For many years the World Health Organization (WHO) has been warning us about, “A post-antibiotic era – in which common infections and minor injuries can kill – far from being an apocalyptic fantasy, is instead a very real possibility for the 21st century”. Antimicrobial resistance (AMR) might not grab our attention like the Coronavirus (COVID-19) but as the WHO has pointed out the consequences of ignoring the rise of AMR are potentially devastating. By turning the spotlight on health systems across the globe, the emergence of COVID-19 should act as a stern warning for healthcare professionals and policymakers causing them to re-examine their preparedness and ability to cope with public health emergencies.
There are two main trends that fuel the potential AMR disaster: new classes of drugs are not being developed and resistance to existing drugs continues unabated. The evolution of resistant strains is a natural process that occurs when microorganisms are exposed to antimicrobial drugs. Misuse of antimicrobial medicines accelerates this phenomenon. Every time a person or animal takes antibiotics, sensitive bacteria are killed, but some resistant pathogens may survive to grow and multiply.
Repeated and improper uses of antibiotics are the primary cause of the increase in drug-resistant bacteria. Antibiotics should be used to treat bacterial infections only since they are not effective against viral infections like the common cold and flu. The prevalence of fake and substandard drugs also raises the probability of resistance to good quality drugs developing.
It is essential to differentiate between fake and sub-standard drugs. Fake drugs are produced by criminals, often with no attempt whatsoever to include active ingredients. If included, there is usually just enough to pass a basic test. Fake drugs not only fail to cure patients’ ailments, but also frequently contain chemicals that cause additional harm to the patient. In contrast, sub-standard drugs, more often than not, while produced by legitimate drug manufacturers, are of poor quality. Sub-standard drugs made with either too little or too much active ingredient often deteriorate before a normal expiry date.
Fake drugs may be highly detrimental to patients who consume them, but sub-standard drugs are far more damaging because they increase the probability of resistance emerging to good quality drugs. Sub-standard drugs have the potential to render an entire class of proven drugs useless.
Pharmaceutical companies invest large amounts of resources – both financial and human – that involve significant opportunity costs, into developing new generations of effective antibiotics. For most drugs, it takes up to ten years for a product to leave the laboratories and be introduced into the market. This reduces by half the twenty-year period of market exclusivity in which governments allow pharmaceutical companies to earn some return on their investment.
Once a product hits the market, pharmaceutical companies, generally, have about one decade in which to recover their costs and clear a profit before a product enters the public domain and joins the thousands of other molecules that already enjoy permanent public domain status. At this point the drug is free to be copied by other companies which then derive a profit from the sale of their mutated product.
In its efforts to combat the growing problem of antimicrobial resistance (AMR), the US government is providing incentives such as fast track review and an extra five years of market exclusivity for pharmaceutical companies through its Generating Antibiotic Incentives Now Act (GAIN Act). With an extra five years of market exclusivity, a company would have up to 15 years to recoup their costs. Given the health community’s growing concerns about the declining effectiveness of antibiotics, it is this kind of regulatory action that is required to stimulate innovation and investment in the pharmaceutical sector to develop the next life-saving antibiotic.
Governments should also consider relaxing the regulatory burden on legitimate producers who are required to fulfil lengthy and expensive registration processes – often a process that they have already undertaken in other countries. If regulators were to harmonise more and accept registrations on a regional basis, it would undoubtedly free up more time and resources to monitor sub-standards and prevent fakes from entering the market. A more efficient process would also relieve the ‘regulation’ pressure on good quality drugs and help us escape the serious threat of wide-scale resistance.
Greater emphasis should be placed on the rational use of antibiotics and measures to curb fake and sub-standard antibiotics that increase the probability of resistance emerging to genuine products. The international community should commit to signing an international treaty on counterfeiting medicines, such as the one proposed by Prof Amir Attaran and Dr Roger Bate. Currently medicine counterfeiters can use all sorts of legal loopholes to get away with what they are doing. Unlike counterfeit currency, there is no consistency in the laws that deal with producers of fake medicines. A global treaty is needed to close the many loopholes and standardise the legal treatment of criminals whose trade is deadly. Such a treaty concerning counterfeit currency has already existed for decades. It is high time one is adopted for medicines to protect the future of humankind.
This article was first published in the February 2020 edition of Med Suite Media