Substandard and falsified medical products: Scope, scale and harm

They are also found to commonly contain corn starch, potato starch or chalk.

Some substandard and falsified medical products have been toxic in nature with either fatal levels of the wrong active ingredient or other toxic chemicals.

Substandard and falsified medical products are often produced in very poor and unhygienic conditions by unqualified personnel, and contain unknown impurities and are sometimes contaminated with bacteria.

 

In November 2017, WHO launched two important publications;

• WHO Global surveillance and monitoring system for substandard and falsified medical products, which highlights the causes, consequences and solutions.
• Study on the public health and socioeconomic impact of substandard and falsified medical products, which examines estimates of the prevalence and cost of the issue;

Both publications provide more information on the scope, scale and harm of substandard and falsified medical products.

 

 

Reports received by WHO from Member States suggest that all therapeutic categories are affected by SF medical products. Anti-infectives, anti-malarials and genito urinary/sex hormones are particularly badly affected. Expensive cardio vascular and oncology products are targeted as well as low priced pain suppressants. Generic and innovator medical products are both vulnerable to falsification as are the most expensive to the cheapest products. Those engaged in the manufacture, distribution and supply of SF medical products have shown they respond quickly to demand, thoroughly understand the market and are fast to exploit opportunities.

 

SF medical products are manufactured in many different countries and in all WHO regions. Member States and the media frequently report successful operations against manufacturers of SF medical products. Some reports refer to large scale manufacturing and others to small back street operations. With the availability of tableting machines, ovens, specialist equipment, ingredients and packaging materials, clandestine manufacturing facilities are quick and easy to assemble and have been discovered in all regions.

 

No countries remain untouched by this issue and work is being done in all WHO Regions. What was once considered a problem suffered by developing and low income countries has now become an issue for all. With the exponential increase in internet connectivity those engaged in the manufacture, distribution and supply of SF medical products have gained access to a global market place. This extends both to consumers and business to business forums. A culture of self-diagnosis and self-prescribing has led to the emergence of thousands of unregulated websites providing unsupervised access to SF medical products. However it is low and middle income countries and those in areas of conflict, or civil unrest, with very weak or non-existent health systems that bear the greatest burden of SF medical products.

 

Some SF medical products do cause serious adverse reactions and sometimes fatalities. When these incidents occur in a close geographic area over a short time period they are more easily identified and reported.

Cases are reported to WHO arising from an unexpected and disproportionate rise in mortality at healthcare facilities. The WHO Global Surveillance and Monitoring System and other WHO vigilance systems pick up these data.

In November 2017, two important WHO publications were launched:

• WHO global surveillance and monitoring system for substandard and falsified medical products, which highlights the causes, consequences and solutions.
• Study on the public health and socioeconomic impact of substandard and falsified medical products, which examines estimates of the prevalence and cost of the issue;

Both publications will provide more information on the scope, scale and harm of substandard and falsified medical products.

 

Most commonly, SF medical products enter the legal supply chain at distribution level through hospitals, clinics, pharmacies and wholesalers, who have obtained medical products from unknown sources and intermediaries without checking their credentials or conducting any due diligence. Supply chains can be long and complex. The more extended the supply chain, the more vulnerable they are to weak links and the insertion of SF medical products.

SF medical products are frequently found in unlicensed and illegal outlets, this includes street markets, hawkers and illegal internet pharmacies. However, they are also reported from legal and regulated venues such as hospitals, clinics, pharmacies and drug stores in all regions. These are precisely the locations where patients should have the highest degree of confidence that the medical products they receive are safe, good quality and effective.

 

Many countries have started to strengthen their legislation in respect of substandard and falsified (SF) medical products and specifically intentionally falsified medical products. Traditionally sanctions have been weak and remain so in many countries. Strong legislation alone is not enough, criminal justice systems need to be willing to handle these types of cases in an effective and efficient manner. National medicines regulatory authorities and law enforcement agencies need to collaborate and awareness raising is required amongst the prosecutors and the judiciary. Many investigations concerning SF medical products are international in nature. This makes gathering evidence more complex. Countries need to have in place mutual legal assistance treaties to permit gathering of evidence from other jurisdictions to support prosecutions. Member States with legal powers to restrain and confiscate assets and recover the proceeds of criminal activity have met with some success. Especially if laws allow for a proportion of the seized assets to be reinvested in purchasing detection devices and laboratory equipment or finance awareness campaigns and training events.

In broad terms the manufacture, distribution and supply of SF medical products is a low risk/high profit activity with disproportionately low sanctions, and as such has attracted the attention of organised criminal activity.

 

Some of those involved in the manufacture, distribution and supply of spurious, falsified and counterfeit medical products have access to sophisticated networks of off shore companies to facilitate the movement of the products, off shore bank accounts to launder the proceeds and flexible freight networks to ship the products to their eventual destinations. They operate a highly organised, professional, lucrative and criminal business. Others involved are relatively disorganised with small illegal manufacturing sites and local distribution.

In broad terms the manufacture, distribution and supply of SF medical products is a low risk/high return activity with disproportionately low sanctions, and as such has attracted the attention of organised criminal activity.

 

The manufacture, distribution and supply of SF medical products is a global issue. With the globalization of the pharmaceutical sector and wide access to internet and communications technologies, no single country or organization can hope to effectively tackle the problem in isolation.

Some aspects of the issue require a regulatory response, others a criminal law response, but most require international collaboration. Many countries rely on existing mutual legal assistance treaties, extradition treaties and co-operative arrangements, others do not have those facilities available.

Having an effective regulatory and criminal legal framework in place at the national level, with dissuasive sanctions, is the first step towards preventing the proliferation of SF medical products. However, in addition to legislation an efficient investigative process and transparent criminal justice system is required to ensure the proportionate application of the law.

The United Nations Office on Drugs and Crime (UNODC) have carried out some work on developing a legislative framework in relation to this topic focusing on fraudulent medicine.

The Council of Europe have drafted the Medicrime convention, which constitutes a binding International Instrument in the field of criminal law on the counterfeiting of medical products and similar crimes involving threats to public health.