oecd-nea perspective on data ec workshop: medical … · 2019-02-19 · quarter 1), 2). 1q 2q 3q 4q...
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[email protected] EC SAMIRA Workshop – 7 February 2019, Brussels 1
OECD-NEA Perspective on Data
EC Workshop: Medical Radioisotopes in the Future:
European Perspective, 07 February 2019
Kevin Charlton
OECD Nuclear Energy Agency
Analyst – Division of Nuclear Development
[email protected] EC SAMIRA Workshop – 7 February 2019, Brussels 2
• Introduce the OECD-NEA
• Advise on status of OECD-NEA High-level group on the security of
supply of Medical Radioisotopes (HLG-MR)
• Recent supply performance challenges
• How the OECD-NEA collects data
• Discuss demand and capacity studies
• Co-operation with OECD Health Division
Overview of Presentation
[email protected] EC SAMIRA Workshop – 7 February 2019, Brussels 3
The Nuclear Energy Agency (NEA)
• The NEA is a specialist agency of the Organisation for
Economic Co-operation Development (OECD), the NEA is an
intergovernmental organisation of 33 industrialised countries
based in Paris
• The NEA MISSION - To assist its member countries in
maintaining and further developing, through international
co-operation, the scientific, technological and legal basis
required for a safe, environmentally friendly and economical
use of nuclear energy for peaceful purpose
• My role is Senior Analyst supporting security of supply of
medical radioisotopes - from 1977 to 2014 I worked in the
medical isotope supply chain
[email protected] EC SAMIRA Workshop – 7 February 2019, Brussels 4
HLG-MR
• The High-Level Group on the Security of Supply of Medical
Radioisotopes (HLG-MR) was established at the request of
NEA member countries, following global supply shortages of 99Mo/99mTc in 2009-2010 that resulted from simultaneous
unplanned outages of ageing research reactors in Canada
and the Netherlands and processing problems in Belgium
2004 2006 2008 2010 2012
Demand and Capacity Trends
Market Capacity
[email protected] EC SAMIRA Workshop – 7 February 2019, Brussels 5
OECD-NEA Forward Plan
• The HLG-MR 4th Mandate ended on 31 December 2018
• At the final HLG-MR Meeting on 9 October 2018, delegates
reconfirmed the recommendation of the activities that should
be transferred to the NTE Programme of Work for the 2019-
2020 period and on 10 October 2019 NDC members
endorsed the following:
• the continued preparation and publication of the Mo-99
Demand and Capacity Projection report series
• retaining the ability to arrange ad hoc meetings of
stakeholders:– proposed meeting date 9 July 2019 in Paris
• retaining the ability to coordinate communications amongst
stakeholders should the need arise
• follow-up work/analysis on OECD Health Division project
[email protected] EC SAMIRA Workshop – 7 February 2019, Brussels 6
• The supply chain has continued to have difficult challenges
• NTP (South Africa) out of operation mid November 2017 to
March 2018
• returned with reduced capacity and increased regulator surveillance
• NTP out of operation again early June 2018
• problem resolved November 2018
• presently working at a maximum of 40% theoretical capacity
• High level of activity from the AIPES Security of Supply (SoS)
working group and Emergency Response Team (ERT)
• weekly meetings and status updates
• some supply shortages, e.g. in January up to 15% of world demand
• other challenges (e.g. Australia, BR2 (Belgium), HFR (Netherlands),
131-Iodine supply)
Recent Supply Chain Challenges
[email protected] EC SAMIRA Workshop – 7 February 2019, Brussels 7
• In 1Q 2018 a specific activity was performed to collect weekly
supply performance data from Generator Manufacturers to
investigate the effect of the ongoing NTP supply problems
• voluntary
• relative
• non-fiscal
• full confidentiality
• Relatively successful
• initial good response level
• some backsliders
• very labour intensive
How does the OECD-NEA collect data??
[email protected] EC SAMIRA Workshop – 7 February 2019, Brussels 8
Market Supply
Performance Review
1Q
2018
Date
Completed
XX/XX/
2018
Generator
Manufacturer Mythical Generators supplied by multiple processors
Week
Number 1 2 3 4 5 6 7 8 9 10 11 12 13 14
Demand
Requirement 1). 90% 100% 100% 100% 100% 100% 110% 110% 100% 100% 100% 100% 100% 100%
%age of Demand
Anticipated 2). 90% 90% 100% 78% 100% 100% 110% 110% 100% 100% 90% 100% 90% 100%
%age of Demand
Delivered 3). 90% 80% 100% 78% 100% 100% 100% 110% 100% 100% 60% 100% 100% 100%
% Shortage
Anticipated 0% -10% 0% -22% 0% 0% 0% 0% 0% 0% -10% 0% -10% 0%
% Shortage
Experienced 0% -20% 0% -22% 0% 0% -10% 0% 0% 0% -40% 0% 0% 0%
How the OECD-NEA collects data??
[email protected] EC SAMIRA Workshop – 7 February 2019, Brussels 9
How the OECD-NEA collects data??
-60%
-40%
-20%
0%
20%
40%
60%
80%
100%
120%
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Sup
ply
Pe
rfo
rman
ce/%
Sho
rtag
e
Mythical Generator Supply Experience
Demand
SupplierCommitment
SupplierPerformance
%age Shortage
[email protected] EC SAMIRA Workshop – 7 February 2019, Brussels 10
Supply Performance to Gen Manufacturers 1Q 2018
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
1 2 3 4 5 6 7 8 9 10 11 12 13
Pro
po
rtio
n o
f G
en
era
tor
Man
ufa
ctu
rers
wit
h
vary
ing
leve
ls o
f sh
ort
age
No Supply
Greater than30% Shortage
Up 30%Shortage
Up 20%Shortage
Up 10%Shortage
No Shortage
Weighted
Average
[email protected] EC SAMIRA Workshop – 7 February 2019, Brussels 11
How the OECD-NEA collects data??
Year 2015 2015 2015 2015 2016 2016 2016 2016 2017 2017 2017 2017 2018 2018 2018 2018 2019 2019 2019 2019 2020 2020 2020 2020
Quarter 1), 2). 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q
Number of Weeks of actual operation 3). 7 8 7 9 7 6 6 10 10 9 2 7 9 5 4 9 10 10 7 3 9 9 8 8
Nominal Maximum Production Level (NMPL) 4). 1500 1500 1500 1500 1500 1500 1500 1500 2500 2500 2500 2500 2500 2500 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000
Estimated Average %age Production Level in that Q 5). 65% 50% 60% 80% 85% 75% 70% 65% 95% 85% 90% 70% 85% 100% 50% 85% 60% 50% 60% 25% 70% 70% 70% 70%
Estimated Average %age of paid ORC held above the Production Level in that Q 6). 15% 30% 20% 0% 0% 5% 10% 15% 0% 0% 0% 10% 0% 0% 40% 5% 30% 40% 30% 65% 20% 20% 20% 20%
Year 2015 2015 2015 2015
Quarter 1), 2). 1Q 2Q 3Q 4Q
Number of Weeks of actual operation 3). 7 8 7 9
Nominal Maximum Production Level (NMPL) 4). 1500 1500 1500 1500
Estimated Average %age Production Level in that Q 5). 65% 50% 60% 80%
Estimated Average %age of paid ORC held above the Production Level in that Q 6). 15% 30% 20% 0%
2018 2018 2018 2018 2019 2019
1Q 2Q 3Q 4Q 1Q 2Q
9 5 4 9 10 10
2500 2500 2000 2000 2000 2000
85% 100% 50% 85% 60% 50%
0% 0% 40% 5% 30% 40%
Mythical Supplier> Historic Recent Prospective
Data Collection Method> Goodwill
[email protected] EC SAMIRA Workshop – 7 February 2019, Brussels 12
• The 2018 Medical Isotope Supply Review: 99Mo/99mTc Market
Demand and Production Capacity Projection, 2018-2023 was
the latest in the report series published in August 2018:-
• Positive news in 2018
• Curium conversion to 100% LEU targets
• positive FDA decision for NorthStar RadioGenix project (non-HEU)
• Negative news in 2018
• NTP problems led to “chronic” shortage situation in some markets
• Nordion/GA/MURR project terminated on economic grounds
• some reported reductions in irradiation capacity from LEU
conversion
• more project delays
Demand and Capacity Review 2018-2023
[email protected] EC SAMIRA Workshop – 7 February 2019, Brussels 13
Processor Targets5
Anticipated Mo-
99 production
weeks/year
Expected available
capacity per week (6-
day Ci) by 20236
Expected available
capacity per year (6-
day Ci 99Mo) by 20236
Estimated first
full year of
production
Project status (January
2018)
MURR/NorthStar Natural Mo
target 52 750 39 000 2019 FDA approval Feb 2018
MURR/NorthStar1 Enriched Mo
target 52 +2 250 +117 000 2020 In production scale up
NorthStar Non-fissile 52 3 000 156 000 2021 Accelerator vendor selected,
initiating scale up
Nordion LEU-SGE 52 3 200 166 400 2020 Phase 2 underway
PROJECT CANCELLED
SHINE LEU solution 50 4 000 200 000 2021 Construction Permit Granted
CNEA LEU 48 2 500 120 000 2021 Building start by end 2018
Korea2 LEU 43 400 17 200 2023+ Construction permit in
review by regulatory body
MARIA: Mo-99
20103 LEU 40 300 12 000 2023+ Financing – not yet agreed
Brazil MR LEU 41 1 000 41 400 2023+
Detailed design still to be
contracted. Construction
depends on budget
China Advanced
RR4 LEU 34 1 000 34 000 2023+
Financing decision after
2017 tests
TABLE 4 – Revised April 2018: Project Delays
[email protected] EC SAMIRA Workshop – 7 February 2019, Brussels 14
The Effect of Multiple Project Delays
200,000
300,000
400,000
500,000
600,000
700,000
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023
6-d
ay C
i 99 M
o p
er
6 m
on
th p
eri
od
Scenario B - "Technological Challenges" Projection Creep with Time
NEA Demandgrowth (+ 35% ORC)
Total processingcapacity - Alltechnologies 2015
Total processingcapacity - Alltechnologies 2016
Total processingcapacity - Alltechnologies 2017
Total processingcapacity - Alltechnologies 2018
[email protected] EC SAMIRA Workshop – 7 February 2019, Brussels 15
• The 2019 Medical Isotope Supply Review: 99Mo/99mTc Market
Demand and Production Capacity Projection, 2019-2024 will
be produced:-
• the data collection process for the report has begun
• publication target for 1st half 2019
• quality will be dependent on the continued co-operation of the
supply chain members and prospective producers
Demand and Capacity Review 2019-2024
[email protected] EC SAMIRA Workshop – 7 February 2019, Brussels 16
• At the 5th meeting of the 4th mandate of the HLG-MR
(February 2018), it was agreed to support co-operative work
with the OECD Health Division (HD)
• final project work proposal amendments were agreed with HD
by a HLG-MR working group
• sufficient Voluntary Contribution pledges were received to allow
HD to perform the work
• work started – early April 2018
• interim update – mid June 2018
• closed session presentation to HLG-MR – 9 October 2018
• open presentation - EANM 2018, Düsseldorf – 17 October 2018
• final report – early 2019 (linked to NucAdvisor SMER study)
Co-operation with OECD Health Division
[email protected] EC SAMIRA Workshop – 7 February 2019, Brussels 17
1 List procedures using radiopharmaceuticals based on 99Mo/99mTc isotopes (external consultant)
2 Survey: elicit health care provider payment mechanisms (OECD Health Division Survey)
3 Compare procedure volumes across countries (co-operation with NucAdvisor - SMER)
4 Overview of need of Tc-99m in clinical use and possible alternatives (external contractor)
5 Analysis of supply chain and comparison to other products (NEA)
6 Develop policy options
Health Division Project outline
[email protected] EC SAMIRA Workshop – 7 February 2019, Brussels 18
www.oecd-nea.org
Thank you for your attention