The Center director began discussions
in 1999 with Drs. David Bell (National Center for Infectious Disease)
and John McGowan (Department of Epidemiology) on the possibility of
organizing a series of activities that would address some of the broader
policy, legal and economic issues that are associated with the challenge
of preventing antimicrobial resistance. These discussions included plans
for a one-day workshop to bring together legal scholars, economists,
international trade policy specialists, pharmaceutical company representatives,
medical researchers and practitioners, health-care delivery system administrators,
and public health personnel.
Out of the discussions, an invitation-only
workshop was designed entitled “Antimicrobial Resistance and the Economics
of Drug Development, Production, and Marketing.” The workshop, held
on May 17, 2000 at the Emory Conference Center, addressed a
series of three related policy questions.
1. How do we promote the development of needed
pharmaceutical products for which current market incentives appear
inadequate?
Background: The development of new antibiotics
is a critical tool in the battle against antimicrobial resistance.
Yet, the economics of pharmaceutical development can limit investment
in new drugs. For example, today, nearly all Staphylococcus aureus
strains are resistant to penicillin, and many have become resistant
to newer methicillin related drugs, which are the treatment of choice
for S. aureus infections. Vancomycin is now the only uniformly effective
drug for S. aureus. However, since 1997, rare strains of S.
aureus with decreased susceptibility to vancomycin have been reported
in Asia, the United States, and Europe. If we are unable to
limit the emergence and spread of resistance -- and to replace drugs
like vancomycin as they lose their effectiveness -- S. aureus may
become untreatable, as it was 60 years ago.
An enzyme identified over 20 years ago kills
S. aureus in vitro. In animal studies, the enzyme has treated
S. aureus infections effectively and without toxicity. A small
company has a patent on the recombinant technique used to produce
the enzyme, although there is no patent on the enzyme itself.
The company has reportedly been unable to interest a larger pharmaceutical
company in developing the product for use as a drug. The stated
reason for the lack of interest is that the enzyme is apparently only
effective against staphylococcal infections and thus a company that
developed and marketed it would not be able to achieve the necessary
return on investment.
2. How do we develop policies that encourage
drug development yet limit the use of drugs to preserve drug effectiveness?
Background: The need for return on investment
can conflict with the need to limit drug use in order to reduce the
development of antimicrobial resistance. Because widespread use of
a drug increases the likelihood of resistance development, some experts
believe that new drugs effective against drug-resistant microbes should
be targeted to treat resistant infections rather than used widely.
However, pharmaceutical companies indicate that they need to be able
to market new drugs widely to recover the costs of drug development.
3. How do we develop international trade policies
that promote the development of new antimicrobial agents and prevent
the spread of antimicrobial resistance?
Background: Efforts to prevent antimicrobial
resistance and encourage the production of new antimicrobial agents
raise issues involving international trade. For example, pharmaceutical
company representatives have stated that the global sales potential
of a new drug is an important consideration in deciding whether to
develop the drug. As in the US, there is a potential conflict
between the need to generate return on investment in new drug development
vs. the need to preserve the useful life of the drug through judicious
use policies. In many developing countries, drug resistance
is an even greater problem than in the US, yet drug regulation and
use policies are very limited. Since drug resistance is a global
problem, harmonization of national policies is important but has been
an elusive goal. To what extent can the international trade
in antimicrobials by multinational drug companies assist or impede
the harmonization of international efforts to limit the spread of
antimicrobial resistance?
The global sales potential of a drug also involves
overseas patent rights. For new drugs, patent rights are protected
by the World Trade Organization agreement on Trade Related Aspects
of Intellectual Property Rights (TRIPS). However,
less affluent countries have sometimes made new drugs available below
prices charged by drug companies by issuing “compulsory licenses”
to produce the drug locally. The pharmaceutical industry, backed
by the US Trade Representative, has protested this practice as a violation
of TRIPS. On the other hand, countries like South Africa, which
has issued compulsory licenses for the production of antiviral agents
for treating HIV/AIDS, have argued that this practice is justified
given the public health need and the high cost of imported AIDS drugs.
How might this difficult issue be approached?
Although the process of developing effective
public health policies for coping with antimicrobial resistance ultimately
requires public discussions of these questions, the workshop organizers
believe that informal off-the-record conversations, which encourage
an open exchange of ideas and views, can help move these discussions
along. Post-workshop feedback indicated that the participants shared
this view and felt that the workshop was a valuable opportunity.
Attendees at Workshop
held in May, 2000.
