that he is entitled to a lower remuneration than he expected at the time of issue of the medical device when he could have requested a possible supplement. Such a situation would unduly interfere with the legal certainty of the two parties concerned. Both the transferee and the insured person must know for sure whether the medical device is to be provided free of charge or whether it is to be paid in full or in part directly.
112. The health insurance undertaking may only determine the amount of the reimbursement of the medical device in advance if it has relevant information on what medical devices are available on the market, what their characteristics are in terms of effect, safety and use and what their price is, or what the costs associated with their use are.
113. Although, according to the contested provisions, the reimbursement of the medical device is not linked to any specific registration or authorisation, it is clear that it will actually only take place if the health insurance company has knowledge of the medical device if it is registered in some way. However, the law no longer provides for the way in which a health insurance undertaking finds that a medical device has been placed on the market and what its characteristics are, or that it is no longer on the market. In fact, this information could not have been found in any way before except through an informal search mechanism. As from 1 April 2015, when the Law on Medical Devices came into force, all medical devices are registered in the Register of Medical Devices, each of which is subject to a notification decision (see paragraph 82). However, there is no obligation of the State Institute for Drug Control to inform health insurance companies about the notification of medical devices. The Act only regulates their access to the National Information System of Medical Devices [§ 77 (3) (e); This provision will become effective on 1 April 2018 and the Register of Medical Devices [Section 79 (1) (f)], to the extent necessary to ensure that their obligations under the public health insurance legislation are fulfilled. The use of this authorisation, including its time context, as well as other possible ways of obtaining information on medical devices, leaves the law to the health insurance company.
114. That condition inevitably leads to the fact that, for at least a certain period of time since its placing on the market, medical devices are neither covered by health insurance companies nor taken into account in the detection of "economically least demanding options'. However, even if health insurance companies were informed of the notification of a medical device without delay, a certain period of time would require its inclusion in the categorisation, price finding and comparison with other variants of a medical device (as defined in Section 3 (6) of the Health Devices Act, i.e. specific models or packages of a medical device). In the case of any medical device, there will be a period after marketing, whether for weeks or months when the contested provisions are not feasible against it. The possibility of implementing them will depend on the specific way in which the health insurance company will determine which medical devices are currently on the market. The law does not lay down any rules or deadlines here. Nor is there any procedural means by which the non-taking of a particular medical device can be objected directly to the health insurance company.
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Regulation Information
| Citation | The Constitutional Court found No 231 / 2017 Coll., on the application for annulment of certain provisions 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 | 31.07.2017 |
|---|---|
| Effective from | - |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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