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Five Further Member State Inspectorates Recognised under EU - US Mutual Recognition System for Medicines

  • 03/12/2018
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The Agreement on Mutual Recognition between the European Union and the United States of America continues its roll-out in the realm of pharmaceutical inspections. On two separate occasions in November 2018, the US Food and Drug Administration (“FDA”) added 5 new EU Member States to its list of countries which it considers to have capable inspectorates to carry out good manufacturing practice (“GMP”) inspections at a level equivalent to that observed in the US. These Member States are Belgium, Denmark, Estonia, Finland and Latvia. The updated list of in total 20 Member States whose inspection results the FDA considers can replace its own inspections can be found here:
https://www.fda.gov/internationalprograms/agreements/ucm598735.htm.
 
The EU and the US thus seem to be on track to have all EU Member States recognised as capable of carrying out pharmaceutical inspections by 15 July 2019. For its part, the FDA had already been earmarked as a capable inspectorate on 1 November 2017.

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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
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    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
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