Regulation (EU) 2019/933 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products

Summary:

Regulation of the European Parliament and of the Council of 20 May 2019 refining certain aspects of patent and Supplementary Protection Certificate (SPC) protection for medicinal products by introducing a manufacturing exemption for export purposes.

Further information:

The European Union's Single Market Strategy announced a targeted recalibration of certain aspects of patent and SPC protection to boost the competitiveness of regulated industries such as the pharmaceutical industry. In May 2016 the European Parliament endorsed the need for action on the EU SPC regime and urged the European Commission to introduce and implement before 2019 an SPC manufacturing waiver, so as to boost the competitiveness of the generics and biosimilars sector, but without undermining the market exclusivity granted under the SPC regime in protected markets.

This initiative proposes an amendment to the European Union's legislation on Supplementary Protection Certificates for medicinal products (Regulation (EC) No 469/2009) and aims to introduce a so-called manufacturing exemption for export purposes (also known as a manufacturing waiver) during the term of an SPC.

The Commission presented the proposal on 28 May 2018. Ambassadors from Member States adopted a general approach on behalf of the Council of the European Union on 16 January 2019, and an informal agreement between the co-legislators on a compromise text was reached on 14 February.

Official

EUR-Lex: COM(2018)317: Proposal for a Regulation amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products https://eur-lex.europa.eu/legal-content/EN/HIS/?uri=COM:2018:317:FIN

EUR-Lex: SWD(2018)240: Impact assessment accompanying COM(2018)317 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=SWD:2018:240:FIN

EUR-Lex: SWD(2018)241: Executive summary of the impact assessment accompanying COM(2018)317 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=SWD:2018:241:FIN

EUR-Lex: SWD(2018)242: Summary of the replies to the public consultation https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=SWD:2018:242:FIN

European Parliament: Legislative Observatory: Procedure File for Proposal on supplementary protection certificate for medicinal products https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?reference=2018/0161(COD)

European Parliament: Legislative Train: Regulation concerning the supplementary protection certificate for medicinal products http://www.europarl.europa.eu/legislative-train/theme-deeper-and-fairer-internal-market-with-a-strengthened-industrial-base-products/file-supplementary-protection-certificate-for-medicinal-products

European Commission: DG Internal Market, Industry, Entrepreneurship and SMEs: Supplementary protection certificates for pharmaceutical and plant protection products https://ec.europa.eu/growth/industry/intellectual-property/patents/supplementary-protection-certificates_en

European Commission: Press Release, 28/05/2018: Pharmaceuticals: Commission refines intellectual property rules http://europa.eu/rapid/press-release_IP-18-3907_en.htm

European Commission: Fact Sheet, 28/05/2018: Supplementary protection certificate for medicinal products [FAQ] http://europa.eu/rapid/press-release_MEMO-18-3908_en.htm

European Commission: Statement, 28/05/2018: Opening remarks by Vice-President Katainen and Commissioner Bieńkowska on the Commission's proposal on Supplementary Protection Certificates http://europa.eu/rapid/press-release_STATEMENT-18-3970_en.htm

Council of the European Union: Press Release, 16/01/2019: EU to help boost exports of generic pharmaceuticals https://www.consilium.europa.eu/en/press/press-releases/2019/01/16/eu-to-help-boost-exports-of-generic-pharmaceuticals/

---

News

EurActiv, 21/01/2019: Discussion heats up over stockpiling of generic drugs under patent protection https://www.euractiv.com/section/health-consumers/news/discussion-heats-up-over-stockpiling-of-generic-drugs-under-patent-protection/

---

Commentary and Analysis

EPRS: At a Glance, April 2019: Supplementary protection certificate for medicinal products http://www.europarl.europa.eu/thinktank/en/document.html?reference=EPRS_ATA(2019)637902

---