E-DRUG: Le Monde diplomatique: Apartheid of Pharmacology
---------------------------------------------------------------------
[copied from Pharm-Policy with thanks; Le Monde Diplomatique
is a very influential french newspaper. This is a long email
but an excellent overview. Copied as fair use. WB]
Le Monde diplomatique January 2000
APARTHEID OF PHARMACOLOGY
Twenty-two million people in Africa are seropositive - 65% of all
the peo- ple infected with the Aids virus world wide. South Africa,
which is particu- larly badly affected, has made fighting the scourge
a priority. But rather than help, in their determination to protect
their patents, the pharmaceutical laboratories are putting treatment
beyond the reach of the poorest patients and countries.
by Martine Bulard*
Sleeping sickness, which is transmitted by the tsetse fly, is making
a come- back, killing 150,000 people every year, especially in
Africa. There is a treatment, eflornithine (Ornidyl), developed by
the American firm Merell Dow in 1985. Costing a small fortune, it
was beyond the reach of those most seriously affected and was
subsequently abandoned. Having "inherited" the drug when it took the
company over, Hoechst Marion Rous- sel has finally agreed to transfer
marketing rights to the World Health Or- ganisation (WHO). But the
WHO lacks the resources to manufacture it. After three years of
talks, the French humanitarian agency M�decins sans fronti�res
(MSF), together with other non-governmental organisations, is hoping
that the product will be available, in some places at least, at the
very start of this year. But if it is to continue to be available, a
sponsor will have to be found. Microsoft Chairman Bill Gates is a
possible candidate.
The remedy for bacterial meningitis, which is particularly prevalent
in the countries of the South, has not been so lucky. Doctors saw
chlorampheni- col in oil as having the advantage of being both cheap
and easy to use. In 1995 Roussel Uclaf (which merged with the
Hoechst group in 1997 to form HMR) stopped making it. Initially, the
International Development As- sociation got it transferred to a
laboratory in Malta. But now the money has run out.
The molecule to treat leishmaniosis, a common parasitic disease in
Africa resulting in very severe skin lesions or death, is no more
profitable. It exists in the laboratory, but has not gone into
production because there is no guar- antee of a "return on the
investment". The list of molecules discovered but which got no
further than the laboratory and of useful medicines abandoned is a
long one. Dr Bernard P�coul, MSF's drugs project coordinator, notes
that, of 1,223 molecules placed on the market between 1975 and 1997,
only 13 are aimed specifically at tropical diseases. And only five
are the outcome of veterinary research (1).
Now that many diseases, such as malaria, sleeping sickness or
tuberculosis, that had been thought to have been conquered are
coming back in force, more virulent than before, the old medicines
are no longer always effective, since more and more bacilli are
showing multiple resistance, whilst the cost of new remedies is
exorbitant. As a result, no serious research is being car- ried out
into a vaccine to replace the good old BCG, even though eight
million more people are infected every year. Of these, the number of
pa- tients - or should we say customers? -- able to pay is estimated
by MSF at 400,000, way below the threshold required to launch an
investment. Somewhere in the world, someone is dying of tuberculosis
every ten sec- onds (2).
For a medicine to be produced commercially, not only does it need a
large market (three quarters of the population), but it must also
make money. A lot of money. As quickly as possible. As World Health
Organisation (WHO) Director General Dr Gro Harlem Brundtland herself
says, "More than a billion fellow human beings have been left behind
in the health revolution" (3).
In fact four fifths of world health expenditure goes on one fifth of
the world population. While drug sales in North America and, to a
lesser extent, Europe, mushroomed between 1993 and 1999, in the
countries of Africa and Asia (excluding Japan) they declined (see
chart). In the case of Aids, the picture is even more devastating:
92% of the world population have to make do with only 8% of total
expenditure.
"If the rich countries do nothing," Professor Fran�ois Bricaire,
head of the parasitology and tropical diseases department of the
Piti�-Salp�tri�re Hospital in Paris, warns, "this human imbalance
will result in an explosion. People know that, on the one hand,
there are medicines to conquer the dis- ease and that, on the other,
they are denied them for lack of resources." For example, triple
therapy (the combination of three types of antiretroviral drugs),
which has cut the Aids mortality rate by 60% in the West, is virtu-
ally inaccessible in the countries of the South.
"We get patients coming to us from Africa who have saved every penny
to pay for their treatment," Professor Bricaire adds. "We get them
back on their feet knowing full well that most of them will not be
able to afford to continue their treatment once they return home.
And then there are those who arrive illegally. We cannot just
abandon them to their fate, so we muddle through, but it is too
random to be satisfactory."
Drugs are not everyday products
According to the World Bank, the number of Aids-related deaths in
Africa will soon exceed the 20 million victims of the plague that
ravaged Europe between 1347 and 1351 (4). With the simple difference
that in those days they did not know how to handle the crisis. Today
science is capable of dealing with epidemics. Many try to conceal
this reality by highlighting the lack of a reliable health
infrastructure in those countries.
They say that some long-term treatments like triple therapies
against Aids would be impossible there, or even dangerous. The
obstacles are real enough: in some countries, wars and population
movements have destroyed the health care system; in others, the
policies imposed by the International Monetary Fund and the World
Bank have had much the same result by re- quiring drastic public
expenditure cuts.
It is ironic to see the same people who helped to dismantle the
health-care structures turning down emergency programmes on the
strength of those systems' very shortcomings. Not only could health
care networks be rebuilt, but there are already premises and staff
(local and expatriate doctors and nurses) qualified to treat
conventional infectious diseases and start long- term treatments for
Aids. Provided they have access to the latest medicines at
affordable prices.
The pharmaceutical industry does not seem to be about to turn over a
new leaf. National Pharmaceutical Industry Association
director-general Ber- nard Lemoine does not hide his annoyance at the
campaign being waged on this issue. He stresses the positive things
being done by the laboratories: temporary price reductions, donation
of unused molecules, grants to foun- dations. But his conclusion is
nevertheless final: "I don't see why special ef- fort should be
demanded from the pharmaceutical industry. Nobody asks Renault to
give cars to people who haven't got one." But that is just it: drugs
are not everyday products.
Not only do the pharmaceuticals companies set their own prices and
select the markets that will push their share prices up, but they
oppose every out- side initiative. Before the first half of 1998
Thailand had only one drug, fluconazole, to treat cryptococcal
meningitis, a fatal disease often associ- ated with Aids; it was
manufactured locally by the American laboratory Pfizer under the
name Triflucan. It was effective, but extremely expensive: 12,000
bahts (around $330) for a pack of 50 tablets. For a patient starting
treatment, that meant a monthly outlay of 15,000 bahts, one and a
half times an executive's salary. Finally, two Thai companies
managed to put on sale an equivalent product for 4,000 to 4,500
bahts a pack. Still too expen- sive for much of the population, but
much more affordable than Triflucan. Six months later sales were
banned: alerted by Pfizer, the United States government had
threatened the Thai authorities that it would impose a duty on their
main exports (timber, jewellery, microprocessors) if they did not
stop making fluconazole.
South Africa almost suffered the same fate. In 1997 the government
passed some health laws allowing local firms to produce treatments
for Aids or to import them bypassing the big corporations' patents.
At once the big American pharmaceutical companies, some of which
have subsidiaries in the Cape, complained, then pressed their
government to take reprisals of the same kind as inflicted on
Thailand. Vice-president Al Gore, head of the US-South Africa
Binational Commission, took the matter in hand himself.
As soon as the confrontation began, the Aids organisations (Act
Up-New York) and James Love and Ralph Nader's Consumer Project on
Technol- ogy began lobbying the US leadership. Gore was unable to
hold a single public meeting for the presidential election without
being questioned on the subject. This campaign, coupled with the
South African government's te- nacity, resulted in the Clinton
administration abandoning all proceedings and retaliatory measures
in September. The laboratories rushed to withdraw their complaints.
True, it will probably be some time before South Africa produces its
first generic medicine, but the first battle has been won.
To measure the scale of the victory, we must look at the changes
made to the world trade rules since the World Trade Organisation
(WTO) was set up (5). Up until 1994 every country was free to make
its own health policy and produce generic medicines without waiting
for the patent to fall into the public domain. India, Egypt and
Argentina, for example, were able to pursue a policy of import
substitution and create a local pharmaceutical in- dustry.
Since 1994, the members of the WTO have had to submit to the
so-called Trips agreements on trade-related aspects of intellectual
property rights. Under this agreement it is, in general, no longer
possible to manufacture a drug or buy it abroad without the
permission (granted in return for payment of royalties) of the owner
of the invention, who holds this power for 20 years. As a result of
pressure from countries like Spain and Canada (6), however, the
Trips do contain exception clauses: in the event of a medical
emergency or hindrances to competition (inventor's refusal to sell
or exces- sively high prices), every government is entitled to have
recourse to "compulsory licences" and parallel imports. Compulsory
licences allow a product to be manufactured without the inventor's
consent, while parallel imports allow it to be bought wherever it is
sold the cheapest.
South Africa, where according to the WHO one adult in six is
seropositive, is an obvious case of medical emergency. The big
pharmaceuticals corpo- rations know that. But, as Pharmaceutical
Research and Manufacturers of America (PhRMA) spokesman Jeffrey
Trewhitt bitterly comments, these South African laws "could set a
very, very bad precedent that could un- dermine legitimate patent
protection around the world. The potential harm from these recent
developments can be expected to reach into many other developing
countries" (7).
Furthermore, all the emergent nations are subject to unbelievable
pressures. Under WTO rules, India, where only one third of the
population has access to drugs, should abandon price controls and
the production of generic medicines. It is easy to see that this
would result in small firms closing down and even fewer people
having access to medical care. Yet the indus- try journal
Pharmaceutiques says that "the reforms and the liberalisation that
are under way are opening up new prospects for pharmaceutical labo-
ratories" (8).
It is certainly too early to draw detailed lessons from the Trips
agreements. But we already know the damage that was caused when the
countries of Latin America were forced to deregulate in 1988.
According to the WHO, drug prices escalated by 44% in Mexico, 24% in
Brazil and 16.6% in Ar- gentina in the space of four years.
But the pharmaceutical lobbies are hoping to use the WTO to get all
ex- ceptions to patent rights abolished. At the same time, they want
greater ac- cess, without cost and without constraint, to the plant
life of the developing countries, since knowledge of their genomes is
one of the keys to future medicines. In other words, they want
complete control over the raw mate- rials and ever tighter protection
for the discoveries made from those plants, making them inaccessible
to the countries they came from (9).
In addition patents are being filed further and further upstream,
which, Pro- fessor Axel Kahn, former chairman of the French National
Consultative Committee on Ethics, explains, is "a considerable
handicap on freedom to create". Until recently, he argues, "a
distinction was made between knowl- edge that is discovered and
belongs to us all and products or processes that are invented and
can be patented" (10). Protecting earlier reduces the scope of
common knowledge. At present, there is five to ten times more
informa- tion on genomes in private, limited access, data banks that
have to be paid for than is freely accessible in the public domain.
As a result, a number of American doctors and researchers say in an
open letter, the use of patents or the exorbitant cost of licences
to prevent doctors and medical laborato- ries from conducting genetic
tests is restricting access to care, lowering its quality and pushing
up costs unreasonably (11).
We are moving towards a situation where a handful of firms have a
mo- nopoly on life and have seized control of genetic diversity.
There is a great danger that the rich countries will officially
become a technological and fi- nancial directorate, a sort of "G8"
for drugs, deciding everything, from the level of research to
whether or not a particular product will be launched. That would
make the imbalances even worse: the developed countries, with plenty
of money to spend, would have the latest treatments, very expensive
and protected by intellectual property rights. The others could
benefit from them when the patent rights were exhausted - 20 years
and several hundred thousand deaths later.
Non-governmental organisations, associations of people suffering
from various diseases, doctors and researchers are mobilising
against these dan- gers. If they differ on strategy, all are agreed
that at the very least the ex- ceptions provided for in the current
Trips agreements must be preserved in the millennium round talks.
This basic minimum could, MSF suggests, give them time to get a
"health exception", just as there is already a "cultural ex- ception".
Patent law cannot be placed above humanity's basic needs. It would
be perfectly sensible to decide that human genome and biodiversity
research should be "global public goods". Monuments like the Angkor
Wat temple or cities such as Venice are considered part of human
heritage. Why not human genetics? Likewise, a stop must be put to
the plundering of the third world: not only should a fee be paid for
using plants originating in those countries, but they should all be
guaranteed the benefit of treatments developed from those plants.
Without waiting for that, how can we fight the epidemics that are
devastat- ing the peoples of the poor countries? Prices could be cut
quickly to make drugs accessible without jeopardising the financial
health of the pharma- ceuticals corporations: those based in France,
for example, spend nearly as much on advertising and promotion as on
research: 11.3% as against 14% of turnover respectively (12).
German Vel�squez, Sara Bennett and Jonathan Quick, who have been
studying health care systems for the WHO for a long time, say that,
unlike the rest of health care, the pharmaceuticals sector is
experiencing serious problems owing to the lack of competition (13).
This has an effect on prices. In fact two thirds of the world market
are in the hands of about 20 large groups. And concentration is
proceeding apace, as evidenced by the merger of HMR and Rh�ne
Poulenc, or the current link-up between Swit- zerland's Novartis and
US giant Monsanto. Of the 25 drugs most widely sold, 20 are
American. There is more or less a single world price, based on those
charged in the US, which are among the highest in the world. Some,
like Dr P�coul, propose that a tax should therefore be levied on the
phar- maceuticals companies' profits, the proceeds of which would go
into a fund to pay for research into tropical diseases and the
production of essential medicines.
Research hampered by patents
While the pharmaceuticals groups carry a tremendous responsibility,
inter- national organisations and governments must not be let off the
hook. France, at least, has shown some signs of action: it has taken
part in the United Nations Programme on HIV/Aids (UNAids); it was
behind the creation of the International Therapeutic Solidarity
Fund, which has brought a lot of hope to the poorer countries. But
these programmes have come to a standstill. France has thrown in the
towel, Europe is doing noth- ing and the US refuses to take part in
most collective actions of any size.
For its part the WHO is now supporting countries making use of
"compulsory licences", but it is still far behind what is needed. It
remains prisoner to an opaque method of operating and an outdated
view of its role. This hampers its ability to innovate and formulate
new objectives for world health. Of course the lack of funding is
just as crucial. But it would be possible to design emergency
programmes making drugs available to health care professionals in
the poor countries at cost price or less. The difference would be
paid by the pharmaceuticals companies, the governments of the
countries concerned and by the developed countries. After all, such
a model was adopted in the 1950s and 1960s to fight smallpox, which
has been eradicated since 1977.
"Financial prudence is not the real enemy," Nobel Prize-winning
economist Amartya Sen explains, but "the use of public resources for
purposes where the social benefits are very far from clear, such as
the massive expenses that now go into the military in one poor
country after another. It is an indi- cation of the topsy-turvy world
in which we live that the doctor, the schoolteacher or the nurse
feels more threatened by financial conservatism than does the
general and the air marshall" (14). And he adds: "the price of
inaction and apathy can be illness and death".
* Journalist
(1) Bernard P�coul, Pierre Chirac, Patrice Trouille, Jacques Pinel, "Access
To Essential Drugs In Poor Countries. A Lost Battle?", Journal of the
American Medical Association, Chicago, vol. 281, 27 January 1997. See
also the dossier in the journal Messages, no. 102, January-February 1999,
published by M�decins sans fronti�res, 16 rue Saint Sabin, 75011 Paris.
http//www.msf.org/
(2) Figures provided by the WHO. Note that 98.8% of victims live in third
world countries.
(3) Dr Gro Harlem Brundtland, statement to the 52nd world health assem-
bly, "Looking ahead for WHO after a year of change", World Health Re-
port, WHO, Geneva, March 1999.
(4) "Intensifying action against HIV/AIDS in Africa", World Bank - Africa
Region, Geneva, June 1999.
(5) See Le Monde diplomatique, November 1999. See also Andr� Ferron,
Philippe Herzog, Bernard Marx, "Pour un contr�le social du cycle du
Mill�naire � l'OMC", L'Option de Confrontations, Montreuil, November
1999.
(6) Spain did not fully recognise the patenting system for drugs until 1992,
Canada in 1993.
(7) Quoted by Mike McKee, "Tripping over Trips", IP Magazine, San
Francisco, September 1999. http://www.ipmag.com/
(8) Jean-Jacques Cristofari, "Facettes indiennes aux 23,700 firmes pharma-
ceutiques", Pharmaceutiques, Paris, no. 53, January 1998.
(9) Jean-Paul Mar�chal, "Making merchandise of biodiversity", Le Monde
diplomatique, English edition, July 1999.
(10) Axel Kahn, Et l'homme dans tout cela, NIL, Paris, to be published in
February 2000.
(11) See The Guardian, London, 15 December 1999.
(12) "L'industrie pharmaceutique: r�alit�s �conomiques 1999", document
published by the Syndicat national de l'industrie pharmaceutique (SNIP),
88 rue de la Faisanderie, Paris.
(13) German Vel�squez, Sarah Bennett and Jonathan D. Quick, "R�les des
secteurs public et priv� dans le domaine pharmaceutique. Incidences sur
l'�quit� en mati�re d'acc�s et sur l'usage rationnel des m�dicaments", WHO,
Geneva, 1997.
(14) Amartya Sen, "Health and development", keynote address to the 52nd
world health assembly, Geneva, May 1999.
Translated by Malcolm Greenwood