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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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    • 05/08/2019
    • Newsletters

    VBB on Belgian Business Law, Volume 2019, No. 07

    The July 2019 issue of our Belgian Business Law newsletter reporting on the latest developments in a range of areas, including competition, data protection, intellectual property and labour law.

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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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    • 18/07/2019
    • Articles

    Transatlantic Cooperation on Medicines - Latest Developments

    A visit to Canada by the Dutch Minister for Medical Care, Bruno Bruins, has given rise to interesting news regarding international cooperation on medicine pricing. According to the attached press release of 17 July 2019, The Netherlands is spearheading an effort to have Canada sign up to the Beneluxa initiative on medicines (http://www.beneluxa.org/). Beneluxa is an international alliance for pharmaceutical policy composed of Austria, Belgium, Ireland, Luxembourg and The Netherlands. Medicine pricing is one of the pillars of Beneluxa along with other areas such as horizon scanning. A possible transatlantic contribution to Beneluxa by Canada would undoubtedly add considerable economic weight to the grouping and to the pricing negotations which it initiates. At the same time, it would create a further layer of technical complexity that may cause an already cumbersome organisation to become entirely unwieldy. Separately, Canada also wants to participate in the International Horizon Scanning Initiative (“IHSI”) in which countries from the Beneluxa group and others seek to identify innovative medicines before they reach the market. The initiative is supposed to inform decision-making on treatment choices and prepare members for tough budgetary discussions. An announcement on the countries that will participate in IHSI is scheduled for October 2019.

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    • 15/07/2019
    • Articles

    Belgium - Request for Premiums and Benefits by Hospitals from Suppliers of Medicines and Medical Devices in Public Procurement Proceedings

    The Federal Agency for Medicines and Health Products (“FAMHP”) has recently come out against hospitals requesting premiums and benefits from firms participating in tender proceedings for the supply of medicines and/or medical devices. According to FAMHP, that practice is not only prohibited by Article 81 of the Law of 17 June 2016 on Public Procurement, but may also run foul of Article 10 of the Law of 25 March 1964 regarding Medicines. At issue is the widespread practice indulged in by hospitals to ask prospective suppliers of medicines or medical devices to take care of unrelated goods and services such as the supply of educational materials and software for patient management or to pay for outreach activities organised by the hospitals. Article 81 of the Law of 17 June 2016 on Public Procurement provides in relevant part that the award criteria of a request for tenders should be connected to the subject of the public procurement procedure. For its part, Article 10 of the Law of 25 March 1964 regarding Medicines prohibits firms, subject to exceptions, from offering or providng benefits in cash or in kind to specific healthcare professionals and institutions in connection with the prescription, administration or supply of medicines or medical devices. Similarly, healthcare professionals and institutions are banned from soliciting or receiving such benefits. Based on a combined reading of these provisions, FAMHP maintains that it is not possible to offer or request free additional services with the supply of medicines or medical devices. According to FAMHP, additional services have to (i) come at a price; or (ii) and this is a puzzling addition, “have to present a cost which expressly forms part of the price of the goods”. Importantly, the services have to present a connection with the goods supplied. FAMHP indicates that this implies that outreach activities or additional software are “not admissible”. It adds that “free competition” should be guaranteed at all times and that a hospital should be able to justify the use of a specific award criterion. In other words, the hospital does not benefit from discretionary powers when crafting and then implementing a procurement procedure. Attached are a circular letter of FAMHP on the subject as well as an opinion delivered earlier this year by the committee for public procurement, an advisory body, which informed the point of view of FAMHP.

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    • 12/07/2019
    • Articles

    Slovakia Final Member State To Benefit From EU-US Mutual Recognition Agreement For Inspections of Manufacturing Sites For Human Medicines

    Slovakia has become the 28th and final EU Member State to be given the powers to carry out good manufacturing practice (“GMP”) inspections at a level equivalent to that prevailing in the US (see attached press release). On 11 July 2019, the US Food and Drug Administration (“FDA”) confirmed Slovakia’s status under the Mutual Recognition Agreement (“MRA”) governing GMP inspections of manufacturing sites for human medicines between the EU and the US. For their part, EU Member States have been able to rely on inspection results produced by the FDA since 1 November 2017. Pursuant to the MRA, the EU and the US now fully recognise inspections of manufacturing sites for human medicines carried out in each other’s territories. Separately, the batch testing waiver existing under the MRA will also start to apply. As a result, qualified persons in pharmaceutical firms based in Europe will no longer be required to carry out the quality controls when these have already been run in the US. The EU and US will continue implementation work for the MRA in hopes of extending its scope to a range of additional products, including veterinary medicines, human vaccines and plasma derived medicinal products.

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