Spain. The Pharmaceutical Intellectual Property and Competition Law Review

The pharmaceutical industry is a strategic industry in Spain, owing not only to the nature of its activity but to its invaluable economic contribution. It is particularly relevant considering its heavy investment in research and development (R&D).

The pharmaceutical industry, which has been directly affected by the covid-19 pandemic, is (and will continue to be) at the forefront of discussions regarding R&D budgets and priorities, digital transformation, transparency, patent protection and cost-reduction measures, among other things. Cost-containment measures will almost certainly continue to play a prominent role in the following years, with a special focus on the authorities fostering generics and biosimilars.

This chapter provides an overview of the current legal situation regarding the pharmaceutical industry in Spain, paying particular attention to the most recent developments from a regulatory, intellectual property and antitrust perspective. In most cases, both the regulations (and guidance and interpretation documents) issued by EU institutions and Spain’s own state and regional regulations, with their peculiarities, are relevant for these purposes.