Health Care Life Sciences

Life Sciences

The Life Sciences sector is rapidly growing all around the world. It's a sector where issues not only develop quickly but can also have a major social and economic impact. This can be seen in areas such as biotechnology and in the development of innovative medicines, medical devices and foodstuffs. In addition to large existing companies (Big Pharma), the Life Sciences sector is also characterised by many start-ups offering innovative products, particularly in the medical device industry. Houthoff’s Life Sciences Team supports some of these innovative start-ups through the Houthoff Incubator Programme. 

Our Life Sciences Team works for companies and organisations in the areas of biotechnology, the pharmaceutical industry, biomedical technologies, innovative foodstuffs, health claims, cosmetics, and medical devices. They focus on providing legal support for R&D, marketing, product transfer and protection, and technologies.

Companies in the Life Sciences sector have to meet complex regulations and compliance rules. This may involve technical product requirements, or rules for market access on issues like obtaining the right licence, registration or certification. The sector is also subject to regulations relating to the use of big data, medical information and personal data. Good manufacturing and distribution practices need to be observed throughout the chain. Companies working in the sector can find it challenging to effectively balance innovation and compliance.


  • recommendation people shaking hands
    First Tier firm.
    Legal 500, Healthcare & life sciences (2017 Edition)

We understand the importance of protecting your products in the global economy through intellectual property rights, including patents and trademarks. Protection of trade secrets and know-how is essential. Parties seek our advice on the protection and exploitation of their intellectual property rights, infringement and invalidity disputes, licences, agreements regarding R&D projects, and the protection of trade secrets and know-how. The Life Sciences Team also advises on matters at the interface between market protection and free parallel trade within the internal EU market and under the Specific Mechanism. 

Correct registration, CE marking and the distribution of pharmaceutical and medical devices and other life science products are very important for our clients. That is why our specialists also advise clients on all aspects of the marketing of medicines, medical devices, biocides and pesticides. Houthoff’s Life Sciences Team employs a multi-disciplinary approach, understands the scientific, ethical and business challenges of the sector, and offers practical and commercially applicable advice.
  • Advising on the competition law aspects of cooperative agreements and mergers of health care providers (including hospitals), including the performance of filings with competition and regulatory authorities.
  • Assisting a Northern European whole sale company for pharmaceutical healthcare products, healthcare equipment, and laboratory products in its due diligence investigation in relation to the IPO.
  • Assisting the interbranch organisation pharmaceutical of wholesale companies in the process of influencing decision making at EU level.
  • Assisting a international health care company in the regulatory due diligence investigation related to a contemplated purchase of a Netherlands based international health care company.
  • Advising almost each pharmaceutical wholesale company active in the Dutch market on various regulatory aspects of the marketing and distribution of pharmaceuticals and medical devices, including the notification, packaging / labelling requirements, the rules on advertising, and CE-marking.
  • Drafting a competition, anti-bribery and regulatory compliance program for a distributor of pharmaceutical products.
  • Advising various EU based start-ups on the regulatory requirements relation to the introduction of innovative medical devices.
  • Advising a Medical Research Center on the regulatory and data protection aspects of the transmission and storage of patient information in relation to the use of specific IT systems from providers based in the United States using local servers.  
  • Advising a large US based manufacturer of over the counter medicinal products on the registration procedures and fees in the EU (with EMA) and the competent authorities in the EU Member States.
  • Advising a UK based company on the regulatory aspects of the manufacturing, testing, distribution and marketing of medicinal products derived from human blood or human plasma.
  • Advising a US based company on the regulatory aspects of the introduction and use in the Netherlands of electronic devices that produce radiation.
  • Advising a US based company on the CE marking of a device for remote monitoring of heart functions.
  • Advising a US based company on the introduction and distribution of new medical devices in the Netherlands / EU.
  • Advising on the establishment of internet pharmacies including various regulatory and competition aspects of internet sales of pharmaceutical products.
  • Advising various companies distributing medical devices and medicinal products on the rules on advertising and hospitality.
  • Advising a company on the CE-marking and other regulatory requirements relating to the introduction and distribution and marketing of a new medical device for the administration of medicines.
  • Advising on the regulatory and other aspects of various acquisitions of companies distributing medical devices and/or medicinal products.
  • Advising a start up company on the regulatory requirements with regard to the distribution of medicines by pharmacies, distributors and agents in relation to an innovative distribution concept.

Publications

Thomas de Weerd

Key Contact

Amsterdam
Advocaat | Partner
+31 20 605 69 85
+31 6 5165 9208
Fleur Tuinzing-Westerhuis

Key Contact

Amsterdam
Advocaat | Counsel
+31 20 605 65 28
+31 6 4397 5040
Gerrit Oosterhuis

Key Contact

Brussels
Advocaat | Counsel
+31 20 605 61 13
+31 6 5135 0908
Greetje van Heezik

Key Contact

Brussels
Advocaat | Senior Associate
+32 2 507 98 10
+32 4 7586 8593