EC Report Calls for New Network of Reference Labs for Human Pathogens

Regulatory NewsRegulatory News | 03 October 2016 |  By 

The European Commission is calling for a formally defined EU-wide system for reference laboratory networks for human pathogens as the benefits are likely to outweigh the costs, according to an analysis of such a system released on Friday.

Currently, many national reference labs for human pathogens have a hard time responding in a coordinated manner to new and emerging infectious threats. The aim of an EU-wide network would be to better respond to cross-border threats, antimicrobial resistance, Clostridium difficile infection surveillance and other pathogen surveillance, as well as to consolidate the operating standards of microbiological reference labs.

The report relies heavily on the “European system of reference laboratories for human pathogens” (EURLOP) project, which found that coordination of reference labs for human pathogens is insufficiently robust for some communicable diseases.

New System

While a large number of such microbiology networks or projects exist (more than 70 microbiology networks, consortia and research groups across the EU), the report says they "suffer from a lack of funding and are highly diverse in terms of scope, organisation and membership. It also identified the lack of an EU-wide accreditation policy for reference microbiology laboratories as a key weakness."

As far as what the commission envisions: "Such a system should have the appropriate flexibility, capacity and resilience for advanced reference materials and resources to be diverted in an effective and timely manner for the study of novel pathogens or identification of significant changes in the incidence or severity of known diseases, as well as for the support of outbreak response by providing the required diagnostic capabilities."

The report also delves into some newer technologies, including the use of next-generation sequencing, which it says is compatible with the creation of such an EU-wide system.

“Although such technology may lead to the transfer of certain microbiology reference activities from national or supranational laboratories to the regional or primary diagnostic level, there will remain a need for expert analysis of the resulting data. Moreover, the use of genomic methods to recognise outbreaks will require the maintenance of an EU-wide database. Indeed, rather than reducing the need for reference laboratories, the use of genomic tools in the sphere of virology (where they have already been available for several years) has, according to the EURLOP study, in fact increased the need for them, in order to consolidate technical approaches and assure quality.”

Other issues that will need to be addressed include the need:

  • for adequate reference laboratory infrastructure at a national level
  • to provide sustainable funding, including for emergency situations
  • to consolidate the focus of the existing networks, for example, by grouping diseases or networks with similar areas of expertise
  • to harness relevant technological improvements
  • to choose the coordination options most suitable in specific cases.

Despite these needs, EURLOP found that more than 50% of countries had capability for 47 communicable diseases, more than 90% of countries had Biosafety level 3 capacity and six had Biosafety level 4 (BSL-4) facilities.

Other weaknesses include competition for funds between diagnostic and reference labs in some countries, an imbalance in distribution of operational BSL- 4 facilities across the EU, an imbalance in microbiological expertise and a lack of collaboration between different sectors (ie. human, veterinary, food and water).

The report also includes four options for coordinating future EU reference labs for human pathogens' activities, concluding that it would be preferable for the network to not have an additional supranational coordination level ("i.e. without an intermediate level where several selected reference laboratories coordinate activities/provide reference services to NRLs in 'their' cluster of Member States appears preferable in the EU context).".



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