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    • 03/12/2019
    • Articles

    EDPB Guidelines on Data Protection by Design and by Default

    On 13 November 2019, the European Data Protection Board (EDPB) published draft guidelines (the Guidelines) on the principle of “Data Protection by Design and by Default” set out under Article 25 of the General Data Protection Regulation (GDPR). The Guidelines explain how controllers must ensure that they effectively implement the “data protection principles and data subjects’ rights and freedoms by design and by default” during the design and life cycle of processing activities. The EDPB underlines that Data Protection by Design and Default is a requirement for all controllers, independent of their size. The examples contained in the Guidelines illustrate the broad range of processing activities to which this principle applies: from setting up membership administration to buying customer relationship management (CRM) software; designing online order forms; improving effectiveness of deliveries (through tracking employees); deciding on loan applications as a financial institution; or using artificial intelligence to profile customers. However, the complexity of implementing this principle will vary based on the individual processing operation. In this regard, the principle of Data Protection by Design and Default is coherent with the “risk-based approach” underlying the GDPR. Please click below for a short client memorandum on these guidelines.

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    • 28/11/2019
    • Articles

    European Commission Publishes State of Health in EU 2019 and Makes Policy Recommendations for Affordable Medicines

    The European Commission published today its Companion Report on the State of Health in the EU 2019 (see, attached – the “Report”) which forms the culmination of a cycle started in 2016 to develop expertise on performance assessments of the health systems in the Member States. The Report accordingly offers a number of general assessments of policy issues such as the decline in vaccination confidence, the digital transformation of health promotion and disease prevention and the requisite holistic approach in the quest for safe, effective and affordable medication. In addition, the Report also publishes key health findings for each of the 28 Member States. In a chapter entitled “Breaking down silos for safe, effective and affordable medicines”, the Report identifies four areas for Member States to focus on: • Building up Member State capacity to assess the value of medical technology – According to the Report, this implies greater cooperation among Member States, as this will bridge the information gap with suppliers. One channel for cooperation would be created by the proposed Health Technology Assessment Regulation which is currently under review by the EU political institutions. • Pooling knowledge and expertise regarding medicine pricing and procurement – The Report favours additional cooperation among and with the national competition authorities that built up expertise on excessive pricing cases and also maps the various forms of governmental cooperation on medicine procurement such as the Beneluxa and Valetta initiatives. • Maximising cost savings from generics and biosimilars – The Report notes that the uptake of these product categories is still unevenly spread across the EU. • Using medicines appropriately in hospitals – The Report calls for an update of best practices that date back to 2010.

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    • 28/11/2019
    • Newsletters

    VBB on Competition Law, Volume 2019, No. 11

    The November 2019 issue of our newsletter, VBB on Competition Law, which covers major developments in competition law at both the European Union and Member State levels.    Click below to view and download the issue

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    • 26/11/2019
    • Articles

    Annual Review Confirms Validity of EU-US Privacy Shield

    On 23 October 2019, the European Commission (Commission) published its report on the Third Annual Joint Review of the EU-US Privacy Shield. The Privacy Shield is a self-certification scheme whereby certified US organisations can more easily receive personal data transferred to them from the EU. Certification is granted when an organisation implements measures in order to protect personal data. At the time of the review, there were more than 5,000 participating companies. In its report, the Commission confirms that the EU-US Privacy Shield continues to provide an adequate level of protection for transfers of personal data. It indicates that important improvements have been made to the framework, but also identifies some areas of concern. The European Data Protection Board (EDPB), which is invited to participate in the annual review process, published its own report on the Third Annual Joint Review on 12 November 2019, essentially confirming the findings of the Commission and making further recommendations on access by public authorities of data transferred to the US under the Privacy Shield. The annual review procedure is an important element in the construction of the Privacy Shield since its predecessor, the EU-US Safe Harbour scheme, was annulled by the Court of Justice of the European Union (CJEU) on 6 October 2015 (Case C-362/14). Whether the improvements suffice for the Privacy Shield to meet the EU requirements will be determined by the European Courts in the coming months. Please click below for a short client memorandum on the Third Annual Review of the EU-US Privacy Shield.

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    • 26/11/2019
    • Articles

    EU Health Ministers to Consider Policies Fostering Cooperation to Improve Access to Medicines and Reduce Medicine Shortages

    The Finnish Presidency of the European Council has invited Member States to a policy debate that will consider avenues towards strengthened cooperation in order to improve access to medicines (see, attached note of 22 November 2019 – the “Note”). The debate should take place during the employment, social policy, health and consumer affairs Council of 9 December 2019. The Note takes stock of the many initiatives that have been taken in recent years at various levels of government and on a wide range of subjects. At the same time, guided by what it describes as the “four phases of a medicine’s lifecycle”, the Note also identifies a number of possible regulatory gaps. It specifically welcomes Member State comments on the requirement to maintain medicines on the market, reduce “uncontrolled market withdrawals” and curb shortages. On this basis, it requests the Member States to take a position on the following issues: 1. Concrete measures to be taken by both Member States and the European Commission to ensure access to medicines and avoid medicine shortages. 2. Possible EU rules to (i) make EU-based back-up manufacturing capacity mandatory; (ii) create earlier warnings of supply interruptions; and (iii) ensure continuity of supply. 3. Strengthened Member State cooperation in areas as diverse as sustainability of budgets and shortages of medicines. While a parting shot for the Finnish Presidency of the Council (In 2020, first Croatia and then Germany will succeed Finland), the Note sets the tone for an ambitious medicines policy to be adopted by the new European Commission which is now expected to become operational on 1 December 2019.

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    • 22/11/2019
    • Articles

    Spanish Competition Authority Accuses Merck Sharp & Dohme of Abuse of Intellectual Property Rights to Delay Third-Party Market Entry

    On 21 November 2019, the Spanish competition authority, the "Comisión Nacional de los Mercados y la Competencia ("CNMC"), showed once again its determination to crack down on anticompetitive practices in the pharmaceutical sector when it announced the start of competition proceedings against Merck Sharp & Dohme S.A. and its European parent company MSD Human Health Holding B.V. (together MSD) (see, attached press release). MSD stands accused of having abused its intellectual property rights, through court action and otherwise, in hopes of delaying third-party entry on the Spanish market for combined hormonal contraceptive medicines of the vaginal ring type. MSD may thus have breached Article 102 of the Treaty on the Functioning of the European Union as well as its Spanish counterpart, namely Article 2 of Law 15/2007 of 3 July 2007 on the Protection of Competition. The CNMC has been quick in reaching its tentative conclusion as on premise inspections in this case took place as recently as May 2019 (see, Van Bael & Bellis Life Sciences Newsflash of 27 May 2019).

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    • 21/11/2019
    • Articles

    European Commission Seeks Increased Awareness of Additional Monitoring System of Medicines

    The European Commission released on 15 November 2019 a report examining the effectiveness of amendments made in 2010 and 2012 to the pharmacovigilance rules governing medicines under additional monitoring (the Report, see, attached). These medicines are identified by the inclusion of a black inverted triangle▼and an explanatory note in the product information. The additional monitoring system applies to medicinal products for which enhanced post-authorisation data collection is needed to ensure that any new safety hazards are identified as promptly as possible and that appropriate action can be initiated immediately.

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    • 19/11/2019
    • Newsletters

    VBB on Belgian Business Law, Volume 2019, No. 10

    The October 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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    • 18/11/2019
    • Articles

    Medicine Shortages - Latest Developments Across Europe

    Medicine shortages remain a high-priority issue for governments across Europe. During the last few days, a new slew of measures and policy initiatives emerged. Norway On 7 November 2019, Norway notified to the European Commission (the “Commission”) proposed powers that would enable the Norwegian Medicines Agency to prohibit medicine wholesalers from making parallel exports of specific medicines if their continuous supply in Norway is at risk (see, attached notification). The notification is based on Directive (EU) 2015/1535 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services. This Directive also applies to the EFTA countries, including Norway, and allows the Commission, EU Member States and EFTA countries to offer their view on the compatibility of the proposed measures with European pharmaceutical law and with the free movement of goods principle. In this case, the consultation period runs until 10 February 2020. Norway stresses that medicine shortages form a growing problem of international dimensions in the face of which small countries such as Norway are nearly powerless. According to Norway, a tailored export prohibition on wholesalers is one of the few adequate and proportionate instruments available to protect the health of the local population. Portugal In Portugal, the Portuguese medicines agency Infarmed published new rules to manage medicine shortages (see, attached rules). They come in the wake of recent statutory powers that sought to strengthen access to medicines by reinforcing the public service obligation of the various stakeholders in the supply chain. (see, Van Bael & Bellis Life Sciences Newsflash of 23 August 2019). Wholesalers must have at least one month’s worth of supplies, while medicine suppliers must ensure two months’ worth of supplies. Suppliers, wholesalers and pharmacies are required to notify the authorities of shortages within 24 hours of becoming aware of the issue, while suppliers with advance knowledge of an emerging shortage issue should notify the authorities at least two months ahead of the shortage. Belgium Belgium has taken a number of practical steps to confine the problem by creating an interagency database for medicines subject to shortages, intensifying the channels of communication between the supply chain stakeholders and generally raising awareness of the existing rules and obligations. At the same time, the Constitutional Court struck down a law limiting parallel exports of medicines as inadequate and incompatible with EU free movement principles (see, Van Bael & Bellis Life Sciences Newsflash of 17 October 2019). As a result, there would seem to be a groundswell of opinion in favour of further measures tackling medicine shortages. For example, a number of members of parliament advocate for higher fines to be imposed on medicine suppliers that fail to comply with existing obligations. Additionally, tighter supply obligations are also under consideration. Meanwhile, the caretaker government is also understood to work on a draft Royal Decree. Medicine shortages are now a politically charged subject and this is illustrated by the lengthy report which the chamber of representatives of the federal parliament just made publicly available. The report covers three hearings on medicine shortages which took place over the last few months before the parliament’s committee on health and equal opportunities (see, attached report). Europe Even though the incoming Commission will not take office until 1 December 2019 at the earliest, it now looks certain that medicine shortages will be high on its healthcare agenda. As a first step, officials of Directorate General SANTE have reportedly already earmarked a study that would look at harmonised rules governing supply obligations, notifications of shortages and monitoring systems. A further study would analyse parallel trade and market withdrawals.

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