Healthcare

The overall challenge for industry players is the extensive regulation of all aspects of the business activities - ranging from research through to distribution, marketing and sales - combined with the difficulty of navigating in a market characterised by public law.

Our practice group is a strategic mix of lawyers with different specialised practice areas who, as a team, have the required expertise to advise all types of industry parties on the industry's legal and tactical challenges, regardless of whether they concern regulatory matters or general business law, including mergers and acquisitions and licensing.


Some of our experts also have knowledge of the healthcare sector seen from the perspective of the public authorities.

Our size enables us to form multi-disciplinary teams made up of experts with valuable industry insight.


This means that we can skilfully advise large and small businesses within:


  • Pharma
  • Biotech
  • Medical Devices
  • Biobanks, CRO and Laboratories
  • Health Services
  • Food supplements, herbal medicinal products and functional foods

PHARMA

Pharmaceutical companies operate in an extremely regulated market characterised by mergers, fierce competition and continuous demand for new products. This calls for legal advice at a highly specialised level.


We have comprehensive first-hand experience in advising on the pharmaceutical industry's challenges, both on a general commercial law level, and also within highly specialised regulatory fields.

In particular, we have insight into the crucial role that intellectual property rights play in enhancing businesses' strategic opportunities in a competitive market, and we have litigated a long list of cases before the courts.

The lawyers in our practice group have a broad range of professional expertise and in-depth industry knowledge. This means that we can put together a team consisting of different specialists, all selected to match your requirements.

We offer advice within:


  • Licensing
  • Patents
  • Trademarks and marketing of pharmaceutical products
  • Product and business-related approvals and other regulatory matters
  • Agreements concerning sales, supply and distribution
  • Joint ventures, mergers and acquisitions, cooperation agreements and other commercial agreements
  • Capital raising for research and development
  • Clinical trials

BIOTECH

The biotech industry is under considerable pressure to develop and commercialise new drug candidates for pharmaceutical companies.To maintain its strong performance, the industry needs to continuously raise capital for research and development.

We have accumulated extensive experience in the biotech sector over a number of years, where our work has included advising large and small biotech companies on the strategic potential of obtaining sourcing capital for product development and, importantly, assistance in securing advantageous agreements concerning the resale or licensing of a developed product or exit from a mature start-up business.

With our high-level legal knowledge about all aspects of the area, we can provide solutions that incorporate business insight and help ensure our clients' ongoing presence in the biotech industry.

Our areas of advice include:

  • Capital raising, and mergers and acquisitions
  • Licensing
  • Research, development, clinical trials, university tech transfers, non-disclosure agreements
  • Patents, trademarks, IP ownership, confidential information, enforcement, and similar
  • Commercial agreements - MTAs, contract work, cooperation agreements, etc..
  • Approvals, permits and other product and business-related regulatory matters

MEDICAL DEVICES

A central challenge for the medical device and diagnostic/rehab industry is the increasingly tighter regulatory framework - which is becoming so extensive that it is shortly expected to rival the rules governing pharmaceutical companies. Industry regulations are further complicated by the fact that they are mainly based on EU law. 


These challenges will certainly not diminish while the market continues to undergo rapid development to produce new types of product, including eHealth and Big Data, and the rate of development outpaces the legislation.


We have many years of experience in assisting suppliers, distributors, EU importers and other businesses in and around the medical device and diagnostic/Rehab industry, and have therefore gained wide-ranging experience concerning medical devices (including in vitro diagnostic devices).

With our in-depth knowledge of the special regulations governing the medical industry, we ensure that our clientscomply with complex EU-law requirements and stay on top of new sets of rules for the classification, testing and marketing of medical devices.


Our advice includes:

  • CE marking, other EU directives, and product and business-related compliance requirements
  • Contact with the authorities
  • Sales agreements, terms of sale and delivery, agency and distribution agreements
  • Procurement, importation, supply agreements
  • Production, licensing, partnerships and other commercial agreements
  • Research, development, clinical trials, technology transfers, non-disclosure agreements
  • Cooperation agreements for medical devices between regions, municipalities and other entities, including private entities.
  • Exports and activities abroad
  • Protection and enforcement of IPRs, including patents and trademarks

BIOBANKS, CRO AND LABORATORIES

Health data is expected to create world-class research and secure Denmark a leading global role in the area. However, there are rigid requirements for the processing of data, particularly where personal data is involved.

Our industry group is well versed in assisting biobanks, CROs, laboratories and suppliers. 


We involve experts from the relevant legal areas, and for personal data issues we always work closely together with our lawyers experts specialising specialised in data protection law. Working this way we help establish the necessary legal framework for our clients, so that they can accommodate research sector needs for attracting investors while at the same time safeguarding patient security.


We advise on:

  • Personal data and international transfers of data
  • Capital raising
  • Approvals and other requirements, and regulatory matters
  • Research, development, clinical trials, non-disclosure agreements
  • Patents, trademarks, and confidential information
  • Commercial agreements

HEALTH SERVICES

The Danish healthcare system is currently under pressure to deliver better healthcare at a lower cost. With such massive pressure on costs, it is expected that there will be further professionalization of working processes via cooperation between different sector players - both within typical supplier relationships and through various partnership types. Interaction between the public sector and an innovative private sector can often result in challenges.


Through our years of experience in working intensely with parties "on both sides" in the healthcare sector, we have gained considerable insight into and a sound understanding of the types of challenges that arise.


Establishing interdisciplinary cooperation between the public and private sectors is one among our core competencies, regardless of whether the cooperation is based on considerations of efficiency or is facilitated through the Danish regulation regarding free choice of healthcare provider.


We are also widely experienced in transferring medical practices, dental clinics and similar.


By bringing together our own multi-disciplinary resources and drawing on the skills of relevant collaborators, we ensure that our clients receive the expert advice they need to develop and maintain efficient working processes and professional cooperation between various parties. 


We assist regions, authorities, hospitals, institutions, businesses and various types of practices on:


  • Cooperation between the public and private healthcare sectors
  • Choice of cooperation type for collaborations between various entities, such as, for example, cooperation to develop new equipment/devices or innovative solutions for the coherent treatment of citizens and patients. 
  • Consortium agreements and grant agreements, including where the development is wholly or partly financed under the EU's Framework Programmes, FP7/Horizon 2020.
  • Commercial exploitation of innovations in a corporate form
  • Public-private partnerships (PPP), and public-private innovation
  • Agreements in implementation of healthcare reforms
  • Tasks completed by regions or municipalities on behalf of other authorities
  • Transfers of medical practices, and dental, physiotherapist and chiropractic clinics
  • Complains and litigation 
  • Patient data and electronic health records
  • Administration of the Danish Health Act and interaction with the administrative law principles, including legal capacity and access to file issues

FOOD SUPPLEMENTS, HERBAL MEDICAL PRODUCTS AND FUNCTIONAL FOODS

The market for food supplements and functional foods is growing rapidly. Increasing interest in the area has resulted in the Danish and European authorities making tougher demands regarding both product manufacturing and marketing and increased their focus on the boundaries between products governed by pharmaceutical regulations and food regulations.


We have been involved with the market since the start of the current and growing wave of food supplements, herbal medicinal products and functional foods making us well-placed to assist all types of producers, distributors and suppliers with a high degree of specialist industry knowledge. This also applies to the products that approach the intersection between food and pharmaceuticals.


Our areas of advice include:

  • Danish and EU law requirements
  • Approval of new products - including securing licences 
  • Marketing and labelling of existing and new products
  • Questions regarding the distinction between food, food supplements and pharmaceuticals
  • Sales agreements, terms of sale and delivery, agency, distribution and private label agreements
  • Purchase, importation, and supply agreements
  • Agreements on licensing, partnerships and contract work, and other commercial agreements
  • Research, development, clinical trials, and non-disclosure agreements
  • Mergers and acquisitions
  • Exports and activities abroad
  • Product safety, recall, and contact with the authorities

Contacts within Healthcare

Søren Skibsted

Partner (London, Copenhagen)
SSK@kromannreumert.com