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 patients. If the Ministry of Health assesses that a shortage of a particular medicine could occur, it will include the product in a so-called reserve stock system. Under this system, medicinal products can be included for a maximum period of 12 months, with the possibility of an extension for a further 12 additional months.
Distributors of medicinal products will then be obliged to establish and maintain pharmacy stocks in a quantity corresponding to the respective average monthly supply. Such a new mechanism, therefore, envisages a greater synergy between drug manufacturers and distributors in order to ensure better availability of medicinal products on the market. At the same time, the amendment is also intended to improve communication and exchanges of information between marketing authorisation holders and the public administration on the actual availability of medicinal products on the market.
Distributors will also be prohibited from distributing medicinal products abroad that have been marked as "restricted availability", thus preventing further exports when it is already evident that availability is or will soon be restricted.
The draft amendment has now been submitted to the lower house of the Czech parliament, which is expected to weigh the proposals in the coming months. If all goes to plan, the amendment is expected to enter into force by the end of 2023.
In any case, the amendment is widely seen as representing an ambitious plan to address, through detailed and strict regulation, frequent market imbalances and fragile supply lines caused by various factors which are often global in nature and beyond the control of the supply chain itself. Indeed, several EU Member States have recently adopted similar regulations, with more states also planning changes. Without question, the availability of medicines is currently a hot topic in Europe and beyond and market analysts anticipate that drug supply shortages will continue to occur more frequently in the near future.
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