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Amendment to the Act on Medicinal Products; new obligations to ensure availability of medicinal products
An amendment to the Act on Medicinal Products entered into effect as of 1 January 2024, imposing numerous new obligations on marketing authorisation holders, distributors and pharmacies, and expanding the existing powers of administrative authorities. The changes are primarily aimed at ensuring the availability of medicinal products for the needs of patients in the Czech Republic and increasing the resilience of the market to supply shortages of medicinal products.
The amendment responds to the frequent medicinal product shortages that patients in the Czech Republic have had to face, especially in the past year, and introduces the following measures:
- Marketing authorisation holders (MAHs) will be obliged to ensure additional supplies of the medicinal product for the needs of Czech patients after notifying the interruption or discontinuation of the marketing of the medicinal product on the Czech market;
- The State Institute for Drug Control (SÚKL) may mark a medicinal product with the “limited availability” attribute. Distributors will then be obliged to supply such medicinal product to pharmacies within 2 business days. Distribution of such medicinal product to foreign countries will be prohibited;
- The Ministry of Health may include a medicinal product in the reserve stock system. Distributors will then be obliged to maintain a minimum stock of that medicinal product;
- Prohibition of discrimination against pharmacies, according to which the distributor may not favour a particular pharmacy in any way when ordering medicinal products;
- Extension of the information obligations of MAHs, distributors and pharmacies towards the administrative authorities; and
- Extension of the competences of SÚKL and the Ministry of Health.
For a more detailed summary of each point, please see our previous article here. Below we focus on the most significant change, namely the obligation of the MAH to ensure additional supplies of medicinal products. We also mention the new features that were incorporated into the amendment during the legislative process.
Obligation of the MAH to ensure additional supplies of medicinal products
If the MAH interrupts or discontinues the marketing in the Czech Republic of a medicinal product which has a fixed reimbursement or maximum price, the MAH will become obliged to supply such medicinal product (or a substitute product) to the Czech market without undue delay in a quantity corresponding to at least:
- double the average monthly supply; or
- the average monthly supply, if the MAH has been marketing the medicinal product in the Czech Republic in the last 2 years without interruption of supply, or if such interruption lasted in total not more than 20 days.
However, there are exceptions to this obligation. The obligation does not apply for one year after the medicinal product has been placed on the market and does not apply to medicinal products defined in Decree of the Ministry of Health (e.g. to the ATC group sotrovimab and influenza or covid vaccines). At the same time, the law allows MAHs to fulfil their obligation by supplying foreign-language batches of medicinal products, subject to prior approval by the SÚKL.
The obligation to ensure additional supplies of medicinal products has a suspended effect. For MAHs, it will apply from 1 June 2024, but for the time being only in half the scope of supplies. The obligation will fully apply from 1 January 2025. The date of the notification of the interruption or discontinuation of the marketing of the medicinal product will be decisive – hence, the obligation will not apply retroactively.
Extension of the competences of SÚKL and the Ministry of Health
In connection with the new obligations of individual entities, certain changes were incorporated into the amendment during the legislative process which also significantly strengthen the powers of SÚKL and the Ministry of Health and which are also reflected in the Public Health Insurance Act.
In particular, the SÚKL is now authorised to issue in the area of price and reimbursement regulation so-called measure to preserve the availability of irreplaceable reimbursed medicinal products and to ensure the availability of medicinal products important from the perspective of public health protection. SÚKL thus may, for example, set an extraordinary maximum price and reimbursement of medicinal products due to their “imminent unavailability” or “importance for the protection of public health”.
For example, the Ministry is henceforth authorised to impose on the health insurance company the reimbursement of a medicinal product substituting a medicinal product with the attribute “limited availability”, and to regulate a special commercial surcharge for the distribution of medicinal products released from the reserve stock system.
At the same time, the Ministry of Health is given powers to regulate the conditions for the distribution, prescription and dispensing of a medicinal product important for the provision of health services, the availability of which is jeopardised. Although the amendment does not define the specific measures in detail, according to the explanatory memorandum to the amendment, these may include, for example, restrictions on the prescription and dispensing of medicinal products or interference with the distribution of medicinal products.
Other adopted changes
In addition to the original draft of the amendment, a number of new changes were incorporated into the amendment during the legislative process. For example, modifications are being made to the eRecept system; in particular, doctors and patients have access to up-to-date information on the availability of medicinal products with the “limited availability” attribute, and the conditions for importing foreign language batches of OTC medicinal products and prescription-only medicinal products are clarified.
Another new feature is the method of designating pharmacies, distribution warehouses and other points of importance for monitoring the availability of medicinal products by means of the so-called workplace identification code.
Applicability
Most of the measures adopted are already effective as of 1 January 2024, with the exception of the obligation for MAHs to ensure additional supplies of medicinal products and the measures concerning medicinal products with the “limited availability” attribute – these will take effect as of 1 June 2024 (while the obligation to ensure additional supplies will fully apply from 1 January 2025 – see above).
Authors: HAVEL & PARTNERS | F. Neuwirth, V. Laštůvková, A. Pospíšilová
Amendment to the Act on Medicinal Products; new obligations to ensure availability of medicinal products
