Experts brainstorm on legal implications of substandard medicine

Attorney General Alliance Africa Programme (AGA-Africa) in collaboration with policy makers of the Pharmaceutical Society of Nigeria (PSN) have rolled out the legal implications of fake medicines.

They also rolled out strategies for safeguarding the pharmaceutical landscape in Nigeria and beyond from the nefarious activities of drug counterfeiters.

Speaking at a two-day workshop on the theme: ‘Combating the menace of substandard and falsified medical product’, acting head, of legal FDA, Ghana, William Agbavitor, said there should be an effective investigation and prosecution of a person who sells or produces fake drugs, noting that an effective investigation will bring such perpetrator to justice.

Partner in PUNUKA Attorney and Solicitor and the Country Coordinator for the AGA-Africa programme, Ebelechukwu Enedah, said the choice of the theme is critical because fake medicines affect and kill people instantly.

“When people get drugs from an avenue where they are not supposed to get it, it also destroys the system, and makes them subscribe to these evil vendors. So, this programme has become very necessary because falsified and substandard medical products are something we consider very necessary to the health of the community.

“We have seen in the society where someone is taking a drug that is suppose to be 150mg and then the drug he’s taking is 5mg and the person isn’t getting better. People are looking for solutions where they are not supposed to look for solutions, while what they needed was 150mg that would have gotten them the health that they need, they couldn’t find that in the health system and then it leads to death. So, this are instances that have become very proliferated in our society,” she said.

President of PSN, Prof. Cyril Usifoh, bemoaned the level of damage substandard and falsified medical products have unleashed on patients all over the world.

According to him, substandard and falsified medical products have been responsible for the deaths of over 300 million children all over the world, a development he described as absolutely unacceptable.

He, therefore, urged pharmacists to rise to the occasion and play their roles as direct stakeholders in ensuring the safety of medicines.

He also urged the government to provide enabling incentives for stakeholders such as the National Agency for Food and Drug Administration Control (NAFDAC) to sustain the culture of vigilance and responsiveness, which it has been known for.

“Poverty and greed are some of the factors responsible for the production of substandard and falsified medical products in Africa, especially in Nigeria. Government needs to intervene urgently,” he said.

On his part, Registrar of the Pharmacy Council of Nigeria (PCN), Babashehu Ahmed, said the fight against substandard medical product remains key to every regulator, especially in the African region with its peculiarities.

“Every regulator needs to wake up and do the right thing by ensuring that the activities of drug counterfeiters are curtailed, no matter their status in society,” he said.

Ahmed cited that prolonged litigation bottlenecks are some of the factors responsible for slow pace of success in combating the criminals. He, however, expressed optimism that the tide would eventually turn against the drug counterfeiters.

“There was a time we had multiple court cases in many locations in Nigeria with some of those cases spanning up to 10 years. The slow response of our judiciary to drug counterfeiting cases does not help us as a regulator. However, we thank God that the trend is fast changing for the better,” he said.

Speaking on the topic ‘A review of the regulatory framework for control of substandard medical products’, Director General of NAFDAC, Prof. Mojisola Adeyeye, represented by the head of Post-surveillance marketing of the agency, Fraden Bitrus enumerated the dangers inherent in substandard and falsified medical products and also outlined measures that can help tackle the menace.

Conceding to the fact that substandard and fake medical products have been responsible for serious health issues and death, due to their failure to treat the ailments they are purported to treat, Bitrus said.

NAFDAC’s approach has always been three-pronged – prevent, detect and respond. Even though she admitted the daunting nature of the fight against drug counterfeiters, she was optimistic that the efforts of her agency have been yielding the desired results, adding that there was room for improvement.

Bitrus identified poor remuneration, lack of personnel to track cross-border trafficking, and backlog of litigations in the complex legal system of Nigeria as some of the impediments against effective drug counterfeiting tracking and control.

He, however, recommended the improvement of information sharing among stakeholders, capacity building, more inter-agency collaborations, good distribution monitoring, the dismantling of the open drug market and an increase in advocacy efforts.