E-drug: MSF letter Lancet: Generic medicines are not substandard
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This letter appearedn today's Lancet in response to a previous
article which argued that 'to rely exclusively on the cheapest
medicines is not good practice.'
MSF would like to clarify that it does not advocate 'only the
cheapest generic drugs from developing countries'. Our concern is
to increase access to safe, effective, and affordable medicines to all
in need.
Ingrid Cox
Medecins sans Frontieres
e-mail: Ingrid_COX@msf.org>
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[Published as fair use. HH]
Lancet 359:(9314), 13 April 2002
Generic medicines are not substandard medicines
Sir--Carol Adelman and Jeremiah Norris (Dec 22/29, p 2174),1 who
work for the industry-funded Hudson Institute, advocate the use of
patented drugs, pointing to what they say are risks associated with
generic drugs. They confuse generic drugs with old, substandard,
ineffective, and counterfeit drugs.
Generic does not mean old. The 1996 World Trade Organisation
(WTO) Agreements mandate all member countries to provide
20-year patent protection for medicines. Before that date, however,
many countries (including Spain, Finland, and India) thought of
medicines as too important to subject to market monopolies and
exempted them from patentability. All drugs in these countries
could, therefore, be generic. This situation is still true for countries
that have not implemented the WTO Agreements.
Drug quality is important. M�decins sans Fronti�res advocates for
improved quality surveillance. We support WHO's efforts to assist
countries by assessing quality of many technically complicated
pharmaceutical products, including the prequalification of generic
antiretroviral suppliers.
Generic does not, however, mean unsafe or ineffective, just as
patented does not necessarily mean safe and effective. Most
medicines on the WHO Model Essential Drugs List are generic.
Many vital patented drugs are excluded from the list because they
do not meet the affordability criteria. For drug resistance and
treatment adherence, generic companies may be in a better position
to provide effective treatments by producing certain combinations
and formulations that brand companies cannot or will not produce.2
Counterfeiting is a separate issue referring to the deliberate and
fraudulent mislabelling of medicines for identity or source.
Counterfeiting mostly concerns expensive branded drugs.
The only consistent practical difference between generic and
patented drugs is their price. Because market monopolies drive
prices up, generic agents are less expensive. The price of patented
drugs is a barrier to access to medicines for many diseases that are
common in less-developed countries. Access to AIDS medicines has
increased strikingly in some countries through the use of generic
drugs.3 Affordable, high-quality, generic alternatives exist for many
diseases causing substantial mortality and morbidity in the
less-developed world (eg, trachoma, kala-azar, and cryptococcal
meningitis4), which, if the right prohealth policies are implemented,
could be used to increase access in all countries in need.
Introduction of market competition through parallel importation
(competition between branded drugs) or compulsory licence
(competition with generic drugs) is an important way to lower drug
prices in a sustainable way. The Brazilian government, for example,
has used extensive generic production and the threat of compulsory
licensing to reduce the price of AIDS drugs. The declaration at the
WTO meeting in Doha in November, 2001,5 which states clearly
that countries can rightfully overcome patents, should encourage
other countries to implement and use a compulsory licensing
system for expensive drugs they deem essential in their health-care
system.
Drug quality, safety, and effectiveness are matters of great
concern. So is lack of access to essential medicines in the
developing world. It is essential for millions of people that the latter
is not limited by confusing and bias concerns over the former.
*Nathan Ford, Ellen 't Hoen
M�decins Sans Fronti�res, London EC1R 5DJ, UK
1 Adelman C, Norris J. Usefulness of foreign aid for health care in
less-developed countries. Lancet 2001; 358: 2174.
2 Laing R. Prevention of antiretroviral anarchy in sub-Saharan
Africa. Lancet 2001; 358: 1819-20.
3 Goemaere E, Kaninda AV, Ciaffi L, Mulemba M, 't Hoen E, P�coul
B. Do patents prevent access to drugs for HIV in developing
countries? JAMA 2002; 287: 841.
4 P�rez-Casas C, Herranz E, Ford N. Pricing of drugs and
donations: options for sustainable equity pricing. Trop Med Int
Health 2001; 6: 960-64.
5 Winestock G, Cooper H. Deal will allow poor nations to ignore
patents to meet public-health need. Wall Street Journal 2001; Nov
14.
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Authors' reply
Sir--It is discouraging that Nathan Ford and Ellen 't Hoen divert
attention from the merits of science to disparage our institutional
affiliation. More than 80% of Hudson Institute funding comes from
individuals, foundations, and governments. We do not cast
aspersions over the funding sources of M�decins Sans Fronti�res
to engage in scientific debate with them.
First, we do not advocate use of only patented drugs. We do
advocate standard practice of using both generic and patented
drugs, as necessary. This policy diverges from that of M�decins
Sans Fronti�res, which advocates using only the cheapest generic
drugs from developing countries such as India.
Second, we do not confuse generic drugs with "old, substandard,
ineffective, and counterfeit drugs", as Ford and 't Hoen say.
Unfortunately, the chances of getting such drugs are much higher
when searching for the cheapest drugs in developing countries. The
high prevalence of these dangerous drugs in Nigeria and southeast
Asia is alarming, as noted by other scientists: "The most probable
cause of the poor quality of drugs is absence of adequate quality
assurance during manufacture. Substandard drugs sold in the
pharmacies of less-developed countries could contribute to global
microbial resistance and therapeutic failure of infectious diseases."1
Our main point is the same as that made by Li Wan Po2 from the
Centre for Evidence-Based Pharmacotherapy, that price should not
be the only basis by which a supplier is chosen. Countries should
buy high-quality generics, high-quality patented drugs, or both. For
the safety of their citizens, however, they should not buy only the
cheapest drugs from developing countries.
While older generic drugs can certainly be appropriate, WHO has
voiced some concerns. They note that the increasing prevalence of
strains of common pathogenic bacteria resistant to widely available,
relatively cheap antimicrobials in the Essential Drug List is
dangerously eroding their effectiveness.3 Rubin4 has noted that it is
not the striking episode of an epidemic due to antibiotic-resistant
organisms that is at issue; rather, it is the growing problem of
endemic infection due to organisms resistant to formulary drugs.
Focusing on patents and compulsory licensing, as do Ford and 't
Hoen, ignores the many real barriers to treating infectious diseases
in poor countries--poverty, corruption, and lack of health-care
infrastructure. In a study of 53 African countries, patents and
patent law were not seen as a major barrier to treatment access,
and the researchers noted that the option to patent antiretroviral
drugs in Africa has frequently gone unexercised.5 If patents and
prices were the most important barrier to improved health care in
developing countries, why has tuberculosis not been treated and
cured with the low-priced, quality generic drugs that have been
available for years?
To assert, as Ford and 't Hoen do, that quality, safety, and
effectiveness are not issues in the access to medicines debate is
wrong and a disservice to the people whom the Hudson Institute
and M�decins Sans Fronti�res wish to help.
*Carol Adelman, Jeremiah Norris
Hudson Institute, Washington, DC 20036, USA
1 Taylor RB, Shakoor O, Behrens RH, et al. Pharmacopoeial quality
of drugs supplied by Nigerian pharmacies. Lancet 2001; 357:
1933-36.
2 Li Wan Po A. Too much, too little, or none at all: dealing with
substandard and fake drugs. Lancet 2001; 357: 1904.
3 Implementation of WHO's revised drug strategy: safety and
efficacy of pharmaceutical products--forty-fifth World Health
Assembly. Geneva: WHO, March 18, 1992.
4 Rubin RH. A comparative analysis of some drugs on the EDL. In:
A discussion paper on the issues raised by a WHO resolution
vis-�-vis US trade interests. Boston, MA: Harvard Medical
International, Oct 3, 1996.
5 Attaran A, Gillespie-White L. Do patents for antiretroviral drugs
constrain access to AIDS treatment in Africa? JAMA 2001; 286:
1886-92. [PubMed]
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