NORWAY TRENDS AND DEVELOPMENTS Contributed by: Camilla Vislie, Magnus Hauge Greaker, Martin Guldbrandt Hansen and Nora Solberg Bjørnnes, Advokatfirmaet Thommessen AS
market exclusivity for orphan drugs. Currently, these medications have ten years of exclusiv - ity, plus additional time for processing generic applications. The European Parliament suggests a new structure with a base period of nine years exclusivity, with a potential extension up to 11 years for drugs addressing significant unmet medical needs. This approach aims to incentiv - ise research and development in rare diseases, ensuring that companies can profit despite lim - ited patient populations. By extending exclusiv - ity for drugs that meet critical needs, the reform seeks to balance innovation with patient access to essential treatments. 3. Stricter requirements for supply security to prevent medicine shortages. Supply Chain Security: The EU pharmaceutical reform aims to enhance supply chain security for critical medicines. The European Parliament’s amendments require marketing authorisation holders to explain and report supply disruptions, with at least six months’ notice for predictable interruptions. The proposal also refines access requirements, allowing for targeted pricing and reimbursement applications, and strengthening the European Medicines Agency’s role in moni - toring shortages. These measures collectively seek to improve supply chain resilience and ensure consistent availability of essential medi - cines across the EU. 4. Introduction of mandatory environmental risk assessments when applying for a market author - isation. Environmental Risk Assessment (ERA): The EU pharmaceutical reform emphasises environmen - tal considerations and sustainability, expanding the scope of Environmental Risk Assessments (ERAs) for marketing authorisation applications.
The European Parliament’s proposal extends ERAs to cover the entire life cycle of medicines, including production risks, and requires descrip - tions of emission reduction strategies. Member states must develop national plans to inform the public and healthcare professionals about proper disposal of unused or expired medicines, monitor disposal rates, and implement measures to increase correct disposal. These new require - ments aim to integrate environmental considera - tions more thoroughly into the regulatory pro - cess, addressing the environmental impact of pharmaceuticals throughout their life cycle and ensuring a more comprehensive approach to drug development and management. 5. New incentives for developing antimicrobial agents to combat resistance. To combat anti-microbial resistance, the EU pharmaceutical reform introduces transfer - able exclusivity vouchers (TEVs) for priority anti-microbials, offering extended data protec - tion. The European Parliament supports TEVs with stricter conditions, proposing 12, nine or six months of additional protection for criti - cal, high, or medium-priority anti-microbials, respectively. TEVs cannot be applied to prod - ucts already benefiting from maximum data protection (8.5 years). Additionally, a milestone payment scheme for new antimicrobial develop - ment is proposed, though manufacturers cannot benefit from both this scheme and TEVs for the same product. These measures aim to incentiv - ise the development of new antibiotics and anti- microbials to address resistant infections, while also implementing stricter requirements for anti- microbial use, including prescription limitations. As an EEA member, Norway will need to imple - ment these changes in national legislation. This could affect various aspects of the pharmaceu -
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