Center for Global Health R&D Policy Assessment

Tuesday morning, the Global Health Council and the American Enterprise Institute hosted a congressional briefing, “Substandard Medicines and the Developing World,” at The Hill to examine the impact of substandard medicines in the global supply chain and the impact of these products on global health. Smita Baruah, CEO of the Global Health Council, moderated the discussion and speakers included Rep. G.K. Butterfield (D-NC), Roger Bate of the American Enterprise Institute (AEI), Bernard Nahlen, Deputy Director of the President’s Malaria Initiative (PMI) at USAID, Scott LaGanga, Executive Director of the Partnership for Safe Medicines, and Melvin Foote, President and CEO of the Constituency for Africa.

Bate kicked off the briefing by defining substandard medications. A substandard drug, Bate explained, is not a degraded drug (a drug, such as acetaminophen, which is past the expiration date and has produced fairly harmful degradation products). Nor is it a counterfeit drug, developed with the intent to deceive consumers of its legitimacy. Rather, a substandard drug is one that is poorly (but legally) made by a licensed manufacturer, but which is not bioequivalent to the originally approved therapeutics. These substandard drugs with manufacturing flaws, such as incorrect chemical ingredients or ingredient ratios, can be less effective (subtherapeutic) and, in the case of antimalarials and antibiotics, can accelerate the emergence of resistance.

Bate claimed that as countries become wealthier and demand for global health product increases, the number of producers and manufacturers of these commodities will increase as well. He argues that many of these new manufacturing entities cropping up in emerging markets (e.g. China, India, and even countries in Africa) do not follow good manufacturing practices (GMP), claiming that almost five percent of antibacterial and antimalarial products that arrive in the market are substandard. However, Bate did not provide many concrete solutions, aside from suggestions about the need to strengthen regulatory processes.

Dr. Nahlen followed Bates with a discussion that also addressed challenges of quality drug access in developing countries, but with a different focus. He spoke about PMI and its role in providing high quality anti-malarial medicines in developing countries. It does this by overseeing the procurement of artemesinin combination therapies (ACTs) from manufacturing to their arrival in the market, and by scaling up the use of rapid diagnostic tests (RDTs). One mechanism Nahlen mentioned was PMI’s Central Emergency Procurement Fund to reduce or eliminate stock outs of ACTs and other malarial commodities in the public sector in endemic countries. Essentially, when money from the Global Fund (one of the largest procurer of anti-malarials and mosquito nets) is delayed, PMI uses this mechanism to fill the gap.

Next, LaGanga emphasized the importance of engaging the entire global health ecosystem and the necessity for education and communication in order to tackle these important issues, and Foote echoed similar sentiments: we need to demand better regulatory enforcement and to develop a system to identify the source of substandard medications.

One of the interesting points that arose a number of times (which the broader malaria community seems to agree upon) was the need for RDTs and the need to train private sector drug shop owners—licensed or not—about proper ACT storage, diagnosis, etc. With the increased availability of ACTs in the market, there is now also a strong need for quality-assured RDTs, or even differential diagnoses tools for fever.

Another important concern is the unpredictability of drug supply, which can be traced in part to the volatility of donor funding, which could exacerbate stock outs, accelerate the emergency of drug-resistance, and potentially increase the number of substandard drugs in the market. Bate pointed out that although organizations such as the Global Fund do a good job requiring the procurement of regulated products, problems sometimes arise during implementation. For example, the Global Fund contracted with a drug company to provide 7 million treatments for western Kenya, but three months later, only provided a half million, resulting in frequent stock outs. Bates believes that these stock outs create an opportunity for those profiting from substandard medications and counterfeit drugs, which find ready market demand for their products.

Each of the speakers provided a reminder of how challenging it is to ensure access to affordable medicines for people in developing countries. Perhaps unintentionally, this event about substandard medicines may have simply reminded us again about even larger problems in global health. Are substandard medicines the biggest challenge in this area? Or should we focus instead the bigger problems of affordability, access, and targeting, and view substandard medicines as an important (but secondary) aspect of these larger problems?