Health InsurancePharmaceutical Sector Inquiry - Highlights Regulatory Shortcomings And Need For A Strong, Effective Patent System In Europe
EFPIA, the voice of the pharmaceutical industry in Europe, acknowledged publication of today"s final European Commission report into the pharmaceutical sector. It demonstrated a welcome shift away from the emotive language of the interim report, with a better balanced, more holistic view of the issues facing the sector. The final report identifies the numerous regulatory obstacles that need to be addressed to achieve more efficient innovative and off-patent pharmaceutical markets to the benefit of consumers and patients.
"We have stated consistently that complex and divergent regulatory barriers are the primary cause of market entry delay for both generic and innovative medicines. We are pleased that the final report recognises this reality;" said Arthur J. Higgins, CEO of Bayer Healthcare and President of EFPIA; "We welcome many of the policy recommendations, such as a more streamlined patent system that reduces costs and increases legal and commercial certainty. We commit to working constructively with the Internal Market Commissioner, Member States, and the European Patent Office to push reforms forward under the Swedish Presidency."
The final report acknowledges the considerable variations in the speed and impact of generic market entry across Member States. Arthur Higgins added, "What is important is that the Commission uses this report to address the issue of competition in the off-patent market. This is an area that can generate savings which could be reinvested to fund innovative medicines."
The Commission has recognised that while certain regulatory interventions incentivise rapid generic entry and drive prices lower, others (particularly price caps) can have the opposite effect. In 2008, a scheme in the Netherlands reduced generic prices by more than 80% by promoting price competition and challenging pharmacists" incentives. This provided annual savings of approximately €25 per citizen, despite being limited to 33 products. By contrast, the potential €3 billion savings that immediate generic entry would have generated in the eight years of the Commission"s interim report represent an annual reduction of only €0.90 per citizen.
In its final version, the report failed to substantiate the initial allegation that patenting strategies dampened innovation1 or delayed generic entry illegitimately. Importantly, the final report does recognize the importance of Europe"s innovative pharmaceutical sector and its very significant R&D efforts. The Commission correctly identifies that the protection of intellectual property rights is of fundamental importance for the pharmaceutical industry and paramount to maintaining Europe"s competitiveness.
1 In 2007 there were record numbers of products in clinical development - almost 4,400 - including 763 for cancer, 224 for cardiovascular diseases, 177 for respiratory diseases and 92 for Alzheimer"s. IMS LifeCycle R&D Focus 2007.
EFPIA