E-drug: EU & Tropical Diseases / Pharmaceutical R&D
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According to a proposal of the European Union, can tropical diseases be
seriously considered as rare diseases ? ...
The majority of medicines used in the treatment of tropical diseases
(ie. infectious diseases predominant in the tropics) were developed over
40 years ago. Some are toxic; others have long and complicated protocols
that make both compliance and the following of the treatment difficult
and so reduce the chances of success of the therapeutic treatment.
Efficacy is further diminished due to emerging resistance to these
long-existing drugs. The disappearance of all strategic and commercial
incentive from the developing world results in the pharmaceutical
industry putting little or no effort in producing new medicines for the
control of prevalent transmissible illnesses. Initiatives have led to
advances in the biology of these diseases and the identification of
candidate medicines, notably the WHO / TDR programmes. But results in
terms of actual medicines remains very limited: of the 1233 new
medicines commercialized between 1975 and 1997, only 11 are for the
treatment of tropical diseases (Trouiller P., International Journal of
Infectious Diseases 1999).
The current situation regarding the lack of research and development
(R&D) in the area of infectious tropical diseases is similar for rare
diseases. Rare diseases are diseases of very low prevalence (< 5/10 000)
and usually of genetic origin. With no incentive other than commercial,
drug manufacturers are not attracted to this restricted market. In the
1980s, the American Government, under the pressure of campaigning
organizations, put in place a framework of initiatives (regulatory,
financial and commercial) in order to encourage R&D into orphan drugs
for rare diseases (US Orphan Drug Act, 1983; URL:
http://www.cptech.org/ip/health/orphan/). These measures have allowed
the commercialization of 152 new medicines in the last 14 years. This
success, a combination of industrial and public health considerations,
led the European Commission (the executive of the European Union) to
draw up a "Proposal for a European Parliament and Council Regulation on
Orphan Medicinal Products" (URL: http://dg3.eudra.org/). The proposal
will be examined by the European Parliament in March or April 1999.
With no established policy in favour of R&D for tropical diseases, the
American Government, now followed by the European Commission, are
considering incorporating this into the Orphan Drug Act and future
European amendments by classifying tropical diseases as rare diseases.
In the US, incremental and atypical measures have already been taken
that have atypically facilitated the clinical development of 3
antiparasitic drugs (3 out of 152): 2 antimalarials (halofantrine,
mefloquine) previously developed and used by the American army in
Vietnam, and 1 trypanocide (eflornithine) which has since been
considered unprofitable and withdrawn from the market.
Medecins Sans Frontieres (MSF) considers that the European proposal will
be probably a good framework of initiative for rare diseases and that
infectious diseases mainly tropical should not be considered of
secondary importance but deserve specific attention (tropical diseases
are not rare diseases!). In this way MSF proposes :
- an amendment to the European proposal to compensate for the inadequacy
with respect to tropical diseases. The "MSF amendment" will be
supported by the European Parliament "Committee on the environment,
public health and consumer protection";
- and a parliamentary resolution that sets the European Commission the
task of addressing the specific issue of tropical diseases; the
resolution will be supported by the parliamentary "Committee on
development and cooperation ".
Besides, MSF in collaboration with WHO, will organise this autumn a
joint workshop on "Drug discovery and development for communicable
diseases: what possible solutions?" (Geneva, Switzerland).
The current MSF campaign is particularly founded on the principal that
every person, wherever they are, and whatever their social and economic
situation, can benefit from the progress in medical and pharmaceutical
research (summarized in a recent paper: Pecoul P, Chirac P, Trouiller P,
Pinel J. Access to essential drugs in poor countries: a lost battle? JAMA
1999; 281(4): 361-7).
Patrice Trouiller, Pharm D, MB
Medecins Sans Frontieres Foundation, Paris - France
E-Mail: pat.trouiller@wanadoo.fr
office@paris.msf.org
[Note from moderator: I agree, they cannot be considered rare diseases! Good
luck with the workshop and do keep us posted. Kirsten Myhr]
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