E-DRUG: BMJ editorial on unsafe medicines
[This BMJ editorial deals with spurious/substandard/falsified/counterfeit
medicines in lower-income countries and the need for strengthening of
regulatory authorities -
copied as Fair Use. It is prompted through the publication of an
Institute of Medicine publication on this issue - the report may be
downloaded for free from the NAP site given as Reference #2. DB]
What to do about unsafe medicines?
BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f5064 (Published 11
Cite this as: BMJ 2013;347:f5064
Gillian J Buckley, program officer1, Jim E Riviere, university
distinguished professor 2, Lawrence O Gostin, university professor3
Because buyers cannot be aware of deceit in the sale of drugs,
regulators need to balance the scales
“Let the buyer beware,” lawyers have cautioned since medieval times.1
This is good advice when buying grain or livestock, but for as long as
there have been markets people have recognized that some products’
defects are not readily apparent to even the savviest shopper. This
problem, now called information asymmetry, is perhaps most acute in the
medicines market, where falsified and substandard drugs blend almost
perfectly with good ones. Because buyers cannot be aware of the deceit
in the sale of drugs, regulators need to step in and balance the scales.
In much of the world, however, the regulation of drugs is neglected. In
this vacuum, drug quality declines and patients suffer.
It is difficult to measure the human suffering caused by unregulated
medicines, a recent Institute of Medicine report concluded.2 Whereas the
burden of specific diseases can be expressed in disability adjusted life
years, quality adjusted life years, morbidity, or mortality, poor
quality drugs go unnoticed by design. Some contain no active ingredient
or reduced doses of the labeled drug. Others may mimic a therapeutic
effect, disguising, for example, paracetamol in antimalarial packaging.
Only through postmarketing surveillance do these problems come to light.
Pharmacovigilance data give an understanding of what drugs are
compromised and where they circulate. A better understanding of such
trends could inform estimates of how much ineffective drugs cost
society, translating the threat into concrete terms that compel
governments and donors to act.
The irony of the problem is that the very data that could motivate
investment in drug regulation depend on market surveillance. In a 2010
assessment, the World Health Organization found that only five of 26
drug regulatory authorities in sub-Saharan Africa had functional
pharmacovigilance systems.3 The situation in major drug producing
nations is no better. In China and India, for example, short staffed
regulatory agencies struggle to inspect and license thousands of
manufacturers, with little staff time left for market surveillance. A
2012 Institute of Medicine report identified poor surveillance as one of
the main barriers to developing drug safety systems in low and middle
income countries.4 The report recommended that the US government and
international organizations invest in pharmacovigilance in these
countries. In a larger sense, the report argued for more donor
investment in medicines regulation in the developing world.
Donor countries stand to benefit from this investment as well. Modern
drug manufacturing relies on ingredients sourced from around the world.
Supervising multinational supply chains is an insurmountable job, even
for well funded regulatory authorities. Drug importing nations would
welcome investments in the technical skills of regulators in drug
producing nations, because these regulators have the first
responsibility for manufacturing oversight. Building health systems,
especially drug regulatory systems, also protects donors’ interests in
global health. Development agencies have invested heavily in reducing
maternal and child mortality and in treating major infectious diseases.
These programs depend on effective medicines, something that cannot be
ensured without a commensurate investment in drug regulation.
Regulators in developing countries should help initiate these
investments. Their agencies have many competing needs: equipment,
training, staffing, reference standards, and infrastructure. The scope
of the needs can be overwhelming, leading to inaction. The Institute of
Medicine report on falsified and substandard drugs recommended that
regulators in low and middle income countries draft strategic plans for
agency development.2 This plan would identify the agency’s priorities
and guide decisions about where to invest first, a manageable first step
even for a small agency. Regulators could then use the plan to advocate
for better support from their ministers and to identify places where
donors could contribute.
Investment in regulatory systems could bring about meaningful
improvements in the health of the world’s poorest people. These
improvements are already well under way. The past 20 years have seen
great advances in global health, but disease treatment programs may soon
face the prospect of diminishing marginal returns. Their continued
success depends on corresponding investments in health systems, of which
the drug regulatory system is an important part. Until governments can
ensure that the drugs in their countries are safe and reliable, patients
face a hopeless disadvantage in navigating the drug market alone. Life
saving drugs, although apparently plentiful, will remain out of reach
Cite this as: BMJ 2013;347:f5064
Competing interests: We have read and understood the BMJ Group policy on
declaration of interests and declare: None.
Provenance and peer review: Not commissioned; not externally peer reviewed.
1. LeViness CT. Caveat emptor versus caveat venditor. Md L Rev 1943;7(177).
2. Institute of Medicine. Countering the problem of falsified and
substandard drugs. National Academies Press, 2013.
3. WHO. Assessment of medicines regulatory systems in sub-Saharan
African countries: an overview of findings from 26 assessment reports.
4. Institute of Medicine. Ensuring safe foods and medical products
through stronger regulatory systems abroad. National Academies Press,