The international legal framework for transporting infectious substances
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Published on: October 3, 2016
Markus Huber1, Ekin Sahin2, Lance D Presser3
1Emerging Threat Diagnostics and Laboratory Biosafety, Epidemic and Pandemic Management, WHO Health Emergencies Programme, World Health Organization, Avenue Appia 20, 1211 Geneva 27, Switzerland.
Objective:
To examine international agreements, standards, policy documents and regulations governing the cross-border transportation of infectious substances and to assess the extent to which fragmented regulatory frameworks affect timely and safe shipment.
Method:
A qualitative document analysis of 30 binding and non-binding legal and policy instruments was conducted and details were entered into a common extraction grid. In addition, the published reports and 64 international participants of World Health Organization (WHO) subregional workshops on the transport of infectious substances legislation, in Istanbul, Türkiye (2022) and Almaty, Kazakhstan (2023), provided an operational perspective. No other interviews or consultations were undertaken.
Findings:
The analysis revealed substantial fragmentation and inconsistency in regulatory frameworks governing the cross-border transportation of infectious substances. Although many countries had ratified or referenced international agreements in national legislation, harmonized and cross-departmental implementation of legislation was lacking. Limitations included: (i) the incomplete adoption of international shipping standards; (ii) bureaucratic delays in approval and licensing processes; (iii) limited technical capacity; and (iv) a lack of standardized procedures and enforcement mechanisms.
Conclusion:
The international regulatory environment for infectious substance transport is complex and targeted interventions are needed, such as harmonizing regulatory frameworks, improving interagency coordination, investing in capacity-building, developing standard operating procedures and aligning policy documents with international best practice. These interventions will help countries meet their obligations under the International Health Regulations (2005), enhance the safe and secure transport of infectious substances and improve global public health preparedness, as required by the recent WHO Pandemic Agreement.
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