Policy and regulatory concerns in planning a biobusiness in
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In less than 30 years, we have built a biotech industry in the U.S. that encompasses at least 1,300 companies that employs 174,000 people, that has brought more than 130 new drugs and vaccines to market, and has taken another 350 into late-stage testing. Just how did that happen? Well, first of all, in the 1970s Congress opted not to prohibit or overly restrict the then-nascent technology of recombinant DNA just because it posed ethical challenges and was, yes, a little bit scary.
Memories of that saga remain fresh for our industry's executives, who helped BIO develop a set of six core Medicare drug coverage principles back in 1999 when President Clinton brought this issue to the forefront. Our principles stress solutions that rely on the private marketplace and competition, that support continuing innovation, and that provide stop-loss coverage for those whose expenses would be catastrophic. We are encouraged by the fact that the leading House bill embraces these principles.
There's no doubt that a Medicare prescription drug plan will eventually pass and be signed into law. Both political parties, as well as the public and the biotech and pharmaceutical industries, recognize this 1965 program has to be overhauled to accommodate pharmaceutical-based 21st century medicine.
Although I've focused today on legislative and regulatory issues, the courts ultimately interpret our nation's laws and regulations in decisions that can have a profound impact, not just on the economics of our industry, but on society at large. Most trade associations only work with the first two branches of government, the Legislative and Executive, but we have come to deal with the Judiciary too. Since few judges have a strong scientific background, Supreme Court Justice Stephen Breyer has called for an "ongoing conversation" among the biotechnology industry, scientists, legal scholars and judges about life-sciences research and its legal dimension.
We've heeded Breyer's call by spearheading The Biojudiciary Project, which will be launched officially on May 21st at the National Press Club. In collaboration with Ernst & Young, the Foundation for Genetic Medicine and two leading Washington law firms, Arnold & Palmer and Ropes & Gray, we've developed an online primer for judges describing federal law pertaining to biotechnology, with discussions of relevant cases-and links to them-as well as an annotated scientific glossary.
The venue of the National Press Club is important, because the media is of course the fourth estate in our government. On any given morning, almost 40 percent of the nation's major daily newspapers run at least one story pertaining to biotechnology. A couple of weeks ago, William Kristol sent me a letter demanding to know if BIO supports patenting of cloned embryos (and of course we don't). The president himself has raised the specters of embryo farms and human life as a commodity.
We did all this in preparation for the day when this once-exotic industry entered the mainstream of public consciousness. That day has arrived. The media and the public are eager to learn about our breakthroughs in the lab, on the farm and in the clinic, and to ponder their implications. They want to know how we're going to bring the benefits of biotechnology to those most in need, how we're managing risks and benefits in clinical trials and protecting patient privacy, how we're balancing the profit motive with altruism, and where scientists will draw ethical boundaries. These are not issues to which our CEOs can devote a lot of time-preoccupied as they are with the dizzying pace of scientific research, clinical development and investor courtship-but they are issues that will have profound consequences for our industry 10, 20 years down the road.
We are in this room today as a result of the decision to allow recombinant DNA research to move forward in the 1970s, the legislation of the early 1980s, and the Diamond vs. Chakrabarty decision, and-perhaps most important-avid public support for life-sciences and biomedical research. You better believe policy matters.
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