In Ukraine, the work of a cord blood bank (donor and personal cord blood) is regulated by:

• the Constitution of Ukraine;
• the Civil Code of Ukraine;
• the Law of Ukraine ‘Basis of the legislation of Ukraine about health protection’ (art. 46);
• the Law of Ukraine ‘About donorship of blood and its components’;
• the Law of Ukraine ‘About licensing of certain kinds of economic activity’;
• the Order of the State committee of Ukraine in questions of regulatory policy and entrepreneurship, the Ministry of health of Ukraine № 38/63 of the 16th of February 2001 ‘About setting licensing requirements for carrying out economic activity on processing of donor blood and its components, manufacturing preparations from it, economic activity in medical practice and carrying out works on disinfection, disinsection, disinfestation (except the works at objects under the veterinary control)’, that was registered by the Ministry of Justice of Ukraine on the 2nd of March 2001 under the № 188/5379;
• the Regulation of the Cabinet of Ministers of Ukraine № 920 from the 16th of June 1998

‘About approval of the Order on processing and storage of donor blood and its components, its realization and manufacturing medicines from it’;

• the Regulation of the Cabinet of Ministers of Ukraine from the 14 of April 1997 № 340

‘About approval of the Order of collecting and storage of personal blood and (or) its components, and blood and (or) its components, received from other donors at the personal expenses’.

According to the article 49 of the Constitution of Ukraine, the state creates circumstances for efficient and affordable health protection for all the citizens. The state favors development of health protection institutions of all forms of property.

According to the part 1 of the article 15 of the Law of Ukraine ‘About donorship of blood and its components’, sampling, processing and storage of the donor blood and its components,  its realization and manufacturing medicines from it are performed by institutions specialized in blood transfusion and relevant subdivisions of health protection institutions, being regulated by the Ministry of health of Ukraine, other ministries and departments and health protection institutions of the Autonomous Republic of Crimea, regions, cities of Kyiv and Sevastopol.

 

Processing and storage of the donor blood and its components, realization of medicines manufactured from it can be performed by a subject of entrepreneur activity (the part 2 of the article 15 of the Law). Thus the named norm establishes a legal basis for foundation of a blood bank (an institution that performs blood storage) by subjects of entrepreneur activity.

According to the part 3 of the article 15 of the Law of Ukraine ‘About donorship of blood  and sampling of its components’,  processing and storage of donor blood and its components, realization of them and manufactured from them medicines by health protection institutions and their subdivisions that were named in the part one of this article and processing, storage of donor blood and its components, realization of manufactured from them medicines by subjects named in the part two of this article are allowed only in presence of an appropriate license issued by the Ministry of health of Ukraine.

Activity of a cord blood bank does not subordinate to the Law of Ukraine ‘About transplantation of organs and other human anatomic materials’ whose action does not extend over the following activities according to the part 2 of the article 3 of this Law:

• donorship of blood and (or) its components and activities related to their use,
• transplantation into a human of his/her own anatomic material.

The order of issuing a license for carrying out economic activity on processing of donor blood and its components and also requirements to the subjects of economic activity intending to carry out such activity are set by the Law of Ukraine ‘About licensing of certain kinds of economic activity’ and the Order of the State committee of Ukraine in questions of regulatory policy and entrepreneurship of the Ministry of health of Ukraine No. 38/63 of the 16th of February 2001 ‘About setting licensing requirements for carrying out economic activity on processing of donor blood and its components, manufacturing preparations from it, economic activity in medical practice and carrying out works on disinfection, disinsection, disinfestation (except the works at objects under the veterinary control)’ registered by the Ministry of Justice of Ukraine on the 2nd of March 2001 under the No. 188/5379.

Taking into account the above-stated, the acting legislation of Ukraine stipulates a possibility of creating banks of blood including umbilical (cord) blood by subjects of economical activity, provided that licensing conditions are fulfilled and the license is received in the established order for the specified type of economical activity by the subjects.

About legal aspects for umbilical (cord) blood withdrawal: the main statements of personal non-pecuniary rights of a person providing natural existence of a natural person, to which the right to be a donor belongs, are fixed by the Civil Code of Ukraine (further CC of Ukraine). According to the part 1 of the article 290 of the CC of Ukraine, a full legal age natural person has a right to be a donor of blood, its components, and organs and other anatomical materials and reproductive cells. Donorship of blood, its components, organs and other anatomical materials, reproductive cells is performed in accordance with the law (the part 2 of the article 290 of the CC of Ukraine).

In accordance with the part 5 of the article 2 of the Law of Ukraine “About donorship of blood and its components”: ”at  will of any full legal age person in the order established by the Cabinet of Ministers of Ukraine, collecting and storage of person’s own blood at own expenses and (or) its components, and also blood and (or) its components received from other donors for using them in necessary circumstances for providing medical help to this person, members of his/her family, and other people.”

According to the paragraph 3 of the Order of collecting and storage of personal blood and (or) its components, and blood and (or)  its  components received from other donors at person’s own expenses, approved by the Resolution of the Cabinet of Ministers of Ukraine № 340 dated 14.04.97, any legally capable person willing to perform collecting and storage of his/her personal blood and (or) its components and blood and (or) its components received from another donor at his/her own expenses makes a contract about collecting of personal or donor blood and a contract about its storage. The contracts are made between the person having such a will and a suitable health protection institution or its specialized subdivision or a subject of entrepreneurial activity according to their authorities.

 

Acting legislation provides legal basis for withdrawal of blood or (and) its components from a person on a paid basis and their storage according to terms determined by a contract made with the person. Contracts are signed by the person, who makes a will and an appropriate institution of health protection or it’s specialized subdivision or a subject of economical activity in accordance with their authorities.

The medical centre ‘Hemafund’ is a subject of economical activity that performs storage of cord blood of women having concluded appropriate contracts with it. It has the appropriate license and follows the acting laws regulating this question.

Moreover, the bank of cord blood ‘Hemafund’ provides personalized (not anonymous and not free as in case of donorship) withdrawal and storage of a fraction of cord blood. The targets of the bank do not include clinical usage of blood components received for storage. The targets include only their storage after appropriate processing and testing. The received fraction stays a property of a family forever which is fixed in the Contract with the parents for exclusion of probability of its usage by others. 

Meanwhile, ‘Hemafund’ Ltd. has worked out certain requirements and follows them in its activity. Being not established by the acting legislation of Ukraine, they provide fulfillment of appropriate safety rates and quality of cord blood and legality of its withdrawal:

• withdrawal (stocking) of cord blood is performed into an one-way sterile package, certified by the Ministry of health of Ukraine according to the approved manufacturer’s Instruction for blood withdrawal;
• cord blood stocking is performed only after a timely explanation about the procedure and the Method of blood withdrawal by a cord blood bank worker to future parents providing that they have signed an Informed consent (the sample is attached), a copy of which stays in the History of delivery at the institution that performs withdrawal of cord blood;
• for minimization of risks, the contract of future parents with Ltd ‘Medical centre ‘Hemafund’ stipulates that “Taking into account the course and medical conditions of a child delivery, the final decision about the cord blood withdrawal is taken by the doctor responsible for the delivery.”

Taking into account the foresaid, activity of a family type cord blood bank, created by Ltd “Medical centre “Hemafund” fully meets the requirements of the acting legislation of Ukraine.

 The legal basis for cord blood withdrawal

Today, there are no special regulatory acts forming the basis and the order of cord blood withdrawal. On the other hand, the acting legislation of Ukraine does not forbid performance of such an activity.

In such conditions, general norms of the acting legislation regulating blood donorship and activities related to it should be applied to legal relationship of cord blood withdrawal with preserving peculiarities linked to a child delivery.

So, according to the part 5 of the article 2 of the Law of Ukraine “About donorship of blood and its components”, withdrawal and storage of own blood and (or) its components received from a person or from other donors can be performed at a will of any legally capable person at his/her own expenses with the purpose to use them in necessary cases for providing medical help to this person, members of his/her family or others.

According to the part 1 of the article 290 of the Civil Code of Ukraine, a full legal age legally capable person has a right to be a donor of blood, its components, and also organs and other anatomical materials and reproductive cells.

The donorship of blood, its components, organs, and other anatomical materials, reproductive cells is performed according to the law.

According to the article 46 of the “Basis of legislation of Ukraine about health protection”, withdrawal of blood, its components for their further usage for medical treating, manufacturing of appropriate medicines or using in scientific studies is performed voluntary by a full legal age legally capable natural person. Blood withdrawal from a natural person or his/her usage as a donor by force or fraudulently is forbidden.

Donorship of blood, its components is performed according to the law.

According to the part 5 of the article 2 of the Law of Ukraine “About donorship of blood and its components”, at will of any legally capable person, withdrawal and storage of own blood and (or) its components and blood and (or) its components received from other donors can be performed at his/her own expenses in the order set by the Cabinet of Ministers of Ukraine with the purpose to use it in necessary cases for providing medical help to such a person, members of his/her family, or other people.

 The order of collecting and storage at personal expenses of personal blood and (or) its components and blood (or) its components received from other donors is set by the Regulation of the Cabinet of Ministers of Ukraine №340 dated 14.04.1997 “About approval of the Order of collecting and storage of personal blood and (or) its components, and blood and (or) its components, received from other donors at the personal expenses” (further – the Order).

According to additions to the part 3 of the Order, any legally capable person, who wishes to perform collecting and storage of personal blood and (or) its components, and blood and (or) its components received from other donors at his/her expenses, makes a contract about collecting of personal blood or donor blood and a contract about its storage. The contracts are signed between the person, who makes such a will and an appropriate institution of health protection or its specialized subdivision or a subject of economical activity in accordance to their authorities on the basis of standard contracts.

 

Moreover, the activity about cord blood withdrawal and storage has to fulfill the requirements of the order of the Ministry of health of Ukraine №385 dated 01.08.2005 “About infection safety of donor blood and its components”.

Taking into account the foresaid, a maternity hospital has a right to collect cord blood during a child delivery for its further cryo-storage in case the requirements of the pointed out legislation acts are met and a written statement of a pregnant woman confirming an informed consent for the named procedure is available, and contraindications and a risk for the woman in childbirth and the newborn child are absent.