Locations
Fieldfisher's Life Sciences regulatory team have written five of the 29 country chapters for the Thomson Reuters Practical Law Distribution and Marketing of Drugs Global Guide, whose new edition was published on 1 June 2018.
These detailed chapters demonstrate the breadth of the life sciences practice across our offices. The firm, through Alison Dennis, is also joint editor with Bär & Karrer of Switzerland. The book is available online from PLC and also includes a facility which allows comparisons between countries.
The team and countries involved in the project are:
• Belgium: Claudio Mereu, Maud Grunchard and Raf Callaerts
• France: Olivier Lantrès
• Germany: Dr Cord Willhöft
• EU: Alison Dennis
• UK: Alison Dennis
The Guide is drafted as a series of questions and answers covering the following subjects, including enforcement regimes in relation to each:
1. Distribution: This covers the authorisations required before drugs might be distributed, including compassionate use programmes allowing limited use for drugs which are not authorised in the particular country and sales to patients, including online sales, which is an area that differs markedly by country even in the EU.
2. Marketing to Consumers: This section includes a discussion of the permitted activities in the promotion of drugs to consumers, as well as the controls exercised by national authorities in respect of these activities, including on social media.
3. Marketing to Professionals: The extensive rules and codes on where the boundaries lie for pharmaceutical companies in relationships with healthcare professionals and the extent to which they might provide hospitality, samples, gift, if at all are outlined. This section also covers the rules on the content of advertisements addressed to healthcare professionals.
Alison Dennis Co-Head of the Life Sciences group, comments: "Fieldfisher's European life sciences team are delighted to have once again collaborated with Thompson Reuters on this easy to use reference on the regulation of the distribution of drugs, and to contribute to five country chapters and to act as co-editor with Bär and Karer".