Open Outcomes Based Regulation (OOBR)

Open Outcomes Based Regulation (OOBR)

WLSA is involved in all of these issues, but our primary effort addresses the root causes of the regulatory problem:

  • The pace of regulation is slow while innovation that creates new products and improves existing products is fast.
  • When the status quo is unhealthy and getting worse, as with chronic diseases and the cost of health care, the failure to act may be more dangerous to more people than allowing the use of new products.
  • Pre-market certification is limited in that it cannot efficiently ascertain all the future risks associated with the use of a product, nor can it predict the future efficacy of a product relative to other interventions and changes in the environment of people’s lives.  Pre-market certification also creates an anti-competitive barrier to entry for better products.

OOBR is based on a fundamental shift in thinking about the relationship of health and health care.  Health care has been at the center of policy activities for decades, leading to the conclusion that more health care would necessarily deliver more health to more people.  This assumption is too often wrong.  WLSA posits that the proper societal goal is better health not more health care.  Medical products and services are just one necessary tool in achieving the goal of better health.

A metaphor for this departure from conventional thinking is the relationship between productivity (factory output, room temperatures) and energy use.  The clear goal is to apply the least amount of energy input required to achieve the desired output.  Hence, the U.S. has tripled its domestic output over the last four decades while holding energy spending about 8% of GDP.  In contrast, health care costs have risen from 8% to 18% of GDP and health status is arguably worse than 40 years ago.  According to the Institutes of Medicine, about one-third of health care spending is wasted.

Open Outcomes Based Regulation would leverage patient engagement and the market to support quality assurance and the continuous evaluation and improvement of efficacy.  The three principal goals of medical product regulation are to ensure that products are high quality, safe and effective.  OOBR’s structure is as follows:

Initiatives graphic

The redesigned system would have the following effects:

Initiatives graphic 2

OOBR adds patient input and the power of the research community to the evaluation of medical products:

OOBR adds voices

OOBR changes the nature of medical products.

With this background, please review our proposal.  

Some other WLSA position papers are linked below: