NEWSLETTER Informace z farmaceutického a medicínského práva

Transcription

1 NEWSLETTER Informace z farmaceutického a medicínského práva No. 34 APRIL /4/2014 NOVINKY The Supreme Administrative Court again on procedural entitlement of an applicant for reimbursement After a longer pause the Supreme Administrative Court commented on procedural entitlement of an applicant for reimbursement of a medicinal product from public health insurance again, concretely in resolution file no. 4 Ads 35/2013 from 23 rd January As you probably know, the Supreme Administrative Court has assessed applicants for determination of maximum price and applicants for determination of conditions and amount of reimbursement under s. 39g subs. 1 of the Act no. 48/1997 Coll., on Public Health Insurance, as parties that are entitled to challenge a decision of an administrative decision of the State Institute for Drug Control (referred to as the Institute ) on price and reimbursement (or a decision of the Ministry of Health on appeal against the decision of the Institute) by an act brought before an administrative court. However, the Supreme Administrative Court has also traditionally emphasized that applicants are not entitled under s. 65 subs. 1 of the Act 150/2002 Coll., the Administrative Code of Justice, but only under subs. 2 of this provision, since they have no public subjective rights that belong exclusively to the insured parties. This interpretation caused that the applicants were not allowed to challenge administrative decisions of the Institute or the Ministry of Health for their incompliance with substantive law, but only with procedural law. However, this rule resulted in substantial restriction of defence ability of applicant within administrative justice because a lot of their objections referred to grave mistakes of the administrative bodies in the area of substantive law or the objections heading towards incompliance with substantive and procedural law could not have been easily separated. This unwelcome state was slightly rectified by a decision of the Supreme Administrative Court file no. 4 Ads 70/2012 for 11 th July 2012, which stated that one the basic procedural rights of applicants for reimbursement consists in their right for proper justification of a decision (we wrote more about this case in October 2012). This decision of the fourth senate of the Supreme Administrative Court corrected a strict conclusion of the third senate of the Court since it caused that applicants for reimbursement should have right that any decision not to include a medicinal product in the list of products covered by the health insurance system contains a statement of reasons based upon objective and verifiable criteria, including, if appropriate, any expert opinions or recommendations on which the decision is based in compliance with article 6 of the Advokátní kancelář Marečková, Křenova 7/438, Praha 6, tel.: , info@mareckova.cz,

2 Directive 89/10/EEC relating to the transparency of measures regulating the pricing of medicinal products f or human use and their inclusion in the scope of national health insurance systems. The mentioned decision of the fourth senate constituted a positive shift in understanding of procedural position of applicants for reimbursement, but it unfortunately did not eliminate disproportion in decision practice of the third and the fourth senate of the Supreme Administrative Court. As the fourth senate concluded that this state cannot be preserved anymore, it decided to submit to an extended senate of the Supreme Administrative Court a question, whether applicants for determination of amount and conditions of reimbursement for public health insurance under s. 39f subs. 2 par. a) of the Act on Public Health Insurance as authorization holders of the medicinal products in question and participants to administrative procedure under s. 39g subs. 1 of the Act, are procedurally entitled under s. 65 subs. 1 of the Administrative Code of Justice, or only under subs. 2 of this provision. The extended senate should therefore bring a final opinion, whether applicants for reimbursement may challenge administrative decisions for breach of not only procedural, but also substantive provisions. We understand very positively the ground on the basis of which the fourth senate decided to bring the case before the extended senate. The fourth senate concretely stated: Restriction of judicial review of decisions of administrative bodies on determination of amount and conditions of reimbursement of medicinal products and food for special medical use from public health insurance only to procedural rights of applicants for reimbursement as participants of the administrative procedures may not be in opinion of the fourth senate grounded by the fact that only duties of insured parties and their corresponding rights for reimbursed health care are subject matter of proceeding held on the basis of the Act on Public Health Insurance. Such a restrictive interpretation does not correspond even with sole grammatical interpretation of s. 1 of the Act on Public Health Insurance, which delimitates 3 pillars of the Act, i.e. 1) public health insurance, 2) extension and conditions, under which health care is provided and 3) the way of determination of price and reimbursement of medicinal products and food for special medical use reimbursed form public health insurance. Deciding on amount and conditions of reimbursement of medicinal products from public health insurance must be therefore understood as an independent part of the Act on Public Health Insurance. Subject matter of the mentioned proceedings is therefore not reimbursement of health care as performance from relationship of an insurance company and the insured party, but determination of reimbursement of medicinal products from public health insurance as an independent set of legal relationships based on s. 1 par. c) of the Act on Public Health Insurance. The three mentioned pillars of the Act on Public Health Insurance imply that the persons, whose public subjective rights are directly affected by a decision on amount of reimbursement of medicinal products and food for special medical use, are not solely the insured parties and health insurance companies, but also authorization holders or importers or inland manufacturers of medicinal products, who apply for determination of amount of reimbursement under s. 39f subs. 2 of the Act on Public Health Insurance and participate in administrative proceedings. The fourth senate means that the applicants must be therefore enabled to challenge a decision on determination of amount of the reimbursement before a court without restriction, i.e. to the extent of their procedural as well as substantive rights.

3 We absolutely agree with the mentioned conclusions of the fourth senate and believe that the result opinion will respect them and follow the opinion of the fourth senate. We suppose that only then a Czech judicial practice will comply with requirements of the Transparency Directive and former decisions of the Court of Justice of the EU. We will inform you of the final result. VZP admitted publication of reimbursement agreements As you could have already noticed, Vseobecna zdravotni pojistovna (referred to as VZP ) has recently admitted publication of agreements on provision and reimbursement of reimbursed services, concluded with providers under s. 17 of the Act no. 48/1997 Coll., on Public Health Insurance, as amended. According to information provided by the VZP approx. 23,000 agreements are concerned, which shall cause deceleration of their publication, since they have been surprisingly not digitalized so far. Agreements made with the biggest providers, i.e. hospitals managed directly by the Ministry of Health, concretely all faculty hospitals, IKEM, Úrazová nemocnice Brno and Ústřední vojenská nemocnice should be published as the first ones. Also all supplements to contracts should be consequently published. Only annexes containing data protected by the Act no. 100/2001 Coll., on Personal Data Protection, should remain unpublished. However, this reservation of the VZP conceals the biggest risk of this media-friendly fight for transparency. It has been evident that VZP is an obliged body under s. 2 of the Act no. 106/1999 Coll., on Free Access to Information, since 16 th January 2003 at the latest, since it administers public resources and is therefore obliged to publish the reimbursement agreements (see e.g. decision of the Constitutional Court file no. III. ÚS 671/02). Identically as many other obliged bodies that have been relentlessly trying to avoid their statutory duty, also the VZP has argued that a trade secret would be breached by publication of such contracts. Nonetheless, the Supreme Administrative Court has already commented on this topic in its decision file no. 3 Ads 33/2006 from 16 th May 2007 and stated: The Supreme Administrative Court emphasizes, that if some information shall fall within protection of a trade secret, it is not sufficient if its only marked as one under s. 9 subs. 1 of the Act no. 106/99 Coll., but it also has to comply with statutory definition. It implies that in compliance with s. 504 of the Act no. 89/2012 Coll., the Civil Code, it would have to be competitively significant, identifiable, valuable and commonly in relevant business circles unavailable facts that relate to undertaking and that are adequately kept in secret by the owner, when compliance with all mentioned conditions is required. The VZP has repeatedly stated that a trade secret hindering publication of reimbursement agreements is given by the amount of reimbursement agreed with concrete providers for particular performance. Nevertheless, this opinion was denied by the Supreme Administrative Court in 2004, when it was stated in decision file no. 7 A 118/2002: The point of s. 9 subs. 2 of the Act is to enable public control of administration of public resources. Since the sole information on price does not say enough about such administration, it is necessary to provide at least general information on performance, for which the prices is paid. A tolerable rate of generalization is then given by the fact, whether it enables assessment of economy of usage of public resources. It is evident from the decisions mentioned above that the VZP has had duty to publish reimbursement agreements for a very long time. According to the information given by the PR department of the VZP the published

4 data should concern monthly reimbursement of concrete hospitals, i.e. especially an amount paid to them by the VZP. However, this sole information does not secure public control of administration of public resources if the provided services are not also published in compliance with the mentioned judicature. The VZP is alleged to be ready to commence process of publication of agreements during April 2014, it will be therefore surely interesting to watch, what kind of data will be published in real. Regarding the previous negative experience we would recommend only slight enthusiasm for now, although we suppose that publication of reimbursement agreements as such is unambiguously positive. The Constitutional Court abrogated a Decree on Spa On 2 nd April 2014 the Constitutional Court proclaimed its decision file no. Pl. ÚS 43/13 that derogates Decree no. 267/2012 Coll., on determination of Indication list for spa rehabilitation care of adults and minors with effect from 1 st January The reasons for derogation of the decree were similar to grounds for cancellation of a decree defining standard and above-standard care that was realized by the Constitutional Court in its decision file no. Pl. ÚS 36/11 from 20 th June 2013 (we wrote more about this issue in August 2013), i.e. lack of legal form of the applied regulation. Before proclamation of the newest decision of the Court, the Ministry of Health was going to issue a new decree that would especially remove restrictions of reimbursement for only one stay per two years and restriction of length of a stay. However, the proposal will have to be adapted to the form of an act, which would postpone the process as such. In addition, the Deputy of the Minister of Health for legislation and law announced that the Ministry firstly aims to analyze the whole text of the decision and take into consideration all objections of the Court, which will probably cause another delay of preparation of the proposal. It is therefore uncertain, whether the Ministry manages to submit the legislative proposal so that it could be passed before the end of this year and fluently follow effectiveness of the cancelled decree. The legislative solution should get a form of annex to Act no. 48/1997 Coll., on Public Health Insurance. We will inform you of the decision in detail in some of the following issues after its thorough analysis. A plan of governmental legislative work The government passed a plan of governmental work for 2014 on 12 th March We have chosen some proposals that could influence the area of pharmaceutical and medical law. A proposal for amendment of the Act no. 235/2004 Coll., on Value Added Tax, and the Act no. 526/1990 Coll., on Prices A proposal for the amendment of the Act on VAT has been already submitted to circulation for comments that shall be terminated on 14 th April. In spite that the government has declared many time its aim to decrease VAT applied to medicinal products and some other products, the submitted material represents solely a technical amendment adapting Czech legislation to the European law. However, we suppose it is very probable that some amendatory proposals will be submitted during its discussion in the Chamber of Deputies, proposing preferably decrease of both rates, as it always happened in past. Nonetheless, we do not expect

5 its approval since the government plans to submit its own proposal later during the year. A proposal for amendment of the Act on Prices has not been even published so far, we therefore do not have closer information on it. A proposal for amendment of the Act no. 156/1998 Coll., on Manures A proposal has been already submitted, comments must be sent until 24 th April. The aim of the amendment is to return authorization for publication of implementary regulations relating to the Act on Manures, which was accidently removed in The Ministry of Agriculture considers this change as necessary, since a Decree no. 474/2000 Coll., on requirements for manures has not been amended since Amendment of the decree may be therefore expected soon as well. A proposal for implementary regulation relating to the Act no. 108/2006, o Social Services A proposal for regulation executing provision of s. 101a of the Act on Social Services should be published during May. This provision concerns provision of special-purpose subsidies by the state to regions in order to finance common expenses related to provision of basic kinds and forms of social services. The regulation should then provide for closer conditions for drawing of subsidies, time limits for their payment or form and content of an application for subsidy and time limit for its submission. The Act on Social Services itself and the Act no. 116/2006 Coll., on Help in Material Shortage should be consequently amended in June. Details of the amendments have not been published yet nut we suppose that they should concern a new regulation of social housing. A proposal for amendment of the Act no. 48/1997 Coll., on Public Health Insurance The Ministry of Health is obliged to submit a proposal for amendment of the Act on Public Health Insurance in June. It is not certain, whether it shall concern return of a regulatory fee of CZK 60 for stay of the insured party in a hospital, as it has been proposed by two coalition partners, i.e. ANO and KDU-CSL. A proposal for the Act no. 40/1995 Coll., on Advertising Regulation, and the Act no. 634/1992 Coll., on Consumer Protection Regarding the fact that both of the mentioned proposals should be submitted by the Ministry of Industry and Trade it is not very probable that they could concern advertising of medicinal products for human use or that the existing government would even prefer return to a proposal for amendment from 2012 (we wrote more about it in August 2012). Other legislative proposals A proposal for a completely new Act on Biocide Products and Active Substances and the concise plan of a new Act on Waste should be published in September. The Act no. 373/2012 Coll., on Specific Health Services should be amended in October and the Act on Protection of Health from Harmful Effects of Tobacco, Alcohol and Other Addictive Substances in December. We will bring you more thorough information on the mentioned proposals when they are published.

6 SIDC published results of control of pharmacies for 2013 The State Institute for Drug Control published on its websites results of controls that were realized in pharmacies and separated departments of dispensation of pharmaceuticals and medical devices (referred to as SDDP ). One of the priorities of monitoring activity in 2013 was control of effectiveness of a system of withdrawal of medicinal product with quality defects, control of appearance of medicinal products on the market after termination of their registration, dispensation and records of OTC medicinal products with restriction, dispensation of non-registered medicinal products, reporting of data on dispensed medicinal products in compliance with Instruction LEK-13 including completeness and verification of reported data, control of evidence of batches of medicinal products at the time of their reception and dispensation and control of compliance with conditions for mail order service of medicinal products. The inspectors realized 801 controls of pharmacies in total in 2013, out of which 31 were realized in hospital pharmacies. 38 controls were realized upon inducement. A separate control of handling with addictive substances was carried out in 330 pharmacies, out of which 25 were controlled upon inducement. The amount of sanctions imposed on the basis of effective decisions was 1.690,000 CZK in total in One of main reasons for imposition of sanctions was dispensation of medicinal products without prescription or on the basis of an invalid prescription, storage and dispensation of medicinal products that should have been withdrawn, usage of medicinal products and auxiliary substances for preparation of medicinal products after the date of expiration or without certificate of their quality, imperfections of piece-evidence of reception and dispensation or operating of a pharmacy after cancellation of registration etc. 89 controls focused on compliance with the Act on Prices and rules of price regulation of medicinal products were carried out in Breach of law was uncovered in 45 cases, the total amount of imposed sanctions came up to 278,000 CZK. The most frequent breach of law was represented by failure to comply with officially determined maximum price or failure to keep records. US on electronic communication The Constitutional Court issued an interesting decision file no. IV. US 1823/13 on 12 th February 2014, in which it repeatedly commented on assessment of attachment without electronic signature. In the mentioned case there was concerned a situation, when the Municipal Court in Brno denies objections of a complainer submitted during a seizure proceeding, referring to the fact that the objections as such, submitted in electronic form as an attachment to an (with secured electronic signature), did not contain secured electronic signature and were not supplemented in a written form according to s. 42 subs. 3 of the Act no. 99/1963 Coll., Code of Civil Procedure, as amended. The Municipal Court in Brno substantiated its decision by a legal opinion that it is insufficient if secured electronic signature is attached only to an and that it must be also attached to every single PDF attachment, which extends information provided in the .

7 However, the complainer naturally did not identify himself with this absurd opinion and brought the case before the Constitutional Court. A similar case was concerned by the Constitutional Court in case file no. IV. US 4787/12, where it adjudicated that it is sufficient from the point of view of content if only an was signed by secured electronic signature, regardless whether also every attachment is also signed by electronic signature. The Constitutional Court did not find any reason to derive from its previous judicature and the challenged decision of the Municipal Court in Brno was therefore abrogated since it breached right of the complainer for due process. The conclusions of the Constitutional Court mentioned above are naturally fully applicable not only to communication with courts, but with all administrative bodies, since s. 37 subs. 4 of the Act no. 500/2004 Coll., Code of Administrative Procedure, contains a provision similar to s. 42 of the Code of Civil Procedure. Opinion of the Municipal Court in Brno may seem as unique for it unreasonable formalism, nonetheless for instance two district courts in Prague still promote this senseless interpretation even in spite of judicature of the Constitutional Court. However, the latest decision of the Constitutional Court luckily shows victory of good sense and implies that bullying requirements of some bodies are out of legal frame.