EBA experts have prepared more than 500 amendments to the draft law on medicines

23/ 09/ 2021

On September 9, 2021, the Verkhovna Rada of Ukraine adopted in the first reading the draft law on medicines (№5547). As previously reported, the EBA Health Care Committee experts have a significant range of conceptual and technical proposals and comments on the voted version of the draft law. And they all are critically important to cbusiness. It is unknown at this time whether all the proposals of the business community will be considered by the deputies before the second reading. However, the last day when the deputies can submit the amendments to the electronic system of the Verkhovna Rada is September 23, 2021. As long as they are submitted, they have a chance to be considered. At the same time, the number of proposals is quite substantive. Thus, the EBA Committee member companies have come up with more than 500 amendments to this draft law, and it’s almost 300 pages. As a result, the professional community is not sure that all the necessary provisions of the draft law will be reviewed by deputies in time and thoroughly. Some of them, in our opinion, may pose a threat to the sustainable way of doing business in Ukraine. Some of the EBA proposals were taken into account in the opinion of the Verkhovna Rada Committee on National Health, Medical Care, and Health Insurance before the first reading. This testifies to the readiness of the main stakeholders to work together and constructively. However, some provisions have not yet come to the optimal version. You need to make sure that no artificial barriers are created for the business and that there are sufficient transition periods for the proposed changes. After all, these issues are related to the availability of medicines for patients. Under any circumstances, it is necessary to avoid a negative impact on the market and the access to medicines for patients. The EBA experts also insist on the need for a thorough technical review of each provision and proposal so that the wording is comparable with other provisions of the draft law not only in essence but also in view of the principles of rulemaking procedure. Without this, it may not be possible to apply in practice a provision that may interfere with the supply chain of essential medicines. We are sure that all parties are open for constructive work therefore we expect the joint finalization of the text shortly. For our part, the EBA is ready to cooperate and provide professional expert assistance. In general, given the number of proposals, the EBA representatives request to continue the professional dialogue between the industry representatives and the relevant VRU Committee in preparation for the draft law for the second reading. According to the business community, the most effective and efficient way, in this case, is the joint processing of all submitted proposals to the document and mutual review of the final version before the second reading. The conceptual provisions, offered by the business, can be found at the following table. Our Committees experts also provide clarifications on the consequences of adopting a provision if the wording of the first reading remains unchanged. According to the business community, it is necessary to involve lawyers, international technical assistance experts, and relevant government authorities in the work of the relevant Committee on such a large-scale task as finalizing and adopting a new law for the pharmaceutical industry. We are confident that only by joint efforts we will be able to bring the pharmaceutical industry of Ukraine to the European level and provide patients of Ukraine with effective, high-quality, modern, and safe medicines. Be the first to learn about the latest EBA news with our Telegram-channel – EBAUkraine.

On September 9, 2021, the Verkhovna Rada of Ukraine adopted in the first reading the draft law on medicines (№5547). As previously reported, the EBA Health Care Committee experts have a significant range of conceptual and technical proposals and comments on the voted version of the draft law. And they all are critically important to cbusiness.

It is unknown at this time whether all the proposals of the business community will be considered by the deputies before the second reading. However, the last day when the deputies can submit the amendments to the electronic system of the Verkhovna Rada is September 23, 2021. As long as they are submitted, they have a chance to be considered. At the same time, the number of proposals is quite substantive. Thus, the EBA Committee member companies have come up with more than 500 amendments to this draft law, and it’s almost 300 pages.

As a result, the professional community is not sure that all the necessary provisions of the draft law will be reviewed by deputies in time and thoroughly. Some of them, in our opinion, may pose a threat to the sustainable way of doing business in Ukraine.

Some of the EBA proposals were taken into account in the opinion of the Verkhovna Rada Committee on National Health, Medical Care, and Health Insurance before the first reading. This testifies to the readiness of the main stakeholders to work together and constructively. However, some provisions have not yet come to the optimal version. You need to make sure that no artificial barriers are created for the business and that there are sufficient transition periods for the proposed changes. After all, these issues are related to the availability of medicines for patients. Under any circumstances, it is necessary to avoid a negative impact on the market and the access to medicines for patients.

The EBA experts also insist on the need for a thorough technical review of each provision and proposal so that the wording is comparable with other provisions of the draft law not only in essence but also in view of the principles of rulemaking procedure. Without this, it may not be possible to apply in practice a provision that may interfere with the supply chain of essential medicines.

We are sure that all parties are open for constructive work therefore we expect the joint finalization of the text shortly. For our part, the EBA is ready to cooperate and provide professional expert assistance.

In general, given the number of proposals, the EBA representatives request to continue the professional dialogue between the industry representatives and the relevant VRU Committee in preparation for the draft law for the second reading. According to the business community, the most effective and efficient way, in this case, is the joint processing of all submitted proposals to the document and mutual review of the final version before the second reading.

The conceptual provisions, offered by the business, can be found at the following table. Our Committee’s experts also provide clarifications on the consequences of adopting a provision if the wording of the first reading remains unchanged.

According to the business community, it is necessary to involve lawyers, international technical assistance experts, and relevant government authorities in the work of the relevant Committee on such a large-scale task as finalizing and adopting a new law for the pharmaceutical industry.

We are confident that only by joint efforts we will be able to bring the pharmaceutical industry of Ukraine to the European level and provide patients of Ukraine with effective, high-quality, modern, and safe medicines.

Be the first to learn about the latest EBA news with our Telegram-channel – EBAUkraine.