Leaders from seven African countries gathered last week in Lomé, Togo, to sign a declaration about criminalizing trafficking of falsified and substandard medicine, a market which is estimated to be worth $200bn (€188bn) and costs the lives of hundreds of thousands of children every year.
The World Health Organization (WHO)’s director-general, Tedros Adhanom Ghebreyesus, told us that the strategies include improving Africa's capacity for local drug manufacturing; however, a precondition to this is the establishment of a proficient regulatory framework.
In-PharmaTechnologist spoke with Pernette Bourdillon Esteve, head of the WHO’s team on falsified and substandard medicines, about what actions it will take for regulators to secure the supply chain and on the importance of strong quality control at all stages.
“A manufacturing industry might only thrive if there is a strong regulatory system, which actually provides the right environment and ensures that everyone has a fair share in the game,” Esteve told us.
“This is what we are working on in Africa and this is why the WHO urges countries to sign and ratify the African Medicines Agency (AMA) treaty,” she continued.
According to Esteve, once the AMA is established and the regulatory framework is settled, “The oversight capacity will be good and therefore the manufacturing capacity should follow.”
The executive noted that due to the scale of globalization in the pharmaceutical industry, the complexity of the drug supply chain is high, raising the need for a ‘safe’ environment for all transactions to occur, whilst protecting the integrity of the supply chain.
“From a patient perspective, it doesn’t matter if the medicine was falsified or substandard, what matters is whether the product worked as expected,” Esteve told us, adding that “product quality can deteriorate or be put at risk at any point of the supply chain,” and therefore the control processes need to be comprehensive.
Consequently, according to the WHO’s executive, criminal groups such as traffickers and smugglers of fakes are not the only ones causing the poor quality of medicine that end up being used by African patients, since manufacturers are also found to be ‘cutting corners’ in their processes.
The three-stage process
“The WHO’s strategy approach includes ‘prevention, detection and response’, meaning that we need to make sure that out of all those who have a stake in the supply chain, everyone demands quality,” Esteve said.
According to Esteve, prevention includes even “the patients, who need to be told not to [buy medicines] on unregistered websites, or unregulated open-air markets,” while concurrently actions are taken to protect the integrity of the supply chain.
Once this is done, the next stage is detection, where the regulatory body has “to improve the capacity to quickly detect [drawbacks], both qualitatively and quantitatively in the medicines’ ingredients.”
Subsequently, at the next stage, the regulator has “to make sure that people are able to report…and remove any barriers so that people are not afraid to do it.”
This is where politics will play an important role, according to Esteve, since “having high-level politicians saying, ‘this is a problem, we acknowledge it’ can contribute to increasing report rates, which can then, finally, lead us to the response.”
“Ultimately, you look at the lessons learned and plan how to prevent recurrence,” she concluded.