oecd-nea perspective on data ec workshop: medical … · 2019-02-19 · quarter 1), 2). 1q 2q 3q 4q...

[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


• 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


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


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


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


• 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


• 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??


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??



-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


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



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


• 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


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


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





• 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


• 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


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


www.oecd-nea.org

Thank you for your attention

oecd-nea perspective on data ec workshop: medical … · 2019-02-19 · quarter 1), 2). 1q 2q 3q 4q...

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