The expression, “A camel is a horse designed by committee” is used to express criticism of group decision-making and bureaucracy, and it certainly paints a convincing picture.

Imagine yourself describing all the features you wanted in a horse-like animal to an organization responsible for creating creatures only to be presented with a camel on the far side of a lengthy and opaque drafting and manufacturing process.

You would be right to be unhappy.

“What’s that?” You might ask, pointing at the unsightly thing on its back.

“It’s a hump!” The committee’s appointed external communications coordinator would enthuse.

“What’s it for?” Is your follow-up question, trying to imagine putting a horse-sized saddle or harness around the unexpected anatomy.

“It stores water in fatty tissue so the animal can go a long time without needing to drink!” The communication coordinate would say with pride.

“Did I ask for that?” You ask, scratching your head to try to conjure that request out of what you thought was a clear recollection of your wants and needs.

“Well, no, but we all agreed it’s better. In fact, I think you’ll find we have added all sorts of things that exceed what you ever imagined!” The committee’s spokesperson will say with conviction.

“Does it also do all the things I asked for?” You wonder aloud, hoping against hope you still might walk away with what you wanted in the first place.

“I regret to say we could not include everything you wanted in the final design, but I’m confident you will be very pleased with this, especially if you’re planning on living in a desert or a barren wasteland,” the committee member promises.

“I wasn’t,” you confess, trying to imagine what this not-horse can and cannot do where you do live.

A camel is a wonderful animal well-suited for its environment, but it is not a horse, will never be a horse, and is not as good as a horse at the things most people want horses to do.

Now imagine the committee got to revisit and revise the camel design every now and again, but they never got to go back to square one and start over with the original horse idea.

It took us a little while to get here, but an argument can be made that this is what has happened to the regulations that govern the pharmaceutical industry. A metaphorical horse would be ideal for the job, and instead we have a metaphorical camel that is frequently revised but will never become a horse.

To be clear, neither the industry nor the regulators nor the public at large wants pharmaceuticals to be less safe or less efficacious. Everyone agrees that businesses developing and manufacturing drugs, therapies, and medical treatments should have firm rules in place that keep positive patient outcomes as the primary and overriding goal, and everything should be set up and monitored and documented to achieve those aims in compliance with those regulations.

That is the horse. Unfortunately, the system we have at present is a camel, and every year the camel gets a little weirder looking, a little less horse-like, and a little more difficult for companies to work with to achieve the work they want and need to do where a horse would be a great help while the camel wanders back and forth across the line in the sand between ‘not as helpful’ and ‘burdensome hindrance.’

Let us also be clear that no one is blaming anyone for how we ended up with the metaphorical camel. As long as there has been a pharmaceutical industry, there have been rules, requirements, and guidelines about how it should function; both internally and externally over the years and decades those rules and guidelines have been updated and modified for good reasons based on new factors.

With that said, speaking on background with both industry leaders and regulators for many years, no one thinks if they started over with a blank sheet of paper they would reinvent the system as it exists today. It probably would not even be close.

As it stands now, there are rules that were created before large molecule and live modality treatments existed that bear no real relation to how these new innovations work. Unfortunately, modifying the existing rules to fit how these new products are created is an imperfect approach with many false starts, delays, and setbacks.

There are also rules that were developed before technologies existed that monitor processes in real-time, document everything, process data, extrapolate projections, and drive production decision-making at speeds that would have staggered the creators of the original regulations. Unfortunately, in many cases the response to the new capabilities has been to divert their improved performance into complicated compliance requirements that would have been unachievable in the analog paper world of yesteryear. While there is certainly nothing wrong with improving visibility and traceability, is the positive patient outcome still the priority, or is it merely documentation for the sake of documentation?

Probably most egregiously, there are rules about how long something should take to do, and those rules were drawn up when timelines were much longer for many, many reasons that are no longer valid or relevant. Unfortunately, when the question ‘how long should it take?’ is revised from time to time, the question is almost always paired with the need for more steps, more documentation, more data, all of which further slows things down.

That’s three ‘unfortunatelys’ in three paragraphs, so let us make sure again that no one is being blamed for how we go here. It makes perfect sense that every new expert asked to weigh in on how things should be done wants to make their own impact based on their own well-reasoned position, and it follows that  when generations of such experts have all built upon the decisions of their predecessors, coordinated with their peers, and reached compromises that satisfy as many well-intentioned viewpoints as possible, how can the result after each revision be anything but a little less streamlined, a little more bureaucratic, possessing a little more scope creep and a little less efficiency?

The story of Operation Warp Speed and how it will be remembered by history is still unfolding, but one thing everyone seems to already agree with is it proves a mandate to accelerate the creation and manufacture of novel medical treatments can achieve things that would be impossible within the normal system. Now not every medical issue out there needs to be addressed the way COVID-19 was addressed —one can even argue perhaps almost no other disease or ailment requires such prioritization or would respond well to being given such leeway— but as a proof of concept that reform is possible that demonstrably improves outcomes for patients, this is an exciting time for the pharmaceutical industry.

There have to be lessons learned that can apply to less high-profile challenges and opportunities.

There have to be ways to have conversations between industry, regulators, and other stakeholders to make some changes inspired by what has been proven to work.

One final point to further complicate all of this? Getting the ball rolling is not something any one group can do on their own. Regulators enforce the system in place, and while they are part of the ongoing conversation about improving the rules, it is not their place to talk about radical changes. The suggestion cannot come entirely from the pharmaceutical industry either, because however well intentioned the reforms may be, the suggestion of self-serving improvements or ‘relaxing the existing standards’ would freeze public goodwill in its tracks. Legislators are not able to launch major reforms either without a clear reason to do so. How then should the movement towards reform begin?

Probably by some kind of committee, and then there is the fear that committee will produce another camel in their quest to design a horse again. Still, the conversations need to happen, and great things can come from small beginnings. Let’s ask ourselves some questions.

Here are some questions to ask about Pharmaceutical Regulatory Reform:

  • Regardless of whether you work in the industry, for a relevant government body, for a scientific or academic institution, or are even just an interested member of the public at large, how open are you discussing how existing pharmaceutical regulation can be revised and simplified, provided positive patient outcomes through safe and effective treatment is in no way compromised and perhaps even improved?
  • What is the best way to start that conversation? Who needs to be involved to guarantee all the relevant stakeholders are in the loop to dispel concerns this push to reform is not about cutting corners or making things easier at the cost of public safety?
  • How can this issue be communicated publicly in a way that secures grassroot support? Real change will require major reform, and that will not happen in secret or in a vacuum.
  • Who should be responsible for making sure the regulations that work are not discarded during in the transformation? How should reformers ensure they do not throw the baby out with the bath water?
  • While industry-wide change would be ideal and should be the end goal, of course these things are done in stages. Where does it make sense to start? With new and emerging treatments that do not line up with existing regulations anyway? With a specific area of medicine where new treatments are struggling to reach people in need? With potential low-hanging fruit to build momentum and win hearts and minds for further reform?
  • If this conversation does turn into a movement, who should its leaders be? How should they be chosen, and how can they be positioned to best work across different lines of responsibility so reform is balanced and ongoing without turning into another ‘designing a horse by committee’ situation?

Geoff Micks
Head of Content & Research
Executive Platforms

Geoff joined the industry events business as a conference producer in 2010 after four years working in print media. He has researched, planned, organized, run, and contributed to more than a hundred events across North America and Europe for senior leaders, with special emphasis on the energy, mining, manufacturing, maintenance, supply chain, human resources, pharmaceutical, food and beverage, finance, and sustainability sectors. As part of his role as Head of Content & Research, Geoff hosts Executive Platforms’ bluEPrint Podcast series as well as a weekly blog focusing on issues relevant to Executive Platforms’ network of business leaders.

Geoff is the author of five works of historical fiction: Inca, Zulu, Beginning, Middle, and End. The New York Times and National Public Radio have interviewed him about his writing, and he wrote and narrated an animated short for Vice Media that appeared on HBO. He has a BA Honours with High Distinction from the University of Toronto specializing in Journalism with a Double Minor in History and Classical Studies, as well as Diploma in Journalism from Centennial College.