How to get a license for a cell bank in Ukraine?

Ukraine belongs to those states where stem and other cell banks are not only allowed to operate, but also regulated. Of course, there are a significant number of regulatory restrictions on such activities, for example:

• strict requirements for the bank’s technical base;
• the need to obtain a license for an umbilical cord blood bank;
• limitations related to the transportation and transfer of the biological material banking results, etc.

However, it is quite possible to start such an activity and develop it as a promising business. In this publication, we will tell you about the practical case of our company, where our lawyers advised a foreign clinic that intended to enter the Ukrainian biobanking market.

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Why is it worth obtaining a license for a cell bank in Ukraine?

The key grounds of our Client to enter the Ukrainian market were as follows:

• Availability of industry regulations: the main regulatory acts in this area are the law on transplantation, licensing regulations on cell banks and a number of decrees of the Ministry of Health;
• Economic expediency, as compared to foreign jurisdictions, launching and maintaining such business in Ukraine can be done with much less investment;
• Affordability not only for Ukrainians, but also for foreign citizens. Although launching a business is more economically beneficial in our country, it does not mean that the payment for services should be proportional. The fact is that entering the Ukrainian market was associated with medical tourism and its prevalence in our country. In addition, the migration policy in Ukraine is much more acceptable for citizens of many countries, who can not conduct these procedures at their home country, as other European jurisdictions provide for a much stricter visa policy.

The main questions that the Client was interested in were related to the need to obtain a license for cord blood banks. The Client already had a Medical License for the general list of specialties.

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The Client’s question: Do I need to license the activity of the cell bank?

The Client’s problem was that only a part of the cycle had to take place in Ukraine, namely the banking. And the cultivation of cells was to be carried out on the Client’s material and technical base abroad. 

Therefore, the Client wondered whether it was possible to obtain a license for individual parts of the cycle - as this could help it save on certain equipment.

As a result of legal analysis, we made the following conclusions:

• The legislation does not allow to obtain a license for blood banks only for a part of the production cycle, so the Client would have to install cryo equipment to store cells, even if he did not intend to store them;
• The transfer of biological material from a cryobank to a third party could only take place in strictly defined cases. For example, for testing or liquidation, but not for processing;
• By adding laboratory specialties to the current Medical License and ensuring the organization of the laboratory, the Client could organize the collection and analysis of biological material;
• The process of exporting such material was subject to a number of regulatory restrictions, but it was practically possible;
• Import of such material after processing abroad, let alone its autologous application (intromission to the donor itself) was legally impossible due to the lack of pre-clinical trials of such treatment with this type of cells.

As a result of the consultation, we offered the Client the following options:

• To organize a clinical trial in Ukraine;
• Or to apply those methods that have been tested in preliminary successful clinical trials.

In addition, our lawyers recommended to relocate processing capacities to Ukraine to avoid cross-border transfer of material.

If you have any questions about the legally correct registration of your medical business in Ukraine, don’t hesitate to call us. We will find the best option even in difficult situations.