The new law imposes obligations on risk assessment, ensuring resilience to disruptions, and reporting. Tamro is committed to supporting this goal to ensure the continuity of medicine and healthcare product distribution in disruption situations, writes Quality and Continuity Business Partner Elina Rintala.
The European Commission's CER directive (Critical Entities Resilience directive) came into force in January 2023. The directive aims to enhance the resilience of society's critical entities, complemented by the NIS2 directive (Network and Information Security directive). Member states are required to transpose the directive into national legislation by October 17, 2024.
In Finland, based on the directive, a national draft law titled "Act on the Protection of Critical Infrastructure and Improvement of Resilience to Disruptions" has been formulated, intended to come into effect in October 17th, 2024 as per the set schedule.
Recognizing and preparing for risks
Medical wholesale activities will fall within the scope of application of both the CER and NIS2 directives as critical services for societal functioning. At Tamro, we have been systematically developing our disruption preparedness and continuity management system for several years.
We have extensively conducted risk assessments and actively implemented measures to mitigate risks. Additionally, we have developed action plans to ensure appropriate response in various disruption scenarios and swift recovery to normal operations.
The new law on the protection of critical infrastructure and improvement of resilience to disruptions will impose obligations on critical entities regarding risk assessment, ensuring resilience to disruptions, and reporting deviations. The aim of the law is to enhance societal resilience and national security by improving the resilience to disruptions and continuity management of critical entities.
Tamro will continue to develop its continuity management system, taking into account the details of the CER directive and the new national legislation. We closely monitor the preparation of national legislation and the progress of measures included therein.
Step towards improving national resilience to crises
The initial measures mandated by national legislation will primarily affect the state level. Alongside the national strategy and risk assessment, the state is officially required to designate critical entities and inform them of their designation. Considering the deadlines set for member states' actions, the obligations imposed by the CER directive and national legislation on entities will officially come into effect around the latter half of 2026.
The new legislation is a significant step towards improving societal resilience to crises. Tamro is committed to supporting this goal and ensuring that we are prepared to meet the requirements of the new legislation. Our aim is to ensure uninterrupted distribution of medical and healthcare products critical for patient safety, even in disruption scenarios.
