SPC manufacturing waiver has entered into force in Norway
Update on the implementation of the SPC manufacturing waiver for pharmaceutical manufacturers into Norwegian law.
Since 2 July 2022, the SPC manufacturing waiver, adopted by the European Parliament in 2019 through Regulation 2019/933, has been available for pharmaceutical manufacturers within the EU. The waiver enables manufacturers of generics and biosimilars to manufacture such medicines for the purpose of exporting them outside the EU during the SPC protection term.
The process for incorporating the waiver into Norwegian law has been lengthy; however, the waiver has now finally entered into force in Norway. On 20 December 2022, the Norwegian Parliament passed the amendment to the Norwegian Patents Act implementing the waiver. The Act entered into force on 1 February 2023, i.e. the SPC manufacturing waiver was fully implemented on this date.
Why has incorporating the SPC waiver been postponed in Norway?
Norway is not an EU Member State, but an EFTA Member State and thus part of the EEA Agreement. Accordingly, the process of implementing a new EU regulation (or an amendment to one) is more complex and often takes longer than that for EU Member States.
First, the relevant regulation needs to be incorporated into the EEA Agreement. A decision to incorporate Regulation 2019/933, introducing the SPC manufacturing waiver, was made by the EEA Joint Committee on 10 June 2022. As of today, the Regulation has yet to be implemented into the EEA agreement.
Second, the regulation needs to be implemented into national law. According to Article 103 of the EEA Agreement, the decision by the EEA Joint Committee is only binding on Norway following fulfilment of constitutional requirements. Pending parliamentary decisions to amend the Patents Act and to amend the EEA Agreement, Regulation 2019/933 is not yet part of the EEA Agreement.
The road to incorporation into Norwegian law
The SPC Regulation is part of the EEA Agreement and incorporated into Norwegian law through Section 62a of the Norwegian Patents Act. The implementation of Regulation 2019/933 will be implemented by an amendment of Section 62a.
In December of 2019, a first proposal to incorporate the regulation into Norwegian law through amending the Patents Act, was introduced by the Norwegian Ministry of Justice and Public Security. The first proposal was distributed for comments from stakeholders during the first quarter of 2020.
On 23 September 2022, the Ministry submitted to the Norwegian Parliament a final proposal for amending the Patent Act and consent to incorporation of Regulation 2019/933 into the EEA Agreement (Prop. 140 LS (2021-2022)). From there, the proposal was sent to the committee stage to be considered in detail. The relevant committee, the Standing Committee on Business and Industry, formed an opinion on the matter and drafted a recommendation to be submitted to the Parliament. The recommendation was submitted on 29 November 2022. The Norwegian Parliament adopted the bill by unanimous vote on 12 December 2022.
The Act entered into force on 1 February 2023, i.e. the SPC manufacturing waiver was fully implemented on this date.
Following the implementation of the waiver, Norway is considered an “EU member state” in terms of Regulation (EU) 2019/933, i.e. when the regulation uses “EU member state”, this will also include Norway. This also means that Norway is considered an “EU member state” with respect to labelling of export products to third countries; there is no need to label products bound for the Norwegian market with the “EU Export” logo or the “EEA export” logo.