Life Sciences - Q1 2026

Life Sciences Quarterly Q1 2026

BAHR

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Table of Contents Regulatory updates Norway ................................................................................................... 5 Case law Norway ...................................................................................................................... 8 Regulatory updates EU .......................................................................................................... 11 Case law EU ............................................................................................................................. 13

Editorial team

Beret Sundet

Eirik Basmo Ellingsen

Tord Fondevik

Knut Sverre S. Andresen

PARTNER

PARTNER

PARTNER

PARTNER

bsu@bahr.no

eiell@bahr.no

tof@bahr.no

knusa@bahr.no

Anja Stensrud Elverum

Fujan Parsa

Anja Medbøe Tamuly

Ingrid Li

MANAGING ASSOCIATE

SENIOR ASSOCIATE

ASSOCIATE

ASSOCIATE

anelv@bahr.no

fupar@bahr.no

antam@bahr.no

ingli@bahr.no 2

Introduction This Q1 2026 edition marks the inaugural issue of our Life Sciences Quarterly. The publication highlights key legal and regulatory

developments affecting the life sciences sector in Norway and the EU,

with a focus on significant regulatory initiatives, new case law and policy

developments from the first quarter of 2026. The updates are particularly relevant to pharmaceutical, biotechnology, medical device and health technology companies.

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Life sciences BAHR serves as a trusted advisor to life sciences companies across all stages of their lifecycle.

We cover the full spectrum of transactional activity in the sector, including capital market transactions, IPOs, M&A, joint ventures and strategic partnerships.

We advise life sciences companies across their business development activities, including protection of IP, R&D agreements, licensing arrangements, agreements relating to manufacturing, clinical trials, supply and distribution. Our lawyers understand the commercial drivers, regulatory constraints, and intellectual property considerations relevant to this sector.

Our team is distinguished for its representation of leading pharmaceutical originators in complex patent disputes. Our litigation team has acted as lead counsel in some of the most high-profile pharmaceutical patent cases in recent years, and we bring unparalleled expertise in pharmaceutical regulations and comprehensive industry knowledge to a wide range of regulatory matters.

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Norway Regulatory updates Implementation of Commission Implementing Regulation (EU) 2024/2699 on cooperation with EMA in the context of the HTA Regulation As reported in the Q4 2025 edition of our Technology and IP Quarterly, Commission Implementing Regulation (EU) 2024/2699 forms part of the so-called HTA Regulation and lays down detailed procedural rules for the cooperation between the Member State Coordination Group on Health Technology Assessment and the European Medicines Agency (“EMA”). The regulation primarily governs the exchange of information in connection with joint clinical assessments and joint scientific consultations of medicinal products and medical devices. To read more about the HTA Regulation, see the Q4 2025 edition of our Technology and IP Quarterly, available here. 1 Following the EEA Committee's decision to incorporate the regulation into the EEA Agreement on 20 March 2026, a Norwegian implementing regulation was announced on 26 March 2026. 2 The regulation is implemented in Norwegian law through amendments to the regulations on medicinal products and medical devices.

For Norwegian market authorisation holders and developers of medicinal products and medical devices, the implementation means that the procedural rules governing cooperation between the Member State Coordination Group and EMA now apply in Norway, including the structured exchange of information underpinning such assessments and consultations.

The Government has launched a ten-year national action plan to boost Norway's position in clinical research On 23 March 2026, the Government announced its ten-year national action plan for clinical trials and clinical research (Nw. Nasjonal handlingsplan for kliniske studier og klinisk forskning). 3 The Government's ambitions include making clinical research an integrated part of all clinical practice and patient care, and positioning Norway among the most attractive countries in Europe for the conduct of industry-sponsored clinical trials. 4 To achieve these objectives, the Government has set out a number of measures, such as: •

Simplifying and coordinating regulatory processes, including through a pilot scheme to test faster approval of multinational studies.

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Developing national real-time data on participation in clinical studies, and ensuring registration in patient records and other administrative systems.

Technology and IP Quarterly – Q4 2025 under point 2.2.1.1. https://europalov.no/rettsakt/europeisk-samarbeid-om-medisinske-metodevurderinger-samarbeid-med-det-europeiskelegemiddelbyra/id-32919 3 https://www.regjeringen.no/no/aktuelt/regjeringen-lanserer-ny-plan-norge-skal-vare-i-europatoppen-for-gjennomforing-avkliniske-studier-og-kliniskforskning/id3153586/?utm_source=regjeringen.no&utm_medium=email&utm_campaign=nyhetsvarsel_dag 4 https://www.regjeringen.no/no/dokumenter/nasjonal-handlingsplan-for-kliniske-studier-og-klinisk-forskning20262036/id3153558/ 1 2

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Investigating whether the additional clinical tasks associated with interventional clinical trials can be accommodated through activity-based funding in hospitals.

Many stakeholders have welcomed the plan; however, it has also attracted some criticism.

The Association of the Pharmaceutical Industry in Norway (“LMI”) has expressed support for a number of the measures set out in the plan and is particularly positive about the clear emphasis on health data, data-driven feasibility and digital recruitment solutions, which it considers could represent a genuine competitive advantage for Norway. At the same time, LMI has expressed concern that the action plan is broader in scope than its predecessor, and that it risks placing even greater strain on existing capacity. 5 The full action plan is available here, and in PDF here.

Norway establishes new national council for priority-setting and sustainability in health and care services On 17 March 2026, the Norwegian Government announced the establishment of a national council for priority-setting and sustainability (Nw. Nasjonalt råd for prioritering og bærekraft) in the health and care sector. 6 The Council will serve as a national arena for strategic and principled discussion of priority-setting questions and long-term sustainability in the health and care services.

The initiative follows the Government`s Priority-Setting White Paper (Nw. Prioriteringsmeldingen), which emphasised that sustainable and equitable priority-setting requires not only technical expertise, but also public legitimacy and cross-sectoral engagement.

The Council's mandate covers a broad range of responsibilities across the health and care sector. It will discuss principled and structural priority-setting questions, and identify and examine challenges relating to long-term sustainability, including overtreatment, overdiagnosis, and resource utilisation. Beyond its analytical role, the Council is also tasked with promoting dialogue and fostering a shared understanding between health authorities, the municipal sector, regional health authorities, professional organisations, service users, research institutions, and the business sector. In addition, the Council will contribute to public communication and awareness-raising on priority-setting and sustainability more broadly.

Finally, it will provide input to the authorities on measures to strengthen transparency, legitimacy, and public trust in the priority-setting system.

Although the Council is primarily a public deliberation body, its work may have practical relevance for businesses operating in the health and care sector. The Council's recommendations on priority-setting and sustainability could influence future policy decisions regarding reimbursement, resource allocation, and the uptake of new treatments and technologies. Companies active in pharmaceuticals, medical devices, and health technology should therefore follow the Council's work closely, as its input to the authorities may shape the regulatory and market access landscape in Norway in the years to come. https://www.lmi.no/2026/03/23/lmi-om-den-nye-handlingsplanen-bra-ambisjonsniva-na-blir-tempo-og-helhetlig-tenkingviktig/ 6 https://www.regjeringen.no/no/aktuelt/regjeringen-oppretter-nytt-nasjonalt-rad-for-prioritering-og-barekraft-i-helse-ogomsorgstjenestene/id3152444/ 5

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NoMA has opened its annual consultation on proposed changes to the list of medicines approved for sale outside pharmacies The Norwegian Medical Products Agency (“NoMA”) determines which medicines may be sold outside pharmacies under the so-called LUA scheme. The LUA list is reviewed and updated on an annual basis, following input from relevant stakeholders. 7 On 12 March 2026, NoMA opened its annual consultation inviting stakeholders and the relevant medical community to submit proposals for changes to the LUA list. The deadline for submissions is 1 May 2026. 8 Whilst NoMA determines which medicines are eligible for sale outside pharmacies, retailers have discretion as to which of the approved medicines they choose to stock. However, certain minimum assortment requirements apply in respect of specific medicines.

Proposals for changes to the LUA list should be submitted to post@dmp.no, with reference to case number 26/09297.

Joint Nordic press release on the use of the JNHB application process for new medicines On 27 February 2026, five Nordic assessment and decision-making bodies, including NoMA on behalf of Norway, issued a joint press release encouraging manufacturers to seek access to their medicines through the Joint Nordic Health Technology Assessment Bodies (JNHB) process, rather than applying separately in each country. 9 The press release states that suppliers in the process of launching new medicines in the Nordic markets should make use of the application process offered by the JNHB. The Nordic countries' joint message is that doing so will contribute to the efficient use of resources for both regulatory authorities and suppliers seeking access to the Nordic market. Furthermore, it will facilitate knowledge-sharing, and patients will gain earlier access to these medicines.

The four joint assessments completed since the JNHB's launch in June 2024 were all finalised within 90 working days. 10 Historic public-private partnership to strengthen health and life sciences in Norway On 10 February 2026, it was announced that AstraZeneca, Oslo University Hospital, the University of Oslo, SINTEF and Oslo Science City had entered into a landmark strategic partnership aimed at accelerating the path from research to patient, improving the quality of clinical studies and enabling better utilisation of health data. 11 The partnership was launched in connection with the opening of the Norway Life Science conference.

The partnership is the first of its kind in Norway, bringing together academia, the health service, applied research and industry in a structured, transparent and collaborative framework on equal terms. The parties have committed to concrete projects within three priority areas: https://www.dmp.no/tilvirkning-import-og-salg/salg-utenom-apotek/liste-over-legemidler-som-kan-omsettes-utenfor-apotek https://www.dmp.no/nyheter/arlig-gjennomgang-av-lua-listen---dmp-ber-om-innspill 9 https://www.dmp.no/nyheter/nordisk-samarbeid-for-raskere-tilgang-til-legemidler 10 https://www.nyemetoder.no/aktuelt/raskere-tilgang-til-nye-medisiner-i-norden/ 11 https://www.lmi.no/2026/02/10/nytt-strategisk-partnerskap-skal-styrke-helse-og-livsvitenskap-i-norge/ 7 8

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• • •

Precision medicine;

Clinical studies; and

Health data and digital home monitoring.

Updated Guidance on the handling of quality defects in medicinal products On 28 January 2026, NoMA updated its guidance on the handling of quality defects in medicinal products as well and the relevant forms for reporting quality defects. The updated guidance replaces the formerly applicable guidance document R 11/2001, and can be found here. 12 Further, a dedicated webpage is established for the publication of “Dear Healthcare Personnel” letters relating to quality defects. The webpage can be found here. 13 According to NoMA, the updates are intended to provide clearer guidance on which information must be included in the initial notification of a quality defect, as well as the information required to be included in a final report before a case can be closed. The guidance further clarifies that NoMA requires that all recalls (suspension of distribution) of medicinal products in Norway be reported. 14 Norway granted central role in three-year EU project to strengthen storage and distribution of medical products in crisis situations In early January 2026, NoMA announced that Norway will play a central role in the three-year EU project Joint Action on Comprehensive and Sustainable Strategic Stockpiles of Medical Countermeasures Used in Crisis (“JA STOCKPILE”). The initiative was established in response to weaknesses in supply chains, crisis management and coordination between EU/EEA countries highlighted during the COVID-19 pandemic (and, more recently, other cross-border crises). 15 The Joint Action aims to strengthen preparedness for serious cross-border health threats by supporting the development of comprehensive and sustainable strategic stockpiles of “medical countermeasures” (including medicines, medical devices and personal protective equipment), enabling faster distribution and deployment in crisis situations.

NoMA will (together with the French Ministry of Health) co-lead one of the project’s work packages on sustainable stockpile management, with a particular focus on the management of products that are rarely used outside crisis situations.

Further information is available on the JA STOCKPILE website available here.

Case law Violations of advertising regulations for medicinal products

https://www.dmp.no/tilvirkning-import-og-salg/import-og-grossistvirksomhet-med-legemidler/tiltak-ved-kvalitetssvikt-palegemidler 13 https://www.dmp.no/tilvirkning-import-og-salg/import-og-grossistvirksomhet-med-legemidler/tiltak-ved-kvalitetssvikt-palegemidler/kjare-helsepersonell-brev-om-kvalitetssvikt 14 https://www.dmp.no/nyheter/oppdaterte-nettsider-og-meldeskjemaer-for-kvalitetssvikt-og-sikkerhetsanordninger-forlegemidler 15 https://www.dmp.no/en/news/noma-central-to-the-joint-action-on-emergency-stockpiles-in-the-eu?utm_source=openai 12

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Violations of advertising regulations may result in fees and compulsory fines. Decisions resulting from such violations are published on NoMA's website after the appeal deadline has expired. The website can be accessed here.

During the first quarter of 2026, NoMA published five new decisions. Three of the decisions were directed at professional actors and pharmaceutical companies, including Ipsen AB, ALKAbelló and Gilead, whilst two were directed at Norwegian influencers. The decisions against the two influencers are summarised below.

Christian Brennhovd In its decision of 9 January 2026, NoMA ordered Norwegian influencer Christian Brennhovd to cease the unlawful advertising of melanotan and retatrutide, neither of which are approved medicinal products in Norway. 16 Brennhovd had been the domain subscriber for the website looksmaxing.no, where these substances were made available for purchase. Additionally, Brennhovd had actively promoted the website through his Snapchat account. NoMA found that this conduct constituted unlawful advertising. Brennhovd was ordered to cease the unlawful advertising but was not issued a fine.

Benedicte Haugaard AS On 17 February 2026, the Ministry of Health and Care Services rejected Benedicte Haugaard's complaint against NoMA's decision of 29 August 2025, in which she was ordered to cease advertising for intravenous treatment with nicotinamide adenine dinucleotide, a substance that does not hold a marketing authorisation in Norway. 17 Benedicte Haugaard had posted a video on Snapchat in which she described receiving this treatment, showed images of the treatment, and portrayed it in a positive manner. The video also included information about where one may seek the treatment. The Ministry found that intravenous treatment with nicotinamide adenine dinucleotide should be classified as a medicinal product, cf. the Norwegian Medicines Act. Furthermore, the Ministry found that posting the video on Snapchat constituted advertising, even though Haugaard had paid for the treatment herself and had not received any payment for posting the video. The Ministry emphasised that influencers may exert a significant degree of influence by virtue of the credibility and trust they command amongst their audience.

https://www.dmp.no/globalassets/documents/tilvirkning-import-og-salg/reklame/brudd-pa-reklamereglene/2026/25_3479915-vedtak-om-palegg-om-stans-av-ulovlig-reklame-for-melanotan-og-retatrutid.pdf 17 https://www.dmp.no/globalassets/documents/tilvirkning-import-og-salg/reklame/brudd-pa-reklamereglene/2026/25_3869klage-pa-vedtak-om-stans-av-ulovlig-reklame-palegg-om-beriktigelse-og-tvangsmulkt__skjult-innhold.pdf 16

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EU Regulatory updates The final text of the EU Pharma Package has now been officially published On 11 December 2025, the Council of the European Union and the European Parliament reached a provisional agreement on the EU pharmaceutical reform package, often referred to as the “pharma package”. 18 To read more about the “pharma package”, see the Q4 2025 edition of our Technology and IP Quarterly, available here. 19 Following the trilogue outcome reached in December 2025, the Committee of Permanent Representatives of the EU Member States (“COREPER”) formally endorsed the agreed texts on 6 March 2026, comprising two legislative instruments: a new Directive and a new Regulation. The final texts have now been officially published. 20 On 18 March 2026, the European Parliament`s SANT Committee subsequently voted on the compromise text. The legislation will now undergo the remaining procedural steps before formal adoption. This includes approval by the Ministers of Health convening in the Employment, Social Policy, Health and Consumer Affairs Council (“EPSCO”), followed by a vote in the European Parliament Plenary. 21 Both steps are expected to take place during autumn 2026, following the required legal-linguistic review of the texts. 22 Once formally adopted, the texts will be translated into all official EU languages and published in the Official Journal of the European Union, after which the legislation will enter into force subject to the corresponding transition periods. The legislation is marked EEA-relevant, and Norway will be required to implement corresponding amendments to its current legislation in due course.

New guidance on the conduct of clinical trials during public health emergencies in the EU EMA has issued a draft guidance document on the conduct of clinical trials during public health emergencies in the EU (“PHEs”). The draft guidance was opened for public consultation on 4 March 2026. The consultation period will last until 30 April 2026. The draft guidance can be found here. 23According to the draft guidance, it is intended for sponsors and all stakeholders involved in the design and conduct of clinical trials in the EU, and shall apply in the absence of available EU legislation related to PHEs, to the extent permitted by national legislation. The draft guidance recommends a harmonised approach to ensure clinical trials can be initiated, adapted and continued efficiently and safely during a PHE, and

https://www.consilium.europa.eu/en/press/press-releases/2025/12/11/pharma-package-council-and-parliament-reach-a-dealon-new-rules-for-a-fairer-and-more-competitive-eu-pharmaceutical-sector/ 19 Technology and IP Quarterly – Q4 2025 under point 2.2.1.5.

20 See https://data.consilium.europa.eu/doc/document/ST-6367-2026-INIT/en/pdf and https://data.consilium.europa.eu/doc/document/ST-6366-2026-INIT/en/pdf 21 https://www.eucope.org/eucope-reacts-to-the-vote-on-the-provisional-agreement-on-the-eu-general-pharmaceuticallegislation-gpl/#:~:text=EUCOPE%20reacts%20to%20the%20vote,the%20European%20life%20sciences%20ecosystem.

22 https://www.europarl.europa.eu/legislative-train/theme-promoting-our-european-way-of-life/file-revision-of-thepharmaceutical-legislation 23 https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guidance-conduct-clinical-trials-during-public-healthemergencies_en.pdf 18

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proposes regulatory mechanisms to accelerate the authorisation of new trials and modifications to ongoing ones. 24 The draft guidance explains how sponsors may consider adaptations of trial design elements where necessary to respond to constraints arising during a PHE, or in order to investigate the prevention or treatment of medical conditions related to the PHE. It is emphasised that any changes to trial design must be assessed and authorized in accordance with the applicable regulatory framework. To streamline the authorisation of clinical trials addressing a PHE, sponsors are encouraged to seek scientific advice from EMA's Emergency Task Force (ETF).The draft also addresses the transfer of trial participants affected by a PHE across investigational sites, affirming that participants’ rights, safety and well-being, as well as the generation of scientifically robust evidence, remain central to regulatory decisions. 25 EMA proposes a concept paper on proof-of-concept data to support the development of anti-cancer medicinal products in paediatric patients On 13 March 2026, EMA opened a public consultation on a concept paper on the development of a reflection paper on proof-of-concept data to support the development of anti-cancer medicinal products in paediatric patients. 26 The concept paper identifies high-level recommendations for the generation and assessment of meaningful proof-of-concept data to support the development of novel products in paediatric oncology, and outlines the key challenges associated with evaluating such data, including the limited translatability of adult data to paediatric cancers, the scarcity of paediatric patient populations, the assessment of non-clinical models, and the absence of a structured regulatory framework for evaluating such data. The concept paper sets out the key evidence domains that will form the basis of a proposed weight-of-evidence assessment framework, to be explored in further detail in the planned reflection paper. The concept paper also proposes a process for consultation with relevant stakeholders, including academic experts and academic consortia, who may contribute scientific input to inform the assessment of Paediatric Investigation Plans in the context of anti-cancer drug development in children. 27 The public consultation period lasts until 30 June 2026, 28 and the forthcoming reflection paper is likely to influence regulatory requirements for Paediatric Investigation Plans.

EMA and FDA published common guiding principles for good AI practice in medicines development On 14 January 2026, EMA and the U.S. Food and Drug Administration (“FDA”) announced that they have jointly identified ten common principles for “good AI practice” across the medicines lifecycle. 29 The principles are intended as high-level guidance on the use of AI in evidence generation and monitoring across all phases of a medicine’s lifecycle, spanning early research, clinical trials, manufacturing and safety monitoring. They are meant to be https://www.ema.europa.eu/en/news/new-guidance-conduct-clinical-trials-during-public-health-emergencies-eu https://www.ema.europa.eu/en/news/new-guidance-conduct-clinical-trials-during-public-health-emergencies-eu 26 https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-reflection-paper-proof-conceptdata-support-development-anti-cancer-medicinal-products-paediatric-patients_en.pdf 27 https://www.ema.europa.eu/en/development-anti-cancer-medicinal-products-paediatric-patients-scientific-guideline#topics 28 https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-reflection-paper-proof-conceptdata-support-development-anti-cancer-medicinal-products-paediatric-patients_en.pdf 29 https://www.ema.europa.eu/en/news/ema-fda-set-common-principles-ai-medicine-development-0 25 25

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relevant not only for medicinal product developers, but also for marketing authorisation applicants and marketing authorisation holders, signalling increased regulatory focus on how AI is governed throughout development and post-authorisation activities.

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The ten principles are:

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Risk-based approach

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Human-centric by design Adherence to standards Clear context of use

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Multidisciplinary expertise

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Model design and development practices

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Data governance and documentation Risk-based performance assessment Life cycle management

Case law Court of Justice of the European Union (Fourth Chamber) – Judgment in Case C 589/24, Almirall BV and Almirall SA v Infinity Pharma BV and Pharmaline BV On 19 March 2026, the Court of Justice (Fourth Chamber) delivered a preliminary ruling in a case referred by the Hoge Raad der Nederlanden (Supreme Court of the Netherlands) concerning the interpretation of Article 3(2) of Directive 2001/83/EC on the Community code relating to medicinal products for human use. The central question was whether Article 3(2) of Directive 2001/83 precludes national legislation subjecting the pharmacy preparation of officinal medicinal products to a national authorisation requirement based on a numerical criterion.

The Court held that where a medicinal product meets all the cumulative conditions set out in Article 3(2), it falls outside the scope of Directive 2001/83, with the result that any national authorisation requirement applicable to such a product falls within the competence of the Member States and is not governed by the directive. The Court further clarified that the conditions in Article 3(2) are exhaustive, and that Article 40(2) of the directive serves a different purpose and cannot be read as introducing a quantitative element into Article 3(2).

General Court (Fourth Chamber) - Neuraxpharm Pharmaceuticals SL v European Commission (Case T-1182/23) and Zakłady Farmaceutyczne Polpharma S.A. v European Commission (Case T-1183/23) On 11 February 2026, the General Court (Fourth Chamber) delivered judgments in two related cases brought by Neuraxpharm Pharmaceuticals SL (T-1182/23) and Zakłady Farmaceutyczne Polpharma S.A. (T-1183/23) against the European Commission, with Biogen Netherlands B.V. intervening in support of the Commission. The cases concerned the Commission’s decisions to revoke centrally authorised marketing authorisations for generic dimethyl fumarate products (referencing Tecfidera), and addressed questions concerning regulatory data and market protection, and the Commission’s power to revoke an MA. The Court dismissed both actions.

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Contact us

Beret Sundet

Eirik Basmo Ellingsen

PARTNER

PARTNER

+47 928 81 385 bsu@bahr.no

+47 920 88 112 eiell@bahr.no

Tord Fondevik

Knut Sverre Skurdal Andresen

PARTNER

PARTNER

+47 934 36 345 tof@bahr.no

+47 951 74 153 knusa@bahr.no

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Notes

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Life Sciences Quarterly Q1 2026

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Disclaimer This publication is provided for general information purposes only and does not constitute legal advice. You should not rely upon it as a substitute for specific legal advice tailored to your particular circumstances. If you require legal advice on any matter addressed in this publication, please contact a BAHR partner.

BAHR accepts no responsibility for any information contained in this publication that may prove to be inaccurate, incomplete, outdated, or incorrect. BAHR excludes all liability (howsoever caused) to you or any third party for any loss or damage arising from the use of, or reliance upon, this publication. Any use of the information contained herein is entirely at your own risk.

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