Advertisement

Direct effect of the Directive Euratom 2013/59 on European hospitals hosting radionuclide therapies

      Radiotherapy involves irradiating tissue, often cancer cells, by irradiating this target with particles such as x rays, gamma rays, electrons, protons or ions. These particles interact with the tissue and produce by ionization free electrons and toxic free radicals proportionally to the energy imparted per unit of mass (named absorbed dose or shortly dose). Along their path, these particles produce by ionization toxic free radicals proportionally to the energy delivery per unit of mass (named dose). Irradiations are mainly performed in two ways. In external beam radiotherapy (EBRT), a medical device set outside the patient produces a particle beam that is focussed to the target. In brachytherapy sealed radiation sources are placed inside or close to the target, while in radionuclide therapy a vector labelled with a radionuclide is injected to the patient, the vector being designed to be preferably taken up by the target.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Physica Medica: European Journal of Medical Physics
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

      1. https://www.ema.europa.eu/en/documents/product-information/lutathera-epar-product-information_en.pdf (accessed 2022 Feb 24).

      2. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2014:013:0001:0073:EN:PDF (accessed 2022 Feb 24).

        • Strigari L.
        • Konijnenberg M.
        • Chiesa C.
        • Bardies M.
        • Du Y.
        • Gleisner K.S.
        • et al.
        The evidence base for the use of internal dosimetry in the clinical practice of molecular radiotherapy.
        Eur J Nucl Med Mol Imag. 2014; 41: 1976-1988
        • Cremonesi M.
        • Ferrari M.E.
        • Bodei L.
        • Chiesa C.
        • Sarnelli A.
        • Garibaldi C.
        • et al.
        Correlation of dose with toxicity and tumour response to 90Y- and 177Lu-PRRT provides the basis for optimization through individualized treatment planning.
        Eur J Nucl Med Mol Imag. 2018; 45: 2426-2441
        • Walrand S.
        • Jamar F.
        Renal and red marrow dosimetry in peptide receptor radionuclide therapy: 20 years of history and ahead.
        Int J Mol Sci. 2021; https://doi.org/10.3390/ijms22158326
      3. Chiesa C, Strigari L, Pacilio M, Richetta E, Cannatà V, Stasi M et al. Dosimetric optimization of nuclear medicine therapy based on the Council Directive 2013/59/EURATOM and the Italian law N. 101/2020. Position paper and recommendations by the Italian National Associations of Medical Physics (AIFM) and Nuclear Medicine (AIMN). Physica Medica. 2021;89:317-26.

        • Flux G.
        • Buscombe J.
        BNMS position statement on molecular radiotherapy.
        Nucl Med Com. 2021; 42: 1061
        • Konijnenberg M.
        • Herrmann K.
        • Kobe C.
        • Verburg F.
        • Hindorf C.
        • Hustinx R.
        • et al.
        EANM position paper on article 56 of the Council Directive 2013/59/Euratom (basic safety standards) for nuclear medicine therapy.
        Eur J Nucl Med Mol Imag. 2021; 48: 67-72https://doi.org/10.1007/s00259-020-05038-9
      4. https://curia.europa.eu/juris/liste.jsf?language=en&T,F&num=148/78, para 22 ( accessed 2022 Feb 24).

      5. https://curia.europa.eu/juris/liste.jsf?language=en&num=C-62/00 (judgement para. 2) (accessed 2022 Feb 24).

      6. https://curia.europa.eu/juris/liste.jsf?num=C-188/89 (opinion 21, accessed 2022 Feb 24).

        • Bakhtina K.R.
        Farrell II and the concept of an ‘Emanation of the State’.
        Ind Intl Comp L Rev. 2018; 18: 241-248https://doi.org/10.2478/iclr-2018-0035
      7. https://curia.europa.eu/juris/liste.jsf?language=en&num=C-53/04 para 29. (accessed 2022 Feb 24).

      8. https://curia.europa.eu/juris/liste.jsf?language=en&num=C-413/15 para 35 (accessed 2022 Feb 24).

        • Chiesa C.
        • Sjogreen Gleisner K.
        • Flux G.
        • Gear J.
        • Walrand S.
        • Bacher K.
        • et al.
        The conflict between treatment optimization and registration of radiopharmaceuticals with fixed activity posology in oncological nuclear medicine therapy.
        Eur J Nucl Med Mol Imaging. 2017; 44: 1783-1786
      9. https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A32001L0083 (accessed 2022 Feb 24).

      10. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A31984L0466 (accessed 2022 Feb 24).

      11. https://eur-lex.europa.eu/eli/dir/1997/43/oj (accessed 2022 Feb 24).

      12. https://www.ema.europa.eu/en (accessed 2022 Feb 24).

      13. https://curia.europa.eu/juris/document/document.jsf?docid=140965&doclang=EN (accessed 2022 Feb 24).

      14. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:52013SC0349 (point 363. art. 59, accessed 2022 Feb 24).