The Pharma Legal Handbook: Czech Republic

Key legal info on biosimilars & biologics in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 119.

 

1. Are biosimilar medicines considered the same as generic medicines in your country?

No, biosimilars are not regarded as generics of biological medicines. Czech legislation implements EU directives, and directly applicable EU regulations on biosimilars and biologics apply. EU legislation establishes that, due to the variability and complex manufacturing process of biologics and biosimilars, more information and studies are needed for approval of biosimilars in comparison to generics.

 

2. Are all biologic medicines, including biosimilar medicines patentable in your country?

We are not aware of any specific exclusions of biologic or biosimilar medicines from patentability. In order to obtain patent protection, all requirements stipulated by Czech law, in particular by Act No. 527/1990 Coll., on Inventions, Designs and Improvement Proposals, as amended, must be met. One of these requirements is novelty. Practically speaking, it may be that typical biosimilar medicines will not be considered sufficiently novel for patent protection. However, we believe the chances of patentability are better if it relates to some specific elements of the biosimilar, such as new formulations involving a biosimilar medicine or a new process for making a biosimilar. A precise expert assessment of these issues would be required in each specific case to provide a more definite opinion on patentability.

 

3. Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in your country? If yes, what is the regulatory framework for the authorization of biosimilar medicines?

Rules set out in the Regulation 726/2004 (“MPA Regulation”)¹ apply to the marketing authorization of biosimilars.

Under the MPA Regulation all medicinal products developed by specified biotechnological processes must obtain a centralized marketing authorization, in accordance with the MPA Regulation, before being put on the EU market. The relevant biotechnological processes are: (i) recombinant DNA technology, (ii) controlled expression of gene coding for biologically active proteins in prokaryotes and eukaryotes, including transformed mammalian cells, and (iii) hybridoma and monoclonal antibody methods.

In the event that a biosimilar is not developed by any of the processes specified above (e.g. naturally derived biologicals) a centralized marketing authorization is not mandatory. Nevertheless, even then there are two options when it is possible to apply for a centralized marketing authorization.

The first option applies to biosimilars where the reference medicinal product has already been authorized through the centralized procedure. These may be awarded centralized marketing authorization if they fulfil the requirements defined in the MPA Regulation as well as requirements arising from Directive 2001/83 (“Directive 83”)².

The second option applies if the applicant is able to show that (i) the biologic constitutes a significant therapeutic, scientific or technical innovation or (ii) that the granting of the marketing authorization is in the interests of patients’ health at the EU level. The European Medicines Agency (the “Agency”) determines whether a biologic constitutes a significant therapeutic, scientific or technical innovation. Similarly, the Agency evaluates the level of patients’ health interest (factors to consider include, for example, whether the biosimilar addresses a specific health issue).

Additionally, as the centralized marketing authorization is not mandatory in these cases, other means of registration can be used instead. These are national registration, mutual recognition procedure and decentralized procedure.

 

4. What kind of data package is needed to obtain approval for a biosimilar drug? Is this any different to the requirements for the original Biologics drug?

In general, less data is required for biosimilars in comparison with original biologics. This is because, rather than establishing the properties of a biosimilar on its own, the documentation provided to obtain approval for a biosimilar is to establish and prove its similarity to the reference biologic so that the proven safety and efficacy properties of the original biologic apply to the biosimilar as well. Additionally, the main aim of the process is to identify possible differences between the original biologic and the biosimilar or rather ensure that there are none, or only those that can be justifiably accepted.

The data required are comparable to the data required for a marketing authorization of other medicinal products. However, in particular, the results of pre-clinical and clinical studies must also be provided if the biosimilar in question does not fulfil the criteria of a generic, as set out in Directive 83.

Given the differences between individual biologics and biosimilars, the required data package differs case-by-case. It is therefore advisable to consult the relevant authority in advance.

 

5. What are the requirements for the choice of the reference comparator product?

The reference medicinal product must be an EEA-authorized medicinal product. Only one reference medicinal product can be used for the comparability program for quality, safety and efficacy studies during the development of a biosimilar.

Furthermore, in order to be able to use the reference medicinal product documentation in an application to register a biosimilar, the data exclusivity period for the reference medicinal product in question must have expired by the time the application for the biologic is submitted.

 

6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?

A non EEA authorized version of the reference medicinal product can be used only for certain studies (e.g. certain clinical and in vivo non-clinical studies) in order to avoid their unnecessary repetition, or alongside a reference medicinal product authorized in the EEA.

However, such non EEA reference medicinal product must be authorized by a regulatory authority with similar standards as the EMA (e.g. authorities participating in the International Council for Harmonisation (ICH)).

Furthermore, the applicant must demonstrate that the non-EEA medicinal product is representative of the EEA reference medicinal product based on scientifically justifiable comparative data, which compare all three medicinal products, i.e. both the EEA-authorized and non EEA-authorized medicinal product, as well as the biosimilar in question. The data needed to provide sufficient scientific justification differ case-by-case; however, they must be assessed along with the application for authorization of the biosimilar; it is therefore advisable to consult the relevant authority in advance.

 

7. How are the prices of biosimilar medicines regulated? Is this any different to the requirements for the original Biologics drug?

The most common method of price regulation is regulation by the maximum price. The maximum price is set in administrative proceedings conducted by the State Institute for Drug Control (“SÚKL”).

The maximum price of a medicinal product is established based on an average of the three lowest manufacturers’ prices in the countries of the reference basket. If the prices of the medicinal product in three countries of the reference basket are not available, then the price can be established based on an agreement between the marketing authorization holder (“MAH”) and a public health insurer (provided the agreement had been entered into in writing, in the public interest and after the defined negotiation procedure). If this method is not possible, then the maximum price is determined based on the closest therapeutically comparable medicinal product available in the Czech Republic, provided that the comparable medicinal product’s price had been determined on the basis of average manufacturers’ prices, as described above. If that method is not possible, then the closest therapeutically comparable medicinal product with the lowest price is found within the reference basket countries.

The maximum price of the very first medicinal product similar to the first medicinal product in a reference group (see below) is established by lowering the price established for the original biologic by 30 percent.

 

8. What is the reimbursement policy for biosimilar medicine? Is this any different to the requirements for the original Biologics drug?

In order for any medicinal product to receive reimbursement it must be authorized first (or approved for use in a specific treatment program). Additionally, if the medicinal product is subject to price regulation, its maximum price must be established first or along with the setting of the reimbursement.

Currently, Czech regulation does not provide any specific rules for the reimbursement of biologics; therefore, the general rules on reimbursement apply.

For the purposes of reimbursement, every medicinal product must be placed into a reference group. Each reference group includes therapeutically interchangeable medicinal products with comparable or close efficacy and safety and similar clinical use; the reason for this is that similar medicinal products should receive a similar level of reimbursement. The list of all reference groups can be found in a decree issued by the Czech Ministry of Health³. However, as not all medicinal products can be placed in these groups, additional “pseudo-reference groups” are often established for medicinal products with unique or new substances. The reimbursement procedure is similar to the one used for the reference groups.

Each reference group has its basic reimbursement. The basic reimbursement is (most commonly) established by using a medicinal product which belongs to the group and is available in the EU and the Czech Republic. The basic reimbursement of the reference group is then set in accordance with the price for the medicinal product with the lowest manufacturer’s price for a defined daily dose (DDD). The SÚKL then uses the basic reimbursement to determine the reimbursement of any medicinal product belonging to the group (and it is set based on the DDD content of that medicinal product).

Additionally, the SÚKL may establish specific conditions for reimbursement (e.g. prescription or indication restrictions). These do not prohibit doctors from prescribing the medicinal product; however, if the conditions are not met, the product will not be reimbursed.

Reimbursement for any biosimilar follows the same set of rules, except for the very first similar product in the relevant reference group (if this product is a biosimilar, then in addition the MAH must undertake to provide the biosimilar to the market for 12 months from the time it obtains the reimbursement). The reimbursement of the first similar product follows the price of the product to which it is similar and is subsequently lowered by a defined percentage (30 percent for biologics). The introduction of the first biosimilar product also results in lowering the basic reimbursement of the relevant reference group by 15 percent.

 

9. Does biosimilar competition impact the reimbursement policy of the originator reference products?

Yes. As described above, introduction of the first biosimilar in the reference group may result in lowering the basic reimbursement of that group by 15 percent.

More significantly, a MAH may negotiate with health insurers on the reimbursement of its medicinal product (e.g. original biologics) provided, in particular, (i) the resulting price for the patient is lower than the one which would have been determined by SÚKL in a proceeding, (ii) all health insurers are a party to the agreement and (iii) the agreement relates to all supplies of the medicinal product on Czech market. In this case, reimbursement of the medicinal product is equal to the price negotiated.

Such negotiations between the MAH and health insurers may therefore affect the basic reimbursement of the relevant reference group.

Furthermore, the SÚKL is entitled by law to conduct reimbursement reviews – either in-depth reviews at least every five years or abbreviated reviews – which affect reimbursement as well. An abbreviated review can be initiated by the SÚKL itself or by any health insurer at any time, so long as the expected yearly savings on health insurance expenditures are CZK 30 million or more (approx. EUR 1.1 mil.). The shortened review affects the entire reference group.

 

10. What is the legal framework for biosimilar medicines prescribing (clinical decision maker) and dispensing (pharmacy level, hospital or retail)? Is this any different to the requirements for the original Biologics drug?

Prescribing and dispensing practices are not regulated at the EU level; they fall under the responsibility of individual member states.

In general a physician is responsible for the treatment of a patient, including prescribing medicines. A physician is free to choose any medicinal product he/she believes is the most suitable for the patient, so long as the treatment falls within his/her specialization (e.g. oncology, rheumatology, etc.; moreover, some medicinal products can only be prescribed by physicians working in specialized hospital centers).

A duly specialized physician can therefore, with the patient’s consent, in theory switch from a biologic to a biosimilar, or even from a biosimilar to another biosimilar. However, in practice this approach is not at all recommended, mainly due to differences among biologics and biosimilars. For example, the Czech Society for Oncology recommends a cautious approach, even when the switch is required by circumstances (i.e. a patient’s intolerance to a specific medicinal product). It further recommends duly explaining to the patient, with duly justifying the switch in the health documentation, and even obtaining informed consent from the patient.

There is no specific standalone legislation for dispensing biologics or biosimilars; therefore, general rules apply. However, in practice, most pharmacies do not have biologics or biosimilars available – mainly due to their cost and only specialized pharmacies at specialized health centers are able to provide biologics or biosimilars. Usually, centers with specialized physicians do have their own pharmacies.

 

11. Is the system considering physician-led switching and/or pharmacy-level substitution (without involvement of the clinical decision maker)?

There is no specific regulation when it comes to switching biologics or biosimilars. In general, the physician decides on what medicinal product will be prescribed to a patient. Thus, the physician can decide whether or not to switch a medicinal product with the patient’s consent. In some areas, such as rheumatology switching from an original biologic to a biosimilar is common. However, there is an ongoing discussion about the effects of switching, multiple switching, the so-called nocebo effects, etc. For these reasons, while not prohibited, for example, multiple switching is definitely not common.

Concerning pharmacy-level substitution, pharmacists may in general inform the patient about possible alternative medicinal products (which must be interchangeable, with similar efficacy and safety, etc.). The pharmacist may then dispense a substitute medicinal product if the patient agrees.

However, the Czech Chamber of Pharmacists does not recommend substitution when it comes to biologics (or biosimilars) due to differences among the products. Any possible substitution should be consulted with the prescribing physician and duly monitored. In practice, such substitution happens only very rarely in pharmacies, in specialized centers, in situations when the biologic or biosimilar prescribed is not available at the moment.

For the sake of completeness we add that any physician, when prescribing, may include the note: “do not substitute” (in Czech: “nezaměňovat”) to a prescription. In this case the pharmacist must dispense only the medicinal product prescribed.

 

12. What are the post – authorisation requirements (including pharmacovigilance, risk management plans, post-approval studies) for biosimilar medicines? Is this any different to the requirements for the original Biologics drug?

There is no biologics – or biosimilars – specific standalone legislation relating to post-authorization requirements. Thus, the general rules for medicinal products apply, including pharmacovigilance post-authorization processes.

However, there are some notable specifics for biologics and biosimilars. Concerning pharmacovigilance, most biologics and biosimilars approved by the Agency are in accordance with the MPA Regulation published (alongside other specific medicinal products) in the “List of medicines under additional monitoring”. As the name of the list suggests, these medicinal products are under additional monitoring from relevant regulatory authorities. In order to indicate their special status, the package leaflet as well as the summary of product characteristics is marked with a black inverted triangle accompanied by a short explanatory sentence and the statement: “This medicinal product is subject to additional monitoring”.

To name a few of the general obligations arising from, in particular, the MPA Regulation, the Agency may e.g. impose an obligation on the MAH to conduct a post-authorization safety study or post-authorization efficacy study, or it may request the MAH to provide data demonstrating that the risk-bene-fit balance of the medicinal product remains favorable, etc. Similar powers are vested in the Czech regulator, the SÚKL, in connection with national registration procedures.

 

13. Are there specific policies and requirements in terms of biosimilar medicines labelling in the event of second medical use patents? Is this any different to the requirements for the original Biologics drug?

As described in our response to question no. 12, most biologics and biosimilars approved by the Agency are included in the “List of medicines under additional monitoring”. This status is indicated in the package leaflet, as well as in the summary of product characteristics of such medicines, with a black inverted triangle accompanied by a short explanatory sentence and the statement: “This medicinal product is subject to additional monitoring”. Aside from that, there are no special requirements with regard to the labelling of biosimilar medicines.

 

14. Have there been any significant legal/judicial developments in relation to biosimilars in your country? (Including but not limited to IP, procurement, competition, misleading information campaign, access to reference comparator product)

There have been no such recent developments in relation to biosimilars in the Czech Republic.

 

15. Are there proposals for reform or significant change to the legal, regulatory, procurement of biosimilars? If yes, when are they likely to come into force?

There are ongoing discussions on possible changes to medicinal product regulation (including biologics and biosimilars and rules for their prescription, etc.). Thus far, nothing specific concerning biosimilars has been proposed.

 

 

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(1) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

(2) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use

(3) Decree No. 384/2007 Coll., on the list of reference groups.

Also from this Legal Handbook

Want to know more about localization in Czech Republic? Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 119.

 

1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies?

As a general rule, there are no localization requirements relating to medicinal products in the Czech Republic. However, some localization rules apply to specific products, such as those connected with the transfusion of blood and blood products. The Czech Ministry of Health can limit the export of these products, and local production can be prioritized if the supply is sufficient. Similarly, export of certain medicinal products can be restricted by Czech authorities.

In addition, there are requirements to obtain an authorization from the relevant Czech authority (in most cases the State Institute for Drug Control, (“SÚKL”) in order to conduct business activities concerning pharmaceuticals in the Czech Republic (manufacturing, distribution, etc.). Authorizations issued by competent authorities from EEA countries are recognized in the Czech Republic.

 

2. Have there been any recent significant changes involving localization rules? If yes, when did they take place and what did they involve?

There have been no significant changes.

 

3. Is the process of obtaining a marketing authorization impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

Yes, to some extent. As a general rule, the Czech Republic does not recognize foreign marketing authorizations.

The Czech Act on Pharmaceuticals¹ does not allow medicinal products to be placed on the market here without first being authorized by either (i) the SÚKL, in a national procedure, mutual recognition procedure or decentralized procedure or (ii) the European Commission in a procedure compliant with a directly applicable EU regulation (i.e. the centralized procedure). Furthermore, marketing authorization holders of any such products must have their registered office an EEA country.

 

4. Is the pricing process for pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No, the pricing process for pharmaceutical products is not impacted by localization policies in the Czech Republic.

 

5. Is the reimbursement of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No, reimbursement of pharmaceutical products is not impacted by localization policies in the Czech Republic.

 

6. Is the access to public or public tenders of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

In general, no. Localization policies do not impact access to public tenders in the Czech Republic.

The law expressly states that the contracting authority must not restrict public tender participation of suppliers who have their registered office (i) an EEA country or (ii) in a state with which the Czech Republic or the EU has an international agreement on access to public tenders.

Even though the contracting authority may include specific conditions in the public tender, it must abide by the principles of equal treatment and non-discrimination and must not restrict competition without due justification. If the conditions of a public tender do not fulfil these principles or fail to follow the rules set by the Public Procurement Act², the Office for the Protection of Competition (i.e. the relevant Czech authority) will terminate the public tender.

 

7. Are import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products impacted by localization policies in your country ? If yes, how so?

The Czech Republic is a member of the European Union Customs Union; therefore, all import tariffs are regulated at the EU level. In particular, the Union Customs Code³ applies.

As regards distribution, anyone with a distribution authorization, from either the SÚKL or any other EU member state’s relevant authority, may distribute medicinal products in the Czech Republic. Distributors holding a license from another EU member state’s relevant authority only need to notify the SÚKL in advance that they plan to begin distribution activities in the Czech Republic (unless the distributor establishes a distribution warehouse in the Czech Republic, then a distribution authorization from the SÚKL is required). Both Czech and EU distributors are guaranteed the same rights and obligations.

Furthermore, under Czech law a holder of a distribution authorization is also entitled to export medicinal products to third countries (i.e. countries outside the EU).

However, in order to import medicinal products from third countries, an authorization to manufacture medicinal products in the scope of import from third countries (the “Import Authorization”) must first be obtained, i.e. a distribution authorization is not sufficient. The Import Authorization is issued by the SÚKL.

In general the taxation of medicinal products in the Czech Republic is not impacted by localization policies. However, indirect incentives do exist, aimed at specific areas, such as research and development (“R&D“). Under the Act on Income Taxes R&D expenses can be deducted from the income tax base. The amount of R&D expenses that can be deducted depends on the expenses recorded in the previous financial year; if they do not surpass expenses from the previous financial year, they can be deducted at 100%. Any expenses over the amount claimed in the previous financial year can be deducted at 110%.

 

8. Are there any other incentives or advantages offered by the current local localization rules in your country? If yes, what are they?

There are no incentives or advantages offered in the Czech Republic that relate exclusively to medicinal products.

 

9. Are there discussions about the possibility of implementing localization policies in your country? If yes, what are the proposed reforms and when should they come into place?

In reaction to the Covid 19 pandemic, discussions have begun regarding the EU’s dependence on medicinal products manufactured in Asia (China in particular) and whether this should be allowed to continue. However, this discussion is in its early stages.

 

 

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(1) Act No. 378/2007 Coll., on Pharmaceuticals

(2) Act No. 134/2016 Coll., on Public Procurement

(3) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code

 

Also from this Legal Handbook

An intro to the legal situation for orphan drugs and rare diseases in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 119.

 

1. What is the definition of Rare Diseases in your country?

The relevant Czech regulation defines rare diseases as those with a very low incidence in the population, within the meaning of the relevant EU regulation. This refers to the definition from Article 3 of the directly applicable regulation (EC) No 141/2000 on orphan medicinal products (“Regulation 141”).

So, under Czech law a rare disease is a life-threatening or chronically debilitating condition affecting not more than five in 10,000 persons in the EU.

 

2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)

Since Regulation 141 is directly applicable in the Czech Republic, Czech law uses the definition of orphan drugs from Article 3 of the Regulation 141 as well.

The definition for orphan drugs (in Czech: léčivé přípravky pro vzácná onemocnění) corresponds to some extent with that of rare disease (in Czech: vzácná onemocnění). However, the definition of an orphan drug is broader when it states that the sponsor of a medicinal product wishing to designate it as an orphan drug must establish that the product is either (i) intended for a rare disease (see the definition in question 1. above) or (ii) intended for another serious disease, while the investment in the product without being designated as an orphan drug would otherwise likely be unprofitable.

Moreover, a medicinal product can be designated an as orphan drug only if (i) no satisfactory method exists for diagnosis, prevention or treatment of the (rare) disease, or (ii) a method exists, but the medicinal product in question would be of significant benefit to those affected by the disease.

Regulation 141 governs the process of designating a drug as an orphan drug.

 

3. What is the regulatory framework for the authorization of an Orphan Drug? (Is this regulatory framework based on Rare Disease status or can it alternatively be based on Orphan Drug foreign status?)

Firstly, an orphan drug must be designated as such before applying for a marketing authorization. The process of designation of an orphan drug follows Article 5 et seq. of the Regulation 141.

An application to the European Medicines Agency (the “Agency”) for a medicinal product to gain orphan drug status may be submitted at any stage of the development of the medicinal product. The Committee for Orphan Medicinal Products (the “Committee”), established within the Agency, then gives its opinion on the medicinal product within 90 days of a (duly) submitted application. The European Commission then decides whether the medicinal product can be designated as an orphan drug within 30 days of the issued opinion. Once approved by the European Commission, the orphan drug is entered in the Community Register of Orphan Medicinal Products.

The process for designation is based on the (rare) disease status (see above); there is no differentiation between sponsors from third-countries and the EU.

Once successfully designated, the sponsor can apply for registration in accordance with the relevant EU regulation on authorization of medicinal products (“MPA Regulation”)¹, i.e. through the general registration process used for any other medicinal product. Once successfully registered, the orphan drug may be used throughout EU member states.

The registration is valid for five years and may be extended for an indefinite term after further review. However, the European Commission can also decide to extend the registration for an additional five-year period (thus postponing the possibility of an indefinite extension by five years), for reasons of pharmacovigilance. As “exposure of an insufficient number of patients to the medicinal product concerned” can be explicitly stated as grounds for justifying an additional five-year registration, this exception may apply to orphan drugs in particular.

 

4. Does your country have pro- visions for relaxed clinical trial/ scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?

A distinction between the designation and authorization of an orphan drug must be made.

The requirements for the designation of orphan drugs are contained in the directly applicable Regulation 141, and are specific to orphan drugs. Additionally, given that an application for designation of such medicinal product can be made at any stage of the product’s development, the documentation required can be considered relaxed. That said, it must be noted that, upon approval of the designation, the sponsor is obliged to submit to the Agency an annual report on the state of development of the designated orphan drug, including, e.g., a review of ongoing clinical studies.

Marketing authorization of an orphan drug follows the rules for a centralized procedure under the MPA Regulation. This procedure does not offer any relaxed approach; however, there are alternative marketing authorizations which allow for some leeway in supporting documentation and scientific evidence requirements. Specifically, there are (i) a conditional marketing authorization and (ii) a marketing authorization under exceptional circumstances, as described below.

 

5. Is there an expedited pathway for Orphan Drugs?

Conditional marketing authorization

The MPA Regulation along with the Commission regulation on conditional marketing authorization (“Commission MA Regulation”)² provide for an expedited pathway for a range of medical products, including orphan drugs.

In duly justified cases, in order to meet “unmet medical needs of patients” a marketing authorization may be granted on the basis of temporarily less complete data than what would be required under the “standard” procedure, provided that the risk-benefit balance for granting such marketing authorization is positive, as well as provided that other requirements arising from the regulation are met. The term “unmet medical needs of patients”, as defined in the MPA Regulation, means a condition for which no satisfactory method of diagnosis, prevention or treatment authorized in the EU exists or, even if a method exists, the medicinal product concerned represents a major therapeutic advantage to those affected.

Additional specific obligations (including a timeframe for their completion) may be imposed in a conditional marketing authorization, such as the obligation to conduct additional studies concerning the risk-benefit balance, etc. Information on such specific obligations is then made available to the public, and the fact that the medicinal product has been granted a marketing authorization subject to specific obligations must be included in the summary of the product characteristics and the package leaflet. Failure to fulfil the specific obligations will result in a change, suspension or revocation of the marketing authorization.

Due to their conditional nature, conditional marketing authorizations are valid for one year only, though on a renewable basis. A renewal application must be submitted six months prior to the expiry of the marketing authorization. Additionally, any conditional marketing authorization can be transformed into a “standard” marketing authorization under the MPA Regulation, provided its outlined specific obligations have been met.

 

Accelerated assessment procedure

It should also be noted that under the MPA Regulation an applicant may request a medicinal product to be assessed in an accelerated assessment procedure. However, this procedure is only possible if the medicinal product in question is of major interest from a public health point of view, in particular, from the point of view of therapeutic innovation.

 

Exceptional circumstances

Finally, “a marketing authorization under exceptional circumstances” may be issued, especially in relation to orphan drugs (please note that orphan drug designation alone is not sufficient to successfully request a marketing authorization under exceptional circumstances).

Under relevant provisions of the Commission MA Regulation, an applicant can file for such marketing authorization provided that the applicant can demonstrate that it is not possible to provide comprehensive data on the efficacy and safety under normal conditions of use, because (i) the indications which the product in question is intended for are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence, or (ii) in the present state of scientific knowledge, comprehensive information cannot be provided, or (iii) it would be contrary to generally accepted principles of medical ethics to collect such information. Additional obligations may be imposed.

A marketing authorization under exceptional circumstances is valid for five years and may be extended for an indefinite term after further review (or for an additional term of five years based on a decision by the European Commission, as described above), similarly to a general marketing authorization.

 

6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?

Where the EU is concerned, once granted by the European Commission, a centralized marketing authorization is valid in all member states as well as throughout the European Economic Area (i.e. Iceland, Liechtenstein and Norway). This also means that should the medicinal product fail to receive an authorization, it may not be placed on the market anywhere in the EU. All decisions of the European Commission are published in the Union Register of medicinal products. However, it has to be noted that this does not apply to reimbursement, which is awarded on an individual country-by-country basis.

 

7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan Drugs?

Under Czech law the reimbursement of orphan drugs is possible; however, there is no specific reimbursement procedure for orphan drugs, i.e. general reimbursement provisions apply.

Even though there is no specific provision or regulation pertaining to orphan drugs, certain provisions of Act No. 48/1997 Coll., on Public Health Insurance (“PHI Act”) are often used to reimburse such medicinal products. These provisions relate to “highly innovative products”, which the PHI Act defines as medicinal products containing an active substance that (i) can be used for the treatment of a disease that so far could not have been treated by any other medicinal product or substance, or that (ii) presents a major improvement in treatment.

There is no need to show cost effectiveness or treatment results in clinical practice for an orphan drug to be reimbursed as a highly innovative product, but certain other requirements apply, including the following: (i) the reimbursement must be in the public interest (a fact assessed by the State Institute for Drug Control (“SÚKL”), i.e. the relevant Czech public authority), (ii) the available information must sufficiently evidence that the orphan drug under consideration is beneficial in a particular treatment, and (iii) the orphan drug must already be reimbursed in at least two countries of a reference basket.

If approved, the highly innovative product is granted reimbursable status for 24 months only; this can be extended for an additional 12 months, i.e. the product may be reimbursed as a highly innovative product for a maximum of 36 months.

Additionally, it must be noted that the PHI Act contains a specific provision – Section 16. This provision allows for the reimbursement of any medicinal product for a patient on an individual case-by-case basis, provided that the medicinal product is the only possible treatment given the health condition of the specific patient. Note that this provision is interpreted very restrictively.

 

8. How are the prices of Orphan Drugs regulated?

No specific regulation applies to the establishment of orphan drug prices, i.e. the general rules for all medicinal products apply. The relevant public authority, the SÚKL, regulates prices by establishing a maximum price.

The most common way to establish a maximum price is by calculating the average of the three lowest prices from countries included in the reference basket.

If this method is not feasible (e.g. the medicinal product in question is not available on the markets in at least three countries included in the reference basket), other methods can be used, such as establishing the price based on the price of a comparable medicinal product, etc.

 

9. In case of reference price based on a basket of countries, what countries are included?

All EU countries are included with the exception of: Bulgaria, Czech Republic, Estonia, Luxembourg, Germany, Austria, Romania, Greece, Cyprus and Malta.

 

10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?

An amendment to the PHI Act and related legislation is currently (May 2021) in the early stages of the legislative procedure, in the Chamber of Deputies of the Parliament of the Czech Republic, which intends to introduce an orphan drugs-specific regulation on reimbursement, among other things.

 

11. Are there proposals for reform or significant change to the regulation of Orphan Drugs? If yes, when are they likely to come into force?

The above-mentioned amendment to the PHI Act and related legislation is still in the very early stages of the legislative procedure; thus, it is currently impossible to estimate the likely date of its entry into force.

 

 

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(1) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

(2) Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorization for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council

Also from this Legal Handbook

Cannabinoid drugs, medicinal cannabis and opioid drugs in Czech Republic – a legal guide. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 119.

 

CANNABINOID DRUGS

1. Are Cannabinoid Drugs authorized in your country?

Cannabinoid Drugs, i.e., drugs containing active compounds of cannabis, such as tetrahydrocannabinol (THC) or cannabidiol (CBD), can be authorized in the Czech Republic under the general legal framework for authorization of drugs. Cannabinoid Drugs must be differentiated from Medicinal Cannabis (dried flowers of the plant Cannabis sativa L. or Cannabis indica L. intended for medicinal purposes), which is subject to a specific legal framework.

 

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

The regulatory authorities with jurisdiction over all drugs, i.e., Cannabinoid Drugs as well as other drugs, are the State Institute for Drug Control and the Ministry of Health. 

 

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

No. Authorization, pricing and reimbursement of Cannabinoid Drugs are regulated by the same legislation as the authorization, pricing and reimbursement of other drugs (please refer to Answer No. 2 of Regulatory, Pricing, and Reimbursement Overview).

 

4. Which are the cannabinoid drugs that have received market approval to date?

The only drug containing cannabinoids which has been authorized in the Czech Republic so far is Sativex (registration No. 63/ 256/11-C, marketing authorization holder: GW Pharma (International) B.V., the Netherlands, type of registration procedure: mutual recognition procedure). 

Sativex contains THC and CBD; every 100 microliters of spray contain 2.7 milligrams of tetrahydrocannabinol (THC) and 2.5 milligrams of cannabidiol (CBD). Sativex is used in the treatment of multiple sclerosis, specifically to treat symptoms related to muscular stiffness (spasticity). Sativex can be prescribed only after other drugs for muscular stiffness proved ineffective. 

 

5. Who can prescribe Cannabinoid Drugs?

Drugs containing cannabinoids (such as Sativex) can be prescribed by any medical doctor authorized to provide healthcare services; although a specific type of prescription is required.

 

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

No, there is no such list.

 

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

Cannabinoid Drugs containing substances classified as narcotic substances (such as Sativex that contains THC) can only be prescribed using the electronic prescription system (eRecept), whereas the electronic prescription must bear a specific label “highly addictive substance”.

Under exceptional circumstances, a specific type of prescription in paper form with a diagonal blue stripe may be used. However, the distribution, use, and disposal of paper prescriptions with a diagonal blue stripe is strictly regulated.

 

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

Drug manufacturers, wholesalers and distributors wishing to sell/distribute authorized Cannabinoid Drugs must obtain the following authorizations: (i) authorization from the Ministry of Health for handling narcotic and psychotropic substances under the Narcotic Substances Act and (ii) authorization from the State Institute for Drug Control for manufacturing and/or distributing drugs under the Act on Drugs.

As regards selling Cannabinoid Drugs to the public, the only organizations authorized to do so are pharmacies, upon a prescription issued by a medical doctor. For details regarding prescriptions, please refer to Answer No. 7 of this Chapter.

 

9. Is there a list of retailers/ distributors authorized to sell Cannabinoid Drugs?

A database of pharmacies is available at the State Institute for Drug Control’s website at the following link: https://prehledy.sukl.cz/prehledy.html#/lekarny

Any pharmacy in the database is authorized to sell (dispense) Cannabinoid Drugs upon presentation of a proper prescription issued by a medical doctor. Pharmacies do not need any special permission to sell Cannabinoid Drugs since they are exempt from the requirement to hold an authorization for handling narcotic and psychotropic substances issued by the Ministry of Health under the Narcotic Substances Act.

A database of distributors is available at the State Institute for Drug Control’s website at the following link: https://www.sukl.eu/modules/distributors/index.php?lang=2

However, there is no information about whether the distributor is authorized to distribute Cannabinoid Drugs in this database, i.e. whether it holds an authorization for handling narcotic and psychotropic substances issued by the Ministry of Health under the Narcotic Substances Act.

 

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

There are no proposals for any significant reform of Cannabinoid Drug regulation.

 

11. When are they likely to come into force?

Not applicable.

 

 

MEDICINAL CANNABIS

12. Is Medicinal Cannabis authorized in the country?

Yes, Medicinal Cannabis has been authorized in the Czech Republic since 2013, but in practice it has only been available to patients since 2015. 

 

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

Medicinal Cannabis falls under the jurisdiction of the State Agency for Medical Cannabis (SAKL) and the Ministry of Health.

Technically, SAKL is only a subdivision of the State Institute for Drug Control as one of the tasks of the State Institute for Drug Control is to serve as an agency pursuant to the Single Convention on Narcotic Drugs (1961).

 

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

Medicinal Cannabis is defined as dried flowers of the plant Cannabis sativa L. or Cannabis indica L. intended for medicinal purposes. 

Medicinal Cannabis can only be prescribed by medical doctors with the appropriate specialization and only for the health indications listed in the Cannabis Decree (No. 236/2015 Coll.). This applies to both locally produced and imported Medicinal Cannabis.

Medicinal Cannabis is dispensed in a form of an individually prepared medicinal product (IPMP), i.e., a medicinal product that is individually prepared for a patient by a pharmacy based on a medical doctor’s prescription. Only Medicinal Cannabis whose levels of THC (tetrahydrocannabinol) fall within 0.3 percent to 25.0 percent and whose levels of CBD (cannabidiol) do not exceed 23.0 percent can be used to prepare an IPMP.

Both locally produced and imported Medicinal Cannabis is available. Following a recent change in the regulation effective from 1 January 2022, a licensing system for producers was introduced in order to facilitate access to locally grown Medicinal Cannabis (please refer to Answer No. 16 of this Chapter 8: Medicinal Cannabis).

Medicinal Cannabis finally became reimbursable on 1 January 2020. Public health insurance currently covers 90% of the price of up to 30 grams of Medicinal Cannabis per month per patient. If approved by the insurance company, this amount can be increased to 180 grams per month per patient.

To be precise, reimbursement covers 90% of the price of the IPMP. The maximum possible price of all IPMPs (whether reimbursed or not) is set in a price regulation issued by the Ministry of Health. The maximum price varies based on the amounts of Medicinal Cannabis used and the size of the packaging, but in general it is calculated with a price similar to the price of the locally produced Medicinal Cannabis and the materials and pharmacy labour used.

 

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

Production and import of Medicinal Cannabis is primarily regulated by the Narcotic Substances Act and the Act on Drugs and their implementing regulations, the most relevant of them being the Cannabis Decree (Decree No. 236/2015 Coll.). The authorities responsible for regulation of the import and production of Medicinal Cannabis are the Ministry of Health (its Inspectorate of Narcotic Drugs and Psychotropic Substances), and the State Agency for Medical Cannabis, whose tasks are carried out by the State Institute for Drug Control. Certain powers related to the import of Medicinal Cannabis are vested in the Customs Administration. 

 

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

Effective 1 January 2022, the previous tender-based single-license and single-producer system was replaced by an application-based licensing system. Any legal entity or entrepreneur who meets the statutory criteria (e.g., has no criminal record) can apply for a cultivation license to grow locally produced Medicinal Cannabis. The statutory criteria may be somewhat restricting as the producer must have a fitted and equipped growing room prior to filing the application for a license. The license may be granted only after a search of the growing room conducted by the State Institute for Drug Control, but not later than within 30 days of filing the application. The search is a paid service billed by the hour at a rate of CZK 900 (approx. EUR 40) per hour. The applicant is obliged to pay a deposit amounting to CZK 26,100 (approx. EUR 1,055) as the price for the services, which is capped at CZK 52,200 (approx. EUR 2,125). The license is valid for 5 years (unless cancelled or revoked) and can be repeatedly renewed. The State Institute for Drug Control must be informed of any changes relating to the license without undue delay; some may even require filing an application for changing the license within 15 days of any change. Additional obligations arise from the license; e.g., the holders must inform the State Institute for Drug Control on the number of cultivated Medicinal Cannabis plants. Furthermore, an authorization for handling narcotic and psychotropic substances issued by the Ministry of Health under the Narcotic Substances Act is required. Failure to obtain an authorization for handling narcotic and psychotropic substances or cancellation of the authorization leads to termination of the cultivation license. 

Suppliers intending to import Medicinal Cannabis from abroad are required to obtain (i) an authorization to distribute medicinal products with an extended scope encompassing distribution to persons authorized to prepare medicinal products (i.e. pharmacies), issued by the State Institute for Drug Control under the Act on Drugs and, (ii) an authorization for handling narcotic and psychotropic substances issued by the Ministry of Health under the Narcotic Substances Act. On top of that, the importer has to secure individual import licenses for each individual supply of Medicinal Cannabis, which are also issued by the Ministry of Health. The import licenses are under the discretion of the Ministry of Health, which has no obligation to issue an individual import license, even if all statutory requirements are met.

 

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

Advertising Medicinal Cannabis to the general public is expressly prohibited. The law is not clear on the possibility of advertising Medicinal Cannabis to experts (i.e., doctors and pharmacists), with the prevailing view being that it is not permitted due to the fact that only medicinal products and substances that are registered in accordance with the Act on Drugs may be advertised while Medicinal Cannabis is not such a registered medicinal product. Academic/scientific debate is possible. Advertising drugs containing narcotic or psychotropic substances to experts (i.e., doctors and pharmacists) is generally possible provided the advertisement is distributed through communication channels designated for these experts and the information contained in the advertisements is precise, current, and verifiable. Other general rules on advertising medicinal products to experts apply as well. For these, please refer to Answer No. 17 of Chapter: Marketing, Manufacturing, Packaging & Labeling Advertising.

Medicinal Cannabis can be distributed by any legal entity or entrepreneur who meets the statutory criteria. In particular such person must obtain an authorization to distribute medicinal products with an extended scope encompassing distribution to persons authorized to prepare medicinal products, i.e., pharmacies. Medicinal Cannabis can then be sold to patients only by pharmacies as an IPMP. 

 

18. How can patients obtain Medicinal Cannabis?

Medicinal Cannabis can be obtained by patients as an individually prepared medicinal product (IPMP) upon a doctor’s prescription in the maximum quantity of 180 grams per month and only by patients who are at least 18 years old.

Medicinal Cannabis can only be prescribed through an electronic prescription system (eRecept) operated by the State Institute for Drug Control. The electronic prescription system includes a Register of Restricted Medicinal Products. One of the purposes of the register is to provide the prescribing doctor and dispensing pharmacist with a tool to check and ensure the compliance with the relevant statutory criteria with respect to a specific patient.

The electronic prescription for Medicinal Cannabis must, in particular, include a specific code. The code is used to divide the Medicinal Cannabis into individual groups based on its species (indica or sativa) and its THC and CBD content (percentage-based) and can be found in Annex 1 to the Cannabis Decree. Furthermore, the prescription must include the dosage and route of administration of the medicinal product.

 

19. Who can prescribe Medicinal Cannabis?

Only doctors with a specific specialization may prescribe Medicinal Cannabis, and only for specific health indications according to the doctor’s specialization. Both the allowed specializations and corresponding health indications are listed in Annex 3 of the Cannabis Decree. 

For example, doctor specializations include clinical and radiation oncology, rheumatology, neurology, psychiatry, etc. and Medicinal Cannabis can be used as an auxiliary treatment to alleviate symptoms accompanying such indications as chronic constant pain, spasticity and related pain from multiple sclerosis, nausea or vomiting in association with cancer or HIV treatment, Tourette syndrome and surface treatment of dermatoses and mucosal lesions.

 

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

A list of doctors authorized to prescribe Medicinal Cannabis is available at the website of the State Agency for Medical Cannabis: http://www.sakl.cz/en/patients/list-of-prescribing-medical-doctors

However, doctors must give their consent to be included in the list and thus the list does not necessarily include all doctors authorized to prescribe Medicinal Cannabis. 

 

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

In order to prescribe Medicinal Cannabis, the specialist doctor must apply to the State Institute for Drug Control for authorization to prescribe. The application is filed via a simple electronic form and merely the doctor’s specialization is verified without the need to provide any documentation. Based on the application, the doctor is granted an access to the Register of Restricted Medicinal Products and may start prescribing Medicinal Cannabis.

Medicinal Cannabis can only be prescribed by doctors authorized to provide healthcare services within the appropriate specialization and only for the health indications listed in Annex 3 of the Cannabis Decree.

 

22. Where is Medicinal Cannabis available?

Any pharmacy may dispense Medicinal Cannabis based on a prescription. In practice, however, it is likely not all pharmacies will be able to and have sufficient supplies and types of Medicinal Cannabis in stock to prepare IPMPs for all patients.

 

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

Any pharmacy may dispense Medicinal Cannabis. A database of pharmacies is available at the State Institute for Drug Control’s website at the following link: https://prehledy.sukl.cz/prehledy.html#/lekarny. 

 

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

The changes made by the recent amendment to the regulation related to Medicinal Cannabis are not fully implemented yet. In particular, the Ministry of Health is yet to issue or amend accompanying implementing decrees.

One of the significant changes introduced by the recent amendments includes the ability to utilize extracts from Medicinal Cannabis in the preparation of IPMPs. An amendment to the Cannabis Decree is currently in the final stages of the legislative process and should provide details on use of extracts (acceptable methods of manufacture, labelling, storage, etc.). This should further facilitate access to Medicinal Cannabis as pharmacies could source prepared extracts rather than Medicinal Cannabis itself.

The Ministry of Health is also yet to issue a decree on the cultivation and processing of Medicinal Cannabis plants, which should provide detailed information on the specifics of cultivation and processing including rules for secure storage, such as CCTV and other security measures to secure a growing room for Medicinal Cannabis plants. The decree is to be inspired by good agricultural and collection practice (GACP) guidelines issued by the European Medicines Agency’s Committee on Herbal Medicinal Products (HMPC). The new licensing system cannot function properly in practice until this decree has been issued.

 

 

OPIOID DRUGS

25. Are Opioid Drugs authorized in your country?

Yes, Opioid Drugs are authorized in the Czech Republic under the general legal framework for authorization of drugs.

 

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

The regulatory authorities overseeing drugs, including Opioid Drugs, are the Ministry of Health and the State Institute for Drug Control.

 

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

No. Authorization, pricing and reimbursement of Opioid Drugs are regulated by the same legislation as the authorization, pricing and reimbursement of other drugs (please refer to Answer No. 2 of Chapter: Regulatory, Pricing, and Reimbursement Overview).

 

28. Which are the Opioid drugs that have received market approval to date?

According to the State Institute for Drug Control’s drug database there are a number of drugs containing opioids that have received market approval and are available with a doctor’s prescription. For example: Morphine (Sevredol, Morphine Kalceks), Oxycodone (Oxycontin), Hydromorphone (Palladone SR), Fentanyl (Adolor, Dolforin), etc.

 

29. Who can prescribe Opioid Drugs?

Any medical doctor authorized to provide healthcare services can prescribe Opioid Drugs; although a specific type of prescription may be required. Limitations on prescription may apply for the purposes of reimbursement of the drugs from public health insurance.

 

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

No, there is no such list.

 

31. What approvals or notifications are required to prescribe Opioid Drugs?

Opioid Drugs can be prescribed by a medical doctor authorized to provide healthcare services, either with a regular electronic prescription or on an electronic prescription labelled “highly addictive substance” depending on the type of the opioid substance contained in the prescribed medicinal product. Under exceptional circumstances, a paper form prescription or a specific type of prescription in paper form with a diagonal blue stripe may be used.

 

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

Drug wholesalers and distributors wishing to sell/distribute authorized Opioid Drugs must obtain the following authorisation s: (i) authorisation  from the Ministry of Health for handling narcotic and psychotropic substances under the Narcotic Substances Act and (ii) authorization from the State Institute for Drug Control for distribution of drugs under the Act on Drugs. 

Drugs containing opioids are dispensed in pharmacies upon a doctor’s prescription (either a regular electronic prescription or upon an electronic prescription labelled “highly addictive substance”, or in exceptional cases on regular paper prescriptions or paper prescriptions with a blue stripe). Any pharmacy may dispense Opioid Drugs. They do not need any special permission to handle opioids since pharmacies are exempt from the requirement for an authorization from the Ministry of Health for handling narcotic and psychotropic substances under the Narcotic Substances Act.

 

33. Is there a list of retailers/ distributors authorized to sell Opioid Drugs?

There is no special list of pharmacies/distributors that sell Opioid Drugs. Nevertheless, the State Institute for Drug Control provides a general search tool of all pharmacies in the Czech Republic on its website: https://prehledy.sukl.cz/prehledy.html#/lekarny. The State Institute for Drug Control also provides a similar general search tool for distributors: https://www.sukl.eu/modules/distributors/index.php?lang=2.

 

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

There are currently no proposals for reform or change to the regulations of Opioid Drugs.

 

35. When are they likely to come into force?

Not applicable.

 

Also from this Legal Handbook

The legal framework for patents and trademarks in Czech Republic Pharma. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 119.

 

1. What are the basic requirements to obtain patent and trademark protection?

One can file for patent protection for any invention, in all fields of technology, provided the invention is new, involves an inventive step, and is capable of industrial application and a fee is paid. Patent protection lasts for 20 years and is subject to yearly maintenance fees.

For trademarks, the main requirements are the ability to be capable of distinguishing the goods or services of one undertaking from those of other undertakings and of being represented on the register in a way that enables the respective authorities and the public to determine the clear and precise subject matter of the protection afforded to its owner. Again, the relevant application fee must be paid. Trademark protection lasts 10 years from the date of application and is renewable every 10 years.

 

2. What agencies or bodies regulate patents and trademarks?

In the Czech Republic both the patent and trademark systems are overseen by the Industrial Property Office.

 

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

There is no specific list of inventions that can be patented. Any invention that meets the requirements of novelty, inventive step, and capability of industrial application can be patented providing this invention is not:

1. a discovery, scientific theory, or mathematical method;
2. an aesthetic creation;
3. a scheme, rule or method for intellectual acts, playing a game or doing business, or a computer program;
4. a presentation of information;
5. a means of surgical or therapeutic treatment of a human or animal body;
6. an invention contrary to public policy or to accepted principles of morality;
7. a plant variety or animal breed or any biological means of production of plants or breeding of animals (except for microbiological means and products of such means).

Under Czech law, any mark that consists of any signs, in particular words, including personal names, or designs, letters, numerals, colors, the shape of goods or of the packaging of goods, or sounds, provided that such marks are capable of distinguishing themselves and can be represented on the register in the manner specified in Answer No. 1 above may be registered.

A trademark will not be registered if it:

1. is devoid of any distinctive character;
2. consists exclusively of signs or indications that may serve, in trade, to designate the kind, quality, quantity, intended purpose, value, geographical origin or the time of production of the goods or of rendering of the service, or other characteristics of the goods or service;
3. consists exclusively of signs or indications that have become customary in the current language or the bona fide and established practices of the trade;
4. consists exclusively of a shape, or other characteristic that results from the nature of the goods themselves, or characteristic that is necessary to obtain a technical result, or characteristic that gives a substantial value to the goods;
5. is contrary to public policy or accepted principles of morality;
6. is of such a nature as to deceive the public, for instance as to the nature, quality, or geographical origin of the goods or service;
7. consists of, or reproduces in its essential elements, an earlier plant variety denomination registered in accordance with European Union legislation or national law, or with international agreements that the European Union or member state concerned is a party to, providing for protection of plant variety rights, provided the registration is sought in respect of plant varieties of the same or closely related species;
8. has not been authorized by the competent authorities and is to be refused pursuant to Article 6ter of the Paris Convention for the Protection of Industrial Property (the Paris Convention);
9. includes badges, emblems or escutcheons other than those covered by Article 6ter of the Paris Convention and that are of particular public interest, unless the consent of the competent authority to their registration has been given;
10. includes a badge or emblem of significant symbolic value, especially religious symbols;
11. is excluded from registration under European Union legislation or international agreements, which the European Union is a party to, providing for protection of traditional terms for wine and traditional specialties.

 

4. How can patents and trademarks be revoked?

A patent will be revoked by the Czech Industrial Property Office if:

1. the invention cannot be protected by a patent;
2. the invention is not described sufficiently clearly and completely so as to be made or devised by an expert;
3. the subject matter of the patent exceeds the content of the originally submitted application to have the invention patented or the subject matter of patents granted on the basis of a division of an application exceed the content of the original application (or if the scope of protection under the patent had been broadened);
4. an authorized person proves that the owner of the patent has no right to the patent;
5. the owner of the patent does not pay the applicable maintenance fee;
6. the owner of the patent renounces ownership of the patent.

A trademark will be revoked on application to the Czech Industrial Property Office or on the basis of a counterclaim in infringement proceedings if:

1. it is identical to an earlier trademark and the goods or services for which registration is sought are identical to the goods or services for which the earlier trademark had been granted;
2. − due to it being identical or similar to an earlier trademark and due to the goods or services covered by the trademarks being similar or identical − there exists a likelihood of confusion on the part of the public in the territory in which the earlier trademark is protected; the likelihood of confusion includes the likelihood of association with the earlier trademark;
3. it is identical or similar to an earlier trademark, irrespective of whether the goods or services that it is to cover are identical, similar or dissimilar to those that the earlier trademark is registered for, where, in the case of an earlier trademark, the trademark has a reputation in the Czech Republic or, in the case of an earlier EU trademark, the trademark has a reputation in the European Union, and where the use without due cause of the trade-mark applied for would take unfair advantage of, or be detrimental to, the distinctive character or the repute of the earlier trademark;
4. an agent or representative of the owner of the trademark applies for the registration thereof in his own name without the owner’s consent, unless the agent or representative justifies his actions;
5. due to it being identical or similar to an unregistered or other mark used in business relations and the goods or services, which the marks relate to, being similar – there exists a likelihood of confusion on the part of the public; the likelihood of confusion includes the likelihood of association;
6. the mark or the owner violates a natural person’s personal rights, in particular the right to one’s name, right to one’s likeness and the right to the protection of one’s speech of a personal nature;
7. it violates rights to copyright;
8. it violates rights to other intellectual property;
9. it was registered in breach of legal requirements;
10. it was not properly used for at least five consecutive years;
11. as a consequence of the owner’s actions or inactivity, the trademark has become the common term used in the trade for a product or service in respect of which it was registered;
12. as a consequence of the use of the trademark by its owner, or with his consent, in respect of the goods or services for which it was registered, the trademark is liable to mislead the public, particularly as to the nature, quality or geographical origin of such goods or services;
13. the owner of the trademark does not request renewal of the registration or does not pay the renewal fee;
14. the owner of the trademark renounces the ownership of the trademark.

 

5. Are foreign patents and trademarks recognized and, if so, under what circumstances?

Foreign patents can be recognized in two ways in the Czech Republic. First, if a European Patent was granted under the European Patent Convention, the patent is recognized after being validated in the Czech Republic. Secondly, a patent granted under the Patent Cooperation Treaty is recognized if the applicant designates the Czech Republic as one of the countries of validity in the initial application.

Foreign trademarks are automatically recognized in the Czech Republic if these are registered as a European Union trade mark (EUTM) or granted under the WIPO’s Madrid System, if the owner designates the Czech Republic as a country of protection. Additionally, well-known unregistered marks are protected by the possibility to oppose a newer identical or similar trademark registration by a third party.

 

6. Are there any non-patent/ trademark barriers to competition to protect medicines or devices?

Generic drugs may not be registered sooner than eight years after the registration of the original drug. In addition, a generic drug may not be marketed in the Czech Republic sooner than 10 years after the registration of the original drug; this period may be extended to 11 years if the marketing authorization holder of the original drug obtains, within the first eight years after registration of the original drug, a registration for one or more new therapeutic indications that are, during the scientific evaluation prior to their registration, considered to be of significant clinical benefit compared with existing therapies.

 

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

There are no restrictions on the types of drugs or devices that can be protected through patents or trademarks other than those already described.

 

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

No. However, license agreements may be registered with the Czech Industrial Property Office in order to make them enforceable against third parties.

 

 

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Click the following links to read more legal articles from Czech Republic:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Also from this Legal Handbook

A brief overview of the situation regarding regulatory reforms in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 119.

 

1. Are there proposals for reform or significant change to the healthcare system?

Digitalization

With respect to Czech legislation, the main topic of proposed regulatory changes is the ongoing process of digitalization. The Ministry of Health is keen to expand and improve the already-existing system of electronic prescriptions (elektronický recept or eRecept in Czech). Electronic prescriptions are already the preferred form over their hard-copy counterparts (hard-copy prescriptions may be issued only in specific situations). Furthermore, an Act on Electronic Healthcare (so-called “e-Health Act”) is currently (spring 2021) being discussed in the Czech Parliament; it is expected to set common technical standards for digitalization and sharing of health records among healthcare providers and patients.

 

Pricing and Reimbursement

Another piece of legislation that is currently (spring 2021) being discussed in the Czech Parliament focuses, among other things, on reimbursements for orphan drugs. Under the current regulation orphan drugs can be awarded reimbursement only as either (i) a highly innovative drug, or (ii) by means of an exceptional reimbursement (referred to as a “Sec. 16 reimbursement”). None of these options is considered sufficient or appropriate, as it often results in orphan drugs not being reimbursed at all; patients are thus de facto denied adequate treatment due to the high price of orphan drugs.

 

Clinical Trial Regulation

The way clinical trials are conducted in the EU will undergo a major overhaul when the Clinical Trial Regulation comes into effect. The Regulation harmonizes the assessment and supervision processes for clinical trials throughout the EU via a publicly available Clinical Trials Information System (CTIS; formerly the EU Clinical Trial Portal and Database). The European Medicines Agency (EMA) will set up and maintain the new information system, in collaboration with the member states and the European Commission. It is currently estimated that the Regulation will enter into effect by January 2022.

 

2. When are they likely to come into force?

For information on the estimates of when the individual changes will come into effect please refer to Answer above.

 

 

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Click the following links to read more legal articles from Czech Republic:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Also from this Legal Handbook

Want to know more about product liability in Czech Republic? Read on! Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 119.

 

1. What types of liability are recognized in your jurisdiction?

Two types of liability are recognized in the Czech Republic:

1. contractual liability, arising from the failure to comply with one’s contractual obligations;
2. non-contractual (civil) liability, arising as a consequence of causing harm to a third party, usually by breach of a legal obligation.

 

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

Contractual liability applies upon the purchase of a product, under a contract of sale; however, it primarily applies to the seller of the product, not the manufacturer. Non-contractual liability applies to manufacturers if their product is sold on the market to third parties who are consequently harmed by the product. Under Czech law, there is also general product liability in respect of damage caused by dangerous products (this is based on the EU Product Liability Directive (85/374/EC)) as well as specific liability in respect of drugs set out in the Act on Drugs, which applies to the holder of the relevant marketing authorization.

Furthermore, the manufacturer and the marketing authorization holder (and the importer, should the importer market the product) are jointly and severally liable in case of a faulty product. Goods are generally considered faulty if they are less safe than reasonably expected, taking into account their purpose and the time of their introduction to the market.

The marketing authorization does not relieve the manufacturer or the holder of the marketing authorization from liability for damage caused by the drug when used in accordance with the Summary of Product Characteristics and the package leaflet. The marketing authorization holder is liable for damage caused by an effect of the drug not listed in the Summary of Product Characteristics (SPC); if such effect is listed in the SPC, the marketing authorization holder is liable as far as it can be proved that he caused such effect. Generally, it is the healthcare provider and not the marketing authorization holder who is liable for damage caused by the use of a drug without a marketing authorization or the use of a drug with a marketing authorization but in a manner, which is not in accordance with the marketing authorization (off-label use).

 

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

Theoretically, liability could extend to a manufacturer’s statutory bodies (such as board members); the basic principle is that if the members of such statutory bodies do not act with due managerial care, they may be personally liable if the injured party is unable to get recourse from the company (manufacturer). In practice, however, most product liability cases concern manufacturers and not their statutory bodies. No such personal liability may be attributed to a manufacturer’s employees. The situation remains unclear with respect to the manufacturer’s representatives (proxies), where a direct recourse against such representative may be available depending on the circumstances.

 

4. How can a liability claim be brought?

A liability claim can be brought through civil courts.

 

5. What defenses are available?

Generally, the plaintiff carries the burden of proof before the court. In practice the manufacturer and/or the marketing authorization holder (or the importer, should the importer market the product) can build a defense with arguments such as:

1. negligent / incorrect use of the product;
2. lack of a causal link between the administration of the drug and the occurrence of the alleged damage;
3. a reasonable assumption that the product was not faulty at the time it was put on the market or that any fault had occurred later;
4. the product was not produced by the defendant;
5. where the manufacturer of a component of the product is concerned, the defect is attributable to the design of the product in which the component has been fitted or to the instructions given by the manufacturer of the product.
6. the product was not marketed by the defendant;
7. the product was not produced or marketed for commercial purposes or within the defendant’s commercial activity;
8. the product was faulty as a consequence of compliance with statutory requirements;
9. he state of scientific and technical knowledge did not allow for identification of the fault;
10. (contractual) awareness of the risk connected to the use of the product; or
11. force majeure.

 

 

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Click the following links to read more legal articles from Czech Republic:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Also from this Legal Handbook

Key legal info on marketing, manufacturing, packaging & labeling, advertising in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 119.

 

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?

DRUGS

The following authorization procedures are available in the Czech Republic for obtaining market authorization of new drugs:

National Procedure

The national procedure applies if the new drug has not yet been authorized in any other EEA member state, and the applicant for the marketing authorization intends to market the new drug only in the Czech Republic. The relevant authority for issuance of a national authorization is the State Institute for Drug Control. The applicant must submit the relevant application electronically. The State Institute for Drug Control reviews and notifies the applicant whether the application is complete within 30 days after having received it. If the application is considered complete, the State Institute for Drug Control will then decide on the marketing authorization within 150 days after the applicant receives a confirmation that the application is considered complete (for generic drugs) or within 210 days (for other drugs).

Decentralized Procedure

The decentralized procedure applies if the new drug has not yet been authorized in any other EEA member state and the applicant for the marketing authorization intends to market the new drug in two or more EEA member states (including the Czech Republic). Identical applications for marketing authorization must be submitted simultaneously to the competent authorities of all concerned EEA member states. The competent authority in the Czech Republic is the State Institute for Drug Control. The application must include a list of all EEA member states to which an application for marketing authorization has been submitted. The applicant requests one of the member states concerned (the so-called reference member state) to prepare an assessment report on the drug. If the Czech Republic is the reference member state with respect to an application, the State Institute for Drug Control prepares a draft of the assessment report and, within 120 days after receipt of the application, provides this report to the other concerned member states for their comments. The final assessment report then serves as a basis for authorization in the respective other member states concerned.

Mutual Recognition Procedure

The mutual recognition procedure is based on the recognition of an existing national marketing authorization (issued in an EEA member state) in one or more other EEA member state(s). The holder of the marketing authorization informs the reference member state that it has submitted an application for mutual recognition to the State Institute for Drug Control. The holder of the authorization also requests the reference member state to prepare an assessment report or to update the report (if it had already been prepared when the original marketing authorization was granted) and to provide it to the State Institute for Drug Control. If the Czech Republic is the reference member state, the State Institute for Drug Control prepares or updates the assessment report, within 90 days of receiving the request to act as the reference member state, and then submits it to the concerned member states for their comments. The final assessment report serves as a basis for authorization in the respective other member states concerned.

Centralized Procedure

Drugs can also be authorized by the European Commission through a single application in all EEA countries via the centralized procedure. This marketing authorization is then valid in all EEA member states, including the Czech Republic and no separate authorization of the State Institute for Drug Control for the Czech Republic is then necessary.

With respect to the authorization process for marketing traditional herbal medicinal products and homeopathic medicinal products please refer to Answer No. 44 of Chapter Traditional Medicines and Over-the-Counter Products.

 

BIOLOGICS

The Act on Drugs specifically addresses biologics only in connection with the authorization procedure for biologics that are similar to a reference biological drug (biosimilars). For information about this please refer to Answer No. 2 below.

 

MEDICAL DEVICES

For placement of a medical device on the EU market, the manufacturer must adhere to the MD Regulation requirements. In particular, the device’s risk classification under MD Regulation classification rules must be determined and, depending on the risk classification, a conformity assessment must be carried out by the notified body or by the manufacturer. If the device passes the conformity assessment, a CE (Conformité Européenne) mark must be affixed to the device to demonstrate compliance.

The MD Regulation introduced the UDI (Unique Device Identification) system. The UDI is a standardized medical device identification system representing a unique medical device identifier listed on the label of each medical device, i.e. directly on the label of the medical device or on its packaging, as well as on all higher levels of packaging. An UDI identifier is a series of numeric or alphanumeric characters created through internationally accepted device identification and coding standards, and it allows for unambiguous identification of specific devices on the market.

In addition the MD Regulation established EUDAMED – the European database on medical devices maintained by the European Commission. EUDAMED is currently a work in progress. Once completed, it will consist of six interconnected modules and a public website. As of April 2021 only the module for registration of actors – that is manufacturers, manufacturer’s representatives and importers – was functioning. The European Commission will make the additional modules (device registration, notified bodies and certificates, clinical investigations, etc.) available on a step-by-step basis as soon as they are functional.

Until EUDAMED becomes fully functional, registration of persons/entities and notification of medical devices before they are placed on the market is to be done under national laws, i.e. the Act on Medical Devices, in its wording valid prior to 26 May 2021, will continue to apply. In order to be able to place a medical device on the Czech market in accordance with the Act on Medical Devices, the manufacturer, its representative, importer, or distributor is obliged to register itself with the State Institute for Drug Control before commencing its activities. Once the State Institute for Drug Control issues its registration confirmation, the person or entity will obtain a registration number. The registration is valid for five years and can be repeatedly extended, always by another five years.

In order to place a medical device on the Czech market in accordance with the Act on Medical Devices, the medical device must be notified to the State Institute for Drug Control within 15 days after the medical device is placed on the market. The notification is valid for five years and can be repeatedly extended always by another five years. Once notification is completed for a specific medical device, any additional distributor or importer only needs to inform the State Institute for Drug Control that it is also distributing or importing the device; it does not need to submit all the documents and information required for the purposes of the initial notification of the marketing of a medical device.

Once EUDAMED becomes fully functional, it will be necessary to register manufacturers, manufacturer’s representatives, and importers as well as medical devices in EUDAMED in accordance with the MD Regulation instead of registering/notifying under the Act on Medical Devices. As of April 2021, registration of manufacturers, manufacturer’s representatives and importers in EUDAMED has been possible on voluntary basis. Even after EUDAMED becomes fully functional, distributors and persons servicing medical devices will only be required to register in a national database maintained by the State Institute for Drug Control.

Specific rules that differ from the above apply to custom-made devices and investigational devices.

 

 

2. What is the authorization process for the marketing of generic versions of these products?

GENERICS

A generic version of a drug also requires a marketing authorization issued by the State Institute for Drug Control. For generics, the applicant must prove that the product is bioequivalent to the reference drug that has been authorized in at least one EEA member state for at least eight years. In addition, the applicant must provide the State Institute for Drug Control with all information and documents as required in the authorization procedure for new drugs, except for the results of toxicological, pharmacological and clinical tests. The holder of the marketing authorization for the generic drug may not place this product on the market until a lapse of 10 or, under certain conditions, 11 years after issuance of the marketing authorization for the reference drug.

 

BIOSIMILARS

If a biological product does not meet the definition of a generic drug, in particular due to differences in the starting material used or technological differences in the production process, only the results of the relevant toxicological and pharmacological tests and the clinical trials related to these differences have to be submitted. It is not necessary to submit to the State Institute for Drug Control results of toxicological and pharmacological tests or already-conducted clinical trials in connection with the reference biological drug.

 

3. What are the typical fees for marketing approval?

The approximate fees for marketing authorizations are:

• National Registration: approx. EUR 3,000 to approx. EUR 11,000;
• Mutual Recognition Procedure: approx. EUR 11,000;
• Decentralized Procedure: approx. EUR 13,000 to approx. 16,500.

The fees above as well as fees for other types of proceedings are stipulated in Decree No. 427/2008 Coll.

 

4. What is the period of authorization and the renewal process?

The marketing authorization of a drug is valid for five years. The State Institute for Drug Control may extend the validity of the authorization on the basis of a written application submitted no later than nine months before the expiry date of the authorization, and on the basis of a review of the risk-benefit balance of the drug.

With respect to medical devices, the registration of the medical device in the Register of Medical Devices is valid for five years and can be extended by another five years on an ongoing basis. The extension request must be delivered to the State Institute for Drug Control no earlier than six months but no later than two months before the registration expires. Once the EUDAMED module for registration of medical devices becomes functional, registration of the medical device in EUDAMED will be required. There is no time limit for validity of the EUDAMED registration, but the information submitted to the database upon registration must be regularly updated and confirmed; initially one year after submission of the information to EUDAMED and then every other year.

 

5. What are the requirements, if any, for post-approval pharmacovigilance?

DRUGS

The marketing authorization holder is obliged to maintain a pharmacovigilance system that complies with the pharmacovigilance system of the Czech Republic. Under this system the marketing authorization holder (i) collects data on risks related to the drugs for which it holds a marketing authorization, (ii) evaluates this data in order to decrease or prevent potential risks and (iii) adopts appropriate measures. Among other responsibilities, the marketing authorization holder has to report any suspected adverse drug reactions to the EudraVigilance database and keep documents related to pharmacovigilance for 10 years from the date it was obtained. The marketing authorization holder is also obliged to appoint a qualified person to be responsible for the pharmacovigilance agenda; this person must permanently and continuously available.

Furthermore, doctors, dentists, pharmacists, and other healthcare practitioners are obliged to report to the State Institute for Drug Control all suspicions of any serious or unexpected effects related to the use of a drug, which could have serious consequences for the health of patients.

 

MEDICAL DEVICES

Medical devices are divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Manufacturers are required to establish and maintain a post-market surveillance and vigilance system for each device in a manner that is proportionate to the risk class and appropriate for the type of device. Manufacturers are required to have available within their organization at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.

Manufacturers are obliged to report:

1. any serious incident involving the device, except side-effects that are expected and documented or subject to trend reporting (see below);
2. any field-safety corrective action, including those undertaken in a third country, in relation to a device that has also been made available on the EU market, if the reason for the field-safety corrective action is not limited to the device that was made available in the third country.

Manufacturers are also required to produce a trend report describing any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side-effects.

Importers, distributors, healthcare providers, service persons, dispensers and sellers are not obliged to report suspected incidents. However, healthcare providers have certain obligations that are related to the suspected incidents – e.g. obligation to take measures to mitigate negative effects of the incident and to cooperate with the manufacturer and regulator in order to establish the cause of the incident.

 

6. Are foreign marketing authorizations recognized?

Foreign marketing authorization of a drug is recognized in the Czech Repu-blic if it had been obtained through the European Medicines Agency under the European Union’s centralized authorization procedure. Otherwise, foreign marketing authorizations other than those mentioned in the previous sentence must be recognized by and registered in the Czech Republic, with the State Institute for Drug Control, e.g. via the mutual recognition procedure (recognition of an existing national marketing authorization by one or more EEA member states) or the decentralized procedure (the application for marketing authorization is submitted simultaneously in several EEA member states). In these cases, a separate authorization issued by the State Institute for Drug Control is still required.

Medical devices to be placed on the European Union market must fulfill requirements described above in Answer No. 1, including notification to the State Institute for Drug Control or, once EUDAMED becomes fully functional, registration of the medical device in EUDAMED.

 

7. Are parallel imports of medicines or devices allowed?

Authorization for the parallel import of medicines may only be granted to the authorization holder for the wholesale distribution of medicines under the following conditions:

1. the medicine is authorized in the EEA member state and in the Czech Republic and the medicine is not being distributed by the marketing authorization holder in the Czech Republic;
2. the medicine will be distributed in the Czech Republic with a quantitatively and qualitatively identical composition and dosage form as that of the medicine authorized in the Czech Republic;
3. the medicine has identical therapeutic effects as the product authorized in the Czech Republic, it does not constitute a risk to public health and it is being used in accordance with the marketing authorization of the reference product.

Parallel trade in medical devices already placed on the market is a lawful form of trade within the internal market of the European Union. The MD Regulation stipulates the conditions under which importers and distributors of medical devices traded in parallel must fulfill obligations that otherwise apply to manufacturers of medical devices. This is the case when the importer/distributor:

1. makes a device available on the market under its name, registered trade name, or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified on the label as such and remains responsible for meeting the requirements placed on manufacturers under the MD Regulation;
2. changes the intended purpose of a device already placed on the market or put into service;
3. modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected. The following actions do not qualify as such modification: (i) provision, including translation, of information supplied by the manufacturer, and of additional information that is necessary in order to market the device in the relevant Member State and (ii) changes to the outer packaging of a device, including a change in the package size, if repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such a way that the original condition of the device cannot be affected by it.

Distributors and importers must have in place a quality management system that, inter alia, ensures that the distributor or importer is informed of any corrective action taken by the manufacturer of the device in question in order to respond to safety issues or to bring the device into conformity with applicable regulations.

For further information please refer to Answer No. 1 above.

 

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?

Any gifts, promises, offers or other incentives made to healthcare professionals in relation to the advertising of drugs for human use are not allowed, unless they are of negligible value and, at the same time, relate to the specific professional’s activity. Accordingly, healthcare professionals may not require or accept such benefits. Under Czech law, only professionals authorized to prescribe or dispense drugs or medical devices are considered healthcare professionals.

Samples of drugs and medical devices can only be provided to healthcare professionals in a limited quantity and they must be marked as “not for sale”. As regards drugs, each sample must correspond to the smallest available packaging of the product. Samples of drugs containing narcotic and/or psychotropic substances are not allowed at all.

Sponsorship of meetings and conventions for experts, including related travel and accommodation costs, is allowed provided that the sponsorship is proportionate to the main purpose of the meeting / convention and that such sponsorship (or any reimbursement of costs) is only provided to healthcare professionals.

Pharmaceutical and medical devices companies in the Czech Republic usually also adhere to ethical codes of the professional associations they belong to, which regulate marketing practices in more detail, such as the codes of the European Federation of Pharmaceutical Industries and Associations (EFPIA) (e.g. the EFPIA HCP Code).

 

9. How is the manufacturing of medicines and devices regulated and by which agencies?

The main supervisory authority for the manufacturing of medicines and medical devices is the State Institute for Drug Control.

The State Institute for Drug Control issues approvals for the manufacturing of medicines and their distribution and issues certificates confirming that the conditions of good manufacturing practice, good distribution practice etc. have been fulfilled. In addition, the Ministry of Health issues the Czech Pharmacopoeia, which sets out procedures for the manufacture of active substances and excipients used in the manufacture and preparation of medicinal products and for their testing and storage.

As regards medical devices, the manufacturer needs to obtain a relevant trade license, which is issued by the Trade Office, and to register itself as a manufacturer in the relevant database. For more details please refer to Answer No. 1 above. The other relevant authorities concerned with the regulation of the manufacturing of medical devices are the Ministry of Health, the Institute of Health Information and Statistics of the Czech Republic, the Czech Office for Standards, Metrology and Testing, the State Office for Nuclear Safety and local trade authorities.

 

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food and Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?

The Czech Republic is a part of the European Union; therefore, the GMP regulations of the European Medicines Agency apply. The EU and the US have entered into a mutual recognition agreement on GMP inspections. The US FDA approved the capability of the Czech Republic to carry out GMP inspections at a level equivalent to that of the United States in March 2018.

 

11. What is the inspection regime for manufacturing facilities?

The State Institute for Drug Control has jurisdiction over inspections of manufacturing facilities for drugs in the Czech Republic. Inspections of manufacturing facilities are carried out by the State Institute for Drug Control to monitor and ensure compliance with the obligations under the Act on Drugs and the requirements of GMPs.

In addition, internal inspections of manufacturers’ premises are also required. According to the guidelines of the State Institute for Drug Control, the following are to be inspected on a regular basis: employees, buildings, facilities, documents, manufacturing procedures, inspections of quality and distribution, how complaints are dealt with, and how goods are removed from the market.

Internal inspections are to be carried out comprehensively and independently by a qualified employee of the relevant manufacturer or by external experts. A written report containing all information identified during the inspection must be produced in relation to every internal inspection and, where appropriate, a solution to the findings should also be proposed.

The State Institute for Drug Control also has jurisdiction over inspections of manufacturing facilities for medical devices. Inspections are carried out to ensure compliance with the obligations under both the MD Regulation and Czech legislation regulating medical devices.

 

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the US FDA/EMA?

Inspections of manufacturing facilities for medicines and medical devices are carried out by the employees of the State Institute for Drug Control. Generally, foreign inspectors are not allowed, but competent authorities of EU member states are required to cooperate with each other when conducting supervision over drugs and medical devices. With respect to drugs, upon request by the competent authority of another EU member state, the State Institute for Drug Control may inform the authority of the contents of its inspection report. With respect to medical devices, regulatory authorities of EU member states are required to share the results of these activities with each other in order to ensure a harmonized and high level of market surveillance in all member states.

Internal inspections can be carried out by the manufacturer’s employees or an external expert engaged by the manufacturer.

 

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

Specific requirements for storage, packaging, and handling of medicinal products are regulated by the Decree of the Ministry of Health and the Ministry of Agriculture No. 229/2008 Coll., on Manufacturing and Distribution of Medicines, which stipulates Good Manufacturing Practice (GMP) Requirements and Good Distribution Practice (GDP) Requirements. Additional requirements are found in Decree No. 84/2008 Coll., on Good Pharmacy Practices (GPP) as well as in relevant guidelines of the State Institute for Drug Control.

Every drug package must contain a package leaflet, unless all the required information is stated on the package itself. The information on the package must be legible and comprehensible, it must be in Czech and the name of the medicinal product must also be written in Braille. The information is approved by the State Institute for Drug Control during the marketing authorization process for the drug. For requirements regarding the information to be provided on the outer packaging please see Answer No. 14 and 15 of Marketing, Manufacturing, Packaging & Labeling Advertising.

The storage location must have sufficient capacity to allow for storage of different kinds of products in a clear manner. It must further meet the conditions of good storage practice – to be clean, dry, and an adequate temperature must be maintained. For products requiring storage at a specific temperature, the temperature must be regularly checked by thermometers strategically placed within the premises. Drugs cannot be stored directly on the floor, near heating devices and cannot be exposed to sunlight. The storage conditions must be checked and monitored on a regular basis.

When handling drugs, specific storage conditions (e.g. in terms of temperature or light) must also be maintained during transport.

Requirements for storage, packaging and handling of medical devices are laid down primarily in the MD Regulation, the New Act on Medical Devices, the Act on Medical Devices (with respect to diagnostic devices in vitro) and in implementing decrees of the Ministry of Health. According to the MD Regulation, each device must be assigned a unique identification, which must be stated in the device’s labeling or on the device packaging. Devices must be packaged so that their characteristics and performance during their intended use are not adversely affected during transport or storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer.

Devices supplied in a sterile state must be packaged in accordance with appropriate procedures to ensure that they are sterile when placed on the market and, provided that the packaging is not damaged, that they remain in compliance with applicable transport and storage conditions until the packaging is opened. Packaging systems for non-sterile devices must maintain the integrity and purity of the device and, if the devices are to be sterilized before use, these systems must minimize the risk of microbial contamination. The packaging system must be suitable with regard to the sterilization method specified by the manufacturer. The MD Regulation sets out the information that must be stated on the packaging maintaining the sterile condition of a device.

Manufacturers are obliged to include an indication of any applicable special storage and / or handling conditions in the device labeling as well as in the UDI database. Importers are obliged to ensure that, while a device is under their responsibility, the storage or transport conditions do not jeopardize its compliance with the general safety and performance requirements set out in the MD Regulation. In addition, importers and distributors are obliged to ensure that the storage or transport conditions comply with the conditions set by the manufacturer.

 

14. What information must be included in medicine and device labeling?

The following information, inter alia, must be included on the outer packaging of a medicinal product:

• the name of the medicinal product followed by its strength and pharmaceutical form and, if applicable, whether it is intended for use by infants, children or adults; if the product contains a maximum of three active substances the international non-proprietary name (the INN) of each such active substance must be included or, if INN is not applicable, its common name;
• the amount (expressed qualitatively and quantitatively) of the active substances in the unit of dosage or in a given volume or weight of the form administered, using their common names in Latin;
• dosage form and pack size;
• manner of administration;
• a warning that the product must be kept out of the sight and reach of children;
•  special warnings, in particular the possibility of affecting the ability to drive or to use machinery, if relevant for the product;
• expiry date (month, year);
• special storage requirements;
• special precautions for the disposal of any unused product or any waste derived from the product, if required to limit the adverse effects of the effects thereof on the environment, in accordance with other legislation;
• the business name and the address of the registered office of the marketing authorization holder, for legal persons, or the name or names, surname and place of business of the marketing authorization holder, for natural persons, and, where applicable, the name of any representative appointed by the marketing authorization holder;
• registration number of the product;
• batch number;
• in the case of dispensing without prescription, instructions for the use of the product.

Specific requirements apply to the contents of the Summary of Product Characteristics (SPC) and package leaflet (PIL).

The following basic information, inter alia, must be included on medical device labeling:

• the name or trade name of the device;
• details that are strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the intended purpose of the device;
• the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business;
• if the manufacturer has its registered place of business outside the EU, the name of the authorized representative and address of the registered place of business of the authorized representative;
• where applicable, an indication that the device contains or incorporates (i) a medicinal substance, including a human blood or plasma derivative, or (ii) tissues or cells, or their derivatives, of human origin, or (iii) tissues or cells of animal origin, or their derivatives;
• where applicable, information about dangerous substances (e.g. substances that are carcinogenic, mutagenic or toxic to reproduction, etc.) contained in the device;
• the lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL NUMBER (in Czech) or an equivalent symbol, as appropriate;
• the UDI carrier;
• an unambiguous indication of the time limit for using or implanting the device safely, expressed at least in terms of year and month, where this is relevant;
• where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided that the date is clearly identifiable;
• an indication of any special storage and/or handling condition that apply;
• if the device is supplied sterile, an indication of its sterile state and the sterilization method;
• warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device, and to any other person. This information may be kept to a minimum if more detailed information appears in the instructions for use, taking into account the intended users;
• if the device is intended for single use, an indication of that fact;
• if the device is a single-use device that has been reprocessed, an indication of that fact, the number of reprocessing cycles already performed, and any limitation as regards the number of reprocessing cycles;
• if the device is custom-made, the words “custom-made device” (in Czech);
• an indication that the device is a medical device. If the device is intended for clinical investigation only, the words “exclusively for clinical investigation” (in Czech);
• for devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a bodily orifice or applied to the skin and that are absorbed by or locally dispersed in the human body, the overall qualitative composition of the device and quantitative information about the main constituent or constituents responsible for achieving the principal intended action;
• for active implantable devices, the serial number, and for other implantable devices, the serial number or the lot number.

Information that is required on the label must be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging.

 

15. What additional information may be included in labeling and packaging?

With respect to drugs, the package leaflet can include symbols or pictograms designed to explain a particular piece of information on the product packaging or in the package leaflet or other information that is useful to the patient. This information must be in line with the SPC and cannot contain promotional elements.

As regards medical devices, instructions for use must be provided together with the devices; however, use instructions are not required for class I and class IIa devices if they can be used safely without any instructions. Residual risks, which are required to be communicated to users or other persons, must be included as limitations, contra-indications, precautions, or warnings in the information supplied by the manufacturer. Where appropriate, the information supplied by the manufacturer can take the form of internationally recognized symbols.

 

16. What items may not be included in labeling and packaging?

Any items that could lead to the product being used incorrectly may not be included in the labeling and packaging. For example, labeling and packaging cannot include advertisements or any generally misleading information.

With respect to medical devices, the labelling must not include text, names, trademarks, pictures and signs that may mislead the user or the patient with regard to the device’s intended purpose, safety and performance. Namely, it is not allowed to use information that (i) ascribes functions and properties to the device that the device does not have, (ii) creates a false impression regarding treatment or diagnosis, functions or properties that the device does not have, (iii) fails to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose or (iv) suggests uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

 

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

In addition to any general rules for advertising, the following rules apply to the advertising of medicines:

• the advertising must be in conformity with the SPC; it must encourage rational use of the medicinal product and must not be misleading;
• different rules apply to advertising to the public and to healthcare professionals (doctors and pharmacists, not nurses); only drugs available without prescription may be advertised to the public;
• medicines containing narcotics or psychotropic substances may only be advertised to healthcare professionals;
• medicines without marketing authorization may not be advertised at all.

In addition to the general advertising requirements, any advertising of medicinal products intended for the public must be executed so that it is clear that it is an advertisement; the marketed medicinal product must be clearly identifiable and the advertisement must contain the particulars specified in the Act on Advertising (e.g. the name of the medicinal product, an explicit and understandable appeal to the users to carefully read the package leaflet that accompanies the medicinal product, information necessary for the proper use of the product).

Advertising of medicinal products intended for the public may not contain certain elements specified in the Act on Advertising, such as:

• giving the impression that consultation with a doctor, medical intervention or treatment is not necessary, especially by offering a diagnosis or offering treatment remotely;
• suggesting that the effects of the medicinal product are guaranteed, are not associated with side effects or are better or equivalent to the effects of another treatment or other medicine for human use;
• suggesting that the use of a medicinal product will improve the health of the person taking it;
• indicating that the failure to use a medicinal product may adversely affect the health of persons; this does not apply to vaccinations or vaccines that have been approved by the Ministry of Health;
• being targeted solely at people under 15 years of age;
• referring to the recommendations of scientists, health professionals or other persons that, by virtue of their actual or presumed social status, could support the consumption of the medicinal product;
• indicating that the medicinal product is a food or cosmetic product or other consumer product;
• suggesting that the safety or efficacy of a medicinal product is only guaranteed by its natural origin;
• using any image of changes to the human body caused by a disease or injury or the effect of the medicinal product on the human body, or parts thereof, in an inappropriate, exaggerated or misleading manner.

This list is not exhaustive.

For information about marketing practices such as gifts, sponsorships, travel, and entertainment, please refer to Answer No. 8 above.

In addition to any general rules for advertising, the following rules apply to the advertising of medical devices:

• only devices that comply with legal requirements for being placed on the market can be advertised. Devices that do not comply with these legal requirements can be presented at fairs, exhibitions and similar events provided that they are clearly marked as not compliant for being placed on the market;
• advertisement of a medical device cannot refer to any specific bodies of state administration;
• different rules apply to advertising to the public and to healthcare professionals; devices for use only by healthcare professionals and devices available only based on a prescription may not be advertised to the public, and samples cannot be provide to the public.

Any advertising of medical devices intended for the public must be done so that it is clear that the marketed product is a medical device or in vitro diagnostic medical device (as appropriate). The advertisement must contain the particulars specified in the Act on Advertising (e.g. the name of the medical device, its purpose, an explicit and understandable appeal to the users to carefully read the instructions for use and information necessary for the proper use of the product, if applicable).

Advertising of medical devices intended for the public may not contain certain elements specified in the Act on Advertising, such as:

• giving the impression that consultation with a doctor, medical intervention, or treatment is not necessary, especially by offering diagnosis or offering treatment remotely;
• suggesting that the effects of the medical device are guaranteed, are not associated with risks, or are better or equivalent to the effects of another treatment or other medical device;
• indicating that failure to use a particular medical device could adversely affect the health of persons;
• being targeted solely at people under 15 years of age,
• referring to the recommendations of scientists, health professionals or other persons that, by virtue of their actual or presumed social status, could support the use of the medical device;
• referring to clinical trials or other processes that are a condition for placing the medical device on the market;
• suggesting that the safety or efficacy of a medical device is only guaranteed by its natural origin.

This list is not exhaustive.

Furthermore, the labelling and advertisement of a medical device must not include text, names, trademarks, pictures, or signs that may mislead the user or the patient with regard to the device’s intended purpose, safety, and performance. Specifically, it is not allowed to use information that (i) ascribes functions and properties to the device that it does not have, (ii) creates a false impression regarding treatment or diagnosis or functions or properties that the device does not have, (iii) fails to inform the user or the patient of a likely risk associated with the use of the device when used for its intended purpose, or (iv) suggests uses for the device other than those stated, implying that they form part of the intended purpose for which the conformity assessment was carried out.

Advertising of medical devices intended for healthcare professionals may only be disseminated through communication channels intended predominantly for healthcare professionals and must contain the following:

• sufficient, verifiable and objective data allowing the healthcare professionals to form their own opinion about the clinical benefit of a particular medical device; data taken from professional publications or from professional press must be accurately reproduced and their source must be stated;
• the basic information included in the instructions for use of the medical device.

 

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

Medicinal products subject to a prescription can only be dispensed in pharmacies. Non-prescription medicinal products can also be sold online (and delivered via post or other delivery service). The online sale of certain non-prescription products may be prohibited by a decision of the State Institute for Drug Control. This is the case with respect to OTC products that can be dangerous to human health and the risk may be avoided (i) by an expert consultation with a pharmacist before the product is used or (ii) by imposing certain restrictions on the dispensing of the product.

Selected medicinal products that can be used without prior consultation with a doctor or pharmacist, such as teas, disinfectants or pain relief medications, may be sold in regular stores, such as gas stations or supermarkets.

A medical device that, even if its intended purpose is observed, could endanger human health or life if not used under a doctor’s supervision may be dispensed only through a medical prescription issued by a doctor. The groups of such devices are listed in a decree of the Ministry of Health. Medical prescriptions are also used when the patient is entitled to reimbursement from the public health insurance.

Medical devices subject to prescription may only be dispensed in pharmacies and through sales points for medical devices contracted by a health insurance, or through a dispensing optician (optical medical devices). Dispensing medical devices subject to an online prescription via consignment delivery is also possible. Medical devices classified as low risk can be sold in regular shops as well as online (and delivered via post or other delivery services).

 

19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?

There are no specific legal regulations for electronic marketing and advertising of medicines and medical devices; general advertising rules thus apply. With respect to advertising of medicines on the internet, the State Institute for Drug Control issued guideline specifying measures ensuring that prescription drugs are not advertised to the general public on the internet.

In addition, if sending advertisements via email, advertisers must comply with specific anti-spam legislation applicable to commercial electronic messages.

 

20. May medicines and devices be advertised or sold directly to consumers?

Yes, except for medicines and devices that require a prescription and devices that, according to the manufacturer’s instructions, are intended for use only by healthcare professionals – those may not be advertised or sold directly (without prescription) to consumers.

 

21. How is compliance monitored?

Compliance with medicines and medical devices advertising regulations is monitored by the State Institute for Drug Control. For monitoring purposes the State Institute for Drug Control is entitled to: (i) request a copy of an advertisement; an advertiser must keep advertisements for five years after the last release / broadcast of the advertisement, (ii) request documentation and information relating to an advertisement; an advertiser must keep this documentation and information for five years after the last release / broadcast of the advertisement, (iii) request from the processor of an advertisement any information about the advertiser or broadcaster of the advertisement, (iv) request from the broadcaster of an advertisement any information about the advertiser, the processor of such advertisement or the person that ordered the broadcast, (v) request evidence from the advertiser on the validity of the claims made in an advertisement, (vi) order the removal or termination, within a reasonable time period, of an advertisement that breaches applicable statutory requirements.

Television and radio advertising for medicinal products is supervised by the Council for Radio and Television Broadcasting.

 

22. What are the potential penalties for noncompliance?

If the State Institute for Drug Control learns of a violation of the Act on Advertising, it prohibits the distribution of the advertisement. In addition, the State Institute for Drug Control may impose a fine of up to approx. EUR 192,000.

 

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Click the following links to read more legal articles from Czech Republic:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Also from this Legal Handbook

Preclinical & clinical trial requirements in Czech Republic – an overview. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 119.

 

1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?

No, clinical trials may be also conducted abroad. If a clinical trial was conducted in a country outside of the European Union, an affidavit confirming that the clinical trial met the ethical requirements of the European Union is required and forms a part of the marketing authorization application.

 

2. How are clinical trials funded?

In the Czech Republic, clinical trials are usually funded by sponsors from the pharmaceutical or medical devices industry. A sponsor is an individual, a company, an institution, or an organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. A sponsor may be represented on the basis of a power of attorney by an individual or a legal entity in matters related to the clinical trial (known as the Representative; this is usually a contract research organization). The sponsor, or its Representative, must be a resident of (if the Representative is an individual), or have its registered seat in (if the Representative is a legal entity), an EU member state. The financing arrangements of the clinical trial are generally regulated by a separate agreement between the sponsor and the investigator as well as the healthcare provider.

 

3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?

A clinical trial protocol is a document describing the aim, arrangement, methodology, statistical consideration, and organization of a clinical trial for drugs, including any potential subsequent versions and amendments thereto. The clinical trial protocol (along with other documents) must be submitted to, and approved by, the relevant Ethics Committee and the State Institute for Drug Control. In order for the clinical trial to qualify for an approval from the State Institute for Drug Control, the relevant Ethics Committee must issue a positive opinion regarding it.

A clinical investigation plan is a document describing the rationale, objectives, design, methodology, monitoring, statistical considerations, organization, and conduct of a clinical investigation for a medical device. The clinical investigation must be approved in advance by the State Institute for Drug Control. On the other hand, clinical investigations of medical devices that are CE marked or that are used within an investigation for its originally designated purpose require only a 30-day prior notification to the State Institute for Drug Control. The clinical investigation plan (along with other documents) is a mandatory part of the application for approval of the clinical investigation. In order for the clinical investigation to qualify for an approval from the State Institute for Drug Control, the relevant Ethics Committee must issue a positive opinion on it.

 

4. What are the requirements for consent by participants in clinical trials?

The participants in a clinical trial should be first thoroughly informed of the scope, nature, potential consequences, and risks of the clinical trial. The participant’s informed consent (i) must be made in writing, (ii) must include the participant’s signature and date of signing, (iii) must be granted voluntarily, (iv) must be adequately documented, and (v) must be granted by an eligible person or his/her representative. If a participant is unable to write, oral consent must be given in the presence of at least one witness and a written record must be made of such oral consent. The informed consent must be drafted in a language easily understandable for the participant of the clinical trial.

 

5. May participants in clinical trials be compensated?

Participants in clinical trials may be compensated for expenses related to their participation in the clinical trial, such as travel or food expenses. Com-pensation must not exceed the costs incurred by the participant. Healthy participants may be remunerated for participating in a clinical trial, and the amount of remuneration must be consistent with the nature of the clinical trial. Financial incentives (other than compensation of costs) are prohibited in the case of minors and adults who are not legally capable of giving informed consent. The relevant Ethics Committee will also review the compensation and remuneration arrangements when providing its opinion on the application for approval of the clinical trial.

 

6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?

One of the statutory conditions for conducting a clinical trial/investigation is the existence of an insurance policy covering the civil liability of the sponsor for any damage caused to any participant as a consequence of the clinical trial. The sponsor is responsible for concluding this insurance policy. When providing its opinion, the relevant Ethics Committee will also review the insurance policy taken out by the sponsor covering liability for damage in the event a participant’s health is negatively affected or if he/she dies as a consequence of the clinical trial/investigation.

Generally, insurance for a clinical trial/investigation does not cover claims resulting from actions that deviate from the clinical trial protocol/clinical investigation plan or from unprofessional treatment or negligence in providing the healthcare services. However, claims arising from unprofessional or negligent provision of healthcare services should be covered by the mandatory insurance of the healthcare provider operating the respective clinical trial site.

 

 

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Click the following links to read more legal articles from Czech Republic:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Also from this Legal Handbook

An insight into regulatory, pricing and reimbursement overview in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 119.

 

1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

The main authorities with jurisdiction over drugs, biologicals, and medical devices in the Czech Republic are the Ministry of Health and the State Institute for Drug Control. Along with these two main regulatory authorities, the following authorities also possess limited and specific jurisdiction over drugs, biologicals and/or medical devices: the Ministry of the Interior, Ministry of Justice, Ministry of Defense, Ministry of the Environment, Ministry of Agriculture, State Veterinary Administration, Institute for State Control of Veterinary Biologicals and Medicines, State Office for Nuclear Safety, Customs Authorities, District Veterinary Authorities and District Authorities.

 

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

The authorization, pricing, and reimbursement of drugs, biologicals and medical devices is regulated primarily by the following acts (and related regulations):

• Act No. 378/2007 Coll., on Drugs, as amended (the “Act on Drugs”);
• Act No. 48/1997 Coll., on Public Health Insurance, as amended (the “Public Health Insurance Act”);
• Regulation (EU) No. 2017/745 on Medical Devices (the “MD Regulation”), effective from 26 May 2021;
• Act No. 268/2014 Coll., on Medical Devices, as amended (the “Act on Medical Devices”), effective from 26 May 2022 the Act on Medical Devices will be replaced by Regulation (EU) No. 2017/746 on In Vitro Diagnostic Medical Devices (the “IVD Regulation”);
• Act No. 89/2021 Coll., on Medical Devices (the “New Act on Medical Devices”); and
• Act No. 526/1990 Coll., on Prices, as amended.

 

3. What are the steps to obtaining authorization to develop, test, and market a product?

In order to conduct testing on drugs that have not yet been registered, it is necessary to obtain clinical trial authorization from the State Institute for Drug Control. To test drugs that have already been registered, it is sufficient to notify the State Institute for Drug Control of the clinical trial.

To introduce a drug to the market, it is necessary to obtain a registration (marketing authorization). There are three types of registrations: (i) National Registration, (ii) Mutual Recognition Procedure and (iii) Decentralized Procedure. National Registration authorizes the marketing of the product solely in the Czech Republic. The other two authorization types allow for the marketing of the product in other EEA member states as well. In addition, a Centralized Procedure by the European Medicines Agency can also be used; it authorizes the product for all EEA member states. In a limited number of exceptions (drugs prepared in a pharmacy based on a prescription for an individual patient, drugs for research and development, etc.) the requirement for marketing authorization does not apply.

Manufacturers and distributors of drugs are required to obtain licenses from the State Institute for Drug Control. A manufacturing license is also required to import drugs from non-EEA states. Distribution licenses issued by EEA member states are recognized in the Czech Republic provided that the distributor submits a notification to the State Institute for Drug Control.

 

4. What are the approximate fees for each authorization?

The approximate fees for each authorization are:

• Authorization of a clinical trial for a not-yet-registered drug: approx. EUR 3,800;
• Authorization of a clinical trial for a registered drug: approx. EUR 800, and EUR 1,700 for accelerated processing;
• National Registration Procedure: approx. EUR 3,000 to approx. EUR 11,000;
• Mutual Recognition Procedure: approx. EUR 11,000;
• Decentralized Procedure: approx. EUR 13,000 to approx. 16,500.

The above fees as well as fees for other types of proceedings are stipulated in Decree No. 427/2008 Coll.

 

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/ registrations renewed?

Marketing authorizations are valid for five years after the decision granting the authorization comes into force and effect, provided that the drug is marketed in the Czech Republic.

The State Institute for Drug Control may extend the validity of the authorization on the basis of an application submitted no later than nine months before the expiry of the authorization and after a review of the risk-benefit balance of the drug. If the extension is approved by the State Institute for Drug Control, the authorization will last for an indefinite term, again, provided that the drug is marketed in the Czech Republic. However, if the State Institute for Drug Control finds that there is insufficient pharmacovigilance data (incl. exposure of an insufficient number of patients to the drug concerned), it may choose to extend the validity of the authorization for a new five-year period instead.

 

6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?

In general, the authorization process is the same for original and generic products. The only difference is that under certain circumstances, the results of preclinical and clinical trials do not have to be submitted in cases where the reference product has been registered in at least one other EEA member state for at least eight years.

The authorization process prescribed by law is the same for local manufacturers as well as foreign-owned manufacturers.

However, applicants for marketing authorization must reside or have their registered seat in the Czech Republic or in another EEA member state.

 

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?

Under Czech law, both biologics and drugs are classified as drugs and are subject to the same regulation under the Act on Drugs, while medical devices are regulated separately. Starting in May 2021 medical devices are regulated under the MD Regulation in combination with the New Act on Medical Devices while in vitro diagnostic medical devices are regulated under the Act on Medical Devices, and from May 2022 they will be regulated under the IVD Regulation. There are no special regulations for combination products. Therefore, any combination of drugs and biologics is regulated by the MD Regulation provided that the drug has an action that is ancillary to that of the action of the device. However, if the action of the drug is principal and not ancillary to that of the device, the product will be regulated by the Act on Drugs, while the relevant general safety and performance requirements set out in the MD Regulation will apply as far as the safety and performance of the device part are concerned. The same applies if the device and the drug form a single integral product which is intended exclusively for use in the given combination and is not reusable.

 

8. How is compliance with regulations monitored and evaluated? Is the regulatory regime comparable with the US Food and Drug Administration or the European Medicines Agency expectations and requirements?

The State Institute for Drug Control monitors compliance with the legal regulation of drugs and medical devices as well as with the performance of obligations imposed on the basis of its decisions and measures with respect to relevant subjects. This includes manufacturers and distributors of drugs and medical devices. It also carries out inspections to ensure compliance with the requirements of GMP (good manufacturing practice), GDP (good distribution practice) and good clinical practice in the area of human pharmacy. The State Institute for Drug Control also operates and manages a pharmacovigilance system for drugs as well as medical devices and participates in pharmacovigilance processes of the European Union.

The regulatory regime is based on EU regulations and directives and is in line with the European Medicines Agency’s expectations and requirements.

 

9. What is the potential range of penalties for noncompliance?

The range of penalties depends on the type of violation and whether it has been committed by a natural person or a legal entity/entrepreneur. Broadly speaking, penalties in the area of drugs range from approx. EUR 3,800 to approx. EUR 770,000. Apart from financial penalties, a prohibition of activity (for up to two years) may be also imposed. In the area of medical devices, penalties range from approx. EUR 7,700 to approx. EUR 1,160,000.

 

10. Is there a national healthcare system? If so, how is it administered and funded?

Yes, there is a national healthcare system in the Czech Republic. It is regulated primarily by the Public Health Insurance Act and based on the principles of universal accessibility to healthcare, solidarity, mandatory health insurance, freedom to choose a health insurance company, and a basic package of healthcare covered by the public health insurance.

Participation in the public healthcare insurance system is mandatory for every person with permanent residency in the Czech Republic and for every employee whose employer has a permanent residence or seat in the Czech Republic. The system is funded through mandatory monthly contributions by (i) employees and self-employed persons, (ii) employers and (iii) the state, which pays the insurance contributions for socially disadvantaged individuals, including children, students, pensioners, etc. Contributions are paid to individual health insurance companies (at present, seven health insurance companies are authorized to provide public health insurance in the Czech Republic; one health insurance company is owned by the Czech state). Health insurance companies are obliged to ensure that their clients have access to healthcare. They play a key role in the system of purchasing healthcare services by contracting with individual healthcare providers.

Czech legislation specifies what types of healthcare are covered by the public health insurance system and the extent of this coverage; basically, the public health insurance system fully covers preventive medical examinations, diagnosis of diseases, and treatment of diseases as specified by applicable Czech law; it also determines the drugs and medical devices that are fully or partially covered by public health insurance and the respective conditions thereof.

In comparison with public health insurance, the share of private health insurance is rather negligible in the Czech Republic.

 

11. How does the government (or public) healthcare system function with private sector healthcare?

In the Czech Republic, public healthcare providers provide the majority of inpatient healthcare services. They are usually profit-making or non-profit-making entities, founded by the Ministry of Health or regional authorities or municipalities. Outpatient clinics are usually under private ownership. There are also a few private healthcare providers that provide inpatient healthcare services. Health insurance companies have agreements in place also with certain private healthcare providers, so certain services provided to the patients by these providers can be fully or partially covered by the public health insurance system.

 

12. Are prices of drugs and devices regulated and, if so, how?

Drug prices are regulated by a pricing regulation issued by the Ministry of Health. The regulation determines which drugs are subject to price regulation (e.g. drugs reimbursed under public health insurance) and sets out a general framework for price regulation. The maximum price for individual products that are subject to price regulation is set by a decision of the State Institute for Drug Control in administrative proceedings on the basis of the reference price calculation method using the three lowest prices in relevant EU countries. Information about whether a product is subject to price regulation and what the maximum price is can be found in a database of drugs maintained by the State Institute for Drug Control.

Prices of medical devices are regulated by a pricing regulation issued by the Ministry of Health. The regulation determines which medical devices are subject to price regulation (e.g. devices reimbursed under public health insurance) and sets out a general framework for price regulation. The final price of a device paid by a consumer must not exceed the sum of the manufacturer’s price (the price for which the device is first placed on the market), the maximum margin allowed by the pricing regulation plus VAT.

 

13. How are the drugs and devices used by patients paid for? What roles do public and private payers play?

In general, drugs and medical devices are fully reimbursable during inpatient care provided that the patient is covered by public health insurance and the healthcare provider has concluded an agreement with the health insurance company of the patient, which pays for the provided services.

In the outpatient sector, drugs are fully or partially reimbursable, if reimbursement is provided for an individual product by a decision of the State Institute for Drug Control in administrative proceedings. Information about the amount to be reimbursed can be found in the drugs database maintained by the State Institute for Drug Control. Otherwise, the patient pays for the drug in full.

As regards medical devices, the law divides them into reimbursement groups according to their functional characteristics and intended use. For each reimbursement group, the law specifies reimbursement conditions and limits (financial limit in CZK per unit, prescription, indication limit, etc.). This categorization does not apply to custom-made medical devices; those are reimbursed based on a percentage rate specified by law. Medical devices prescribed in the context of outpatient healthcare services are eligible for reimbursement so long as they are included in the appropriate reimbursement group. Thus, manufacturers seeking to have their medical devices categorized as reimbursable must notify the State Institute for Drug Control of the reimbursement group to which the device belongs. Similarly, to have a medical device removed from a group or switched from one group to another the manufacturer must also notify the State Institute for Drug Control of such change. The State Institute for Drug Control publishes on its electronic notice board a full list of medical devices eligible for reimbursement under public health insurance. This list is valid for the following calendar month. Devices not included in the list are paid by the patient in full.

 

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

Drugs may be dispensed by (i) pharmacies, (ii) transfusion units of healthcare providers (transfusion products and blood derivatives), (iii) nuclear medicine units of healthcare providers (radiopharmaceuticals), and (iv) immunological or microbiological units of healthcare providers and facilities for public health protection. In addition to this, drugs can be used by healthcare providers during the provision of healthcare services.

Medical devices may be dispensed by (i) pharmacies, (ii) optics and (iii) dispensers contracted by insurance companies. Dispensing medical devices remotely via consignment delivery is also possible.

Dispensers are compensated through the public healthcare system to the extent to which the drugs and devices are reimbursed under the public healthcare system. Any remainder of the price of the drug or device is paid by the patient.

 

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

Only pharmacists or other persons with a sufficient professional qualifications are allowed to dispense drugs and/or medical devices.

Pharmacies and other dispensers of drugs are, inter alia, required to:

• buy drugs only from manufacturers, distributors, or other pharmacies;
• handle drugs properly in line with their marketing authorization;
• ensure that the patient is adequately informed about the proper use of the drug;
• ensure that the patient is informed about similar products that are reimbursed by the public health insurance system;
• keep complete and conclusive records of stock, receipts, and the dispensing of drugs;
• immediately notify the State Institute for Drug Control of suspected adverse reactions to drugs;
• verify security features and discard the unique identifier of the dispensed product equipped with security features under applicable regulations.

Dispensers of medical devices are, inter alia, required to:

• dispense only devices for which a declaration of conformity has been issued and that have been CE marked; this does not apply if the device is custom-made;
• comply with the requirements of good storing practices;
• provide the patient with all information about facts that may affect his/her safety and health in connection with the use of the medical device;
• discard and store separately all medical devices that cannot be used for reasons specified in the Act on Medical Devices (e.g. when there is a reasonable suspicion that the safety and health of patients or third parties are endangered or when the period for safe use or implantation of the device has expired, etc.);
• when dispensing a device on the basis of an electronic prescription, immediately inform the central repository of electronic prescription via the eRecept system that the prescribed device has already been issued; and
• archive all medical prescriptions for medical devices not reimbursed from public health insurance for a period of five years.

Specific rules apply to dispensing a device via consignment delivery.

 

 

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Click the following links to read more legal articles from Czech Republic:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Also from this Legal Handbook

The ins and outs of traditional medicines and OTC products in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 119.

 

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

Traditional herbal medicinal products and homeopathic medicinal products are subject to specific regulation set out in the Act on Drugs.

Traditional herbal medicinal products for human use will be granted marketing authorization following a simplified authorization procedure provided that they meet the following conditions:

• they are intended for oral, external or inhalation use;
• they are intended to be administered only at a certain strength and dosage;
• their indications correspond solely to the indications of traditionally used herbal medicinal products, and have been determined and devised on the basis of their composition and purpose for use without the need for supervision by a doctor for diagnostic purposes, prescription or treatment monitoring;
• the period of traditional use (i.e. 30 years, of which at least 15 years are in the EEA) has expired;
• there is sufficient data on the traditional use of the medicine in question; in particular, it has been shown that the product is not harmful under the specific conditions of use and that the pharmacological effects or efficacy of the product are evident on the basis of long-term use and experience.

The simplified process for obtaining marketing authorization generally follows the standard procedure with the difference that some of the standard application requirements do not apply. If a specific herbal medicinal product has been used in EEA member states for less than 15 years, but it still fulfills the remaining requirements for the simplified authorization procedure, the State Institute for Drug Control submits the application to the Committee on Herbal Medicinal Products (HMPC), which has been set up at the European Medicines Agency, in order to assess whether the requirements for the simplified registration procedure have been met.

Homeopathic medicinal products are subject to a simplified marketing authorization under which no evidence of therapeutic efficacy is required provided that they meet the following conditions:

• they are administered orally or externally;
• no therapeutic indication is stated on their label or in any information concerning the product; and
• dilution can guarantee the safety of the product.

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

Yes, subject to certain restrictions (please refer to Answer No. 17 of Chapter: Marketing, Manufacturing, Packaging & Labeling, Advertising). In addition, any advertisement as well as the labeling and package leaflet of a traditional herbal medicinal product must contain the following text (in Czech): “The use of this traditional herbal medicinal product is based solely on experience gained through long-term use”.

 

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

All medicinal products, including traditional herbal and homeopathic medicines, are subject to general advertising restrictions as set out by the Act on Advertising. For further information please refer to Answer No. 17 of Chapter: Marketing, Manufacturing, Packaging & Labeling, Advertising.

The Act on Drugs also establishes a specific requirement for the advertising of traditional herbal medicinal products, i.e. that the packaging or leaflet must contain the following text (in Czech): “The use of this traditional herbal medicinal product is based solely on experience gained through long-term use”.

 

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

Over-the-counter medicinal products are regulated by the Act on Drugs and its implementing regulations. The process of obtaining marketing authorization, manufacturing, distribution, etc. is in general the same as for all other medicinal products. For more information please refer to the Answers in Chapter: Marketing, Manufacturing, Packaging & Labeling, Advertising.

Whether a medicine may be distributed without a prescription is determined by the State Institute for Drug Control in accordance with applicable provisions of the Act on Drugs. This act specifies under what conditions the State Institute for Drug Control may allow the distribution of a medicinal substance without a doctor’s prescription. A medicine may not be distributed without a prescription if (i) it could, even if used correctly, constitute a direct or indirect hazard when used without medical supervision, (ii) it is often and widely used improperly and as a consequence may represent a direct or indirect danger to human health, (iii) contains substances or preparations of substances whose efficacy or adverse effects require further monitoring, or (iv) it is intended for parenteral administration.

 

5. Are there any limitations on locations or channels through which OTC products may be sold?

The majority of OTC products may only be sold in pharmacies or through a pharmacy’s online shop. The online sale of certain OTC products may be prohibited by a decision of the State Institute for Drug Control; this may be done with respect to OTC products that can be dangerous to human health and the danger can be prevented by (i) an expert consultation with a pharmacist before using the product or (ii) imposing certain restrictions on the dispensing of the product.

Selected medicinal products that can be used without consulting a doctor or pharmacist, such as teas, disinfectants or painkillers, can also be sold in other outlets, such as stores at gas stations or supermarkets. There is no need to obtain any specific license to sell these products (a regular retail trade license suffices); however, the business owner has to inform the State Institute for Drug Control about the commencement and termination of such operations (sale) and has to ensure that each individual selling any such products obtains a certificate of professional competence. The business owner can only purchase the medicinal products from distributors and manufacturers holding the relevant license from the State Institute for Drug Control. The business owner also has to ensure that the medicinal products are stored separately from other products.

 

6. What health, advertising, and marketing claims may be made for OTC products?

Advertising and marketing of OTC products are regulated by the same regulations as other medicinal products. For further information please see Chapter: Marketing, Manufacturing, Packaging & Labeling, Advertising, in particular Answer No. 17.

 

7. Can OTC products be marketed or advertised directly to the public?

Yes, OTC products can be advertised directly to the public. For further information please see Chapter: Marketing, Manufacturing, Packaging & Labeling, Advertising, in particular Answer No. 38.

The majority of OTC products can be sold directly to the public through pharmacies or their online shops. Online sale of certain OTC products may be prohibited by a decision of the State Institute for Drug Control. Certain medicinal products that can be used without consulting a doctor or pharmacist, such as teas, disinfectants or painkillers, can also be sold in other outlets, such as stores at gas stations or supermarkets.

 

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

The State Institute for Drug Control re-evaluates the dispensing classification of a medicinal product when extending the marketing authorization of a product or if new findings concerning the product are discovered. In the context of the re-evaluation, the State Institute for Drug Control aims to ensure that medicinal products with the same strength, packaging size and active substance are classified in the same dispensing category.

If it is concluded that the dispensing category needs to be changed during the renewal of the marketing authorization process, the State Institute for Drug Control will change the dispensing category within its decision on the extension of the marketing authorization. In other cases, the State Institute for Drug Control will initiate a procedure to amend the marketing authorization. The marketing authorization holder is then required to submit proposals for amendments to the Summary of Product Characteristics, package leaflet and labeling on the packaging of the product to the State Institute for Drug Control.

 

9. What are the requirements for the importation of either traditional medicines or OTC products?

Generally, in order to import medicinal products (including traditional herbal and over-the-counter medicinal products) from non-EEA countries, it is necessary to obtain a manufacturing authorization from the State Institute for Drug Control. The imported medicinal products must comply with the GMP requirements. Every batch of imported medicinal products manufactured in a third country must undergo an analysis in an EEA member state of all the active substances contained therein, in accordance with the registration requirements, before it can be released onto the EEA market (including the Czech market). Certain third countries have a mutual recognition agreement in place between the EU and such third country. In this case, special conditions are applicable for importation, e.g. full analytical testing may not be required. If a medicinal product has been released in another EEA member state, it is possible to import it into the Czech Republic under the authorization for wholesale distribution of medicinal products.

Importation from the countries of the European Union is permitted within the concept of the parallel trade of medicines in accordance with the principle of free movement of goods within the EU. For further information please see Chapter: Marketing, Manufacturing, Packaging & Labeling, Advertising, in particular Answer No. 28.

 

 

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Click the following links to read more legal articles from Czech Republic:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs