Czech MPs approve law to tackle drug shortages, pharma industry unconvinced

Czech Parliament has approved a law amendment setting out new obligations for suppliers and distributors of medicines, pharmacies and state authorities in what the Health Ministry hopes will tackle medicine shortages, but the pharmaceutical sector is unconvinced.

The Ministry of Health proposed the legislation in response to the low availability of certain drugs in the country, such as penicillin. This comes when the EU’s pharmaceutical package addressing similar challenges is discussed at the European level.

The key change is the obligation for pharmaceutical suppliers to report supply disruptions and ensure the delivery of medicines to pharmacies for one or two months after the reporting.

Distributors and pharmacies will be required to provide the State Institute for Drug Control with daily updates on the stock levels of medicines with limited availability. This will give the Health Ministry oversight of shortages and general availability through distribution channels.

The law should also ensure fair distribution of medicines across pharmacies, as these will be obliged to order medicine with limited availability only in the “usual quantity”, preventing the hoarding of certain drugs.

At the same time, distributors cannot favour specific pharmacies when supplying medicines.

“This is a very substantial amendment, which I dare say is the biggest change in the last 15 years, with patients at the forefront. If possible, the medicine should be in every pharmacy; there should be enough of it, and the patient should know where it is available,” said Health Minister Vlastimil Válek (TOP 09, EPP) after the approval of the amendment.

Industry: The law does not address the shortages 

However, pharmaceutical companies are doubtful about the impacts of the new legislation. According to David Kolář, director of the Association of Innovative Pharmaceutical Industry (AIFP), the amendment “will not solve the shortages of medicines”.

“It only gives the Health Ministry and the State Institute for Drug Control more time, tools and information on the market situation. For the amendment to actually prevent shortages, it would have to focus on the specific groups of medicines that have experienced outages and, in particular, on their causes,” Kolář told Euractiv.

According to Kolář, the state authorities will have more information about the market situation and acquire more time and tools to find alternatives in case of shortages, which he sees as a positive aspect. However, he does not consider it as a solution.

“The negative aspect of the amendment is mainly the fact that it does not address what it was supposed to address, i.e. drug shortages. It is not based on an analysis of shortages and their causes, it does not target specific medicines or groups of medicines, it does not facilitate measures to ban the export of medicines at risk of re-export,” Kolář explained.

Representatives of the generic industry take a similar view.

Filip Vrubel, director of the Czech Association of Pharmaceutical Companies (ČAFF), representing leading producers and suppliers of generic and biosimilar drugs in Czechia, said the approved amendment to the Medicines Act will not prevent drug shortages.

“It will have little effect, and it brings new obligations for all players on the market,” he told Euractiv.

“More precisely, these are new administrative obligations, such as reporting huge amounts of data, the need to evaluate them, holding certain stocks, etc. This means incurring further considerable costs,” Vrubel added.

He also pointed out that the amendment deals mainly with reporting and fair distribution across pharmacies but does not secure more medicines on the market.

“What is sorely lacking in the approved version of the amendment are measures that would strengthen market resilience and competitiveness, provide guarantees for the procurement of medicines, and encourage greater stocks of medicines to be held by the state,” Vrubel noted.

The amendment still needs to be approved by the upper house of parliament and the senate, but given its smooth passage in the lower house, the green light is expected.

“I believe the law will come into force on 1 January (2024),” Minister Válek wrote on X.

[By Aneta Zachová |Euractiv.cz – Edited by Vasiliki Angouridi | Euractiv.com]

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