COMMISSION STAFF WORKING DOCUMENT Accompanying document    COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL ON MEDICAL APPLICATIONS OF IONIZING RADIATION  AND SECURITY OF SUPPLY OF RADIOISOTOPES FOR NUCLEAR MEDICINE   COM(2010) 423
Date: 2010-08-06
Institutions: European Commission
Subjects: health control, health legislation, ionising radiation, nuclear medicine, public health, radiation protection

EN 

EN 

   EN 

 
 
EUROPEAN COMMISSION 

Brussels, 6.8.2010 
SEC(2010) 974 

COMMISSION STAFF WORKING DOCUMENT 

Accompanying document  

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT AND THE COUNCIL 
ON MEDICAL APPLICATIONS OF IONIZING RADIATION  
AND SECURITY OF SUPPLY OF RADIOISOTOPES FOR NUCLEAR MEDICINE 

COM(2010) 423 final 

EN 

   EN 

 
 
 
  
 
 
 
 
PART 1 

PART 2  

MAIN  EU  INSTRUMENTS  RELEVANT  TO  THE  MEDICAL  APPLICATIONS  OF 
IONIZING RADIATION 

MAIN  PROVISIONS  OF  THE  EXISTING  REGULATORY  FRAMEWORK  FOR 
MEDICAL EXPOSURES (DIRECTIVE 97/43/EURATOM) 

PART 3 

SUPPLY OF RADIOISOTOPES FOR MEDICAL USE  

PART 4 

ROLE AND ACTIVITIES OF INTERNATIONAL ORGANIZATIONS IN THE FIELD OF 
MEDICAL  APPLICATIONS  OF  IONIZING  RADIATION  AND  IN  THE  FIELD  OF  THE 
SUPPLY  OF  MEDICAL  RADIOISOTOPES  -  STATEMENTS  PROVIDED  BY  IAEA, 
ICRP, NEA, UNSCEAR AND WHO  

EN 

2 

   EN 

 
 
 
 
1. 

MAIN  EU  INSTRUMENTS  RELEVANT  TO  THE  MEDICAL  APPLICATIONS  OF  IONIZING 
RADIATION 

1.1. 

Instruments under Euratom provisions 

1.1.1.  Legislative tools 

The  Euratom  Basic  Safety  Standards  Directive1  defines  the  European  legal  framework  for 
radiation  protection  of  workers  and  the  general  public,  based  on  the  following  main 
principles: 

(cid:131)  Justification  of  all  new  types  of  practices  resulting  in  exposure  to  ionizing  radiation 
before being first adopted by their economic, social or other benefits in relation to the 
health detriment they may cause. 

(cid:131)  Optimisation of protection to ensure that the radiation exposures of workers, members 
of the public and the population as a whole are kept as low as reasonably achievable, 
economic and social factors being taken into account. 

(cid:131)  Limitation  of  the  exposure  to  ensure  that  the  sum  of  the  radiation  doses  from  all 
relevant practices will not exceed the legal dose limits for workers or members of the 
public. Dose limits do not apply to patients and other medically exposed individuals. 

The  Basic  Safety  Standards  Directive  establishes  a  system  of  national  reporting  and 
regulatory  authorization  of  activities  resulting  in  exposure  to  ionizing  radiation.  It  also 
requires a system of inspection to enforce the legal requirements to be established in Member 
States. 

The  Medical  Exposure  Directive2  supplements  the  Basic  Safety  Standards  Directive  by 
providing specific requirements for health protection of patients and other medically exposed 
individuals  against  the  dangers  from  ionizing  radiation.  The  Medical  Exposure  Directive 
provides a legal framework based on the basic radiation protection principles of justification 
and  optimization  taking  into  account  the  specificity  of  medical  exposure  as  deliberate 
exposure of people for their own health benefit. 

The  Basic  Safety  Standards  Directive  is  currently  being  recast  with  four  other  radiation 
protection Directives, including the Medical Exposure Directive. 

1.1.2.  Other tools 

The Commission acts in multiple other ways to support the safe use of ionizing radiation in 
medicine,  including  elaboration  of  European  guidelines,  support  of  research  on  medical 
applications  of  ionizing  radiation  and  involvement  in  activities  fostering  information 
exchange and involvement of stakeholders. 

1  

2  

Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection 
of the health of workers and the general public against the dangers arising from ionizing radiation, OJ L 
159, 29 June 1996 
Council  Directive  97/43/Euratom  of  30  June  1997  on  health  protection  of  individuals  against  the 
dangers of ionizing radiation in relation to medical exposure, and repealing Directive 84/466/Euratom, 
OJ L 180, 9 July 1997 

EN 

3 

   EN 

 
                                                 
The  Directorate-General  for  Energy  maintains  a  Radiation  Protection  publications  series3, 
which  is  a  useful  source  of  information  and  guidelines  on  specific  aspects  of  radiation 
protection,  including  on  medical  exposure.  The  Commission  published  in  this  series  studies 
and  guidelines  on  training  of  medical  staff  in  radiation  protection,  referral  guidelines  for 
imaging, diagnostic reference levels, acceptability criteria for medical installations, etc. Most 
recently, guidelines have been published on the evaluation of population doses from medical 
radiodiagnostic procedures (RP 154) and on clinical audit (RP 159). 

Euratom Framework Programme 7 is currently funding a number of projects on medical uses 
of radiation, the expected impact being an optimisation of doses to patients in clinical practice 
through  improving  knowledge  and  perfecting  imaging  practices  and  techniques4.  Better 
understanding  of  the  effects  of  and  associated  risks  from  doses  of  radiation  received  during 
medical examinations has been identified as a priority topic by the "High Level Expert Group 
on Low Dose Risk Research"5. 

The Joint Research Centre, through the Institute for Transuranium Elements (ITU, Karlsruhe), 
uses its unique facilities and expertise in handling highly radioactive alpha-emitting nuclides 
to  develop,  produce  and  test  novel  methods  for  cancer  treatment6.  In  addition  ITU  is 
contributing  to  pre-clinical  studies  and  clinical  trials  through  the  provision  of  radioisotopes, 
training, equipment and radiochemical support to hospitals and cancer research centres. 

The  Commission  supports  information  exchange  and  co-operation  between  Member  States 
and with stakeholders on issues relating to the use of ionizing radiation in medicine. In 2010 
the  Commission  launched  the  European  Medical  ALARA  Network  (EMAN)7  as  a 
stakeholders'  network  dealing  with  radiation  protection  of  patients  and  medical  staff.  The 
Commission organizes or co-sponsors ad-hoc meetings on different aspects of the safe use of 
radiation in medicine8 and participates in the activities of regional, European and international 
networks and organizations. 

In  its  work  on  radiation  protection  of  patients  the  Commission  is  advised  by  the  Working 
Party on Medical Exposure of the Group of Experts created under Article 31 of the Euratom 
Treaty9.  Medical  exposure  topics  are  an  important  part  of  the  annual  scientific  seminars10 
organized by the Article 31 Group of Experts to review the research implications on the health 
and safety standards. 

1.2. 

Instruments under EC provisions 

1.2.1.  Legislative tools 

Equipment used in the medical exposure procedures falls under the requirements of Council 
Directive 93/42/EEC, amended by Directive 2007/47/EC11. The Directive's main purpose is to 

3  
4  
5  
6  
7  
8  
9  
10  
11  

http://ec.europa.eu/energy/nuclear/radiation_protection/publications_en.htm  
http://cordis.europa.eu/fp7/euratom 
http://www.hleg.de  
http://itu.jrc.ec.europa.eu 
http://www.eman-network.eu 
http://ec.europa.eu/energy/nuclear/events/index_en.htm 
http://ec.europa.eu/energy/nuclear/radiation_protection/article_31_en.htm  
http://ec.europa.eu/energy/nuclear/radiation_protection/scientific_seminar_en.htm  
Council  Directive  93/42/EEC  of  14  June  1993  concerning  medical  devices,  OJ  L  169,  12  July  1993; 
amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007, 
OJ L 247, 21 September 2007 

EN 

4 

   EN 

 
                                                 
ensure that medical devices placed on the European market do not compromise the safety and 
health  of  patients,  users  and  other  individuals.  This  legal  framework  specifies  that  the 
emission of unintended radiation must be reduced as far as possible (Article 11.3.1) and that 
the  instructions  for  use  must  give  sufficiently  detailed  information  in  order  to  avoid  the 
misuses (Article 11.4.1). The medical devices must meet the essential requirements for their 
design and construction, including those for justification of the intended use of the equipment 
on  the  basis  of  risk/benefit  weighting  (Article  11.2.1)  and  for  incorporation  of  technical 
features  for  radiation  protection  of  patients,  users  and  other  individuals  (Articles  11.1.1  and 
11.3.1).  This  is  ensured,  inter  alia,  through  a  system  of  harmonized  standards  (Article  5)12, 
pre-market conformity assessment procedures (Article 11) and appropriate supervision by the 
competent  authorities  (Articles  11.13,  14.1,  14.2,  15.1,  15.2  and  15.7).  The  Commission  is 
considering a revision of the legal framework for medical devices 

According  to  Council  Recommendation  on  patient  safety13  patients  should  be  informed  of 
patient  safety  standards,  best  practices,  safety  measures  in  place  and  complaint  and  redress 
systems.  Member  States  should  disseminate  best  practices  and  maintain  adverse  events 
reporting and learning systems allowing them to develop efficient solutions and interventions. 
Information  and  communication  technology  tools,  such  as  electronic  health  records  or  e-
prescriptions, can contribute to achieving these objectives. 

As  far  as  Directive  2004/40/EC  on  the  protection  of  workers  from  the  risks  related  to 
exposure  to  electromagnetic  fields  at  work  is  concerned,  the  deadline  for  transposing  was 
postponed to 30 April 201214, in order to find solutions to reported implementation problems 
and to amend it as appropriate. One of the issues encountered in the current Directive is that it 
may unduly restrict the use of Magnetic Resonance Imaging (MRI) in medicine and research. 
This could result in increased use of diagnostic procedures using ionizing radiation, with an 
unintended adverse effect on the health of patients and workers. 

1.2.2.  Other tools 

The objective of the Health research theme15 of the Framework Programme 7 is to improve 
the  health  of  European  citizens  and  boost  the  competitiveness  and  innovative  capacity  of 
European  health-related  industries  and  businesses,  while  addressing  global  health  issues. 
Research  into  medical  imaging  is  an  important  part  of  the  health  theme.  In  general,  the 
objectives of the supported projects are on development and refinement of imaging techniques 
and methodologies, rather than on improved radiation protection of patients, which can be one 
of the outcomes of new technology, such as detector development.  

Under  the  second  programme  of  Community  action  in  the  field  of  health  (2008-13)16  it  is 
foreseen  to  promote  the  establishment  of  risk  assessment  networks  of  "radioactive  threats" 

12  

13  

14  

15  
16  

Issued  by  the  European  standards  bodies  in  this  area,  CEN  or  CENELEC.  Latest  list  of  harmonized 
standards – OJ C 293, 2 December 2009 
Council  Recommendation  of  9  June  2009  on  patient  safety,  including  the  prevention  and  control  of 
healthcare associated infections, O.J. C151 of 3 July 2009 
by Directive 2008/46/EC amending Directive 2004/40/EC on minimum health and safety requirements 
regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields)  
http://cordis.europa.eu/fp7/health/home_en.html  
Decision  No  1350/2007/Ec  of  the  European  Parliament  and  of  the  Council  of  23  October  2007 
establishing a second programme of Community action in the field of health (2008-13), O.J. L 301 of 
20 November 2007 

EN 

5 

   EN 

 
                                                 
and  risks  in  the  EU.  The  aim  is  to  develop  risk  assessment  capacity  in  the  health  field  for 
"radioactive threats". 

The  so-called  "exploratory  process  on  the  future  of  the  medical  devices  sector"  was  put  in 
place  during  the  second  half  of  2009.  The  objective  of  the  process  was  to  establish  an 
overview  of  public  health  and  industrial  challenges,  to  identify  current  dynamics  of  the 
medical  devices  sector  and  to  highlight  key  topics  of  interest  at  the  European  level.  The 
initiative provided patients, consumers, healthcare professionals, insurers and medical devices 
industry  with  an  opportunity  for  the  first  time  at  EU  level  to  share  their  views  on  existing 
challenges. One major issue identified was the need to promote innovation for the benefit of 
patients, healthcare professionals, industry and society, and in particular to reduce barriers to 
interaction and involvement of all stakeholders. A particular emphasis was put on the need to 
ensure a close cooperation between industry, healthcare professionals and users to better adapt 
research and innovation to the societal needs. The appropriate follow-up is being considered. 

EN 

6 

   EN 

 
2. 

MAIN  PROVISIONS  OF  THE  EXISTING  REGULATORY  FRAMEWORK  FOR  MEDICAL 
EXPOSURES (DIRECTIVE 97/43/EURATOM) 

2.1. 

Justification provisions of Medical Exposure Directive (Article 3) 

According to the MED the medical exposure shall show a sufficient net benefit, weighing the 
total  potential  diagnostic  or  therapeutic  benefits it produces against the individual detriment 
that  the  exposure  might  cause,  taking  into  account  the  available  alternative  techniques 
involving  no  or  less  exposure  to  ionizing  radiation.  The  justification  shall  be  done  on  two 
levels: all new types of practices shall be justified in advance before being generally adopted, 
subject to  review  whenever new  important evidence about their efficacy or consequences is 
acquired;  and  all  individual  procedures  shall  be  justified  in  advance  taking  into  account  the 
specific objectives of the exposure and the characteristics of the individual patient. 

The  Medical  Exposure  Directive  does  not  give  much  specificity  on  how  the  general 
justification  of  medical  exposure  practices  shall  be  done.  Yet,  there  are  several  relevant 
requirements  specifying  that:  the  Member  States  shall  take  appropriate  steps  to  avoid 
unnecessary  proliferation  of  radiological  equipment;  fluoroscopy  examinations  without  an 
image  intensification  or  equivalent  techniques  are  not  justified;  fluoroscopic  examinations 
without  devices  to  control  the  dose  rate  shall be  limited  to  justified  circumstances;  and  that 
new  radiodiagnostic  equipment  shall  have,  where  practicable,  a  device  informing  the 
practitioner of the quantity of radiation produced during the procedure. 

On the other hand, the Directive specifies several practical requirements aiming at avoiding 
unnecessary individual exposures including that: 

(cid:131)  The  prescriber  and  the  radiological  practitioner  shall  be  involved  as  specified  by 
Member  States  in  the  justification  process  at  the  appropriate  level  and,  in  particular, 
they shall seek previous diagnostic information or medical records and consider them 
to avoid unnecessary exposure. 

(cid:131)  The Member States shall ensure that recommendations concerning referral criteria for 
medical exposure, including radiation doses, are available to the prescribers of medical 
exposure. 

(cid:131)  Any  medical  exposure  shall  be  effected  under  the  clinical  responsibility  of  a 

practitioner, the "clinical responsibility" including justification of the procedure. 

(cid:131)  Clinical audits shall be carried out in accordance with national procedures. 

2.2. 

Optimization provisions of Medical Exposure Directive (Article 4) 

Medical  Exposure  Directive  requires  that  the  radiation  doses  from  medical  procedures  shall 
be  kept  as  low  as  reasonably  achievable  consistent  with  obtaining  the  required  diagnostic 
information  or  therapeutic  outcome,  taking  into  account  economic  and  social  factors.  The 
optimization  process  shall  include  the  selection  of  equipment,  the  consistent  production  of 
adequate  diagnostic  information  or  therapeutic  outcome  as  well  as  the  practical  aspects, 
quality assurance including quality control and the assessment and evaluation of patient doses 
or administered activities. 

On  more  practical  level,  the  Directive  provides  for  optimization  of  the  medical  radiation 
procedures by: establishment and use of diagnostic reference levels; establishment of written 

EN 

7 

   EN 

 
protocols  for  every  type  of  standard  radiological  practice  for  each  piece  of  equipment; 
equipment  being  subject  to  appropriate  radiation  protection  surveillance,  quality  assurance, 
acceptance  and  in-service  testing  and  dose-measuring  devices  requirements;  appropriate 
involvement  of  a  medical  physics  expert  in  the  planning  and  conduct  of  the  procedure; 
provision  of  adequate  theoretical  and  practical  training  of  the  involved  staff,  including  the 
radiological  practitioner,  the  medical  physicist  and  the  technical  staff  physically  conducting 
the procedure. All these requirements shall be subject to special attention when children are 
medically exposed, when the radiological techniques is used in a health screening programme 
or the technique used involves high doses to the patient, such as interventional radiology, CT 
or radiotherapy. 

2.3. 

Other important provisions of Medical Exposure Directive (Articles 11, 12 and 
13) 

The  Medical  Exposure  Directive  requires  from  Member  States  to  ensure  that  all  reasonable 
steps to reduce the probability and the magnitude of accidental or unintended doses of patients 
from  radiological  practices  are  taken.  Member  States  shall  also  ensure  that  distribution  of 
individual  dose  estimates  from  medical  exposure  is  determined  for  the  population  and  for 
relevant reference groups of the population as may be deemed necessary. 

Finally,  the  Medical  Exposure  Directive  requires  that  the  provisions  of  the  Directive  are 
enforced through a system of regulatory inspections. 

EN 

8 

   EN 

 
3. 

SUPPLY OF RADIOISOTOPES FOR MEDICAL USE 

3.1. 

Current situation with the supply and use of radioisotopes in nuclear medicine 

3.1.1.  Nuclear medicine 

to 

form 

Nuclear  medicine  is  a  branch  of  medicine  that  uses  radioisotopes  (radionuclides)  for  the 
diagnosis  and  treatment  of  various  diseases,  including  some  of  the  most  important  and 
frequent ones, like cancers and cardiovascular diseases. It uses radioisotopes combined with 
pharmaceuticals 
radiopharmaceuticals,  after 
radiopharmaceuticals.  These 
administration  to  the  patient  by  injection,  inhalation  or  orally,  reach  and  accumulate  in 
specific  organs  or  tissues,  and  can  be  detected  non-invasively  with  high  sensitivity.  This 
unique ability distinguishes nuclear medicine from most other imaging modalities, by being 
primarily a functional and molecular imaging technique, studying and visualising molecular, 
cellular  and  physiological  processes  and  functions,  as  opposed  to  traditional  anatomical 
imaging  such  as  computed  tomography  or  most  of  magnetic  resonance  imaging.  Therefore, 
nuclear  medicine  imaging  procedures  often  identify  abnormalities  early in  the  progress  of  a 
disease – long before many medical problems become apparent with other diagnostic tests. 

There are about 100 different nuclear medicine imaging procedures available today, including 
for the diagnosis of hyperthyroidism, cardiac stress tests to analyse heart function, bone scans 
for  orthopaedic  injuries  or  cancers,  lung  scans  for  embolism,  and  liver,  gall  bladder  and 
kidney  procedures  to  diagnose  their  dysfunctions.  Over  10,000  hospitals  worldwide  use 
radioisotopes  in  medicine  and  a  vast  majority  of  the  procedures  (about  90%)  are  for 
diagnosis17.  

3.1.2.  Molybdenum-99/Technetium-99m in nuclear medicine 

Technetium-99m  (Tc-99m)  is  the  most  widely  used  isotope  in  nuclear  medicine  diagnostic 
applications,  accounting  for  around  90%  of  all  radioisotopes  used,  which  corresponds  to 
around  25-30  million  examinations  yearly  worldwide,  among  which  about  7  million  in 
Europe.  Tc-99m’s  main  use  is  for  cardiac  imaging  and  bone  scans  to  detect  cancer,  where 
early  and  reliable  diagnosis  is  critical.  Europe  is  the  second  largest  consumer  of  Tc-99m, 
accounting  for  22%  of  global  market  (after  the  United  States  –  44%),  followed  by  Japan  - 
14%, and the rest of the world - 20%. Tc-99m demand is rising worldwide due to the ageing 
population  of  Europe  and  North  America,  and  the  growing  use  of  the  isotope  in  emerging 
countries. The predicted annual growth rate in "developed countries" is of about 3%. As for 
the  expectations  regarding  the  replacement  of  imaging  modalities  that  use  Tc-99m,  major 
changes are currently not expected27. 

Tc-99m  is  a  gamma  emitter  with  a  half-life  of  only  6  hours.  Thus  it  allows  for  scanning 
procedures  which  collect  data  rapidly  and  keep  total  patient  radiation  exposures  low. 
However, the short half life presents a problem in terms of a reliable supply chain since Mo-
99/Tc-99m  cannot  be  stockpiled.  To  allow  a  more  practical  arrangement,  the  supply  of  Tc-
99m  is  provided  by  producing  Molybdenum-99  (Mo-99),  which  decays  into  Tc-99m  with  a 
half-life of 66 hours. The parent isotope - Mo-99 is produced in a limited number of nuclear 

17  

Preliminary  Report  on  Supply  of  Radioisotopes  For  Medical  Use  And  Current  Developments  In 
Nuclear Medicine, SANCO/C/3/HW D(2009) Rev. 8, 30 October 2009 

EN 

9 

   EN 

 
                                                 
research reactors by irradiation of uranium targets. Once irradiated, the targets are shipped to 
specialized  processing  facilities  where  the  Mo-99  is  extracted  from  the  irradiated  targets  by 
dissolving  the  targets  and  purifying  the  solution  into  a  pharmaceutical-grade  substance. 
Finally, the processed Mo-99 is shipped for the production of the technetium generators, from 
which  Tc-99m  can  be  eluted.  The  technetium  generators  are  delivered  to  nuclear  medicine 
facilities and hospitals for administration to the patient. Some other production schemes exist, 
but,  as  of  today,  their  yield  is  much  lower  and  the  activity  produced  is  too  small  to  be  of 
importance for the world market. 

3.1.3.  Molybdenum-99 global supply chain 

Only  seven  government-owned  nuclear  research  reactors  provide  about  95%  of  the  world’s 
Mo-99 production: the NRU reactor in Canada, the HFR reactor in The Netherlands, the BR2 
reactor in Belgium, the OSIRIS reactor in France, the SAFARI reactor in South Africa, since 
March  2010  the  MARIA  reactor  in  Poland  and  since  May  2010  the  REZ  reactor  in  Czech 
Republic.  Several  other  smaller  reactors  provide  local  and  regional  supplies  with  no  major 
influence on the global market.  

Almost all the above-listed reactors are over 40 years old and are approaching the end of their 
life span. Because of this they have an increasing need for planned maintenance cycles and a 
growing  frequency  of  unplanned  production  interruptions.  As  a  result,  global  supply  of 
radioisotopes became more fragile in recent years. Ten interruptions have occurred around the 
world since 1997, of which five in the last 3 years. In August 2008, the HFR reactor in The 
Netherlands, one of Europe’s main research reactors producing Mo-99, was shutdown due to 
gas bubbles detected in the main cooling system. It remained shutdown until February 2009. 
In addition, routine maintenance shutdowns of the HFR reactor were undertaken in July and 
September 2009, with another major 6-month shutdown started on 19 February 2010 to repair 
the reactor’s cooling water pipework18. In May 2009, the detection of a heavy water leak at 
the NRU reactor in Canada - also a major global supplier of Mo-99 (together with the NRU 
reactor supplies 65% of the world's Mo-99) - led to an extended shutdown, with the facility 
not expected to be fully operational until July 201019. The European Association of Nuclear 
Medicine  (EANM)  showed  by  means  of  a  survey  amongst  its  members  that  the  supply 
shortage  that  occurred  in  autumn  2008  seriously  affected  fourteen  European  countries 
(Belgium,  Croatia,  Czech  Republic,  France,  Germany,  Greece,  Hungary,  Iceland,  Ireland, 
Lithuania, Netherlands, Slovakia, Switzerland and United Kingdom). 

3.1.4.  Economics of the Mo-99/Tc-99m supply chain 

The supply chain of radioisotopes for medical use is characterized by the interaction of public 
and  private  actors  and  relies  on  global  cooperation  and  partnership  between  a  number  of 
government and private stakeholders. The nuclear research reactors in which radioisotopes are 
produced  are  owned  by  governments  all  over  the  world.  Private  companies  manufacture 
radiopharmaceuticals  and  distribute  them  to  hospitals  and  other  healthcare  providers 
(including  private  practices);  some  of  the  hospitals,  in  which  most  of  the  nuclear  medicine 
procedures  are  carried  out,  are  publicly  owned,  some  are  operated  by  the  private  sector. 
Finally, public social security schemes, which provide reimbursements for a large number of 
nuclear medicine procedures, decide on the amounts they reimburse for such procedures. 

18 
19 

High Flux Reactor powered down and repairs begun - NRG Press Release – 19 February 2010 
AECL provides update on NRU activities - NRU Status Update #57 - 26 May 2010 

EN 

10 

   EN 

 
                                                 
The  government-owned  reactors  where  radioisotopes  are  produced  were  constructed  in  the 
1950s  and  1960s  for  a  variety  of  research  related  purposes  (nuclear  research  and  material 
science). When Mo-99 production from those reactors was developed, it was considered as a 
“sideline” activity, so that reactor operators only required reimbursement of direct short-run 
marginal costs. The historical neglect of the broader direct and indirect costs led to prices for 
target irradiation that were too low to be of interest to industrial and commercial investors, at 
least  at  the  level  of  production  of  raw  Mo-99.  This  created  a  scenario  in  which,  indirectly, 
some  governments  (those  with  medical  radioisotope-producing  reactors)  subsidize  the  Tc-
99m  radiopharmaceuticals  for  their  health  services  or  those  of  other  European  and  non-
European countries. 

In  addition,  historical  prices  have  not  been  also  sufficient  to  support  the  development  of 
significant new investment in Mo-99 processing sector. As a consequence the limited number 
of Mo-99 processing facilities (2 in Europe) increases unreliability in the supply chain.   

A study on the economics of the upstream and downstream Mo-99 and Tc-99m supply chain 
is  part  of  the  work  plan  of  the  OECD/NEA  High-Level  Group  on  Medical  Radioisotopes 
(HLG-MR)  established  in  May  2009.  This  group  currently  comprises  21  experts  from  13 
countries, the European Commission and the International Atomic Energy Agency. The group 
oversees  and  assists,  where  necessary,  efforts  of  the  international  community  to  address  the 
challenges  of  medical  isotope  supply  reliability.  The  study  on  the  economics  is  designed  to 
provide  a  solid  factual  basis  to  develop  recommendations  on  how  the  market  might  be 
structured  and  also  aims  to  propose  a  possible  environment  that  will  attract  sufficient 
investment  in  medical  radioisotope  production  and  associated  infrastructure.  Establishing 
conditions  conducive  to  encouraging  the  necessary  market-based  private  and/or  public 
investment  to  bring  forward  additional,  diversified  sources  of  global  and  regional  supply  is 
considered  essential  to  the  development  of  a  better  functioning  market.  The  study  will  also 
aim to provide a better understanding of the costs of supplying Mo-99 amongst end users in 
order to support a better functioning market.  

3.2. 

Action undertaken by the Union in response to the latest supply crises 

3.2.1.  The EU Health Security Committee 

As  a  result  of  the  2008  supply  shortage,  EU  Health  Ministers,  at  their  meeting  of  8-9 
September  2008,  called  on  the  Commission  to  play  an  active  role  in  the  exchange  of 
information  on  the  situation.  Ministers  called  for  an  emergency  meeting  of  the  EU  Health 
Security Committee to be convened in order for the Committee to exchange information on 
the  situation  and  discuss  possible  actions  which  could  be  taken  to  deal  with  the  lack  of 
medical radioisotopes. The European Commission convened an emergency audio-conference 
of the EU Health Security Committee on 11 September 2008. The item was further discussed 
in audio-conferences of the EU Health Security Committee of 30 September and 28 October 
as well as in a plenary meeting of the Committee of 5-6 November 2008 and 18 June 2009. 
The members of the EU Health Security Committee called on the European Commission to 
play an active part in the coordination of EU-wide actions to respond to the shortage. 

3.2.2.  The  EU  Task  Force  on  Radiopharmaceuticals  set-up  by  the  European  Medicines 

Agency 

The European Medicines Agency (EMA), in order to further elaborate on a strategy to address 
the  supply  shortage  of  radiopharmaceuticals,  has  setup  a  Task  Force  which  is  composed  of 

EN 

11 

   EN 

 
representatives  of  the  European  Commission,  Heads  of  Medicines  Agencies  of  the  EU 
Member States and the EMA. The Agency has produced a report, with status as of 24 October 
2008,  to  the  European  Commission  on  the  Supply  Shortage  of  Radiopharmaceuticals20.  As 
part  of  this  Report,  the  EU  Task  Force  on  Radiopharmaceuticals  set-up  by  the  EMA 
concluded  with  reference  to  longer-term  aspects  that  there  is  a  need  to  further  explore 
possibilities 
this 
recommendation, the Committee for Medicinal Products for Human Use (CHMP) agreed an 
action plan in May 2009 involving the organisation of a workshop with experts in the field of 
the  place  of 
clinical  radiology  and  nuclear  medicine  with  a  view 
radiopharmaceuticals, labelled with radioisotopes produced in reactors, in clinical practice in 
the  EU  in  the  longer  term  and  to  shed  light  on  the  possible  alternatives  that  are  currently 
available and those that may become available in the future.  

the  EU.  Following 

radiopharmaceuticals 

for  alternatives 

to  address 

in 

to 

3.2.3.  The EMA Workshop on Radiopharmaceuticals  

The workshop took place in London on 4-5 February 2010 and confirmed that Tc-99m is the 
most commonly used radionuclide, thus a shortage in its supply can have major consequences 
in several areas where nuclear medicine imaging provides support in diagnosis and follow-up 
of treatment. 

The  experts  participating  at  the  Workshop  concluded  that  Tc-99m  use  is  increasing,  in 
particular  in  neurology  and  cardiology,  and  the  current  use  in  bone  imaging  is  still  high 
although it is expected to decrease as other alternatives become available. Some other nuclear 
medicine  imaging  techniques  which  do  not  involve  Tc-99m  could  be  used  in  the  future, 
including  positron  emission  tomography  (PET21),  although  it  is  noted  that  PET  is  currently 
highly dedicated mostly for oncology and partly for neurology but difficult for cardiology due 
to  patient  load  and  the  lack  of  currently  approved  radiopharmaceuticals  for  myocardial 
perfusion.  Considering  the  restraints  in  availability  of  PET  cameras,  patient  management, 
approved  indications  of  use,  availability  of  PET  radiopharmaceuticals  and  long  time  scales 
from research and development to the clinics, and the cost and trained staff implications of the 
single  photon  (SPECT22)  to  positron  emission  computed  tomography  switch,  other 
alternatives need to be considered at short term in case of Tc-99m shortage. Options include 
but are not limited to thallium (Tl-201) chloride for cardiology or gallium (Ga-67) citrate for 
infections,  but  these  are  associated  with  increased  radiation  dose  and  cost,  and  decreased 
image quality. Reducing the activity of Tc-99m needed per patient, in particular by favouring 
the  use  of  newer  software  or  new  hardware  with  more  sensitive  detectors  (in  development) 
could also be considered. 

For various indications there are currently no identified alternatives to the use of technetium 
without  encompassing  a  risk  on  patient  management.  Tc-99m  seems  to  be  essential  for 
paediatric  scintigraphies,  sentinel  lymph  node  scintigraphy  and  intraoperative  detection  for 

20 

21  

22  

Report to the European Commission on the Supply Shortage of Radiopharmaceuticals (status as of 24 
October 2008), EMEA/51183/2009 
PET  (positron  emission  tomography)  is  a  nuclear  medicine  imaging  technique,  and  as  such  produces 
images  of  functional  and  molecular  processes  in  the  body.  The  system  detects  pairs  of  gamma  rays 
emitted  indirectly  by  a  positron-emitting  radionuclide  administered  to  the  body.  Two-  or  three-
dimensional  images  of  radionuclide  concentration  within  the  body  are  reconstructed  by  computer 
analysis techniques.  
SPECT  (single  photon  emission  computed  tomography)  is,  like  PET,  a  nuclear  medicine  imaging 
technique. But it uses gamma-emitting radionuclides and a gamma camera, like the more conventional 
nuclear medicine planar imaging. However, it is also able to produce three-dimensional information.  

EN 

12 

   EN 

 
                                                 
cancer  treatment,  parathyroid  pre-  and  intra-operative  detection,  lung  scintigraphy,  pre-
surgical localisation  of  epileptogenic  foci  in  pharmaco-resistant  epilepsy,  and  bone  imaging 
for better indication of surgery in osteoid osteoma. 

3.2.4.  The EC Preliminary Report on Supply of Radioisotopes for Medical Use and Current 

Developments in Nuclear Medicine 

Following  deliberations  and  discussions  at  political  and  technical  level  and,  against  the 
background of the fragility in supply of radioisotopes for medical use around the world, the 
European Commission established an ad hoc inter-service group on the issue at the beginning 
of  2009  which  has  since  produced  a  Preliminary  Report  on  Supply  of  Radioisotopes  for 
Medical  Use  and  Current  Developments  in  Nuclear  Medicine23.  The  report  includes,  in 
addition  to  description  of  current  uses  of  radioisotopes,  supply  situation  and  available 
production  capacities,  the  information  about  possible  future  initiatives  regarding  nuclear 
reactor  capacities,  radiopharmaceuticals  and  nuclear  medicine,  both  at  EU  and  international 
level. The conclusions of the report were presented to the EU Health Security Committee in 
June 2009 and noted by the EU Health Ministers in July 2009. 

3.2.5.  The Council Conclusions on the Security of Supply of Radioisotopes 

On  4  November  2009  the  European  Commission  presented  its  Report  to  the  Council  of  the 
European Union. On that basis and noting that it is an appropriate time to react to the Report 
and give guidance for future work in addressing the continuing tight situation in the market 
for  supply  of  radioisotopes,  the  Swedish  Presidency  of  the  Council  prepared  draft  Council 
Conclusions on the Security of Supply of Radioisotopes for Medical Use. Following several 
rounds of examinations, on 2 December 2009 the Atomic Questions Group reached agreement 
on the text, which was finally adopted at the Council meeting held on 15 December 200924. 

3.2.6.  The EC Meeting on the Security of Supply of Medical Radioisotopes in EU Member 

States 

In  the  Council  Conclusions,  the  Commission  was  invited  to  investigate  with  relevant 
stakeholders different possible short-, medium- and long-term solutions to secure the supply 
of radioisotopes for medical use in the European Union, taking account of production facility 
projects in Member States, of technical developments and of predictions of future demand of 
radioisotopes in medical applications.  

In  response  to  this  invitation  of  the  Council,  the  Directorate-General  for  Energy  hosted  a 
Meeting  on  the  Security  of  Supply  of  Medical  Radioisotopes  in  EU  Member  States  in 
Luxembourg  on  4–5  May  2010,  aimed  at  providing  a  forum  to  exchange  information  on 
possible medium-term solutions and on details of the most promising reactor opportunities for 
securing  Mo-99  production  in  the  long  term.  About  50  participants  from  20  Member  States 
attended  the  meeting,  including  the  main  stakeholders  (reactor  operators,  Mo-99  processors 
and Mo-99/Tc-99m generator producers), the representatives from international organizations 
and professional associations (OECD/NEA HLG-MR, AIPES and EANM).  

23 

24 

Preliminary  Report  on  Supply  of  Radioisotopes  For  Medical  Use  And  Current  Developments  In 
Nuclear Medicine, SANCO/C/3/HW D(2009) Rev. 8, 30 October 2009 
Council  Conclusions on  the Security  of  Supply of  Radioisotopes for  Medical  Use, 2986th Agriculture 
and Fisheries Council meeting, Brussels, 15 December 2009 

EN 

13 

   EN 

 
                                                 
•  The  participants  of  the  meeting  agreed  that  use  of  Tc-99m  is  increasing  by  about 
3%/year  in  "developed  countries"  and  that  within  nuclear  medicine  techniques,  Tc-
99m will remain an important isotope. 

• 

It was highlighted that currently only EU can supply its full own Mo-99/Tc-99m needs 
(of  course  when  reactors  are  in  operation),  that  is  why  the  European  production 
network is unique. 

•  They  agreed  that  there  is  no  sufficient  incentive  for  existing  research  reactors  to 
produce  Mo-99  and  for  new  ones  to  be  constructed  with  the  current  economic 
structure of the Mo-99/Tc-99m supply chain. Therefore a study on the economics of 
the  upstream  and  downstream  Mo-99  and  Tc-99m  supply  is  essential  to  identify  a 
financial  model  to  support  the  infrastructure  in  an  economically  sustainable  manner 
and to recognise the global nature of the supply chain. Such study is part of the work 
plan of the NEA Secretariat of the HLG-MR and will be published in the second half 
of 2010. 

•  The  participants  agreed  that  new  multi-purpose  research  reactors  are  the  lowest-risk 
path to new Mo-99/Tc-99m production capacity, as for dedicated isotope facilities the 
ongoing  revenues  from  isotope  sales  would  be  insufficient  to  cover  the  ongoing 
operating expenses.  

•  The  need  for  harmonized  radioisotope  transport  arrangements  and  uranium  target 
design  was  highlighted  together  with  the  need  for  co-operative  work  to  enable  the 
future conversion to LEU targets in an efficient, timely and sustainable way.  

•  A  need  for  increased  efficiency  of  Tc-99m  use  was  addressed  by  the  participants 

(timely delivery and optimization of the use of generators along the week, etc.). 

• 

It  was  agreed  that  alternative  Mo-99  production  technologies  should  be  investigated 
but  this  is  research  and  development  over  a  long  timescale,  if  it  works  at  all,  and 
would  only solve one  or  few isotopes  needs at a time. Indeed, reactors also produce 
many  medical  radioisotopes  other  than  Tc-99m,  in  particular  therapeutic  ones,  even 
though currently needed in lower quantities. 

•  A Position Paper by CEA, NRG, SCK•CEN and TUM25 on a Reference Scenario for 
sustainable Mo-99 production in Europe, presented at the meeting was welcomed by 
the participants. In the position paper, the major European research reactor operators 
who are already producing, or are in a position to produce in the next few years, Mo-
99 on a large scale proposed to work in an alliance to increase the future security of 
supply of medical isotopes by:  

o  further  strengthening  the  existing  European  infrastructure  network  approach 
that is supported by the position of European Research Reactors as described 
in  the  Strategic  Research  Agenda  of  the  Sustainable  Nuclear  Energy 
Technology Platform, 

o  working to a jointly endorsed set of common principles, 

o  ensuring recovery of the investment costs of new and existing infrastructure, 

25 

CEA - French Atomic Energy and Alternative Energies Commission (France)   
NRG - Nuclear Research & Consultancy Group (The Netherlands) 
SCK•CEN - Belgian Nuclear Research Centre (Belgium) 
TUM - University of Technology, Munich (Germany) 

EN 

14 

   EN 

 
                                                 
 
 
o  ensuring  availability  of  “on  call  spare  capacity”  and  charging  for  its 

availability. 

•  As presented at the meeting the Reference Scenario would: 

o  add  a  significant  level  of  additional  Tc-99m  supply  in  Europe  starting  from 

2014, 

o 

increase and strengthen the existing European supply network, 

o  provide appropriate back-up capacity increasing the security of supply, 

o  have sufficient capacity to back-up supply elsewhere in the world. 

•  According  to  this  paper  the  facilities  able  to  produce  Mo-99  at  the  significant  levels 
required for the medium-term European needs must be located in Europe. A possible 
European  irradiation  network  for  Mo-99  production  should  include  the  existing 
facilities still operating in the medium term: 

o  BR2 (Mol, Belgium) an existing Multi-purpose Research Reactor operated by 
SCK•CEN  (maximum  capacity:  >100%  of  European  needs  when  operating. 
Operates 140 days per year; in 2010 the production capacity of BR2 has been 
increased by about 50%, by addition of one irradiation cycle, and by increasing 
the  number  of  devices),  expected  to  leave  service  by  2022  provided  that  the 
new MYRRHA facility is in operation, 

o  HFR  (Petten,  The  Netherlands)  an  existing  Multi-purpose  Research  Reactor 
owned by the European Commission and operated by NRG, expected to leave 
service by 2018 provided PALLAS is in operation (maximum capacity: >100% 
of European needs when operating. Operates 280 days per year), 

o  OSIRIS (Saclay, France) an existing Multi-purpose Research Reactor operated 
by the CEA (maximum capacity: ~ 25 % of European needs when operating. 
Operates 180 days per year), expected to leave service in 2015, 

o  MARIA  (Swierk,  Poland)  an  existing  Multi-purpose  Research  Reactor 
operated  by  POLATOM,  who  has  started  production  in  February  2010 
(maximum capacity: ~ 10 % of European needs when operating). 

And new reactors, subject to appropriate funding being available in due time: 

o  FRM II (Munich, Germany) a new Research Reactor operated by TUM since 
2005, able to irradiate uranium targets from 2014 (maximum capacity: 50% of 
European needs when operating. Operates 240 days per year), 

o  JHR (Cadarache, France) a new Materials Testing Reactor under construction 
to  be  operated  by  CEA,  start  of  operation  foreseen  2015  (present  planned 
capacity: 25% of European needs; could be extended up to 50% of European 
needs when operating. Planned operation 220 days per year), 

o  PALLAS  (Petten  or  Zeeland,  The  Netherlands)  a  proposed  Multi-purpose 
Research Reactor to be operated from 2017 by NRG to replace HFR (estimated 
capacity:  >100%  of  the  European  needs  when  operating.  Planned  operation 
300 days per year), 

o  MYRRHA  (Mol,  Belgium)  a  proposed  Accelerator  Driven  System  (ADS) 
scheduled  to  be  operated  by  SCK•CEN  from  2022  (estimated  capacity: 
equivalent  replacement  of  BR2's  capacity.  Planned  operation  240  days  per 
year). 

EN 

15 

   EN 

 
•  A  minimum  of  200 - 250%  “peak  reactor  capacity”  was  defined  as  necessary  for 
Europe to ensure continuity of production during normal scheduled reactor refuelling 
and maintenance shutdown periods.  

•  Reactor operators agreed that existing European expertise might be used in the longer 
term to build and operate one or perhaps two new Mo-99 processing plant(s) in a more 
southerly location in Europe.  

•  They also agreed that at this moment it doesn't appear critical to consider construction 
of  new  generator  production  facilities,  since  the  3  existing  largest  facilities  should 
remain operational beyond 2015. 

3.3. 

Further  involvement  of  the  Commission  to  address  the  shortage  of  supply  of 
radioisotopes for medical use  

3.3.1.  European research reactors infrastructure  

The  Sustainable  Nuclear  Energy  Technology  Platform  (SNETP)26  promotes  research, 
development  and  demonstration  in  the  area  of  nuclear  systems  and  safety  in  line  with  an 
agreed  vision  and  strategic  research  agenda  (SRA),  consistent  with  Strategic  Energy 
Technology  Plan  (SET-Plan)  goals.  SNETP's  SRA  also  identifies  future  needs  regarding 
research  infrastructures  and  competences,  including  new  large  flexible  irradiation  facilities, 
three of which (JHR in France, PALLAS in the Netherlands and MYRRHA in Belgium) have 
clear potential for radioisotope production in the future. 

3.3.2.  Financing mechanisms to ensure a sustainable supply of radioisotopes 

3.3.2.1.  Euratom loan 

Article  172  of  the  Euratom  Treaty  foresees  the  possibility  that  "loans  for  the  financing  of 
research or investment shall be raised on terms fixed by the Council." 

The Council has created such a facility in 1977, under which investments can be financed in 
Member States relating to industrial production of electricity in nuclear power stations or for 
industrial  nuclear  fuel  cycle  facilities.  Since  1994,  projects  aiming  at  improving  the  safety 
level  of  nuclear  power  stations  can  also  be  financed  in  non-member  States  (currently 
Armenia,  Russia  and  Ukraine).  The  maximum  amount  is  limited  to  20%  of  the  investment. 
Currently, the amount available (of a total of €4 billion) is around €600 million. As Euratom 
loans are given at market conditions, the beneficiary benefits from the AAA credit rating of 
the Community to obtain best possible financing conditions. The loans are supplementary to 
financing arrangements with other parties. 

Since an evaluation will be done soon, the possibility of extending the scope of the loans to 
include  research  reactors  with  envisaged  production  of  radioisotopes  could  be  explored.  An 
extension  of  the  Euratom  loan  could  contribute,  in  the  mid-  and  long-term,  to  guarantee 
sufficient  output,  and  thus  security  of  supply,  of  radioisotopes  for  patients  in  the  European 
Union. Such a modification of the terms would be decided by the Council. 

The provisions for this option are laid down in (Art. 172, 177(5) Euratom Treaty). 

26  

Strategic Research Agenda, SNETP, May 2009, http://www.snetp.eu 

EN 

16 

   EN 

 
                                                 
3.3.2.2.  European Investment Bank loan 

The European Investment Bank (EIB) offers the possibilities of loans and guarantees. In the 
case of a small reactor producing radioisotopes, an individual loan of a maximum of 50% for 
a project of more than € 25 million is possible.  Again, the beneficiary would benefit from the 
AAA credit rating. The loan has to be paid back with interests, while a grace period for capital 
repayment  may  be  granted  during  construction  for  a  reactor.  Hence,  the  production  of 
radioisotopes has to generate a cash flow for the repayment of capital and interests. Technical 
assistance, if needed, could be given in addition to financial support. 

3.3.2.3.  Joint Undertaking 

Joint Undertakings are possible for projects of "fundamental importance to the development of 
the nuclear industry in the Community" (Article 45 Euratom Treaty). If the security of supply 
of radioisotopes for medical use were considered of such fundamental importance, knowledge 
and resources could be bundled in a Joint Undertaking, consisting of 

(cid:131)  Several private undertakings or 

(cid:131)  Several public entities (Member States, Euratom, international organisation) or 

(cid:131)  A public-private partnership. 

Depending on this definition, a Joint Undertaking might also have the function of controlling 
the entire cycle of supply of radioisotopes (i.e. from irradiations of uranium "targets" via the 
extraction of Mo-99 to production and distribution of Tc-99m generators to end users)27 as to 
ensure a better balance between public financing and private benefit.  

3.3.3.  Facilitating transport of medical isotopes 

3.3.3.1.  Simplification of administrative procedures for the trans-border transport of medical 

isotopes  

Improvements on the side of research reactor production alone are not sufficient to assure a 
global supply security of medical radioisotopes. The transport of such radioactive materials is 
also  vital.  2.5  million  packages  containing  radioactive  material  are  estimated  to  be  shipped 
annually  across  the  European  Union,  which  represents  about  2%  of  all  dangerous  goods 
packages.  Most  of  these  packages  (almost  90%)  contain  relatively  small  quantities  of 
radioactive material for medical purposes, including radioisotopes. 

The  currently  existing  comprehensive  and  stringent  transport  regulatory  framework  has 
proven  to  be  effective  in  minimising  the  radiological  impact  for  normal  and  accidental 
conditions  of  transport.  However,  the  national  deviations  and  disparities  in  the  regulatory 
requirements and practices, which often appear to be minor, can have a major impact on trans-
boundary  transport  of  radioactive  material  in  terms  of  the  extra  effort,  time  and 
(technical/financial)  resources  required  by  transport  operators  to  comply  with  the  specific 
national duties and requirements. Consequently, these can represent a major regulatory burden 
for  shippers  and  carriers  involved  in  intra-community  and  international  radioactive  material 

27 

Hence, there would be a parallelism to the function of the Euratom Supply Agency (ESA) as owner and 
potentially  "clearing  house"  of  ores/source  materials/special  fissile  materials  (under  chapter  6  of  the 
Euratom Treaty), which was also considered of fundamental importance for the supply of materials 

EN 

17 

   EN 

 
                                                 
transport  operations.  These  also  increase  the  potential  for  non-compliances  and  shipment 
denials. 

Following  a  three-year  preparation  period  during  which  the  Commission  with  the  help  of 
independent  experts  looked  into  the  Community  legislation  on  the  transport  of  radioactive 
materials,  the  health  and  safety  aspects  related  to  it  and  the  implementation  of  Community 
legislations,  the  Commission  is  currently  examining  the  possibility  of  a  new  Council 
regulation  establishing  a  Community  system  for  registration  of  carriers  of  radioactive 
material,  with  the  intention  to  harmonise  and  simplify  administrative  procedures  while 
ensuring accessibility and transparency of this activity.  

The  new  Council  regulation  does  not  specifically  address  the  transport  of  medical 
radioisotopes but covers it. The main reason for this Regulation is, on one side, to try to ease 
the operation of the carriers by requesting one unique notification/authorisation of carriers for 
their operation on the whole territory of the EU. On the other side, the Regulation will provide 
the Competent Authorities (for the Radiation Protection aspects) with a global and exhaustive 
vision of the transport of radioactive materials on their national territory. 

The new proposal will not solve all issues related to the Transport of Radioactive Materials 
but  will  simplify  it:  carriers  will  be  required  to  register  once  into  an  electronic  notification 
system and there provide the information on the nature of their transport activity in the EU. 
On  this  basis  the  national  Competent  Authority  of  the  carrier  will  deliver,  or  not,  the 
authorisation, valid for a period of five years and for all countries where the carrier declared 
operation. Procedures for the control and monitoring of the respect of rules for transport and 
radiation protection will continue to be applied nationally.  

3.3.3.2.  European Regional network on Denials of Shipment of Radioactive Material  

Delays  and  denials  of  shipments  of  radioactive  material,  even  if  consignments  are  prepared 
fully  in  compliance  with  the  regulations,  have  been  identified  by  the  IAEA  as  a  cause  of 
concern.  They  can  result  in  additional  risk  and  cost,  economic  hardship  and  at  worst 
consumers being denied products which include radioactive material.  

A  Regional  Workshop  on  Denials  of  Shipment  of  Radioactive  Material  for  the  European 
Region was held in Luxembourg from 17-19 June 2009. The Workshop was organised by the 
IAEA in cooperation with the European Commission. 

The purpose of this workshop was to raise awareness of all parties concerned, i.e. suppliers, 
recipients,  regulators,  carriers/consignors  and  international  organizations  of  the  problems 
relating  to  denials  of  shipment  of  radioactive  material  with  a  view  to  determining  effective 
measures  to  prevent  or  reduce  the  instances  of  denials  in  the  countries  of  these  broad 
geographical areas.  

One of the outputs of the event was the establishment of a European regional network with a 
specific  action  plan,  involving  the  parties  concerned,  and  aimed  at  adopting  accepted 
approaches to solving this problem. 

EN 

18 

   EN 

 
4. 

ROLE  AND  ACTIVITIES  OF  INTERNATIONAL  ORGANIZATIONS  IN  THE  FIELD  OF 
MEDICAL APPLICATIONS OF IONIZING RADIATION AND IN THE FIELD OF THE SUPPLY 
OF  MEDICAL  RADIOISOTOPES  -  STATEMENTS  PROVIDED  BY  IAEA,  ICRP,  NEA, 
UNSCEAR AND WHO 

INTERNATIONAL ATOMIC ENERGY AGENCY  
(IAEA) 

Role of IAEA in the medical application of ionizing radiation 

Technology 

As stated in Article II of its Statute the IAEA provides, under the technology pillar, various 
services  to  its  Member  States  (MS)  to  'accelerate  and  enlarge  the  contribution  of  atomic 
energy to peace, health and prosperity throughout the world". In the medical application the 
IAEA provides assistance to MS in radiation medicine and on radioisotope production. 

The  IAEA's  activities  and  services  to  MS  in  radiation  medicine  involve  policy  dialogues, 
evaluation  of  needs  assessment,  technical  advice,  education  and  training,  coordinated 
research  projects,  peer  reviews,  provision  of  equipment,  technical  publications,  databases, 
networking  and  public  information.  Three  main  areas  of  radiation  medicine  in  focus  are: 
nuclear medicine, diagnostic radiology and radiation oncology. 

Nuclear  medicine  imaging  procedures  with  unsealed  radioactive  sources  have  become 
essential in managing the two major groups of non-infectious diseases, cardiovascular disease 
and  cancer  in  IAEA  Member  States.  The  IAEA  helps  establish  new  nuclear  medicine 
facilities,  encourages  their  integration  with  diagnostic  radiology  procedures  and  facilitates 
appropriate human resources capacity building. 

In  diagnostic  radiology,  several  documents  have  been  written  by  the  IAEA  to  support  the 
quality  and  sustainability  of  mammography  services  with  continued  work  also  in  digital 
mammography  and  computerised  tomography.  It  is  also  foreseen  to  provide  advice  and 
expertise  for  the  radiological  diagnosis  of  medical  conditions,  including  cardiovascular 
disease  and  cancer  in  Member  States.  The  emerging  use  of  tele-radiology  in  developing 
Member States is also under active investigation, in collaboration with WHO. 

In  radiation  oncology,  the  IAEA  works  with  a  variety  of  stakeholders,  including  agencies 
within  the  United  Nations,  governments,  hospitals,  and  research  institutes  to  address  the 
shortage  of  cancer  treatment  resources  in  Member  States  as  documented  in  the  IAEA 
directory  of  radiotherapy  centres,  DIRAC.  The  IAEA  also  promotes  research  and  clinical 
applications  of  radiation  in  repairing  tissue  damage.  Many  new  physical,  biological  and 
pharmaceutical tools are tested in IAEA clinical trials, through coordinated research projects, 
before they are introduced as improved standard treatments. 

The Programme of Action for Cancer Therapy has been established to introduce and improve 
access  to  radiation  cancer  treatment  in  low  income  countries  in  cooperation  with  national 
programmes for cancer control and in collaboration with WHO and other NGOs. 

The IAEA supports Member States with technical guidance for implementing and reviewing 
QA programmes at hospitals. The IAEA has published dosimetry protocols, which are widely 
used  worldwide.  Traceable  dosimetry  calibration  services  are  provided  through  the 
IAEA/WHO Network of Secondary Standards Dosimetry Laboratories (SSDLs). Independent 

EN 

19 

   EN 

 
dosimetry  audits  and  comprehensive  clinical  audits  are  offered  by  the  IAEA  to  radiation 
medicine facilities in Member States. In particular, the IAEA/WHO postal dose audit service 
for radiotherapy dosimetry has been in operation for over 40 years and checked radiotherapy 
beam calibrations in hospitals in 120 countries worldwide. Comprehensive clinical audits are 
provided  for  Member  States  through  Quality  Assurance  Team  for  Radiation  Oncology 
(QUATRO),  Quality  Assurance  in  Nuclear  Medicine  (QUANUM)  and  Quality  Assurance 
Audit in Diagnostic Radiology for Improvement and Learning (QUAADRIL). 

Well qualified staff is vital for safe and effective use of radiation in medicine. The IAEA has 
published standardized syllabi for education and training of health professionals working in 
radiation  medicine  and  supports  continuing  education  through  training  courses  and 
workshops. 

In the area of radioisotopes production the IAEA implements coordinated research projects, 
organises topical review meetings, compiles technical documents and updates, and provides 
direct  assistance  to  MS  through  national  and  regional  projects  under  technical  cooperation 
programme; further, it extends cooperation support to relevant international events/meetings 
dealing  with  medical  isotopes  and  radiopharmaceuticals.  The  IAEA  activities  related  to 
medical isotopes and their products can be summarized as follows: 

1.  Capacity  building  and  strengthening  practices  in  production  and  quality  control  of 
radioisotopes  and  radiopharmaceuticals:  Responding  to  MS  requirements,  mainly  through 
topical meetings, technical knowledge dissemination and mostly under TC projects; 
2. Fostering  development  of  products  identified  to  be  suitable  for  wider  production  and/or 
distribution so as to enhance their availability and utilisation: Reactor-produced lutetium-177 
& its products and generator-produced yttrium-90 and its products that can be made in several 
centres; 
3. Facilitating  adoption  of  PET  tracers  and  radionuclide  therapy  in  support  of  cancer 
management:  Coordinate  evaluation  and  deployment  of  products:  (i)  specific  fluorine-18 
tracers (beyond fluorodeoxyglucose, FDG) for efficacious diagnosis; (ii) Lu-177 phosphonate 
for  metastatic  bone  pain  palliation;  (iii)  Y-90  or  Lu-177  peptide  conjugates  for  treating 
neuroendocrine tumours; 
4. Supporting  measures  in  addressing  shortages  of  Mo-99  supplies  and  related  aspects  of 
research  reactor  functions:  i)Identifying  and  encouraging  reactors  with  suitable  features  for 
Mo-99  production  and  facilitating  cooperative  efforts  for  regional  production  and  supplies; 
ii)Assistance to adopting LEU-based production technology for Mo-99 production as well as 
alternate  routes  for  Mo-99  or  Tc-99m  production.  Iii)  Contribution  to  and  cooperation  with 
other 
instituted  High  Level  Group  on  Medical 
international 
Radioisotopes (HLG-MR); 
5. Dissemination of technical know-how, best  practices and guidelines, on medical isotopes 
and  radiopharmaceuticals,  relating  to  infrastructural  facilities  and  operational  processes 
involved; 
6. Education  and  training  of  radiopharmacists  and  technologists;  networking  of  researchers, 
end  users  and  other  stakeholders;  providing  appropriate  forum  and  facilitating  international 
cooperation and sustainable collaboration. 

initiatives,  e.g.  NEA 

Safety 

All IAEA activities under the pillar of safety have the ultimate goal to enhance the safety and 
protection  of  people  and  the  environment.  One  of  the  IAEA's  functions  is  described  in  its 
Statute  as:  "to  establish  or  adopt...  standards  of  safety  for  protection  of  health  and 
minimization of danger to life and property ... and to provide for the application of these ...". 

EN 

20 

   EN 

 
Concerning  the  safe  use  of  ionizing  radiation  the  IAEA  is  undertaking  various  activities 
according to its mandate that can be summarized as follows, and which are essential for the 
global improvement of safety in the medical field: 

1. Building the appropriate safety infrastructure 

It supports Member States in the establishment and strengthening of: 

•  A legal and regulatory framework (laws, regulations and guides, well established, 

independent and competent regulatory body) that sets out clear safety requirements for 
workers, patients and public protection, for control of radioactive sources from their 
production or import to their disposal or export; 

•  A National strategy and a responsible Agency for ensuring the protection of patients 
and  safer  use  of  radiation  in  diagnostic,  interventional  and  therapeutic  medical 
procedures; 

•  A  National  strategy  and  a  responsible  Agency  for  the  management  of  radioactive 

waste; 

•  National  and  international  transport  regulations  (incompatible  regulations  between 

states and transport modes would prevent global trade). 

•  Relevant  technical  services  in  radiation  safety  (dosimetry,  calibration  of  detection 

equipments, education and training). 

2. Capacity building and networking for health professionals 

Direct  capacity  building  for  the  safe  use  of  radiation  in  medical  applications  for  cancer 
diagnosis and treatment in Member States is provided through: 

•  Education  and  training  in  radiation  medical  safety  for  health  professionals  in 
cooperation with WHO, including the development of guidance and training material; 
•  Knowledge  exchange  through  IAEA  web  site  on  radiation  protection  of  patients  for 

health professionals ( http://rpop.iaea.org); 

•  Direct  technical  assistance  to  Member  States,  such  as  training,  missions,  advice  and 

provision of tools, as well as appraisals; 

•  Development  of  educational  safety  reporting  systems  for  prevention  of  unintended 

exposures in radiological procedures and radiotherapy; 

•  Working towards prevention of unnecessary medical exposures by strengthening the 
justification  process  of  individual  medical  exposures  such  as  by  International 
Campaigns to increase awareness. 

The International Action Plan for the Radiation Protection of Patients, established in 2002 
with  a  network  of  international  organizations,  professional  bodies  and  experts  in  its 
Steering Panel, ensures the effective implementation of capacity building measures for the 
safe,  optimized  and  justified  use  of  ionizing  radiation  in  medical  applications.  Capacity 
building is also provided at a broader level, for all stakeholders involved in the safety of 
radiation medicine: 

•  Education and training for radiation protection officers and regulators; 
•  Promotion  and  support  of  all  networking  activities  and  international  cooperation 
(forums  of  regulators,  steering  committee  on  denial  of  shipment,  networks  for 
optimization of workers exposure in medical activities, ...); 

•  Promotion  of  international  relevant  undertakings:  joint  convention  for  proper 
management of radioactive waste and disused sources, code of conduct on the safety 
and security of radioactive sources, to ensure cradle to grave management, including 

EN 

21 

   EN 

 
import/export controls; 

•  Promotion and support of regional and international workshops to alleviate problems 

shipping radioactive material, to set strategies for waste management. 

EN 

22 

   EN 

 
INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION 
(ICRP) 

The Role and Activities of ICRP in the Area of Medical Applications  
of Ionizing Radiation and in the Field of the Supply of Medical Radioisotopes 

As  an  observer  to  the  Inter-Agency  Committee  on  Radiation  Safety  (IACRS),  the 
International  Commission  on  Radiological  Protection  (ICRP)  was  asked  by  the  European 
Commission to describe its role and activities in the area of medical applications of ionizing 
radiation  and  in  the  field  of  the  supply  of  medical  radioisotopes.  As  an  observer,  ICRP 
contributes to and supports the work of IACRS, but does not specifically endorse any reports 
or statements of IACRS. 

ICRP,  established  in  1928  at  the  second  International  Congress  on  Radiology,  is  an 
independent,  international  organization  that  advances  for  the  public  benefit  the  science  of 
radiological  protection,  in  particular  by  providing  recommendations  and  guidance  on  all 
aspects of protection against ionizing radiation. The primary aim of these recommendations is 
to  contribute  to  an  appropriate  level  of  protection  for  people  and  the  environment  without 
unduly limiting the desirable human activities that may be associated with radiation exposure. 

Thus the scope of ICRP’s mandate includes, inter alia, radiological protection issues related 
to medical radioisotopes and more broadly the use of ionizing radiation in medicine, but does 
not include any role related to the supply of medical radioisotopes. 

In  preparing  its  recommendations,  ICRP  considers  the  fundamental  principles  and 
quantitative  bases  upon  which  appropriate  radiological  protection  measures  can  be 
established,  while  leaving  to  the  various  national  protection  bodies  the  responsibility  of 
formulating  the  specific  advice,  codes  of  practice,  or  regulations  that  are  best  suited  to  the 
needs of their individual countries. 

ICRP  offers  its  recommendations  to  regulatory  and  advisory  agencies  and  provides  advice 
intended  to  be  of  help  to  management  and  professional  staff  with  responsibilities  for 
radiological  protection.  Legislation  in  most  countries  adheres  very  closely  to  ICRP 
recommendations. In addition, the International Atomic Energy Agency (IAEA) International 
Basic  Safety  Standards  for  Protection  against  Ionizing  Radiation  and  for  the  Safety  of 
Radiation  Sources  (commonly  referred  to  as  “the  BSS”)  is  based  heavily  on  ICRP 
recommendations,  and  the  International  Labour  Organisation  (ILO)  Convention  115, 
Radiation  Protection  Convention,  General  Observation  1992,  refers  specifically  to  the 
recommendations  of  ICRP.  Thus,  ICRP  recommendations  form  the  basis  of  radiological 
protection standards, guidance, regulations, programmes, and practices worldwide. 

ICRP  is  comprised  of  a  Main  Commission,  a  Scientific  Secretariat,  and  five  standing 
Committees on: Radiation effects, Doses from radiation exposure, Protection in medicine, the 
Application of ICRP recommendations, and Protection of the environment. In addition, ICRP 
uses Task Groups comprised of Committee members and other experts relevant to the subject 
at hand. All told, ICRP membership includes about 100 eminent scientists and policy makers 
in all areas of radiological protection from more than twenty-five countries. 

ICRP Committee 3 on Protection in Medicine currently has 16 members, as well as observers 
from WHO and IEC, and is concerned with protection of persons and unborn children when 
ionizing  radiation  is  used  for  medical  diagnosis,  therapy,  or  biomedical  research,  and  also 
with the assessment of medical consequences of accidental exposures. 

EN 

23 

   EN 

 
In  recent  years  Committee  3  has  produced  a  number  of  relevant  ICRP  publications, 
distributed  through  the  Annals  of  the  ICRP,  including:  Radiation  Protection  in  Medicine; 
Radiation  Dose  to  Patients  from  Radiopharmaceuticals;  Managing  Patient  Dose  in  Multi-
Detector  Computed  Tomography;  Radiation  safety  aspects  of  brachytherapy  for  prostate 
cancer  using  permanently  implanted  sources;  Prevention  of  high-dose-rate  brachytherapy 
accidents; Release of Patients after Therapy with Unsealed Radionuclides; Managing patient 
dose  in  digital  radiology,  Radiation  and  your  patient  –  a  guide  for  medical  practitioners; 
Diagnostic  reference  levels  in  medical  imaging  –  review  and  additional  advice;  Managing 
Patient  Dose  in  Computed  Tomography;  Prevention  of  accidental  exposures  to  patients 
undergoing  radiation  therapy;  Avoidance  of  Radiation  Injuries  from  Medical  Interventional 
Procedures; and, Pregnancy and Medical Radiation. 

In  addition,  Committee  3  has  recently  completed  two  ICRP  publications:  Preventing 
accidental  exposures  from  new  external  beam  radiation  therapy  technologies;  and, 
Radiological  protection  education  and  training  for  medical  diagnostic  and  interventional 
procedures for healthcare staff and students. 

Among the ICRP publications in development or planned for the near future within the area 
of  radiological  protection  in  medicine  are  reports  on:  secondary  cancer  risk  after  modern 
radiotherapy;  practical  recommendations;  dose  to  patients  from  radiopharmaceuticals; 
radiation  protection  for  cardiologists  performing  fluoroscopically  guided  procedures; 
radiation  protection  in  charged  particle  radiotherapy;  protecting  children;  follow  up  of 
persons  accidentally  exposed;  avoiding  adverse  radiation  effects  to  doctors  and  patients  in 
fluoroscopically guided procedures - practical guidelines; widening the use of reference levels 
for  interventional  radiology,  digital  radiology  and  new  technology;  and,  screening  with 
ionizing radiation in asymptomatic individuals. 

ICRP is also developing advice on radiation detriment and effective dose, including the use of 
these quantities in medicine. 

EN 

24 

   EN 

 
ORGANISATION FOR ECONOMIC CO-OPERATION AND 
DEVELOPMENT/NUCLEAR ENERGY AGENCY  
(OECD/NEA) 

High Level Group on the Security of Supply of Medical Radioisotopes 

Background 

The  NEA  has  been  requested  by  member  countries  to  become  involved  in  global  efforts  to 
ensure a reliable supply of Molybdenum-99 (Mo-99) and its decay product, Technetium-99m 
(Tc-99m), the most widely used medical radioisotope. 

Currently five reactors commissioned between 43 and 53 years ago produce 90 to 95% of the 
total global supply of Mo-99. Given the age of these reactors, there are issues related to their 
longevity and reliability, with unexpected shutdowns occurring more often. Most recently the 
Canadian  National  Research  Universal  Reactor  (the  NRU)  was  shutdown  in  May  2009  as  a 
result of a leak in the reactor vessel and only expects to return to service at the end of July 
2010. In addition, the High Flux Reactor in the Netherlands and the OSIRIS reactor in France 
are  scheduled  to  be  down  for  extended  maintenance  periods.  Some  of  these  reactors  are 
expected to reach their end of life in the next six years. 

NEA Involvement 

At  the  request  of  the  Government  of  Canada,  the  NEA  hosted  a  workshop  of  international 
experts  and  stakeholders  in  January  2009  to  identify  the  challenges  faced  in  providing  a 
reliable supply of Tc-99m and Mo-99 and measures that should be taken to ensure this supply. 
Over 90 participants were in attendance, with representatives from governments, universities, 
reactor operators, processors, generator manufacturers and distributors, industry associations, 
the  medical  community,  international  organizations  and  regulators.  There  was  unanimous 
support  for  the  establishment  of  a  working  group  to  carry  forward  the  conclusions  of  the 
workshop and to identify the practical measures that should be taken. 

Formation of the High Level Group on Medical Radioisotopes  

The NEA Steering Committee established the High Level Group on the Security of Supply of 
Medical  Radioisotopes  (HLG-MR)  in  April  2009.  This  group  is  currently  comprised  of  20 
experts  from  11  countries,  the  European  Commission  and  the  International  Atomic  Energy 
Agency,  and  is  being  funded  by  its  members  through  voluntary  contributions.  The  group 
oversees  and  assists,  where  necessary,  efforts  of  the  international  community  to  address  the 
challenges of medical isotope supply reliability. The NEA secretariat supports the group and 
brings its expertise to the issue. 

The main objective of the HLG-MR is to strengthen the reliability of Mo-99/Tc-99m supply 
in  the  short,  medium  and  long  term.  In  order  to  reach  this  objective  the  group  has  been 
reviewing  the  Mo-99  supply  chain,  working  to  identify  the  key  areas  of  vulnerability,  the 
issues  that  need  to  be  addressed  and  the  mechanisms  that  could  be  used  to  address  those 
issues. In the process of its work, the group acknowledges the common goal of converting to 
low enriched uranium {LEU) targets and fuel. 

The HLG-MR is aware that there are a number of other on-going forums related to medical 
isotope  supply  reliability  and  is  ensuring  that  efforts  are  not  duplicated.  Bringing  the 

EN 

25 

   EN 

 
international community together to discuss, share and learn, and applying NEA expertise on 
nuclear  issues  and  economic  studies,  represent  important  contributions  to  the  current  global 
effort. 

Meetings of the HLG-MR 

At  the  first  meeting  on  17-18  June  2009,  the  first  instalment  of  a  rolling  action  plan  was 
agreed  upon.  The  plan  included  undertaking  an  economic  analysis  of  the  supply  chain, 
increasing  useful  and  regular  communications  to  users  about  Mo-99  and  Tc-99m  supply 
availability,  developing  protocols  to  inform  stakeholders  of  unanticipated  events,  and 
coordinating  reactor  schedules.  The  action  plan  also  included  assessing  options  to  increase 
short-, medium- and  long-term  production. These options include demand side  management 
(e.g., promoting efficient patient scheduling, using alternative procedures) and producing Mo-
99 from alternative reactors or technologies. In terms of bringing new supply to market, the 
action  plan  included  work  to  identify  regulatory  issues,  especially  those  related  to  the 
transportation of Mo-99 and Tc-99m, and measures to address these issues 

On  14-15  December  2009,  the  second  meeting  of  the  HLG-MR  occurred  with  invited 
representatives  of  the  nuclear  regulation  community,  the  medical  isotope  industry  and  the 
nuclear medicine community. Participants welcomed the positive actions that have been taken 
to  date,  such  as  the  progress  on  the  economic  study,  the  development  of  communication 
protocols and the coordination and communication of reactor schedules. Participants agreed to 
a  list  of  actions  to  further  improve  the  management  of  the  current  shortage  and  to  work  to 
increasing reliable supply - the second instalment of the rolling action plan. This list included 
developing  and  implementing  communication  protocols;  sharing  guidelines  with  the  global 
health  community  on  the  efficient  use  of  available  supplies  of  Mo-99  and  Tc-99m;  and 
examining opportunities for securing longer-term medical radioisotope supply 

In addition, the HLG-MR will continue its work on examining the economics of the Mo-99 
supply chain, regulatory impacts, transport difficulties and opportunities for securing Mo-99 
production.  The  Group  will  start  work  to  assess  issues  related  to  processing  capacity  and 
future Tc-99m demand. 

Economic Study 

As part of the work plan, the NEA Secretariat is undertaking a study on the economics of the 
upstream  Mo-99  and  Tc-99m  supply  chain,  given  the  possibility  of  a  market  failure  in  the 
supply chain whereby the economic structure does not provide sufficient incentive for current 
reactors to produce Mo-99 or for additional production reactors to be constructed. The study, 
expected to be completed in mid-2010, will develop a solid factual basis of the economics of 
the  supply  chain  with  the  goal  of  providing  recommendations  to  governments  on  how  to 
create a sustainable economic environment that would encourage the  investments needed to 
ensure reliable medical isotope supplies. 

Future Work 

The  work  of  the  HLG  is  being  progressed  through  the  rolling  action  plan.  Two  reports  are 
being  prepared:  the  economic  study  and  a  mid-term  diagnostic  report.  The  latter  will 
summarise the actions of the HLG-MR and Mo-99 stakeholders and will include information 
about  the  Mo-99  situation,  the  issues  affecting  its  reliable  supply,  and  actions  needed  to 
address these issues. 

EN 

26 

   EN 

 
The  HLG-MR  will  hold  its  next  meeting  in  June  2010,  again  inviting  supply  chain 
stakeholders to share their perspectives. The HLG-MR will continue with its efforts to address 
the issues that negatively affect security of Mo-99 supply and will produce a final report in 
mid-2011. 

EN 

27 

   EN 

 
UNITED NATIONS SCIENTIFIC COMMITTEE  
ON THE EFFECTS OF ATOMIC RADIATION  
(UNSCEAR) 

Role 

1. 
The United Nations General Assembly in its resolution 913(X)  of 3 December 1955 
established  a  Scientific  Committee  to  compile  and  evaluate  information  on  the  global  and 
regional levels and trends of exposure to ionizing radiation from all sources (including from 
medical applications and the supply of radioisotopes for nuclear medicine), and on the health 
effects of exposure. 

2. 
The  Committee  therefore  acts  as  the  focal  point  for  systematic  assessments  of  the 
global  and  regional  exposures  to  ionizing  radiation  used  in  medicine28.  It  also  identifies 
emerging issues and future research needs in the field. Its findings are reported to the General 
Assembly;  and  from  time  to  time  the  United  Nations  publishes  the  associated  detailed 
evaluations29,  which  are  used  by  governments,  international  organizations  and  the  scientific 
community  in  supporting  decisions  related  to  the  use  of  radiation  in  medicine.  The 
evaluations  represent  the  formal  scientific  underpinning  for  relevant  international  standards 
and capacity building programmes in the field of radiation protection, including of patients30 
and medical workers31. They also provide independent benchmarks and trends for evaluating 
development programmes, and represent an extensive knowledge base for education purposes. 

3. 
The  principal  objectives  of  the  recent  assessments  of  medical  exposure  have 
essentially  been  to  establish  the  annual  frequency  of  medical  examinations  and  procedures 
involving  the  use  of  radiation,  as  well  as  their  associated  doses.  The  data  for  these 
assessments  are  obtained  by  survey  of  United  Nations  Member  States,  review  of  the  open 
scientific literature, and evaluation of specialized reports of national or regional institutes or 
organizations. 

The  Assembly  designated  21  Member  States  of  the  United  Nations  as  members32  of 
4. 
the  Committee;  their  scientific  representatives  and  delegations  scrutinize  syntheses  of 
information  prepared  by  experts  engaged  by  the  small  Vienna-based  secretariat.  The 
European  Commission  has  frequently  participated  in  the  annual  UNSCEAR  sessions  as  an 
observer. 

Activities 

5. 
The Committee assesses patient exposure using data collected through the UNSCEAR 
Survey  of  Medical  Radiation  Usage  and  Exposures  (a  questionnaire  is  sent  to  each  United 
Nations  Member  State  requesting  information  on  the  frequency  of  various  procedures  and 
associated doses — in the areas of diagnostic/interventional radiology, nuclear medicine, and 
radiotherapy  —  and  numbers  of  associated  staff  and  equipment).  The  Committee  assesses 
occupational  exposure  (including  for  medical  staff  involved  in  diagnostic  radiology,  dental 

28 
29 
30 

31 

32 

Assessments of medical exposures were issued in 1958, 1972, 1977, 1982, 1988, 1993, 2000, and 2008 
Available on http://www.unscear.org 
International  action  plan  for  the  radiological  protection  of  patients,  prepared  by  IAEA  in  consultation 
with WHO, PAHO, and UNSCEAR, GOV/2002/36-GC(46)/12 
Action plan for occupational radiation protection, prepared by IAEA and ILO, GOV/2003/47-GC(47)/7 
Annex 2 
Argentina, Australia, Belgium, Brazil, Canada, China, Egypt, France, Germany, India, Indonesia, Japan, 
Mexico, Peru, Poland, Russian Federation, Slovakia, Sudan, Sweden, United Kingdom, and the United 
States of America 

EN 

28 

   EN 

 
                                                 
radiology,  nuclear  medicine,  radiotherapy,  and  other  medical  uses)  using  data  collected 
through the UNSCEAR Global Survey of Occupational Radiation Exposures. UNSCEAR has 
also  synthesized  information  from  the  literature  on  serious  accidents,  including  those 
involving medical uses of radiation. 

6. 
The  Committee’s  strategic  objective  for  the  period  2009–2013  is  to  increase 
awareness and deepen understanding among decision-makers, the scientific community 
and  civil  society  of  radiation  exposure  and  its  health  and  environmental  effects  as  a 
sound basis for informed decision making on radiation-related issues. 

7. 
Medical  exposure  of  patients  has  been  identified  as  a  key  thematic  priority  for  the 
period. The Committee will continue its surveillance on the dramatic increased global usage, 
both in terms of the numbers of people exposed and the levels of exposure for new medical 
procedures, and identify and communicate emerging issues. The secretariat envisages the next 
assessment to be issued in 2013. 

8. 
Over the intervening period, UNSCEAR is seeking to: (a) streamline the conduct of its 
evaluations  by  establishing  a  standing  expert  group  to  maintain  surveillance  on  emerging 
issues  and  to  regularly  review  new  information;  (b)  enhance  the  mechanisms  for  data 
collection, analysis and dissemination; and (c) raise awareness, and improve communication 
of the findings to decision-makers and the public. 

9. 
With  regard  to  enhancing  data  collection,  UNSCEAR  intends  to  take  account  of 
lessons identified by the EU’s DOSEDATAMED project, specifically to focus its survey on 
the most important medical procedures contributing to population dose. There also appears to 
be  an  opportunity  to  harmonize  the  various  international  mechanisms  and  formats  for 
collecting data on both patient and worker exposures with a view to avoiding duplication and 
improving the quality of the evaluations. UNSCEAR will seek to consult with the EC on these 
matters as appropriate. 

10.  With respect to assessing the risks of radiation exposure, the Committee has regularly 
reviewed  published  clinical,  epidemiological  (including  those  derived  from  follow-up  of 
people medically exposed) and radiobiological information with respect to cancer risks. It has 
also  evaluated:  the  developmental  effects  in  utero  of  pre-natal  irradiation;  risks  for  diseases 
other than cancer; radiation effects on the immune and the nervous systems; the early effects 
of  high  radiation  doses;  the  mechanisms  by  which  radiation  effects  occur,  including  DNA 
repair  and  mutagenesis,  non-targeted  effects  and  adaptive  responses  in  cells  and  organisms; 
the influence of dose and dose rate on risk; and the combined effects of radiation and other 
agents. Currently the Committee is assessing the uncertainty associated with its radiation risk 
estimates. 

EN 

29 

   EN 

 
WORLD HEALTH ORGANIZATION  
(WHO) 

Role and activities of the World Health Organization  
related to medical applications of ionizing radiation 

WHO is the agency within the United Nations system with specific mandate on international 
public health work. A mechanism for internal collaboration between relevant WHO programs 
addressing  radiation  and  human  health  is  in  place  to  coordinate  actions,  promote  synergies 
and avoid duplication of efforts. 

The WHO Department of Public Health and Environment (PHE)33 conducts a Radiation and 
Environmental Health programme34 which comprises a Global Initiative on Radiation Safety 
in  Health  Care  Settings  (GI)  to  mobilize  the  health  sector  towards  safer  use  of  radiation  in 
medicine35.  This  initiative  brings  together  health  authorities,  international  organizations, 
professional  bodies,  scientific  societies  and  academic  institutions  in  concerted  action  to 
improve the implementation of radiation safety standards in healthcare settings. The strategic 
approach adopted includes activities in the areas of risk assessment, risk management and risk 
communication: 

Cooperation with UNSCEAR was strengthened within the GI to improve data collection and 
assist  countries  through  capacity  building  and  technical  support  to  conduct  national  surveys 
on medical exposures. This collaboration with UNSCEAR includes plans towards shaping a 
global  research  agenda  on  health  effects  from  medical  exposures,  considering  a  strategic 
research agenda on radiation risks of medical exposures early in life. 

The  GI  is  currently  focusing  on  justification  of  medical  exposures.  An  international 
consultancy on referral guidelines (RGs) for appropriate use of radiation imaging was held in 
March  2010  gathering  experts  from  23  international,  regional  and  national  professional 
societies  from  all  WHO  regions,  as  well  as  representatives  from  the  EC  and  IAEA36.  An 
international collaboration was established to develop a global set of evidence-based RGs as 
tools  for  justification.  Plans  to  facilitate  the  RGs  implementation,  monitor  their  use  and 
evaluate  the  impact  in  different  clinical  settings  were  proposed37.  The  GI  advocates  for  the 
inclusion of radiation protection  (RP) contents in the curricula of medical and public health 
schools and will promote the use of RGs as education tools for medical students and young 

33 
34 

35  
36 

37 

http://www.who.int/topics/environmental_health/en/ 
http://www.who.int/ionizing_radiation/en/ 
http://www.who.int/ionizing_radiation/about/med_exposure/en/index.html. 
Alliance  for  Radiation  Safety  in  Paediatric  Imaging-  Image  Gently  Campaign,  American  College  of 
Radiologists  (ACR),  Argentine  Society  of  Radiology  (SAR),  African  Society  of  Radiology  (ASR), 
Association of General Practitioners (Geneva), Canadian Association of Radiologists (CAR), Chinese 
Society  of  Radiology  (CSR),  European  Commission  (EC),    European  Society  of  Radiology  (ESR), 
Federal Office for Radiation Protection (BfS, Germany), Hong Kong College of Radiologists (HKCR), 
Inter-American  College  of  Radiologists  (CIR),  International  Atomic  Energy  Agency  (IAEA), 
International  Pediatric  Association  (IPA),  International  Radiology  Quality  Network  (IRQN),  
International  Society  of  Radiology  (ISR),    International  Society  of  Radiographers  and  Radiological 
Technologists (ISRRT), National Centre for Child Health and Development (NCCHD, Japan), Nuclear 
Safety  Authority  (ASN,  France),  Pan  American  Health  Organization  (PAHO),  Royal  and  Australian 
New Zealand College of Radiologists (RANZCR),  Royal College of Radiology (RCR, UK) and World 
Health Organization (WHO) 
More information is available at 
http://www.who.int/ionizing_radiation/about/med_exposure/en/index2.html 

EN 

30 

   EN 

 
                                                 
 
doctors.  A  number  of  activities  are  being  conducted  in  the  field  of  radiation  protection  in 
pediatric health care (e.g. workshops, specialists seminars, training for pediatricians). A tool 
kit  on  radiation  risk  communication  in  paediatric  imaging  is  being  developed,  including 
ethical  considerations  and  guidance  on  informed  consent.  A  workshop  on  radiation  risk 
communication in pediatric imaging will be held in September 2010. 

WHO  is  cooperating  with  EC,  IAEA,  ILO,  IOMP,  IFMBE,  IRPA  and  ISRRT38  in  several 
activities/projects  addressing  staffing  needs,  in  particular  addressing  medical  physicists 
training  and  recognition  and  role  of  radiographers  and  radiation  technologists  in  the 
implementation  of  radiation  protection  (RP)  policies.  A  global  plan  of  action  for  worker's 
health is being implemented by WHO between 2008-2017 to assess and manage occupational 
hazards including ionizing radiation, in cooperation with ILO and IAEA.  

WHO conducts a patient safety programme (PSP) that promotes patient safety reporting and 
learning systems, including taxonomy and development of an International Classification for 
Patient Safety39.WHO established the "Patients for Patients Safety" global network to support 
patient engagement40. The Technical Manual on Radiotherapy Risk Profile41 developed by the 
PSP was presented during the International Conference on Modern Radiotherapy, organized 
by the ASN in cooperation with EC, IAEA and WHO.  

The  use  of  radiation  in  health  care  is  also  addressed  through  the  Global  Action  Against 
Cancer  to  promote  the  basic  components  of  cancer  control:  prevention,  early  detection, 
diagnosis  and  treatment,  and  palliative  care.  WHO  collaborates  with  the  IAEA  in  the 
Programme of Action for Cancer Therapy (PACT)42. Through the International Agency for 
Research  on  Cancer 
(IARC)  WHO  coordinates  and  conducts  experimental  and 
epidemiological research on the causes of cancer, including ionizing radiation.  

WHO  assists  countries  in  establishing  and  optimizing  the  use  of  health  technologies.  The 
Department  of  Essential  Health  Technologies  (EHT)  conducts  a  program  on  Diagnostic 
Imaging  and  Medical  Devices  (DIM)  aimed  at  making  safe  and  reliable  diagnostic  imaging 
services  available  to  as  many  as  possible,  and  providing  advice,  guidance  and  technical 
support for developing and maintaining diagnostic imaging services43.  
The WHO Department of Essential Medicines and Pharmaceutical Policies (EMP)44 through 
its  Quality  Assurance  and  Safety  (QAS)  program  is  involved  in  the  setting  of  standards  for 
essential medicines. These standards address good manufacturing practices (GMP) and good 
distribution practices (GDP) for pharmaceutical products, including radiopharmaceuticals. A 
GMP  text on  radiopharmaceuticals  was  developed  in  collaboration  with  IAEA  and  plans  to 
revise  and  update  this  text  are  considered.  WHO/EMP  has  collaborated  with  the  IAEA 

38 

39 
40 
41 
42 

43 
44  

EC:  European  Commission,  IAEA:  International  Atomic  Energy  Agency,  ILO:  International  Labour 
Organization, IOMP: International Organization of Medical Physics, IFMBE: International Federation 
of Biomedical Engineering, IRPA: International Radiation Protection Association, ISRRT: International 
Society of Radiographers and Radiation Technologists. 
http://www.who.int/patientsafety/implementation/taxonomy/en/. 
http://www.who.int/patientsafety/patients_for_patient/en/. 
http://www.who.int/patientsafety/activities/technical/radiotherapy_risk_profile.pdf. 
 http://www.who.int/topics/cancer/en/  and   
http://www.who.int/mediacentre/news/releases/2009/who_iaea_cancer_programme_20090526/en/ 
http://www.who.int/diagnostic_imaging/en/index.html 
http://www.who.int/medicines/about/en/index.html 

EN 

31 

   EN 

 
                                                 
 
on quality  control testing,  and  the monographs  emanating  from this  collaboration  will  be 
included in a future publication of the International Pharmacopoeia45.  

WHO  engages  in  international  partnership  when  joint  action  in  the  field  of  radiation 
protection is needed. This policy is reflected in its engagement in the current BSS46 revision 
process  as  a  member  of  the  joint  BSS  Secretariat  and  its  participation  in  the  Inter-Agency 
Committee  for  Radiation  Safety  (IACRS).  In  the  field  on  RP  in  medical  exposures  the 
collaboration comprises EC, ICRP47, ILO, IAEA, IRPA48, NEA49 and UNSCEAR.  

45 

46 

47 
48 
49 

More information about distribution is available at:    
http://whqlibdoc.who.int/trs/WHO_TRS_908.pdf#page=36 
http://www.who.int/medicines/areas/quality_safety/quality_assurance/distribution/en/index.html 
http://www.who.int/medicines/publications/pharmacopoeia/overview/en/index.html 
http://www.who.int/medicines/publications/pharmacopoeia/radiopharm/en/index.html 
BSS: International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety 
of Radiation Sources 
ICRP: International Commission on Radiological Protection. 
IRPA: International Radiation Protection Association. 
NEA Committee on Radiation Protection and Public Health (CRPPH), expert group on  Public Health 
Perspective in Radiological Protection (EGPH) 

EN 

32 

   EN