Article

The main objective of the amendment to the Act on Medicinal Products is, among other things, to ensure the availability of medicines for patients in the Czech Republic in the event of their current unavailability, as well as to prevent their unavailability. The author of the amendment to the Act on Medicinal Products is the Government of the Czech Republic.

On December 29, 2023, Act No. 456/2023 Coll., amending Act No. 378/2007 Coll., on medicinal products and on amendments to certain related acts (the Medicinal Products Act), as amended, and Act No. 48/1997 Coll., on public health insurance and on amendments and supplements to certain related acts, as amended (hereinafter also referred to as the “amendment to the Act on Medicinal Products”), amended Act No. 378/2007 Coll. on medicinal products and on amendments to certain related acts (Act on Medicinal Products) (hereinafter also referred to as the “Act on Medicinal Products”), which regulates the handling of medicinal products in the Czech Republic (hereinafter also referred to as the “CR”).

The Medicinal Products Act incorporates the relevant European Union regulations within the scope of this legal regulation in the CR and, in connection with directly applicable European Union regulations, regulates:

1. research, manufacture, preparation, distribution, control, and disposal of medicinal products and drugs,
2. registration, post-registration monitoring, prescription and dispensing of medicinal products, sale of reserved medicinal products and provision of information,
3. international cooperation in ensuring the protection of public health and the creation of a single market for medicinal products in the European Union,
4. keeping records of the activities referred to in points (a) and (b).

The amendment to the Medicinal Products Act was drafted by the Government of the Czech Republic. The Chamber of Deputies of the Czech Republic approved the draft amendment to the Medicinal Products Act on November 15, 2023, as amended. The amendment to the Medicinal Products Act is valid from December 29, 2023, and part of this amendment is effective from January 1, 2024, while the part of the amendment regulating in particular the rights and obligations of the entities concerned in relation to the labeling of medicinal products with the phrase “limited availability” (Sections 33a to 33c of the Medicinal Products Act) will only take effect on June 1, 2024.

The main objective of the amendment to the Medicinal Products Act is, among other things, to ensure the availability of medicinal products for patients in the Czech Republic in the event of their current unavailability, as well as to prevent their unavailability, as the relevant public authorities will have new obligations, which have been added to all links in the supply chain, to report up-to-date information on the quantity of medicines available to patients in the Czech Republic. Many new institutions have also been established with the aim of eliminating the unavailability of medicines.

Following the amendment to the Medicinal Products Act, we would like to summarize and explain in more detail the most significant proposed changes and new legal provisions.

New powers of the Ministry of Health of the Czech Republic (hereinafter also referred to as “MoH CR”)

The MoH CR has been granted new powers defined directly by the Act on Medicinal Products, on the basis of which, under the conditions of the new legislation, the MoH CR

1. issues a measure of a general nature classifying a medicinal product in the reserve stock system,
2. issues measures of a general nature imposing an obligation to release stocks of a medicinal product included in the reserve stock system for distribution to pharmacies,
3. issues measures of a general nature whereby, in the event of a threat to the availability of a medicinal product essential for the provision of healthcare services, it may adjust the conditions for its distribution, prescription, and dispensing.

New powers of the State Institute for Drug Control (hereinafter also referred to as “SÚKL”)

New powers have also been added to the SÚKL, defined directly by the Act on Medicinal Products, on the basis of which, under the conditions of the new legislation, the SÚKL

1. issue a general measure designating medicines as “limited availability” if all the conditions defined in the Medicines Act are met
2. upon request from the Ministry of Health of the Czech Republic, provide or make available the data necessary for the issuance of a general measure pursuant to Sections 77c to 77e and Section 77g of the Medicines Act
3. assigns to distributors for each distribution warehouse, to manufacturers for each production site and each warehouse, to marketing authorization holders, transfusion service facilities, healthcare providers providing pharmacy care for each pharmacy and each separate department for the dispensing of medicines and medical devices, an identification code for the workplace

New obligations of the holder of a marketing authorization for medicinal products

1. The new legislation specifies and extends the components of the notification by holders of marketing authorizations regarding the interruption or termination of supplies of medicinal products and information on the current quantity of the medicinal product available to the marketing authorization holder for the needs of patients in the Czech Republic.
2. The new legislation introduces an obligation for the holder, at the request of the State Institute for Drug Control, to provide data on the planned volume and time intervals of supplies of medicinal products for human use to the market in the Czech Republic (so that it is clear whether there is an imminent risk of unavailability of the medicinal product for the provision of healthcare services and for patients in the Czech Republic).
3. the new legislation imposes a new obligation on the holder to indicate the distributor or distributors through which it ensures the distribution of a medicinal product labeled “limited availability” (the purpose is to increase the awareness of pharmacies where they can order such a medicinal product)
4. The new legislation imposes an obligation on the holder (after the notified date of interruption or termination of supplies) to ensure the availability of a medicinal product for human use for the needs of patients and to supply this medicinal product (or another medicinal product that can replace it) to the market in the Czech Republic in a quantity corresponding to at least twice the average monthly supply of the medicinal product for which the interruption or termination of supply has been notified or the average monthly supply of the medicinal product for which the interruption or termination of supply has been notified. The holder may also fulfill this obligation, with the permission of the SÚKL, by supplying a medicinal product whose packaging and package leaflet are not in the Czech language.

Marking of medicinal products with the indication “limited availability”

The SÚKL shall label a medicinal product with the indication “limited availability” for the time strictly necessary by issuing a measure of a general nature in accordance with the following procedure:

• without undue delay after receiving notification of the interruption or termination of the marketing of the medicine, the SÚKL shall publish this information together with information on the date of interruption or termination of the marketing of the medicine and whether the medicine is replaceable by another medicine and, if so, by which
• The SÚKL shall evaluate the information provided by the marketing authorization holder and other information it has collected on the medicinal product for which the suspension or termination of marketing in the Czech Republic has been reported. If, after evaluation, the SÚKL concludes that the current quantity of the medicinal product does not sufficiently cover the needs of patients in the Czech Republic and that this need cannot be replaced by another medicinal product in the appropriate quantity, it shall mark such a medicinal product with the indication “limited availability” for the necessary period of time.
• If a medicine is marked as “limited availability” and all other conditions specified in the Act on Medicinal Products are met, it cannot be distributed abroad.

New obligations for distributors of medicinal products

1. The amendment to the Medicines Act introduces new reporting obligations for distributors. Distributors must provide the SÚKL with the following information in electronic form

• the quantity of human medicines marked with the label “limited availability” that were available at the end of the day preceding the day on which the label was affixed,
• the quantity of this human medicinal product available to them at regular intervals,
• the quantity of the medicinal product available to them at the request of the SÚKL in the event of a suspicion by the SÚKL that the availability of a human medicinal product is at risk

1. the new legislation requires distributors to ensure the supply of medicines to operators authorized to dispense medicines in quantities and at intervals corresponding to the needs of patients in the Czech Republic,
2. when ordering medicines for human use, distributors may not give preference to a specific operator authorized to dispense medicines,
3. in the case of a medicine ordered pursuant to Section 82(3)(h) or (l) of the Medicinal Products Act, the distributor is obliged to ensure its delivery within two working days of receiving the request, if the medicine is available
4. the distributor is obliged not to distribute abroad a medicine marked “limited availability” which has been designated by the holder of the marketing authorization for the Czech market.
5.  
6. It should be emphasized here that the ban on the distribution of medicines abroad will only apply to medicines marked with the label “limited availability” whose supplies on the Czech market are threatened, whereby only medicines for which the following have been reported may be marked with the label “limited availability” an interruption or termination of supplies do not sufficiently cover the needs of patients in the Czech Republic and cannot be replaced by another medicine, and only for the necessary period and on the basis of data obtained from the marketing authorization holder on the volume of supplies of medicines placed on the market in the Czech Republic and from distributors on the volume of human medicines which they have distributed, or a medicine that is a substitute for the medicine for which the interruption or termination has been notified.
7.  
8. in the case of a medicine included in the reserve stock system, the distributor is obliged to immediately create and maintain a stock of that medicine in an amount corresponding to the average monthly volume of that medicine distributed by it

New obligations for pharmacies

Pharmacies, like other holders, have also been given new reporting obligations and are now required, among other things, to provide the SÚKL with information on the quantity of medicines marked “limited availability.”

Under the new legislation, in the case of a human medicine labeled “limited availability,” the pharmacy operator is required to order it in such a way that the quantity of such a medicinal product in the pharmacy does not exceed the quantity corresponding to the usual number of packages dispensed per calendar week in the last 12 calendar months, and use it exclusively for dispensing to patients or healthcare providers; if the pharmacy operator has not dispensed any packages of the human medicine so labeled in the last 12 calendar months, it may only order the quantity specified in a valid medical prescription submitted to the pharmacy.

Reserve stock system

In order to predict the demand for medicines that are important for the provision of healthcare services, the Ministry of Health of the Czech Republic evaluates information on the indications and use of medicines that may affect their availability to patients in the Czech Republic. If, after evaluating this information, the Ministry of Health of the Czech Republic concludes that the planned volume of supplies of human medicines to the market in the Czech Republic does not correspond to the predicted need for human medicines, it shall include the human medicine in the reserve stock system by means of a general measure. Such a general measure shall be issued by the Ministry of Health of the Czech Republic for a maximum period of 12 months, with the possibility of renewal for a further 12 months.

Prohibition of discrimination against pharmacies by doctors

The new legislation stipulates that when prescribing medicines, doctors are obliged to act in such a way as to avoid favoring a particular healthcare provider offering pharmacy care or interfering with the patient's right to choose a healthcare provider offering pharmacy care. This provision of the amendment to the Medicines Act thus introduces a ban on discrimination against pharmacies or influencing patients in their decision as to which pharmacy will dispense their medicine. The Act also stipulates the mandatory disclosure of information on medicines marked as “restricted availability.” Information such as the quantity of the medicine and its availability will thus be accessible to the prescribing doctor and also to the patient to whom the medicine is prescribed.

eRecept system

In order to inform the patient about the availability of a specific medicine prescribed to the patient, the healthcare provider may use the service for viewing electronic prescriptions provided by the State Institute for Drug Control through the eRecept system. This eRecept system service provides healthcare providers providing pharmacy care with information about

• the name of the human medicine prescribed on the electronic prescription,
• the number of packages of the human medicine prescribed on the electronic prescription,
• the validity period of the electronic prescription.

As the purpose of the amendment to the Act on Medicinal Products is primarily to ensure the availability of medicinesin the event of interruption or termination of supplies to the market and to regulate the reporting of current stocks of medicines whose availability is threatened, individual links in the supply chain, with the aim of enabling the rapid collection of comprehensive data on the current quantity of given medicines on the market in the Czech Republic and the possible use of institutions to ensure the availability of medicines, it will be interesting to see whether the new legislation will succeed in ensuring or improving the availability of medicines in the Czech Republic.

The law firm Hronček & Partners, s. r. o. is ready to provide you with comprehensive legal advice in connection with the amendment to the Medicinal Products Act and, in particular, its application in practice. Please do not hesitate to contact us if you need any assistance or have any questions.