Conflict of interest in Health Technology Assessment decisions: case law in France and impact on reimbursement decisions

Article English OPEN
Frybourg, Sandrine ; Remuzat, Cécile ; Kornfeld, Åsa ; Toumi, Mondher (2015)
  • Publisher: Journal of Market Access & Health Policy
  • Journal: Journal of Market Access & Health Policy, volume 3, issue 1 (eissn: 2001-6689)
  • Related identifiers: doi: 10.3402/jmahp.v3.25682, pmc: PMC5956286
  • Subject: Research Article | Council of State | HTA | Loi Bertrand | conflict of interest | HAS | Sunshine Act | Debate Pieces

The slow reaction of French authorities to the so-called Mediator® saga in 2009 in France led to investigations that questioned the way conflicts of interest are reported. France implemented the Loi Bertrand (‘Bertrand Law’) in May 2013, known as the ‘French Sunshine Act’, with the aim of specifying the scope of disclosure obligations. This policy research reviewed the Loi Bertrand and reported case law from the French Council of State (COS) related to conflicts of interest in French Health technology assessment (HTA) opinion. The Loi Bertrand requires the publication of most of the agreements concluded between health-care professionals and companies and covers a vast range of health products. Commercial sales agreements of goods and services concluded between manufacturers and health-care professionals are a strong exception to this disclosure obligation. Six cases examined by the COS were analyzed, most of them related to the publication of guidelines or the removal of products from the list of reimbursed drugs and devices. These cases have been reviewed, as well as the impact of the ruling on reimbursement decisions. Four cases led to suspension or invalidation of decisions based on the Haute Autorité de Santé (HAS) recommendations due to conflicts of interest. In the two other cases, the HAS provided post hoc declarations of interest when required by the COS, and the COS considered the conflicts of interest as irrelevant for the decision. It appears that the COS based its decisions on two main criteria: the acknowledgement of negative conflicts of interest (a link with competitors) and the absence of declarations of conflicts of interest, which have to be presented when required by legal authorities irrespective of when they were completed (even posterior to the HAS opinion). However, the number of cases that have been decided against the HAS remains very limited with respect to the volume of assessments performed yearly. The strengthening of the regulation on declarations of interest might lead to more transparency but also to more cases decided by the COS. A new press investigation (in March 2015) related to alleged cases of conflict of interests led policy makers to amend the Bertrand Law in April 2015 and require the disclosure of amounts paid to health-care professionals by the industry.Keywords: conflict of interest; Sunshine Act; Loi Bertrand; HAS; Council of State; HTA(Published: 9 December 2015)Citation: Journal of Market Access & Health Policy 2015, 3: 25682 - http://dx.doi.org/10.3402/jmahp.v3.25682
  • References (46)
    46 references, page 1 of 5

    1. Chazan D. France pledges reform after diabetes drug scandal BBC News [Internet]. 2011. Available from: http://www.bbc.co. uk/news/world-europe-12200506 [cited 2014 June 18].

    2. Legifrance. [Law no. 2011 2012, related to the reinforcement of the health safety of drugs and health products]. 2011. Available from: http://www.legifrance.gouv.fr/affichTexte.do?cidTexte JORFTEXT000025053440&categorieLien id [cited 2014 June 18].

    3. Lo B, Field MJ. Conflict of interest in medical research, education, and practice. Washington, DC: National Academies Press; 2009.

    4. Chailland M. [Explanatory dictionary of waters and forests] [Archive], Vol 1, Google books, page 115.

    5. Grassley C. Grassley, Kohl say public should know when pharmaceutical makers give money to doctors. 2007. Available from: http://www.grassley.senate.gov/news/news-releases/ grassley-kohl-say-public-should-know-when-pharmaceuticalmakers-give-money [cited 2014 June 18].

    6. Federal Register. Medicare, Medicaid, Children's Health Insurance Programs; Transparency reports and reporting of physician ownership or investment interests [updated August 2013]; 2013. Available from: https://www.federalregister.gov/ articles/2013/02/08/2013-02572/medicare-medicaid-childrenshealth-insurance-programs-transparency-reports-and-reportingof [cited 2014 June 18].

    7. Mullard A. Mediator scandal rocks French medical community. Lancet. 2011;377:890 2.

    8. Le Monde. [Mediator: Two counsellors of Xavier Bertrand in 2006 had acquaintances with Servier]. 2011. Available from: http://www.lemonde.fr/societe/article/2011/01/11/mediator-deuxconseillers-de-xavier-bertrand-en-2006-avaient-des-liens-avecservier_1464316_3224.html [cited 2014 June 18].

    9. Haute Autorite´ de Sante´. [Clarification of the Haute Autorite´ de Sante´ on Mediator]. 2010. Available from: http://www.has-sante. fr/portail/jcms/c_1004608/fr/mise-au-point-de-la-haute-autorite-de-sante-sur-mediator [cited 2014 June 18].

    10. Legifrance. [Decree no. 2013-414, related to the transparency of benefits granted by enterprises producing or marketing sanitary and cosmetic products intended for human use]. 2013. Available from: http://www.legifrance.gouv.fr/affichTexte. do;jsessionid ?cidTexte JORFTEXT000027434029&date Texte &oldAction rechJO&categorieLien id [cited 2014 June 18].

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