Article

One of the main objectives of the amendment to the Medicines Act is to ensure the availability of medicines for patients in the Czech Republic, both in cases where they are currently unavailable and by preventing such shortages from occurring. The amendment to the Medicines Act was drafted by 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 to Certain Related Acts, as amended (hereinafter also referred to as the “Amendment to the Medicines Act”), amended Act No. 378/2007 Coll., on Medicines and on Amendments to Certain Related Acts (the 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”).

Within the scope of this legislation in the CR, the Medicines Act incorporates the relevant European Union regulations and, in accordance with directly applicable European Union regulations, governs:

1. research, manufacture, preparation, distribution, control, and disposal of medicines and medicinal products,
2. registration, post-registration monitoring, prescribing and dispensing of medicines, sale of restricted medicines, and provision of information,
3. international cooperation in ensuring the protection of public health and the creation of a single market for medicines in the European Union,
4. maintenance of records regarding the activities listed in subparagraphs (a) and (b).

The author of the amendment to the Medicines Act is the Government of the Czech Republic. The Chamber of Deputies of the Czech Republic approved the draft amendment to the Medicines Act on November 15, 2023, as amended by proposed amendments. The amendment to the Medicines Act is valid as of December 29, 2023, and part of this amendment is effective as of January 1, 2024, while the part of the amendment regulating, in particular, the rights and obligations of the entities concerned in connection with labeling medicines with the indication “limited availability” (Sections 33a to 33c of the Medicines Act) will not take effect until June 1, 2024.

The main objective of the amendment to the Medicines Act is, among other things, to ensure the availability of medicines for patients in the Czech Republic, both in cases of current unavailability and by preventing such unavailability, as the relevant public authorities will, thanks to new obligations imposed on all links in the supply chain regarding the reporting of up-to-date information on the quantity of medicines available to patients in the Czech Republic, have the means to do so. Numerous measures aimed at eliminating medicine shortages have also been introduced.

In light of the aforementioned amendment to the Act on Medicinal Products, we would like to use this article to summarize and further clarify the most significant proposed changes and the new legal framework.

New Powers of the Ministry of Health of the Czech Republic (hereinafter also “MOH CR”)

The MOH CR has been granted new powers defined directly by the Medicines Act, under which, in accordance with the conditions of the new legal framework, the MOH CR

1. issues a measure of a general nature classifying a medicine into the reserve stock system,
2. issues a measure of a general nature imposing an obligation to release stocks of a medicinal product included in the reserve stock system for the purpose of distribution to pharmacies,
3. issues a measure of a general nature by which, 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 “SÚKL”)

New powers have also been granted to the SÚKL, defined directly by the Act on Medicines, under which, in accordance with the conditions of the new legislation, the SÚKL

1. issues a measure of a general nature designating medicines as having “limited availability” upon fulfillment of all conditions defined by the Act on Medicines
2. upon request by the Ministry of Health of the Czech Republic, it provides or makes available the data necessary for the issuance of a general measure pursuant to Sections 77c through 77e and Section 77g of the Medicines Act
3. assigns to distributors, for each distribution warehouse, to manufacturers for each manufacturing site and each warehouse, to marketing authorization holders, to blood transfusion service facilities, and to healthcare providers offering pharmacy services for each pharmacy and each separate department for the dispensing of medicines and medical devices, an identification code for the facility

New obligations of marketing authorization holders

1. The new legislation specifies and expands the components of marketing authorization holders’ reports on the interruption or termination of drug supplies and information on the current quantity of the drug that the marketing authorization holder has available to meet patient needs in the Czech Republic
2. The new legislation introduces an obligation for the holder, upon request by the State Institute for Drug Control (SÚKL), 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 (to determine 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 establishes a new obligation for the marketing authorization holder to specify the distributor or distributors through whom they ensure the distribution of a medicinal product labeled with the indication “limited availability” (the purpose is to increase awareness among pharmacies regarding which distributor they can order such a medicinal product from)
4. The new legislation establishes an obligation for the marketing authorization holder (after the notified date of interruption or termination of supplies) to ensure the availability of a medicinal product for human use to meet patient needs and to supply this medicinal product (or another human medicinal product that can replace it) in a quantity corresponding to at least twice the average monthly supply of the medicinal product for which the interruption or termination of supply was notified, or the average monthly supply of the medicinal product for which the interruption or termination of supply was notified. The holder may fulfill this obligation, with the approval of the SÚKL, by supplying a medicinal product whose labeling and package insert are not in the Czech language.

Marking of Medicines with the “limited availability” Indicator

The SÚKL shall mark a medicine with the “limited availability” indicator for the necessary period of time by issuing a measure of a general nature in accordance with the following procedure:

• without undue delay after receiving notification of the suspension or termination of the marketing of a medicinal product, the SÚKL shall publish this information along with details regarding the date on which the suspension or termination of the marketing of the medicinal product will take effect, and whether this medicinal product is replaceable by another medicinal product and, if so, by which one
• The SÚKL will evaluate the information provided by the marketing authorization holder and other information it has gathered regarding the medicinal product for which a suspension or termination of marketing in the Czech Republic has been reported. If, following its evaluation, the SÚKL concludes that the current supply of the medicinal product does not sufficiently meet the needs of patients in the Czech Republic and, at the same time, this need cannot be met in an adequate quantity by another medicinal product, it shall designate such a medicinal product as “limited availability” for the necessary period
• If a medicinal product is designated with the “limited availability” indicator and all other conditions specified by the Medicines Act are met, the distribution of such a medicinal product abroad is not permitted

New Obligations for Medicinal Product Distributors

1. With the amendment to the Medicines Act, new reporting obligations have been imposed on distributors. The distributor must electronically provide the State Institute for Drug Control (SÚKL) with data

• on the quantity of the medicinal product for human use that is marked with the “limited availability” indicator that were available to them as of the end of the day preceding the day of labeling with this indicator,
• on the quantity of this human medicinal product that they have available, at regular intervals,
• on the quantity of the medicinal product that they have available, upon request by the SÚKL in the event that the SÚKL suspects a threat to the availability of the human medicinal product

1. The new legislation requires the distributor to ensure the supply of medicinal products to operators authorized to dispense medicinal products in quantities and at intervals corresponding to the needs of patients in the Czech Republic,
2. the distributor must not give preferential treatment to a specific operator authorized to dispense medicinal products when ordering medicinal products for human use,
3. in the case of a medicinal product ordered pursuant to Section 82(3)(h) or (l) of the Medicinal Products Act, the distributor is required to ensure its delivery within 2 business days from the date of receipt of the request, provided that the medicinal product is available,
4. the distributor is obligated not to distribute a medicinal product labeled as “limited availability,” which has been designated by the marketing authorization holder for the Czech market, to foreign countries.
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6. It should be emphasized here that the ban on the distribution of medicines abroad will apply only to those medicines marked with the “limited availability” label whose supplies on the Czech market are at risk, and only those medicines for which a suspension or termination of supplies has been announced may be marked with the “limited availability” label, do not sufficiently cover the needs of patients in the Czech Republic, and this need cannot be met by another medicine, and this applies only for the necessary duration and based on data obtained from the marketing authorization holder regarding the volume of medicines placed on the market in the Czech Republic and from distributors regarding the volume of medicinal products for human use which they distributed, or a medicinal product that serves as a substitute for the medicinal product for which a suspension or discontinuation was announced.
7.  
8. in the case of a medicinal product included in the reserve stock system, the distributor is required to immediately establish and maintain a stock of that product in a quantity corresponding to the average monthly volume of that medicinal product distributed by the distributor

New Obligations for Pharmacies

Pharmacies, like other holders, have also been assigned new reporting obligations; specifically, in addition to other information, they must provide the State Institute for Drug Control (SÚKL) with data on the quantity of medicinal products marked with the “limited availability” indicator

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

Reserve Stock System

In order to forecast the demand for medicines critical to 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 human medicinal product supplies to the market in the Czech Republic does not correspond to the predicted demand for human medicinal products, it shall, by means of a general measure, include the human medicinal product in the reserve stock system. The Ministry of Health of the Czech Republic issues such a general measure for a maximum period of 12 months, with the possibility of renewal for an additional 12 months.

Prohibition of Discrimination by Physicians Against Pharmacies

The new legislation stipulates that when prescribing medicines, physicians are required to act in such a way as to avoid favoring a specific healthcare provider offering pharmacy services or interfering with the patient’s right to choose a healthcare provider offering pharmacy services. This provision of the amendment to the Medicines Act thus introduces a ban on discrimination against pharmacies, or influencing patients in their decision regarding which pharmacy will dispense the medication. The Act also mandates the disclosure of information regarding medications labeled as “limited availability.” Information such as the quantity of the medicine and availability details will thus be accessible to the prescribing physician as well as to the patient to whom such a medicine is prescribed.

eRecept System

In order to inform the patient about the availability of a specific medication prescribed to them, a healthcare provider may use the service for viewing electronic prescriptions provided by the State Institute for Drug Control (SÚKL) via the eRecept system. This eRecept system service provides healthcare providers offering pharmacy care with information on

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

Since the primary purpose of the amendment to the Medicines Act is to ensure the availability of medicines in the event of an interruption or cessation of market supply and to regulate reporting of current medicine stocks whose availability is at risk, individual links in the supply chain—with the aim of enabling the rapid collection of comprehensive data on the current quantity of such medicines on the market in the Czech Republic and the potential use of mechanisms to ensure the availability of medicines—it will be interesting to see whether the new legislation succeeds 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 regarding the amendment to the Medicines Act, particularly concerning its practical application. Please do not hesitate to contact us if necessary or if you have any questions.