ARE NO RULES BETTER THAN BAD RULES ?

The Dangers of Thoughtless Compliance and the Importance of GOOD Rules.

Reading time for a safer world? Less than 6 minutes

Like many of you I’ve been following the coroner’s inquest into the tragic death of 15-year-old Natasha Eden Leperouse with interest (https://www.bbc.co.uk/news/uk-england-london-45637711).

For me it was personal. My children, like Natasha, have severe food allergies of the anaphylactic, life threatening type. Natasha purchased a baguette from Pret a Manger (Heathrow airport) and scrutinised the label for allergens. It’s what every allergy sufferer habitually does… always check. Since sesame seeds (her anaphylactic trigger) weren’t listed, she purchased and ate the baguette. Hours later she died from an allergic reaction.

The inquest exposed how Natasha had been let down by both lawmakers and Pret.

• EU regulations state that sesame is one of 14 allergens consumers must be made aware of when used as a food ingredient
• However, EU regulations allow member states to decide how information about ‘non-pre-packaged food’ (the baguette) is provided
• The UK’s Food Regulation Agency allows ‘freshly handmade, non-pre-packaged food’ to not be individually labelled. Why? To make life easier for food producers rather than protect allergy sufferers!
• So, although Pret listed allergy warnings around their shops, packaging on individual products did not list allergen advice on the item, where allergy suffers need it most. So, Pret complied with the law. A bad law. They focused on meeting the rules, not the needs of allergic consumers making a potentially life or death decision. Is this safe to eat?

To make this tragedy worse Pret knew its practices were risky.  There had been 8 sesame related allergic reactions in the previous year, and they failed to act.

What can we all learn from this tragedy?  

• Bad rules can be worse than no rules because those they seek to protect are lulled into a false sense of security. No sesame on the label means no sesame in the baguette, right?
• Complex rules can be bad rules. Rules must provide immediate clarity. Rules that meet complexity with complexity, are worse than no rules at all. Complex rules lead to confusion, short cuts and rule breaking. For rules to be effective they must be simple.
• Once written, rules become obsolete. The world has changed. To remain effective rules must continue to evolve in light of new evidence, shifting objectives, changing conditions and real-life experience. Every rule has a expiry date, usually short.
• Rules that try to satisfy everyone are bad rules. Good rules focus only on 'who' and 'what' matters most. Everything else is a dangerous distraction.
• Bad rules stifle the innovation we need to improve and grow. Remember, rules describe the minimum requirements. It’s amazing how many companies have ‘to stay in regulatory compliance’ in their mission statement. Aiming to comply with minimal requirements is hardly aspirational for an industry built on innovation and smart risk taking.
• Bad rules try to cover every eventuality. Good rules focus on the 20% that matters most.
• Bad rules are written in isolation, without the participation of those who understand the situations in which they will be used. Our regulations would be so much better if patients, and their advocate groups were sitting at the head of the rule making table. 

Pharma and Medical Device companies have thousands of rules. From corporate & site policies, to SOPs and work instructions and everything in between. One company I recently visited had over 14,000 of them. Mostly bad, some dangerous. All were over-complex and written without user involvement - providing the dangerous illusion of control and order…when there was none.

SOME IMPORTANT QUESTIONS FOR YOU…

Are your rules good or bad? Do they benefit the patient, or are they just a tick box exercise to satisfy the box checkers? Do you focus on meeting rules or meeting genuine needs of those who matter most?

Do YOU have Good Rules or Dangerous Rules? Here's how to find out:

Ask as many of your colleagues as possible the following questions: Do we…

• Apply a ‘less is more’ approach to our rules? After all, smaller rules are simple rules, and simple rules work.
• Have a high trust environment that actively encourages people to challenge rules without fear?
• Have confidence to challenge regulators when we’re asked to comply with bad rules?
• Have methods of trending failures to tell us if rules aren't being followed or are just plain bad?
• Use failures (warnings) to encourage people to rip up the rule (even the whole book) and start again?
• Have surveillance systems that inform the need for new rules to be established or old rules to be removed (screening for new harms/hazards or hazardous situations)?
• Make compliance easy? Prets reason for not labelling products was that allergy advice was posted ‘in the shop’. Next time you're at Heathrow go to Pret. It’s noisy and crazy busy. Customers need simple, easy access to allergy advice. Listed on the product, not on a shelf meters away, obscured by other customers. Remember, if you want people to comply - rules must be simple.
• Involve our patients and their advocate groups when we write our corporate polices?
• Annually review how good our rules are - based on performance and feedback?
• Educate our people in the ‘why’ (the rules matter) before the ‘how’ (to follow)?

If you have plenty of Yes's well done. Your rules are safe.

And Questions for our Regulators…

• When will you start writing rules and regulations with patient representation. If you don’t, how do you know they’re fit for purpose?
• When will you start reviewing rules that are no longer fit for purpose? E.g. the rules governing Post Approval Changes discourages the improvements and innovation patients desperately need. This is a bad rule - everyone loses.
• When will you change the rule making process to keep up with the speed of science and technology? Rule 'scoping' must start early on. It's an evolutionary process and must involve all stakeholders with patients and their advocate groups at the head of the table.
• Do we have too many rules? Has the (almost) exponential growth in their number resulted in safer, better quality and more cost-effective medicines? Is it time for a mass culling?

I love the following quotes:

"There are no rules here. We're trying to accomplish something." Edison

 “Rules are for obedience of fools and for the guidance of wise men." Day

Don't get me wrong, I'm all for rules and regulations - but only good ones. I went on a speed awareness course recently because I was caught driving too fast on the motorway. I am now a better, safer driver as a result. Good rules rigorously enforced make a difference.

So, are your rules good or bad? Do they benefit the patient, or do they just tick a box? Do you focus on meeting rules or meeting genuine needs of those who matter most?

Please let me know what you think and share with your network. In our line of business, I truly believe that bad rules are worse than no rules at all.