Upozornění na aktuální informace SANTE-SOHO k mezinárodnímu transportu lidských tkání a buněk a krve v kontextu COVID-19 pandemie

SÚKL upozorňuje, že SANTE-SOHO vydalo aktuální informace k mezinárodnímu transportu lidských tkání a buněk a krve v kontextu COVID-19 pandemie:  

In the context of the Covid19 pandemic, we herewith keep you updated on related EU-level developments in SoHO that you might find useful. Please disseminate this information as you see fit.

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1.      Cross-Border transport of SoHO. The European Commission has clarified in this document (point 25) that Substances of Human Origin (SoHO) are considered to be essential goods/services for which free circulation within the EU is crucial.

 

In particular for transport of following SoHO it is essential to facilitate border passage:

·       Organs for transplantation

·       Bone marrow or cord blood for transplantation (haematopoetic stem cells)

·       Blood for transfusion

·       Plasma for transfusion

·       Plasma for manufacturing medicinal products

 

Please note that the above Commission Communication refers to this recent European Commission Guidelines for border management measures to protect health and ensure the availability of goods and essential services adopted on 16 March 2020. They stipulate a. o. that control measures should not cause serious disruption of supply chains or of essential goods/services of general interest and Member States should designate priority lanes for freight transport (e.g. via ‘green lanes').

 

We draw your attention that annex 3 of the clarification document includes a Template of Certificate for International Transport Workers  which might also be useful precisely for couriers who do not have a certificate of professional competence or at least a certificate recognised at EU level.

 

 

2.      The ECDC report on SoHO and COVID-19 is now published and includes a risk assessment and preparedness measures for a safe supply of different SoHO. The document is addressed to the national competent authorities for SoHO, blood and tissue establishments, organ procurement organisations and transplant centres.

 

3.      Convalescent plasma (plasma with antibodies from recovered COVID-19 patients)

 

Blood services in many EU countries are reported to be preparing for collection and transfusion of convalescent plasma and many plan to start studies soon; collection has already started in some. Plans for the collection of convalescent plasma appear to be most advanced in IT, DE, UK, FR, NL and DK. Many are working on protocols for application and at least one clinical trial is underway. The European Blood Alliance (EBA) is mapping the current efforts and informing SANTE/SoHO regularly on progress.

 

SANTE/SoHO is talking in parallel to some the National Competent Authorities (members of the GAPP Joint Action’s work on blood) to see how authorisation and outcome assessment of such convalescent plasma therapies can be facilitated. Feel free to contact us if you wish to have more information on this.

 

For those of you already looking into this, we would like to share with you an FDA document on convalescent plasma. We expect further guidance on convalescent plasma and we will share with you when available.

 

4.      Other: we have understood that, following some initial reduction in collection, citizens have responded very well to calls for donation and demand for blood for transfusion is reduced. Most EU Member States have now a good supply levels of blood components for transfusion.

 

The SoHO functional mailbox (sante-soho@ec_europa_eu) remains operational, and can be contacted in case of need.

Oddělení dohledu nad zpracováním biologických materiálů
26.03.2020