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The Upcoming Amendment to the Act on Pharmaceuticals: Will it Mark the end of Drug Shortages?

The Upcoming Amendment to the Act on Pharmaceuticals: Will it Mark the end of Drug Shortages?

Czech Republic
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For the last couple of months, we have all experienced a shortage of certain pharmaceuticals on the market, especially antibiotics or pharmaceuticals for fever reduction for children. Given that this situation reoccurs almost every flu season, the Ministry of Health of the Czech Republic has newly established a formal working group monitoring the availability of pharmaceuticals on the market. The Ministry of Health is also preparing the amendment to the Act on Pharmaceuticals so that it can, on its own or in cooperation with the State Institute for Drug Control („SUKL“), better respond to urgent drug shortages in case of crisis situations.

In principle, the amendment should introduce rules to better monitor the current amount of pharmaceuticals available on the Czech market, i.e. at pharmacies or held by distributors. Marketing authorisation holders will be required to inform the SUKL of the reasons for the shortage and the corrective measures being taken, together with information on the current stocks of the product. In addition, marketing authorisation holders will also have to ensure the supply of the product for two months after the date of interruption or termination of supply.

Doubtless this measure will help to bridge a short-term lack of pharmaceuticals. But what measure would help bring an end to systematic and long-term drug shortages? The legislation in Poland can partly serve as inspiration. A few years ago, Polish lawmakers introduced the institute of the Chief Pharmaceutical Inspector (“GIF”). Any distributor is in principle obliged to notify its intention to distribute pharmaceuticals listed by the Polish Ministry of Health to a foreign entity. The GIF is entitled to raise an objection against this notification within seven days after receiving it, especially if there is a risk that the pharmaceutical would no longer be available on the domestic market. If no objection is raised within 30 days, the pharmaceutical may be exported.

We can therefore see possible inspiration from the Polish legislation in the list of drugs prohibited for export in the Czech Republic. Nevertheless, while in the Czech Republic this tool was used only in a small number of cases, in Poland the GIF prohibited export in almost 1,000 cases in the first month of its activity alone.

Indeed, this solution comes with many other legal issues as well, such as the elimination of parallel trade of pharmaceuticals or the question of free movement of goods in general. But if we face an exceptional situation with an urgent shortage of critical drugs, this model might at least be worth considering.

By Vladena Svobodova, Associate, JSK, PONTES

 

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