Determination of risks for business entities in the sphere of manufacturing medicines in military conditions in Ukraine

Abstract

The aim: determination of risks for business entities in the field of production of medicinal products under the conditions of martial law in Ukraine.

Materials and methods. The research materials are the results of a sociological survey in the form of a questionnaire among representatives of the senior management heads of structural units related to the environmental component of business entities' activities in the pharmaceutical production field. Method of sociological survey was used to collect primary information. A questionnaire was conducted, and respondent’s answers were registered using google-forms. The method of comparative analysis and generalization of statistical data was used to process the results.

Results. The study identified, analyzed, and assessed risks for business entities in producing medicinal products under martial law in Ukraine.

Significant risks of the destruction of infrastructure and the occurrence of man-made disasters have been identified. Thus, 10 % of pharmaceutical enterprises received critical damage, which makes it impossible to operate the enterprise until the destructive consequences are eliminated; another 15 % received some damage, but the company's activities are carried out. More than 75 % of enterprises can fully comply with the current licensing conditions (LC) for producing and selling medicinal products under martial law.

How critical risks were assessed: supply of raw materials and materials (logistics problems) (60 %); decrease in demand for the company's products (45 %); termination of gas supply (45 %); power outage (40 %); inflation, rising prices of raw materials and energy resources (35 %); termination of communications (35 %); difficulties in purchasing equipment, consumables, devices (30 %); termination of water supply (30 %); lack of competent personnel (30 %).

In the zone of critical risk at this stage remains the ability and willingness of enterprises to work following the plans of the state environmental policy following the Association Agreement between the EU countries and Ukraine. Respondents admit that the company lacks resources to comply with all requirements (20 %), that environmental aspects of activity are currently irrelevant (25 %), and that there are not enough competent specialists to implement the environmental policy and support the relevant procedures (25 %); that there is not enough informational support from the State (30 %).

Conclusions. In fact, 30 % of pharmaceutical enterprises are located in regions that are currently included in the List of territories where hostilities are (were) being waged or temporarily occupied. In general, Ukrainian business entities in the field of pharmaceutical production remain in the zone of uncertainty and significant risk of man-made disasters, non-fulfilment of requirements regarding production conditions, technological processes and constant quality control of production, non-fulfilment of environmental safety of production due to the direct threat of destruction of infrastructure and supply chains, due to the threat of termination of reliable supply of electricity, gas, water, resources, as well as due to high migration of qualified personnel.

Considering the current state of the economy and the environmental consequences of the war, particularly man-made disasters, the implementation of plans to comply with the state environmental policy and the fulfilment of some requirements of the Association Agreement between the EU and Ukraine is at risk.

In the long term, careful scientifically based planning of the rehabilitation program of the pharmaceutical sector is needed, taking into account the risks of pharmaceutical pollution and the adverse impact of the pharmaceutical industry on the natural environment, in particular through the implementation of environmental management systems (EMS) as part of the overall management system of the enterprise to manage environmental aspects; fulfilment of mandatory legal requirements and voluntary obligations following the goals and environmental policy of the enterprise; and to address issues related to risks and opportunities, especially concerning emergency preparedness and emergency response.