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    • 24/06/2019
    • Articles

    More Details Emerge Regarding Fine Imposed by Belgian Competition Authority on Professional Organisation of Pharmacists

    At the end of May 2019, the Belgian Competition Authority (“BCA”) imposed a fine of EUR 1 million on the professional organisation of pharmacists (“Orde der Apothekers”/ “Ordre des pharmaciens”) (the “PO”) because the PO had taken a range of exclusionary measures to thwart the development of MediCare-Market, a successful retailer of both medicines and other, less regulated health products (see, Van Bael & Bellis Life Science Newsflash of 5 June 2019). The BCA has now published the non-confidential version of its decision of 28 May 2019 (the “Decision”) which, as is customary, contains the report of the prosecutor in competition matters (“auditeur”/”auditeur”), submissions of the complainant and of the targeted entity, as well as the actual reasoning of the competition college, the decision-making body of the ABC (see, attached). The BCA found that the PO had relied on a range of techniques to hamper MediCare-Market’s development, including disciplinary proceedings and court action. Interestingly, the BCA also blamed the PO for limiting price competition, even though the scope for such competition was narrow as far as medicines are concerned. However, the BCA took issue first and foremost with attempts made by PO to stifle competition for health products other than medicines. For example, PO had taken court action against MediCare-Market on account of publicity made by that company which promised price reductions on non-pharmaceutical products. In PO’s view, this constituted unethical behavior unbecoming of a pharmacist. The ABC disagreed and added that, to the contrary, MediCare-Market’s actions had been welcome in that they made pharmacists aware of the legitimacy of price competition for products other than medicines. While the BCA is somewhat ambiguous on this, it also seemed to favour price competition for medicines in forms such as end-of-year reductions. This is illustrated by the start of the BCA’s analysis which refers to an OECD finding of 2017 that the pricing level for medicines in Belgium is too high compared to that of its neighbouring countries. Additionally, the BCA made short shrift of the PO’s public service remit. Relying in part on a 2014 judgment of the EU General Court which confirmed a European Commission decision which had found the French “Ordre national des pharmaciens” to be in breach of the competition rules (case T-90/11, Ordre national des pharmaciens and others v. European Commission, ECLI:EU:T:2014:1049), the BCA maintained that legitimate public-service obligations cannot serve as a pretext for anti-competitive behaviour. Similarly, the BCA also rejected the general interest arguments that PO was supposedly right in pursuing MediCare-Market in order to (i) protect the credibility of the pharmacist’s profession; (ii) safeguard public health; and (iii) guard against the excessive consumption of medicines. The BCA went even further by positing that the general approach followed by the PO to foreclose MediCare-Market or at least stunt its development amounted to a restriction of competition by object. Showing its anticompetitive effects was therefore not necessary (the BCA still went on to demonstrate the adverse effects on competition resulting from the PO’s conduct).

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    • 14/06/2019
    • Newsletters

    VBB on Belgian Business Law, Volume 2019, No. 05

    The May 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. Please click below to read the issue.

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    • 13/06/2019
    • Articles

    Pharmaceuticals - Export Manufacturing Waiver and Stockpiling Waiver Enter into Force on 1 July 2019

    Pharmaceuticals - Export Manufacturing Waiver and Stockpiling Waiver Enter into Force on 1 July 2019 On 11 June 2019, the Official Journal of the European Union published Regulation (EU) 2019/933 of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate (“SPC”) for medicinal products (the “Regulation”). The modifications introduced by the Regulation encroach on the normal operation of the SPC which, broadly, extends the patent protection afforded to active substances of medicines. More precisely, they allow EU-based companies to manufacture in the EU a generic or biosimilar version of an SPC-protected medicine during the term of the SPC, for the double purpose of either exporting to non-EU countries where protection has expired or never existed (“manufacturing waiver”), or stockpiling the medicine during the final 6 months of SPC protection ahead of entry on the EU market immediately after the SPC has lapsed (EU Day-1 entry) (“stockpiling waiver”). The manufacturing and stockpiling waivers extend to related acts that are “strictly necessary” for such manufacturing or storing, even though such acts would otherwise require the consent of the SPC holder. According to the preamble to the Regulation, such related acts could include possessing, offering to supply, supplying, importing, using or synthesising an active ingredient for the purpose of making a medicinal product, or temporary storing or advertising for the exclusive purpose of exporting to third-country destinations. The Regulation requires producers of generic or biosimilar medicines to (i) notify the relevant competent authority in the EU Member State in which the manufacturing is to take place; and (ii) inform the SPC holder of their intention to manufacture a generic or biosimilar version of the protected medicine. Manufacturers will have to provide information on issues such as the markets where the new products will be exported to. For its part, the national authority will have to make that information publicly available. Further, in the case of products manufactured for the purpose of export to third countries, a specific logo will have to be affixed to the product’s outer packaging and, if feasible, to its immediate packaging. The Regulation will enter into force on 1 July 2019 and will become directly applicable in all EU Member States. However, the new rules will not apply to SPCs that have already taken effect before 1 July 2019. As regards SPCs that have not taken effect before that date, the following principles apply: • immediate application to SPCs that are applied for on or after 1 July 2019; and • application from 2 July 2022 to SPCs that have been applied for before 1 July 2019 and that take effect on or after that date. According to the Regulation’s preamble, the new rules are supposed to “strike a balance between restoring a level playing field between [producers of generic or biosimilar medicines established in the EU and those established in third countries, the former allegedly being “at a significant competitive disadvantage”] and ensuring that the essence of the exclusive rights of [SPC] holders […] is guaranteed in relation to the Union market”. However, advocates of intellectual property rights regard the manufacturing and stockpiling waivers as major victories for the generic and biosimilar industries and a dangerous step down the path of erosion of intellectual property rights (see, Van Bael & Bellis Life Sciences Newsflashes of 28 May 2018, 21 January 2019 and 23 April 2019).

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    • 12/06/2019
    • Articles

    Luxembourg and The Netherlands Next in Line To Benefit From EU-US Mutual Recognition Agreement For Inspections of Manufacturing Sites For Human Medicines

    Luxembourg and The Netherlands have become the 25th and 26th EU Member State able to carry out good manufacturing practice (“GMP”) inspections at a level equivalent to that prevailing in the US. The US Food and Drug Administration (“FDA”) confirmed as much on 10 June 2019. As a result, Luxembourg and The Netherlands now form part of 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. There are now just two more Member States left for assessment and this process is anticipated to be completed on 15 July 2019. The latest announcement of the European Medicines Agency ("EMA") on the subject can be found here: https://www.ema.europa.eu/en/news/two-additional-countries-benefit-eu-us-mutual-recognition-agreement-inspections-1. The EMA also updated again its Questions and Answers document on the impact of the MRA: https://www.ema.europa.eu/en/documents/other/questions-answers-impact-mutual-recognition-agreement-between-european-union-united-states-10-june_en.pdf.

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    • 11/06/2019
    • Articles

    Belgium - New Combined Reimbursement Rules for Personalised Medicines and Companion Diagnostics

    The Belgian Official Journal of 5 June 2019 contains two Royal Decrees that create the regulatory framework for the combined reimbursement procedure of personalised medicines and companion diagnostics (“CDx”) in accordance with the tight reimbursement deadlines that apply to medicines but did not previously govern the CDx. As a result, the reimbursement of new CDx (or predictive biomarkers) often lagged that of the associated medicines and resulted in a reimbursement gap. The new combined reimbursement procedure involves the cooperation of bodies responsible for respectively medicines and CDx in a “Platform CDx” and implies a single Health Technology Assessment of the “package” that consists of the medicine and the predictive biomarker. The Minister of Social Affairs will authorise or reject the package for reimbursement in a single reimbursement decision. The combined reimbursement procedure will also entail the registration of all reimbursed tests and of the test results. In future, these will allow for more informed policy decisions regarding personalised medicine and the reimbursement of healthcare services in this area. The modified regulatory framework consists of a new chapter VIII dedicated to personalised medicines in Annex 1 to the Royal Decree of 1 February 2018 governing the reimbursement of medicines. In addition, the list of categories of healthcare services (“nomenclatuur van geneeskundige verstrekkingen”/“nomenclature des prestations de santé”) contained in the annex to the Royal Decree of 14 September 1984 was expanded with a new Article 33ter that will specifically contain a category of CDx and will be updated frequently to reflect technological and scientific developments. The new rules will enter into force on 1 July 2019.

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    • 05/06/2019
    • Articles

    Belgian Competition Authority Fines Professional Organisation of Pharmacists

    The Belgian Competition Authority (“BCA”) announced today that it has imposed a fine of EUR 1 million on the professional organisation of pharmacists known as “Orde der Apothekers”/”Ordre des pharmaciens” (the “PO”) (see attached press release in three language versions). The PO is tasked by law with organising the profession of pharmacist and maintaining the ethical standards of that profession. Pharmacists are also subject to a number of public service obligations. The PO was found to have misused these significant responsibilities for the commercial gain of its members. According to the BCA, the PO took a range of exclusionary measures to thwart the development of MediCare-Market, a successful new retailer that combines the sale of medicines with that of other, less regulated health products, wellness products, cosmetics, nutrition products and the like (see, Van Bael & Bellis Life Sciences Newsflashes of 9 November 2018 and 20 June 2017). The BCA took issue with the PO’s decision to start disciplinary procedures and court action and seek the help of public authorities to stop MediCare-Market. It also challenged the PO’s publication of threatening messages aimed at MediCare-Market. The BCA stressed that while some of these steps, such as taking court action, are normally legitimate, in this case they formed part of an overarching anticompetitive strategy. In harsh words, the BCA labelled the PO’s decisions a competitive restriction by object in breach of Article IV.1, Code of Economic Law and Article 101, Treaty on the Functioning of the European Union. It specified that the decisions of the PO had “harmed greatly consumer welfare” by reducing price competition for medicines and by limiting innovation. The BCA’s observations on medicine pricing are remarkable given the tight regulation of prices for medicines, including over-the–counter medicines, in Belgium.

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    • 31/05/2019
    • Articles

    World Health Organisation Approves Resolution on Price Transparency

    On 28 May 2019, the final plenary of the World Health Assembly (“WHA”), the decision-making body of the World Health Organisation (“WHO”), approved a resolution entitled “Improving the transparency of markets for medicines, vaccines and other health products”. The resolution, originally proposed by Italy, was adopted on the last day of the 72nd WHA, which took place in Geneva from 20 to 28 May 2019. According to WHO officials, this “landmark measure” could have lasting impact on prices in markets for urgently-needed health products, ranging from treatments for cancer and hepatitis, to insulin. The goal of the resolution is to improve transparency in pharmaceutical markets, from the cost of research and development, including clinical trials, to the prices negotiated by countries and the amount of public funding given. More specifically, the resolution calls on states to “take appropriate measures to publicly share information on the net prices of health products” which it defines as “the amount received by manufacturers after subtraction of all rebates, discounts, and other incentives”. It also asks the WHO’s secretariat to monitor the impact of transparency on access to medicines, including the effect of differential pricing. Many countries co-sponsored the resolution, including Brazil, Japan, Norway, Spain, Switzerland, Thailand and the United States. Others, however, such as Germany, Hungary and the UK, strongly disagreed with the resolution’s far-reaching implications and disassociated themselves from it on voting day. In particular, debates took place over the costs relating to research and development. The final language underlines the voluntary nature of the resolution, urging states to “take the necessary steps, as appropriate, to support dissemination of and enhanced availability of and access to aggregated results data and, if already publicly-available or voluntarily-provided, costs from human subject clinical trials regardless of outcomes or whether the results will support an application for marketing approval, while ensuring patient confidentiality”. This version is watered-down from the original text, which did not include the voluntary provision, and instead called on states to provide the cost information as necessary. The resolution coincides with what would seem to be a general trend towards more price transparency. For example, on 15 May 2019, Beneluxa cited transparency as a “key contributor to achieving sustainability of access to medicines”. Conversely, Poland is reportedly working on legislation that would limit information on negotiations with pharmaceutical companies. Though Poland was part of the consensus to approve the resolution, it initially was against it, since it has been trying to limit making public information on medicine prices. Pharmaceutical companies and lobby groups disagree about the impact of this resolution on the industry. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) warned that disclosing prices could make it harder for the industry to offer lower prices to poorer countries. The group also raised concerns about how much time was given to the discussions relating to the resolution, a feeling that was shared by the opposing countries, such as Germany. On the other hand, some groups applauded the resolution, seeing it as an essential step to improve universal access to medicines. The WHA is, as noted, the decision-making body of the WHO and is attended by delegations from all WHO Member States. It focuses on a specific health agenda prepared by the Executive Board. Resolutions, though not legally binding, represent the will of member states and the highest level of commitment. The WHA can also adopt binding decisions, but these need to be presented as a convention or an agreement and require a two-thirds majority.

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    • 27/05/2019
    • Articles

    Spanish Competition Authority Carries Out Another Series of Dawn Raids in Pharmaceutical Sector

    The Spanish competition authority, the "Comisión Nacional de los Mercados y la Competencia ("CNMC"), published today two press releases indicating that it carried out on premise inspections with two pharmaceutical firms suspected of having engaged in abusive behaviour (see attached press releases). One case involves an inhalator indicated for the treatment of obstructive pulmonary disorders in adults. The firm at issue is accused of shutting out competitors for the supply of the product to health services and hospitals throughout Spain. The second case relates to a combined hormonal contraceptive medicine on a recently liberalised market. The press release suggests (but does not say so expressly) that the targeted firm may have tried to stop generic market entry. It did so (and on this point the press release is explicit) by the allegedly anti-competitive use of court action and laws in order to hinder market entry. The inspections follow on the heels of another dawn raid on account of suspected abuse of dominance with regard to a medicine indicated for the treatment of specific autoimmune diseases (see, Van Bael & Bellis Life Sciences Newsflash, 25 April 2019).

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    • 27/05/2019
    • Articles

    Belgium - Medicine Shortages - Further developments

    The docket of the Constitutional Court (“CC”) shows that in at least 7 new cases, various parties are challenging specific aspects of the Law of 7 April 2019 modifying the Law of 25 March 1964 on medicines as regards the unavailability of medicines (see attached excerpts from the list of pending CC cases). One case description expressly indicates that the targeted provision is the rule which limits the categories of customers to which a wholesaler (“WS”) with a public-service WS status (groothandelaar-verdeler/grossiste-répartiteur) is allowed to supply. These groups of potential customers are (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 Newsflashes of 8 and 17 May 2019). By contrast, the other case descriptions do not identify a precise provision, even though they mention in general terms the rules “imposing limitations on wholesalers with a public-service WS status”. Significantly, some challenges involve both a request for suspension and a request for annulment of the provision(s) at stake. At present, no details are publicly known of the arguments in support of the challenges.

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