During the large-scale war with the Russian Federation, we observed many scandals related to the provision of low-quality turnstiles to the Ukrainian military. It is possible that we may soon hear more than one story about low-quality prosthetics or software for them. The fact is that the issue of quality and monitoring of, in principle, all medical devices in Ukraine is not sufficiently regulated by law. In turn, this promotes corruption, monopolies and, worst of all, threatens the health and lives of Ukrainians.

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European standards are not up to date?

Let's start with what medical devices are. You need to understand that these are no longer bandages, rubber gloves or droppers. Nowadays this is a fairly wide range of different products used to care for the health of citizens.

For example, these are devices and devices for diagnostics and monitoring of health status, prevention, therapy; surgical devices; implants, etc. And here it is important to understand that the complication of their use for various reasons (in particular, legislative ones) affects how we assess their safety and clinical effect. This means it directly affects everyone’s health..

I would like to note that in the European Union, where Ukraine is moving, sufficient work is being done in the development of the medical device market so that, on the one hand, there is no excessive regulation of business, and on the other hand, human rights and freedoms are ensured, in particular, to protect their rights. Regulations adopted in the EU should facilitate patient access to effective and safe medical advances in science and technology. That is, to all the best that is used in medicine today.

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What's in Ukraine?

To understand this, you just need to review a few time periods. But, looking ahead, I note: although the large-scale war revealed many problems (for example, the quality of the same turnstiles), one may get the impression that the issue of regulating and guaranteeing safety in healthcare is not the time.

So, in July 2021, the National Security and Defense Council of Ukraine adopted a decision put into effect by the corresponding presidential decree, which, in particular, obliged the government to develop the Law of Ukraine “On Medical Devices”.

Five months later, the first version of the bill was published on the website of the Ministry of Health. This legislative initiative appeared on the Verkhovna Rada website in July 2022 - a year after the decision of the National Security and Defense Council. Of course, here it is necessary to make allowances for the large-scale Russian invasion, which somewhat slowed down this process, but the following periods of wandering through committees and relevant commissions confirm the “not the right time” thesis..

Thus, more than two years have passed since July 2022 until the bill was included on the agenda for consideration by parliament. It is already 2025, but there is still no conclusion from all commissions regarding the bill “On Medical Products”.

The legislative initiative itself is small in scope and, I am sure, there is something to add to it. At the same time, the draft law takes into account the relevant Council of Europe Convention on Counterfeiting Medical Products and Similar Crimes (the so-called MEDICRIME Convention), and relevant documents, in particular, from the European Commission. In short, all our obligations under the Association Agreement with the EU.

But that's not all. In 2013 (let me emphasize, almost 12 years ago) Ukraine adopted technical regulations for three subtypes of medical devices. Meanwhile, in the EU all these regulations were updated in 2017. We still live according to old technical regulations, which lag behind European ones by at least seven years, and from modern realities - by all 12. Therefore, I rightly believe that this issue should be among the first to be considered by the government.

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Pros and cons of the bill.

Now there are a lot of nuances associated with the use of medical devices that are not regulated at all.

At the same time, for example, the bill “On Medical Products”:.

provides for the elimination of ambiguous interpretation of their classification - that is, which category/class does this or that medical product belong to?;

regulates the issue of advertising of such goods, etc..

However, gaps remain in the legislative initiative. For example, the issue of a combination product (that is, a combination of a medical device and a therapeutic agent) has not been fully resolved.. Thus, the proposed draft law establishes some criteria for such combination products, but this is clearly not enough, because the same regulations of the European Union indicate that for such products there must be a scientific conclusion either from the European Medicines Agency or the relevant national structures.

In addition, comments on the regulation of combined products in the bill were also provided by the Main Scientific Expert Directorate (GNEU), a structural unit within the Verkhovna Rada apparatus that conducts a mandatory examination of all bills submitted to the Verkhovna Rada. This remark concerned the very strange wording that for a combined product the State Expert Center of the Ministry of Health can take into account in whole or in part the certificates obtained under EU procedures. That is, even GNEU saw in this corruption risks in relation to combined products that stand on the line between a medicinal product and a medical device. To understand: in the EU, each such combined product is subject to assessment depending on what main function it performs - either medicines are more important there, or the properties of the medical product itself, where therapeutic agents are accompanying.

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So what do we have today?

In recent years, quite a lot of developments have appeared, innovative leaps have been made in the market of medical devices and therapeutic agents, but Ukrainian legislation simply does not keep up with innovations. In fact, we have only one bill, which has been in limbo for more than two years and does not even regulate all issues. However, I will emphasize once again: the issue is important, it is long overdue for many reasons - from the point of view of both safety and prevention of counterfeit, and the emergence of new combined products, etc..

Back in 2024, the action plan of the Ministry of Health included an item on the development of new technical regulations regarding medical devices, but to date we have not seen any results in this direction. I hope that this will still be done, in particular taking into account the new requirements of the European Union.

In addition, in my opinion, Ukraine should take more seriously issues related to product defects, incidents (for example, deterioration in a person’s health after using a medical product), adverse events. That is, all those that in everyday life we \u200b\u200bcall medical errors. The European regulations take all this into account, and we also need to implement this into Ukrainian legislation.

It is advisable to do this at the level of a bill, and not just some by-laws. After all, the number of people who need to use medical products will, unfortunately, increase every year, especially in connection with Russian aggression. The same applies to combined products, the market of which does not stand still and is constantly evolving.. Such products require close attention from the state - monitoring and control. And even more so the development of artificial intelligence technologies in medical practice.

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