Insights & news

Transatlantic Cooperation on Medicines - Latest Developments

  • 18/07/2019
  • Articles

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.

Attachments:

Key contacts

Related practice areas

Related insights

Sign up for updates
    • 23/08/2019
    • Articles

    Portugal Latest EU Member State to Tackle Medicine Shortages and Regulate Parallel Trade in Medicines

    In Portugal, an amending decree-law of 16 August 2019 which entered into force on 19 August 2019 seeks to strengthen access to medicines by reinforcing the public service obligation of the various stakeholders in the supply chain. That obligation involves the duty to ensure a continuous supply of medicines. It prohibits abusive or discriminatory practices such as directly or indirectly refusing to fulfill medicine orders or applying differing deadlines. The new decree-law reinforces the public-service obligations for pharmaceutical companies to ensure that medicines make it to wholesalers who have a duty of their own to supply pharmacies and other retailers. Those who hold a marketing authorisation must constantly monitor their stock positions and communicate possible shortages both to the other stakeholders and Infarmed, the Portuguese health agency. The decree-law also clarifies the dual role of wholesalers which have to (i) supply the domestic market; and (ii) operate as logistical service providers. Furthermore, the new decree-law makes an attempt to limit parallel trade by precluding wholesalers from selling medicines to other countries or other distributors, unless they have first made sure to supply the domestic market. Finally, the amendments bolster the ability of Infarmed to enforce the new rules. A communication which Infarmed issued to publicize the new rules is attached. Portugal thus becomes the latest EU member state to tackle medicine shortages and interfere with parallel trade in medicines. It is expected that the new European Commission which will start operations at the end of the year will also address this issue.

    Read more
    • 19/08/2019
    • Articles

    Belgium - Medicine Shortages - New Development

    At the end of July 2019, Febelco and PharmaBelgium-Belmedis, two wholesalers (“WS”) with a public-service WS status (groothandelaar-verdeler/grossiste-répartiteur – “WSD”), and the National Association of Wholesaler-Distributors (NVGV/ANGR) filed with the Constitutional Court (“CC”) a petition for annulment of Article 3, 2° of the Law of 7 April 2019 “modifying the Law of 25 March 1964 on medicines as regards the unavailability of medicines” (Wet van 7 april 2019 tot wijziging van de Wet van 25 maart 1964 op de geneesmiddelen voor wat de onbeschikbaarheden van geneesmiddelen betreft/Loi du 7 avril 2019 modifiant la Loi du 25 mars 1964 sur les médicaments en ce qui concerne les indisponibilités de médicaments) (see attached excerpts from the list of pending CC cases). Pursuant to Article 3,2°, WSD are no longer allowed to supply medicines to customers of their choice and should limit their supplies to specific customer categories, namely (a) other WSD; (b) community pharmacists; and (c) hospitals recognised under applicable rules (see Van Bael & Bellis Life Sciences Newsflashes of 8 May 2019 and of 17 May 2019).

    Read more
    • 05/08/2019
    • Articles

    Court of Justice of European Union Creates Questionable Regulatory Shortcut for Parallel Imports of Generic Medicines

    The Court of Justice of the European Union recently issued a puzzling judgment regarding parallel imports of generic medicines. Please find attached a case note discussing the judgment. We also attach a copy of the judgment itself.

    Read more

Subscribe to our updates

Please select the practice areas you are interested in: *