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[e-drug] Experience in changing national health guidelines (2)

E-DRUG: Experience in changing national health guidelines (2)

Dear Bonnie,

I have many years of experience of all systems you mentioned in a West
European country, and in the early years after the downfall of communism in
Eastern Europe. Only very few countries have managed to bridge the gap
between drug registration and political issues like drug lists, national
policy, reimbursement etc. The original aim of drug registration was the
defence of human health (the antifreeze affair in 1937 with the FDA, the
thalidomide disaster in Europe); gradually drug registration has been
politicized and become an instrument of industry and country economics to
guarantee a healthy position and growth of "big pharma".  This is
especially true in countries with an economically important pharmaceutical
industry (UK, Germany, Switzerland).

However, pressure upon medical (and
automatically pharmaceutical) expenditure has tremendously increased during
the last few years, but registration authorities have kept their distance
to these problems because the matter of cost is not within their legal
terms of reference. Authorities in charge of drug lists and reimbursement
policies have an information problem because their data are provided by
industry (and partly by academic advisers) on a voluntary, not a legal,
basis, and quantity and price restrictions are not in the best interest of
industry (and, by the way, most pharmacists).

The only exception used to be
Australia, where traditionally there have always been close contacts
between the registration authorities and the reimbursement agency (the
Pharmaceutical Benefits Scheme), and, as far as I know, also overlapping
membership of committees etc. That is the main reason why the (US) industry
is now fighting tooth and nail to destroy that system.
As you know Australia is still the only "Western" country with an official
national drug policy.

Most countries have therefore divided the responsibility over three
different sectors:

(1) drug registration as separate entity - only judging quality;

(2) drug reimbursement - affordability and

(3) drug lists and formularies instituted on a local basis (promotion of
rational use of
drugs, not necessarily lower cost); local health authorities, university
departments/hospitals, medical associations etc. I fully agree with you
that the whole system should be much more integrated, but that is not the
present reality.

I hope that these comments are of some help to formulate your thoughts
about the matter.

Best wishes,

Leo Offerhaus

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