TABLE 6.
National legislative penalties for breach of patient safety
| Country | Penalties for breach of section of relevant legislation in third column | Related and linked articles and sections to patient safety in second column |
|---|---|---|
| Austria | (84(1) (18)) “EUR 25 000 in repetitive cases … up to EUR 50 000.” | (34(5)) “The supply of the test subjects with the investigational product is safe and appropriate” a |
| Denmark | (35) “a fine or imprisonment up to 4 months” | (48 – The Regulation) – “Monitoring – Rights, safety and well‐being of subjects.” b |
| France | (6) “Failure to comply with articles 37, 42, 43 and 93 of European regulation (EU) No. 536/2014 … on the communication of information intended to be made available to the public in the union database is punishable by one year imprisonment and a fine of 15 000 euros.” | (42 – The Regulation) – “Reporting of SUSARS by the Sponsor to the Agency” c |
| Germany | (97) “not exceeding 25 000 euros. … In the case of the death … up to … 600 000 euros or … annuity … up to 36 000 euros, in the case of the death … up to … 120 million euros or … annuity … up to 7.2 million euros” | (97(2) (9)) “conducts the clinical trial of a medicinal product in breach of Section 40 sub‐section 1 sentence 3 number 7, (foreseeable risks involved in the clinical trial)” d |
| Ireland | (44) “not exceeding €3000 and/or to imprisonment … not exceeding six months” | (24) “Protection of clinical trial subjects” e |
| Italy | 41(4) “subject to pecuniary administrative sanction from 15 000 to 90 000 euros” | Art 3(1) – “The protection of the rights, safety and well‐being of subjects of experimentation prevails over the interests of science and of the company.” f |
| Malta | “It shall be an offence for the sponsor to start a clinical trial in Malta unless the Ethics Committee has issued a favourable opinion and the Licensing Authority has not informed the sponsor of any grounds for non‐acceptance.” | “Section 9 ‐ Commencement of a clinical trial” g |
| UK | (52) “a fine not exceeding the statutory maximum and/or to imprisonment for a term not exceeding three months … on conviction on indictment and/or to a fine or to imprisonment for a term not exceeding two years” | (28) “Protection of clinical trial subjects” h |
Austria: Section 34(5) and Section 84(1) (18) Austrian Medicinal Products Act. https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=10010441. Accessed 20 December 2020.
Denmark: Regulation 35 and 48 The Danish Act on Clinical Trials of Medicinal Products Law on Clinical Trials on Medicinal Products Law No. 620 of 08/06/2016 (Applicable). https://laegemiddelstyrelsen.dk/en/news/2016/new‐danish‐act‐on‐clinical‐trials/~/media/0BDD2C209E3A472EB4DFC00661683433.ashx. Accessed 20 December 2020.
France: Article L 1126‐12 Public Health Code. https://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000032719520&dateTexte=&categorieLien=id. Accessed 30 January 2021. Article 6 Ordinance No. 2016‐800 of June 16, 2016 relating to research involving the human person. https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000032719520/. Accessed 30 January 2021.
Germany: Regulation 97 and 97(2) (9) Medicinal Products Act. http://www.gesetze‐im‐internet.de/englisch_amg/englisch_amg.pdf. Accessed 4 January 2021.
Ireland: Regulation 24 and 44 Statutory Instrument No. 190/2004 European Communities (Clinical Trials on Medicinal Products for Human Use), Regulations 2004. http://www.irishstatutebook.ie/eli/2004/si/190/made/en/print. Accessed 4 January 2020.
Italy: Article 41(4) and 3(1) Legislative Decree 6 November 2007 n. 200. Implementation of Directive 2005/28/EC containing detailed principles and guidelines for good clinical practice relating to investigational medicinal products for human use as well as requirements for the authorization to manufacture or import such medicinal products. https://www.normattiva.it/uri‐res/N2Ls?urn:nir:stato:decreto.legislativo:2007;200. Accessed 22 January 2021.
Malta: Section 9 Clinical Trials Subsidiary Legislation (S.L. 458/43). http://justiceservices.gov.mt/DownloadDocument.aspx?app=lom&itemid=11281&l=1. Accessed 22 January 2021.
UK: Regulation 28 and 52 The Medicines for Human Use (Clinical Trials) Regulations 2004. http://www.legislation.gov.uk/uksi/2004/1031/contents/made. Accessed 21 December 2020. Regulation The Human Medicines Regulations 2012. https://www.legislation.gov.uk/uksi/2012/1916/contents/made. Accessed 21 December 2020.