Insights & news

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

  • 03/12/2018
  • Articles

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.

Key contacts

Related practice areas

Related insights

Sign up for updates
    • 25/04/2019
    • Articles

    Spanish Competition Authority Raids Pharmaceutical Firm over Suspicions of Abusive Market Behaviour in Relation to Autoimmune Medicine

    The Comisión Nacional de Los Mercados y La Competencia, the Spanish competition authority (“CNMC”), announced today that, earlier this week, it carried out a dawn raid at the premises of an unidentified pharmaceutical firm (see, attached press release). The targeted firm is thought to have abused its dominant position in one or more markets involving the treatment of various unspecified autoimmune diseases. The CNMC suspects that the firm pursued an exclusionary commercial strategy in its dealings with health services (“Servicios de Salud”) and hospitals. The CNMC points out that the medicine at issue went off-patent and that any attempt to corner a market that is supposed to be free following the expiry of relevant patents amounts to a very serious infringement of the competition rules.

    Read more
    • 23/04/2019
    • Articles

    European Parliament Approves Manufacturing Waiver and Reduces Scope of SPC-Based Patent Rights in Medicines

    On 17 April 2019, the European Parliament (“EP”) approved a modification to Regulation No. 469/2009 which governs the supplementary protection certificate (“SPC”) for medicinal products. The modification creates a “manufacturing waiver” that encroaches on the operation of the SPC which, broadly, extends the patent protection afforded to active substances of medicines. The modification will allow EU-based companies to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the certificate, for the double purpose of either exporting to a non-EU market where protection has expired or never existed, or stockpiling the medicine during the final 6 months of SPC protection ahead of entry on the EU market once the SPC has lapsed. The “stockpiling” exception goes beyond the proposal which the European Commission initially tabled in May 2018 (see, Van Bael & Bellis Life Sciences Newsflash of 28 May 2018) and did not form part of the text which the Member States determined as their negotiating position in January 2019 (see, Van Bael & Bellis Life Sciences Newsflash of 21 January 2019). Still, the Council of the European Union is now expected to endorse the text adopted by the EP following a political agreement reached among the EU institutions in February 2019. Once published in the Official Journal of the EU, the modification to Regulation No. 469/2009 will enter into force 20 days later and will become directly applicable in all EU Member States. However, the full effects of the SPC waiver will only kick in 3 years after the date of that entry into force, currently expected to be around 1 July 2022. The creation of a manufacturing waiver is regarded as a major victory for the generic and biosimilar industries. Conversely, EFPIA, the European association of innovative pharmaceutical companies, has labelled the move as a “negative signal to the world that Europe is devaluing its intellectual property framework”. EFPIA therefore hopes that the next European Commission, which will take office following the European elections to be held between 23 and 26 May 2019, will “redress the balance, supporting research, development and innovation more broadly” (EFPIA press release of 17 April 2019).

    Read more

Subscribe to our updates

Please select the practice areas you are interested in: *