E-drug: Re: US compulsory licensing proposal for medicines
-------------------------------------------------------------------------
[Many including the moderator, will disagree with the following, but that
does not mean sanctioning... More wanting to join the debate? KM]
Suppose that compulsory licensing had, in fact, passed in 1962. Some of
the
then-leading firms were already starting, in response to a quantum jump in
regulatory requirements of scantily tested practicality, to diversify out
of
pharmaceuticals into consumer products, mostly of the type sold in the
front
end of US, Canadian, and UK pharmacies -- Squibb bought a candy company,
Roche
went into the perfume business, Lilly bought Elizabeth Arden, MSD went into
the
water softener and throat lozenge businesses, and so forth. But the
economic
incentives were still in place, and, after a rather long period of modest
commercial successes, the remarkable success of cimetidine in the latter
1970's
brought most companies back to the molecular roulette table, whereupon most
pharma firms divested their candy, perfume, cosmetics, etc. businesses and
went
back to their last.
What would today's pharmacopoiea look like, had the economic incentives
been
drastically curtailed by compulsory licensing in 1962? My guess is that it
would have been close to that of the old Soviet Union, which, in 70 years
of
experimentation with all manner of socio-economic levelling (plus the
digging,
to continue the 'earth metaphor', of a horrendous number of graves),
produced
substantively useful new drugs in numbers that could be counted, if not
with
just the fingers, at most with fingers + toes. Meanwhile, driven by
prospects
of large economic returns, plus whatever glimmers of beneficence also
motivate
it, the pharma industry of N America, Western Europe, and Japan produced at
a
rate of 20-50 new drugs per year from 1950 onwards.
What proportion were or are 'substantive'? Probably 1 in about 6 or 7,
most of
the rest being various forms of 'me-too' follow-ons, some of which, e.g.,
ranitidine, atorvastatin, atenolol, and the OROS-form of nifedipine, turned
out
to be the medically preferred product over the first-entry in its
respective
field, as they represented genuine improvements over the first- or
earlier-entry products in their respective fields. Substantive drugs or
drug-classes include streptomycin, isoniazid, the tetracyclines, a variety
of
corticosteroids for systemic, inhalational, and topical dermatologic &
ophthalmologic use, erythromycin, halothane, the oral steroidal
contraceptives,
L-DOPA and several decarboxylase inhibitors, rifampicin, cimetidine,
ranitidine, omeprazole, taxol, aldomet, reserpine, a variety of oral and
topical (for ophthalmologic use) beta blockers, a variety of calcium
antagonists, a variety of ACE inhibitors, a variety of angiotensin-2
receptor
inhibitors, furosemide and several other loop diuretics, the statins, a
variety
of antifungals, several antiplatelet agents, a variety of antivirals
including
antiretrovirals, plus others. I didn't include penicillin, as it was
developed
under governmental auspices during WWII.
In the annals of unintended consequences, destroying economic incentives
leads
the list of catastrophe-makers, draggiing down whole countries that once
were
prosperous and could feed themselves. In the case of compulsory licensing
of
novel pharmaceuticals, the consequence -- I presume unintended -- would be
a
complete system of compulsory licensing with no drugs worth licensing, per
Santayana's dictum..
John Urquhart, MD, FRCP(Edin)
Professor of Pharmaco-epidemiology, Maastricht University, Maastricht, NL
Chief Scientist, AARDEX Ltd/APREX Corp, Zug CH & Union City, CA USA
Professor of Biopharmaceutical Sciences, UCSF, San Francisco
home offiice: 975 Hamilton Ave, Palo Alto, CA 94301 USA
email: urquhart@ix.netcom.com.
.
--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Information and archive http://www.healthnet.org/programs/edrug.html
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.