BERLIN, July 7, 2011 /PRNewswire/ --In an address to the Federation of German Industries Conference in Germany today, John C. Lechleiter, Ph.D., chairman, president and chief executive officer of Eli Lilly and Company, offered to help build a new level of trust between the biopharmaceutical industry and government health care regulators. Lechleiter said collaboration can harness innovation to help meet growing health care demands within increasingly constrained budgets, create an environment where biopharmaceutical innovation can thrive, and achieve victories on behalf of the people who are counting on medical advances to live longer healthier lives.
Lechleiter, who in 2012 will serve as the chairman of PhRMA, the U.S.-based association of global pharmaceutical research and biotechnology companies, noted that Germany is the third-largest market in the world for most of the industry, including Lilly.
"Although Lilly is based in the U.S., we have deep roots here in Germany and enormous respect for this country's legacy as a pharmaceutical powerhouse," said Lechleiter. "However, in no other place in the world has the environment for innovative pharmaceuticals changed more in the last 12 months than it has in Germany." He noted that "recent health care reforms are jeopardizing the country's legacy of pharmaceutical innovation," but added: "At the same time, I see Germany as a place where the pharmaceutical industry can achieve a breakthrough – a fresh start if you will – to develop more constructive and collaborative relationships."
Lechleiter said government and industry are on the same side in the fight against disease. "We are collaborators, not competitors. We need to work together in a spirit of openness and trust, and our industry bears responsibility for helping to build – or rebuild – that trust."
To open the dialogue, Lechleiter discussed recent health care reforms in Germany that have created barriers for innovation. He cited action last year by the German government to freeze prices for pharmaceuticals already in the market and to increase significantly the mandatory rebates that industry must pay to the health system on sales of its products. As well, in a law known by its German acronym AMNOG, parliament imposed a complex new regulatory mechanism to assess the added benefit of new pharmaceutical products entering the German market, linking future net prices to the outcomes of this assessment.
"No other country in the world has a set of requirements quite like those imposed by AMNOG. The potential effects are serious: launches of new medicines that can benefit patients delayed or withdrawn, erosion of Germany's strength in pharmaceutical innovation, and the loss of high-paying jobs in research and development."
He said that AMNOG proposes to determine the value of a medicine in "a wholly unnatural way: at the time it is launched in the market, before any real-world experience with the new product is available." In addition, he said, the understanding of innovation reflected in German regulation fails to account for the full value of innovation, with too much short-term focus on holding down costs "by imposing impossible standards on new treatments that some of the most effective medicines of the past never would have met."
"Given that AMNOG is now the framework we have for assessing the value of new medicines," he said, "I believe it's vitally important to find ways within that framework to allow patients and the health care system to benefit from pharmaceutical innovation." He suggested, for example, that "the 'Early Assessment' could be used not to define the potential of a new medicine as low as possible to save money, but rather to take a comprehensive view of its potential value for patients."
Lechleiter will be in Germany for the next 7 days meeting with government officials, members of parliament, and regulators to make a case for greater dialogue and trust between industry and health care regulators. "For companies like Lilly to make the enormous investments necessary to develop new medicines, we need predictability and certainty in the regulatory process that will determine whether or not those medicines will ever reach patients. We in industry are prepared to work with regulators to help define clear, transparent, and workable approaches to regulation, and we want to work in the same way with health care policy makers to lay out the process that determines the value of innovation."
"We're on the same side in this fight. We have a common enemy – disease, disability, and premature death," said Lechleiter. "And we have a common interest in the only means by which our health system can help more people live longer and healthier within constrained budgets – and that's innovation."
"I know I speak for colleagues in the biopharmaceutical industry when I say that we seek a regular, open, and structured dialogue in Germany with the government and the health care system," Lechleiter concluded.
About Lilly's presence in Germany
Germany is one of Lilly's most important markets. Last year the company celebrated its 50th anniversary in Germany, and its presence in the country spans the full spectrum of its business with nearly 1,000 employees. Lilly's German headquarters are in Bad Homburg and it packages and distributes Lilly products to more than 90 countries in Europe, the Middle East, and Africa from its manufacturing facility in Giessen. The company is currently conducting more than 120 clinical trials in the country alone, involving more than 14,000 patients and testing 26 potential new medicines. Heidelberg is the international development base for Lilly's subsidiary ImClone Systems, focused on development of new cancer treatments. Earlier this year, Lilly and Boehringer Ingelheim entered into a global alliance for the development and marketing of at least four potential treatments for diabetes.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information ─ for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.