News from the Life Science sector - ENLI updates guides and QALY is postponed

ENLI's new guide - ENLI (the Ethical Committee for the Pharmaceutical Industry) has decided to allow the use of patients as speakers for a trial period of one year starting on 1 June 2020. Further, ENLI has updated its guides regarding financial support and pre-launch.

Starting on 1 June 2020, medicinal companies may use patients as speakers, however, presupposing that   several requirements are observed. The selection of patients must be made in cooperation with relevant patient associations, and the medicinal companies must be able to document how the patients were chosen. The patients can only speak about the disease as such and must not mention circumstances relating to the treatment with specific medicines. The patient presentation must be part of an event about the disease and must not be the sole or primary purpose of said event. The trial period allowing patients as speakers is described in ENLI's newsletter of 7 May 2020 here (in Danish only).

Further, ENLI's guide on financial support has been clarified with regard to transport and online meetings. According to the updated guide on financial support, online meetings are covered by ENLI's rules on promotion, including the requirement for professionalism; meaning that medicinal companies can support professional activities if most of the activity is professional. The updated guide are accessible here (in Danish only).

Additionally, the Q & A section in ENLI's guide regarding pre-launch has been updated, and ENLI has added Q & A's on whether and when medicinal companies can inform pharmacies of upcoming products, that medicinal companies cannot provide information on medicines not yet approved in Denmark at exhibition stands, based on which criteria they can mention such medicines in a press release, and whether medicinal companies can answer questions from journalists about medicines that have yet to be approved. You can see the new Q & A's (nos. 13, 15, 21 and 22) here (in English).

Postponement of QALY

Finally, due to the current COVID-19 situation, the implementation of the Danish Medicines Council's portended new assessment method, the so-called QALY measure, has been postponed three months from 1 October 2020, as originally planned, to 1 January 2021. See our earlier insight about the QALY method here (in English). The postponement has been approved by the board of the Danish Regions. According to the Danish Medicines Council, ongoing cases about new medicines, which have been subject to a dialogue meeting between the Danish Medicines Council and a medicinal company, and for which a preliminary application has been submitted prior to 1 January 2021, will be completed according to the present procedure and method. You can read the Danish Medicines Council's article about the postponement here (in Danish only).

Latest news on Life Science

Life Science