While Brexit is a major topic of discussion for lawyers in the Czech Republic, Prague-based Baker McKenzie Partner Milena Hoffmanova, who heads the office’s Czech Pharmaceuticals & Healthcare group, is focused on the issue of the timely flow of affordable medicinal products from manufacturers to patients.
Hoffmanova is critical of a draft amendment to the Czech Pharmaceuticals Act that was approved by the Lower Chamber of the Parliament on September 24, 2019 after the Senate's objections were out-voted. “We are of the opinion that the current amendment will not be enforceable due to its infringement with EU laws,” she says, pointing out that “two years ago the Parliament enacted a similar amendment, but although it entered into force, it was not enforced by the regulatory authorities as it was deemed to be too vague and in conflict with the EU law.” That amendment from two years ago required Marketing Authorization Holders (MAHs) — companies authorized to market specific medicinal products in one or more EU member states — to deliver pharmaceutical products to distributors based on those distributors' market share. The new amendment obliges MAHs to supply pharmaceutical products to distributors based on their request to an extent corresponding to two-week demand from pharmacies. “Although the new law was created to change the situation they are still quite similar,” she sighs.
To fix these problems, Hoffmanova says the Czech Ministry of Health has prepared a new draft law, which is currently in the Lower Chamber of the Parliament. “The law introduces completely different rules and is truly a game-changer,” she says, enthusiastically. This new law, if enacted, would cancel the two previous amendments and introduce regulations impacting the distribution of medicinal products without obliging MAHs to generally deliver products to distributors. It would introduce the obligation for MAHs to establish emergency channels through which they would be obliged to supply pharmacies with medicinal products that were prescribed to specific patients if the pharmacies were not able to obtain these medicinal products elsewhere. Hoffmanova says that, unlike the previous amendments, which might have protected the interests of the distributors but could not ensure an efficient distribution of medicinal products for patients, this new draft law finally focuses on making medicinal products available to patients in pharmacies rather than forcing MAHs to cooperate with distributors with which they do not want to trade.
Hoffmanova says that the Czech pharmaceutical market has become more active recently. “We see that problems that were there all the time are now being brought to light and being addressed, not always in the best way – but the Ministry of Health has become active in recent years and is trying to address issues.” She admits, however, that the rapid pace of change in applicable legislation makes it difficult for companies. “Often companies do not have time to adapt to these changes,” she says. “For example, the distribution system for medicinal products takes a year to amend, but pharmaceutical companies are given only two months to change, which is impossible. Nobody can adapt to such massive changes within two months,” she says. “It is just impossible!”