Insights & news

Denmark - Danish Medicines Agency Vows to Step up Enforcement to Ensure Publication of Clinical Trial Results

  • 07/10/2020
  • Articles

The Danish Medicines Agency (DMA) announced on 6 October 2020 that it is stepping up enforcement against clinical trial sponsors who fail to report the results of clinical trials in accordance with applicable rules (see, attached press release). The DMA intends to avail itself in the future of the possibility offered by Danish law to request the public prosecutor to prosecute sponsors who fail to publish clinical trial results in a timely fashion. Such sponsors risk a fine or imprisonment of up to four months.
 
While the DMA would mainly seem to be targeting non-commercial sponsors, who allegedly fall short of their reporting obligations more often than commercial sponsors, the second category of sponsors should expect increased enforcement activity as well.
 
The DMA’s announcement illustrates and reflects a broader European trend towards increased transparency of clinical trial results. Further transparency with regard to clinical trials will be introduced through the EU Clinical Trials Information System (EU portal and EU database, together CTIS), which will centralise and contain detailed information on the authorisation, conducting and results of each clinical trial carried out in the EU. Subject to limited exceptions, this information will be publicly available. The go-live date of the CTIS has been postponed repeatedly due to IT difficulties. The European Medicines Agency has indicated that the audit of the CTIS, which is a necessary prerequisite for the system to go live, will commence in November 2020.
 
At present, the EU Clinical Trials Register already publishes summary results of interventional clinical trials conducted in the EU or in the European Economic Area (see, https://www.clinicaltrialsregister.eu/ctr-search/search).

Attachments:

Key contacts

Related practice areas

Related insights

Sign up for updates
    • 20/10/2020
    • Articles

    European Commission Presents 2021 Work Programme - Implications for Life Sciences

    The European Commission (the Commission) presented on 19 October 2020 its work programme for 2021 (the Work Programme) which outlines its ambitions for the coming year in a large series of policy areas ranging from the energy and climate remediation-centered European Green Deal over the digital economy to a push for European democracy. Life sciences and public health feature less prominently in the Commission’s plans than some observers may have expected. This somewhat guarded approach may be due in part to the Commission’s efforts that are already under way in matters such as the Covid-19 pandemic, the Pharmaceutical Strategy for Europe which the Commission intends to unveil on 24 November 2020, and Europe’s Beating Cancer Plan which the Commission is scheduled to adopt on 9 December 2020. The Work Programme announces the following health-related measures for 2021 under the banner of a European Health Union:

    Read more
    • 16/10/2020
    • Newsletters

    European Commission Seeks to Harmonise Member States' Vaccination Plans for COVID-19

    On 15 October 2020 the European Commission (the Commission) published a Communication entitled “Preparedness for COVID-19 vaccination strategies and vaccine deployment” (the Communication - see, attachment). The Commission thus seeks to harmonise Member States’ vaccination plans for tackling Covid-19. The plan logically follows from the Commission’s efforts to advance purchase possible Covid-19 vaccines. The Commission has already entered into agreements with three suppliers and three or four more such agreements are in the pipeline (see, Van Bael & Bellis Life Sciences News Alerts of 12 October 2020, 21 September 2020, and 31 August 2020). They all form part of the European Vaccines Strategy which the Commission unveiled at the beginning of the Summer (see, Van Bael & Bellis Life Sciences News Alert of 18 June 2020). In publishing the Communication, the Commission is now making further inroads into sensitive Member State terrain. As the Commission acknowledges, “the responsibility for health policy lies with Member States, and national strategies may differ due to several contributing factors such as different healthcare system capacities, population structure or epidemiological situation” (Communication, p. 9). At the same time, the Commission considers it important “to ensure the coordination of national responses to the pandemic” (Id.). On that basis, the Communication first identifies key elements “for effective Covid-19 vaccination strategies” and lists associated actions. These involve developing vaccination services, storage and transportation facilities and vaccination registries. Additionally, the Commission stresses the need for clear communication and for tackling head-on misinformation. Significantly, the Commission also contemplates studies of vaccine effectiveness and safety. The Communication’s second step is to have the Member States identify priority groups for the initial phases of vaccine deployment. The Communication cites such categories and again lists a series of associated preparatory actions. The Communication concludes with a number of bridging steps towards widespread vaccine availability.

    Read more

Subscribe to our updates

Please select the practice areas you are interested in: *