Helena Nilsson
Partner, Member of the Swedish Bar AssociationProfile
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.
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.
23 May 2023
Life Sciences Report May 202323 May 2023
Extended transition period for MDR23 May 2023
Swedish Food Agency says ‘probiotics’ cannot be used as category name for food supplements23 May 2023
Commission proposes EU pharmaceutical reform11 Nov 2022
Life Sciences Report November 202211 Nov 2022
TLV reviews the price cap system23 May 2022
Life Sciences Report May 202225 Nov 2021
Life Sciences Report November 202124 May 2021
Life Sciences Report May 202124 May 2021
Health claims for botanical products12 Nov 2020
Life Sciences Report November 202026 May 2020
Life Sciences Report May 202028 Nov 2019
Life Sciences Report November 201920 Nov 2019
Brexit – a never-ending story?16 May 2019
Pricing and financing of pharmaceuticals16 May 2019
Collaborative model for introduction of medtech15 Nov 2018
Medical Device Regulation: halfway there?01 Nov 2018
Life Sciences Report November 201806 Nov 2017
EMA prepares for Brexit06 Nov 2017
Opinion from the Advocate General regarding classification of software as medical devices17 May 2017
Two new regulations for medical devices08 Feb 2017
Fyra nya delägare på Setterwalls02 Nov 2016
New rules for safety features on packaging01 Nov 2016
Mail order pharmacies in other EU states may disregard fixed pricing, says European Court of Justice17 May 2016
“Active Bacteria” an Illegal Health Claim25 Nov 2015
Life Sciences Report November 201501 Nov 2015
Must the app be CE marked?20 May 2015
Life Sciences Report May 201528 Nov 2014
Life Sciences Report November 201423 May 2014
Life Sciences Report May 201401 May 2014
Pharmaceuticals for Special Needs01 May 2014
Pricing and availability of pharmaceuticals”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.”
Legal 500
”Applying her extensive experience and skills in the life sciences industry, Helena Nilsson has been instrumental in several of our key projects and cases.”
Legal 500
”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