EN    EN EN 
 
EN    EN  EUROPEAN COMMISSION 
Brussels, 6.8.2010 
SEC(2010) 974 
  
COMMISSION STAFF WORKING DOCUMENT 
Accompanying document  
  
COMMUNICATION FROM THE CO MMISSION 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 2   EN PART 1 M AIN EU INSTRUMENTS RELEVANT TO THE MEDICAL APPLICATIONS OF 
IONIZING RADIATION  
 
PART 2  M AIN PROVISIONS OF THE EXISTING REGULATORY FRAMEWORK FOR 
MEDICAL EXPOSURES (DIRECTIVE 97/43/E URATOM ) 
 
PART 3 S UPPLY OF RADIOISOTOPES FOR MEDICAL USE  
 
PART 4 R OLE 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 3   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: 
 Justification
 of all new types of practices resulti ng in exposure to ionizing radiation 
before being first adopted by their economic, so cial or other benefits  in relation to the 
health detriment they may cause. 
 Optimisation  of protection to ensure that the ra diation exposures of workers, members 
of the public and the populati on as a whole are kept as lo w as reasonably achievable, 
economic and social factors being taken into account. 
 Limitation  of the exposure to ensure that the sum of the radiation doses from all 
relevant practices will not exceed the lega l 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 establ ishes 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 le gal requirements to be established in Member 
States. 
The Medical Exposure Directive2 supplements the Basic Safe ty Standards Directive by 
providing specific requirements for health prot ection of patients and other medically exposed 
individuals against the dangers  from ionizing radiation. Th e Medical Exposure Directive 
provides a legal framework based on the basic radiation protecti on principles of justification 
and optimization taking into account the specific ity of medical exposure as deliberate 
exposure of people for their own health benefit. 
The Basic Safety Standards Directive is curr ently being recast with four other radiation 
protection Directives, including th e 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  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 
2  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 4   EN The Directorate-General for Energy maintain s a Radiation Protection publications series3, 
which is a useful source of information a nd guidelines on specific aspects of radiation 
protection, including on medical exposure. The Commission publis hed 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 f unding 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 techniques
4. Better 
understanding of the effects of and associated risks from dose s 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, thr ough 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 studi es 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 radiati on in medicine. In 2010 
the Commission launched the European Medical ALARA Network (EMAN)7 as a 
stakeholders' network dealing with radiation protection of patients an d medical staff. The 
Commission organizes or co-sponsors ad-hoc meeti ngs 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 prot ection of patients the Commissi on is advised by the Working 
Party on Medical Exposure of th e Group of Experts created unde r 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 re view the research imp lications on the health 
and safety standards. 
1.2. Instruments under EC provisions 
1.2.1.  Legislative tools 
Equipment used in the medical exposure procedur es falls under the requirements of Council 
Directive 93/42/EEC, ame nded by Directive 2007/47/EC11. The Directive's main purpose is to 
                                                 
3  http://ec.europa.eu/energy/nuclear/r adiation_protection/publications_en.htm  
4  http://cordis.europa.eu/fp7/euratom 
5  http://www.hleg.de  
6  http://itu.jrc.ec.europa.eu 
7  http://www.eman-network.eu 
8  http://ec.europa.eu/energy/nuclear/events/index_en.htm 
9  http://ec.europa.eu/energy/nuclear/r adiation_protection/article_31_en.htm  
10  http://ec.europa.eu/energy/nuclear/radia tion_protection/scientific_seminar_en.htm  
11  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 5   EN ensure that medical devices placed on the Euro pean market do not compromise the safety and 
health of patients, users and other individual s. 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 justificati on of the intended use of the equipment 
on the basis of risk/benefit weighting (Artic le 11.2.1) and for incorporation of technical 
features for radiation protection of patients, users and ot her 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 (A rticle 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 lega l 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 be st practices and maintain adverse events 
reporting and learning systems allo wing them to develop efficient solutions and interventions. 
Information and communication technology tools, such as electronic he alth records or e-
prescriptions, can contribute to  achieving these objectives. 
As far as Directive 2004/40/EC on the protec tion 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 Resonan ce Imaging (MRI) in medicine and research. 
This could result in increased use of diagnostic pro cedures using ionizing radiation, with an 
unintended adverse effect on the he alth 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 th e competitiveness and innovative capacity of 
European health-related industr ies and businesses, while addr essing 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 develo pment 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, su ch 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  Issued by the European standards bodies in this area, CEN or CENELEC. Latest list of harmonized 
standards – OJ C 293, 2 December 2009 
13  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 
14  by Directive 2008/46/EC amending Directive 2004/40/EC on minimum health and safety requirements 
regarding the exposure of workers to the risks aris ing from physical agents (electromagnetic fields)  
15  http://cordis.europa.eu/fp7/health/home_en.html  
16  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 6   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 chal lenges, to identify current dynamics of the 
medical devices sector and to hi ghlight key topics of interest  at the European level. The 
initiative provided patients, consumers, healthca re professionals, insure rs 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 innovati on for the benefit of 
patients, healthcare professionals , industry and society, and in pa rticular 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, health care professionals and users to better adapt 
research and innovation to the societal needs. The appropriate follow-up is being considered. 
 
EN 7   EN 2. MAIN PROVISIONS OF THE EXISTING REGULATORY FRAMEWORK FOR MEDICAL 
EXPOSURES (DIRECTIVE 97/43/E URATOM ) 
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 a ccount the available alternative techniques 
involving no or less exposure to ionizing radi ation. The justificati on 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 evid ence about their efficacy or consequences is 
acquired; and all individual pr ocedures shall be justified in  advance taking into account the 
specific objectives of the exposure and th e characteristics of th e individual patient. 
The Medical Exposure Directive does not give  much specificity on how the general 
justification of medical exposur e practices shall be done. Yet, there are several relevant 
requirements specifying that: the Member States shall take appropriate steps to avoid unnecessary proliferatio n of radiological equipment; fluor oscopy 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 radi ation produced during the procedure. 
On the other hand, the Directiv e specifies several practical requirements aiming at avoiding 
unnecessary individual e xposures including that: 
 The prescriber and the radiological pract itioner shall be involved as specified by 
Member States in the justification process at the appropriate level and, in particular, they shall seek previous diagnostic informa tion or medical records and consider them 
to avoid unnecessary exposure. 
 The Member States shall ensure that reco mmendations concerning referral criteria for 
medical exposure, including radiation doses, ar e available to the pr escribers of medical 
exposure. 
 Any medical exposure shall be effected under the clinical responsibility of a 
practitioner, the "clinical re sponsibility" including justif ication of the procedure. 
 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 ra diation doses from medi cal procedures shall 
be kept as low as reasonably achievable cons istent with obtaining the required diagnostic 
information or therapeutic outcome, taking in to 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 optimiza tion of the medical radiation 
procedures by: establishment and use of diagnostic reference levels; establishment of written 
 
EN 8   EN protocols for every type of standard radiol ogical practice for each piece of equipment; 
equipment being subject to appr opriate radiation protection surv eillance, quality assurance, 
acceptance and in-service testing and dose-meas uring 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 involve d staff, including the 
radiological practitioner, the me dical physicist and the technical  staff physically conducting 
the procedure. All these requireme nts shall be subject to special  attention when children are 
medically exposed, when the radiological techni ques is used in a heal th screening programme 
or the technique used involves high doses to th e patient, such as interventional radiology, CT 
or radiotherapy. 
2.3. Other important provisions of Medical Exposure Direc tive (Articles 11, 12 and 
13) 
The Medical Exposure Directive re quires 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 St ates shall also ensure that distribution of 
individual dose estimates from medical expos ure is determined fo r the population and for 
relevant reference groups of the population as may be deemed necessary. 
Finally, the Medical Exposure Directive require s that the provisions of the Directive are 
enforced through a system of regulatory inspections. 
 
EN 9   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 
Nuclear medicine is a branch of medicine th at uses radioisotopes (radionuclides) for the 
diagnosis and treatment of various diseases , including some of th e most important and 
frequent ones, like cancers and cardiovascular di seases. It uses radioisotopes combined with 
pharmaceuticals to form radiopharmaceutical s. These radiopharmaceuticals, after 
administration to the patient by injection, inhalation or orally, reach and accumulate in specific organs or tissues, and can be detect ed non-invasively with high sensitivity. This 
unique ability distinguishes nuclear medicine from most other imaging modalities, by being 
primarily a functional and molecular imaging t echnique, studying and visualising molecular, 
cellular and physiological processes and functi ons, as opposed to tr aditional anatomical 
imaging such as computed tomography or most  of magnetic resonance imaging. Therefore, 
nuclear medicine imaging procedures often id entify abnormalities early in the progress of a 
disease – long before many medical problems beco me apparent with other diagnostic tests. 
There are about 100 different nuclear medicine imaging procedures ava ilable today, including 
for the diagnosis of hyperthyroidism, cardiac st ress tests to analyse heart function, bone scans 
for orthopaedic injuries or cancers, lung sc ans for embolism, and liver, gall bladder and 
kidney procedures to diagnose their dysf unctions. Over 10,000 hospitals worldwide use 
radioisotopes in medicine and a vast majo rity of the procedur es (about 90%) are for 
diagnosis
17.  
3.1.2.  Molybdenum-99/Technetium-99m in nuclear medicine 
Technetium-99m (Tc-99m) is the most widely us ed isotope in nuclear medicine diagnostic 
applications, accounting for around 90% of al l 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 imag ing 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 th e 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 th e isotope in emerging 
countries. The predicted annual gr owth rate in "developed count ries" is of about 3%. As for 
the expectations regarding the replacement of  imaging modalities th at use Tc-99m, major 
changes are currently not expected
27. 
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 k eep total patient radiation exposures low. 
However, the short half life pres ents a problem in terms of a reliable supply chain since Mo-
99/Tc-99m cannot be stockpiled. To allow a mo re 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 10   EN research reactors by irradiation of uranium targets. Once irradiat ed, 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 solu tion 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 ge nerators are delivered to nuclear medicine 
facilities and hospitals for administration to th e patient. Some other production schemes exist, 
but, as of today, their yield is much lower an d 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 an d 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 increas ing need for planned maintenance cycles and a 
growing frequency of unplanne d production interruptions. As a result, global supply of 
radioisotopes became more fragile in recent year s. 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 syst em. 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 s hutdown started on 19 February 2010 to repair 
the reactor’s cooling water pipework
18. In May 2009, the detection of a heavy water leak at 
the NRU reactor in Canada - also a major gl obal supplier of Mo-99 (together with the NRU 
reactor supplies 65% of the world's Mo-99) - le d to an extended shutdo wn, with the facility 
not expected to be fully operational until July 201019. The European Association of Nuclear 
Medicine (EANM) showed by means of a su rvey 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 us e is characterized by th e interaction of public 
and private actors and relies on global cooperation and partne rship between a number of 
government and private stakeholde rs. The nuclear research reacto rs 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 hosp itals, in which most of  the nuclear medicine 
procedures are carried out, ar e publicly owned, some are operated by the private sector. 
Finally, public social security schemes, whic h provide reimbursements for a large number of 
nuclear medicine procedures, decide on the am ounts they reimburse for such procedures. 
                                                 
18 High Flux Reactor powered down and repairs begun - NRG Press Release – 19 February 2010 
19 AECL provides update on NRU activities - NRU Status Update #57 - 26 May 2010 
 
EN 11   EN The government-owned reactors where radioiso topes are produced were constructed in the 
1950s and 1960s for a variety of re search related purposes (nuc lear research and material 
science). When Mo-99 production from those react ors was developed, it was considered as a 
“sideline” activity, so that reactor operators on ly required reimbursement  of direct short-run 
marginal costs. The historical ne glect of the broader direct and i ndirect costs led to prices for 
target irradiation that were too low to be of interest  to industrial and comme rcial investors, at 
least at the level of production of raw Mo-99. This create d a scenario in which, indirectly, 
some governments (those with medical radioi sotope-producing reactors) subsidize the Tc-
99m radiopharmaceuticals for their health serv ices or those of other European and non-
European countries. 
In addition, historical prices have not been also suffici ent to support the development of 
significant new investment in Mo -99 processing sector. As a c onsequence the limited number 
of Mo-99 processing facilitie s (2 in Europe) increases unreliability in the supply chain.   
A study on the economics of the upstream and dow nstream Mo-99 and Tc-99m supply chain 
is part of the work plan of the OECD/N EA High-Level Group on Medical Radioisotopes 
(HLG-MR) established in May 2009. This gr oup currently comprises 21 experts from 13 
countries, the European Commission and the In ternational 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 possi ble environment that will attract sufficient 
investment in medical radioi sotope production and associated  infrastructure. Establishing 
conditions conducive to encouraging the nece ssary market-based private and/or public 
investment to bring forward additional, divers ified 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 unders tanding of the costs of suppl ying Mo-99 amongst end users in 
order to support a bette r 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 Minister s, 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 fo r an emergency meeting of the EU Health 
Security Committee to be conve ned 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 Commi ssion convened an emergency audio-conference 
of the EU Health Security Committee on 11 Se ptember 2008. The item was further discussed 
in audio-conferences of the EU Health Secu rity Committee of 30 September and 28 October 
as well as in a plenary meeting of the Co mmittee of 5-6 November 2008 and 18 June 2009. 
The members of the EU Health Security Co mmittee 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 Radiopharmaceuti cals 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, ha s setup a Task Force which is composed of 
 
EN 12   EN representatives of the European Commission, Heads of Medicines Agencies of the EU 
Member States and the EMA. The Agency has produ ced 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 For ce on Radiopharmaceuticals set-up by the EMA 
concluded with reference to l onger-term aspects that there is a need to further explore 
possibilities for alternatives to radi opharmaceuticals in the EU. Following this 
recommendation, the Committee for Medicinal Pr oducts for Human Use (CHMP) agreed an 
action plan in May 2009 involving th e organisation of a workshop w ith experts in the field of 
clinical radiology and nuclear medicine with a view to address the place of 
radiopharmaceuticals, labelled with  radioisotopes produced in reac tors, in clinical practice in 
the EU in the longer term and to shed light on  the possible alternativ es that are currently 
available and those that may beco me available in the future.  
3.2.3.  The EMA Workshop on Radiopharmaceuticals  
The workshop took place in London on 4-5 Februa ry 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 imag ing provides support in di agnosis and follow-up 
of treatment. 
The experts participating at the Workshop co ncluded 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 (PET
21), although it is noted that PET is currently 
highly dedicated mostly for oncology and partly  for neurology but di fficult for cardiology due 
to patient load and the lack of currently  approved radiopharmaceuticals for myocardial 
perfusion. Considering the restraints in availa bility of PET cameras, patient management, 
approved indications of use, availability of PET radiopharmaceuticals and long time scales 
from research and development to the clinics, an d the cost and trained st aff implications of the 
single photon (SPECT22) to positron emission comput ed tomography switch, other 
alternatives need to be consid ered 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 in creased radiation dose an d cost, and decreased 
image quality. Reducing the activity of Tc-99m n eeded 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 ar e currently no identified alternat ives 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 intrao perative detection for 
                                                
 
20 Report to the European Commissi on on the Supply Shorta ge of Radiopharmaceuticals (status as of 24 
October 2008), EMEA/51183/2009 
21  PET (positron emission tomography) is a nuclear medicine imaging technique, and as such produces 
images of functional and molecular processes in th e 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.  
22  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 13   EN cancer treatment, parathyroid pre- and intr a-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 Ra dioisotopes for Medical Use and Current 
Developments in Nuclear Medicine 
Following deliberations and discussions at po litical and technical level and, against the 
background of the fragility in s upply of radioisotopes for me dical use around the world, the 
European Commission established an ad hoc in ter-service group on the issue at the beginning 
of 2009 which has since produced  a Preliminary Report on S upply of Radioisotopes for 
Medical Use and Current Develo pments in Nuclear Medicine23. The report includes, in 
addition to description of current uses of radioisotopes, supply si tuation and available 
production capacities, the information about possi ble future initiatives  regarding nuclear 
reactor capacities, radiopharmaceuticals and nucl ear 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 H ealth Ministers in July 2009. 
3.2.5.  The Council Conclusions on the Secu rity of Supply of Radioisotopes 
On 4 November 2009 the European Commission pr esented its Report to  the Council of the 
European Union. On that basis a nd noting that it is an appropri ate 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 Pres idency of the Council prepared draft Council 
Conclusions on the Security of Supply of Radi oisotopes 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 th e Council meeting held on 15 December 2009
24. 
3.2.6.  The EC Meeting on the Security of Supply of Medical Radioisotopes in EU Member 
States 
In the Council Conclusions, the Commission wa s 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 Eur opean Union, taking account of production facility 
projects in Member States, of technical develo pments and of predictions of future demand of 
radioisotopes in medical applications.  
In response to this invitation of the Council,  the Directorate-Gene ral for Energy hosted a 
Meeting on the Security of Supply of Medica l 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 (reacto r operators, Mo-99 processors 
and Mo-99/Tc-99m generator produ cers), the representatives from  international organizations 
and professional associations (OEC D/NEA HLG-MR, AIPES and EANM).  
                                                 
23 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 
24 Council Conclusions on the Security of Supply of Radioisotopes for Medical Use, 2986th Agriculture 
and Fisheries Council meeting,  Brussels, 15 December 2009 
 
EN 14   EN • The participants of the meeting agreed th at use of Tc-99m is increasing by about 
3%/year in "developed countri es" and that within nuclear  medicine techniques, Tc-
99m will remain an important isotope. 
• It was highlighted that curre ntly only EU can supply its full own Mo-99/Tc-99m needs 
(of course when reactors are in operati on), that is why the European production 
network is unique.  
• They agreed that there is no sufficient in centive for existing research reactors to 
produce Mo-99 and for new ones to be co nstructed 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-9 9m supply is essential to identify a 
financial model to support the infrastructur e 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-pur pose research reactors are the lowest-risk 
path to new Mo-99/Tc-99m pr oduction capacity, as for dedica ted isotope f acilities the 
ongoing revenues from isotope sales would be insufficient to cover the ongoing 
operating expenses.  
• The need for harmonized radioisotope tr ansport arrangements and uranium target 
design was highlighted together with the n eed 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 us e of generators along the week, etc.). 
• It was agreed that alternative Mo-99 pr oduction technologies shoul d 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 TUM
25 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 positi on 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 Eur opean 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 co sts of new and existing infrastructure, 
                                                
 
25 CEA - French Atomic Energy and Alte rnative Energies Commission (France)  
NRG - Nuclear Research & Consultancy Group (The Netherlands)  
SCK•CEN - Belgian Nuclear Re search Centre (Belgium)  
TUM - University of Technology, Munich (Germany) 
 
EN 15   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 ex isting 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 need s 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 y ear; in 2010 the production cap acity of BR2 has been 
increased by about 50%, by addition of one irradiatio n 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), e xpected to leave service in 2015, 
o MARIA (Swierk, Poland) an existin g Multi-purpose Research Reactor 
operated by POLATOM, who has st arted production in February 2010 
(maximum capacity: ~ 10 % of European needs when operating). 
And new reactors, subject to appropriate  funding being availa ble in due time: 
o FRM II (Munich, Germany) a new Resear ch Reactor operated by TUM since 
2005, able to irradiate uranium target s from 2014 (maximum capacity: 50% of 
European needs when operating. Operates 240 days per year), 
o JHR (Cadarache, France) a new Materi als Testing Reacto r under construction 
to be operated by CEA, start of operation foreseen 2015 (present planned capacity: 25% of European needs; coul d be extended up to 50% of European 
needs when operating. Planned operation 220 days per year), 
o PALLAS (Petten or Zeeland, The Neth erlands) a proposed Multi-purpose 
Research Reactor to be operated fr om 2017 by NRG to replace HFR (estimated 
capacity: >100% of the European need s when operating. Pl anned operation 
300 days per year), 
o MYRRHA (Mol, Belgium) a proposed Accelerator Driven System (ADS) 
scheduled to be operated by SCK•CE N from 2022 (estimated capacity: 
equivalent replacement of BR2's capacity. Planned operation 240 days per 
year). 
 
EN 16   EN • A minimum of 200 - 250% “peak reactor ca pacity” was defined as necessary for 
Europe to ensure continuity of producti on during normal scheduled reactor refuelling 
and maintenance shutdown periods.  
• Reactor operators agreed that existing Europe an expertise might be used in the longer 
term to build and operate one or perhaps tw o 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 f acilities, 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 SR A also identifies future needs regarding 
research infrastructures and competences, includ ing new large flexible irradiation facilities, 
three of which (JHR in France, PALLAS in th e Netherlands and MYRRHA in Belgium) have 
clear potential for radioisot ope 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 ra ised 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 industr ial production of electricity in nuclear power stations or for 
industrial nuclear fuel cycle facilities. Sin ce 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 am ount 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 bene ficiary benefits from the AAA credit rating of 
the Community to obtain best possible financin g conditions. The loans are supplementary to 
financing arrangements with other parties. 
Since an evaluation will be done soon, the possibi lity of extending the scope of the loans to 
include research reactors with  envisaged production of radioiso topes could be explored. An 
extension of the Euratom loan could contribu te, in the mid- and long-term, to guarantee 
sufficient output, and thus security of supply, of  radioisotopes for pati ents in the European 
Union. Such a modification of the te rms 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 17   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 lo an 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 w ith 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 give n 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 us e were considered of such f undamental importance, knowledge 
and resources could be bundled in a Joint Undertaking, consisting of 
 Several private undertakings or 
 Several public entities (Member States, Eu ratom, international organisation) or 
 A public-private partnership. 
Depending on this definition , a Joint Undertaking might also have the function of controlling 
the entire cycle of supply of ra dioisotopes (i.e. from irradiati ons of uranium "targets" via the 
extraction of Mo-99 to producti on 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 administrat ive procedures for the trans -border transport of medical 
isotopes  
Improvements on the side of research reactor production alone are not su fficient to assure a 
global supply security of medical radioisotopes. The transport of such radioactive materials is 
also vital. 2.5 million packages containing radi oactive 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 stri ngent transport regulatory framework has 
proven to be effective in minimising the ra diological impact for normal and accidental 
conditions of transport. Howeve r, 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 radioac tive material in terms of the extra effort, time and 
(technical/financial) resources required by trans port 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-comm unity 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 material s/special fissile materials (under chapter 6 of the 
Euratom Treaty), which was also considered of fundamental importance for the supply of materials 
 
EN 18   EN transport operations. These also increase th e potential for non-compliances and shipment 
denials. 
Following a three-year preparation period duri ng 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 rela ted to it and the implementation of Community 
legislations, the Commission is currently ex amining the possibility of a new Council 
regulation establishing a Community system fo r registration of carriers of radioactive 
material, with the intention to harmonise and simplify administrative procedures while 
ensuring accessibility and tran sparency of this activity.  
The new Council regulation does not specifi cally address the tr ansport 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 uni que 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 Pr otection aspects) with a global and exhaustive 
vision of the transport of radioactive materials on their national territory. 
The new proposal will not solve a ll issues related to the Trans port of Radioactive Materials 
but will simplify it: carriers will be required to re gister 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 Author ity of the carrier will deliver, or not, the 
authorisation, valid for a period of five years an d for all countries where the carrier declared 
operation. Procedures for the control and monitori ng of the respect of ru les 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 whic h 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 awaren ess of all parties conc erned, i.e. suppliers, 
recipients, regulators, carrier s/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 establ ishment 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 19   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 IA EA 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 ar eas of radiation medicine in focus are: 
nuclear medicine, diagnostic ra diology and radiation oncology. 
Nuclear medicine imaging procedures with unsealed radioactive sources have become 
essential in managing the two major groups of no n-infectious diseases, cardiovascular disease 
and cancer in IAEA Member States. The IA EA helps establish new nuclear medicine 
facilities, encourages their in tegration with diagnostic radiol ogy procedures and facilitates 
appropriate human resources capacity building. 
In diagnostic radiology, several documents ha ve 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, incl uding cardiovascular 
disease and cancer in Member States. The emerging use of tele-ra diology in developing 
Member States is also under active inve stigation, in collaboration with WHO. 
In radiation oncology, the IAEA works with a variety of stakeholders, including agencies 
within the United Nations, govern ments, hospitals, and research  institutes to address the 
shortage of cancer treatment resources in Member States as documented in the IAEA 
directory of radiotherapy centr es, DIRAC. The IAEA also prom otes 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 ha s been established to introduce and improve 
access to radiation cancer treatment in low in come countries in cooperation with national 
programmes for cancer control and in co llaboration with WHO and other NGOs. 
The IAEA supports Member Stat es with technical guidance fo r implementing and reviewing 
QA programmes at hospitals. The IAEA has published dosimetry protocols, which are widely 
used worldwide. Traceable dosimetry ca libration services ar e provided through the 
IAEA/WHO Network of Secondary Standards Do simetry Laboratories (SSDLs). Independent 
 
EN 20   EN dosimetry audits and comprehensive clinical audits are offered by the IAEA to radiation 
medicine facilities in Member States. In pa rticular, the IAEA/WHO postal dose audit service 
for radiotherapy dosimetry has been in operati on for over 40 years a nd 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 Im provement and Learning (QUAADRIL). 
Well qualified staff is vital for safe and effectiv e use of radiation in medicine. The IAEA has 
published standardized syllabi for education and training of health professionals working in 
radiation medicine and s upports continuing education through training courses and 
workshops. 
In the area of radioisotopes production the IAEA implements coordi nated research projects, 
organises topical review meetings, compiles te chnical documents and updates, and provides 
direct assistance to MS through national a nd regional projects under technical cooperation 
programme; further, it extends cooperation supp ort to relevant international events/meetings 
dealing with medical isotopes and radiopharm aceuticals. The IAEA activities related to 
medical isotopes and their products can be summarized as follows: 
1. Capacity building and strengt hening practices in productio n and quality control of 
radioisotopes and radiopharmaceuticals: Responding to MS requirements, mainly through 
topical meetings, technical knowledge disse mination 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: React or-produced lutetium-177 
& its products and generator-produced yttrium-90 a nd its products that can  be made in several 
centres; 
3. Facilitating adoption of PET tracers and radionuclide ther apy in support of cancer 
management: Coordinate evaluation and deploy ment 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 en couraging reactors with suitable features for 
Mo-99 production and facilitatin g cooperative efforts for regi onal production and supplies; 
ii)Assistance to adopting LEU-based productio n technology for Mo-99 production as well as 
alternate routes for Mo -99 or Tc-99m production. Iii) Cont ribution to and cooperation with 
other international initiatives, e.g. NE A instituted High Level Group on Medical 
Radioisotopes (HLG-MR); 
5. Dissemination of technical know-how, best pr actices and guidelines, on medical isotopes 
and radiopharmaceuticals, relating to infrastr uctural facilities and operational processes 
involved; 
6. Education and training of radi opharmacists and technologists; networking of researchers, 
end users and other stakeholders; providing appr opriate forum and facilitating international 
cooperation and sustainable collaboration. 
Safety 
All IAEA activities under the pillar of safety have the ultim ate 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 sa fety for protection of health and 
minimization of danger to life and property ... and to provide for th e application of these ...". 
 
EN 21   EN Concerning the safe use of ionizing radiati on the IAEA is undertak ing 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 appropriat e 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 safe ty 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 pr otection of patients 
and safer use of radiation in diagnostic , interventional and therapeutic medical 
procedures; 
• A National strategy and a responsible Agen cy for the management of radioactive 
waste; 
• National and international transport regula tions (incompatible regulations between 
states and transport modes would prevent global trade). 
• Relevant technical se rvices in radiation safety (dos imetry, 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 a pplications for cancer 
diagnosis and treatment in Memb er States is provided through: 
• Education and training in radiation medi cal safety for health professionals in 
cooperation with WHO, includ ing the development of guida nce and training material; 
• Knowledge exchange through IA EA web site on radiation protection of patients for 
health professionals ( http://rpop.iaea.org); 
• Direct technical assistance to Member Stat es, such as trainin g, missions, advice and 
provision of tools, as well as appraisals; 
• Development of educational safety repor ting systems for prevention of unintended 
exposures in radiological pr ocedures and radiotherapy; 
• Working towards prevention of unnecessary medical expos ures by strengthening the 
justification process of individual medi cal exposures such as by International 
Campaigns to increase awareness. 
The International Action Plan for the Radiati on Protection of Patients,  established in 2002 
with a network of international organizatio ns, professional bodies  and experts in its 
Steering Panel, ensures the effective implemen tation of capacity building measures for the 
safe, optimized and justified use of ionizing radiation in medical ap plications. Capacity 
building is also provided at a broader level, for all stakeholde rs involved in the safety of 
radiation medicine: 
• Education and training for radiation protection officers and regulators; 
• Promotion and support of all networking act ivities 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 unde rtakings: joint convention for proper 
management of radioactive waste and disu sed sources, code of conduct on the safety 
and security of radioactive s ources, to ensure cradle to grave management, including 
 
EN 22   EN import/export controls; 
• Promotion and support of regional and intern ational workshops to alleviate problems 
shipping radioactive material, to se t strategies for waste management. 
 
EN 23   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 Pr otection (ICRP) was asked by the European 
Commission to describe its role and activities in  the area of medical app lications of ionizing 
radiation and in the fi eld of the supply of medical radioi sotopes. As an observer, ICRP 
contributes to and supports the work of IACRS, but does not sp ecifically endorse any reports 
or statements of IACRS.  
ICRP, established in 1928 at the second International C ongress on Radiology, is an 
independent, international organization that ad vances for the public be nefit the science of 
radiological protection, in particular by providing recommendations and guidance on all 
aspects of protection against i onizing radiation. The primary ai m of these recommendations is 
to contribute to an appropriate level of prot ection for people and the environment without 
unduly limiting the desirable human activities that may be associat ed with radiation exposure. 
Thus the scope of ICRP’s mandate includes, in ter alia, radiological pr otection issues related 
to medical radioisotopes and more  broadly the use of ionizing radiation in medicine, but does 
not include any role related to th e supply of medical radioisotopes. 
In preparing its recommendations, ICRP c onsiders the fundamental principles and 
quantitative bases upon which appropriate radiological protection measures can be 
established, while leaving to  the various national protecti on 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 regulator y and advisory agencies and provides advice 
intended to be of help to management and professional staff with responsibilities for 
radiological protection. Legisl ation in most countries adhe res very closely to ICRP 
recommendations. In addition, the Internationa l Atomic Energy Agency  (IAEA) International 
Basic Safety Standards for Protection agains t 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 Obse rvation 1992, refers specifically to the 
recommendations of ICRP. Thus, ICRP reco mmendations form the basis of radiological 
protection standards, guidance, regulations , programmes, and practices worldwide. 
ICRP is comprised of a Main Commission, a Sc ientific Secretariat, and five standing 
Committees on: Radiation effects,  Doses from radiation exposure , Protection in medicine, the 
Application of ICRP recommendations, and Prot ection of the environment. In addition, ICRP 
uses Task Groups comprised of Committee member s and other experts relevant to the subject 
at hand. All told, ICRP membership includes about 100 eminent scientis ts 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 memb ers, as well as observers 
from WHO and IEC, and is con cerned with protection of persons and unborn children when 
ionizing radiation is used for medical diagnosis, therapy, or bi omedical research, and also 
with the assessment of medical consequences of accidental exposures. 
 
EN 24   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 Radiopharm aceuticals; 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, Radi ation and your patient – a guide for medical practitioners; 
Diagnostic reference levels in medical imag ing – review and additional advice; Managing 
Patient Dose in Computed Tomography; Prev ention of accidental exposures to patients 
undergoing radiation therapy; A voidance of Radiation Injuries  from Medical Interventional 
Procedures; and, Pregnanc y and Medical Radiation. 
In addition, Committee 3 has recently co mpleted two ICRP publications: Preventing 
accidental exposures from new external be am radiation therapy technologies; and, 
Radiological protection educati on and training for medical diagnostic and interventional 
procedures for healthcare staff and students. 
Among the ICRP publications in development or pl anned for the near future within the area 
of radiological protection in medicine are reports on: secondary cancer risk after modern 
radiotherapy; practical recommendations; do se to patients from radiopharmaceuticals; 
radiation protection for cardiologists perf orming fluoroscopically guided procedures; 
radiation protection in charge d particle radiotherapy; prot ecting children; follow up of 
persons accidentally exposed; avoiding adverse ra diation effects to doctors and patients in 
fluoroscopically guided procedures  - practical guidelines; wideni ng the use of reference levels 
for interventional radiology, digital radiology  and new technology; and, screening with 
ionizing radiation in as ymptomatic individuals. 
ICRP is also developing advice on  radiation detriment and effec tive dose, includ ing the use of 
these quantities in medicine. 
 
EN 25   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 pro duce 90 to 95% of the 
total global supply of Mo-99. Give n the age of these reactors, ther e are issues related to their 
longevity and reliability, with unexpected shut downs occurring more often. Most recently the 
Canadian National Research Universal Reacto r (the NRU) was shut down in May 2009 as a 
result of a leak in the reactor vessel and only e xpects to return to serv ice at the end of July 
2010. In addition, the High Flux Reactor in the Ne therlands and the OSIRIS reactor in France 
are scheduled to be down for extended mainte nance 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 a ttendance, with representatives from governments, universities, 
reactor operators, processors, ge nerator manufacturers and distri butors, industry associations, 
the medical community, international organizat ions 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 practica l measures that should be taken. 
Formation of the High Level Gr oup on Medical Radioisotopes  
The NEA Steering Committee established the Hi gh 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 Comm ission and the International Atomic Energy 
Agency, and is being funded by its member s through voluntary contributions. The group 
oversees and assists, where necessary, efforts of  the international community to address the 
challenges of medical isotope supply reliabi lity. The NEA secretariat supports the group and 
brings its expertise to the issue. 
The main objective of the HLG-MR is to streng then the reliab ility of Mo-99/Tc-99m supply 
in the short, medium and long term. In orde r 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 mech anisms 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 th at efforts are not duplicated. Bringing the 
 
EN 26   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 firs t 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 protoc ols to inform stakeholders of unanticipated events, and 
coordinating reactor schedules. The action plan al so included assessing options to increase 
short-, medium- and long-term production. Th ese options include de mand side management 
(e.g., promoting efficient patient scheduling, us ing alternative proced ures) and producing Mo-
99 from alternative reactors or technologies. In terms of bringing new supply to market, the 
action plan included work to identify regulator y issues, especially those related to the 
transportation of Mo-99 and Tc-99m, a nd 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 co mmunity, the medical is otope industry and the 
nuclear medicine community. Participants welcomed the positive actions that have been taken 
to date, such as the progress on the econom ic study, the development of communication 
protocols and the coordination a nd communication of reactor schedul es. Participants agreed to 
a list of actions to further improve the manage ment 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 protoc ols; 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 di fficulties 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 Secretaria t is undertaking a study on  the economics of the 
upstream Mo-99 and Tc-99m supply chain, given th e possibility of a ma rket failure in the 
supply chain whereby the economic structure does  not provide sufficient incentive for current 
reactors to produce Mo-99 or for additional pro duction reactors to be constructed. The study, 
expected to be completed in mid-2010, will deve lop a solid factual basi s of the economics of 
the supply chain with the goal of providi ng 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 th rough the rolling action plan. Two reports are 
being prepared: the economic study and a mid-term diagnos tic report. The latter will 
summarise the actions of the HLG-MR and Mo- 99 stakeholders and will include information 
about the Mo-99 situati on, the issues affecting its reliab le supply, and actions needed to 
address these issues. 
 
EN 27   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 28   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 ioni zing radiation from all sources (including from 
medical applications and the supply of radioiso topes 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 i onizing radiation used in medicine28. It also identifies 
emerging issues and future research needs in th e 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, interna tional 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 protecti on, including of patients30 
and medical workers31. They also provide independent benc hmarks and trends for evaluating 
development programmes, and represent an ex tensive knowledge base for education purposes. 
3. The principal objectives of the recent assessments of medical exposure have 
essentially been to establish the annual fre quency of medical examin ations and procedures 
involving the use of radiation,  as well as their associat ed 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. 
4. The Assembly designated 21 Member States of the United Nations as members32 of 
the Committee; their scientific representati ves and delegations sc rutinize syntheses of 
information prepared by experts engaged by the small Vienna-based secretariat. The 
European Commission has frequently particip ated in the annual UNSCEAR sessions as an 
observer. 
Activities  
5. The Committee assesses patient exposure us ing 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 va rious 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 Assessments of medical exposures were issued in 1958, 1972, 1977, 1982, 1988, 1993, 2000, and 2008 
29 Available on http://www.unscear.org 
30 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 
31 Action plan for occupational radiation protection, prepared by IAEA and ILO, GOV/2003/47-GC(47)/7 
Annex 2 
32 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 29   EN radiology, nuclear medicine, radiotherapy, and other medical uses) using data collected 
through the UNSCEAR Global Survey of Occu pational 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 d ecision-makers, the scientific community 
and civil society of radiation exposure and its health and environmental effects as a 
sound basis for informed decision ma king on radiation-related issues.  
7. Medical exposure of patients has been identi fied as a key thematic priority for the 
period. The Committee will continue its surveillan ce 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 emergi ng issues. The secretariat envisages the next 
assessment to be issued in 2013. 
8. Over the intervening period, UNSCEAR is s eeking to: (a) streamlin e the conduct of its 
evaluations by establishing a standing expert  group to maintain surveillance on emerging 
issues and to regularly review new informa tion; (b) enhance the mechanisms for data 
collection, analysis and disse mination; and (c) raise awaren ess, and improve communication 
of the findings to decision-makers and the public. 
9. With regard to enhancing data collecti on, 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 contribut ing 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 expo sures 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 radi ation exposure, the Committee has regularly 
reviewed published clinical, epidemiological  (including those derived from follow-up of 
people medically exposed) and radiobiological inform ation with respect to cancer risks. It has 
also evaluated: the developmental effects in uter o of pre-natal irradiatio n; risks for diseases 
other than cancer; radiation eff ects on the immune and the ner vous systems; the early effects 
of high radiation doses; the mechanisms by wh ich radiation effects occur, including DNA 
repair and mutagenesis, non-targ eted effects and adaptive res ponses 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 un certainty associated with its radiation risk 
estimates. 
 
EN 30   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 h ealth is in place to coordina te 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 In itiative 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 a cademic 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 with in 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 justificatio n of medical exposures. An international 
consultancy on referral guidelines (RGs) for appr opriate use of radiati on imaging was held in 
March 2010 gathering experts from 23 internat ional, regional and national professional 
societies from all WHO regions, as well as  representatives from the EC and IAEA36. An 
international collaboration was es tablished 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 setti ngs were proposed37. The GI advocates for the 
inclusion of radiation protection (RP) contents in the curricul a of medical and public health 
schools and will promote the use of RGs as education tools for medical students and young 
                                                 
33 http://www.who.int/topics/environmental_health/en/ 
34 http://www.who.int/ionizing_radiation/en/ 
35  http://www.who.int/ionizing_radiation/ about/med_exposure/en/index.html. 
36 Alliance for Radiation Safety in Paediatric Imag ing- 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), Inte rnational 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 H ealth Organization (PAHO), Royal and Australian 
New Zealand College of Radiologists (RANZCR),  Royal College of Radiology (RCR, UK) and World 
Health Organization (WHO) 
37 More information is available at  
http://www.who.int/ionizing_radiation/ about/med_exposure/en/index2.html 
 
EN 31   EN doctors. A number of activities are being conducted in the fiel d of radiation protection in 
pediatric health care (e.g. work shops, specialists seminars, trai ning for pediatricians). A tool 
kit on radiation risk communication in paedia tric imaging is being developed, including 
ethical considerations and guidance on inform ed consent. A workshop on radiation risk 
communication in pediatric imagi ng 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 radiogra phers and radiation t echnologists in the 
implementation of radiation protection (RP) po licies. 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 developm ent of an International Classification for 
Patient Safety39.WHO established the "Patients for Pa tients Safety" global network to support 
patient engagement40. The Technical Manual on Ra diotherapy Risk Profile41 developed by the 
PSP was presented during the International C onference on Modern Radiotherapy, organized 
by the ASN in cooperation with EC, IAEA and WHO.  
The use of radiation in health care is al so addressed through the Global Action Against 
Cancer to promote the basic components of cancer control: preven tion, early detection, 
diagnosis and treatment, and palliative care . WHO collaborates with the IAEA in the 
Programme of Action for Cancer Therapy (PAC T)42. Through the International Agency for 
Research on Cancer (IARC) WHO coordi nates and conducts experimental and 
epidemiological research on the causes of  cancer, including ionizing radiation.  
WHO assists countries in esta blishing and optimizing the use of health technologies. The 
Department of Essential Health Technologi es (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 maintain ing diagnostic imaging services43.  
The WHO Department of Essential Medici nes 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 addres s good manufacturing pr actices (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 co llaborated with the IAEA 
                                                 
38 EC: European Commission, IAEA: International Atom ic 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. 
39 http://www.who.int/patientsafety /implementation/taxonomy/en/. 
40 http://www.who.int/patientsafe ty/patients_for_patient/en/. 
41 http://www.who.int/patientsafety/activitie s/technical/radiotherapy_risk_profile.pdf. 
42  http://www.who.int/topics/cancer/en/  and  
 http://www.who.i nt/mediacentre/news/rel eases/2009/who_iaea_cancer_p rogramme_20090526/en/ 
43 http://www.who.int/diagnostic_imaging/en/index.html 
44  http://www.who.int/medicines/about/en/index.html 
 
EN 32   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 wh en 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, IL O, IAEA, IRPA48, NEA49 and UNSCEAR.  
                                                
 
45 More information about distribution is available at:   
http://whqlibdoc.who.int/trs/ WHO_TRS_908.pdf#page=36 
http://www.who.int/medicines/ar eas/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 
46 BSS: International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety 
of Radiation Sources 
47 ICRP: International Commission on Radiological Protection. 
48 IRPA: International Radiation Protection Association. 
49 NEA Committee on Radiation Protection and Public Health (CRPPH), expert group on  Public Health 
Perspective in Radiological Protection (EGPH)