New interesting decisions from ENLI

In connection with the publication of ENLI's newsletter on 20 March 2023, a number of interesting decisions have been published. These concern, among other things: The boundary between information material and advertising, clarification of new practice on statements on environmental and climate issues in relation to the concept of professionalism, invitations to training events should be addressed to management, distribution of donated equipment to patients and sponsorship of podcast.

The boundary between information material and advertising

A pharmaceutical company experienced a high demand for knowledge about the treatment of a specific disease. The company therefore applied for prior authorisation to send unsolicited material in the form of an information leaflet on the treatment of the disease to healthcare professionals. The Investigator's Panel considered that this was advertising, in particular as

  1. the company would distribute the material unsolicited,
  2. the material mentioned, among other things, some of the company's own products; and
  3. the material contained an adapted and abridged reproduction of a treatment guide, which was not found to be unabridged and reproduced objectively or neutrally

The Investigator Panel also found that the Promotion Code's exception on "Disease Awareness" material did not apply, as the focus of the material was mainly on treatment. For material to be considered "Disease Awareness", information about disease must be in focus, and any information about treatment may only be limited.   

Clarification of practice on climate and environmental impact statements

Earlier this year, Plesner wrote about how ENLI had expanded the concept of professionalism so that it now also includes information on the environmental consequences of the use of medicines, provided that a number of conditions are met. ENLI has now clarified that this is not permitted in situations where a pharmaceutical company's other medicines are also mentioned. 

Invitations to training events must be sent to management 

It is ENLI's opinion that it is contrary to the regional agreements that posts about continuing education events, e.g. on LinkedIn, encourage the reader to contact a department manager for registration for events. It is ENLI's position that pharmaceutical companies should instead use the procedure described in the regional agreements. That is, invitations must be sent to the management, which itself decides whether employees should be offered continuing education. 

Distribution of donations to patients

In a decision made by ENLI's Appeals Board, a pharmaceutical company had donated cooler bags to a hospital, after which the hospital could pass these on to the patients. As the distribution was to be made via a hospital, and not the patients' own doctor, the Donation Code applied instead of the Promotion Code. Since the Donation Code does not contain provisions prohibiting hospitals from handing out donations to patients, and since the Donation Code states that the hospital has the right of disposal over donations, the hospital could hand out the cooler bags to the patients. 

However, the Investigators' Panel found that "branding" could not be applied to the bags. 

Sponsorship of podcasts

A pharmaceutical company had requested prior authorisation to sponsor a podcast on a disease area. The podcast was considered to be a continuing education event. The Investigator Panel found that advice on the choice of platform, launch and strategy was equivalent to planning activities, which is not authorised in the context of sponsoring training events. The company was therefore not authorised to sponsor these activities. 

Do you want to know more?

Read the full ENLI newsletter (in Danish)

Please feel free to contact Plesner's Life Science team if you want to know more.

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