Will the patients pay more for the medication? Changes in law are coming

Innovative drug manufacturers can regain their advantage again. Planned changes in regulations will enable them to block cheaper counterparts even after years. Experts warn: the market, patients and state budget may be affected.

A six-month deadline will vanish to request protection in the intellectual property dispute; this will benefit manufacturers of innovative medicines, who, even after a fewer years, will be able to request the removal of the cheaper counterpart of their product from the marketplace - writes on Monday "Journal of Law Newspapers".

According to the newspaper, "the civilian Law Codification Commission intends to reverse any of the changes that were introduced into the civilian Procedure Code in March 2023". "It concerns, among another things, the rules governing the protection of intellectual property rights which are utilized in disputes between drug manufacturers. The mechanics is simple. Thanks to the safety provided even before the substantive settlement of the case, the maker of the innovative substance on which the patent expired blocks the entry into the marketplace of the cheaper (general) equivalent" - explains "DGP".

As the paper emphasizes, "on the continuation of the monopoly, not only producers of generic drugs lose out, but besides patients and NFZ". "From the Ministry of wellness (MZ) data, entering the marketplace of a cheaper counterpart generates multimillion savings for the public payer. "In May 2022 the refund covered the first mention equivalent of Revlimid (...) in this case, the specified inclusion of the refund of the first equivalents (a fewer simultaneously, from May 2022) caused a spectacular simplification in the cost of the unit of this molecule, while after a year the simplification amounted to about 99%" - reads a letter from 3 November 2023 sent by Deputy Minister Mark Kos to the Minister of Justice.

The diary recalls that "until the entry into force of the March 2023 amendment of the alleged duty, i.e. the maker of generic medicines, it was not until the court received the order to safe the charges". "In practice, he could not defend himself. The revised regulations changed that" - he added.(PAP)