New rules on meal vouchers for employees

We would like to inform you that on Thursday 19 November 2020, the Chamber of Deputies approved the so-called tax package (a law, which amending certain laws in the area of tax and other laws), which should, if the legislative process will be successfully completed, come into force on 1 January 2021. Part of this tax package is the adjustment of the so-called meal voucher tax regime, which aimto increase the number of people using a tax-advantaged subsidy for employee meals, reduce the administration related to contributing to employees‘ meals, and reduce employers tax costs connected to such support (especially costs and fees associated with meal vouchers).

Meal voucher flat rate complements the existing options of tax-advantage benefits provided by the employer in connection with the diet of employees. Newly, employers will be able to provide to employees, besides the company meals or meal vouchers, also subsidy to diet directly and in the form of cash. In addition, such subsidy will be exempt from all taxes on the part of the employee (only up to 70% of the upper limit of the meal voucher that can be paid to employees who are remunerated on a business trip lasting 5 to 12 hours).

According to the current rules, the employer can claim up to 55% of the price of the food or meal voucher provided per shift as a tax-deductible expense. The remaining 45% of the price is paid either by the employee himself or the entire amount is paid by the employer (Whereas the mentioned 45% of the price can no longer be claimed by the employer as a tax-deductible expense). This tax-advantaged remains at meals voucher flat rate – however, the employer will now be able to pay off this amount directly to his employee in form of cash.

Similarly, as in meal vouchers, the meal vouchers flat rate has a maximum amount that the employer can claim as a tax-deductible expense. Such limit is 70% of the upper limit of the specified diet provided in connection with a business trip of employee remunerated with a salary, which lasts 5 to 12 hours (the amount of the diet is every year set up by the Ministry of Labour and Social Affairs in the relevant decree). Therefore, if the employer decided to pay off the maximum possible amount of the subsidy to diet, at a situation where there is a 22 working days per month, the maximum amount of the allowance that could be claimed as a tax-deductible expense would be CZK 1,584 per month.

The advantage of the meal voucher flat rate is also the fact that the employee will not have to prove to the employer that the granted subsidy spent on lunches. Therefore, the employer will not arise the costs related to the obligation to control the use of the provided subsidy.

More information about the meal voucher flat rate you will also find in the statement of the Ministry of Finance of the Czech Republic: https://www.mfcr.cz/cs/aktualne/tiskove-zpravy/2020/prehledne-co-prinasi-stravenkovy-pausal-39391.

News in judicial decisions on reimbursement of medicinal products

The Supreme Administrative Court of the Czech Republic (the “SAC”) addressed the issue of reimbursement of medical products in one of its recent decisions. In his decision, the SAC assessed the decision of the State Institute for Drug Control (the “SIDC”) of 5 September 2013, case SUKLS263940/2012 and came to several conclusions which are concerning the following areas: (i) review of the agreement on the agreed highest producers´ price by administrative authorities; and (ii) determination of the basic reimbursement of products during the vesting period. Below you can see a more detailed analysis of the assessed questions.

Review of the agreement on the agreed highest producers’ price by administrative authorities

In this matter, the SAC referred to an earlier judgment of the Constitutional Court of the Czech Republic, which stated that in relation to research in the public interest carried out at the determination of the amount and conditions of reimbursement of the medicinal product is the responsibility of the administrative authority (State Institute for Drugs Control) to verify, whether the agreement on the agreed price contains an obligation to ensure the availability of the product on the Czech Republics market.

In this case, the administrative authority during the assessment of agreement on the highest price (i) did not consider whether there is a realistic presumption of actual availability of the reference product and (ii) if this agreement consists an obligation to ensure availability, (iii) nor did they verify whether the subject, which executed the agreement in last two years, had not committed an offence under Section 39q (1) letters b) and c) of the Public Health Insurance Act. According to the mentioned judgment of the Constitutional Court of the Czech Republic, administrative authorities have a legal obligation to assess the public interest, i.e. they have obligation to verify whether the agreement contains an obligation to ensure product availability and that even in a situation where they intend base from the presumption of the product availability. According to the SAC, if such an obligation was not explicitly agreed in the agreement, the presumption of the availability of the product cannot be applied and it cannot be guaranteed that this reference product will be actually present in the Czech Republic´s market. In the event that the administrative authorities did not verify whether the assessment agreement contains an obligation of availability and was based only on the presumption of availability, they would have acted in clear violation of the judgment of the Constitutional Court of the Czech Republic.

The SAC stated that the condition for applying the conclusive presumption of availability is that the relevant agreement on agreed price contains unambiguous and undoubted commitment of the marketing authorization holder of the mentioned product, that he ensure availability of this product on the Czech Republic´s market in the sufficient amount throughout the efficiency of the agreement.

Determination of the basic reimbursement of products during the vesting period

In the assessed situation, SIDC set out the amount of reimbursement of the medicinal product according to Section 39c (2) letter a) of the Public Health Insurance Act. Under other provisions of the mentioned Act by implementing legislation should be stipulated, among other things, the vesting period for assessing the availability and determining the price of the producer. By this regulation is a decree, which implements certain provisions of the Public Health Insurance Act, according to which the price of a product for determining the basic reimbursement of other products is found out to the extent of 21 days from the date of initiation of the subject administrative procedure.

It is also important, that the quoted decree in Section 12 (2) explicitly excludes thus defined the vesting period for the case of the procedure according to Section 39c (2) letters c) or d) Public Health Insurance Act, but not for the procedure pursuant to Section 39 (2) letter a) the same law, which the administrative authorities applied in this time assessed case. By the linguistic interpretation, the SAC came to conclusion, that is necessary to strictly distinguish between these two procedures.

The erroneous procedure had in the assessed case results that administrative authorities incorrectly came out when determining the reimbursement from agreement on agreed price with agreed delayed effectiveness. The price for the reference medicinal product, which was agreed in the agreement, became effective after the expiration of the vesting period of 21 days from the initiation of the administrative procedure, SAC nevertheless took this price into account when he was assessing the price. In addition, the consideration of the mentioned agreement was possible only due to incorrect official procedure of SAC, when the decision of SAC was not issued within the period stipulated by law. This resulted in the violation of the principles of legitimate expectations, transparency, and predictability of the result of administrative proceedings.

The Supreme Administrative Court of the Czech Republic, therefore by the new case law, that the basic reimbursement could not be set out on the basis of the price agreed in the agreement on the agreed price, whose effect was to occur in the future, even though this price was lower than the price of others products, which were included in the price comparison, but only prices, which were valid during the vesting period can be taken into account. According to the SAC “Although it is possible to understand the complainant´s point of view (SAC), according to which it may be more advantageous from the term of the public health insurance system and the interest of insured persons to take into account, when determining the price the current state,  at the time, when the administrative decision is taking. However, during application of the relevant legislation, it cannot be disregarded that if the rules for determining the vesting period should fulfil their purpose, which consists, inter alia, in maintaining predictability and transparency of decision-making in a given area of the exercise of public authority, it must be in advance clearly determined the vesting period, which in addition shall be set out strictly and shall not allow any discretion of the administrative authority, that might in an unpredictable way affect to the rights of the parties in proceedings.”

The Amendment to the Business Corporations Act

We would like to inform you that, on 13 February 2020, the biggest amendment to the Business Corporations Act (Act No. 90/2012 Coll.) (the “Business Corporations Act”) amended by Act No. 486/2016 Coll. (the „Amendment“) since 2012, entered into force. Amendment, in general, is entering into effect on 1 January 2021.

In this way, we would like to inform you about the most fundamental changes that the Amendment brings. If you are interested in a more detailed overview, do not hesitate to contact us.

Between the main goals of the Amendment belongs reduction of the administrative and regulatory burden on business corporations, the regulation of mandatory provisions, the adjustment of the monistic internal structure of the joint-stock companies and others.

With the effectiveness of the Amendment, arises for the business corporations obligation to adjust their articles of association or their founding acts into the mandatory provisions of the Amendment and filed their consolidated version to the collection of deeds of the Czech Commercial Register on 1 January 2022 at the latest. Unless otherwise is stipulated by the Amendment, the business corporation must within 6 months from the effective date of the Amendment, to register in the Czech Commercial Register facts which have not been registered so far. If the business corporation fails to do so, the consequence ultimately could be even liquidation.

The reduction of the administrative burden establishment of Ltd.

The new legislation removes some administrative burdens related to the establishment of business corporations, which will ease the establishment of “low-cap” companies Ltd. Newly from 1 January 2021 for limited liability companies whose amount of the financial contribution of a shareholder in the capital corporations not exceed CZK 20,000, it will be possible to deposit the contribution in cash and directly into the hands of the administrator of the deposit and not only to a special bank account. Given the fact that the administrator of the deposit can be for example, a notary, this gives the shareholders of the business companies possibility to establish a limited liability company within one visit of a notary.

Regulation of the monistic internal structure of the joint-stock company

Part of the Amendment is also the adjustment of the setting of the monistic model of the joint-stock company´s management, which, as it turned out, does not correspond to the monistic internal system of joint-stock companies known from the legal systems of other European countries, which the model should reflect. Pursuant to the Amendment, the provision of the Business Corporations Act, which stipulates the obligation to establish the statutory director within the monistic internal structure of the joint-stock company, should be repealed. Therefore, from the efficiency of the Amendment, only obligatory bodies would be General Meeting and the Administrative Board. Administrative Board would have competence for the company´s business management and at the same time competence to control the company´s activities. This change should bring clarification in the matter of the distribution of the powers in the joint-stock company body in the monistic model structure. Both executive and supervisory powers would be concentrated in the scope of power of a single body, the Administrative Board will be thus empowered to manage and decide about all common company’s business activities.

The number of members of the Administrative Board will be maintained at 3 members, unless the Statute of the company set out a higher number, except for the admissibility of a one-member or two-member Administrative Board, in s situation where a joint-stock company has only sole shareholder. However, this possibility of a lower number of members of the Administrative Board must be regulated in the Statute of the company.

Transfer of a share in a private partnership

The Amendment breaks the mandatory provision of the current Business Corporations Act regulation, which ban the transfer of partners’ shares in a private partnership. This ban is established in the current legislation due to the personal nature of the private partnership, where the partners are jointly and severally liable for the company´s obligations. However, the legislator by this change does not want to interfere with the personal nature of the private partnership, for this reason, the ban is only broken, when the condition of the consent of all other partners to the transfer of the share, is fulfilled. Without the consent in question, the Partnership Agreement will not be efficient.

Change for legal entities in elected bodies

In accordance with Section 154 of Act No. 89/2012 Coll., The Civil Code (the “Civil Code”), it is possible, that a function in elected bodies of a legal entity perform another legal entity if this other legal entity appoints a natural person to represent her; otherwise, the legal person is represented by a member of its statutory body. Here, however, a problem arises. The mentioned statutory body may be a legal entity, then it is necessary to proceed again according to Section 154 of the Civil Code, but the same situation may occur again, and the whole process will be so-called chaining.

The Amendment newly sets out the obligation of a legal entity, who performs the function of an elected body in a capital corporation or cooperative to authorize a natural person who meets the legal prerequisites and requirements for the performance of the given function. Without the election of such a natural person, it will not be possible to register a legal entity as a member of the elected body of the legal entity in the Czech Commercial Register. The legal entity has 3 months to register the authorized representative or new authorized representative in cases when the authorized representative of the legal entity expires. If the legal entity does not fulfil this obligation, her function as a member of the elected body shall expire, ex lege.

Executive contract with the member of the statutory body

The Amendment also introduces several relatively fundamental changes in the area of the executive contracts with the member of the statutory body. The Amendment supplement a legislative “gap” in the issue of approving executive contracts with the member of the statutory body. The current legislation does not explicitly solve the consequences of omission to approve of an executive contract with a member of the statutory body by the supreme body of capital companies. However, the interpretation infers relative nullity (the agreement is valid until the entitled person invokes its invalidity). In practice, this means, that can appear a situation, where the statutory body executes his function for several years based on an agreement, which latter, based on an appeal by the entitled person, declare invalid ex tunc. This would mean that already paid remuneration would be unjust enrichment of the statutory body. The Amendment thus newly establishes, that without the approval of the supreme body, the executive contract with the member of the statutory body does not take effect. The agreement becomes effective, even retroactively to the date of its conclusion, when it is approved, but this rule is dispositive, so it is left to the discretion of the supreme body of the capital company.

Another situation and problem that will newly be explicitly regulated, in the area of the executive contract with the member of the statutory body, by the Amendment is adversarial of the executive contract with the member of the statutory body and
memorandum of association. If there will be a conflict between these two documents, the rules set out in the memorandum of association shall apply, except in the event, when executive contract with the member of the statutory body is approved by the majority of shareholders required to amend the memorandum of association, then executive contract with the member of the statutory body will apply.

Decisions per rollam

The regulation of the institute of decision-making per rollam (decision-making outside the General Meeting) is one of the parts of the Amendment that is aiming to simplification the administrative burden of companies.

The current legal regulation set out that the decision per rollam of the General Meeting of a capital company must be in the form of a public document, i.e. notarial deed. This rule means that each separate statement of a shareholder or partner must be in the form of a notarial deed. That fact entails considerable administrative costs for larger capital companies. The Amendment adjust this procedure. Therefore, it will no longer be necessary for each individual statement of a shareholder or partner to be made in the form of a notarial deed. Newly the draft itself will be in the form of a notarial deed, then this draft in question will be copied, and this copied draft will be sent to all shareholders or partners, who submit their statements on this copy of the notarial deed with an officially certified signature. The whole process will then be verified by a notarial deed of decision-making per rollam.

Distribution and payment of profits and another capital

Due to the recent case law developments in the field of distribution and payment of profits and another capital, it was appropriate to respond to these developments at the legislative level and at the same time correct the imperfect transposition of European legislation into the relevant provisions of the Business Corporations Act.

The current legal regulation brings in the area payment of the other capital large debates, due to its vagueness, because in practice this leads to a different approach, this is caused by a fact, that on the contrary, the rules for distribution and payment of profits are strictly regulated. The Amendment is trying to the mentioned vagueness in the payment of another capital fix and adding in places, where current legal regulations mention profit postscript “and another capital”. It will be possible to make a payment from another capital in the same way as a profit payment only on the basis of regular or extraordinary financial statements.

In connection to the relevant case law, according to the Amendment, it will be possible to use regular or extraordinary financial statements approved by the body of a business corporation for the distribution of resources until the end of the accounting period following the accounting period for which they were prepared.

Sets out the so-called balance test in the Amendment legislator transposes the EU legislation (Directive (EU) 2017/1132 of the European Parliament and of the Council). The balance test is already included in the current legislation, but it is not mandatory for all types of business corporations, newly it is becoming mandatory for all business corporations. This will unify the calculation for the maximum amount which is paid for all types of business corporations. At the same time, the Amendment set outs the obligation to perform a balance test before the General Meeting decides about the distributions of the profits and that under the threat of nullity of this decision.

The Amendment further obliges all types of business corporations to apply the so-called test of the equity, which should secure a telling overview of the company´s capital.

Furthermore, the rules for the return of the distributed profits will be stricter. The protection of good faith will no longer apply in relation to the distributed profits. In other words, the partners or shareholders will have to repay the profits distributed to them, in the case where the distributions of the profit were in breach of legal rules, even though they did not know about this fact. From the logical point of view, there will be an exception for shareholders, for whom the protection of good faith in relation to the distributions of profits will be retained.

End

The full wording of government proposal amendment of the Act No. 90/2012 Coll. may be found here: https://www.psp.cz/sqw/text/tiskt.sqw?O=6&CT=363&CT1=0.

In case of any questions, please do not hesitate to contact us via email info@kastnerpies.cz.

The Amendment to the Labour Code has entered into force

 

We would like to inform you that, on 26 June 2020, an amendment to the Labour Code (Act No.262/2006 Coll.) entered into force. The aim of this amendment was primarily (I) to simplify the implementation of several rights of an employer and an employee during the performance of work (in particular, by amending the legal regulation of leave and adjusting the rules for a transfer of rights and obligations in a employment relationship); (II) to simplify the performance of work itself (especially by anew regulation of the so-called job sharing by more employees); and (III) to back up and regulate communication between the parties to the employment relationship. The amendment also transposes into the Czech law certain rules of the EU law, in particular Directive of the European Parliament and of the Council (EU) No. 2018/957 amending the EU rules on the posting of workers in the framework of the provision of services.

The abovementioned amendment to the Labour Code comes into effect gradually. Changes in regulation of leave, compensation for damages, as well as the adjustment of the new institute of the job sharing will come into effect on 1 January 2021. Other amendments to the LabourCode entered into effect on 30 July 2020.

Leave

The new legislation eliminates some shortcomings of the previous regulation and provides a new way of calculating leave based on a new mathematical model based on a single unit of time – a planned and worked hour. The amendment brings equal conditions for taking leave for all employees with the same weekly working hours, regardless of the specific way of scheduling work shifts. The amendment to the Labour Code also cancels the leave for days worked and retains in force only the legal regulation of leave for a calendar year / its proportional part and an additional leave. The basic conditions for the formation of the right to leave, including the scope of obstacles at work that are or are not considered to be a work performance for the purposes of leave, as well as the rules for taking leave, have in principle been maintained in the new legislation.

Job sharing

The amendment to the Labour Code also includes the regulation of the new institute of the labour law, the so called job sharing, the aim of which is to help and support disadvantaged groups of employees on the labour market who prefer shorter working hours with greater time flexibility. According to the new legislation, the employer will be entitled to establish a so-called shared job position, which, on the basis of individual agreements with employees, will be filled with two or more employees performing the same type of work during agreed reduced working hours, and these employees will be able to schedule their working hours into shifts on the basis of their mutual agreement. However, the sum of the agreed working hours of all employees sharing one job position will not be able to exceed the specified weekly working hours. Each of the parties will be able to terminate the abovementioned agreement between the employer and each employee with a 15-day notice period, however such termination will not automatically lead to the termination of the job sharing.

Damage compensation

The amendment to the Labour Code also brought changes in compensation for injury to the health of employees during the performance of work duties. For example, there is a change in the amount of compensation for injury to health or the scope of persons entitled to such compensation for non-pecuniary damage provided to surviving relatives of an employee. The amendment also introduces into the Labour Code the institute of one-off compensation for non-pecuniary damage in the event of particularly serious injury to an employee’s health, which will be used in exceptional cases where the consequences of such injury are so extensive that these consequences are comparable to the death of an employee.

Delivery of documents

Regarding the amendment to the Labour Code, there are also changes in the regulation of delivery of documents between the employer and the employee. The amendment now allows the employer to deliver documents concerning the employment relationship to the employee via the employee’s databox if the employee agrees to such delivery. At the same time, the amendment introduces the legal fiction of delivery of a document to employee via a data box on the 10 th day from the day of delivery of the document to the data box.

When sending documents using a postal service provider, the employer will now send the documents to the address communicated in writing by the employee upon request. The employee will thus be primarily responsible for the accuracy and timeliness of his / her data for the delivery of documents. The amendment further stipulates a new legal fiction of delivery of a document to an employer who refuses to accept delivery of such document – the document will be considered delivered on the day when the employer refuses to take over the document or fails to cooperate with the employee in delivery of the document.

Other changes

In addition to the abovementioned changes, the amendment to the Labour Code also brings, for example, changes in the area of posting workers / employees of the employer from another EU Member State to the territory of the Czech Republic for the purpose of transnational provision of services. The amendment primarily regulates the rules of remuneration of posted employees(regulation of new employee rights to night supplement, travel allowances, etc.), as well as the conditions of accommodation of such employees in the Czech Republic, which the employer must comply with when posting workers.

The full wording of Act No. 285/2020 Coll., which amends the Labour Code, may be found here: https://www.psp.cz/sqw/sbirka.sqw?O=8&T=689.

In case of any questions, please do not hesitate to contact us via email (info@kastnerpies.cz).

 

Kastner & Pieš is a new member of Biolaw association

We are pleased to announce that as of 1st November 2019, we became members of Biolaw association, which associates independent law firms with focus on life sciences industry regulation. Our membership expands our existing network of corresponding law firms and allows our clients to obtain experienced legal support in more countries.

We usually reach out to our corresponding firms in case of compliance audits and programs, international questionnaires or protection of intellectual property.

If you would like to know more, please do not hesitate to contact us at info@kastnerpies.cz or check out the association’s websites http://www.jusmedico.com/biolaweurope

MoH approved Clinical Trial Agreement template in CZ and SK

We would like to inform you that, on 3rd May 2019, the Ministry of Health of the Czech Republic published on its website a Methodological Guideline on the Content of a Clinical Trial Agreement of a clinical trial of medicinal products for human use dated 30th April 2019, which includes a template Clinical Trial Agreement. The Ministry requested all clinical trial sponsors and healthcare providers involved in clinical trials to use such a template agreement as much as possible. The guideline is applicable to all Ministry-directly-managed hospitals (all of the major ones).

The template agreement is designed as a 3-party agreement between a sponsor, a site and an investigator. The agreement is bilingual (Czech and English) and reflects relevant EU and Czech legislation as well as key GDPR aspects.

The main objective of this template agreement is to shorten and simplify the process of executing a clinical trial agreement between sponsors and healthcare providers. The use of a template agreement should also lead an increase in the number of clinical trials performed in the Czech Republic and to the improvement of the Czech Republic’s position in international competition in clinical research. The Ministry’s ideal is that if the agreement will not be amended, it should be automatically accepted by the Ministry directly-managed hospitals.

The Methodological Recommendation in question is available on the website of the Ministry of Health of the Czech Republic, in the section “Legislation” and in the subsection “Clinical trial” (http://www.mzcr.cz/Legislativa/obsah/klinicke-hodnoceni_4016_11.html).

The Ministry of Health of the Slovak Republic approved a similar template Clinical Trial Agreement. The template agreement is a part of the Order of the Minister of Health No. 4/2018 and it is available on the website of the Ministry of Health of the Slovak Republic which is available on the website of the Slovak Ministry of Health (https://www.health.gov.sk/Clanok?Prikaz-4-2018). The Order of the Minister, with respect to the template agreement, is effective from 1st June 2019.

Our office was involved in the preparation of both of the agreements in the Czech Republic and Slovakia.

Please do not hesitate to contact us in case of any questions via our email (info@kastnerpies.cz).

Proposal for emergency distribution channel of pharmaceuticals in Czech Republic

The Czech Ministry of Health (“MoH”) is currently working on a draft legislation implementing an emergency distribution system (inspired by the Slovakia where something similar was introduced in April last year) that should, in the opinion of the MoH, prevent re-export of medicinal products from the Czech Republic and improve availability of the medicinal products on the Czech market. The MoH would like to introduce a specific emergency distribution channel based on which a pharmacy could order a medicinal product directly from the MAH if it cannot be reliably supplied through a standard distribution channel. The whole system is introduced in reaction to repeated complaints from pharmacies regarding unavailability of various medicinal products that are the subject of parallel trade.

The emergency distribution system should work in a way where MAH will have to establish and operate an electronic information emergency system for ordering of Rx products. If a pharmacy cannot procure a medicinal product from a distributor, it will be able to order it through the emergency system. The marketing authorization holder will be obliged, on the basis of this order, to supply the pharmacy with the required medicinal product within two working days of receipt of such order. If the marketing authorization holder fails to comply with this obligation, it will may be subject to significant fines. The draft amendment also provides exemptions from the obligation to supply a medicinal product, for example in case of the reported outage based on objective obstacles.

In relation to the emergency channel, the MoH intends to introduce additional measure that should ensure better availability of medicinal products (only for those with reimbursement) for Czech patients. Specifically, same as in Slovakia, the MoH will introduce a statutory provision based on which reimbursed medicinal products may only be exported to another country with express MAH’s consent. Therefore, the MAH will be fully responsible for assessing the availability of his medicinal product on the Czech market and, if it is not endangered, the medicinal product may be exported abroad with his consent.

The proposal of the Ministry of Health needs to go through the whole legislative process and it is expected to be effective in the course of the next year or beginning of 2020. However, especially the second part (related to consent with export of products) is criticized since it may constitute a competitive issue and violation EU competition law. From our experience in Slovakia, this right of the MAHs is rarely used as there is a potential risk of competition law consequences, even on the EU level.

The concrete text of the statutory amendments is not yet published and the information above is result of information communicated by the MoH’s representatives and thus maybe subject of additional changes.