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Court of Justice of European Union Creates Questionable Regulatory Shortcut for Parallel Imports of Generic Medicines

  • 05/08/2019
  • Articles

The Court of Justice of the European Union recently issued a puzzling judgment regarding parallel imports of generic medicines. Please find attached a case note discussing the judgment. We also attach a copy of the judgment itself.

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    • 23/08/2019
    • Articles

    Portugal Latest EU Member State to Tackle Medicine Shortages and Regulate Parallel Trade in Medicines

    In Portugal, an amending decree-law of 16 August 2019 which entered into force on 19 August 2019 seeks to strengthen access to medicines by reinforcing the public service obligation of the various stakeholders in the supply chain. That obligation involves the duty to ensure a continuous supply of medicines. It prohibits abusive or discriminatory practices such as directly or indirectly refusing to fulfill medicine orders or applying differing deadlines. The new decree-law reinforces the public-service obligations for pharmaceutical companies to ensure that medicines make it to wholesalers who have a duty of their own to supply pharmacies and other retailers. Those who hold a marketing authorisation must constantly monitor their stock positions and communicate possible shortages both to the other stakeholders and Infarmed, the Portuguese health agency. The decree-law also clarifies the dual role of wholesalers which have to (i) supply the domestic market; and (ii) operate as logistical service providers. Furthermore, the new decree-law makes an attempt to limit parallel trade by precluding wholesalers from selling medicines to other countries or other distributors, unless they have first made sure to supply the domestic market. Finally, the amendments bolster the ability of Infarmed to enforce the new rules. A communication which Infarmed issued to publicize the new rules is attached. Portugal thus becomes the latest EU member state to tackle medicine shortages and interfere with parallel trade in medicines. It is expected that the new European Commission which will start operations at the end of the year will also address this issue.

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    • 19/08/2019
    • Articles

    Belgium - Medicine Shortages - New Development

    At the end of July 2019, Febelco and PharmaBelgium-Belmedis, two wholesalers (“WS”) with a public-service WS status (groothandelaar-verdeler/grossiste-répartiteur – “WSD”), and the National Association of Wholesaler-Distributors (NVGV/ANGR) filed with the Constitutional Court (“CC”) a petition for annulment of Article 3, 2° of the Law of 7 April 2019 “modifying the Law of 25 March 1964 on medicines as regards the unavailability of medicines” (Wet van 7 april 2019 tot wijziging van de Wet van 25 maart 1964 op de geneesmiddelen voor wat de onbeschikbaarheden van geneesmiddelen betreft/Loi du 7 avril 2019 modifiant la Loi du 25 mars 1964 sur les médicaments en ce qui concerne les indisponibilités de médicaments) (see attached excerpts from the list of pending CC cases). Pursuant to Article 3,2°, WSD are no longer allowed to supply medicines to customers of their choice and should limit their supplies to specific customer categories, namely (a) other WSD; (b) community pharmacists; and (c) hospitals recognised under applicable rules (see Van Bael & Bellis Life Sciences Newsflashes of 8 May 2019 and of 17 May 2019).

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    • 24/07/2019
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    Belgium and Italy - Consumer Protection Organisations File Excessive Pricing Complaints Against Biogen Over Price of Spinraza®

    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.

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