Insights & news

Belgium - Medicine Pricing | Avastin-Lucentis and Related Matters

  • 09/10/2019
  • Articles

The prices of medicines took again centre stage during the plenary session of Tuesday 8 October 2019 of the federal Parliament (see attached). At issue were specifically the prices and reimbursement status of Lucentis (Novartis) and Avastin (Roche). Five members of parliament wanted to learn why the Minister of Social Affairs and Public Health (the “Minister”) had failed to rely on a possibility which the Court of Justice of the European Union (“CJEU”) expressly created in November 2018 to reimburse the off-label use of a medicine for budgetary reasons (see, Van Bael & Bellis Life Sciences Newsflash of 21 November 2018).
Under the approach proposed by the members of parliament at issue and endorsed by the CJEU, Avastin would be reimbursed for the treatment of the eye-condition wet age-related macular degeneration (“AMD”) while it has no therapeutic indication for the treatment of that condition. Avastin would thus function as a replacement for Novartis’ significantly more expensive Lucentis which does benefit from a therapeutic indication covering AMD. For its part, Avastin only has a marketing authorisation for a range of unrelated oncology indications.
In her response, the Minister explained that she had managed to secure beneficial reimbursement conditions for Lucentis by concluding a Managed Entry Agreement (“MEA”) whose financial conditions are confidential. Additionally, the Minister defended her medicines policy of the last few years which was based on budgetary prudence, rewards for innovation and international cooperation among payers.
However, this response did not satisfy the members of parliament who had raised the Avastin/Lucentis matter. They engaged in broadsides against Novartis, the wider pharmaceutical industry, the Belgian Competition Authority (which allegedly failed to investigate a competition complaint against Novartis and Roche) and the Minister. They promised further fireworks in a fresh debate on Avastin/Lucentis in the parliamentary committee for health and equal opportunities scheduled on Wednesday 9 October 2019 as well as during hearings on innovative expensive medicines which will take place in November 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: *