Tag Archives: Italian Association of Pharmaceutical Companies

An Update on the Latest Amendments to the Italian Pharma Industry Association’s Code of Ethics

Amendments to the Italian pharmaceutical industry association’s (Farmindustria) Code of Ethics have been introduced on January 19, 2022 https://www.farmindustria.it/app/uploads/2018/06/2022-GENNAIO-19.pdf.

One of the most important changes concerns section 4.7, which defines Patient Support Programs (PSP) as initiatives implemented by pharmaceutical companies aimed at making available additional services for the direct benefit of patients. Such services are not intended to replace the services of hospitals and other healthcare organizations. For more information on PSP, check out our previous blog post https://lawhealthtech.com/2022/02/07/new-guidelines-on-patient-support-programs-adopted-by-italian-pharma-industry-association/ .

Besides, other important amendments have been introduced:

  • Training and Information to Non-Prescribers: new section 3.25 (i) allows pharmaceutical companies to carry out training and information activities aimed at healthcare professionals who are not authorized to prescribe medicines, but are involved in the treatment management, provided that such activities do not have any promotional purpose and that the information provided is linked to their roles in patients’ treatment management; and (ii) extends to such professionals the possibility to attend events, courses and congresses, as long as such events do not concern topics relating to medicines;
  • Information to the Public: new section 3.26 (i) allows pharmaceutical companies to provide unsolicited information to the public, through personnel not belonging to commercial or marketing areas, relating to products and diseases pertaining to the relevant therapeutical area, provided that such information does not have a commercial nature and matches the information set forth in the package leaflet or institutional information channels; and (ii) confirms that a full literal reproduction of the package leaflet information may be published on the companies’ websites available to the public;
  • Interactions Other than Medicines Promotion: new section 3.28 (i) allows pharmaceutical companies to provide information on medicines to various stakeholders such as institutions, professionals, organizations, etc., without this falling within the scope of medicines promotion; and (ii) specifically regulates the possibility to carry out, during the medicine’s life cycle, institutional and market access activities or other non-promotional interactions towards institutions and health care professionals, as well as account management activities aimed at ensuring the application of commercial policies through interactions with public or private counterparties involved in the medicines procurement processes and activities aimed at the mutual sharing of non-promotional information and data.

The above new provisions of the industry Code of Ethics undoubtedly aim at regulating several aspects of the day-to-day promotional and educational activities of pharmaceutical companies that have been so far ignored by the industry association regulations. However, the new previsions are quite vague in their scope and it remains to be seen whether they will have any meaningful impact on the market practices in the pharmaceutical sector.

The Italian Administrative Supreme Court Opens New Perspectives for Therapeutic Equivalents

By rejecting an appeal from Novartis, the Italian Administrative Supreme Court, with its decision n. 1306 of April 1st, 2016, focused on the notion of therapeutic equivalence under Italian law. Having underlined the difference with the concept of bioequivalence and having broadened its possible future application, the decision is likely to push forward the trend of public health care institutions to increase competition between pharmaceutical companies in the context of public tender offers, possibly for the benefit of taxpayers and patients.

The controversy arose from an opinion issued by the Italian Medicines Agency (“AIFA”) which, in a tender procedure held by Tuscany region, evaluated the drug Lucentis by Novartis (active ingredient ranibizumab) as a therapeutic equivalent to Eylea by Bayer (active ingredient aflibercept). This allowed the regional public administration to have the said drugs compete against each other in the same tender offer.

Debates as to whether Lucentis and Eylea are equivalent in terms of functions are not indeed new in the pharmaceutical scene and have caused many headaches to Novartis, let alone the critical issues raised in relation to Lucentis by the Italian Antitrust Authority.  Not a surprise, then, that Novartis tried to defend its product, alleging the illegitimacy and erroneousness of AIFA’s evaluation, which stated that the cheaper option by Bayer (Euro 780) is equally safe and effective in the treatment of macular degeneration as it is its more expansive (Euro 902) drug.

Novartis, nevertheless, failed in its claims. The Italian Administrative Supreme Court confirmed the validity and correctness of AIFA’s evaluation, together with the decision of the lower court, affirming, inter alia, that:

  • therapeutic equivalence is different from bioequivalence because the latter implies the identity of the active ingredient whether the former does not (indeed, FDA’s indications on the issue are rather similar);
  • the authority of AIFA in determining therapeutic equivalence is legitimate under Italian law;
  • evaluations regarding therapeutic equivalence cannot be based exclusively on the products’ leaflet: they are instead well motivated if they verify that (i) the drugs belong to the same Anatomical Therapeutic Chemical class; (ii) the drugs are subject to a similar route of administration and (iii) the drugs release the active ingredient in comparable ways.

Therapeutic equivalence, as it has recently emerged from Italian legislation and case law (in particular, from the decision discussed herein), is seen as a threat by pharmaceutical companies, unnerved by the increased competition effects.

Indeed, the debate has been escalated to a more general level by the Italian association of pharmaceutical companies, which challenged in many ways AIFA’s guidelines on therapeutic equivalence. As a consequence, a few days ago AIFA precautionary suspended for ninety days the said guidelines.

It looks like the match has just begun. Nevertheless, pharmaceutical companies should consider carefully on which side they should play. In fact, the expansion of the application of therapeutic equivalence, as a general trend, does not seem to be stoppable in a constant spending review context. Perhaps pharmaceutical companies should positively contribute to shape, rather than to stop, therapeutic equivalence and exploit its potential for the business in terms of new opportunities to access tender offer procedures.