18 June 2013
We are awash with regulation. Healthcare and medicines are particularly affected.
For instance, in their wisdom, European lawmakers have deemed it inappropriate for medicines to be advertised. And this in the 21st century, with open information access, calls for transparency and the empowered and informed patient. Of course, the logic of such restrictions reflect real-world anxieties, but they also reflect the anxieties of another age. If we examine regulatory practices, we’ll find that in the main they use instruments that would have been popular in the 1950s and 1960s. Today, more subtle and information rich tools are available.
We regulate to coerce people and organisations to behave in certain ways that they would not, of their own volition, otherwise do. This coercion is legitimate if it arises through due process and democratic accountability, and not just the whim of the regulator or government. Sometimes this coercion has perverse consequences, such as with medicines where the legitimate manufacturer of a product is prohibited from publicising a product, but all manner of snake-oil salesman can make all manner of inappropriate claims for medicines, each pits or peanut butter as a sunscreen! The truth lies somewhere but regulations make truth-telling more difficult and not always in the public interest.
What I want to propose draws its inspiration from the US, with Don Berwick and colleagues suggested Triple Aim tool for determining high-value intervention targets (the three are: quality of care, patient satisfaction, and cost).
The Regulatory Triple Aim would comprise three tests, the simultaneous failure of which would indicate that the proposed regulation should not be considered further.
- Will the regulation produce poor quality or substandard outcomes? This is likely to be measured through evidence or insight into perverse consequences, weak enforcement, lack of suitable performance data, etc.
- Will the regulation produce dissatisfaction amongst the regulated? This is comparable to the patient satisfaction and goes to whether the regulation is appropriate and proportionately coercive and will it enjoy high degrees of compliance.
- Are there avoidable costs associated with the regulation? This is an interesting test as it actually asks two things:  is there an incremental burden of costs associated with regulation and  is the cost proportionate to the benefits.
As a formula, we have Quality (#1) + Satisfaction (#2) divided by Costs (#3) = Value for Money.
We need ways to sharpen our focus on regulation, and we need to ensure that there is not too much of it for the value we seek to achieve.
Let’s test it with the regulation that was intended to control refillable olive oil containers or pots in restaurants, something that more insightul minds eventually decided was a silly thing to do (I’ll wager though that has just gone into hibernation while a study is commissioned to find evidence that such refillable containers are full of fake olive oil or somesuch and then it will re-emerge), but it did get a long way along the regulatory process without anyone (group think?) challenging it — are people really that dumb? I wonder how that happened — did no one apply a Wilson matrix to this to see if the distribution of costs and benefits was properly understood? Anyway, back to Triple Aim.
Olive Oil in Refillable Pots or Containers
Would regulating olive oil in refillable pots or containers …
1. … produce poor quality or substandard outcomes?
2. … produce dissatisfaction?
3. … create avoidable costs?
Triple failure, meaning answering YES to each question, would suggest this would not be a good idea.
Post your assessments and comments. Obviously, if you’ve got better examples, (such as regulation of clinical trials or whatever) please feel free to expand the scope.