Substandard and falsified medical products*

In 2012, the World Health Assembly established the Member State Mechanism to address the issue of tackling substandard and falsified medical products in a a transparent and inclusive way, from a public health perspective. The WHA65.19 resolution recognized the need to enhance support to national and regional regulatory authorities to protect public health and promote access to affordable, safe efficacious and quality medical products, to promote the prevention, detection, and response of substandard and falsified medical products. The main objective of the Member State Mechanism is to identify major needs and challenges and make policy recommendations to strengthen national and regulatory capacities. The growing phenomenon of the falsification of medical products threatens the right to life, as enshrined in different international human rights instruments. In its resolution 20/6, the Commission on Crime Prevention and Criminal Justice urged Member States to prevent trafficking in fraudulent medicines by introducing legislation, as appropriate, covering, in particular, all offences related to fraudulent medicines, such as money-laundering, corruption and smuggling, a well as the confiscation and disposal of criminal assets, extradition and mutual legal assistance, to ensure that no stage in the supply chain of fraudulent medicines was overlooked. 

According to the limited number of studies on the magnitude of the problem, organized criminal groups engage in falsified medical product-related crime using the same routes and techniques employed in the trafficking in other illicit commodities. In so doing, they exploit gaps and discrepancies in national legislation and criminal justice systems. In many countries, criminal groups use new technologies and platforms such as darknet sites to traffic in falsified medical products and avoid detection by law enforcement authorities. The WHO focuses on safeguarding public health and promoting access to affordable, safe, efficacious and quality medical products, WHO does not focus on criminal investigations. 

Despite the growing nature of the problem, legal and regulatory systems around the world are facing numerous challenges in effectively combating these types of products. Such challenges include weak or inconsistent legal frameworks and ineffective criminal laws that often fail to criminalize attempt, participation by accessories and the possession and sale of illegally obtained medical products. Online and distance selling of medical products are also growing concerns but are often still inadequately addressed. Many medical product sector-specific laws are inadequate and not harmonized with other laws and international standards. Some laws lack definitions, provide for insufficient penalties and fail to designate offences as predicate offences in anti-money-laundering legislation.

The World Health Organization (WHO) recognizes that substandard and falsified medical products are most likely to be found where access to affordable, quality, safe and effective medical products is constrained, standards of governance are low or the tools and technical capacity to ensure good practices in manufacturing, quality control and distribution are limited. While the deleterious impacts of substandard and falsified medical products are difficult to quantify, there is no doubt that such products have a multidimensional impact that includes health, economic and socioeconomic consequences. They endanger health, prolong illness, kill, promote antimicrobial resistance and the spread of drug-resistant infections, undermine confidence in health professionals and health systems, create distrust about the effectiveness of medical products, waste resources, cut into the limited budgets of families and health systems and provide income for criminal networks.