Jakob Wested

The European Union (EU) is currently overhauling its pharmaceutical regulations, seeking to mature a single market for medicines as part of a ‘European Health Union’. We reflect on the interactions between regulations and markets in these reforms and investigate what this single market for medicines may mean in practice. We note how the proposed reforms aim to ensure equitable access to innovative treatments, yet at the same time, tie this access directly to regulatory exclusivities, limiting price competition. The reforms also do not seek full pricing transparency: prices will remain largely opaque and be set at the national levels rather than created through market exchange and open competition at the EU level. The envisioned single market for medicines thus remains a market that operates without direct reference to price − a situation not addressed head-on by the proposed reforms.

At the turn of the 21st century, a new cluster of technologies has emerged as a new frontline in biotechnology. Synthetic biology, system biology, nanotechnology, as well as improved sequencing, more sophisticated recombinant DNA technologies and bioinformatics are all part of this cluster constituting the next generation of biotechnology [1]. The CRISPR genome editing technology exemplifies many of the challenges that can be expected in future technological development. A broad investigation of this technology and its embedment in legal, institutional and technological frameworks thus may serve to form some initial outline of what the future may bring. Legal discourse increasingly finds itself intertwined in various complex social and technological perspectives. The implications of the increased speed of technological development and the acknowledgement of the broad impact of technological development highlights the need to consider how law may attain a more proactive approach in order to keep abreast with development as well as considerations of a foundation for law to engage in interdisciplinary discourse addressing the broader issues of technological development.

In October 2017, the EU Commission announced a consultation on supplementary protection certificates (SPCs), research exemptions and Bolar-provisions. Granting generic and biosimilar manufacturers limited access to patented inventions during the market authorization procedure is important to allow them to have a marketable product upon patent expiry. However, the boundaries of this right are still unclear, and substantial differences seem to persist between various jurisdictions. Thus, the intersection of the provisions of the TRIPS agreement and the interpretation of the various research exemptions and Bolar-provisions implemented in national legislations has been a source of uncertainty and controversy for many years.

This report is based on the material and input that was presented and discussed at the webinar with the title: “Perspectives on limitations to patentability”. The Webinar and the theme where introduced by Prof. Timo Minssen. Then Prof. Nari Lee gave a presentation introducing some of the context and considerations related to TRIPS art 27 and the concept of technological neutrality. Then Dr. Mike Snodin presented some central points form his recent article considering the so-called “Correa Guidelines” and their compatibility with the obligations enshrined in TRIPS art 27. After the introduction and the two presentations, the open discussion turned to questions, comments and considerations of related issues such as the need for alternative incentives, purpose bound product protection, user driven solutions and post-grant instruments.

An effective and just sharing of resources for innovation needs a supportive infrastructure. One such infrastructure of both historic and contemporary significa