EU SPC waiver for generic pharmaceuticals producers
The awaited regulation which will introduce a “manufacturing waiver” for EU SPCs relating to medicinal products has been formally adopted by the EU Council and is expected to enter into force on 1 July 2019 (dependent on the date of publication of the Regulation in the EU’s Official Journal).
Broadly speaking, the regulation will introduce an exception to the protection granted to an original medicine by an SPC for export purposes and/or for stockpiling, provided that particular conditions are met.
Initially, the regulation will affect only SPCs that are applied for on or after the date of entry into force of the regulation. However, three years after the date of entry into force, the regulation will also affect SPCs applied for before that date, but which have become effective after that date.
In summary, the exception applies to:
- manufacture of a product for the purposes of export to third countries (where protection of the original medicine does not exist or has expired) and to related acts which are strictly necessary for that manufacture or export; and
- only in the last six months of validity of the SPC, manufacture of a product for the purposes of storing in the Member State of manufacture (in order to market the product in the EU after expiry of the SPC) and any related acts strictly necessary for that manufacture or storage.
The exception will only operate if certain conditions are met. For example, key requirements are that:
- the maker (the person on whose behalf the relevant manufacture takes place) has provided certain information required by the regulation to both the authorities of the Member State of manufacture and to the SPC holder at least three months in advance of manufacture or an earlier related act;
- the maker has duly informed others involved in the commercialisation of the product who are performing excepted acts; and
- the maker has affixed to the packaging of the product the specific logo provided for by the regulation indicating clearly that it is only for export.
In its press release the Council said that “The regulation will remove the competitive disadvantages faced by EU-based manufacturers of generics and biosimilars vis-à-vis manufacturers established outside the EU in global markets.”