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Legal and Ethical Aspects of Ghostwriting in Medicine

  • Varia - Ethics
  • Published:
Archivum Immunologiae et Therapiae Experimentalis Aims and scope

Abstract

Ghostwriting in medicine represents a highly significant problem in both legal and ethical terms, and particularly in recent years owing to a sudden increase in the practice. The main goal in this paper is to present the legal and ethical rules connected with the ghostwriting phenomenon. The problem is presented in the context of international, European and Polish law. From a legal perspective the issues bound up with ghostwriting are those of the notion and authorship of a work, authors’ rights (both moral rights and copyright), the content of these rights and their nature, as well as the question of the transfer of such rights. From the point of view of ethics there arises a need for reflection on honesty, accuracy and credibility as defined both generally and scientifically.

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References

  • Act of 4 February 1994 on copyright and related rights. J Laws 00.80.904

  • Bainbridge DI (2009) Intellectual property, 7th edn. Pearson Longman, Harlow, England, New York

    Google Scholar 

  • Barta J, Czajkowska-Dąbrowska M, Ćwiąkalski Z et al (2001) Ustawa o prawie autorskim i prawach pokrewnych. Komentarz. Dom Wydawniczy ABC, Warszawa

  • Berne Convention for the Protection of Literary and Artistic Works of September 9, 1886, completed at PARIS on May 4, 1896, revised at BERLIN on November 13, 1908, completed at BERNE on March 20, 1914, revised at ROME on June 2, 1928, at BRUSSELS on June 26, 1948, at STOCKHOLM on July 14, 1967, and at PARIS on July 24, 1971, and amended on September 28, 1979. Available at the WIPO (World Intellectual Property Organisation) web site: http://www.wipo.int/treaties/en/ip/berne/trtdocs_wo001.html. Accessed 3rd June 2010

  • Case T-68/89 (1991) ECR 1992 p. II-1403

  • Cases C-92/92 and C-326/92, ECR 1993 p. I-05145

  • Colston C (1999) Principles of intellectual property law. Cavendish Publishing Limited, London-Sydney

    Google Scholar 

  • Colston C, Middleton K (2005) Modern intellectual property law, 2nd edn. Cavendish Publishing Limited, London

    Google Scholar 

  • Commission Staff Working Paper on the review of the EC legal framework in the field of copyright and related rights, available at: http://ec.europa.eu/internal_market/copyright/docs/review/sec-2004-995_en.pdf. Accessed 15 June 2010

  • Cornish WR (1981) Intellectual property: patents, copyright, trade marks and allied rights. Sweet & Maxwell, London

    Google Scholar 

  • Cullen DJ (1997) Ghostwriting in scientific anesthesia journals. Anesthesiology 87:197–290

    Article  Google Scholar 

  • Declaration of Geneva adopted by the 2nd General Assembly of the World Medical Association, Geneva, Switzerland, September 1948 and amended by the 22nd World Medical Assembly, Sydney, Australia, August 1968 and the 35th World Medical Assembly, Venice, Italy, October 1983 and the 46th WMA General Assembly, Stockholm, Sweden, September 1994 and editorially revised at the 170th Council Session, Divonne-les-Bains, France, May 2005 and the 173rd Council Session, Divonne-les-Bains, France, May 2006, available at: http://www.wma.net/en/30publications/10policies/c8/index.html. Accessed 15 June 2010

  • Gawlik Z, Janiak A, Jedliński A et al. (2009) In: Kidyba A (ed) Kodeks cywilny. Komentarz. Tom I. Część ogólna. Wolters Kluwer Polska-LEX, Warszawa

  • Goldstein P (2001) International copyright. Oxford University Press, Oxford

    Google Scholar 

  • Gotzsche PC, Kassirer JP, Woolley KL et al (2009) What should be done to tackle ghostwriting in the medical literature? PLoS Med 6:e23

    Article  PubMed  Google Scholar 

  • Holderness M (1998) Moral rights and authors’ rights: the keys to the information age. J Info Law Technol. Available http://www2.warwick.ac.uk/fac/soc/law/elj/jilt/1998_1/holderness/. Accessed 28 June 2010

  • Jacobs A (2005) The involvement of professional medical writers in medical publications: results of a Delphi study. Curr Med Res Opin 21:311–316

    Article  PubMed  Google Scholar 

  • Jacobs A, Wagner E (2005) European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications. Curr Med Res Opin 21:317–322

    Article  PubMed  Google Scholar 

  • Josselin M (1992) The concept of the contract for the exploitation of author’s rights: a comparative-law approach. Copyright bulletin (UNESCO). Fortieth anniversary of the Universal Copyright Convention 26:6–16

  • Kase FJ (1967) Copyright thought in Continental Europe. Its development. Legal theories and philosophy. Fred B. Rothman & Co, New York

    Google Scholar 

  • Kassirer JP (2009) Ghostwriting is difficult to define, and we need more evidence of its frequency and impact. In: Gotzsche PC et al. (2009) What should be done to tackle ghostwriting in the medical literature? PLoS Med 6:e23

  • Keeling DT (2003) Intellectual property rights in EU Law. vol I. Oxford University Press, Oxford

    Google Scholar 

  • Lagnado M (2003) Professional writing assistance: effects on biomedical publishing. Learned Publishing 16:21–27

    Article  Google Scholar 

  • Langdon-Neuner E (2008) Medical ghost-writing. Mens Sana Monographs 6:257–273. Available at http://www.msmonographs.org/text.asp?2008/6/1/257/33006. Accessed 28 June 2010

    Google Scholar 

  • McJohn SM (2006) Copyright. Examples and explanations. Aspen Publishers, New York

    Google Scholar 

  • Niżankowska AM (2007) Prawo do integralności utworu. Wolters Kluwer Polska, Warszawa

    Google Scholar 

  • Patterson LR (1968) Copyright in historical perspective. Vanderbilt University Press, Nashville

    Google Scholar 

  • Phillips SG, Carey LA (1999) Whose article is it anyway? Lancet 354:1563

    Article  CAS  PubMed  Google Scholar 

  • Radkova L (2001) Moral rights of authors in international copyright of the 21st Century: time for consolidation? LL.M, University of British Columbia, Faculty of Law. Vancouver. Available at https://circle.ubc.ca/bitstream/handle/2429/12202/ubc_2002-0216.pdf. Accessed 28 June 2010

  • Resnik DB (1998) The ethics of science. An introduction. Routlege, New York

    Google Scholar 

  • Ricketson S (1987) The Berne Convention for the protection of literary and artistic works: 1886–1986. Centre for Commercial Law Studies, Queen Mary College

  • Rollin BE (2006) Science and ethics. Cambridge University Press, Cambridge

    Book  Google Scholar 

  • Rosenblum K (ed) (2004) Intellectual property law in the European community: a country-by-country review. World Trade Executive Inc, Concord

    Google Scholar 

  • Rushton M (1998) The moral rights of artists: Droit Moral ou Droit Pécuniaire? J Cult Econ 22:15–32

    Article  Google Scholar 

  • Seville C (2006) The internalisation of copyright law. Books, Buccaneers and the Black Flag in the Nineteenth Century. Cambridge University Press, Cambridge

    Book  Google Scholar 

  • Seville C (2009) EU intellectual property law and policy. Edward Elgar, Cheltenham

    Google Scholar 

  • Shamoo AE, Resnik DB (2009) Responsible conduct of research, 2nd edn. Oxford Univesrity Press, Oxford-New York

    Book  Google Scholar 

  • Swedberg K (2008) Who is an author? Editorial. Eur J Heart Fail 10:523–524

    Article  PubMed  Google Scholar 

  • The International Covenant On Economic, Social And Cultural Rights. Available at: http://www2.ohchr.org/english/law/cescr.htm. Accessed 28 June 2010

  • The Treaty of Rome of March 25 1957 adopted in Rome. Available at: http://ec.europa.eu/economy_finance/emu_history/documents/treaties/rometreaty2.pdf. Accessed 15 June 2010

  • The Universal Copyright Convention adopted in Geneva on September 6, 1952. Available on the UNESCO web site: http://portal.unesco.org/en/ev.php-URL_ID=15381&URL_DO=DO_TOPIC&URL_SECTION=201.html. Accessed 3rd June 2010

  • The Universal Declaration of Human Rights. Available at: http://daccess-dds-ny.un.org/doc/RESOLUTION/GEN/NR0/043/88/IMG/NR004388.pdf?OpenElement. Accessed 28 June 2010

  • Wikipedia contributors, Ghostwriter. Wikipedia, the Free Encyclopedia, http://en.wikipedia.org/w/index.php?title=Ghostwriter&oldid=369722172. Accessed 13 June 2010

  • World Association of Medical Editors (2005) Ghost writing initiated by commercial companies. Available at http://www.wame.org/wamestmt.htm#ghost.2005. Accessed 13 June 2010

  • World Intellectual Property Organization Copyright Treaty, adopted in Geneva on December 20, 1996, text available at the WIPO web site: http://www.wipo.int/treaties/en/ip/wct/trtdocs_wo033.html. Accessed 3rd June 2010

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Authors and Affiliations

  1. Chair of Public International and European Law, Faculty of Law, Administration and Economics, University of Wrocław, Uniwersytecka 22/26, 50-145, Wrocław, Poland

    Agata Wnukiewicz-Kozłowska

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  1. Agata Wnukiewicz-Kozłowska
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Correspondence to Agata Wnukiewicz-Kozłowska.

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Wnukiewicz-Kozłowska, A. Legal and Ethical Aspects of Ghostwriting in Medicine. Arch. Immunol. Ther. Exp. 59, 1–9 (2011). https://doi.org/10.1007/s00005-010-0105-y

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  • DOI: https://doi.org/10.1007/s00005-010-0105-y

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