The EU system of regulatory exclusivities and rewards – towards a better-balanced legal framework of access to healthcare technologies

Project objective

This project focuses on regulatory exclusivities and rewards as instruments of legal protection for innovative medicines. While recognising their immense practical meaning for providing another kind of monopoly for pharmaceutical innovations—next to patents and SPCs —the project aims to investigate whether and how these instruments affect access to generic medicines and contribute to a well-balanced IP system for pharmaceuticals in Europe.

The three specific project’s objectives are:

1. Determining the scope of market exclusivity in EU law and in the law of individual EU Member States to identify potential differences between these regimes and to recommend a systemically consistent interpretation of the relevant provisions.

2. Analysing and evaluating amendments proposed by the EC from the perspective of the innovative and the generic industry, the reimbursement payer and, ultimately, from the point of view of the public health interests, thus contributing to a broad public debate on this issue in Poland and Europe.

3. Identifying how regulatory exclusivity can be strategically exploited, establishing the scale of the investigated phenomenon, and evaluating it from the perspective of a sustainable system for supporting competitiveness, innovation, and access to healthcare technologies.

Research

The current and planned framework of regulatory exclusivities and rewards will be analysed. This analysis will include legal acts of the EU and national level, judgements of the CJEU and national court, and legal scholarship. Empirical research will be performed on real-life data from a database containing data on patents, SPCs, regulatory data, and market protection for the EU and individual EU countries.

Significance for Lawmaking and Application

The effects of works planned within the first objective will be of use to national courts and the CJEU in the event of a dispute concerning infringement of market exclusivity, which – given the recent increase in disputes related to regulatory exclusivity – is highly likely to arise.

The research findings resulting from the works on the second objective will be important for developing a position on the proposed changes for policymakers and other stakeholders. The project’s empirical findings, in line with the third objective, will serve to validate the proposed legislative changes given the potential use of the new regulations to achieve the strategic objectives of the healthcare industry.

The research as a whole is supposed to provide valuable insights for policymakers, enabling the creation of regulations that strike a balance between fostering innovation and ensuring access to modern and effective medicines.