Global Leadership in Medical Innovation
Global Leadership in Medical Innovation Backgrounder
It may seem to some as though there aren't many truly American industries anymore. With increasing competition from other countries - including some that are only now emerging as competitors - in a growing global marketplace, and with historically American sectors like automobiles continuously losing ground to foreign competition, it looks like America's best days are behind us.
However, in the highly innovative biopharmaceutical sector, which tends to invest roughly 70 percent of its research and development dollars here in the U.S., this couldn't be further from the truth.
A recent report released by the Council for American Medical Innovation (CAMI) and conducted by Battelle underscores this point.
We know that many biopharmaceutical companies have seen job losses in recent years. However, the report, "Gone tomorrow?" found that the sector suffered less of a hit recently than most other industries: biomedical industry jobs grew 1.5 percent from 2007 to 2008, while the overall economy declined by 0.7 percent.
As a sector that supports more than three million jobs across the country, that 1.5 percent is a pretty big deal.
We know that the biopharmaceutical sector has historically grown at a very strong rate. Because of this track record, and the fact that despite the recent economic downturn, our companies continued to invest in the R&D on which their future is based - we are confident that our sector will contribute in a major way to the country's economic recovery. However, the point here is not to pat ourselves on the back.
Quite simply, the report makes clear that America's global leadership in medical innovation is ours to lose. Are we still at the top in terms of R&D investment, groundbreaking new medicines, medical progress, and more? Absolutely. We see it every day in the work that we do, no matter what role we play in our companies - we all work toward the same goal of creating a life-saving new medicine.
However, a lot of factors are at work that could diminish our role as world leader in medical innovation, and the report clearly spells out many of them.
A lot of people have come to simply accept that this is our role, and assume that it will always be that way. That's a dangerous assumption to make. In a costly, risky, unpredictable business like biopharmaceuticals, we need all the help that we can get to assure that our environment is sound, both in terms of policy and regulation.
What does this mean? It means that we aren't immune to the effects of negative policy decisions. While many people think that our companies are so strong, with such large profits, that they can absorb the hit caused by onerous policies, it's just not true. It's why we work constructively with lawmakers to educate them about potential consequences of the work they do, both positive and negative.
It also means that as an industry whose every product is highly regulated by the Food and Drug Administration, we are subject to the effects of decisions and processes that are overseen by the FDA. This is an important part of our business, and it means that when the decisions and processes are unpredictable or even seemingly arbitrary, it can present serious challenges for us. On the same token, the stronger and more reliable the FDA review process is, the better for our companies, the products we develop, and the public's health in general.
The CAMI report addresses this lack of certainty and predictability in our dealings with the FDA and calls for expanded resources to better ensure that patients are able to get the groundbreaking new medicines that they need without compromising the safety or integrity of the review process.
The report further emphasizes the importance of public-private partnerships, which can help to boost start-ups and emerging companies, facilitate the transfer of a potential new therapy from early-state university research to our companies' labs, and more.
It also calls for a renewed focus in our education system on the subject matters - such as science, technology, math and engineering - that will create America's innovative workers of the future.
Unfortunately, challenges to our global leadership do not only exist in the U.S. Indeed, as some in America appear to take for granted our sector's presence, foreign leaders have come to more highly appreciate the benefits that our companies offer, and have been advocating and creating policies and programs intended to woo our companies away.
As the CAMI report points out, the U.S. did, in the past, make steps to support our strong and innovative sector. It was one of the first countries, for example, to offer an R&D tax credit to our companies. However, our leaders have not kept up those early efforts, and certainly not to the scale of foreign lawmakers.
The different reception that we are given by our national leaders and by many foreign national leaders is clear. Conversely, at a state level, we see significant programs and policies that focus on the growth of the life sciences sector, including biopharmaceuticals.
From financial incentives to state investment in university-related research parks, many of our local leaders have been very effective at implementing strategies to support the sector and encourage the job creation that our companies provide.
We now hope that our national leaders, be they in Congress or in the White House, will hear the call for innovation and for jobs. We hope they will work with us to strengthen the environment in America for our sector so that we can continue to resist the lure of foreign leaders. The fact is, the work that we do is essential to America's competitiveness and the health of our people.