On January 16, 2008 the European Commission (the “Commission”) announced that it launched an inquiry into the pharmaceuticals sector under Article 17 of Regulation (EC) 1/2003. The Commission is concerned that competition within the pharmaceuticals sector may be restricted or distorted. In particular, the Commission highlighted the decline of innovation.
In its announcement, the Commission highlighted that market distortion may be occurring in the patenting or exercise of patenting products, vexatious litigation and/or collusive agreements, which may limit consumer choice, reduce economic incentives to invest in research and development and damage public and private health budgets. The Commission is conducting unannounced inspections to gain immediate access to relevant information and is targeting pharmaceutical suppliers of innovative and generic medicines for human use. In addition, the Commission holds the powers to inspect consumer and professional health care organizations and authorities granting patents and marketing authorizations for drugs. The Commission intends to publish its preliminary report for consultation in autumn 2008 and it expects to publish the final report in spring 2009.