Public policy and regulatory economics


Corporations, trade organizations, government agencies, and other participants in the pharmaceutical, biotechnology, and healthcare industries need insight and analysis of the trends and forces in economics and public policy that shape the world in which they operate. Bates White professionals have deep experience and understanding of market structures, business situations, regulatory issues, and public policy institutions that influence key trends. We are experts in assessing healthcare pricing and reimbursement issues, quantifying and analyzing the economic impact of regulatory policies, and evaluating a wide range of business challenges as they relate to legislative and regulatory concerns. Our team combines in-depth industry expertise with regulatory and case law knowledge to deliver reports and publish papers used for internal decision making, discussions with key stakeholders, high-level policy makers, and thought leaders, as well as a basis for communications to the general public. We have provided reports to various clients and have presented and written on such topics as the Affordable Care Act, Medicaid reform, and government healthcare programs and policy priorities for both domestic and international markets.

  • Prepared a report for research-based pharmaceutical and biotechnology companies evaluating potential compliance costs resulting from Affordable Care Act price reporting requirements to government agencies. The report was included in the organization’s submitted comments on regulatory guidance.
  • In response to changes to the regulatory requirements for reporting prices to Texas Medicaid’s Vendor Drug Program (VDP), collaborated with compliance attorneys to develop price-calculation algorithms for a generic manufacturer. Assessed the impact of these algorithms on VDP reimbursement and pharmacy profitability.
  • Engaged to provide economic analyses for various global life sciences companies. Example projects include evaluating the market for blood plasma products in light of public policy related challenges to pricing and reimbursement and potentially changing demand for specific blood proteins; assessing economic and political sustainability of spending and price trends for oncology products in several major international markets; and evaluating the link between investments in health and economic well-being over time and across countries. These analyses provide white papers for client use and potential external communication initiatives.
  • Evaluated the net benefits associated with granting patent term restoration for a brand name pharmaceutical for which the US Patent and Trademark Office did not grant such extension. Bates White’s work resulted in a white paper that updated a previous CBO legislative scoring document. The analysis focused on the likely benefits associated with continued marketing and the resulting expanded use of the brand name drug in terms of improved clinical outcomes relative to existing therapies.
  • Prepared a white paper for the National Association of Manufacturers (NAM) to evaluate restrictive trade policies in place in India, among which is failure to grant patents on innovative medicines. The report accompanies NAM’s submission to the United States International Trade Commission which is conducting an investigation into trade and industrial policies in India as they affect the US economy.
  • On behalf of Medicaid disability claimants, evaluated a state Medicaid agency’s application of an econometric model for benefit determination and provided guidance on best arguments against such application.
  • Performed an economic impact analysis of research and development (R&D) activities for a leading non-profit stem cell foundation, working with scientists to evaluate programs and assess impact on future economic activity.
  • For a leading industry organization and a global life sciences company, analyzed R&D activity by life sciences companies, strategic issues and trends relating to emerging funding models for R&D including venture philanthropy and public-private partnerships, and evaluated potential impacts of changes in government assessment of R&D in its measurement of macroeconomic activity.
  • Authored study, with support of SBIR grant funding, exploring the use of statistical pattern-recognition algorithms for use in conjunction with MRI as a non-invasive diagnostic tool for detecting atherosclerosis. The study was published in a peer-reviewed journal.