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    • 21/10/2020
    • Articles

    Social Elections 2020 | What Are the Last Points of Attention?

    Referring to our Belgian Newsletter of July 2020, you will find in the news alert below an overview of the last points of attention regarding the social elections of 2020 (the Social Elections), which should be organised at the latest between 16 and 29 November 2020.

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    • 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:

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    • 19/10/2020
    • Newsletters

    VBB on Belgian Business Law, Volume 2020, No. 9

    The September 2020 issue of our Belgian Business Law newsletter reporting on the latest developments in a range of areas, including competition, data protection, intellectual property and labour law

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    • 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.

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    • 13/10/2020
    • Articles

    Court of Justice of European Union Rules on Updating of Documentation of Medicinal Products Subject to Parallel Import Licence

    Attached is a note discussing the judgment of the Court of Justice of the European Union (CJEU) in kohlpharma II. The judgment deals with updates to the documentation of medicinal products subject to a parallel import licence in situations where the marketing authorisation of the reference product in the Member State of importation has expired. It appears that the CJEU attaches a greater weight to the free movement principles than to the protection of public health.

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    • 12/10/2020
    • Articles

    Third Agreement for Supply of COVID-19 Vaccine between European Commission and Janssen Pharmaceutica

    As part of its European Vaccines Strategy adopted in June 2020 (see, Van Bael & Bellis Life Sciences News Alert of 18 June 2020), the European Commission (the Commission) announced on 8 October 2020 that it approved a third agreement providing for access to a potential vaccine against Covid-19 (see, attached press release). The Commission’s partner for this new agreement is Janssen Pharmaceutica (Janssen) which has promised to sell vaccines to EU Member States for up to 400 million people. Member States may decide to donate the vaccine to lower and middle income countries or redirect it elsewhere in Europe. The agreement follows similar deals with AstraZeneca and Sanofi-GSK (see, Van Bael & Bellis Life Sciences News Alert of 31 August 2020 and Van Bael & Bellis Life Sciences News Alert of 21 September 2020). Janssen is developing its Covid-19 vaccine on its AdVac® technology platform which also formed the basis for other existing and potential vaccines against such conditions as Ebola.

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    • 07/10/2020
    • Articles

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

    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).

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    • 07/10/2020
    • Articles

    United Kingdom - CMA to Investigate Withdrawal of Bipolar Medication under Competition Rules

    On 6 October 2020, the Competition and Markets Authority (CMA) started an inquiry into Essential Pharma to determine whether that company abused an allegedly dominant position when announcing the withdrawal from the UK market of Priadel®, a lithium based medicine indicated for the first line treatment of bipolar disorder and for the treatment and prophylaxis of recurrent depression and aggressive or self-harming behaviour (see, attached press release). Priadel® is also prescribed for the off label treatment of cluster headaches. The vast majority of UK patients who take a lithium based medicine rely on Priadel®. Only a small minority of the relevant patient group use other medicines such as Camcolit®, also supplied by Essential Pharma, and Liskonum®, whose marketing authorisation is held by Teofarma. According to the CMA, the withdrawal of Priadel® raises two major issues. First, switching bipolar medication is a delicate health matter because patients should as a rule be kept on the same brand of lithium to ensure that a consistent serum lithium level is maintained. For its part, the Medicine and Healthcare Products Regulatory Agency advised in a supply disruption alert that the switching of products will require individualised determination of dose, close monitoring of serum lithium levels and vigilance for relapse and tolerability in all cases. Second, the remaining treatments on the market are more expensive. The CMA expressed its appreciation for Essential Pharma’s decision to continue supplies of Priadel® pending pricing discussions with the UK Department of Health and Social Care.

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    • 01/10/2020
    • Articles

    Belgium - New Federal Government Announces Tough Budgetary Environment but also Support for Life Sciences Industry

    The newly formed Belgian federal government has identified healthcare as its highest priority (see, attached report of the government’s architects, Messrs. De Croo and Magnette – Dutch and French versions – the Report). This focus is exemplified in a wide range of measures that involve tackling the Covid-19 crisis and preparing for new similar epidemics. It also gives rise to significant additional budgetary spending of EUR 1.2 billion on healthcare staff and mental healthcare (these are outlays that have actually already been earmarked in Parliament and in an industry agreement with union representatives) and a special budget line for Covid-19 related matters. In addition, the overall healthcare budget will be allowed to increase in real terms by 2.5% per year. However, this rate of growth will not necessarily apply to all components of the healthcare budget. Some parts, including that covering medicines, will remain “stable” over a number of years (Report, Dutch version, p. 11). In the same vein, the “excessive consumption of care and medicines” will be tackled (Report, p. 10) and specific measures will seek to reduce prescriptions of antibiotics, antidepressants and antacids (Report, p. 13). In order to contain the medicines budget, the Report relies on established recipes such as international cooperation (Beneluxa cooperation and joint procurement mechanisms at the European level); the “efficient use” of medicines; a medicines policy that reflects the “needs of citizens” and is in the interest of public health; and an increased market share of inexpensive medicines and biosimilars (Report, p. 13). The Report also promises a “thorough reform” of pricing and reimbursement procedures and managed entry agreements (Report, p. 13). While the Report points to a tough budgetary environment for pharmaceuticals, it also indicates a willingness of the government to support the life sciences industry and create a “health and biotech valley” that is conducive to research and development, clinical trials and local production (Report, p. 13). On the point of local manufacturing, the Report echoes a concern voiced across Europe that the production of strategic medicines and active substances should occur locally (see e.g., Van Bael & Bellis Life Sciences News Alert of 25 September 2020). Interestingly, the government promises to maintain the channels of communication which the previous government had established and will seek to conclude a new agreement with the pharmaceutical sector defining mutual rights and obligations.

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