E-DRUG: Sri Lanka Regulatory Authority assures price control (3)
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Dear Pascale Verhoeven
Thank you for an interesting and thoughtful comment. It deserves a long
reply, so maybe a cup of tea (Ceylon Tea!) or (Lao?) coffee while reading
this.
There are four factors that need to be taken into account in the Sri Lankan
situation which ensures that cancelling the registration would
ensure affordable medicines and therefore benefit the public.
First, the medicines which had their Registration cancelled were the ones
that were the most expensive. Thus the next in line would be cheaper and
cost the patients less. Some cancelled registrations were of the originator
brands where the "rent for innovation - the patent" has run out and
therefore the cost of the medicines was the Active Pharmaceutical
Ingredient (API), production costs and then downstream costs plus a fair
return on investment (and does not include the unacceptable extortionate
rent).
Second, competing products cannot increase their prices as the prices were
fixed at their registration. If the more affordable products increase the
market share that is good for affordability in public health.
Third, Sri Lanka has a State Medicines Procurement Agency from the 1970s
(the State Pharmaceuticals Corporation) which procures on International
Generic Tender (with quality safeguards) and sells at a fixed markup which
makes their products the most affordable in the market. This is a 50 year
old "Health Based Model of Pharmaceutical Pricing" which clearly has stood
the test of time. Check the prices
http://www.spc.lk/pub/pricecomparison.pdf (USD 1 = LKR 185)
- note price difference in mebendazole. The difference of 1000% is due to the Business Based Model of Pharmaceutical Pricing of the Multinational Pharmaceutical Companies and their Country Agent.
The mebendazole provided by the State Pharmaceuticals Corporation to the
Government Health Services, has made a major contribution to eliminating
soil transmitted helminthiasis as a Public Health problem (so no issues
with quality).
https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(19)30253-0/fulltext
Fourth, the Registration (QSE) and Cost Effectiveness (CE) is divided
between different institutions in High Income Countries (e.g Medicines and
Healthcare products Regulatory Authority (MHRA) and National Institute of
Health and Care Excellence (NIC). The Low and Middle Income Countries are
frequently shown this model and asked to follow. This is a model chosen by
HICs and is not fixed. The four (QSE and CE) can be combined as has been
done by Sri Lanka in setting up it's National Medicines Regulatory
Authority.
So FINALLY, this action of cancelling registration of expensive products
that have violated the registration criteria, will promote affordability
without any detriment to Public Health.
A side comment - in this instance, the local agents (in Sri Lanka) of the
multinational pharmaceutical companies openly violated the Regulations of
Registration. What action will the multinational companies take? Continue
their commercial (and profitable) association with the local agents despite
open violation of the Regulations?
Now onto the issue of QES. Yes, " .... active ingredient, source, polymorph
(mebendazole), quality/purity standards, ...". The issue of PCA levels in
paracetamol is still under discussion and there is no action at present.
However if this brings about an increase in price of a commonly used
medicine, the question of overall Risk vs Benefit in Public Health
particularly, applies in Low and Middle Income countries (LMICs).
As Universal Health Coverage is poor in LMICs, patients pay Out of Pocket
for medicines. With the fixed limited income, the extra cost is often at
the cost of basics such as food. The increased price (and long term benefit
of a small chance of decrease in cancer) of PCA free paracetamol may be at
the short term cost of lesser food (and bigger chance of malnutrition).
Which would E-druggers prefer?
A note on cost of medicines - this is very difficult as there are multiple
viewpoints often with hidden agendas. A useful Price Point / Benchmark can
be got from the British National Formulary Smartphone App (in the
"Medicines" section for a particular drug). Check the negotiated generic
price of a medicine; yes it cannot be directly taken/compared to the Retail
Price but gives an indication of what a generic product (registered in a
high income country) will offer. Frequently it is much less than the prices
in LMICs.
A question: E-druggers - did any of your countries have an earlier State
Medicines Procurement Agency? I would like to know.
Prof Krisantha Weerasuriya
(Was that answer worth the cup of tea/coffee?)
Kris Weerasuriya <krisantha@gmail.com>