There are many unresolved issues that impede the elimination of poor quality medicines.
Progress impeded by confusion over definitions
Although there has been an awakening of interest in the problem of poor quality medicines in the last few decades, issues around terminology and definitions have ended up drowning the discussions in a way that has not been productive.
The term ‘counterfeit’ has induced much controversy because, when the word is used technically, it refers to trademark infringement, rather than public health violation. The term ‘falsified medicines’ takes into account the public health issue of poor quality medicines1, and makes it clear that the implications are far more serious than buying fake shoes or watches. Whereas falsified medicines are produced fraudulently, substandard medicines refer to those produced by genuine companies, but negligence and errors in production lead to them being poor quality.
The terms ‘counterfeit/falsified’ and ‘substandard’ are often used interchangeably, incorrectly. Such confusion results in it being very difficult to discuss the issues objectively, accurately measure the extent of the problem of poor quality medicines, and to plan interventions to tackle the issue. However, it is vital to make distinctions, because the reasons for their dissemination on the pharmaceutical market, and the associated countermeasures, differ considerably.
Ensuring a market free of poor quality medicines: a steep and rocky path
The first step in the fight against poor quality medicines is their identification. Medicine regulatory authorities (MRAs) in many low- and middle-income countries have limited financial and human resources, and the lack of rapid, affordable and well-adapted techniques to investigate the quality of suspicious medicines (see article 2 in this e-issue), means that it can take weeks, or even months to obtain the results of medicine quality analysis.
Once a medicine is confirmed to be falsified or substandard, communication is needed to act swiftly to protect patients. In developed countries, rapid communication to health professionals nationally or even regionally usually allows relatively fast recall of the batch from the market. In developing countries, the task is much more difficult because of various factors, including the limited capacity of national MRAs.
Action is also required to prevent those who produce or distribute poor quality medicines from continuing. Those involved in the release of substandard medicines on the market are usually easily identifiable, and the actions to take are more straightforward – improvement in manufacturing processes and quality control.
However, for criminal deception things are more complicated, as the manufacture of falsified medicines is a phantom illegal industry. However, there are cases in which researchers, in collaboration with other key actors (police, customs, INTERPOL, and the World Health Organization) were able to identify and precipitate the dismantling of at least part of the trade in falsified medicines, such as that of fake artesunate in South East Asia.3
The lack of global criminal laws
In the past decades, more open and free trade allowed the expansion of the pharmaceutical market and better access to medicines, but it was not necessarily accompanied by the implementation of laws to prevent the manufacture and trade of poor quality medicines. In most countries, criminal laws to prosecute those who manufacture falsified medicines are incredibly weak or nonexistent2, making this crime low risk but high profit. For example, in the Netherlands, an offender will not be incarcerated unless he/she gets caught twice!
The way forward
Assessment of the prevalence of poor quality medicines using trustworthy methodology, and investigations of the most cost-effective solutions, are urgently needed. Harmonized and internationally accepted terms and definitions are essential prerequisites. The term ‘counterfeit’ should be reserved for trademark violations and should not be used to impede access to good quality generics. For example, seizures and long-term containment of good quality generic medicines in the European Union have meant that people in developing countries have been denied access to good quality medicines; these seizures were based on allegations of infringement of intellectual property rights in the country of transit even though the generic medicines in question were legal in their countries of origin and destination. Such seizures are not in the interests of public health.
Generic medicines have been vital in allowing patients access to affordable medicines. Sustainably tackling the issue of poor quality medicines should not be viewed in isolation to improving access to medicines—medicines need to be good quality to fulfill their function. Improving good manufacturing practices to combat substandard medicines is required, for example by strengthening and expanding WHO’s pre-qualification programme. New solutions adapted to the developing world to secure the drug supply chain are also urgently needed.
WHO estimated that 30% of countries have inadequate MRAs or none at all. Although it is unclear how this figure was derived, the limited capacities of MRAs in low- and middle-income countries often makes investigation of poor quality medicines and action impossible. Strengthening national MRAs is likely to be a key factor in sustainably improving the quality of medicines.
Raising patients’ awareness of poor quality medicines is also important, as they may notice when their medications change in appearance or taste, or note adverse drug reactions. Healthcare providers should also be more aware of the problem, especially in cases of unexpected treatment failure or in the face of puzzling clinical syndromes. However, engaging patients and health professionals is not sufficient; rapid detection techniques to authenticate medicines need to be made available, and national and regional systems are also required to enable rapid and efficient countermeasures.
In 2012, 1.4 million packets of falsified medicines containing no active ingredients were seized. This seizure included artemether-lumefantrine, the most widely used artemisinin-based combination treatment for P. falciparum malaria. This was brought to public attention via Facebook five months after it was identified, and in the printed press 11 months after the event!4 Involving all the stakeholders in the communication of problems related to poor quality medicines would help reduce the delay in making information publicly available.
The WHO Medical Product Alert system that allows national focal points to report newly-discovered falsified or substandard medicines is an important source of information and advocacy but is not mandatory. The e-drug and e-med systems also report medicine quality problems in English and French, respectively. Reporting of falsified and substandard medicines to relevant authorities has recently been included in the ‘Access to Medicine Index’, which ranks pharmaceutical companies’ efforts to improve access to medicine in developing countries. This may be a major step forward that will encourage reporting, but a global system for the mandatory dissemination of information is essential to inform interventions.
Better cooperation between national customs officers, MRAs, police, pharmaceutical companies, civil society and other major stakeholders must be reached. Some commentators advocate for a global treaty such as those existing for human trafficking, banknote counterfeiting or the production of counterfeit tobacco products5, as it can help governments strengthen their laws and cooperate internationally. Implementing laws to class the falsification of medicines as an international crime would facilitate combating the criminal networks involved in the falsified medicines epidemic.
Other articles in this series:
- Five Things You Might Not Know About Medicine Quality
- How Can We Detect Poor Quality Medicines?
- Challenges in Tackling the Issue of Poor Quality Medicines
- Hot Spots: Recent Evidence on the Quality of Currently Recommended Antimalarials
- Newton, P. N. et al. The primacy of public health considerations in defining poor quality medicines. PLoS Med. 8, e1001139 (2011).
- Attaran, A. Stopping murder by medicine: introducing the model law on medicine crime. Am. J. Trop. Med. Hyg. 92, 127–32 (2015).
- Newton, P. N. et al. A collaborative epidemiological investigation into the criminal fake artesunate trade in South East Asia. PLoS Med. 5, e32 (2008).
- Newton, P. N. et al. Falsified medicines in Africa: all talk, no action. Lancet. Glob. Heal. 2, e509–10 (2014).
- Attaran, A. et al. How to achieve international action on falsified and substandard medicines. BMJ 345, e7381 (2012).