By Marium Qaiser – August 1, 2023
As many in the life sciences sector know, antibiotics are the most counterfeited medicines in the world. They account for 28% of global counterfeit medicines, and counterfeit antibiotics are estimated to represent 5% of the global antibiotic market.
Substandard and falsified antibiotics are medicines that do not meet the quality standards set by regulatory authorities. These medicines are often of inferior quality or contain incorrect ingredients or amounts of active ingredients. They may also contain toxic contaminants or be expired.
The rise of counterfeit antibiotics is a concern because it is a significant contributing factor to the rise in antimicrobial resistance (AMR). The WHO estimates that more than 700,000 people die each year due to drug-resistant infections, and the number is expected to increase.
SO, WHY ANTIBIOTICS?
Counterfeiters of pharmaceuticals succeed in large part by exploiting weaknesses in supply chains, which are often fragmented with poor regulatory frameworks. This is often the case in countries of low to middle income, otherwise known as LMICs.
In many of these countries, the demand for antibiotics is higher than the supply. This has led to a growth of so-called “entrepreneurs” who keep an eye on drug stocks to track when antibiotics are running low. Then they manufacture counterfeits from their garages to sell to pharmacists.
Due to a lack of regulation and enforcement in such regions, as well as a lack of access to quality healthcare, the antibiotic “gray market” is fertile ground for exploitation. To add to the problem, there is a lack of resources for health authorities to test for the authenticity of the medicines in circulation.
HOW DOES THIS IMPACT THE PHARMACEUTICAL AND BIOTECH INDUSTRY?
These counterfeits impact the pharma and biotech industry in many ways. When patients unknowingly use counterfeit or substandard medications such as counterfeit antibiotics, their conditions may worsen or the drugs may have no effect, leading to increased healthcare costs and poor treatment outcomes. Counterfeit and substandard drugs hamper patient access to effective treatments and lead to further problems, such as resistance.
The presence of counterfeit and substandard drugs undermines the reputation and trust of pharmaceutical and biotech companies. Patients, in turn, may lose confidence in legitimate products, leading to a decline in sales and market share for genuine manufacturers.
As anyone in the industry knows, it takes considerable effort and resources to regain trust and restore the reputation of pharmaceutical and biotech companies affected by counterfeits, which can ultimately lead to significant economic losses. This often results in revenue losses due to reduced sales, increased expenses for investigating and combating counterfeit operations, and the cost of legal actions against counterfeiters. Additionally, companies may need to invest in anticounterfeiting technologies and measures, further adding to their financial burden.
Counterfeit drugs involve the unauthorized use of patent formulations, trademarks, and copyrights of pharmaceutical and biotech companies. This undermines the value of intellectual property rights and discourages investment in research and development. The industry relies heavily on innovation and the protection of intellectual property to drive progress, and counterfeiting undermines this foundation.
The presence of counterfeit and substandard drugs poses challenges for regulatory bodies responsible for ensuring the safety, quality, and efficacy of pharmaceutical products. In my view, these regulatory authorities need to invest additional resources in monitoring, detecting, and combating counterfeit operations. Stricter regulations and enforcement measures may be necessary, further increasing the regulatory burden for legitimate manufacturers.
WHAT NEEDS TO CHANGE?
Currently, in collaboration with the pharmaceutical industry and other stakeholders, Interpol plays a crucial role in combating substandard and counterfeit medicines. Interpol facilitates the exchange of information between law enforcement agencies and the pharmaceutical industry.
For their part, pharmaceutical companies provide valuable intelligence on suspicious products, counterfeit operations, and emerging trends in counterfeiting. This information helps Interpol identify criminal networks and global and country-level hotspots, and it helps target their activities effectively.
Interpol works in collaboration with the pharmaceutical industry to conduct training programs to enhance the capabilities of law enforcement agencies in identifying and investigating counterfeit medicines. These training initiatives focus on various aspects such as product authentication, supply chain security, forensic analysis, and legal frameworks.
While these efforts are significant, to combat the problem of substandard and falsified antibiotics governments must work with pharma and biotech companies to take a multipronged approach. This should include enacting laws and regulations to ensure the quality and safety of medicines, conducting surveillance to detect and remove substandard and falsified products from the market, and providing training and education to healthcare professionals and patients on the responsible use of antibiotics.
Fortunately, there are several initiatives underway to combat this problem in this vein. Here are some examples:
- The WHO and other collaborators have developed the Global Surveillance System (GSS) for antimicrobial resistance. With this initiative, partners make a collective effort to detect and monitor drug-resistant infections and any associated counterfeit antibiotics. This relies on sharing intelligence and tracking information pertaining to AMR. All those data help identify patterns and trends related to counterfeit antibiotics, supporting targeted interventions.
- The Global Pharma Health Fund (GPHF) minilab set is a low-cost testing device used for rapid counterfeit medicines detection. This initiative has been instrumental in identifying and combatting counterfeit antibiotics anywhere in the world.
- Track-and-trace mechanisms also have been used on antibiotics and other drugs to ensure authenticity throughout the supply chain. These systems rely on products having a bar code, unique serial number, and identification methods to track the movement of antibiotics all the way from the manufacturing facilities to the wholesalers, pharmacies, and hospitals.
As these examples show, by working together, governments, international organizations, and private-sector pharmaceutical companies can make significant progress in ensuring that people around the world have access to safe and effective medicines.
In addition, governments must work to strengthen the pharmaceutical supply chain. This includes increasing the transparency of the supply chain, improving quality control systems, and introducing traceability systems to track the movement of medicines from the manufacturer to the patient.
NO ONE-SIZE-FITS-ALL APPROACH
Finally, the WHO should keep in mind that there is no one-size-fits-all solution. It needs to address the different levels of maturity in infrastructure and healthcare systems in each country by listening and gathering insights from all those handling antibiotics in the supply chain. Everyone needs to be involved with regulatory authorities to ensure a watertight process and to identify the gaps.
Pharmaceutical companies need to be looking at the challenges on the ground in each individual country and work in unison with the governments and regulatory authorities as the dynamics will vary from one country to another.
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