Pharma report calls for “wide debate” in Europe

Pharmaceutical professionals should have a “wide-ranging” debate on how IP can be tailored in the face of “major changes” to the industry, including the possibility of “prolonged exclusivity” for certain medicines, according to a report.

In a paper published yesterday, June 5, the European Federation of Pharmaceutical Industries and Associations (EFPIA) said several changes over the last decade, including the development of technologies, had led to new products and the research and development that go with them.

The report calls for a “wide-ranging debate among all stakeholders – patients, providers, suppliers, regulators, and policymakers – on how the IP regime for medicines can be tailored to this new generation”.

Describing the IP system as a “key enabling factor” of innovation the report said it “provides the necessary incentives to research and development focussed on addressing global health needs.”

It suggested the possibility of “prolonged exclusivity” for medicines that are “consecutively” approved new indications over their lifecycle to “justify the additional investment in research and clinical development.”

The report added: “The IP system and, especially, patent protection are intended to allow innovators to recoup their investment and earn a fair return for a limited and legally defined period of time”.

EFPIA represents the pharmaceutical industry operating in Europe.

The report; Health & Growth – Working together for a healthy Europe is part of a wider paper “outlining steps” toward a “integrated strategy” for the life sciences sector in Europe.

“With new incentives, IP frameworks and regulatory pathways, European society is more likely to benefit from breakthrough clinical advantages aligned with European health priorities,” it said.

Speaking at the report’s launch, Christopher Viehbacher, CEO at Sanofi and president of EFPIA, expressed the need for “significant improvement” in health outcomes, supported by increased innovation.

The strategy was launched in Lyon, France, during EFPIA’s annual meetings. EFPIA said further action and discussion on the report will continue.

The report can be read here.