Tema broja

PRAVO I POLITIKA

ODGOVORNOST PROIZVOĐAČA VAKCINE U PRAKSI EVROPSKOG SUDA PRAVDE

Sažetak

Autorka pokušava da doprinese stišavanju bure koja se u stručnoj medicinskoj i najširoj nestručnjačkoj javnosti neopravdano podigla povodom pogrešnih medijskih interpretacija odluke Evropskog suda pravde u slučaju C–621/15 (N.W and others v Sanofi Pasteur) iz juna 2017. U tom cilju prikazuje činjenično stanje i način na koji se ovaj francuski slučaj našao pred Evropskim sudom pravde, razmatra sporna pravna pitanja i način na koji je Evropski sud na njih odgovorio, ukazuje na različitost pojmova uzročnosti u pravu i u medicinskoj nauci. Presuda Evropskog suda ne menja postojeći režim odgovornosti proizvođača vakcine, već razjašnjava standarde koje nacionalna pravila dokaznog postupka treba da ispune da ne bi bila u suprotnosti s pravilom iz čl. 4 Direktive o odgovornosti za proizvode s nedostatkom. Po tom pravilu teret dokazivanja nedostatka u proizvodu, nastale štete i uzročne veze između nedostatka i štete pada na oštećenika. Kada ne postoje naučna saznanja o tome da li je određena vakcina uzrok odnosno da li doprinosi pojavi određenog oboljenja, pravična raspodela povećanog rizika u uslovima ubrzanog tehnološkog razvoja i asimetrije informacija nalažu da se ne isključi svaka mogućnost da se uzročna veza u sudskom postupku dokazuje i drugim sredstvima, a ne samo rezultatima medicinskih istraživanja.

Ključne reči:

Reference

    1. Караникић Марија, „Одговорност за штету од ствари с недостатком за који се није могло знати“, Анали Правног факултета у Београду, бр. 2/2005.
    2. Cane Peter, Responsibility in Law and Morality, Hart Publishing, Oxford – Portland, 2002.
    3. Douville Thibault (éd.), La réforme du droit des contrats. Commentaire article par article de l’ordonnance du 10 février 2016 portant réforme du droit des contrats, du régime général et de la preuve des obligations, Gualino, Paris, 2016.
    4. Green Michael, “The Intersection of Factual Causation and Damages”, DePaul Law Review, No. 55/2006.
    5. Haertlein Lauren L., “Immunizing Against Bad Science: The Vaccine Court and the Autism Test Cases”, Law and Contemporary Problems, Vol. 75, 2012.
    6. Hart H. L. A., Honoré Tony, Causation and the Law, Clarendon Press, Oxford, 2002 (репринт издања из 1990).
    7. Honoré Tony, “Causation and Remoteness of Damage”, in: André Tunc (ed.), International Encyclopedia of Comparative Law, Vol. 11. Torts, Max Planck Institute, Hamburg, 1970.
    8. Honoré Tony, “Causation in the Law”, in: The Stanford Encyclopedia of Philosophy (ed. Edward N. Zalta), Internet, plato.stanford.edu/archives/win2005/entries/causation-law, 20/10/2017.
    9. Schroeder Christopher H., “Causation, Compensation and Moral Responsibility”, in: Philosophical Foundations of Tort Law (ed. David G. Owen), Clarendon, Oxford, 1995.
    10. Schulze Reiner, Wicker Guillaume, Mäsch Gerald, Mazeaud Denis (éds.), La réforme du droit des obligations en France, 5èmes journées franco-allemandes, Société de législation comparée, Paris, 2015.
    11. Simler Philippe, Commentaire de la réforme du droit des contrats et des obligations, LexisNexis, Paris, 2016.
    12. Spier Jaap (ed.), Unification of Tort Law: Causation, Kluwer Law International, The Hague – London – Boston, 2000.
    13. Stapleton Jane, “Law, Causation and Common Sense”, Oxford Journal of Legal Studies, Vol. 8, 1988.
    14. Stapleton Jane, “Perspectives in Causation”, in: Oxford Essays in Jurisprudence: Fourth Series (ed. Jeremy Horder), , OUP, Oxford, 2000.
    15. Stapleton Jane, “Scientific and Legal Approaches to Causation”, in: Causation in Law and Medicine (eds. Ian Freckelton, Danuta Mendelson), Aldershot, Ashgate Publishing, 2002.
    16. Stein Alex, “The Domain of Torts”, Columbia Law Review, Vol. 117, 2017.
    17. Stratton Kathleen, Ford Andrew, Rusch Erin, Wright Clayton Ellen (eds.), Adverse Effects of Vaccines: Evidence and Causality, Consensus Study Report, National Academies of Sciences, Engineering, and Medicine, Washington, 2012.
    18. Weinrib Ernest, “A Step Forward in Factual Causation”, Modern Law Review, No. 38/1975.
    19. Wright Richard, “Causation in Tort Law”, California Law Review, No. 73/1985.

    PROPISI I SUDSKE ODLUKE

    1. Закон о заштити потрошача, Службени гласник РС, бр. 62/2014 и 6/2016 (други закон).
    2. Пресуда Управног суда II–9 У 11958/2015 од 20. октобра 2015.
    3. Code civil des Français, Version consolidée au 1 octobre 2017, Internet, www.legifrance.gouv.fr, 20/10/2017.
    4. Consolidated version of the Treaty on the Functioning of the European Union (TFEU), OJ 115, 9 May 2008.
    5. Directive 85/374/EEC of 25 July 1985 concerning liability for defective products, OJ L 210, 7 August 1985, 29–33, amended by Directive 1999/34/EC concerning liability for defective products, OJ L 141, 4 June 1999, 20–21.
    6. Judgment of the Court (Fifth Chamber) of 21 January 2016, Case C-74/14, Eturas UAB and Others v Lietuvos Respublikos konkurencijos taryba, ECLI:EU:C:2016:42.
    7. Judgment of the Court (Fourth Chamber) of 20 November 2014, Case C‑310/13, Novo Nordisk Pharma GmbH v S., ECLI:EU:C:2014:2385.
    8. Judgment of the Court (Fourth Chamber) of 5 March 2015, Joined Cases C‑503/13 and C‑504/13, Boston Scientific Medizintechnik GmbH v AOK Sachsen-Anhalt – Die Gesundheitskasse and Betriebskrankenkasse RWE, ECLI:EU:C:2015:148.
    9. Judgment of the Court (Second Chamber) of 21 June 2017, Case C–621/15, N.W and others v Sanofi Pasteur MSD SNC and others, ECLI:EU:C:2017:484.
    10. Judgment of the Court (Sixth Chamber) of 15 October 2015, Case C-310/14, Nike European Operations Netherlands BV v Sportland Oy, ECLI:EU:C:2015:690.
    11. Opinion of Advocate General Michal Bobek, 7 March 2017, Case C‑621/15, N.W and others v Sanofi Pasteur MSD SNC and others, ECLI:EU:C:2017:176.

    IZVORI SA INTERNETA

    1. Вакцине се сада могу кривити за болести без научних доказа, Internet, www.ba.n1info.com/a170625/Svijet/Svijet/Vakcine-se-sada-mogu-kriviti-za-bolesti-bez-naucnih-dokaza.html, 20/10/2017.
    2. Контроверзна пресуда Европског суда о вакцинама: Ова одлука могла би да угрози животе милиона деце, Internet, www.blic.rs/vesti/drustvo/kontroverzna-presuda-evropskog-suda-o-vakcinama-ova-odluka-mogla-bi-da-ugrozi-zivote/586wr1x, 20/10/2017.
    3. Anti-vaxxers Triumph? EU Court Says Vaccines Can Be Blamed for Diseases Without Proof, Internet, www.haaretz.com/science-and-health/1.797069, 20/10/2017.
    4. Decision by Europe’s top court alarms vaccine experts, Internet, http://www.sciencemag.org/news/2017/06/decision-europe-s-top-court-alarms-vaccine-experts, 20/10/2017.
    5. EU court: Vaccines can be blamed for illness without scientific evidence, Internet, www.edition.cnn.com/2017/06/21/health/vaccines-illness-european-court-bn/index.html, 20/10/2017.
    6. EU court: Vaccines can be blamed for illnesses without proof, Internet, https://www.apnews.com/b0dd5e7933564f45bd3f4d55eedd40ae, 20/10/2017.
    7. European Court of Justice ruling could open floodgates for spurious vaccination claims, Internet, www.telegraph.co.uk/science/2017/06/22/european-court-justice-ruling-could-open-floodgates-spurious, 20/10/2017.
    8. Science Won’t Save Vaccines From Lawsuits Anymore, Internet, www.foreignpolicy.com/2017/06/26/science-wont-save-vaccines-from-lawsuits-anymore, 20/10/2017.
    9. Scientific evidence about vaccines and the EU Court, Internet, https://www.euroscientist.com/scientific-evidence-eu-court, 20/10/2017.
    10. Scientific Evidence and the EU Court, Internet, www.factcheck.org/2017/07/scientific-evidence-eu-court, 20/10/2017.
    11. Vaccine ruling from Europe’s highest court isn’t as crazy as scientists think, Internet, www.nature.com/news/vaccine-ruling-from-europe-s-highest-court-isn-t-as-crazy-as-scientists-think-1.22222, 20/10/2017.
    12. Vaccines can be blamed for any illness even with lack of evidence says EU court, Internet, www.news-medical.net/news/20170621/Vaccines-can-be-blamed-for-any-illness-even-with-lack-of-evidence-says-EU-court.aspx, 20/10/2017.
    13. Vaccines can be deemed defective without scientific proof, EU court rules, Internet, www.fiercepharma.com/vaccines/eu-court-rules-vaccines-can-be-deemed-defect-without-scientific-proof, 20/10/2017.
    14. WHO Information Sheet: Observed Rate of Vaccine Reactions. Hepatitis B Vaccine, June 2012, Internet, www.who.int/vaccine_safety/initiative/tools/Hep_B_Vaccine_rates_information_sheet.pdf, 20/10/2017.

     

PERIODIKA Srpska politička misao 4/2017 УДК 347.5:614.47]:341.645(4-672EU) 137-159
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