Helena Nilsson Partner, Member of the Swedish Bar Association +46 10 690 04 56 +46 70 946 34 65 helena.nilsson@setterwalls.se Practice areas: Dispute resolution Industries: Life Sciences / Intellectual property, marketing and media law Languages: swedish, english Office: Malmo Assistant: Ulrika Karlsson Visit Linkedin profile Download vCard 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. Read more Read less To our people careerrecommendationscasesarticles careerrecommendationscasesarticles 2011-,Setterwalls2001-2010,The Ministry of Health and Social Affairs, expert and enquiry secretary2000-2001,Skåne and Blekinge Court of Appeal, associate judge1999-2000,Malmö District Court, reporting clerk1998-1999,Skåne and Blekinge Court of Appeal, reporting clerk1996-1998,Kalmar District Court, law clerk1996,Lund University, LL.M. 30 Oct 2020 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 13 Mar 2019 Setterwalls has assisted Ascelia Pharma in this year’s first listing at Nasdaq Stockholm 03 Jan 2018 Setterwalls advisor to Sverigeförhandlingen 21 Jun 2017 Setterwalls assists BONESUPPORT in connection with listing on Nasdaq Stockholm 15 May 2017 Setterwalls advises Integrum AB (publ) in connection with its IPO on Nasdaq First North 23 Nov 2016 Setterwalls assists Alligator Bioscience AB in connection with listing on Nasdaq Stockholm 10 Jun 2014 Setterwalls assists LIDDS in connection with fundraising and listing on NASDAQ OMX First North 23 Mar 2023 Proposal for a directive on new rules on environmental claims 11 Nov 2022 Life Sciences Report November 2022 11 Nov 2022 Clarifications on the marketing of electronic cigarettes and refill containers 11 Nov 2022 TLV reviews the price cap system 11 Nov 2022 Classification of products in the borderland between cosmetic and medicinal products 17 Oct 2022 Update of Standard Contractual Clauses: the deadline is approaching 23 May 2022 Life Sciences Report May 2022 23 May 2022 Use of nutrition and health claims in trademarks and brand names 23 May 2022 TLV presents methods for health economic evaluations for new therapies 19 May 2022 The new regulation on in vitro diagnostic medical devices becomes applicable 22 Apr 2022 Setterwalls’ specialists explain the regulatory framework for life sciences products and services in the ICLG: Drug and Medical Device Litigation 2022 25 Nov 2021 CTIS – A new single application point for clinical trials in the EU 25 Nov 2021 Life Sciences Report November 2021 24 May 2021 Life Sciences Report May 2021 24 May 2021 The Patent and Market Court of Appeal rejects the Image Rule of the Alcohol Act – a high-profile case about moderation and proportionality 24 May 2021 Marketing restrictions, age requirements and health warnings? – Proposed new regulations for tobacco-free nicotine products 24 May 2021 Changed rules on the Swedish Keyhole label – Can ready meals be healthy? 24 May 2021 Health claims for botanical products 26 Apr 2021 Setterwalls' specialists explain the regulatory framework for life sciences products and services in the ICLG: Drug and Medical Device Litigation 2021 13 Nov 2020 LIF Calls for Review of Parallel-import Clauses in Side Agreements 13 Nov 2020 Increased Restrictions on the Use and Manufacture of Products Containing PFOA 13 Nov 2020 New Rules on Tariff Rate Quotas for Importing Agricultural Products 12 Nov 2020 Life Sciences Report November 2020 05 Nov 2020 Recent interpretation of EU law allows sale of insects as food on the Swedish market 26 May 2020 Life Sciences Report May 2020 25 May 2020 Brexit happened – what will occur to your EU IP rights? 14 May 2020 New EU rules on origin labelling of food improve consumer protection 17 Apr 2020 COVID-19: The EU Commission adopts digital toolbox in order to support exit strategies 07 Apr 2020 The EU Commission proposes postponement of the MDR 27 Mar 2020 Clinical trials during a pandemic – COVID-19 and its impact on clinical trials 26 Mar 2020 The Commission seeks to delay the implementation of MDR by one year 24 Mar 2020 MedTech Europe calls for postponement of implementation of MDR and IVDR 28 Nov 2019 Life Sciences Report November 2019 20 Nov 2019 Brexit – a never-ending story? 16 May 2019 Pricing and financing of pharmaceuticals 16 May 2019 Collaborative model for introduction of medtech 16 May 2019 Restricted access to statistics – a threat to the pharmaceutical market in Sweden? 16 May 2019 Government mandate to Swedish Medical Products Agency regarding off-label prescribing 15 Nov 2018 Medical Device Regulation: halfway there? 15 Nov 2018 Insurance coverage when medications are prescribed off-label 01 Nov 2018 Life Sciences Report November 2018 22 May 2018 Inquiry into the protection of research results in Sweden 22 May 2018 Harmonised European whistleblower protection rules: a proposed new directive and implications for life sciences 06 Nov 2017 EMA prepares for Brexit 06 Nov 2017 Processing Personal Data in Health and Medical Care 06 Nov 2017 Opinion from the Advocate General regarding classification of software as medical devices 17 May 2017 Two new regulations for medical devices 17 May 2017 Review of the system for funding, reimbursing and pricing of medicines 08 Feb 2017 Fyra nya delägare på Setterwalls 02 Nov 2016 New rules for safety features on packaging 01 Nov 2016 Mail order pharmacies in other EU states may disregard fixed pricing, says European Court of Justice 17 May 2016 “Active Bacteria” an Illegal Health Claim 17 May 2016 E-cigarettes are not medicinal products in Sweden 25 Nov 2015 Life Sciences Report November 2015 01 Nov 2015 Must the app be CE marked? 01 Nov 2015 Focus of the new phamaceutical and pharmacy investigation 20 May 2015 Life Sciences Report May 2015 02 May 2015 Pharmaceutical products for animals, automated dose dispensing of pharmaceuticals and pricing of orphan medicinal products 01 May 2015 See your doctor in the ”cloud” – click send and say aahhh! 28 Nov 2014 Life Sciences Report November 2014 01 Nov 2014 New ceiling price model in Sweden’s pharmaceutical benefits system 01 Nov 2014 CJEU: A product must have a beneficial effect to be a medical product 23 May 2014 Life Sciences Report May 2014 01 May 2014 Pharmaceuticals for Special Needs 01 May 2014 Pricing and availability of pharmaceuticals 11 Jan 2011 Setterwalls recruits a specialist in the field of pharmaceuticals and pharmacies from the Government Offices Legal 500 (2023) Client Choice Who’s Who Legal Global Law Expertis ”Very good knowledge about Swedish Pharma market and legal environment; high responsiveness and to-the-point work results.”Legal 500”Helena's level of experience in the life science and MedTech industries, and her vast experience with the authority procedures that govern these industries, make her an important part of the extended team”Client Choice”Helena Nilsson is very knowledgeable when it comes to pharmaceutical law and is always up to date with respect to the latest developments in this field ”Client Choice”Helena is a great lawyer and business partner; she is always engaged with our matters and provides proactive advice where needed”Client Choice”Helena has an in-depth knowledge of the pharmaceutical industry and is therefore able to provide very valuable legal advice”Client Choice”A strategic thinker with experience in life sciences matters”Who's Who Legal”She adapts quickly to understand the matter at hand and what is at stake, and uses her excellent pharma knowledge to help her client in a very pragmatic way”Who's Who Legal”Helena is very hands-on and client orientated. She is pragmatic, down-to-earth without losing focus on critical business objectives”Who's Who Legal”Helena Nilsson’s advice is always of high quality, suited for our business needs and comes promptly”Who's Who Legal”She has outstanding knowledge of the health business and provides clear advice”Who's Who Legal”Helena provides high quality of advice through an ability to balance formal legal requirements, knowledge of praxis and understanding of business needs.”Client Choice”Helena Nilsson has the commercial awareness of aspects and trends that may affect advice and risk level.”Client Choice”It is always a great pleasure to work with Helena Nilsson. Helena shows time and again that she is very knowledgeable when it comes to pharmaceutical law in the broadest sense and her knowledge is always up to date.”Client Choice”Helena offers pragmatic advise, is highly responsive and reaches out to us proactively in case there are any relevant legal developments within her jurisdiction.”Client Choice”She provides invaluable advice in high-pressure situations”Client Choice”She always puts her client's interest first”Client Choice”She is extremely orderly, and strictly complies with all deadlines”Client Choice