Nataliia Duginova, attorney-at-law
Krystyna Demchenko, Junior Associate
The spread of blood-borne diseases in the 1990s raised the issue of the need to regulate effectively the safety of blood and its components in the European Union.
As a consequence of the political decision, pursuant to Article 168 (4) of the Treaty on the Functioning of the EU, during 2003-2005 a number of directives were adopted aimed at establishing high basic standards in this field, which were subsequently introduced into the national legislations of the EU member states.
As early as 2014, the European Court confirmed in its decision that Directive No. 2002/98 / EC, which sets standards for the quality and safety of the collection, testing, treatment, storage and dissemination of human blood and its components, also covers products made from blood and its components (in particular, in the case of C-512/12 of blood plasma), in terms of processes such as collection and testing thereof.
By February 15th, 2018, all EU Member States will also have to harmonize their legislation with the good practice guidelines provided in Recommendation No. R (95) 15.
And what about Ukraine? In the height of the HIV / AIDS pandemic, officials acknowledge the existence of numerous problems, such as:
Are urgent solutions needed to protect people's health and life? Of course. One of the incentives is the Association Agreement between the EU and Ukraine.
The Association Agreement between the EU and Ukraine laid the foundations for the development of sectoral cooperation in the field of healthcare in Ukraine and the EU, including in the field of quality and safety of substances of human origin, in particular blood.
In particular, it establishes a three-year period after the Agreement comes into force for the implementation of the sectoral acquis, namely of the following directives in the field of blood services:
Directive No. 2002/98 / EC establishing quality and safety standards for the sampling, testing, treatment, storage and dissemination of human blood and its components, as well as amending Directive No. 2001/83 / EC;
Directive No. 2004/33 / EC on certain technical requirements for blood and its components;
Directive No. 2005/62 / EC on community standards and specifications relating to a quality system for blood establishments (hereinafter - Commission Directive No. 2005/62 / EC);
Directive No. 2005/61 / EC on the requirements for tracing and reporting serious adverse reactions and events.
The implementation of the aforementioned acquis acts should take place this year in accordance with paragraph 71 of the Action Plan for the Implementation of Section V of the Association Agreement between the EU and Ukraine (approved by Cabinet of Ministers Decree No. 503-р / 2017).
The first steps in this direction have already been taken, but have not yet been brought to a logical conclusion.
However, the very first steps towards the implementation of EU legislation have led to a conflict.
The law "On the Donation of Blood and its Components" did not include a provision on the mandatory license for the processing of donor blood and its components, the manufacture of drugs from them, except for the activities of umbilical cord blood banks, other tissues and human cells.
Simultaneously, the licensing of this type of economic activity was not included in the law "On Licensing of Economic Activities" (in particular, Article 7 of this law).
Overcoming this conflict is possible by making appropriate changes to the law of Ukraine "On Licensing of Economic Activities." Such an attempt was made. Thus, on February 6th, 2017, a draft law "On Amending Certain Legislative Acts of Ukraine on Licensing of Economic Activities and State Supervision (Control)" was put for public discussion, which finally proposed to restore the licensing process for this type of activity.
However, its destiny is unknown, it is not registered with the Verkhovna Rada. In addition, it needs to be updated in view of the recent amendments to the law "On Licensing of Economic Activities" in terms of licensing the production of veterinary drugs.
After making appropriate changes to this law, it will also be necessary to develop new licensing conditions for the processing of donor blood and its components, the manufacture of drugs from them, other than the activities of the umbilical cord blood banks, other tissues and human cells that the Cabinet of Ministers must approve.
Among other things, they should include provisions on the authorized person, the rules of documentation, the system of accounting, reporting and exchange of information, as well as the tracking and reporting of serious adverse reactions and events, to bring the current legislation of Ukraine into compliance with the provisions of Directive No. 2005/61 / EU.
Thus, to date, the legislation of Ukraine still requires systematic changes to be brought in line with international standards in the field of safety and quality of donor blood and its components, which will give more chances for saving lives and preserving the health of many people.
At this stage it is necessary to take into account the further evolution of EU law, as well as to consider further steps to improve the situation.
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