Pharma & life sciences
Pharmaceutical clients regularly face branche-specific legal matters, such as parallel imports, counterfeiting, licensing, permits, pharmacovigilance, clinical trials, privacy, compliance and transparency issues. Moreover in their daily business remuneration and pricing matters pop up complex juridical questions may arise with regard to the market access of medicinal products and medical devices. Further they need to be aware of the specific laws and regulations regarding advertising, such as pharmaceutical advertising, making food and health claims and incentives. For our clients we evaluate advertising campaigns, such as advertisements, commercials, social media and websites. We advise about the organization of (scientific) meetings and special events.
We litigate in the field of civil and administrative law and are very experienced in handling complaint procedures with the Medicines Advertising Code Foundation (Stichting CGR).
In 2017 and 2018, various fines were imposed by the Minister of Medical Care on the operator of this website (“Dokteronline”), located in Curaçao, for (1) offering without a license so-called UR and UA medicines and advertising such medicines, as well as (2) selling medicines online to Dutch consumers, while it does not have the mandatory EU logo for the online sale of medicines.
Although E-health is a major spearhead in healthcare, there are also forms of digital care that are under scrutiny and have meanwhile been found impermissible by the court.
In our newsletter of April 2017, the Bill for review of the Dutch Medicines Act (DMA) by reason of technical improvements and increase of the fine maximum was already discussed. The final Act was published on 15 November 2018 and entered into force on 1 January 2019.
On 1 February 2019, the so-called pharmacist exemption in the Dutch Patent Act 1995 (DPA) has become effective.
News Announcement Parker Advocaten 28 december 2018There’s so much we share. So why not share the same name? From 1 January 2019, De Grave De Mönnink Spliet Advocaten is joined by Scope Advocaten, continuing under the name Parker Advocaten. Taking a different...