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Act on Pharmaceuticals Amendment

We would like to inform you that as of 1 January 2024, the pharmaceutical industry in the Czech Republic is impacted by the most complex amendment of pharmaceuticals regulation in many years (amendment to the Medicinal Products Act No. 378/2007 Coll. – “Amendment”). Please, find below a summary of the most important changes introduced by the Amendment.

The aim of the Amendment is to ensure the availability of medicinal products for human use (“MP”) in the event of interruption or termination of their supply to the market (stock out). The Amendment is therefore primarily aimed at marketing authorization holders (“MAH”), distributors and pharmacy operators.

1. Medicinal product marked with “limited availability” label and related obligations of the subjects

The regulatory body for oversight of pharmaceuticals – State Institute for Drug Control (“Institute”) – is entitled to mark MP with the “limited availability” label if (i) the MP has a fixed reimbursement from public health insurance or a maximum price, (ii) it has been notified of a suspension or termination of marketing, (iii) it is not covered by an exemption (e.g. seasonal vaccines etc.) and (iv) the Institute assesses, on the basis of available data, that the current quantity of the MP does not sufficiently cover the needs of patients in the Czech Republic and that this need cannot be replaced in an adequate quantity by another MP of equivalent therapeutic qualities.

For a MP marked as “limited availability”, for which an interruption or termination of supply has been notified, the MAH must:

·         update such notification with information on the action taken to remedy the situation; and

·         publish, through a publicly accessible professional information service, a list containing the distributor or distributors distributing the MP marked with “limited availability” label.

The distributor is obliged to:

·         supply any pharmacy that orders MP marked with “limited availability” label, in accordance with the limits set, with such MP within 2 working days of the date of the order, if the MP is available.

·         not distribute abroad MP marked with “limited availability” label that has been designated by the MAH for the Czech market. 

·         provide the Institute with data on the quantity of the MP marked “limited availability” available at the end of the day preceding the date of the marking of the MP and subsequently, at regular intervals, on the current available quantity.

Pharmacies are only allowed to order MP with the “limited availability” label within the following limits. A pharmacy operator (i) must not order the affected MP so that the quantity in that pharmacy exceeds the usual number of units dispensed in a calendar week in the past 12 calendar months, or the number of units listed on a prescription if no MP has been dispensed in the past 12 months, and (ii) must use the MP solely for dispensing to patients or health care providers. For dispensaries, the limits are set on the same principle with minimal differences.

2. Changes to the MAH’s obligations regarding the supply of medicinal products

The Amendment removes the obligation of MAH to supply any distributor who makes a written declaration to the MAH that it requires MP for patient care so that the distributor has MP in quantities corresponding to at least the so-called biweekly average demand (so-called protected channel).

MAH shall be newly obliged to ensure the supply of certain MP in case of interruption or termination of its marketing without undue delay in a quantity corresponding to at least twice the average monthly supply of the MP for which the interruption or termination of supply was notified, or in a quantity corresponding to the average monthly supply if the MAH has marketed this MP on the Czech market without interruption of supply/interruption in the last two years for a total of max 20 days.

Subject to the Institute’s approval, the above obligation can be fulfilled by supplying MP with labelling and package leaflet in a language other than Czech. In case of refusal of such a request, MAH does not have to fulfil the obligation in the quantity specified in the request.

The above obligation to supply shall not apply:

·         for a period of 12 months from the date of placing the MP on the market in the Czech Republic;

·         in relation to MP for which no reimbursement or maximum price has been fixed; or

·         in relation to MP established by specific implementing legislation.

3. Changes to distributors’ obligations

The Amendment preserves the general obligation of the distributor to ensure the availability of MP for the needs of patients in the Czech Republic. There is a new specific that provides that the distributor must not favour a particular pharmacy in any way when supplying the MP. The impact of this provision may be significant from both competition law perspective as well as commercial practise.

In case of ordering a shortage MP with the “limited availability” label by a pharmacy in a quantity not exceeding the given limits (see point 1 above), the distributor is obliged to ensure its delivery within 2 working days from the receipt of the request, if the MP is available. If the distributor does not have such MP in stock, it will not be obliged to supply them to the pharmacy. This new regulation responds to situations in which a pharmacy orders an MP from a distributor that the distributor has in stock, but the distributor prefers to place a later order from another pharmacy without a compelling reason.

4. Reserve stock system

In accordance with the proposed Amendment, the Ministry of Health is authorized to include MP significant for the provision of health services in the Czech Republic in the so-called reserve stock system if the planned volume of MP supplies on the market in the Czech Republic does not correspond to the predicted need for MP. This may be done for a maximum period of 12 months, which may be repeatedly extended for another 12 months.

The listing of MP into the reserve stock system is particularly associated with the distributor’s obligation to immediately create and maintain a stock of MP in a quantity corresponding to the average monthly volume of such MP distributed by it. The distributor cannot dispose of the stock unless instructed by the Ministry of Health.

If the volume of MP included in the reserve stock system does not cover the current needs of patients, the Ministry of Health may impose an obligation to release reserve stocks of that MP for distribution to operators authorized to dispense.

5. MAH’s new information obligations

MAH is obliged to provide in the notification of suspension/termination of placing MP on the market in the Czech Republic the data on the current quantity of MP available to the MAH as of the date of notification and intended for the market in the Czech Republic. 

Furthermore, at the request of the Institute, if the Institute suspects a threat to the availability of MP, the MAH is obliged to provide data on the planned volume and time intervals of supply of MP to the market in the Czech Republic or data on the current quantity of MP intended for the market in the Czech Republic and available to the MAH. The Amendment imposes a similar obligation on the distributor.

If you wish to discuss how the Amendment will affect your business, we will be happy to assist you.

Mgr. Eliška Toušková Attorney-at-Law

eliska@kastnerpies.cz