Belgium - Pharmaceutical Industry Remains Prime Enforcement Target for Belgian Competition Authority
On 20 July 2023, the Belgian Competition Authority (BCA) published its annual report (here and here) as well as, belatedly, its enforcement priorities for 2023 (see, attachments - the Note). As in previous years (see for example, Van Bael & Bellis Life Sciences News and Insights of 16 May 2022), the pharmaceutical industry will be a prime enforcement target of the BCA. For example, on 24 January 2023, the BCA imposed a fine of EUR 2,782,808 on Novartis for allegedly abusive behaviour. Novartis was found guilty of misleading ophthalmologists, hospitals and public authorities in warning against the off-label use of Avastin®, an oncology medicine of Roche, to treat wet age-related macular degeneration (AMD) at the expense of its own, more expensive product Lucentis® which, unlike Avastin®, is indicated for the treatment of AMD (see, Van Bael & Bellis Life Sciences News and Insights of 25 January 2023). The BCA said it would continue to “[pay] close attention to all links in the value chain” (Note, English version, p. 6).
Additionally, the pharmaceutical industry may also come under scrutiny from the BCA in indirect ways. For example, the BCA indicated that it would follow closely the conduct of private parties responding to requests for public tenders. BCA will focus on new detection tools, in cooperation with other competition authorities, and will give priority to bid rigging cases (Note, English version, p. 8). While the BCA cited the construction industry as an example, it can be expected to monitor also the hospital sector whose consolidation is already in the BCA’s crosshairs (Note, English version, p. 6 and BCA press release of 14 July 2023).
The BCA’s efforts in this regard will be complemented shortly by new rules designed to increase competition for biological medicines. On 20 July 2023, the federal Council of Ministers approved a draft Royal Decree that creates new public procurement rules to increase competition for biological medicines by lowering market entry barriers for biosimilars. Once adopted, the new Royal Decree will:
- require hospitals to organise a public tender within nine months following the date of reimbursement of a biosimilar medicine;
- limit the duration of agreements resulting from public tenders to two years (subject to two possible extensions of one year as long as no biosimilar enters the market);
- ban the use of specific tendering criteria that are considered to reduce competition for biological medicines.