Helena NilssonPartner, Member of the Swedish Bar Association
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.
The Ministry of Health and Social Affairs, expert and enquiry secretary
Skåne and Blekinge Court of Appeal, associate judge
Malmö District Court, reporting clerk
Skåne and Blekinge Court of Appeal, reporting clerk
Kalmar District Court, law clerk
Lund University, LL.M.
30 Oct 2020The 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 2019Setterwalls has assisted Ascelia Pharma in this year’s first listing at Nasdaq Stockholm
03 Jan 2018Setterwalls advisor to Sverigeförhandlingen
23 Nov 2016Setterwalls assists Alligator Bioscience AB in connection with listing on Nasdaq Stockholm
18 Dec 2023The start of something bigger? First administrative fines based on the UTP Directive now imposed in Sweden
06 Dec 2023Life Sciences Report December 2023
06 Dec 2023Switch of biological medicinal products
06 Dec 2023Pharmaceutical marketing compliance
06 Dec 2023National exceptions for relabelling with new safety features – increased legal certainty and patient safety?
23 May 2023Life Sciences Report May 2023
23 May 2023Extended transition period for MDR
23 May 2023Swedish Food Agency says ‘probiotics’ cannot be used as category name for food supplements
23 May 2023Commission proposes EU pharmaceutical reform
17 Apr 2023ICLG – Drug and Medical Device Litigation 2023: Setterwalls’ specialists explain the regulatory framework for the life sciences industry
11 Nov 2022Life Sciences Report November 2022
11 Nov 2022TLV reviews the price cap system
23 May 2022Life Sciences Report May 2022
22 Apr 2022Setterwalls’ specialists explain the regulatory framework for life sciences products and services in the ICLG: Drug and Medical Device Litigation 2022
25 Nov 2021Life Sciences Report November 2021
24 May 2021Life Sciences Report May 2021
24 May 2021The Patent and Market Court of Appeal rejects the Image Rule of the Alcohol Act – a high-profile case about moderation and proportionality
24 May 2021Marketing restrictions, age requirements and health warnings? – Proposed new regulations for tobacco-free nicotine products
24 May 2021Health claims for botanical products
26 Apr 2021Setterwalls' specialists explain the regulatory framework for life sciences products and services in the ICLG: Drug and Medical Device Litigation 2021
12 Nov 2020Life Sciences Report November 2020
26 May 2020Life Sciences Report May 2020
28 Nov 2019Life Sciences Report November 2019
20 Nov 2019Brexit – a never-ending story?
16 May 2019Pricing and financing of pharmaceuticals
16 May 2019Collaborative model for introduction of medtech
15 Nov 2018Medical Device Regulation: halfway there?
01 Nov 2018Life Sciences Report November 2018
22 May 2018Harmonised European whistleblower protection rules: a proposed new directive and implications for life sciences
06 Nov 2017EMA prepares for Brexit
06 Nov 2017Opinion from the Advocate General regarding classification of software as medical devices
17 May 2017Two new regulations for medical devices
08 Feb 2017Fyra nya delägare på Setterwalls
02 Nov 2016New rules for safety features on packaging
01 Nov 2016Mail order pharmacies in other EU states may disregard fixed pricing, says European Court of Justice
17 May 2016“Active Bacteria” an Illegal Health Claim
25 Nov 2015Life Sciences Report November 2015
01 Nov 2015Must the app be CE marked?
20 May 2015Life Sciences Report May 2015
02 May 2015Pharmaceutical products for animals, automated dose dispensing of pharmaceuticals and pricing of orphan medicinal products
28 Nov 2014Life Sciences Report November 2014
23 May 2014Life Sciences Report May 2014
01 May 2014Pharmaceuticals for Special Needs
01 May 2014Pricing and availability of pharmaceuticals
”Helena has had a long and broad experience in the life sciences industry, and has a keen interest to understand business goals and tactics.”
”Helena and her team are very responsive and have an in-depth industry knowledge.”
”Over several years, Helena Nilsson and her associates skilfully navigated complex legal issues to achieve a successful outcome. She is incredibly knowledgeable and brings a calm, practical manner to litigation, which is highly unusual. I have worked with Helena and her team for the last 10 years. They are unfailingly responsive, reliable and trustworthy.”
”Applying her extensive experience and skills in the life sciences industry, Helena Nilsson has been instrumental in several of our key projects and cases.”
”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