E-DRUG: Lowest cost for HIV/AIDS drugs?
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[copied from PHARM-POLICY with thanks;
2 messages combined into one. WB]
Right now we are receiving a lot of calls about the drug companies
announced donations policy. I'll stand corrected, but it seems as
though these offers are not particularly new, in terms of the discounts.
I've been hearing about discount offers of 70 to 80 percent for some
time, at least since 1997 in some markets, based upon my own
recollections.
I also don't think it is particularly helpful or honest at this point to
sit around and talk as if the big pharma drug companies are going to
solve the access problem. Basically, they are trying to defend high
prices all around the world. When they offer donations of various types
they are usually to avoid deeper cuts in prices, and the manage and
control the process.
If people really are concerned about not sounding too radical, then I
can see how it makes sense to pay lots of attention to the various big
pharma dialogue type efforts, because that's what they define as
respectable. But at the end of the day and after the body count
mounts, people should begin to address the obvious:
1. Prices can come down much much more, but only if production and
distribution are done with some intelligence and seriousness of purpose,
2. For low cost generic production, there are many barriers to entry in
national markets, that will have to be solved. These will include both
regulatory and IPR issues.
3. It is important to get generic production runs as high as possible,
and to have procurement be as competitive as possible, to get good (low)
prices. This would be best, by far, if done at a global level. (I
mentioned earier, based upon discussions with a producer, that if
everything was done right, it might be possible to get 3 drug cocktails
manufactured at $20 per month. But whatever the number, it would be
quite a bit lower than the 70 to 80 percent discounts off the US price
that big Pharma is talking about.)
4. There is no international leadership on this now, because
intellectual property rights are too controversial, so action in the
short term is unlikely.
5. The US, the EU and probably Japan oppose doing much more than
talking to big Pharma about charity and discounts. This will only go so
far.
6. I should add that even a serious effort to obtain very cheap generic
production will be inadequate for huge numbers of the infected
populations, due to poor infrastructure. But that doesn't mean it isn't
helpful, useful or moral to expand treatment opportunties where it is
possible.
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In recent discussions with generic producers, I was told that with
large production runs for global delivery (in more than one national
market), it would be possible to produce Nucleoside Analogue Reverse
Transcriptase Inhibitors (drugs such as AZT, ddI, ddC, d4T, 3tC and
Abacavir) for about 5 cents per pill, or 21 cents per day, for a 4 pill
daily regime. The company that made this estimate is already producing
4 of these drugs in smaller quantities (at higher costs).
I was also told that the producer thought that it could produce
Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors
(NNRTI) for about the same cost, and that a three drug regime (two from
Nucleoside Analogue Reverse Transcriptase Inhibitors and one drug from
either of the other class of drugs), could be produced for about 63
cents per day, or about $230 per year.
I was told there are very large economies of scale, and that it would
only be possible to get these low unit costs if there was large
production. But the sense was that such prices are possible, if society
has the will to organize efficient production and registration
globally. I think this is very encouraging. Even if millions of
persons could not afford medicines at less than $20 per month and could
not afford the supporting care, there are many that could, using their
own resources and the existing medical infrastructures. Certainly many
of the skilled workers in a country could, for example.
In my mind, the international institutions need to work on 2 related
strategies.
1. There needs to be an comprehensive examination of the barriers to
entry for cheap drugs in every developing country. This should include
an examination of regulatory (drug registration requirements, health
registration data exclusivity, etc) and intellectual property issues
(compulsory licensing authority). This is what the WHO should be doing,
but other agencies could do this too.
2. It would be extremely useful to have a global effort to obtain
compulsory licenses and drug registrations for inexpensive generic
versions of HIV/AIDS drugs. If an international agency like the WHO,
UNAIDS or the World Bank applied for the compulsory licenses and sought
registration, governments would be more likely to move ahead, quickly,
because there would be less negative publicity regarding the weakening
of intellectual property rights. This is unlikily to happen in the face
of opposition from the US and the EU.
If we don't do (1) and (2), it is because we don't think it is
important to get the price of drugs down as much as is possible. In
other words, we are willing to tolerate hundreds of thousands of
preventable deaths, in deference to the power of the large
pharmaceutical companies. I think this is wrong, and I think we need
to push harder for real action.
Jamie
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