The development of three highly effective vaccines in record time was not only a rare piece of good news in 2020, but an incredible scientific achievement – and one delivered by our much-maligned drug companies. So often seen as the bad guys, Big Pharma has ridden to our rescue when we needed them the most. So does this mean that our system of drug development is working just fine after all?
It is said that war is a major driver of innovation. The idea is that an all-consuming threat brings a clarity of purpose and focuses a nation’s resources on solving specific problems. This leads to technological jumps in certain areas, which then have wider applicability when the war is over – in aviation, radar or nuclear physics. The Covid-19 pandemic was the pharmaceutical industry’s war. While in normal times research and development is spread across a range of diseases, suddenly it was absolutely clear what the priority was – and, crucially, absolutely clear that if you developed an effective treatment or vaccine you would sell bucketloads of it. With such a singular clarity of purpose, our drug development system has delivered, and in some style.
But what does this impressive system do in peacetime? Like any other market, the answer is that efforts are directed towards the things that are most likely to make money. Unlike many other markets, however, the ability to make money is entirely dependent on government regulation – and specifically patents. This is because pharmaceutical R&D is very expensive, but the marginal cost of manufacturing a drug is very cheap. The value of R&D is held in the intellectual property, so for there to be any incentive to develop new drugs, this needs protecting. While drugs are under patent they are hugely profitable because the manufacturer is granted a government-sanctioned monopoly, but as soon as the patent expires anyone can manufacture a generic version and the profitability largely evaporates.
The problem with profits relying so heavily on regulation is that the nature and specific detail of those regulations – rather than patient demand or social benefit – start to be the main factors driving behaviour. This has resulted in the development of a range of “me-too drugs”, designed to be just different enough from an existing product to get a fresh patent, with little regard to whether they provide a significant benefit to patients over and above what’s currently available. In normal times, a large slice of pharmaceutical R&D effort goes into these sorts of products, which are a less risky way to deliver profits than pursuing genuinely novel products.
In stark contrast to the response to Covid-19, these incentives leave some of our biggest public health concerns woefully underserved by pharmaceutical R&D. More than 700,000 people are estimated to die each year as a result of antimicrobial resistant infections, which the WHO describes as a global crisis. But this crisis – or rather the volume of drugs that you would sell if you fixed it – just isn’t big enough to convince the industry that it’s worth going through the expensive and risky R&D process required to develop genuinely novel medicines. Many drug companies have simply stopped working on new antibiotics. Of those that are in development, many are me-too products with limited benefits over what’s already available and only two out of 50 are active against the multi-drug resistant Gram-negative bacteria, which the WHO considers a top priority.
This year has shown the incredible scientific capability that we have been able to maintain across our universities and the pharmaceutical industry, and how effectively they can work together to develop innovative techniques and crack difficult problems. Whatever else our system has or has not been doing, we can be thankful that it has achieved this. But we also know that in normal times, the current system of regulations and incentives fails to target this capacity at our biggest public health problems.
There are two different lessons we might take from this. One is that, in the absence of anything better, we at least have a system that maintains an impressive capacity that can deliver incredible results if we ever find ourselves in a truly all-consuming crisis. Poorly targeted R&D in normal times might be a price worth paying for this, and allowing companies to play the regulations for huge profits a necessary evil. Or we may take the view that this year has shown us what could be possible under a different system. If we were able to focus pharmaceutical R&D on novel discovery in areas of genuine priority, perhaps we could deliver astounding results every year, without the need for a global pandemic.