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Cost-benefit analysis of reference laboratories for

human pathogens Aisha SAUER DG SANTE C3 – Crisis Management and Preparedness in Health

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EU Health Programme

• The EU Health Programme contributes to the EU obligation to ensure that human health is protected as part of all its policies, and to work with Member States to improve and protect the health of its citizens.

• The third EU Health Programme 2014-2020 was published in March 2014 and provides funding of 446 million € for a 7-year period.

• One objective is to identify and develop coherent approaches and implement for better preparedness and coordination in health emergencies.

• Several EU initiatives on laboratory support for preparedness have been funded under the Public Health Programme in the past.

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EURLOP study

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• At present, there is no EU-wide system for reference laboratory networks for human pathogens that would consolidate operating standards of microbiological reference laboratories or provide resilience when significant cross-border outbreaks occur.

• The EU Human Pathogen Reference Laboratories Options Project (EURLOP) developed strategic options for an overarching EU reference laboratory system for different classes of pathogens.

• The EURLOP study proposed a tier-based system of EURLs designed to provide an EU-wide system that is accessible to all Member States. Several options for EURLs were developed, each based on a different levels of service provision.

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EURLOP conclusions

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• The report concluded that there is a need to improve EU-wide provision of reference microbiology for human pathogens.

• However, no option was considered wholly appropriate for an overarching EU-wide Reference laboratory provision.

• A cost-benefit analysis on the options to strengthen the existing coordination of reference microbiology provision in the EU was not included in the EURLOP study.

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Cost-benefit analysis on reference laboratories for human pathogens

• The recently published cost-benefit analysis on reference laboratories for human pathogens builds the EU Human Pathogen Reference Laboratories Options Project (EURLOP).

• The purpose of the study was to provide a cost-benefit analysis and analysis of regulatory options to strengthen the existing coordination of reference microbiology provision in the EU, in order to support the European response coordination to outbreaks of relevant infectious agents.

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Options analysed in cost-benefit analysis

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Core functions of an EU-RL network

1. Reference diagnostics

2. Reference material resources

3. Scientific advice

4. External Quality Assurance (EQA)

5. Training

6. Collaboration and research

7. Monitoring, alert and response

8. Governance of the network

Based also: ECDC Technical Report on Core functions of microbiology reference laboratories for communicable diseases, June 2010

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Data collection tools Interviews with coordinator(s) and funding entity of

case study networks

Survey of members of case study networks

Complementary desk research

Type of collected data

Costs by core function identified, including:

Budgeted costs (quantitative)

Additional costs of coordinators, funding entities and network members (quantitative)

Benefits, in terms of:

Monetary benefits of network members (quantitative)

Non-monetary benefits for network members (rating scale)

Non-monetary benefits for society overall (rating scale)

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• The final report will be available in June 2016

Overview of case study networks

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Median costs

The median costs of functions were calculated

among the case study networks in order to derive a picture of typical costs for specific functions.

These were calculated separately, e.g. at the level of each cost item, for each tier and function separately.

The annual median total network costs amount to EUR 781 091, which include budgeted costs, co-financing contributions (if applicable) and additional costs incurred for network activities by coordinators, funding entities and member laboratories.

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Conclusions on potential cost factors

Based on a review of factors that may explain differences in costs between case study networks, we concluded that the scope of activities and the type of pathogens covered by the network appear to play a role in differences in overall costs between case study networks.

In contrast, neither the type of coordination structure nor differences in the size and geographical coverage of the networks appear to play a significant role in differences in overall costs of the case study networks.

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Annual median network costs by function

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Assessed non-monetary benefits for network members

Methods employed

Staff expertise

Quality and accuracy of data/results produced

Image or reputation

Access to information, communication and/or collaboration among laboratories in the network

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3.9

4.3

4.3

4.4

4.4

1 2 3 4 5

Improving the image and reputation oflaboratories in the network

Improving access to information,communication and/or collaboration among

laboratories in the network

Improving staff expertise of laboratories inthe network

Improving the quality and accuracy ofdata/results produced in laboratories in the

network

Improving methods employed by laboratoriesin the network

Not at all Very much

The network has contributed to...

Non-monetary benefits of network members

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Non-monetary benefits for society overall assessed

Reduction in the disease burden and related costs in the EU

Improved public health surveillance in the EU

More timely and accurate detection of pathogens in the EU

Improved laboratory preparedness and the capacity of coordinated response to outbreaks in the EU

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Non-monetary benefits for society

3.5

4.2

4.4

4.6

1 2 3 4 5

Reduction in the disease burden and relatedcosts in the EU

Improved public health surveillance in the EU

More timely and accurate detection ofpathogens in the EU

Laboratory preparedness and the capacity ofcoordinated response to outbreaks in the EU

Not at all Very much

The network has contributed to...

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Summary of non-monetary benefits

• Collaboration and research

• Governance

• Reference diagnostics

• Reference material resources

• EQAs

• Training

Improved information and communication

Improved image and reputation

Functions of EU laboratory network Benefits for network members

Improved laboratory methods

Improved staff expertise

Improved quality of results

Benefits for society overall

More timely and accurate detection

of pathogens

Improved public health surveillance

• Monitoring, alert and response

• Scientific advice to EU institutions

Increased laboratoy

preparedness and capacity of

coordinated response

Re

du

ctio

n in

dis

eas

e b

urd

en

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Comparison of overall costs and benefits for society overall

At EUR 523 635 in the reference year, the median costs for coordinators and the funding entity of running a European reference laboratory network for human pathogens appear well within the range of what could be considered reasonable in order to achieve the benefits for society identified.

The link to reduction is disease burden/costs is only indirect, although cost-of-illness/burden-of-disease studies provide estimates in the range of billions of euros per year for key pathogens.

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Comparison of overall costs and benefits for network members

In a network of a typical size (e.g. 30 laboratories), each laboratory bears a net monetary cost of EUR 5 903.

As the non-monetary benefits tend to be at least in line with the costs involved for each function, it is likely that they make up for the remaining EUR 5 903 net costs involved to a large extent.

On balance, benefits induced for network member laboratories are likely to outweigh the costs they incur for implementation of the network activities.

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The case for an EU-RL system

In conclusion, the results of this study indicate that the benefits (monetary and non-monetary) of maintaining a formally-defined overarching system of EU reference laboratory networks are likely to outweigh costs, both in a Member State (participating member laboratory) and in an EU perspective (coordinator and funding entity).

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Issues to be addressed in creating a reference laboratory system

The need for adequate reference laboratory infrastructure at national level

The need to provide sustainable funding, including for emergency situations

The need to define the focus of the networks, potentially by grouping diseases in line with existing approaches

The need to choose the coordination options most suitable in specific cases

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National reference lab infrastructure

There is substantial variation in the reference laboratory infrastructure across Member States

The EURLOP study already emphasised that an overarching EU-RL system must be underpinned by an efficient and co-ordinated system of primary laboratories at the individual Member State level

Any future system of EU reference laboratory networks will require that adequate and sustainable reference laboratory services are in place at the national level

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Choice of coordination option

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Questions?

Aisha SAUER DG SANTE C3 – Crisis Management and Preparedness in Health

http://ec.europa.eu/health/preparedness_response/publications/index_en.htm