New Czech Medicines Act takes force, boosting pharma efficency, tackling shortages

Czechia has enforced new legislation since 1 June aimed at reducing the impact of drug shortages on patients while enhancing the efficiency of the pharmaceutical market.

A new amendment to the Czech Medicines Act, designed to bolster patient protection, improve market transparency, and tighten the rules for exporting medicines abroad, is now in force. This legislation represents significant overhauls of pharmaceutical regulations in recent years, making the Czech pharmaceutical market more resilient to disruptions, argues the Czech health ministry.

“The amendment to the Medicines Act is not only patient-centric but also significantly enhances the information flow among market players. It is one of the most substantial pharmaceutical legislative reforms in recent years, greatly increasing the resilience of the Czech pharmaceutical market against shortages and minimising their impact on citizens,” said Czech Deputy Minister of Health Jakub Dvořáček.

‘Limited availability’ export ban

One of the pivotal changes under the new law is the obligation for marketing authorisation holders to ensure the availability of a medicinal product in quantities corresponding to one to two months of average supply if they announce an interruption or cessation of its market presence in Czechia.

This requirement aims to bridge short-term shortages and provide time to address more prolonged supply issues.

The legislation also introduces a “limited availability” status designated by the State Institute for Drug Control (SÚKL) for medicines whose current stock levels do not adequately meet patient needs and cannot be sufficiently replaced by other drugs with similar therapeutic properties.

This status triggers an automatic ban on exporting such medicines abroad.

Pharmacies and distributors are now required to report their stock levels, and ordering these drugs will be regulated to maximise efficiency and ensure availability across the country.

Improvements in the eRecept system

The new amendment also aims to improve the Czech electronic prescription system, the so-called “eRecept”.

“For medicines with limited availability, patients will have the ability to identify which pharmacies stock the medication through eRecept reports. Additionally, other changes to the eRecept system will include the possibility of viewing a child’s medication record with a legal guardian’s document or granting a mandate for access to one’s data recorded in the eRecept system to another person,” explained Tomáš Boráň, director of SÚKL.

Pharmaceutical industry remains concerned

While the legislation has been largely praised by the health ministry, the Czech Association of Pharmaceutical Companies (ČAFF) has raised concerns about potential unintended consequences.

One such issue is the paradoxical increase in the number of reported shortages due to pharmaceutical companies’ efforts to comply with the new obligations and avoid penalties.

“Although we are currently working with regulatory authorities to establish methodologies to prevent false warnings of shortages, there is a risk of an increase in the number of reports for various reasons, as we warned during the legislation’s approval,” said Filip Vrubel, executive director of ČAFF, the association representing the Czech generic industry.

Vrubel added: “These preventive reports will burden not only the companies themselves but also SÚKL, which will be evaluating the reports, further complicating the market situation for both doctors and patients,”

Impact of German Legislation on Czech Market

According to ČAFF, a significant external risk to drug availability in Czechia comes from new German legislation, which mandates a six-month stock of medicines for suppliers involved in tenders with German health insurers. This requirement poses a serious threat to smaller markets in Central and Eastern Europe, the association argues.

“The six-month stock requirement for all medicines consumed in Germany represents 25% of the entire EU supply. This volume corresponds to the annual consumption of medicines in eleven Central and Eastern European countries, including the Czech Republic,” Vrubel remarked.

“Such legislation, which negates the principle of solidarity in redistributing medicines within the EU, can lead to the depletion of medicines from smaller markets to meet German regulatory obligations. We see this as the current greatest threat to ensuring drug availability for patients in the Czech Republic,” he warned.

The Czech government remains committed to mitigating the impact of drug shortages. The daily updated database of drug shortages on the SÚKL website will continue to provide crucial information to all stakeholders, the Czech ministry highlighted.

[By Aneta Zachová, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]

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