The fight against counterfeit medicines: a legal analysis

Project directed by Daniel Kraus. With the collaboration of Hugues Jeannerat, Yannick Sollberger (PhD student), and Pascal Witzig.

The research project’s primary goals are: – Legal analysis of existing means of control, consisting of a review of the regulatory and structural measures implemented at the international level and in three countries selected for this study: Switzerland, Vietnam, and South Africa. – Suggestions for improvements. In particular, we will seek to identify which legal instruments should be implemented and define which organization(s) (i.e., World Health Organization (WHO), World Trade Organization (WTO), World Intellectual Property Organization (WIPO), United Nations (UN) or others) is or are most likely to lead the fight against counterfeit medicines.

French commentary on the Therapeutic Products Act

Project edited by Daniel Kraus and Gilles Aebischer.

This draft commentary concerns the legislation on therapeutic products comprised of the Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA, RS 812.21). The TPA aims to ensure that therapeutic products placed on the market meet the criteria of quality, safety, and efficacy to protect the health of humans and animals. In particular, it regulates the activities of the pharmaceutical and medical technology (medtech) industries. The project aims to provide the first detailed analysis of the TPA in French, which will be presented as a commentary. This method will make it possible to centralize the current state of knowledge in pharmaceutical law and provide information on the conditions of application of the articles of the law and the interpretations to be given to them. The commentary will be aimed at practitioners (lawyers, in-house counsel, administrative and judicial staff) and scientists.

Open Source Hardware

Project directed by Daniel Kraus; Quentin Adler. Doctoral student SNSF.

Free and Open Source Licenses – whose legal effects decompartmentalize and virtualize immaterial goods subject to copyright – are at the heart of the phenomenal worldwide success of free software. Without these standard contracts, the communities of contributors who jointly develop these technologies would have found it extremely difficult to structure themselves or, in any case, to deploy themselves with the strength and efficiency we know. Since the 2000s, technical progress has made it possible to envisage similar models of technological development based not (just) on bits but on atoms. Open Source Hardware, also known as Libre Hardware, is emerging and promises to continue its ascent. Nevertheless, its legal basis is more delicate and heterogeneous because, unlike Open Source Software models, free licenses, designed primarily for copyright, are not sufficient on their own to guarantee adequate legal security, all the more so as the game is now also being played in the physical world. The use of patent law or industrial design law is a tempting option, but it still frightens people and doesn’t solve everything. Open Source Hardware Licenses have been promulgated, but what do we know about them? Finally, who is to blame for this sudden unleashing of the forces of technology? In the face of so much uncertainty, we must establish the game’s rules by defining how it works. Open Hardware is already bearing fruit, opening the way to new horizons of technical progress and human solidarity. Switzerland is well positioned to seize this opportunity, provided it offers the legal certainty this socio-economic model needs. As the first building blocks in the edifice, our project aims to contribute to this, and thus achieve the following objectives: (a) Firstly, to analyze and synthesize, for the first time, the effectiveness of the legal framework for Open Source Hardware models and their specific licenses, in the light of Swiss law in its international context; (b) Secondly, to examine and propose measures for convergence between Open Source Hardware  licenses and patent and technical design law, understood in the international context; (c) In addition, to analyze the new risks posed by incipient “home-based” industrialization from the national perspective of legal liability, in order to increase the predictability of the law and protect against them; (d) Finally, to examine the framework conditions legally necessary to ensure the prosperity of Open Source Hardware models in Switzerland, and then to draw up a specimen model contract that can serve as an enforceable, predictable, transposable legal foundation in line with the practice and philosophy of Open Source Hardware. The results of this project will, if well received, benefit inventors, technical research and training institutions, industry, and the emancipation of everyone who wishes to use their freedom.