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ANNEX

Strengthening Biological Safety and Security in Ukraine in line with UNSCR 1540 (2004)

1.   Background

The Ukrainian legislation prohibiting biological weapons is detailed and comprehensive. However, a significant part of this legislation and regulation is outdated and fails to meet international norms and standards. It therefore requires urgent revision and updating to increase harmonisation with the respective world standards.

There is no framework law on biosafety and biosecurity in Ukraine that outlines establishment of a biosafety and biosecurity system and its proper functioning (for example, which would legally identify the central executive body dealing with biosafety and biosecurity and carrying out expert and monitoring functions). Further, there is not currently comprehensive cooperation between all involved ministries, agencies and organizations for preventing and responding to emergency situations related to biological threats.

Mechanisms for state control of adherence to biosecurity requirements during work with biological agents are also absent. There is no register of economic and non-economic actors working with hazardous biological agents in the territory of Ukraine. Furthermore, those actors that work with hazardous biological agents are not obliged by law to have relevant permits. In fact, elimination of the permit system resulted in a situation where there is no reporting and control of adherence to the biosafety and biosecurity requirements in microbiological laboratories, the actual number of which is unknown. A normative document that regulated accounting, transportation, storage and transfer of hazardous biological materials was annulled. The applicable documents pay little attention to other aspects of biosecurity, such as verification of staff reliability and protection of confidential information.

Against the background of the pace of growth of agricultural production, bio-production, transport and external trade relations in the modern world, human and veterinary medicine face many problems specifically associated with the risk of proliferation of biological materials, in particular infectious and parasitic diseases common among people and animals.

Today the main threats relating to biological and food security in Ukraine are associated with African swine fever, bird flu, foot and mouth disease, and multidrug-resistant bacterial pathogens. There are natural focal risks of outbreaks of anthrax, rabies, classical swine fever and tularaemia. Ensuring food and biological security is a sensitive issue that cannot be solved without the involvement of reliable means of monitoring, forecasting and early diagnosis of emergent and economically significant infections of animals, including zoonotic infections. Biological and food security in Ukraine can only be addressed via integration of basic research in genetics and molecular biotechnology in veterinary and human medicine and diagnosis.

Staff of the majority of Ukrainian life sciences laboratories are experienced in handling dangerous biological materials. However, modern biosafety and biosecurity principles and approaches, modern techniques and practices, and codes of conduct linked to modern practices are very rare in laboratories. A number of life science laboratories possess moderate amounts of modern equipment but, due to the lack of operational training on such equipment, the laboratory personnel do not use it or use it in an inappropriate manner. In addition, the existing system of advanced training for some categories of life scientists does not cover all appropriate biosafety and biosecurity issues. All these factors can result in a decrease in the level of biosafety and biosecurity at laboratories where dangerous biological materials are handled.

As a result of the above analysis, three projects have been prepared by the OSCE with a view to strengthening overall biological safety and security in Ukraine. These projects have been developed in cooperation with the relevant Ukrainian authorities. All projects would be implemented in line with the respective provisions of the Ukrainian Government's Action Plan on the implementation of the EU-Ukraine Association Agreement.

The projects would also be implemented taking into account relevant good practice and lessons learned, identified during the ongoing implementation of Decision (CFSP) 2017/1252 in support of the strengthening of chemical safety and security in Ukraine.

2.   Objective

The overall objective of this Decision is to support OSCE projects aiming at strengthening biological safety and security in Ukraine in line with Ukraine's obligations under the BTWC and UNSCR 1540 (2004), as well as in accordance with the EU-Ukraine Association Agreement.

3.   Description of the projects

3.1.   Harmonisation of existing Ukrainian regulations on biosafety and biosecurity with international standards

3.1.1.   Objective of the project

3.1.2.   Description of the project

3.1.3.   Expected results of the project

3.1.4.   Project beneficiaries

3.2.   Establishing veterinary surveillance system sustainability in Ukraine for EDP-related diseases

3.2.1.   Objective of the project

3.2.2.   Description of the project

3.2.3.   Expected results of the project

3.2.4.   Project beneficiaries

3.3.   Awareness-raising, education and training for life scientists on biosafety and biosecurity

3.3.1.   Objective of the project

3.3.2.   Description of the project

3.3.3.   Expected results of the project

3.4.   Project beneficiaries

4.   Administrative support for the implementation of the projects

Dedicated personnel in the OSCE Secretariat and in the office of the OSCE Project Coordinator in Ukraine will coordinate and manage the implementation of the project activities set out in Section 3 in order to further develop the collaborative framework between the Ukrainian partners, including through the development of relevant new project proposals and national measures.

The supporting personnel will perform the following tasks:

5.   Duration

The total estimated duration of the projects will be 36 months.

6.   Technical implementing entity

The technical implementation of this Decision will be entrusted to the Conflict Prevention Centre of the OSCE Secretariat and the OSCE Project Coordinator in Ukraine. The OSCE will implement the activities under this Decision in cooperation with other international organisations and agencies, in particular with a view to ensuring effective synergies and avoiding duplication.

7.   Reporting

The OSCE Secretariat will prepare regular reports, as well as reports after the completion of each of the activities described. The final reports should be submitted to the European Union no later than six weeks after the completion of the relevant activities.

8.   Steering Committee

The Steering Committee for these projects will be composed of a representative of the High Representative and a representative of the implementing entity referred to in section 6 of this Annex. The Steering Committee will review the implementation of this Decision regularly, at least once every 6 months, including through the use of electronic means of communication.

9.   Estimated total cost of the projects and European Union financial contribution

The total cost of the projects is EUR 1 913 900 .