Helena Nilsson
Partner, Member of the Swedish Bar AssociationPractice areas:
Office:
Assistant:
Profile
As an attorney, I assist companies in the Life Sciences sector in a wide variety of issues, often with a regulatory connection.
I specialize in Life Sciences and thus work with legal issues in, for example, the pharmaceutical, medical technology, cosmetics and food sectors. I focus primarily on regulatory issues, such as market access as well as marketing and distribution within the mentioned sectors and in other strictly regulated industries, but also work with commercial disputes.
My daily work includes various types of permits, price and subsidy issues, substitution, data protection, collaboration between industry and health care and medical personnel, information and marketing, and various types of agreements in the area, such as research, development – and other cooperation agreements. My work also includes commercial disputes in both court and arbitration.
For many years I worked with pharmaceutical and pharmacy legislation at the Swedish Government Offices and have been deeply involved in the Government’s reform work in the pharmacy market, first as first secretary to the report that led to the deregulation of the pharmacy market, and thereafter as subject specialist at the Swedish Ministry of Health and Social Affairs. I am also trained judge and associate judge of appeal in the Court of Appeal of Skåne and Blekinge. In addition, I am also a speaker at seminars and confer-ences in the relevant industries and have written a large number of articles in Life Sciences.
Språk: English, Swedish, Swedish
Karriär
2011-
Setterwalls
2001-2010
The Ministry of Health and Social Affairs, expert and enquiry secretary
2000-2001
Skåne and Blekinge Court of Appeal, associate judge
1999-2000
Malmö District Court, reporting clerk
1998-1999
Skåne and Blekinge Court of Appeal, reporting clerk
1996-1998
Kalmar District Court, law clerk
1996
Lund University, LL.M.
Rekommendationer
Case
Setterwalls advised in connection with the Swedish Competition Authority’s investigation of suspected coordination of price levels on generic drugs
Setterwalls has advised EQL Pharma in connection with listing on Nasdaq Stockholm
Setterwalls has assisted KKR in connection with the acquisition of Immedica Pharma
The Swedish Food Agency’s fees deemed in violation of EU law – Setterwalls has successfully represented several meat producers in the Administrative Court of Appeal
Setterwalls has assisted Ascelia Pharma in this year’s first listing at Nasdaq Stockholm
Setterwalls assists BONESUPPORT in connection with listing on Nasdaq Stockholm
Setterwalls advises Integrum AB (publ) in connection with its IPO on Nasdaq First North
Setterwalls assists Alligator Bioscience AB in connection with listing on Nasdaq Stockholm
Setterwalls assists LIDDS in connection with fundraising and listing on NASDAQ OMX First North
Artiklar
The Swedish Dental and Pharmaceutical Benefits Agency proposes new regulations on applications for subsidies and the pricing of medicinal products
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The Swedish Government is proposing new rules to enhance controls of fraud within the agri-food chain
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The Swedish Medical Products Agency is stepping up its market surveillance of e-commerce in medical devices
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Two Judgments on Sales of Alcoholic Beverages in Sweden on Producers’ Sites – Opening Hours Are Not Required to Match Those of Systembolaget
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Updates in the ethical rules – how are pharmaceutical companies affected?
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Withdrawal of the proposed Green Claims Directive by the European Commission
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Important decision on the distinction between marketing and non-commercial information in relation to medicinal products
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Significant fine upheld for unfair trading practices in the agricultural and food sector: A landmark case on the Swedish implementation of the UTP Directive
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Court ruling: Delivery of cosmetic products that do not comply with labelling requirements constitutes an unfair marketing practice
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Preliminary ruling from the European Court of Justice on plant-based “steak” and “sausage”
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Fighting Antibiotic Resistance: Global and European legal strategies driving research and innovation
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The Swedish and Danish Competition Authorities have carried out dawn raids at companies active in the pharmaceutical sector
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The Swedish Supreme Administrative Court seeks guidance from the CJEU on the interpretation of the provisions of EU law on the labelling of food for special medical purposes
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EMA’s new recommendations to strengthen supply chains of critical medicines – a short recap of what and why
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Overview of recent developments regarding the distinction between marketing and non-commercial information in relation to medicinal products
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ICLG Drug and Medical Device Litigation Guide 2024: Setterwalls’ specialists explain the regulatory framework for the life sciences industry
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The start of something bigger? First administrative fines based on the UTP Directive now imposed in Sweden
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National exceptions for relabelling with new safety features – increased legal certainty and patient safety?
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EU Artificial Intelligence Act: potential implications for healthcare AI
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Swedish Food Agency says ‘probiotics’ cannot be used as category name for food supplements
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ICLG – Drug and Medical Device Litigation 2023: Setterwalls’ specialists explain the regulatory framework for the life sciences industry
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Clarifications on the marketing of electronic cigarettes and refill containers
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Classification of products in the borderland between cosmetic and medicinal products
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The new regulation on in vitro diagnostic medical devices becomes applicable
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Setterwalls’ specialists explain the regulatory framework for life sciences products and services in the ICLG: Drug and Medical Device Litigation 2022
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The Patent and Market Court of Appeal rejects the Image Rule of the Alcohol Act – a high-profile case about moderation and proportionality
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Marketing restrictions, age requirements and health warnings? – Proposed new regulations for tobacco-free nicotine products
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Changed rules on the Swedish Keyhole label – Can ready meals be healthy?
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Setterwalls' specialists explain the regulatory framework for life sciences products and services in the ICLG: Drug and Medical Device Litigation 2021
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Increased Restrictions on the Use and Manufacture of Products Containing PFOA
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Recent interpretation of EU law allows sale of insects as food on the Swedish market
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COVID-19: The EU Commission adopts digital toolbox in order to support exit strategies
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Clinical trials during a pandemic – COVID-19 and its impact on clinical trials
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MedTech Europe calls for postponement of implementation of MDR and IVDR
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Restricted access to statistics – a threat to the pharmaceutical market in Sweden?
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Government mandate to Swedish Medical Products Agency regarding off-label prescribing
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Harmonised European whistleblower protection rules: a proposed new directive and implications for life sciences
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Opinion from the Advocate General regarding classification of software as medical devices
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Mail order pharmacies in other EU states may disregard fixed pricing, says European Court of Justice
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Pharmaceutical products for animals, automated dose dispensing of pharmaceuticals and pricing of orphan medicinal products
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