NORWAY TRENDS AND DEVELOPMENTS Contributed by: Camilla Vislie, Magnus Hauge Greaker, Martin Guldbrandt Hansen and Nora Solberg Bjørnnes, Advokatfirmaet Thommessen AS
industry in Norway, one point being that a high proportion of companies are established within life sciences sector, but only a few are scaled up in Norway. This means that the value already invested in Norway is not necessarily realised here. The same can be said about Norwegian research results within life sciences. Norwegian research results are to a high degree an export good, meaning that the large scale return on investment is not necessarily realised in Norway. Consequently, there is room for development, and the Norwegian Parliament decided in 2021 to facilitate Norwegian pharmaceutical produc - tion, which was described as “a moon step for the Norwegian health industry”. EU pharmaceutical reform: potential implications for Norway The EU’s comprehensive pharmaceutical reform, proposed by the European Commission in April 2023, could have significant consequences for the Norwegian pharmaceutical market through the EEA Agreement. The overarching goals of the reform are to make medicines more accessible and affordable while enhancing the competitiveness of the EU’s pharmaceutical industry. Specifically, it aims to ensure access to safe, effective, and affordable medicinal products across all member states, improve medicinal product supply chains, and create an attractive environment for pharmaceu - tical research and development (R&D) in Europe. By balancing these objectives, the reform seeks to address both public health needs and eco - nomic interests in the European pharmaceutical sector.
Key points of the reform include: 1. Adjustment of regulatory data production (RDP), with proposals for a 7.5-year data pro - tection period and potential extension. Regulatory Data Protection (RDP) Reform: The EU pharmaceutical reform proposes significant changes to the current data protection mecha - nism for medicinal products. Currently, pharma - ceutical companies enjoy eight years of data protection under the 8+2 system, which pre - vents generic manufacturers from using their original research data. This is followed by an additional two years of market protection, dur - ing which generics cannot be marketed but can prepare for market entry. The European Parlia - ment suggests reducing this to 7.5 years, with potential extensions up to 8.5 years based on specific criteria such as addressing unmet medical needs, conducting comparative clini - cal studies, or performing research and devel - opment within the EU. The proposed reforms aim to balance innovation incentives for origi - nal drug developers with the need for generic market competition. Pharmaceutical Industries have expressed concerns that shorter protec - tion periods might diminish Europe’s competi - tiveness in drug research and development. The proposed changes include nuanced provisions for extensions, such as additional protection for new therapeutic indications with significant clini - cal advantages, reflecting a nuanced approach to intellectual property protection in the pharma - ceutical sector. 2. Extended market exclusivity for rare disease medications, with potential for up to 11 years of protection. Market Exclusivity for Rare Disease Drugs: The EU pharmaceutical reform proposes changes to
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