Czech Amendment To The Medicines Act Seeks To Address Drug Shortages

• Jurisdiction: European Union
• Law Firm: Kinstellar
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Biotechnology & Nanotechnology
• Author: Mr Tom' Čihula
• Published date: 03 July 2023

June 2023 - On 14 June 2023, the Czech government approved a draft amendment to the Medicines Act. The aim is to improve the availability of medicines on the market and to mitigate the potential negative impacts of recent and ongoing medicines supply shortages.

To this end, the proposed amendment creates new obligations for operators in the medicines market, in particular (i) additional obligations following the interruption or discontinuation of the supply of a given medicinal product; and (ii) a mandatory system of reserve stocks.

The specific proposed form of these obligations is as follows:

(i) Obligations after a supply interruption or termination

Under the proposed plan, marketing authorisation holders (MAHs) will be obliged to continue to make available certain medicinal products after an interruption or discontinuation of supplies, with a statutory minimum quantity of up to twice the given medicinal product's average monthly usage.

However, the Ministry of Health (MoH) will be able to issue exemptions via a special list of medicinal products to which this obligation will not apply. Medicinal products will also generally be exempted for the first 12 months after being placed on the market in the Czech Republic.

In addition, the State Institute for Drug Control (SUKL) will be able to designate certain medicinal products as being "restricted availability" where the MAH has notified an interruption or termination of supplies in the Czech Republic - if the SUKL assesses that the current available quantity of the given medicinal product does not meet the current needs of patients in the Czech Republic. The SUKL will also designate as "restricted availability" substitute medicinal products for which the MAH has notified an interruption in marketing.

Within 30 days of the designation of a medicinal product as "restricted availability", the MAH must make public any information on the measures taken in the Czech Republic to overcome supply restrictions. At the same time, if they have the given medicinal product in stock, distributors will be obliged to supply such medicinal products to pharmacies within two working days of receiving a request.

(ii) Medicinal product reserve system

According to the draft amendment, the Ministry of Health should also monitor - using data obtained from mandatory reports by market operators - whether the planned supply of medicinal products corresponds to the anticipated needs of Czech...