I Know What This Drug Did Last Summer: Pharmacovigilance as a Mechanism For Consumer Protection
DOI:
https://doi.org/10.11606/issn.2316-9044.rdisan.2023.192083Keywords:
Consumer Protection, Drugs, Pharmacovigilance, PreventionAbstract
Drugs are, by their own nature, especially risky products, in particular those that just reached the market and were developed in a short time, such as the COVID-19 vaccines. The potential hazards they can involve for patients/consumers require additional measures of consumer protection, in addition to the general legal framework of manufacturer’s liability. This paper focused on one of these additional measures: pharmacovigilance, i.e., the post-commercialization monitoring of pharmaceutical products, from the perspective of European law. The aim of this paper was to demonstrate the role of pharmacovigilance in the prevent ion of harm caused by defective drugs and consequent consumer protection, highlighting its benefits and flaws. Pharmacovigilance is not a miraculous solution and has its flaws. However, it can be a useful tool for the management of benefit-risk to ensure appropriate drug use after marketing. Liability for defective products only addresses compensation for injur ies that already occurred, while pharmacovigilance intervenes ex-ante to prevent the occurrence of some of those damages.
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ABBOTT, Ryan. Big data and pharmacovigilance: using health information exchanges to revolutionize drug safety. Iowa L. Rev., v. 99, p. 225-292, 2013. Available at: https://ilr.law.uiowa.edu/sites/ilr.law.uiowa.edu/files/2023-02/ILR-99-1-Abbott.pdf.
AGÊNCIA NACIONAL DE VIGILÂNCIA SANITÁRIA - ANVISA. Instrução Normativa (IN) n. 63, de 22 de julho de 2020. Available at: https://www.in.gov.br/en/web/dou/-/instrucao-normativa-in-n-63-de-22-de-julho-de-2020-269155503. Accessed on: 2 Nov. 2022.
AGÊNCIA NACIONAL DE VIGILÂNCIA SANITÁRIA - ANVISA. Resolução da Diretoria Colegiada (RDC) n. 406, de 22 de julho de 2020. Available at: https://www.in.gov.br/en/web/dou/-/resolucao-de-diretoria-colegiada-rdc-n-406-de-22-de-julho-de-2020-269155491. Accessed on: 2 Nov. 2022.
AMERICAN MEDICAL ASSOCIATION - AMA. AMA Code of Medical Ethics. 8.8 Required Reporting of Adverse Events. Available at: https://code-medical-ethics.ama-assn.org/sites/amacoedb/files/2022-08/8.8.pdf.
APIFARMA. Ensaios Clínicos em Portugal. 2013. Available at: https://www.aibili.pt/ficheiros/EstudoInvestigClinica_em_Portugal_jun2013vf.pdf. Accessed on: 10 August 2021.
ARNARDOTTIR, Arna H. et al. Additional safety risk to exceptionally approved drugs in Europe? Br. J. Clin. Pharmacol., v. 72, n. 3, p. 490-499, Sept. 2011. https://doi.org/10.1111/j.1365-2125.2011.03995.x.
ARZNEIMITTELGESETZ – AMG (Gesetz über den Verkehr mit Arzneimitteln). Available at: https://dejure.org/gesetze/AMG. Accessed on: 28 Oct. 2022.
BALDO, Paolo; FRANCESCON, Sara: FORNASIER, Giulia. Pharmacovigilance workflow in Europe and Italy and pharmacovigilance terminology. International Journal of Clinical Pharmacy, v. 40, n. 4, p. 748-753, 2018. Available at: https://link.springer.com/content/pdf/10.1007/s11096-018-0711-z.pdf. https://doi.org/10.1007/s11096-018-0711-z, at 750-752.
BARD, Jennifer S. Putting patients first: how the FDA could use its existing powers to reduce post-market adverse events. IHLR, v. 10, p. 495-557, 2013. Available at: https://mckinneylaw.iu.edu/ihlr/pdf/vol10p495.pdf.
BARRY, Arden R.; KOSHMAN, Sheri L.; PEARSON, Glen J. Adverse drug reactions: the importance of maintaining pharmacovigilance, CPJ/RPC, v. 147, n. 4, p. 233-238, 2014.
BÉGAUD, B.; CHASLERIE, A.; HARAMBURU, F. Organization and results of drug vigilance in France. Rev. Epidemiol. Sante Publique, v. 42, p. 416-423, 1994.
BENNETT, C. et al. Evaluation of serious adverse drug reactions: a proactive pharmacovigilance program (RA DAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturers. Archive Intern. Med., v. 157, n. 10, p. 1041-1049, 2007.
CAMPOS, Santiago Pereira; ORDIOZOLA, Miguel. Aplicando la normativa protectora de los consumidores por deficiencias en advertencias de riesgo en el prospecto de medicamentos. Revista de Direito Sanitário, v.19 n.1, p. 188-198, 2018. Available at: https://www.revistas.usp.br/rdisan/article/view/148136. https://doi.org/10.11606/issn.2316-9044.v19i1p188-198.
CANDORE, Gianmario et al. The impact of mandatory reporting of non-serious safety reports to EudraVigilance on the detection of adverse reactions. Drug Saf., v. 45, p. 83–95, 2022. Available at: https://link.springer.com/content/pdf/10.1007/s40264-021-01137-0.pdf. https://doi.org/10.1007/s40264-021-01137-0.
CHEN, Brian K.; YANG, Y. Tony. Post-marketing surveillance of prescription drug safety: past, present, and future. J. Legal Med., v. 34, n. 2, p. 193-213, 2013. https://doi.org/10.1080/01947648.2013.800797.
EDWARDS, I. R.; ARONSON, J. K. Adverse drug reactions: definitions, diagnosis, and management. Lancet, v. 356, n. 9237, 1255-1259, 2000. https://doi.org/10.1016/S0140-6736(00)02799-9.
EMA’s governance during COVID-19 pandemic. European Medicines Agency, 2020. Available at: https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/emas-governance-during-covid-19-pandemic. Accessed on: 27 Oct. 2022.
EUDRAVIGILANCE – European Database of suspected adverse drug reaction reports. Available at: https://www.adrreports.eu/.
EUROPEAN MEDICINES AGENCY - EMA. EMA/333964/2020. Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines. Available at: https://www.ema.europa.eu/en/documents/other/pharmacovigilance-plan-eu-regulatory-network-covid-19-vaccines_en.pdf. Accessed on: 21 June 2021.
EUROPEAN MEDICINES AGENCY – EMA. Guidance on the Format of the Risk Management Plan (RMP) in the EU – In Integrated Format, 2017. Available at: https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-rmp-eu-integrated-format-rev-2_en.pdf.
EUROPEAN MEDICINES AGENCY – EMA. Safety of COVID-19 vaccines. Available at: https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/safety-covid-19-vaccines. Accessed on: 20 Oct. 2022.
EUROPEAN Medicines Agency recommends withdrawal of medicinal products containing veralipride. European Medicines Agency, 23 July 2007. Available at: https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-withdrawal-medicinal-products-containing-veralipride. Accessed on: 4 Nov. 2021.
EUROPEAN PATIENTS’ FORUM – EPF. The New EU pharmacovigilance legislation: Directive 2010/84/EU and Regulation No. 1235/2010 Guidance for Patient Organisations, 2012. Available at: https://www.eu-patient.eu/globalassets/policy/pharmaceuticalpackage/epf-guidance-pharmacovigilance-for-patient-organisations.pdf. Accessed on: 21 June 2021.
EUROPEAN UNION - EU. Commission Implementing Regulation (EU) n. 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council. Available at: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:159:0005:0025:EN:PDF. Accessed on: 2 Nov. 2022.
EUROPEAN UNION - EU. Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A31985L0374.
EUROPEAN UNION - EU. Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. 2010a. Available at: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF. Accessed on: 2 Nov. 2022.
EUROPEAN UNION - EU. Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance. Available at: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:299:0001:0004:EN:PDF. Accessed on: 2 Nov. 2022.
EUROPEAN UNION – EU. COM(2022) 495 - Proposal for a directive of the European Parliament and of the Council on liability for defective products. Available at: https://single-market-economy.ec.europa.eu/document/3193da9a-cecb-44ad-9a9c-7b6b23220bcd_en. Accessed on: 11 nov. 2023.
EUROPEAN UNION - EU. Regulation (EU) n. 1027/2012 of the European Parliament and of the Council of 25 October 2012 amending Regulation (EC) n. 726/2004 as regards pharmacovigilance. Available at: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:316:0038:0040:EN:PDF. Accessed on: 2 Nov. 2022.
EUROPEAN UNION - EU. Regulation (EU) n. 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) n. 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) n. 1394/2007 on advanced therapy medicinal products. 2010b. Available at: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF. Accessed on: 2 Nov. 2022.
EVANS, Barbara J. Seven pillars of a new evidentiary paradigm: the food, drug, and cosmetic act enters the genomic era. Notre Dame L. Rev., v. 85, p. 419-524, 2010. Available at: https://scholarship.law.nd.edu/cgi/viewcontent.cgi?article=1154&context=ndlr.
FAUS, Jordi et al. Medicinal product regulation and product liability in Spain: overview. 2020. Available at: https://www.faus-moliner.com/wp-content/uploads/2020/02/2018-09-01-Art%C3%ADculo.pdf. Accessed on: 1 Nov. 2022.
FERREIRA-DA-SILVA, Renato et al. The role of pharmacovigilance in the COVID-19 pandemic. Acta Med. Port., v. 34, n. 3, p. 173-175, Mar. 2021. Available from: https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/15375. Accessed on: 16 Nov. 2022.
GLAXOSMITHKLINE to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data. Office of Public Affairs, July 2, 2012, https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report.
GONZÁLEZ CASTILLO, Joel. Products liability in Europe and the United States. Revista Chilena de Derecho, v. 39, n. 2, 2p. 77-296, 2012. Available from: https://www.scielo.cl/pdf/rchilder/v39n2/art03.pdf. https://dx.doi.org/10.4067/S0718-34372012000200003.
GONZÁLEZ SANCHIDRIÁN, Silvia; MARÍN ÁLVAREZ, Jesús Pedro; DEIRA LORENZO, Javier et al. Serratia marcescens bacteraemia outbreak in haemodialysis. Comment on “Serratia marcescens bacteraemia outbreak in haemodialysis patients with tunnelled catheters due to colonisation of antiseptic solution. Experience in 4 hospitals. Nefrologia, v. 38, n. 1, p. 94-96, 2018. https://doi.org/10.1016/j.nefro.2016.12.003.
GORDON, Paul. Fear of the soul: in defence of therapeutic freedom. Journal of the Society for Existential Analysis, v. 24, n. 2, 17-228, 2013.
GREEN, Michael D. Prescription drugs, alternative designs, and the restatement (third): preliminar reflections. Seton Hall L. Rev., v. 30, p. 207-231,1999. .
GUIDANCE for Industry: E2BM data elements for transmission of individual case safety reports. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER), April 2002. Available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073092.pdf. Accessed on: 5 Mar. 2021.
KLIKA, Christoph; KAEDING, Michael; SCHMÄLTER, Julia. The EU Pharmacovigilance System and adverse drug reaction reporting in practice: a critical assessment. European Journal of Risk Regulation, v. 8, n. 4, p. 772-778, 2017. https://doi.org/10.1017/err.2017.67.
KOVAC, Mitja et al. Pharmaceutical Product Liability, Litigation Regimes, and the Propensity to Patent: An Empirical Firm-Level Investigation. SAGE Open, v. 11, n. 2, 2021. https://doi.org/10.1177/21582440211009470.
LASSER, Karen E. et al. Timing of new black box warnings and withdrawals for prescription medications. JAMA, v. 297, n. 17, p. 2215-2220, 2002.
LENGSAVATH, Marina et al. Social media monitoring and adverse drug reaction reporting in pharmacovigilance: an overview of the regulatory landscape. TIRS, v. 51, n. 1, p. 125-131, 2017. https://doi.org/10.1177/2168479016663264.
LOUGHLIN, Kevin; GENERALI, Joyce. The guide to off-label prescription drugs: new uses for FDA-approved prescription drugs. New York: Free Press, 2006.
MANN, Justin. FDA adverse event reporting system: recruiting doctors to make surveillance a little less passive. Food and Drug Law J., v. 70, n, 3, p. 371-394, 2015.
MATOS, Cristiano; HUNSEL, Florence van; JOAQUIM, João. Are consumers ready to take part in the pharmacovigilance system? - a portuguese preliminary study concerning ADR reporting. Eur. J. Clin. Pharmacol., v. 71, n. 7, p. 883-890, 2015. https://doi.org/10.1007/s00228-015-1867-2, at 883.
MAZZITELLO, Carmela et al. Pharmacovigilance in Italy: an overview. J. Pharmacol. Pharmacother., v. 4, n. 1, p. S20-S28, 2013. https://doi.org/10.4103/0976-500X.120942.
MCBRIDE, W.G. Thalidomide and congenital abnormalities. Lancet, v. 278, n. 7216, p. 1358, Dec. 1961. https://doi.org/10.1016/S0140-6736(61)90927-8.
MCINTYRE, J. et al. Unlicensed and off label prescribing of drugs in general practice. Arch. Dis. Child, v. 83, n. 6, p. 498-501, 2000. https://doi.org/10.1136/adc.83.6.498.
MCNAUGHTON, Rhian; HUET, Gwenaël; SHAKIR, Saad. An investigation into drug products withdrawn from the EU market between 2002 and 2011 for safety reasons and the evidence used to support the decision-making. BMJ, v. 4, n. 1, p. e004221, 2014. https://doi.org/10.1136/bmjopen-2013-004221.
MEYER, Harrison. Collective products liability actions in the European Union and the United States: a Vioxx case study. International Law and Politics Online, n. 53, p. 18-26, at 20-22, 2020. Available from: https://www.nyujilp.org/wp-content/uploads/2021/02/Meyer-Formatted.pdf.
MUJALLID, Osama; ALGHAMDI, Salem. ADR reporting through Twitter from patient perspective. In: TWENTY-FOURTH AMERICAS CONFERENCE ON INFORMATION SYSTEMS, 2018. Available at: https://aisel.aisnet.org/cgi/viewcontent.cgi?article=1558&context=amcis2018. .
OWEN, David G. Deterrence and desert in tort: a comment. Calif. L. Rev., v. 73, p. 665-676, 1985. https://doi.org/10.2307/3480339.
PEPE, Vera Lúcia Edais; HILLEGONDA, Maria Dutilh Novaes. Sistema Nacional de Farmacovigilância no Brasil e em Portugal: semelhanças, diferenças e desafios. Cadernos de Saúde Pública, Reports in Public Health, v. 36, n. 7, e00043019, 2020. Available from: https://www.scielo.br/j/csp/a/tKrThkFd8QvGbfVgfJFYCJK/?format=pdf&lang=pt. https://doi.org/10.1590/0102-311X00043019.
RÄGO, Lembit; SANTOSO, Budiono. Drug regulation: history, present and future. In: VAN BOXTEL, Chris; SANTOSO, Budiono; EDWARDS, I. Ralph (Eds.). Drug benefits and risks: international textbook of clinical pharmacology (revised 2nd edition). IOS Press and Uppsala Monitoring Centre, 2008.
RAPOSO, Vera Lúcia. Danos causados por medicamentos: enquadramento jurídico à luz do ordenamento europeu. Almedina; Coimbra, 2018.
RAPOSO, Vera Lúcia. Pigs don't fly and you cannot expect absolutely safe COVID-19 vaccines (but you should expect a fair compensation). Eur. J. Health Law, v. 28, n. 2, p. 165-183, Apr. 2021. https://doi.org/10.1163/15718093-BJA10042.
RAPOSO, Vera Lúcia. Prescrição off-label de medicamentos e de dispositivos médicos. Lex Medicinae, v. 11, n. 21, p. 35-75, 2014.
RAPOSO, Vera Lúcia. Safe drugs versus innovative drugs (can we have both?). Advanced Pharmaceutical Bulletin, v. 10, n. 3, p. 334-337, 2020. https://doi.org/10.34172/apb.2020.041.
RAPOSO, Vera Lúcia; MORBEY, Wei Wang. Product liability in Europe and China. China Legal Science, v. 60, 2015.
RICH, Robert. Reaching Closure on Health-Related Controversies. In: AGICH, George (Ed.) Responsibility in health care. US, London: D. Reidel Publishing Company, 1982. p. 245-259.
RODWIN, Marc A. Five un-easy pieces of pharmaceutical policy reform. J. Law Med. Ethics, v. 41, n. 3, p. 581-589, 2013. https://doi.org/10.1111/jlme.12067.
SAHU, Ram Kumar et al. Adverse Drug reactions monitoring: prospects and impending challenges for pharmacovigilance. SpringerPlus, v. 3, 2014. Available from: https://springerplus.springeropen.com/counter/pdf/10.1186/2193-1801-3-695.pdf. https://doi.org/10.1186/2193-1801-3-695.
SANTORO, A. et al. Promoting and Protecting public health: how the european, union pharmacovigilance system works. Drug Saf., v. 40, n. 10, p. 855-859, 2017. https://doi.org/10.1007/s40264-017-0572-8.
SCHATZ, Stephanie N.; WEBER, Robert J. Adverse drug reactions. CNS/Pharmacy Practice, p. 5-26, 2015. Available from: https://www.accp.com/docs/bookstore/psap/2015B2.SampleChapter.pdf.
SCIENCE PHARMA. What is Eudravigilance? Available at: https://www.sciencepharma.com/blog/what-is-eudravigilance/. Accessed on 1 Nov. 2022.
SHARRAR, Robert G.; DIECK, Gretchen S. Monitoring Product safety in the postmarketing environment. Ther. Adv. Drug Saf., v. 4, n. 5, p. 211-219, 2013. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4125313/pdf/10.1177_2042098613490780.pdf. https://doi.org/10.1177/2042098613490780.
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