Life Science – the framework for future health innovation

The life sciences industry is a critical driver of health innovation, balancing the challenges of research, development, and regulation. With significant investments and focus on enhancing treatment efficacy, the industry is shaping the future of healthcare. As new technologies and regulatory frameworks evolve, staying ahead of these trends is essential for navigating the opportunities and risks that will define tomorrow's breakthroughs.

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Life Science in Norway

The stakeholders in Norway's life sciences sector range from large, well-established international companies to small, niche firms. Despite their differences, these stakeholders often face the same fundamental commercial and legal challenges, particularly in areas such as patent protection and regulatory compliance.

As innovation continues to drive this industry, staying ahead of evolving regulations and market trends is crucial. Here, you can explore how the Norwegian regulatory framework for research, development, production, and sale of pharmaceuticals and medical devices is shaping the future of health innovation.

Patent enforcement in Norway

Patent protection is often of decisive importance within the life sciences sector. In Norway, patent matters are governed by the Act on Patents (the Patents Act). The Patent Act governs various aspects related to patents, including the requirements for patentability, the prosecution of patent applications, administrative oppositions, and infringements and invalidity proceedings.

Norway ratified the European Patent Convention (EPC) and became a member of the European Patent Office (EPO) on 1 January 2008. In general, the Norwegian Patent Act is fully consistent with the substantive provisions of the European Patent Convention (EPC). European patents may be validated and thereby become effective in Norway. For European patents that are granted in English, only the claims must be translated into Norwegian for the patent to take effect in Norway.

What does it take to place a medicinal product on the Norwegian market?

A manufacturer planning to market a medicinal product in Norway must both apply for a marketing authorization and establish a maximum price, as well as comply with statutory requirements.

Below is an overview of several of the requirements that apply to the marketing of medicinal products for humans (human medicines).

Patented medicines: The substitution list and the stepped-price system

When the patent protection for patented medicinal products expires, other manufacturers are free to offer equivalent products. Medicinal products that the Norwegian Medical Products Agency (the NOMA) considers interchangeable – meaning they contain the same active ingredient at the same strength, are biosimilar or bioequivalent, are medically equivalent, have the same dosage form, and have comparable pack sizes – will be included in the NOMA's list of interchangeable medicinal products (the substitution list).

Such competition helps to drive down prices for the relevant medicinal products. To ensure that this market situation benefits patients and society, a stepped pricing system has been introduced for interchangeable medicinal products. When a medicinal product loses its patent protection and competition arises from generic or biosimilar products, and the medicinal product is added to the NOMA's substitution list, the stepped price will come into effect. Pharmacies are required to have at least one medicinal product at the stepped price within each substitution group.

Legal framework for medical devices in Norway

In Norway, the marketing, use, and testing of medical devices are regulated by the Medical Devices Act of 7 May 2020, and the Medical Devices Regulations of 9 May 2021. The regulations cover all objects that are intended by the manufacturer to be used on humans and have a medical purpose.

The Norwegian legislation is harmonized with the EU regulations in this area, meaning that the legal framework for medical devices in Norway is essentially the same as that in EU countries.

Clinical trials of medicinal products for human use

Clinical trials of a medicinal product are conducted to gain knowledge about how the medicinal product works, what side effects it may have, and how it is metabolized in the body. Such trials contribute to increased understanding of the types of treatments that can be provided and which treatment is the most effective, thereby offering significant societal benefits.

Clinical trials are subject to strict regulatory requirements. Regulation (EU) No. 536/2014 provides a unified European regulation for clinical trials of medicinal products for humans. This regulation has been implemented into Norwegian law through the Medicinal Products Regulation (FOR-2009-12-18-1839), ensuring that the rules governing clinical trials in Norway align with those applicable in the EU.

EU pharmaceutical reform

On 26 April 2023, the European Commission presented a proposal for a new directive and a new regulation to reform EU medicinal product legislation.

The objectives include ensuring access to safe, effective, and affordable medicinal products in all member states, improving the supply of medicinal products, and creating an attractive environment for medicinal product research and development (R&D) in Europe.

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Legal expertise for the life science industry

Our lawyers have in-depth knowledge of the life science industry and continuously stay updated on national and international trends and developments that may affect the regulatory framework and market conditions. This way, we are always able to provide tailored advice.

At Thommessen, we assemble complementary teams to provide our clients with expert assistance across all areas. We have significant expertise and experience in areas such as patent law, medicinal product legislation, medical devices, and food products, as well as administrative law, public procurement, EU and EEA law, corporate law, M&A, competition law, and data protection.

Our lawyers assist a number of international and Norwegian businesses operating in the fields of pharmaceuticals, biotechnology and medical equipment, as well as businesses wanting to invest in life science operations.

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