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
Date: 2010-08-06
Institutions: European Commission
Subjects: health control, health legislation, ionising radiation, nuclear medicine, public health, radiation protection

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EUROPEAN COMMISSION 

Brussels, 6.8.2010 
COM(2010) 423 final 

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 

SEC(2010) 974 

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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 

1. 

INTRODUCTION 

Nuclear technology is important for electricity production and for a wide range of research, 
industrial  and  medical  applications.  Nuclear  medicine,  which  is  an  important  part  of  the 
medical applications of ionizing radiation, has developed tremendously over the past decades. 
It provides up-to-date medical diagnosis and treatment of many important diseases, including 
some  of  the  most  serious  and  frequent  ones  like  cancer,  cardiovascular  diseases  and  brain 
diseases.  

The branches of medicine using radiation sources include: 

•  nuclear medicine, where radioisotopes are used for diagnosis and treatment, 

•  radiological imaging, using X-rays for diagnostic, planning or guiding purposes, and 

•  radiotherapy, using radiation sources for cancer treatment. 

As  stated  in  the  Commission’s  2007  Nuclear  Illustrative  Programme1,  medical  uses  of 
ionizing  radiation  are  becoming  increasingly  important,  but  these  new  technologies  also 
administer ever-increasing radiation doses to the patient. This Communication identifies key 
challenges in this area, in particular: 

•  improving radiation protection of patients and staff, 

•  securing supply of radioisotopes for nuclear medicine. 

The Commission addresses this Communication to the European Parliament and the Council 
and  in  order  to  propose  a  long-term  perspective  on  the  medical  application  of  ionizing 
radiation in the Union and to stimulate the discussion on the necessary actions, resources and 
distribution  of  responsibilities  to  address  challenges  in  this  field.  The  Communication 
provides an overview of main challenges and aims at providing visibility of the Community 
actions. 

The  Communication  looks  into  these  actions  from  a  broad  perspective.  Beyond  the  concern 
for  radiation  protection  the  main  perspective  is  that  of  an  efficient  and  sustainable  public 
health  policy.  Within  this  framework  the  medical  profession  as  well  as  the  suppliers  of 
medical  equipment  and  of  radioisotopes  play  a  crucial  role.  For  this  purpose  the 
Communication also covers the legislation and programmes outside the relevant provisions of 
the Euratom Treaty. 

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Communication from the Commission to the Council and the European Parliament "Nuclear Illustrative 
Programme", COM(2007) 565, 4 October 2007 

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2. 

RECENT  DEVELOPMENTS  AND  CHALLENGES  IN  THE  MEDICAL  APPLICATIONS  OF 
IONIZING RADIATION 

The medical use of ionizing radiation encompasses nuclear medicine, in which radioisotopes 
are used for specific diagnostic examinations or for therapy, and radiological X-ray imaging 
for  similar  diagnostic  purposes,  both  including  treatment  planning  or  guidance  (e.g. 
interventional  radiology).  Radiotherapy  is  another  use  which  includes  brachytherapy  and 
external beam radiotherapy. 

Ionizing radiation has been used in medicine for more than a century and has proven to be an 
essential  component  of  modern  medical  diagnosis  and  treatment.  The  technology  has  made 
much progress in the past decades and it is fair to speak of a technological revolution, in X-
ray  imaging  through  (spiral)  computerized  technology,  in  nuclear  medicine  through  the 
introduction of novel radioisotopes and techniques, and in radiotherapy through sophisticated 
computerized treatment planning and precision in the delivery of the radiation to the tumour, 
so as to limit exposure of healthy tissue. 

At the same time ionizing radiation is a cause of concern because the exposure of the body 
may  cause  a  health  detriment.  The  overall  population  exposure  due  to  medical  procedures 
overwhelms any other man-made exposure. All over the world, the number of medical X-ray 
examinations is around 4 billion per year. The protection of the patient, and of medical staff, 
in  medical  practice,  is  therefore  a  priority  task  for  the  Commission  under  the  Health  and 
Safety Chapter of the Euratom Treaty. 

The new medical techniques have considerably enhanced this concern. The benefit in medical 
diagnosis  and  treatment  has  come  with  an  increase  in  the  overall  exposure.  Accidental  or 
unintended exposures have also become more frequent, especially in radiotherapy. The use of 
radioisotopes  on  the  other  hand  faces  a  dramatic  shortage  of  supply,  essentially  due  to  the 
ageing  of  research  reactors  used  for  their  production,  which  has  consequences  on  patients' 
health care.  

2.1. 

Patient-related issues 

Medical  procedures  are  by  far  the  largest  man-made  source  of  radiation  exposure  of  the 
population. Exposure increased further in the past decades by the mass introduction of new 
radiation  techniques  for  diagnosis  and  treatment  of  patients.  At  the  same  time,  part  of  the 
diagnostic  procedures  is  performed  without  clear  medical  need  and/or  with  above-optimal 
radiation  doses.  In  radiotherapy,  but  also  in  interventional  medicine  and  in  Computed 
Tomography  (CT),  accidents  and  mistakes  can  cause  severe  radiation  injuries  to  patients. 
These  issues  are  especially  important  when  it  comes  to  children  or  individuals  exposed  to 
radiation for disease screening purposes. 

Some level of patient radiation exposure is inherent to various medical procedures. When the 
procedure  is  initiated  and  conducted  appropriately  all  medical  benefits  it  provides  outweigh 
the  risk  associated  with  the  radiation  exposure.  However,  without  appropriate  precautions, 
patients  may  be  exposed  to  radiation  without  real  clinical  need  or  benefit.  This  may  result 
from performing a procedure that is not justified given the patient’s individual characteristics, 
history and symptoms, from a radiation dose above the optimal for the examination or from 
accidents. 

There is a significant deficiency in the practical implementation of the system of justification 
of radiological X-ray imaging, the medically unjustified procedures being at least one fifth of 

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all examinations  and up to three fourths for some specific cases2. At the same time there is 
growing use of medical imaging3, while new technology (e.g. Computed Tomography (CT), 
Positron  Emission  Tomography  (PET)  and  hybrid  modalities)  often  involves  higher  patient 
doses in comparison with traditional techniques. 

Children  are  especially  sensitive  to  ionizing  radiation  and  deserve  special  attention.  This 
should  include  robust  justification  of  the  procedure  and  optimization  of  the  exposure  and 
dosimetry protocols to their body size. Special attention shall also be given to the protection 
of  the  unborn  child  in  the  case  of  pregnant  women  and  to  the  exposure  of  children  when  a 
breastfeeding mother is diagnosed or treated with radioisotopes. 

Exposure to high doses of radiation can cause direct injuries (such as burns or hair loss) and 
even  death.  In  Europe,  cases  of  significant  accidental  exposure  of  patients  occurred  in 
radiotherapy, where very high doses are routinely delivered to targeted parts of the patient's 
body.  Radiation-induced  injuries  are  not  uncommon  in  interventional  procedures,  where  the 
patient is often exposed to radiation for long periods of time. Several cases of radiation burns 
have  recently  occurred  (in  the  US  and  Japan)  following  CT  examinations,  during  which 
patients  were  accidentally  exposed  to  much  higher  doses  of  radiation  than  typical  for  such 
procedures. 

In radiotherapy, about one in twenty patients will experience side effects and complications 
following treatment4, even if the procedure has been planned and conducted correctly. This is 
fed  by  differences  in  individual  sensitivity  to  radiation  exposure,  which  are  still  not  fully 
understood. 

New advanced radiotherapy techniques are sometimes broadly commercialised and marketed 
without  sufficient  evidence  of  improved  survival  and  quality  of  life  of  cancer  patients. 
Regulatory  requirements  to  approve  the  use  of  a  new  technique  in  radiotherapy  are  not  as 
developed as those for a new therapeutic drug. Very often the pace of innovation is so high 
that it could be in conflict with the development of quality assurance programmes. 

Similarly, new imaging techniques and equipment are often introduced on the market without 
appropriate justification and regulatory supervision and their use is authorized before specific 
examination  protocols,  quality  assurance  procedures  and  training  of  the  relevant  staff  are  in 
place. This is especially challenging for equipment used outside radiology departments, which 
is the case in various interventional procedures and for the small and portable X-ray devices 
made available to medical doctors, dentists and other medical professionals. 

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These  numbers  are  confirmed  by  a  number  of  studies  from  Europe  and  the  United  States,  one  of  the 
most  recent  being  a  Finish  study  on  "Unjustified  CT  examinations  in  young  patients",  European 
Radiology, May 2009, http://www.springerlink.com/content/5m63p50k6377152v 
According to a March 2009 report by the National Council on Radiation Protection and Measurements 
(NCRP), the U.S. population’s total exposure to ionizing radiation has nearly doubled over the past two 
decades; this is largely attributable to increased exposure from CT, nuclear medicine, and interventional 
X-ray fluoroscopy. A report of the French Institute for Radiation Protection and Nuclear Safety (IRSN, 
April  2010)  shows  that  the  radiation  exposure  of  the  French  population  from  medical  diagnostic 
procedures increased by 57% between 2002 and 2007, largely due to the increased number of CT scans 
and nuclear medicine procedures with, respectively 26 and 38 % 
International  Conference  on  Modern  Radiotherapy  (Versailles,  2-4  December  2009)  -  Synthesis  and 
Main Findings, ASN/DIS, 27 May 2010, http://www.conference-radiotherapy-asn.com 

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The EU Health ministers, in their recommendation on patient safety of June 20095, indicate 
that  patients  should  be  informed  and  empowered  by  involving  them  in  the  patient  safety 
process.  When  ionizing  radiation  is  used  for  medical  diagnosis  or  treatment  patients  should 
receive  adequate  information  on  the  benefits  and  the  limitations  of  the  procedure  and  the 
potential radiation exposure effects, to enable them to take informed decisions. 

2.2. 

Staff-related issues 

Medical staff bears a great deal of responsibility for ensuring radiation safety of patients but 
also  their  own.  Lack  of  knowledge  about  the  radiation  doses  involved  in  the  procedures, 
general underestimation of health risks from ionizing radiation and, in some cases, shortage 
of  staff  not  only  feed  the  patient-related  radiation  protection  issues  but  also  lead  to 
unnecessarily high radiation exposure of some professional groups. 

Various  medical  procedures  expose  medical  personnel  (medical  doctors,  radiographers  and 
radiation  technologists,  nurses,  etc.)  to  ionizing  radiation.  There  are  wide  variations  in  the 
practice and in the corresponding radiation doses among different medical establishments, in 
some cases the medical staff receiving doses around or even above the established dose limits. 
There  are  also  problems  with  the  effective  monitoring  of  the  medical  staff  doses,  partly 
relating to the attitude and the radiation safety culture of the staff. 

The  availability  of  an  appropriate  number  of  adequately  qualified  staff  is  an  important 
element  of  the  system  for  health  protection  in  any  practice  involving  exposure  to  ionizing 
radiation. This is crucial for the deliberate exposure of patients, where the control of the doses 
depends  largely  on  the  personnel  involved  in  the  planning,  conduct  and  follow-up  of  the 
procedure. There is a lack of qualified medical physicists (Medical Physics Expert, as defined 
in Article 2 of Directive 97/43/Euratom), which are in insufficient numbers in some countries 
and whose role is often not sufficiently appreciated. 

The  rapid  development,  growing  complexity  and  easy  availability  of  medical  radiation 
technology poses new challenges on the training of the professionals involved in radiological 
procedures.  Today,  many  medical  specialties  have  access  to,  and  use,  radiological  imaging 
without having enough knowledge of the radiation exposure involved in the procedures and of 
the possible detriment of the exposure on their patients and on themselves. The professionals 
delivering the exposure in general receive at least basic training on radiation protection and on 
the specificity of the procedure but huge differences exist among the different Member States 
on  how,  and  to  what  extend,  this  requirement  in  Directive  97/43/Euratom  is  effectively 
implemented. 

2.3. 

Cross-cutting issues 

2.3.1.  Regulatory control of medical exposures 

Practices  involving  medical  exposure  are  subject  to  regulatory  supervision  by  the  Member 
States' competent authorities in radiation protection. The  regulatory control  should be based 
on  a  system  of  authorization,  inspection  and  enforcement  complemented  by  national 
regulations,  regulatory  guidance  and,  where  appropriate,  involvement  with  other  regulators 
and stakeholders. 

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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 

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Member  States  have  transposed  the  Euratom  radiation  protection  provisions  and  secondary 
legislation  (Euratom  Basic  Safety  Directive6  and  Medical  Exposures  Directive7)  in  their 
national law and have national regulatory authorities in charge of radiation protection of the 
public  and  the  workers.  However,  the  practical  implementation  of  the  requirements  for 
radiation  protection  of  patients,  and  in  some  cases  of  medical  staff,  is  often  weak.  This  is 
caused,  to  some  extent,  by  an  unclear  distribution  of  responsibilities  between  national 
authorities and by the lack of adequately trained regulatory staff. 

2.3.2.  Emerging  evidences  for  radiation  induced  cardiovascular  diseases  and  radiation 

induced cataracts 

Recent scientific findings indicate that there is an increased risk of cardiovascular diseases in 
the  range  of  radiation  doses  typical  for  certain  radiotherapy  and  interventional  procedures, 
which could also  be  reached for patients undergoing repeated radiodiagnostic  examinations. 
There is ongoing research to explain the underlying biological mechanisms and to define the 
most radiosensitive part of the heart. 

Another issue of concern is the scientific evidence from the last few years that the eye lens is 
more  sensitive  to  radiation  exposure  than  previously  thought.  Currently,  the  internationally 
recommended  limits  for  radiation  doses  to  the  lens  are  under  review,  to  be  most  likely 
followed  by  changes  in  the  legally  prescribed  limits.  Meanwhile,  Member  States  may 
consider  reviewing  the  arrangements  for  radiation  protection,  dosimetry  and  medical 
surveillance of staff exposed to high eye doses. 

2.4. 

Supply and use of radioisotopes in nuclear medicine 

Radioisotopes  are  used  in  medicine  for  the  diagnosis  and  treatment  of  various  diseases, 
including  some  of  the  most  important  ones,  like  cancers,  cardiovascular  and  brain  diseases. 
Over  10000  hospitals  worldwide  use  radioisotopes  for  the  in  vivo  diagnosis  or  treatment  of 
about  35  million  patients  every  year,  of  which  9  million  in  Europe.  The  majority  of  the 
nuclear  medicine  procedures  today  are  for  diagnosis,  with  about  100  different  nuclear 
medicine  imaging  procedures  available.  Imaging  using  radioisotopes  is  often  indispensable, 
for  instance  due  to  its  ability  to  identify  various  disease  processes  early,  long  before  other 
diagnostic tests. Technetium-99m (Tc-99m) is the most widely used (diagnostic) isotope. 

Europe  is  the  second  largest  consumer  of  Tc-99m,  accounting  for  more  than  20%  of  the 
global market. Tc-99m  demand  is  rising  worldwide, mostly due to the ageing population of 
Europe and North America, and its growing use in emerging countries8. 

The production of Tc-99m is a complex process which includes irradiation of uranium targets 
in nuclear research reactors to produce Molybdenum-99 (Mo-99), extraction of Mo-99 from 
targets in specialised processing facilities, production of Tc-99m generators and shipment to 
hospitals. Due to their short decay times, Mo-99 and Tc-99m cannot be stockpiled and must 

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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 
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 

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be produced continuously and delivered to hospitals weekly. Any supply disruption can lead 
to  a  situation  where  crucial  diagnostic  imaging  tests  must  be  cancelled  or  postponed  with 
negative and sometimes life-threatening consequences for patients. 

Unfortunately,  the  current  Tc-99m  supply  relies  on  an  unsustainably  low  number  of 
production  reactors.  Worldwide,  only  seven  government-owned  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. The five reactors in Europe provide around 60% of the 
production.  

All those reactors were constructed 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  costs  led  to  prices  for 
target irradiation that were and still are too low to be of interest to industrial and commercial 
investors,  at  least  at  the  level  of  production  of  raw  Mo-99.  Therefore  the  present  economic 
structure does not provide sufficient incentive for current reactors to produce Mo-99 and for 
new ones to be constructed. 

As those reactors were constructed in the 1950s and 1960s, they are approaching the end of 
their  lifespan,  which  causes  an  increasing  need  for  planned  maintenance  shutdowns  and  a 
growing  frequency  of  unplanned  production  interruptions.  As  a  result,  the  global  supply  of 
radioisotopes  has  become  more  fragile,  particularly  in  recent  years.  Ten  interruptions  have 
occurred around the world since 1997, of which five in the last 3 years. 

The European Union already undertook several initiatives to respond to the critical situation 
regarding  the  supply  of  radioisotopes  for  medicine  in  2008-2010.  The  issue  has  been 
discussed  by  the  EU  Health  Security  Committee  and  by  the  Council,  who  came  with 
conclusions9 calling for further actions by the Commission and Member States. The European 
Medicines  Agency  and  the  Commission  took  several  initiatives  to  identify  possible  short-, 
medium-  and  long-term  solutions  to  the  current  situation,  including  the  organization  of  a 
Workshop  on  Current  Use  and  Future  Needs  of  Radiopharmaceuticals  Labelled  with 
Radionuclides Produced in Reactors and Possible Alternatives (February 2010) and a Meeting 
on the Security of Supply of Medical Radioisotopes in EU Member States (May 2010). 

The  Commission  co-operates  with  international  organizations  and  stakeholders  under  the 
High-Level Group on Medical Radioisotopes (HLG-MR) created by the OECD/NEA, aimed 
at  overseeing  and  assisting,  where  necessary,  efforts  of  the  international  community  to 
address the challenges of medical radioisotopes supply reliability.  

3. 

WAY FORWARD 

In  response  to  the  above  challenges  and  taking  into  account  the  existing  instruments  under 
Euratom and EC provisions, the Commission proposes the following actions: 

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Council  Conclusions on  the Security  of  Supply of  Radioisotopes for  Medical  Use, 2986th Agriculture 
and Fisheries Council Meeting, Brussels, 15 December 2009 

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3.1. 

Strengthen the existing regulatory framework 

The  Basic  Safety  Standards  Directive  is  currently  being  recast  with  four  other  radiation 
protection  Directives,  including  the  Medical  Exposure  Directive.  The  recast  of  Euratom 
radiation protection legislation will allow to better integrate the protection of patients with the 
protection  of  medical  staff  and  the  management  of  effluents  and  radioactive  waste  from 
nuclear  medicine;  it  is  also  an  opportunity  for  better  distinguishing  medical  exposures  from 
the  deliberate  exposure  of  individuals  for  other  purposes,  e.g.  security  screening.  While  the 
spirit  of  recast  calls  for  few  amendments  to  the  Directives,  it  will  strengthen  some 
requirements  so  as  to  meet  the  concerns  highlighted  in  this  Communication,  for  instance  to 
enhance the safety culture in the medical area and prevent accidental or unintended exposures. 

There  is  a  need  to  enhance  the  regulatory  supervision  of  medical  applications  of  ionizing 
radiation  to  ensure  that  the  legal  requirements  are  respected.  A  clear  delineation  of 
responsibilities is needed and independence of the regulatory authority for radiation protection 
from other responsibilities in the public health sector, as well as its competence and resources, 
must be ensured. Increased networking between national regulators will be promoted for the 
consensual development of common practical tools, complementary to the legal initiatives of 
the Commission. 

Strengthening the implementation of the requirements of the Directive is not only a matter of 
legal  enforcement  but  even  more  so  of  motivating  the  stakeholders  and  of  providing  tools 
facilitating practical implementation. The Commission will further undertake studies to assess 
the effectiveness of the requirements, launch projects and seek advice from the Art. 31 Group 
of Experts to provide guidance endorsed by the medical profession. 

Good radiation protection in medical applications as well as enhanced safety culture depend 
on  the  availability  of  technical  expertise,  for  instance  to  ensure  proper  dosimetry  in 
radiotherapy.  The  role  of  the  Medical  Physics  Expert  will  therefore  be  strengthened  in  the 
recast  Euratom  legislation  and  greater  mobility  of  such  experts  will  be  fostered  through 
harmonisation of the requirements for the recognition of their expertise. 

The Commission will continue to monitor the trends in medical exposures and develop better 
instruments for the collection of data. Such information will allow focusing efforts on specific 
aspects  and  developments.  The  Commission  will  associate  national  regulatory  authorities  in 
these efforts. 

3.2. 

Raise awareness and safety culture 

Promoting radiation protection in medical applications is a challenge in an environment where 
the  perspective  on  life  and  health  is  very  different  from  other  practices.  The  medical 
profession must receive adequate training as part of its curriculum and receive regular updates 
on good practice, but above all has to be made sensitive to its responsibility in ensuring both 
good medical care and adequate radiation protection. 

National  health  policies  should  recognise  the  possible  risks  of  a  proliferation  of  new 
technology and make arrangements to ensure the justification of all medical exposures. This 
policy will be pursued jointly by the Commission services in charge of health policy and those 
in charge of radiation protection. 

Awareness also needs to be raised among patients and among the general population, so that 
an  adequate  dialogue  between  patients  and  the  referring  practitioner  leads  to  justified 

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radiological  examinations.  Radiological  examination  of  a  patient  without  an  appropriate 
referral from a medical professional is in principle excluded. The awareness of parents with 
regard  to  high  exposures  of  children  (e.g.  through  CT)  is  crucial.  The  Commission  will 
prepare information and publicity campaigns to this effect in cooperation with national health 
authorities. 

3.3. 

Fostering  radiation protection and sustainable supply and  use of radioisotopes 
in medicine through research 

Further research can lead to improved protection of patients and medical staff as well as to the 
development of a more sustainable supply and use of radioisotopes in medicine. In line with 
current practice, and the strategic approach being developed within MELODI10, future actions 
within  the  Euratom  Framework  Programme  will  concentrate  on  better  understanding  the 
health  risks  from  exposure  to  low  doses  of  ionizing  radiation,  including  the  individual 
sensitivity to radiation exposure, thereby leading to optimised health protection and, possibly, 
changes in regulation. The more general health theme under the EU Framework Programme 
should integrate appropriate protection of patients and staff with consideration of the further 
development  of  medical  radiation  technology  and  the  more  efficient  use  of  the  available 
isotopes.  The  development  of  harmonised  uranium  targets  (including  the  transition  to  low-
enriched targets) and transport containers will require the close collaboration of the medical 
radioisotope production sector. 

The  Sustainable  Nuclear  Energy  Technology  Platform  (SNETP)11  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. 

3.4. 

Integration of policies 

Medical  applications  of  ionizing  radiation  call  for  good  integration  of  different  policies,  on 
public  health,  research,  trade  and  industry  as  well  as  radiation  protection.  With  regard  to 
nuclear  medicine  further  integration  with  nuclear  safety,  waste  management,  transport  and 
research is required. 

The  success  of  efforts  towards  improving  the  situation  rests  to  a  large  extent  on  the 
manufacturers  of  medical  devices  and  of  radiopharmaceuticals.  Since  the  marketing  of 
medical devices is subject to EC legislation, a standing platform for looking into the radiation 
protection features of such devices needs to be set up. Research on novel medical technology 
shall  bear  in  mind  not  only  medical  justification  but  also  its  impact  on  the  population 
exposure. 

It  will  be  important  to  ensure  that  the  planning  of  X-ray  health  screening  programmes  at 
national  or  European  level  take  into  account  the  risks  from  mass  exposure  of  healthy 
individuals to ionizing radiation. The screening should therefore focus on target groups of the 
population for which the benefit is demonstrated to outweigh the radiation-related risk.  

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Multidisciplinary European Low-Dose Initiative, http://www.melodi-online.eu 
Strategic Research Agenda, SNETP, May 2009, http://www.snetp.eu 

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Patient  and  staff  protection  should  be  managed  in  an  integrated  way,  in  particular  in 
interventional imaging, nuclear medicine and CT.  

3.5. 

International cooperation 

The  issues  in  Europe  are  very  much  the  same  as  in  other  parts  of  the  world.  While  the 
"Western" world shares the feature of over-consumption and resulting increase of exposures, 
the problems of developing countries are not so much the proliferation of equipment but the 
unbalance  between  old-fashioned  equipment  and  novel 
the 
infrastructure  and  training  are  lacking.  The  WHO  and  regional  organisations  (PAHO12)  are 
very active in developing policies in this area, and IAEA has built up important programmes 
and information tools. All these efforts must be coordinated and the Commission will support 
all initiatives in this direction.  

technology  for  which 

The  shortage  of  isotopes  is  a  world-wide  problem.  Therefore  the  Commission  continues  to 
participate actively in the work of the OECD/NEA for a global approach of the issue. Within 
the  EU,  the  Commission  will  further  built  up  a  network  of  information  and  serve  as  an 
observatory. 

3.6. 

Financing mechanisms to ensure sustainable supply of radioisotopes 

The possibility of financing mechanisms to ensure a sustainable supply of radioisotopes in the 
interest  of  public  health  and  an  equitable  share  of  public  expenditure  by  all  Member  States 
will  be  explored  together  with  the  Council  and  European  Parliament,  and  the  Commission 
will ensure appropriate follow-up to the Council Conclusions on this matter. The needs will 
be established on the basis of the conducted technical and economic studies and of a reference 
scenario for the replacement of ageing reactors. 

For  this  purpose  the  Commission  could  envisage  two  mechanisms.  Euratom  loans  (Article 
172 of the Euratom Treaty) to support isotope production projects may provide an incentive 
for  appropriate  investment  in  research  reactors  and/or  in  production  facilities.  European 
Investment Bank loans and guarantees may also serve this purpose.  

In  addition,  it  could  be  examined  whether  a  Joint  Undertaking  (Article  45  Euratom  Treaty) 
may  be  useful  in  achieving  not  only  a  regular  and  sustainable  supply,  but  also  in  gaining 
control  of  the  entire  cycle,  from  irradiations  of  uranium  "targets"  to  distribution  of  Tc-99m 
generators to end users, so as to ensure a better balance between public financing and private 
benefit. This instrument will require a thorough preliminary analysis of all organisational and 
financial aspects.  

3.7. 

Facilitating transport of radioisotopes 

The  Commission  will  soon  make  a  proposal  for  the  simplification  of  administrative 
procedures  for  the  trans-border  transport  of  radioactive  materials,  which  might  facilitate 
transport of radioisotopes for medical use. 

12 

Pan American Health Organization, http://new.paho.org 

EN 

10 

   EN