The plan by Czech Minister of Health, Vlastimil Válek, to resurrect penicillin production in the Czech Republic encounters significant hurdles, according to Filip Vrubel, the Director of the Czech Association of Pharmaceutical Companies (ČAFF). Vrubel notes that European manufacturers receive a meager 60 to 130 Czech crowns for a pack of this antibiotic, making it challenging to compete with Asian counterparts. He suggests that reviving production should be contemplated at a pan-European level.

Minister Válek has expressed a keen interest in revitalizing domestic antibiotic production, with a focus on penicillin, which has become increasingly scarce in the market. His objective is to ensure that production occurs within the Czech Republic, especially for drugs with high consumption rates domestically and abroad, with penicillin serving as a prime example.

The Minister plans to engage potential producers, extending invitations not only to pharmaceutical companies but also to research institutions, universities, and specific university hospitals. These discussions are in their initial stages, aimed at exploring various possibilities while ensuring compliance with the legal requirements governing drug production, as outlined by Ondřej Jakob, spokesperson for the Ministry.

Vrubel emphasizes the importance of pinpointing the specific phase of penicillin production to be reintroduced in the Czech Republic. This can range from the production of active ingredients (APIs) alone, the manufacturing of tablets from supplied APIs, to the final assembly of tablets and packaging. He highlights that the earlier the production phase, the more intricate and costly it becomes due to the necessary approvals.

According to ČAFF, addressing drug production on a pan-European scale presents a more viable solution. Vrubel argues that investing in similar production phases of identical drugs across individual countries is economically and strategically counterproductive, particularly given the higher production costs and stringent environmental and labor regulations faced by European manufacturers.

Penicillin, renowned for its medicinal properties, was discovered in 1928 by British microbiologist Alexander Fleming. Czechoslovakia commenced penicillin production in 1949. The current challenges stem from European companies’ inability to compete with Asian manufacturers due to higher production costs and stringent regulatory standards related to the environment and labor. Coupled with limited support for drug production within the Czech Republic, the prospects for domestic penicillin production face additional obstacles.

The availability of antibiotics, including penicillins, has been plagued by chronic issues that were exacerbated during the COVID-19 pandemic due to disruptions in production chains. Anticipated amendments to the Medicinal Products Act aim to enhance drug supply and ensure equitable distribution among pharmacies based on previous consumption patterns.

Article by Prague Forum