Pharmaceuticals - Export Manufacturing Waiver and Stockpiling Waiver Enter into Force on 1 July 2019
On 11 June 2019, the Official Journal of the European Union published Regulation (EU) 2019/933 of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate (“SPC”) for medicinal products (the “Regulation”). The modifications introduced by the Regulation encroach on the normal operation of the SPC which, broadly, extends the patent protection afforded to active substances of medicines. More precisely, they allow EU-based companies to manufacture in the EU a generic or biosimilar version of an SPC-protected medicine during the term of the SPC, for the double purpose of either exporting to non-EU countries where protection has expired or never existed (“manufacturing waiver”), or stockpiling the medicine during the final 6 months of SPC protection ahead of entry on the EU market immediately after the SPC has lapsed (EU Day-1 entry) (“stockpiling waiver”).
The manufacturing and stockpiling waivers extend to related acts that are “strictly necessary” for such manufacturing or storing, even though such acts would otherwise require the consent of the SPC holder. According to the preamble to the Regulation, such related acts could include possessing, offering to supply, supplying, importing, using or synthesising an active ingredient for the purpose of making a medicinal product, or temporary storing or advertising for the exclusive purpose of exporting to third-country destinations.
The Regulation requires producers of generic or biosimilar medicines to (i) notify the relevant competent authority in the EU Member State in which the manufacturing is to take place; and (ii) inform the SPC holder of their intention to manufacture a generic or biosimilar version of the protected medicine. Manufacturers will have to provide information on issues such as the markets where the new products will be exported to. For its part, the national authority will have to make that information publicly available. Further, in the case of products manufactured for the purpose of export to third countries, a specific logo will have to be affixed to the product’s outer packaging and, if feasible, to its immediate packaging.
The Regulation will enter into force on 1 July 2019 and will become directly applicable in all EU Member States. However, the new rules will not apply to SPCs that have already taken effect before 1 July 2019. As regards SPCs that have not taken effect before that date, the following principles apply:
- immediate application to SPCs that are applied for on or after 1 July 2019; and
- application from 2 July 2022 to SPCs that have been applied for before 1 July 2019 and that take effect on or after that date.
According to the Regulation’s preamble, the new rules are supposed to “strike a balance between restoring a level playing field between [producers of generic or biosimilar medicines established in the EU and those established in third countries, the former allegedly being “at a significant competitive disadvantage”] and ensuring that the essence of the exclusive rights of [SPC] holders […] is guaranteed in relation to the Union market”. However, advocates of intellectual property rights regard the manufacturing and stockpiling waivers as major victories for the generic and biosimilar industries and a dangerous step down the path of erosion of intellectual property rights (see, Van Bael & Bellis Life Sciences Newsflashes of 28 May 2018, 21 January 2019 and 23 April 2019).