The Commission's preliminary report on the pharma sector inquiry, published on 28 November, alleges that "competition in this industry does not work as well as it should".
However, pharma industry federation EFPIA immediately shot back, ridiculing the Commission's "very selective use of facts" and claiming that the report "focused on the wrong issues".
The main findings of the report point to "problems" in how so-called "originator companies" that develop and sell new medicines delay market entry of cheap generics, blocking one another's innovation and thus the discovery of new drugs.
Competition between originator companies and generic companies
According to the report, originator companies are using "a variety of methods" with the objective of delaying or blocking market entry of generic companies to maintain high income streams for themselves. They also result in "significant additional costs for public health budgets – and ultimately taxpayers and patients," noted the EU executive.
The practices identified include:
- Multiple patent applications for the same medicine (so-called patent clusters);
- initiation of disputes and litigation;
- conclusion of patent settlements which constrain market entry of generic companies, and;
- interventions before national authorities when generic companies ask for regulatory approvals.
Competition among originator companies themselves
The report also found that companies that create new medicines applied defensive patenting strategies "primarily aimed at blocking competitors in the development of new medicines," which resulted in a decline in innovation "as evidenced by the decline of new chemical entities reaching the market".
According to the Commission, the sector inquiry showed that originator companies defensively patent compounds to block the development of a new medicine from a competitor, with no intention of pursuing these patents in order to bring a new or improved medicine to the market.
Originator companies were also found to have concluded agreements in case of patient litigations. A high density of contractual agreements between originator companies was observed, in particular concerning the marketing and commercialisation of drugs.
Myths and mischaracterisations, says big pharma
Meanwhile, leading industry players in the innovative pharmaceutical sector voiced their disappointment over the report, which they claimed "would make good headlines but will in the end only serve those who want to undermine this industry".
Arthur J. Higgins, CEO of Bayer HealthCare and president of the European Federation of Pharmaceutical Industries and Associations (EFPIA), argued that the report had "not reached any conclusions that the industry's activities have impeded competition" and claimed that the Commission's conclusions were rife with "myths and mischaracterisations".
Higgins argued that the Commission had misunderstood the dynamics of the industry and overemphasised the issue of defensive patent strategies, which he described as a "red herring". "Patents only work if you have the right to defend them," he said.
Rather, he argued that the Commission should focus on the lack of competition in the generics sector: "Why do we pay more for our generics than US citizens?," he asked.
Higgins said he believed the Commission had been "overwhelmed by how much data we gave them" and asked the EU executive to focus on the facts. "This industry has nothing to hide," he concluded.
