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Veterinary Medicinal Products - Publication of Regulation (EU) 2019/6

  • 10/01/2019
  • Articles

After four years of negotiations, Regulation (EU) 2019/6 governing veterinary medicinal products was adopted on 11 December 2018 and officially published on 7 January 2019. The new Regulation, which will apply as of 28 January 2022, aims to establish a modern regulatory framework for veterinary medicinal products. The attached memorandum discusses its most striking features.

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    • 05/08/2019
    • Articles

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

    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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    • 24/07/2019
    • Articles

    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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    • 19/07/2019
    • Articles

    Belgium - Medicine Shortages - Constitutional Court Suspends Statutory Provision Limiting Exports For Benefit of Local Patient

    Yesterday the Constitutional Court suspended 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 tot wijziging van de wet van 25 maart 1964 op de geneesmiddelen voor wat de onbeschikbaarheden van geneesmiddelen betreft / Loi modifiant la loi du 25 mars 1964 sur les médicaments en ce qui concerne les indisponibilités de médicaments) (the “Law”). Pursuant to Article 3,2°, wholesalers (“WS”) with a public-service WS status (groothandelaar-verdeler/grossiste-répartiteur) are no longer allowed to supply medicines to customers of their choice and should limit their supplies to specific customer categories, namely (a) other WS with a public-service WS status; (b) community pharmacists; and (c) hospitals recognised under applicable rules (see, Van Bael & Bellis Life Sciences Newsflash of 8 May 2019 and of 17 May 2019). The Constitutional Court suspended this provision at the request of a number of regular wholesalers (the “Plaintiff Wholesalers”) who claimed that the new rule had cut off a major source of supplies - WS with a public-service WS status - which they had not been able to replace. The Plaintiff Wholesalers showed, first, that they were able to put forward weighty arguments against the challenged provision and, second, that they would suffer serious harm that would be difficult to undo if the challenged provision were not suspended. Weighty Arguments While the Plaintiff Wholesalers put forward four different sets of arguments, the Constitutional Court focused on the compatibility of the challenged provision with the rules of the Treaty on the Functioning of the European Union (“TFEU”) which guarantee the free movement of goods. The Constitutional Court considered that the Plaintiff Wholesalers could no longer source supplies from the WS with a public-service status which, in turn, reduced their ability to export medicines from Belgium. According to the Constitutional Court, the challenged provision therefore amounted to a measure of equivalent effect as a quantitative restriction on exports in breach of Article 35, TFEU. The Constitutional Court added that such a measure can be justified on the grounds of the protection of health and life of humans as provided for by Article 36, TFEU and that, in theory, making sure that medicines are in sufficient supply on the Belgian territory to serve the patients on that territory would qualify as an objective protected by Article 36, TFEU. However, the Constitutional Court went on to affirm that for two reasons the challenged provision was not suitable to achieve that objective. First, the file did not show that the export activities of regular WS actually had an adverse influence on the availability of specific medicines in Belgium. Moreover, the government had not been able to dispel that impression with fresh evidence. Second, WS with a public-service WS status are only allowed to furnish medicines to regular WS if they are sure to be in a position to meet their public-service obligations. The Constitutional Court concluded that Article 36, TFEU could not come into play and that, as a result, there were weighty arguments in favour of a suspension on the basis of Article 35, TFEU. Serious Harm Difficult To Undo The Constitutional Court found that the Plaintiff Wholesalers had been deprived of a major source of supply and had not been able to find alternative supply channels, such as direct purchases from the marketing authorisation holders. The Constitutional Court also noted that Parliament had failed to create a reasonable transition period, thus exacerbating the predicament of the regular WS to a point where a number of these WS found themselves on the edge of bankruptcy. According to the Constitutional Court, all of these findings justified the suspension of Article 3, 2°. Yesterday’s judgment puts a spanner in the works by compromising part of the outgoing government’s recent efforts to reduce medicine shortages. While the Constitutional Court was not impressed with the evidence produced to justify the export restriction, the new federal government will probably have to pursue similar and possibly better documented avenues to remedy some of the existing medicine shortfall problems. The Constitutional Court could still reach a different conclusion when reviewing the action for annulment against Article 3,2°, but the chances of this happening would seem remote. The judgment of the Constitutional Court is attached.

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