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Slovakia Final Member State To Benefit From EU-US Mutual Recognition Agreement For Inspections of Manufacturing Sites For Human Medicines

  • 12/07/2019
  • Articles

Slovakia has become the 28th and final EU Member State to be given the powers to carry out good manufacturing practice (“GMP”) inspections at a level equivalent to that prevailing in the US (see attached press release). On 11 July 2019, the US Food and Drug Administration (“FDA”) confirmed Slovakia’s status under 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.
Pursuant to the MRA, the EU and the US now fully recognise inspections of manufacturing sites for human medicines carried out in each other’s territories. Separately, the batch testing waiver existing under the MRA will also start to apply. As a result, qualified persons in pharmaceutical firms based in Europe will no longer be required to carry out the quality controls when these have already been run in the US.
The EU and US will continue implementation work for the MRA in hopes of extending its scope to a range of additional products, including veterinary medicines, human vaccines and plasma derived medicinal products. 


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    • 15/07/2019
    • Articles

    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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    • 09/07/2019
    • Articles

    France Presents Plan To Tackle Medicine Shortages and Adds Sense of Urgency to European Discussions

    Agnès Buzyn, the French Minister for Solidarity and Health, presented on 8 July 2019 a four-year plan to tackle medicine shortages in France (see, annex). The plan is the latest move in what is gradually becoming a wave of new rules and policy initiatives across Europe to fight the lack of availability of specific medicines. The plan reflects a four-pronged approach that includes the following measures: 1. Increased transparency and enhanced channels of communication between all stakeholders, including individual patients and patient organisations 2. New strategies for preventing, mitigating and managing medicine shortages • Power for community pharmacists, subject to conditions, to substitute out-of-stock medicines of major therapeutical importance (“médicaments d’intérêt thérapeutique majeur “ – “MITM”); • Focus on antibiotics that run an out-of-stock risk; • Further development of management plans for out-of-stock medicines (“plans de gestion des pénuries” – “PGP”) and creation of enhanced management plans for medicines that have already faced supply problems (“PGP renforcé”); • Specific measures targeting hospitals and wholesaler-distributors. 3. Reinforced national coordination and increased European cooperation • Increased powers for regulator (“Agence nationale de sécurité du médicament et des produits de santé – “ANSM”) to tackle supply quota systems (“contingentements”) and to import substitute medicines, including competing products; • Powers for specific public institutions to stock and distribute MITMs; • Pursuit of European rules, including definitions of key concepts such as medicine shortage and medicines of major therapeutical importance; • Advocacy in Europe of European or French production of key pharmaceutical ingredients and medicines; • Increased focus on joint procurement of essential vaccines; • Exchange of information between Member States on medicines hit by shortages. 4. Modified institutional architecture • The new plan will be implemented and steered by a “Comité de pilotage” (“COPIL”) and supported by a task force composed of representatives of the various competent ministries. ANSM will also be given a more prominent role. The French plan is certain to be met with close attention in France and abroad as it plays into the often expressed and at times overstated fears of supply disruption of medicines. Following repeated similar statements by other policy makers and interested parties (see e.g., Van Bael & Bellis Life Sciences Newsflash of 28 June 2019), the plan is certain to catapult this issue on the list of top health priorities of the incoming European Commission.

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