The development of the microbiome field may require that regulatory bodies adopt new approaches to product approval. This will entail new guidance about the processes for obtaining approval to commercialize new microbiome based therapeutics, diagnostics, nutritional supplements including when and under what circumstances the use of a new drug must be preceded and/or accompanied by the use of a diagnostic or screening test. New approaches to clinical trial design and use of animal models may also be required, which will have a profound effect on the industries involved.
If the health care system is to secure the full benefits of this new field, it must provide full and fair reimbursement for new technologies, products and services, based on market principles to the extent possible. The unit cost of new products could be greater than the products they are replacing; yet these new products may offer superior results. The reimbursement system - both governmental and private payers - must have coverage and payment policies that support the timely adoption of new microbiome technologies, including diagnostics, therapeutics and adjunctive therapies.
TMBC seeks to engage the relevant regulatory and reimbursement authorities to provide its input and thinking into development of regulation in the microbiome field.