Posted: November 7th, 2022
Implementation of the SPC manufacturing waiver into Norwegian law, by Guro Nybø, Nora Bratheim, Lars Erik Steinkjer and Gunnar Meyer, Wikborg Rein
The SPC manufacturing waiver was adopted by the European Parliament in 2019 through Regulation 2019/933 amending Regulation (EC) no 469/2009 concerning the supplementary protection certificate for medicinal products (the SPC Regulation). 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.
As from 2 July this year the waiver has been available for pharmaceutical manufacturers within the EU. On the other hand, the process for incorporating the waiver into Norwegian law is still ongoing. Recent developments, however, indicate that the SPC manufacturing waiver may enter into force in Norway on 1 January 2023.
Why is the SPC waiver still not available 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.
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.
Proposal for implementation submitted in September 2022
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 this year, 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)).
The process ahead and expected timeline
The proposal from the Ministry is now at the committee stage, where the Parliament refers the proposal to the relevant committee for it to be considered in detail. The committee will form an opinion and draft a recommendation which they submit to the Parliament. Next, the proposal will be subject to two separate readings by the Parliament.
It is likely that the proposal will be adopted by the Parliament by the end of December 2022, and that the amendments to the Patent Act and implementation of the SPC waiver will enter into force on 1 January. In summary, we expect the SPC manufacturing waiver will be adopted and implemented into Norwegian law with effect from 1 January 2023, or alternatively, during the first half of 2023.
The proposal from the Norwegian Ministry of Justice and Public Security (Prop. 140 LS (2021-2022)) can be read here (in Norwegian).