Global Leadership in Medical Innovation:

“Ours to Lose”

America is the world leader in biopharmaceutical research and innovation

• Roughly 70% of all R&D dollars are spent domestically

• More than 3 million jobs are supported by biopharmaceutical research companies in America

• Congressional Budget Office: “Pharmaceutical firms invest as much as five times more in research and development, relative to their sales, than the average U.S. manufacturing firm.”

The effect on the economy

• While some companies certainly lost jobs during the downturn, the sector as a whole fared better than others. The biomedical industry grew 1.5% in jobs from 2007 to 2008, while the overall economy declined by 0.7%.

• On average, biopharmaceutical employees paid roughly three times the federal and state taxes as employees in the rest of the economy in 2006.

• The sector’s contribution to GDP in 2006 was triple the average contribution in the rest of the economy.

• Direct employment in the sector grew at more than twice the rate of the rest of the economy from 1996 - 2006.

The effect on health

• Americans generally enjoy access to groundbreaking new medicines before the rest of the world.

• In 2009 alone, 34 new medicines were approved by the Food and Drug Administration.

• In the U.S., average life spans for women jumped from 74.7 years in 1970 to 80.4 in 2005. For men, it leapt from 67.1 years to 75.2.

Medical advances have saved millions of lives

• According to the American Cancer Society (ACS), cancer death rates dropped 19.2% among men from 1990 to 2005 and 11.5% among women from 1991 to 2005. The ACS partially attributed this drop to advances in treatment.

• According to the American Heart Association, from 1999 to 2005, the cardiovascular disease death rate dropped 26.4%, while the death rate specific to coronary heart disease declined 34.3% during the same period.

• Since the introduction of highly active anti-retroviral therapy in 1995, the annual number of deaths due to AIDS has dropped by more than 70%, according to the Centers for Disease Control and Prevention.

Many states have implemented policies intended to grow the sector

• North Carolina was one of the first states to target the biopharmaceutical sector for development, investing $1.2 billion to grow the sector between 1998 and 2008.

• Maryland has invested heavily in growing the sector, creating a cluster of biopharmaceutical companies along the I-270 corridor. Governor O’Malley has committed $1.1 billion to be invested between 2010 and 2020.

However, the federal government has not shown the same continued initiative

• According to a recent report commissioned by the Council for American Medical Innovation (CAMI), the U.S. was one of the first countries to offer an R&D tax credit to encourage innovation.

• The government has failed to continue these incentives, just as foreign entities are increasing their efforts to woo away America’s biopharmaceutical research companies, and the jobs they offer.

• The paradigm should be the U.S. against foreign governments. Instead, the lack of federal programs end up pitting, for example, North Carolina’s efforts against Singapore’s.

CAMI: Challenges abound for biopharmaceutical research companies

• Increasing complexity of the science behind our R&D is demanding and costly, and requires more advanced technology and more complex clinical trials.

• Regulatory review and the approval process for new medicines is not keeping pace with scientific advances, and has become unpredictable and inconsistent.

CAMI: Challenges (cont’d)

• As the risk of biopharmaceutical research has increased, early financing and private investment in R&D (such as venture capital) are becoming harder to find. This funding is very important to early-stage research.

• The transition of early-stage research to the development of a new medicine has been hindered by barriers to public-private partnerships.

• The U.S. talent pipeline for medical innovation – our next generation of workers – is at risk.

How do we meet these challenges?

• We agree with CAMI that America needs a national medical innovation agenda to help to support our companies, our potential life-saving new medicines, and our jobs.

• As biopharmaceutical workers, this is not just about policy. This is about our livelihood and our futures.

CAMI: The Recommended Agenda

• The report by CAMI recommends several action items for each of the main challenges.

• The recommended agenda emphasizes additional public-private partnerships.

• We benefit from these partnerships in many ways and feel that a national medical innovation agenda would be a big step toward supporting growth of the sector.

Regulatory policy examples

• FDA funding and resources need to be increased to better meet agency need, providing for improved predictability and quality of review.

• The R&D process is already very risky. An unpredictable review process can add a burdensome level of risk.

• Other recommendations include reimbursement policies that encourage use of new technologies and better international regulatory harmonization.

Private investment examples

• Strengthen the federal R&D tax credit by making it permanent and raising it to levels that would allow it to better compete with foreign incentives.

• Encourage venture financing and investment through a variety of incentives.

• Provide federal financing support for biomedical infrastructure at university research parts; in many cases, this would supplement existing state efforts.

Translational research examples

• The early-stage research done by universities and researchers funded by the NIH is a big part of the R&D process.

• This work could be encouraged in a variety of ways, including: a budget growth strategy for the NIH; more university-industry collaboration; enhanced support for technology transfer; funding for the Cures Acceleration Network and its work in rare diseases; and more.

Talent examples

• A renewed effort to improve science, technology, engineering and mathematics (STEM) by increased funding in our schools can help to prepare the next generation of biopharmaceutical sector workers.

• Programs to retrain existing workers to transition to the biopharmaceutical sector could be applied to vocational and technical schools and community colleges. This would create a near-term improvement in the talent pool.

• Government incentives would increase the number of students pursuing graduate degrees and careers in the biosciences in the U.S.

A hope for the future

• The CAMI report includes very detailed recommendations about the many strategies that a medical innovation agenda could use to support the health care sector, including biopharmaceuticals.

• Regardless of the end result, it is important to begin a dialogue about how our jobs can contribute to the health of our patients and the rebuilding of America’s economy.