Today's guest blog comes from Dave Ricks, Senior Vice President and President of Lilly Bio-Medicines, ahead of his participation in the German Marshall Fund's Brussels Forum on 21-23 March.
This week I am in the heart of Europe, Brussels, to attend a series of meetings to discuss the progress of the Transatlantic Trade and Investment Partnership (TTIP).
In this post I want to look at the strength of biopharmaceuticals as a U.S. industry sector, creating jobs and exports for the U.S., as well as the potential we have to transform the lives of patients.
The U.S. has become the world leader in biopharmaceutical innovation. Biopharmaceutical companies invested over $ 48.5 billion for the discovery and development of medicines in 2012. Additionally, the U.S. conducts 80% of the world’s R&D in biotechnology, which explains why our country holds the intellectual property (IP) rights to most new medicines and studies the most amount of compounds in the biopharmaceutical pipeline.
Employment provided by the biopharmaceutical sector is very high. More than 810,000 people work in the sector in the U.S., and the industry supports nearly 3.4 million jobs.
Despite the long period of economic contraction in the U.S., our industry has held on to its employees, and maintained high levels of R&D investment.
Chronic diseases account for 75% of the U.S.’s healthcare bill. 7 out of 10 deaths result from chronic diseases, and almost 1 out of every 2 adults (133 million Americans) had at least one chronic illness in 2005. This not only has a devastating impact on individuals, their families and careers, but a major bearing on the U.S. economy and labor market.
As an industry, we are very much aware that we cannot rest on our past and current achievements, and we need to ensure a stable environment to continue developing new and better treatments for patients. This process continues getting tougher every year. It is estimated that developing a new medicine takes 10-15 years on average, costing approximately $ 2 billion.
TTIP represents a key opportunity to remain competitive and to strengthen transatlantic pharmaceutical
discovery. The U.S. and Europe account for more
than 75% of global R&D in life-sciences, 1.4 million jobs in the sector, and 80% of global sales of new
TTIP must tackle issues that hinder the true potential of the transatlantic pharmaceutical market. In order to unlock this potential, we need an ambitious, comprehensive agreement that addresses regulatory compatibility; upholds intellectual property protection and enforcement; and seeks greater market access and transparency.
Pursuing regulatory convergence is the cornerstone of TTIP – we fully support this goal.
We expect that TTIP can contribute to reconcile divergences between the systems and reduce bureaucratic barriers to trade while ensuring consumers’ greater access to safe, high-quality medicines. We are not talking about de-regulating or about lowering standards; on the contrary, our industry seeks harmonization towards the highest standards to facilitate and spur innovation in the pharmaceutical sector.
Building on the long-standing cooperation between FDA and EMA, further alignment of regulatory processes and procedures can reduce redundant testing and optimize deployment of limited regulatory agency resources.
But advancing on regulatory convergence is not enough: trade agreements like TTIP must uphold the highest IP standards to protect and promote innovation and the economic growth it supports. The value that IP-intensive industries bring to the U.S. economy is unquestionable: 38% of U.S. GDP, 55 million U.S. jobs and 74% of U.S. exports, according to this Global Intellectual Property Center study.
TTIP can provide the opportunity to underscore the need to promote high-level standards in trade agreements; encourage cooperation of patent offices towards a grace period; provide for effective pediatric incentives and enhanced patent enforcement; and seek alignment on regulatory data protection across the Atlantic. To foster future competitiveness, both U.S. and EU IP systems should be open to further adaptation and alignment in order to incentivize research into unmet needs.
Finally, we believe TTIP can help underscore the importance of pricing and reimbursement systems that reflect the full value that biopharmaceutical medicines can bring to patients and society at large. This includes the value of allowing patients or caregivers to return to work, and impacts on wider health care system efficiency. An annex on market access principles is critical for ensuring patients rapidly gain access to new treatments, and to allow the industry to maintain and grow direct and indirect employment.
We welcome the efforts by TTIP negotiators in bringing our markets closer in these still challenging economic times. We encourage them to continue to aim high and translate their unwavering political support into ambitious, tangible outcomes in all three areas I have highlighted today. If done right, TTIP can greatly benefit patients and help the industry in U.S. to continue to be a driver for scientific progress and improved health outcomes.