E-drug: Re: Drug Approval Criteria (cont'd)
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- It takes two in the developed world, but one will do in the developing
An observation on Drug Approval Criteria from experience. Perhaps the sub
title may be "The Theory and Practice of Making Drugs available through
Approval"
There is no universally accepted basis/criteria for drug registration but
the "science" i.e. safety, efficacy and quality are generally accepted. The
developed countries implement this and strongly recommend that the
developing countries also do this.
However most developed countries which have the second step of evaluating
cost (Australia - PBS, Europe - reimbursement schemes, negative/positive
lists) which means for a drug to be available to the vast majority of the
population (i.e. through the state health care system), it must pass that
hurdle too. An example from Australia - finasteride is registered but NOT
approved by the Pharmaceutical Benefit Scheme (PBS).
The developed countries rarely have such cost evaluation system and also
very little of insurance schemes. It is either a limited list (based mainly
on the EDL) in the public sector or pay "out of pocket" in the private
sector for the total cost of any of the drugs that has been registered in
the country.
When drug regulators in the developed world ask for such cost evaluation
data we are told that it is NOT a part of the registration process and
cannot be considered. The "market" in the private sector will decide
through the "prescriber" whether the product is cost-effective. We all know
about the "market" and the "prescriber" in pharmaceuticals. It is so
perfect, that no health care scheme in a developed country in Europe allows
prescribers to prescribe what is registered. Prescribing must be done
within the re-imbursement guidelines.
What does this practically lead to? The UK has 17 benzodiazepines (all
registered properly) but only 5 of them (in generic form) are available in
the National Health Service (NHS) and therefore to the vast majority of the
patients/public. Presumably even if the Minister of Health goes to his
Family Practitioner, he will get a generic (which will be cheap) from one
of the five, unless he wants a private prescription. Note that even the
grand father of them all (Valium) is not available in the NHS - see the
British National Formulary
In the developing countries, a poor farmer has the "freedom" to pay for the
most expensive of the branded benzodiazepines (in a private prescription).
That is because it is safe, effective and of acceptable quality BUT also
because the registration process was not allowed to ask about cost.
Dr K Weerasuriya
Secretary, Drug Evaluation Sub-Committee
Ministry of Health, Colombo, SRI LANKA
& Department of Pharmacology
Faculty of Medicine, University of Colombo.
PS The ultimate irony is that a drug may be registered in a developed
country but unavailable to the patients because the reimbursement
negotiations have not been completed ("me-too" and therefore reimbursement
not more than existing product?). However this Registration is used to push
through the registration in the developing countries and the product
released to the market for the "fortunate" patients in the developed world.
Dr Krisantha Weerasuriya tel/fax +94 1 695230
Department of Pharmacology email <phrm_cmb@slt.lk>
Faculty of Medicine, Kynsey Road
University of Colombo
P O Box 271
Colombo 00800, SRI LANKA
personal email <kw_twcp@slt.lk>
personal fax +94 1 573170
[Note from moderator: Excellent! I fully agree with your points which are
very important observations. Kirsten Myhr]
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