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    • 19/02/2019
    • Newsletters

    VBB on Belgian Business Law, Volume 2019, No. 01

    The January 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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    • 18/02/2019
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    Belgium - Bill regarding Reimbursement of Pharmaceutical Specialties

    On 7 February 2019, the federal government submitted a bill regarding the reimbursement of pharmaceutical specialties to the federal chamber of representatives (Bill 54 3535/001) (the “Bill”). The Bill provides for the following saving measures designed to contain the pharmaceutical budget: • More significant price decrease on the basis of turnover for medicines that have benefited from reimbursement for 15 years (“volume cliff”) (There will be a staggered system providing for a range of turnover figures between EUR 1.5 million and EUR 70 million). • Extension of maximum price (“ceiling price”) system from medicines delivered in the community pharmacy to medicines delivered in the hospital pharmacy. • Start of cheapest prescriptions and prescription quota systems in hospital environment. • Further limitation of invoicing level open to hospitals to 85% of the official price. This system applies to a segment of the medicines open to competition, namely medicines falling under the reference reimbursement system. It is designed to channel to the public purse part of the savings made by hospitals from discounts obtained from their suppliers. • Adaptation of definition of “cheap prescription”. • Medicines in reimbursement category F will now also be made subject to the price cuts applying to “old” medicines (reimbursed for 12 or 15 years). The reimbursement basis of medicines of category F is a flat fee per indication, treatment or analysis. • Definition of specific compensating levy for 2019 (“compenserende heffing”/”cotisation compensatoire”). • Limited increase of pricing transparency for medicines subject to Managed Entry Agreements: Members of the General Council (the top body within the Public Institute for Illness and Disability Insurance) and of the Auditing Court (which verifies and oversees the spending of the government) will be given access to aggregated price information (as a rule on the ATC1 level, i.e., the top level of the Anatomical Therapeutic Chemical Classification System of medicines). The qualifying members will be required to sign a non-disclosure agreement. The government is apparently confident that the Bill will garner a majority in the chamber. The Bill can be found here:

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    • 14/02/2019
    • Articles

    Overview of the EU’s Single-Use Plastics Directive

    This client alert provides an overview of the EU’s forthcoming “Directive on the reduction of the impact of certain plastic products on the environment”, otherwise known as the single-use plastics Directive. The Directive is expected to enter into force in late spring or early summer 2019 and will have a major impact on the future of the EU plastics market. It is important for both traders and manufacturers to understand how their businesses may be affected as the requirements of the Directive are phased in over the next two to five years.

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    • 12/02/2019
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    European Parliament Raises Issue of Alleged Excessive Pricing of Orphan Medicine

    In a response to two parliamentary questions of 6 February 2019, the member of the European Commission (the “Commission”) responsible for health and food safety Vytenis Andriukaitis announced that the case of chenodeoxycholic acid Leadiant (“CDCA”) will be taken on board in the European Commission’s ongoing assessment of the rules governing orphan medicines. According to the Commissioner, the case is also likely to inform competition investigations of possible excess pricing cases (see attached parliamentary questions and answer). CDCA is indicated for the treatment of patients afflicted with cerebrotendinous xanthomatosis, a rare metabolic disorder. These patients are unable to produce enough of the primary bile acid chenodeoxycholic acid. When primary bile acids are lacking, the body produces abnormal bile acids and other substances instead which accumulate throughout the body, causing damage. Because the number of patients with this condition is very limited, the disease is considered ‘rare’, and CDCA was designated as an orphan medicine in December 2014. CDCA is also a hybrid medicine in that it is similar to a reference medicine, Xenbilox, with the same active substance. However, Xenbilox differs from CDCA in that it is only authorised to dissolve cholesterol gallstones, an indication in use since the 1970s under the name Chenofalk. Leadiant Biosciences (“LB”), the marketing authorisation holder of CDCA, is accused of having monopolised chenodeoxycholic acid and then acquired the exclusive marketing rights associated with the orphan medicine designation of CDCA. The price for the medicine would have gone up considerably. According to one of the Members of Parliament who raised the issue, LB now charges EUR 140 per pill in specific markets, while the medicine cost 30 eurocents per pill when it was still sold as an anti-gallstone medicine. The accusation of excessive pricing is understood to be under review by the Dutch competition authority. The case raises a range of issues and themes that have recently come to the fore in political discussions across the European Union, including the status of orphan medicines; the tackling of excessive prices under the competition rules (the European Commission has not only started a procedure of its own in another file, but says it also supports various efforts of national competition authorities in that area); and possible cooperation among Member States with regard to medicine pricing and reimbursement, a controversial subject which the Commission stresses belongs to the exclusive competencies of the individual Member States.

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    • 30/01/2019
    • Articles

    Belgium - Liberalisation of distribution channel for medical devices

    A Royal Decree of 18 December 2018 regarding the liberalisation of the distribution channel for medical devices (the “Royal Decree”) was published in the Belgian Official Journal on 28 January 2019. The Royal Decree abolishes a number of provisions for the purpose of allowing supermarkets and other stores to also sell, as from 7 February 2019, certain medical devices that until now could only be sold through pharmacies (these devices are listed in the Royal Decree of 18 March 1999 on medical devices, annex XIII, items 1.1 through 1.5). Belgium thus seeks conformity with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices pursuant to which “Member States shall not refuse, prohibit or restrict the making available on the market or putting into service within their territory of devices which comply with the requirements of this Regulation” (Article 24). The Royal Decree applies to all medical devices that are available without prescription. In practice, it is expected to impact mainly the distribution of sterile medical devices, such as tubes and band aids, which until now could be sold only through pharmacies. By contrast, the sale of medical devices available on prescription remains limited to pharmacies. The supermarkets and other stores that will sell medical devices under the Royal Decree will have to meet the same quality, security and traceability criteria as the pharmacies and will need to register in advance with the Federal Agency for Medicines and Health Products. According to the Minister of Public Health, Maggie De Block, foreign examples show a marked price decrease of medical devices when these are also made available outside the pharmacy channel. The Minister hopes that the Royal Decree will have the same effect on pricing. Here goes a link to the Dutch and French versions of the Royal Decree of 18 December 2018 : Royal Decree of 18 December 2018

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    • 29/01/2019
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    Pharmaceuticals - European Commission Publishes Competition Law Enforcement Report and Declares Such Enforcement Continuing Priority

    The European Commission published today an overview of the enforcement activities of the European competition authorities, i.e., the Commission itself and the national competition authorities of the 28 Member States (the “Competition Pharmaceutical Enforcement Report” or “CPER”). The CPER covers the period 2009-2017 and follows the Commission’s wide-ranging inquiry into competition in the pharmaceutical sector which in July 2009 gave rise to its sector-inquiry final report (http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/index.html). According to the CPER, the competition enforcement activities have focused on two main objectives, namely access to cheaper medicines and access to innovative medicines. Access to cheaper medicines The Commission maintains that, in addition to their work in the merger control arena, the European competition authorities have made significant efforts to investigate and penalise practices that result in higher medicine prices. It offers as an example the patent settlement agreements reviewed at the European level and in the UK in order to curb market-entry delaying effects that may result from some agreements of that nature. Only last month, the Commission suffered something of a setback in that respect following the partial annulment by the General Court of decisions which it had adopted in the Servier cases (see, Van Bael & Bellis Life Sciences Newsflash of 24 December 2018). Other enforcement cases intended to bring down medicine prices include the excessive pricing cases pursued or pending in Denmark, Italy, the United Kingdom and before the European Commission. Interestingly, the CPER also cites the procedures conducted by the French competition authority against disparaging statements made by incumbents regarding newly launched generic rival products. Access to innovative medicines and increase of choice The Commission’s focus under this heading seems to be on preserving competition in pipeline products when applying the merger control rules. When it comes to classical competition enforcement, the Commission again refers to its actions against attempts to delay generic market entry. The Commission considers such action necessary to guarantee the end of the innovator’s market exclusivity and spur further innovation on the innovator’s part. The CPER concludes by making it clear that enforcement of the competition rules in the pharmaceutical sector “remains a matter of high priority”. The Commission says it will pay particular attention to new industry practices and to new market trends such as the emergence of biosimilars. At the same time, the Commission acknowledges that “there are limits to what competition law can do”. It specifies that sustainable access to affordable and innovative medicines will depend on the efforts of all stakeholders, including the pharmaceutical sector, governments and regulators, health care providers and patients. For good reason, the CPER not only discusses the application of the competition rules but also repeatedly refers to regulatory action. The Commission issued today the following documentation:

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    • 23/01/2019
    • News

    Thibaut D’hulst speaks on data protection in eHealth applications at a symposium in Brussels

    On 16 January 2019, Van Bael & Bellis associate Thibaut D’hulst spoke at a symposium entitled “Health and Case in a Digitising World: Integrating eHealth into Public Healthcare Systems” organized by the Public Policy Exchange and held in Brussels. The subject of Thibaut’s presentation was the protection of personal data in eHealth applications. Other speakers at the event included Marco Marsella, Head of Unit eHealth, Well-being and Aging, DG CONNECT, European Commission and Eva Van Assche, Guest Professor & Researcher, Thomas More University of Applied Sciences. The event was chaired by Nicke Guldemond, Professor Integrated Care & Technology, Erasmus University Rotterdam, The agenda of the symposium is available here.

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    • 23/01/2019
    • Articles

    Mental Health Europe Presents Study on European Sunshine and Transparency Rules in Healthcare

    Mental Health Europe (“MHE”), a European non-governmental network organisation active in developing mental health policies, presented on 23 January 2019 its study on transparency rules in European healthcare (“Shedding light on transparent cooperation in healthcare. The way forward for sunshine and transparency laws across Europe” – the “Study”, copy attached). MHE is of the opinion that there is a lack of transparency about the relationship between what it refers to as the “health industry” (essentially suppliers of medicines and pharmaceuticals) and healthcare professionals (“HCPs”), healthcare organisations (“HCOs”) and patient organisations (“POs”). According to MHE, this is a particular problem in the mental health sector and has created an excessive reliance on medication as the prime form of treatment of mental conditions. This has prompted MHE to carry out the Study and make a legal analysis of interactions between the life science industries on the one hand and HCPs and HCOs on the other. The scope of the Study is larger than that of similar earlier initiatives (there was, for example, the mapping exercise carried out in 2017 by a team of researchers from academia and a non-governmental organisation – see, Van Bael & Bellis Life Sciences Newsflash of 22 March 2018). This is because the Study covers more countries, including countries outside the European Union such as Norway and Russia, and also addresses more than transparency rules (which require the publication of transfers of value) to discuss related anti-corruption and conflict-of-interest legislation. The countries under review in the Study present a patchwork of mandatory rules and self-regulation with varying scopes of application. This finding has caused MHE to make the following policy recommendations: • to create minimum standards for the harmonisation of transparency reporting at the European level; • to establish a comprehensive and binding set of rules governing the disclosure of transfers of value. In the European Union these rules should take the form of a Directive; • to raise awareness of conflicts of interest in both medical education and medical practice and establish rules to manage such conflicts; • to broaden scope for independent medical education, including continuing medical education; • to expand independent funding for “unbiased” research; • to make users of mental health services more attuned to conflicts of interest.

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    • 22/01/2019
    • Articles

    EFPIA Expresses View regarding International Governmental Cooperation on Pricing of and Access to Medicines

    Nathalie Moll, the Director General of the pharmaceutical industry’s European association EFPIA, has mounted a rather blunt attack against efforts by a range of EU Member States to colloborate on medicine pricing and access. In a note posted recently on EFPIA’s website (https://www.efpia.eu/news-events/the-efpia-view/blog-articles/policy-principles-on-cross-country-collaborations-on-medicines-pricing-and-access/), Ms. Moll wrote that there has been constant “noise” regarding governmental cross-country collaboration on access to medicines, but that the results amounted to “[n]ot so much”. In Ms. Moll’s view, governmental cooperation across borders should yield broader access to medicines for patients. Otherwise, such cooperation is “energy wasted”. While it is true that the start of cross-country collaboration on medicine pricing and access has been much slower in reality than the impression created by official statements, it is probably premature to judge a budding and complex structure for cooperation. That realisation must have prompted EFPIA to come up with a set of proposed constructive guiding principles for successful cooperation (see attached). According to EFPIA, these principles should inform government action in the now established areas of cooperation in organisations such as Beneluxa, namely (i) horizon scanning; (ii) Health Technology Assessment; (iii) information sharing; and (iv) joint pricing negotiations. Additionally, EFPIA also mentions public procurement. In EFPIA’s view, cross-country collaboration on these matters should result in: • a broader and/or accelerated access to medicines for patients; • no additional market barriers, price controls or other forms of duplication; • a consistent approach by countries with similar economic and health-related requirements; • voluntary participation by industry; and • guaranteed confidentiality of sensitive information, including pricing and reimbursement arrangements.

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