In October, the UK’s Medicines and Healthcare Product Regulatory Authority (MHRA) instructed an Indian drug production plant to recall five of its products. This came after an MHRA inspection found deficiencies in the site’s quality and manufacturing systems.
Recalls happen, and they’re generally not very exciting (unless your company is involved in which case they are very stressful). But the interesting part here is not that the MHRA ordered a recall, but that the order was only partial. For 10 other medicines, ‘concerns over the continuity of supply’ outweighed the quality concerns and so the MHRA permitted the company to continue supplying them.
‘We cannot allow suppliers to become too big to fail’
Traditionally, the pharmaceutical industry believed that if a company failed to manufacture to the right quality standard they lost the right to sell their drug products – end of story. The MHRA’s dilemma demonstrates that this now seems to have changed. Company X cuts corners to reduce costs and prices and so cuts itself a majority slice of the market. When the regulator then finds its standards unmet, the company’s slice is so large that removing its products from the market may jeopardise patients because of supply restrictions.
In a world where medical care budgets are being squeezed and health managers are looking to reduce costs, there is a demand for cheaper medicines. But quality comes at a price, especially when it’s a quality standard like pharmaceutical good manufacturing practice. Inevitably, the cultures of low cost and high quality must clash. The regulators are driving quality up; that’s their job. Yet at the same time the customers are driving costs down, and that’s their job too. (And remember that in nationalised healthcare systems like the UK’s, the customers who pay are not the final consumers who swallow.)
In recent years, pharmaceutical manufacture has changed with the adoption of risk management and product life-cycle initiatives, but quality assurance (QA) remains a core principle. QA is, or should be, as much a part of the pharmaceutical industry as science and money. One of the key mantras of QA is that quality has to be ‘built into a product’, and not ‘tested into a product’. Think of cars: they work when they leave the showroom (the test), but ‘quality’ shows only after several thousand miles.
I’m old enough to remember the concept of a ‘Friday car’: a vehicle beset by mechanical problems because it was manufactured on a Friday when the production line workers were thinking more about the weekend than the engine. If you cut corners in your quality systems, you cut the quality of your product (or at least it’s down to luck if the product is any good).
Last year’s meat supply scandal in Europe occurred because of failures in the quality assurance systems of the meat industry. The blame, by some quarters at least, was placed with bulk buying customers (again not consumers) forcing producers to operate with cost, not quality, as the prime driver. As the meat industry claws its way out of that problem, pharma seems to be standing on the brink of it. It might be worth bearing in mind that the FDA was born after Upton Sinclair
’s exposé of the Chicago meat industry over 100 years ago.
Too big to fail
Faced with a difficult call, I think the MHRA acted correctly. They decided that the risk to patients of not getting their medication outweighs the risks of them being harmed by the drugs being made without the proper checks and cross checks. The MHRA found itself on the horns of a dilemma (hopefully, horns made of keratin with a prion disease-free certificate), but it is cost-cutting procurement processes and squeezed healthcare budgets that have provided the bull.
We need to take a good look at supply diversity: we cannot allow the situation where suppliers are too big to fail. It’s time to raise the bar across the pharmaceutical supply line from producer to patient. And quality needs to become a procurement factor. Modern inspections should close out with an openly available risk statement, which is then factored into purchasing tenders. Producers can be very cagey about showing what their inspection turned up, but this secrecy allows a ‘just-pass supplier’ to be as valuable as one who has invested in a rigorous system that produces a consistent high quality product. If we don’t safeguard quality, we might soon find ourselves talking about ‘Friday capsules’.
Steven Ford is a researcher at the Strathclyde Institute for Pharmacy and Biomedical Sciences, UK