E-DRUG: RFI: Country Attitudes Toward Generic Substitution (5)
-------------------------------------------------------------
Dear E-druggers,
Let�s all be honest to Lenny. Politics, politics and
politics and marketing, that�s what makes the
difference between countries who go for generic
substition and the ones who don�t.
Price or quality are a non issue, simply because:
a. in most cases countries don�t pay for drugs themselves and
b. regulatory bodies make sure that both generic and
originator product are of similar quality.
To reply to Gary Malone�s e-mail, I actually think
that most generics even provide better quality since
most are registered very recently, whilst the
originator drugs were registered at least 10 years
ago. Everybody will agree that in the meantime the
requirements for registering a drug have been
tightened considerably. For example, was anybody
investigating polymorphism on raw materials, obliged
to use identical specifications for assay and
impurities at release and at end of shelf life or
performing stability studies at 40 �C/75 % RH ten
years ago. I don�t think so.
To get back to my statement that politics and
marketing are the main issues here I just wanted to
present some practical examples off what I have
experienced in the last 6 years of working for a
generic company:
� It is very difficult to get a generic registered in
a country where the originator has its head office.
Files got lost, the regulatory office blatantly
refused to review the generic files and in one case
where the regulatory body did co-operate the
originator threatened to sue the regulatory body for
commercial damages if they granted permission for our
generic product to enter the market. The end result
being that our generic did not get registered.
� Opinion leaders in all clinical fields are supported
by major industries. In one case this led to a
publication on severe side effects caused by our
generic product. This could be valid, but the authors
did not acknowledge that they were working for the
originator. In a later issue an erratum was published,
but offcourse the damage was already done.
� In college, most medical students will hear about
medicines by brand name and not by generic name. All
of them know what Viagra is, but who knows what
sildenafil does?
� Generic companies hardly used advertising to back up
their products. More and more you now find that
generics are also branded to counter the promotional
activities of big pharma. Brands built trust, but the
real question is in what? (NB. Just read The healthy
skeptiscm site which featured in e-drug yesterday)
� For some strange reason many people support the
opinion that if they deal with small companies that
these can not be GMP or that these can not do good
science. Overlooking, that GMP is not an issue of
quantity but of quality, and that for example most
Nobel awarded research has been performed by
individuals.
� Another strategy has been to describe generic
companies as vultures that only live by preying on the
valuable research done by originators. Again people
forget that most originator companies themselves deal
in me-too drugs, not much different from generics if
you ask me, and that the true basic research is mostly
performed by universities and other public
institutions.
� Last but not least, many people will say, generic
companies are only in it for the money. Just look at
Gary's e-mail. Come on, does anyone seriously believe
that big pharma is only in it to save people�s lives?
Just look at the amount of money spent on third world
diseases like malaria, bilharzia, trypanosomiasis etc
and compare this with the amounts spent on research to
find new life-style drugs or on finding the 9th
statin?
To end this mail, I just wanted to state that if WHO
and others would go one step further than just
recommending generics, but activily advocate the use
of approved generics from whatever company and country
it could have an enormous impact on the substitution
rate.
Hans Platteeuw
Project Manager Pharmaceutical R&D
Formerly working for Synthon (The Netherlands), now
Dafra (Belgium).
E-mail: hansplatteeuw@yahoo.com
Disclaimer: The comments given in this e-mail reflect
my own personal opinion and are not approved or
endorsed by either of the companies listed above.
--
To send a message to E-Drug, write to: e-drug@healthnet.org
To subscribe or unsubscribe, write to: majordomo@healthnet.org
in the body of the message type: subscribe e-drug OR unsubscribe e-drug
To contact a person, send a message to: e-drug-help@healthnet.org
Information and archives: http://www.essentialdrugs.org/edrug