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An amendment to the Czech Pharmaceuticals Act seeks to improve the availability of drugs for patients

Will the new law ensure that medicinal products are timely delivered to the pharmacy in which the patient presented their prescription?

It is one of the fundamental duties of the state to ensure that quality healthcare is available everywhere within its reach. This also means that medicinal products ("drugs") are available at pharmacies to answer patients' needs. In this respect, current law suffers from several shortcomings. The health ministry has therefore initiated a comprehensive amendment bill to the Pharmaceuticals Act, with the goal to ensure the timely supply of drugs to pharmacies while respecting the existing distribution relationships in the field of pharmaceuticals.

The authors of the bill envision a combination of three measures designed to ensure the availability of pharmaceuticals.

Firstly, when faced with bottlenecks of supply, the health ministry should have the authority to allow (on the basis of temporary exemptions) the distribution, issuance, and use of drugs which do not fulfill the formal requirements of the law, as long as the quality and safety of the given medicinal product is ensured.

A second measure is aimed against wild exports of drugs to locations outside the Czech Republic. The market authorization (MA) holder would always have to first determine whether the needs of patients in the Czech Republic are sufficiently safeguarded by current supplies before they may export a given drug abroad. Medicinal products designated for deliveries to the Czech Republic may only be exported to another EU member state or a third country by the MA holder or by a distributor who has been authorized to perform drug exports.

The third measure is in response to scenarios in which a patient presents prescription in a pharmacy but the pharmacy finds itself unable to order the medicinal product through standard distribution channels. Going forward, MA holders would have to establish and operate an emergency information system for ad hoc orders and supplies, and be obliged to ensure that the pharmacy is able to issue the drug to the patient within two business days from receipt of the order (by arranging for the supply either by itself or through a distributor, based on an agreement between the MA holder and the distributor on drug supplies within the emergency system. If such an agreement is made, then the statutory obligation to supply the ordered drug to the pharmacy within two business days will also bind the distributor). Compared to the current legal framework, the obligation to supply medicinal products would thus be shifted from the distributors to (primarily) the market authorization holder.

The proposed legislation concerns only the availability of medicinal products covered by public health insurance and issued to patients on the basis of a prescription (Rx drugs), i.e., OTC drugs are not being addressed by the bill.

The amendment bill is currently in the early stages of the lawmaking process.

Source:
Electronic library of legislation in progress, accessible at: https://apps.odok.cz/veklep