New amendments to draft law No. 13420 threaten medicine shortages and patient health – EBA

12/ 08/ 2025

The European Business Association warns that the proposed amendments to Draft Law No. 13420 could deprive Ukrainians of access to many essential medicines and disrupt the operation of state pharmaceutical supply programmes. According to information received in the course of work, the amendments were submitted to the Verkhovna Rada Committee on Finance, Taxation and Customs Policy as part of work on the Draft Law of Ukraine “On Amendments to the Tax Code of Ukraine and Other Laws of Ukraine Regarding Support for Enterprises of the Defence Industry” No. 13420 of 25 June 2025. In particular, it is proposed to amend Part 14 of Article 9-1 and Part 2 of Article 17 of the Law of Ukraine “On Medicinal Products” No. 123/96-VR of 4 April 1996. First and foremost, it should be noted that the essence of the proposed amendment does not correspond to the purpose of the draft law, as it envisages regulating the medicinal products market rather than supporting defence industry enterprises. Given its significant impact on Ukraine’s healthcare system, EBA representatives believe that any changes to Law No. 123/96-VR should be considered within the profile Verkhovna Rada Committee on National Health, Medical Care and Medical Insurance. Key risks: Medicine shortages due to mandatory state laboratory control of all batches of medicinal products imported into Ukraine, without exceptions for their origin. The introduction of mandatory state laboratory testing for every batch of medicines, even those already inspected in EU countries, is a step backwards and sets a precedent of mistrust towards the EU and countries with strict regulatory authorities and systems, the very ones we are striving to join and whose example we follow. Moreover, Ukraine does not have the resources to implement this. Undermining procurement transparency through the automatic substitution of medicines without competition or agreement between parties. The proposal to allow suppliers to automatically replace products without a competitive process contradicts public procurement legislation. Such a practice opens the door to abuse, reduces competition, and undermines trust in procurement procedures. Clinical risks for patients due to the proposal to substitute medicines in signed contracts with “equivalent” ones, even if they are unregistered or imported in parallel. Reducing “equivalence” merely to name, dosage, and form disregards other critically important parameters. This could result in medicines with significant differences being deemed “equivalent,” posing dangers for patients with a narrow therapeutic range. The combination of these changes poses a real threat of supply disruptions, price increases, reduced competition, and lower interest from international manufacturers in operating in Ukraine. For patients, this means the risk of interrupted treatment; for the state, it weakens the resilience of the healthcare system during wartime. The European Business Association calls on MPs not to support these amendments and to consider any legislative changes in the healthcare sector only after discussion within the relevant parliamentary committee.

According to information received in the course of work, the amendments were submitted to the Verkhovna Rada Committee on Finance, Taxation and Customs Policy as part of work on the Draft Law of Ukraine “On Amendments to the Tax Code of Ukraine and Other Laws of Ukraine Regarding Support for Enterprises of the Defence Industry” No. 13420 of 25 June 2025.

In particular, it is proposed to amend Part 14 of Article 9-1 and Part 2 of Article 17 of the Law of Ukraine “On Medicinal Products” No. 123/96-VR of 4 April 1996.

First and foremost, it should be noted that the essence of the proposed amendment does not correspond to the purpose of the draft law, as it envisages regulating the medicinal products market rather than supporting defence industry enterprises. Given its significant impact on Ukraine’s healthcare system, EBA representatives believe that any changes to Law No. 123/96-VR should be considered within the profile Verkhovna Rada Committee on National Health, Medical Care and Medical Insurance.

Key risks:

Medicine shortages due to mandatory state laboratory control of all batches of medicinal products imported into Ukraine, without exceptions for their origin. The introduction of mandatory state laboratory testing for every batch of medicines, even those already inspected in EU countries, is a step backwards and sets a precedent of mistrust towards the EU and countries with strict regulatory authorities and systems, the very ones we are striving to join and whose example we follow. Moreover, Ukraine does not have the resources to implement this.
Undermining procurement transparency through the automatic substitution of medicines without competition or agreement between parties. The proposal to allow suppliers to automatically replace products without a competitive process contradicts public procurement legislation. Such a practice opens the door to abuse, reduces competition, and undermines trust in procurement procedures.
Clinical risks for patients due to the proposal to substitute medicines in signed contracts with “equivalent” ones, even if they are unregistered or imported in parallel. Reducing “equivalence” merely to name, dosage, and form disregards other critically important parameters. This could result in medicines with significant differences being deemed “equivalent,” posing dangers for patients with a narrow therapeutic range.

The combination of these changes poses a real threat of supply disruptions, price increases, reduced competition, and lower interest from international manufacturers in operating in Ukraine. For patients, this means the risk of interrupted treatment; for the state, it weakens the resilience of the healthcare system during wartime.

The European Business Association calls on MPs not to support these amendments and to consider any legislative changes in the healthcare sector only after discussion within the relevant parliamentary committee.