AUTH/3414/11/20 - Complainant v Novartis

Alleged promotion of pipeline products on company website

  • Received
    04 November 2020
  • Case number
  • Applicable Code year
  • Completed
    16 July 2021
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous, contactable complainant complained about the promotion of three pipeline products (QGE031, QMF149 and QVM149) on a Novartis Pharmaceuticals UK Ltd webpage.

The complainant noted the table of pipeline products on the webpage and alleged that one of the three pipeline products promoted was QGE031 (ligelizumab) subcutaneous injection which was an anti-IgE monoclonal antibody with the potential indication of chronic spontaneous urticaria which was in Trial Phase II with a planned filing date of 2021. The complainant stated that there was clear mention of indication, generic names and mechanism of action. The complainant concluded that his/her complaint was similar to Cases AUTH/3037/4/18 and AUTH/3274/10/19 and that as there was no restriction to members of the public and health professionals, there were many breaches of the Code.

The detailed response from Novartis is given below.

In the Panel’s view, it was not necessarily unacceptable for a company to refer in general terms to its pipeline products on its corporate website, however, language, context, location, layout, intended audience and overall impression were important factors when deciding whether such references were acceptable. Such references should not, otherwise, constitute promotion of an unlicensed medicine.

The Panel noted Novartis’ submission that the webpage at issue was not directed at health professionals and was not located in a promotional section of the Novartis website; it was hosted on the Novartis corporate website which had a broader intended audience solely for information purposes and to demonstrate its commitment to research in respiratory care. The company submitted that the Novartis’ corporate website was not intended to be promotional. Access to the page required a reader to click through three different links; the webpage could be found by going to the Novartis UK website homepage, and clicking on ‘Our Work’, then ‘Disease Area’, then ‘Our work in Respiratory and Inflammation’.

The Panel further noted Novartis’ submission that a reader could also potentially be led to the webpage by carrying out a web search. It was, however, unclear to the Panel what search terms would be required for this to occur.

The Panel noted that three products were listed within the table namely: QGE031 (ligeliizumab), QMF149 (indacaterol, mometasone furoate in fixed-dose combination), and QVM149 (indacaterol, mometasone furoate, glycopyrronium bromide in fixed-dose combination).

The downloaded page from the link provided by the complainant that included the table of data was introduced by:

‘At Novartis, we are focused on improving the lives of the millions of people affected by respiratory and inflammation diseases and continue to research, develop and launch innovative therapies which treat chronic obstructive pulmonary disease, chronic spontaneous urticaria and severe allergic asthma. The table below outlines our current research within respiratory and inflammation diseases.’

The common name (non-proprietary name), mechanism of action, potential indication/disease area, route of administration, trial phase and planning filing dates for all three products were stated within the table.

The Panel noted that below the table it stated ‘Click on the conditions for more information about our work’ followed by the heading ‘Asthma’ beneath which it provided asthma statistics within the UK and stated, inter alia, that ‘At Novartis, as well as furthering scientific research, we work to ensure people in need receive the most effective medicine for their condition as promptly as possible’. This was followed by some of the work that the company carried out including training for health professionals in severe allergic asthma and working with hospitals to conduct reviews and audits of their data on asthma exacerbations.

The Panel considered that whilst the style of the table was low key and included scientific information about what were, at the time of its publication, three potential products, the entire webpage might be seen as implying or claiming that QMF149 and QVM149 listed in the table were potentially effective, innovative treatments for severe allergic asthma. Whilst the reference to both products being in Phase III research might imply that their respective trials had not been successful and thus the planned filing in 2019 had not taken place, it might equally give the impression, in November 2020 at the time of the complaint, that the products were available or were likely to be available shortly. The information was, however, at the time of the complaint in November 2020, inaccurate as acknowledged by Novartis as both products were licensed.

The Panel considered that the information in the table within the context of the webpage, including the opening paragraph and information below the table, promoted QMF149 and QVM149 which were, at the time of the complaint, prescription only medicines to the public and breaches of the Code were ruled.

The Panel noted that QGE031 was not classified as a prescription only medicine at the time of the complaint. The Panel considered that the information provided in relation to QGE031 within the context of the opening paragraph and the inclusion of information on two of the company’s products, which were licensed at the time of the complaint, promoted an unlicensed medicine and a breach of the Code was ruled.

In addition to its comments above, the Panel noted that the webpage in question was neither directed to, nor limited to, an audience of health professionals and other relevant decision makers and thus was not advertising to that audience. The Panel, therefore, considered that the allegations relating to the promotion to health professionals were not relevant. The Panel ruled no breaches of the Code.

The Panel was very concerned to note that the webpage at issue, which had been issued in October 2016, had not been updated since then including when QMF149 and QVM149 received their marketing authorisations. The company had failed to maintain high standards in this regard and a breach of the Code was ruled as acknowledged by Novartis.

In the Panel’s view, on balance, noting its comments above, the circumstances in this particular case did not warrant a ruling of a breach of Clause 2 which was a sign of particular censure and reserved for such. The Panel therefore ruled no breach of Clause 2.