Pharma & life sciences
Pharmaceutical companies regularly come into contact with industry-specific legal issues, such as parallel imports, counterfeiting, licensing, permits, pharmacovigilance, medical research, privacy, compliance and transparency. In addition, reimbursement and price issues often play a role in their business operations, and legally complex situations can arise in the marketing authorization of medicines and medical devices. They must also take into account specific regulations with regard to advertising, such as pharmaceutical advertising, making nutrition and health claims and favoritism. For our clients we assess advertising campaigns, such as advertisements, commercials, social media and websites. We also advise on the organization of meetings and events. We conduct proceedings in the field of civil and administrative law and are very experienced in conducting complaints procedures at Stichting CGR.
The new Policy Rules on Administrative Fines have been published in the Government Gazette (Staatscourant) and take effect from 1 January 2024.
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.