Patients face considerable risks from fake and illegal pharmaceutical products. The risks are even greater in low and lower-middle income countries, where the rates of illegal medicine are much higher and seem to be getting worse as criminals become increasingly sophisticated and capable.
It’s a situation that warrants urgent attention. Cambodia is a useful example of a developing economy that needs to make several changes if it wants to protect the public in relation to illegal and fake pharmaceutical products:
- Pharmacies and clinics must meet minimum storage conditions, and breaches of these standards were identified and penalized;
- The judiciary and health officials must stop (or at the very least, limit) the practice of giving warning notices to those that sell illegal medicine;
- Illegal pharmacies and clinics should be shut down and offenders processed in court;
- Any person who has a pharmacist qualification and either permits another person or another venue to use their license, or employs unqualified people to work in their venue and administer medicine, must be prosecuted; and
- All pharmaceutical companies must contribute appropriately to market surveillance and control activities. These companies have a responsibility to ensure their product (or product representing itself as theirs) is not placing patients at risk.
The trends occurring in the pharmaceutical industry mean that this change is urgently required. As traditional pharmaceutical ‘blockbusters’ shift off patents, there will be a significant shift to generic manufacturers, bringing competition, lower prices and finer profit margins. These are the circumstances that will actually see counterfeiting and grey market trade in pharmaceuticals thrive.
It’s also important to consider that there is a new wave of biopharmaceuticals that are yet to receive attention from counterfeiters. This type of pharmaceutical product is the next wave of innovations and patents, representing expensive treatments for cardiovascular, respiratory and other ageing-related conditions (such as cancer, Alzheimer’s disease and Parkinson’s disease).
The pharmaceutical industry is unlikely to change willingly during this time of patent expiry and margin pressure. Governments and regional bodies like ASEAN need to act decisively to ensure the public is protected through an effective system of supply chain regulation and control.
Its also time that the multilateral organisations such as the UNODC, WHO and WTO take concrete action against pharmaceutical crime, particularly in South East Asia. The UNODC made a resolution against pharmaceutical crime some time ago, but are yet to have an active presence in the region, despite the growing public health crisis.