The Belgian consumer protection organisation Test Aankoop / Test Achats (“TA”) announced today that it submitted a complaint to the Belgian Competition Authority against Biogen, the marketing authorisation holder of Spinraza® (active substance: nusinersen)(see attached press release). Spinraza® is a medicine used to treat 5q spinal muscular atrophy “(SMA”), a genetic disease that causes weakness and wasting of the muscles, including the lung muscles. The disease is linked to a defect on chromosome 5q and symptoms usually start shortly after birth. SMA is a rare disease and Spinraza® was designated as an orphan medicine by the European Medicines Agency back in 2012. Spinraza® has so far also been the only medicine to obtain reimbursement following joint negotiations with the Belgian and Dutch authorities under the umbrella of the Beneluxa arrangement (see, Van Bael & Bellis Life Sciences Newsflash of 12 July 2018). TA’s competition complaint seems to form part of a larger effort directed by European consumer organisation BEUC which has also given rise to a complaint before the Italian competition authority (see attached). In its complaint, TA alleges that Biogen is charging excessive prices for Spinraza®. It maintains that research has shown an unjustifiable imbalance between the investments made by Biogen and the price charged by the firm. TA therefore urges the BCA to qualify Biogen’s conduct as abusive, order Biogen’s pricing practice to be stopped and impose a fine on Biogen. This case, if pursued, would be a first in Belgium and probably around Europe. While a number of excessive pricing cases have been initiated in the pharmaceutical sector by both national competition authorities and the European Commission, no such procedure would seem to have been started against a patented product that benefits from orphan medicine status. This is probably no coincidence, because monopoly prices resulting from intellectual property rights and regulatory schemes such as those encouraging the development of orphan medicines are a reward for risky investment, a consideration which TA seems to ignore. The fact that innovation should be encouraged and rewarded would also appear to be irrelevant from TA’s perspective. In addition and paradoxically, TA acknowledges that it does not actually know which price Biogen is charging since this forms the subject of a Managed Entry Agreement whose financial terms are confidential. The list prices cited in TA’s press release are unlikely to be accurate. Lastly, it will be difficult for the BCA to find that Biogen engaged in abusive conduct when that firm had to face the powerful buyers that are the Belgian and Dutch reimbursement authorities.