A long-awaited amendment to the Czech Medicines Act came into force on 1 January 2024. What practical impact will it have?
The amendment addresses the recurring and extended shortages of certain medicinal products on the Czech market over recent months or years. It gives the Ministry of Health a previously unavailable tool to more effectively prevent shortages in the supply of medicines on the Czech market.
Crucially, marketing authorisation holders are now obliged to supply the medicinal product for two more months after the actual interruption or termination of supplies to the Czech market.
Distributors of "restricted availability" medicinal products, i.e. medicines that are listed by the Ministry of Health, must maintain reserve stocks of the medicine corresponding to an average monthly supply. In so doing, the Ministry of Health hopes to bridge short-term as well as longer-term shortages of some medicine supplies.
The amendment also mandates an information obligation, requiring entities in the distribution chain to report current stocks of medicinal products at risk of scarcity to the State Institute for Drug Control.
Nonetheless, the attentive reader will notice that the "stock" obligation applies only to medicinal products for human use that are covered by public health insurance or for which a maximum price has been set. Put simply, over-the-counter drugs such as Nurofen or Ibuprofen will not be subject to the stock obligation, but, for instance, antibiotics will be.
A penalty of up to CZK 20,000,000 maybe imposed for a breach of the newly introduced obligations.