10:45 31.05.2018

EBA calls on parliament to lift bill on medicines from consideration, review document

2 min read
EBA calls on parliament to lift bill on medicines from consideration, review document

The European Business Association (EBA) has called on parliament to lift a bill on medicines, which a working group of the parliamentary healthcare committee is working on, from consideration and review the document.

"Having recently received one version of the bill for consideration, representatives of the EBA Health Committee report on significant flaws and risks inherent in it, and if adopted, the proposed provisions may affect the stability of undertaking the mission to supply drugs to patients in our country by pharmaceutical companies. Some of the provisions negate the recent achievements in the pharmaceutical sphere, which help to remove obstacles in the way of patients receiving innovative medicines," the EBA said in a press release.

The association expressed surprise at the "trend to hasty processing of the text of the bill," in which, according to the EBA committee members, there are some understated provisions, "and some of them completely unacceptable."

"The volume of negative consequences to which they can lead is significant," the EBA said.

In particular, the EBA said that the bill will create additional difficulties for importers, and also believes that the introduction of a special code for marking medicine packages in 2020 envisaged by the bill does not take into account the ultimate goal of this innovation and the amount of preparatory work that needs to be done for this.

In addition, the EBA said that the bill abolishes the simplified registration of medicines that have already been registered by a centralized procedure in the European Medicines Agency (EMA) and a number of countries with a rigid regulatory system.

"The simplified procedure was introduced only from the beginning of 2018, and for biased reasons it did not work for a long time, demanding technical changes. Inconsistency of the state policy in the event of this change would obviously have amazed the international community not for the benefit of Ukraine's image. Having no other effective levers for attracting innovative treatment to Ukraine, the abolition of the simplified procedure seems inexpedient," the EBA said.

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