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

  • 22/11/2019
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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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    • 28/11/2019
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    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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    • 26/11/2019
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    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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    • 21/11/2019
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    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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