Insights & news

Belgium - Medicine Pricing | Avastin-Lucentis

  • 10/10/2019
  • Articles

On 9 October 2019, there was a second debate in federal parliament on the status and role of Avastin and Lucentis in opthalmological care (see, attached parliamentary proceedings). As was the case the preceding day in the plenary session of the federal Parliament (see, Van Bael & Bellis Life Sciences Newsflash of 9 October 2019), the new debate in the committee for health and equal opportunities was again tense and offered a platform for intervening members of parliament to publicise known positions that are highly critical of the approach adopted by the Minister of Social Affairs and Public Health towards Roche and Novartis and of the pharmaceutical industry in general.
For her part, the Minister firmly defended her policy explaining that (i) she had received expert advice against establishing the reimbursement of Avastin in the off-label indication for the treatment of wet age-related macular degeneration (“AMD”); and (ii) she had ensured, by concluding a Managed Entry Agreement with Novartis, that the price for the treatment of AMD with Lucentis would be equivalent to that of a hypothetical treatment of AMD with Avastin.
Several members of parliament advocated further hearings with representatives of the agencies involved in this file, including the Federal Agency for Medicines and Health Products, the Commission for the Reimbursement of Medicines and the Belgian Competition Authority (“BCA”).
In response to these requests, a hearing with the BCA, which received a complaint alleging anticompetitive arrangements between Lucentis and Novartis, will take place at an as yet unspecified date under the aegis of the committee for economic affairs. The debate promises to be interesting as it will afford the BCA the opportunity to explain its scrutiny of the pharmaceutical sector which it has earmarked as a priority industry for supervision. This is reflected in recent events, including the request of the Minister of Economic Affairs to the BCA to review the pricing practices of Leadiant (see, Van Bael & Bellis Life Sciences Newsflash of 9 September 2019) and the unannounced inspections earlier this week seeking to ferret out allegedly anticompetitive conduct hindering the market development of biosimilar products in the hospital channel (see, Van Bael & Bellis Life Sciences Newsflash of 8 October 2019).         

Key contacts

Related practice areas

Related insights

Sign up for updates
    • 12/02/2020
    • Articles

    UK Competition and Markets Authority Consolidates Hydrocortisone Probe On Account of Excessive Pricing and Other Competition Violations

    The UK Competition and Markets Authority announced this morning that it has issued a supplementary statement of objections (“SSO”) in its inquiry into alleged excessive and unfair pricing, anti-competitive agreements and abusive conduct in relation to the supply of hydrocortisone tablets in the UK (see, attachment). The CMA has been conducting three separate investigations in this matter and has issued previous statements of objections on four occasions between December 2016 and February 2019 (see, Van Bael & Bellis Life Sciences Newsflash of 6 March 2017). The new SSO has brought all these cases together and has allowed the CMA to reconsider specific aspects of its provisional findings in the previous statements of objections. The CMA accuses a range of companies, including Auden Mckenzie and its successor Accord-UK (previously: Actavis UK), Waymade and Advanz Pharma (previously: Concordia and AMCo), of having charged excessive and unfair prices for hydrocortisone tablets and having entered into agreements that cemented a prevailing dominant position on the market. The CMA also seeks to attribute liability to other parties which at various points in time had ownership of some of the accused firms. Hydrocortisone tablets are the primary treatment for people suffering from the life-threatening Addison's disease which causes adrenal glands to produce insufficient amounts of natural steroid hormones. According to the CMA, there are limited alternative treatments for hydrocortisone tablets.

    Read more
    • 07/02/2020
    • Articles

    Belgian Council of State Clarifies Role of Concerned Member States in Decentralised Marketing Authorisation Procedure

    On 16 January 2020 the Belgian Council of State reaffirmed the limited discretionary powers of a concerned Member State to call into question the assessments carried out by the Reference Member State in a decentralised procedure. It relied heavily on the case law of the Court of Justice of the European Union in the field. Please find attached a note on the judgment as well as its text.

    Read more
    • 03/02/2020
    • Articles

    Belgium - Medicine Shortages

    The Belgian Official Journal publishes today a Law of 20 December 2019 modifying various laws to tackle medicine shortages (Wet van 20 december 2019 tot wijziging van diverse wetgevingen wat de tekorten aan geneesmiddelen betreft/Loi du 20 décembre 2020 modifiant diverses législations, en ce qui concerne les pénuries de medicaments – the Law). For a summary of the Law’s key features, we refer to the Van Bael & Bellis Life Sciences Newsflash of 20 December 2019. The Royal Decrees that will complement the Law have not yet been published. We understand this still may take some time. The Law will enter into force on 13 February 2020 (i.e., 10 days following its publication in the Belgian Official Journal), with the exception of Articles 2 and 4 that started to apply on 31 January 2020.

    Read more

Subscribe to our updates

Please select the practice areas you are interested in: *