Publications of Varjú, M.

Generic or Specific? The Frames of Stem Cell Procurement Regulation in Europe

The procurement of stem cells, which is a crucial source-material in biomedical research promising the development of novel therapies in regenerative medicine, is subject to regulation using generic and technology-specific provisions throughout Europe. The relevant national regulatory regimes, while they share common regulatory frames, exhibit considerable differences as a matter of the regulatory approach followed, the biological level regulated, or of the context in which technologies for stem cell procurement are regulated. This variety indicates that legal regulation may resort to different means so as to secure a connection with the technology regulated. It is proposed that for improving “regulatory connection” states should consider engaging in regulatory borrowing from other systems covering both generic and specific instruments of technology regulation.

Creating European Markets through Regulation: The Case of the Regulation on Advanced Therapy Medicinal Products

This article analyses the EU regulatory efforts to create a European market for advanced therapy medicinal products. It focuses on the pitfalls of European regulatory intervention in a difficult market which is characterised by multiple, often contradictory stakeholder expectations, rapid scientific and technological change, and ethical diversity. It contends that while the Regulation on Advanced Therapy Medicinal Products was, in principle, equipped to address these challenges, its fundamental paradigms and choices, and its treatment of some of the dilemmas of the emerging technology market, undermined its ability to establish the balanced and sustainable market desired by the EU legislator.

Patenting Stem Cells in Europe: The Challenge of Multiplicity in European Union Law

The recent judgment by the European Court of Justice in Brüstle ended the long-standing controversy concerning the patentability of inventions involving human embryonic stem cells in European patent law as harmonized by the Biotechnology Directive (Directive 98/44/EC). The Court of Justice, in line with EPO practice, confirmed that Article 6 of the Biotechnology Directive excluding the patentability of industrial or commercial uses of human embryos prevents patenting human embryonic stem cells. The judgment is open to criticism on account of its interpretation of the relevant ethical principles laid down in the Biotechnology Directive in an environment characterized by moral pluralism and by a multiplicity of legal fora with jurisdiction to interpret those principles.