Scientific advances in our understanding of the molecular and genetic causes of disease offer opportunities to advance a new approach to healthcare. This new approach, personalized medicine, will allow healthcare providers to identify the most appropriate therapeutic intervention and/or dosage for an individual based on his or her personal bio-molecular characteristics, thereby maximizing clinical benefit and reducing the risk of side effects. Healthcare providers may also be able to identify a preventative measure that is particularly suited to a particular sub-population. Through personalized medicine, many health care interventions may occur much earlier and with greater precision than ever before.
In order to advance the development of personalized medicine, public policies must reflect the scientific and clinical value that innovative technologies – diagnostics, therapeutics, preventive measures, and research tools – bring to patient care. BIO urges that the following key principles be integrated into public policy:
Any regulatory approval processes and oversight mechanisms for personalized medicine products must be risk-based, transparent and predictable, and must ensure product safety, effectiveness, and accuracy. Elements include:
A clear pathway that encourages early collaboration for the approval of therapeutics and companion diagnostics.
Modernized product development and approval pathways for innovative personalized medicine technologies.
Adoption of personalized medicine products requires reimbursement policies that reflect the value that those products provide to patients.
Intellectual property protections that provide incentives for innovation should be developed and maintained.
The federal government should maintain robust funding for scientific research to enable new discoveries in personalized medicine.
The training and education of healthcare providers should be a priority so that personalized medicine innovations can be implemented and translated into clinical practice.
Improvements in the healthcare information infrastructure are necessary in order to support effective implementation of personalized medicine.