At a hearing today held by the House Energy and Commerce Subcommittee on Health on “Examining the Drug Supply Chain,” BIO President for Advocacy, Law and Public Policy Tom DiLenge testified on the innovative biopharmaceutical development and delivery system and its enormous contributions to patient health and the U.S. economy.
In his testimony, DiLenge cited the factors that have allowed American companies to take a leading role in biopharmaceutical innovation, responsible for nearly 60 percent of all new medicines developed across the world.
Those factors include America’s outstanding scientists, savvy entrepreneurs, world-class research universities, a culture of learning from setbacks, and investors willing to take risky bets on life-saving cures.
While many other countries have similar capabilities, they don’t have the same degree of innovation that we do here in America. What’s the catalyst for America’s outsized leadership role? “Because we have a public policy environment that incentivizes investment in innovation,” DiLenge testified, including:
- Strong and predictable intellectual property (IP) rights and a reliable system for IP transfer, licensing and collaboration;
- An efficient and predictable regulatory environment that strives to keep up with advances in biomedical science; and
- Payment systems that reward innovation and encourage free-market competition.
DiLenge noted that we are on the cusp of harnessing new discoveries and technologies that would have been unimaginable a decade ago – but these breakthroughs also come with their own challenges:
These include advances such as immuno-oncology – in which we attack cancer by activating the body’s own immune system against it. And gene therapy – in which we use a patient’s own cells to develop a medicine tailored for that patient, or use other genetic techniques to repair or replace defectives genes.
Yet as our scientific understanding grows, our R&D processes actually become more complex, not easier. And while R&D costs go up and up, the patient populations to be served are becoming more targeted, reducing the ability to spread costs.
As DiLenge noted, we recognize that can mean that some medicines are expensive – and BIO is united in our resolve to work with other stakeholders in our healthcare system to ensure that patients are able to affordably access the life-saving miracle medicines that our companies are developing. The way to do this, DiLenge said, is “to harness – not abandon – the free market that has delivered amazing innovations for patients and made America first in the world in biomedical innovation.” As DiLenge notes, BIO is working through the Council for Affordable Health Coverage to:
- Increase marketplace competition by speeding regulatory approval of more innovative drugs, and promoting greater and faster generic and biosimilar entry once patents and exclusivities for innovator drugs have expired;
- Move towards a drug payment system that is based on value and patient outcomes rather than volume, by removing regulatory and legal barriers that hamper value-based arrangements and communications between innovators and payers;
- Empower patients and providers with more data on drug costs and value to help them make more informed choices; and
- Oppose innovation-killing ideas like price controls, drug importation, or direct government “negotiation” of drug prices in Medicare.
Read his full testimony here.