[Pharm-policy] APARTHEID OF PHARMACOLOGY - Le Monde diplomatique (fwd)

[Robert Weissman]

Le Monde diplomatique =09=09=09=09        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=
=20
than help, in their determination to protect their patents, the
pharmaceutical=20
laboratories are putting treatment beyond the reach of the poorest patients=
=20
and countries.

=09by 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=
=20
treatment, eflornithine (Ornidyl), developed by the American firm Merell=20
Dow in 1985. Costing a small fortune, it was beyond the reach of those=20
most seriously affected and was subsequently abandoned. Having=20
"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.=20
After three years of talks, the French humanitarian agency M=E9decins sans=
=20
fronti=E8res (MSF), together with other non-governmental organisations, is=
=20
hoping that the product will be available, in some places at least, at the
very=20
start of this year. But if it is to continue to be available, a sponsor
will have=20
to be found. Microsoft Chairman Bill Gates is a possible candidate.=20

The remedy for bacterial meningitis, which is particularly prevalent in the=
=20
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=
=20
1995 Roussel Uclaf (which merged with the Hoechst group in 1997 to=20
form HMR) stopped making it. Initially, the International Development As-
sociation got it transferred to a laboratory in Malta. But now the money ha=
s=20
run out.

The molecule to treat leishmaniosis, a common parasitic disease in Africa=
=20
resulting in very severe skin lesions or death, is no more profitable. It
exists=20
in the laboratory, but has not gone into production because there is no gua=
r-
antee of a "return on the investment". The list of molecules discovered but=
=20
which got no further than the laboratory and of useful medicines abandoned=
=20
is a long one. Dr Bernard P=E9coul, MSF's drugs project coordinator, notes=
=20
that, of 1,223 molecules placed on the market between 1975 and 1997,=20
only 13 are aimed specifically at tropical diseases. And only five are the=
=20
outcome of veterinary research (1).

Now that many diseases, such as malaria, sleeping sickness or tuberculosis,=
=20
that had been thought to have been conquered are coming back in force,=20
more virulent than before, the old medicines are no longer always effective=
,=20
since more and more bacilli are showing multiple resistance, whilst the cos=
t=20
of new remedies is exorbitant. As a result, no serious research is being ca=
r-
ried out into a vaccine to replace the good old BCG, even though eight=20
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=
=20
400,000, way below the threshold required to launch an investment.=20
Somewhere in the world, someone is dying of tuberculosis every ten sec-
onds (2).=20

For a medicine to be produced commercially, not only does it need a large=
=20
market (three quarters of the population), but it must also make money. A=
=20
lot of money. As quickly as possible. As World Health Organisation=20
(WHO) Director General Dr Gro Harlem Brundtland herself says, "More=20
than a billion fellow human beings have been left behind in the health=20
revolution" (3).

In fact four fifths of world health expenditure goes on one fifth of the
world=20
population. While drug sales in North America and, to a lesser extent,=20
Europe, mushroomed between 1993 and 1999, in the countries of Africa=20
and Asia (excluding Japan) they declined (see chart). In the case of Aids,=
=20
the picture is even more devastating: 92% of the world population have to=
=20
make do with only 8% of total expenditure.

"If the rich countries do nothing," Professor Fran=E7ois Bricaire, head of =
the=20
parasitology and tropical diseases department of the Piti=E9-Salp=EAtri=E8r=
e=20
Hospital in Paris, warns, "this human imbalance will result in an explosion=
=2E=20
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." F=
or=20
example, triple therapy (the combination of three types of antiretroviral=
=20
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=20
pay for their treatment," Professor Bricaire adds. "We get them back on=20
their feet knowing full well that most of them will not be able to afford t=
o=20
continue their treatment once they return home. And then there are those=20
who arrive illegally. We cannot just abandon them to their fate, so we=20
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=20
will soon exceed the 20 million victims of the plague that ravaged Europe=
=20
between 1347 and 1351 (4). With the simple difference that in those days=20
they did not know how to handle the crisis. Today science is capable of=20
dealing with epidemics. Many try to conceal this reality by highlighting th=
e=20
lack of a reliable health infrastructure in those countries.=20

They say that some long-term treatments like triple therapies against Aids=
=20
would be impossible there, or even dangerous. The obstacles are real=20
enough: in some countries, wars and population movements have destroyed=20
the health care system; in others, the policies imposed by the Internationa=
l=20
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=
=20
structures turning down emergency programmes on the strength of those=20
systems' very shortcomings. Not only could health care networks be rebuilt,=
=20
but there are already premises and staff (local and expatriate doctors and=
=20
nurses) qualified to treat conventional infectious diseases and start long-
term treatments for Aids. Provided they have access to the latest medicines=
=20
at affordable prices.=20

The pharmaceutical industry does not seem to be about to turn over a new=20
leaf. National Pharmaceutical Industry Association director-general Ber-
nard Lemoine does not hide his annoyance at the campaign being waged on=20
this issue. He stresses the positive things being done by the laboratories:=
=20
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=20
Renault to give cars to people who haven't got one." But that is just it:=
=20
drugs are not everyday products.

Not only do the pharmaceuticals companies set their own prices and select=
=20
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,=
=20
fluconazole, to treat cryptococcal meningitis, a fatal disease often associ=
-
ated with Aids; it was manufactured locally by the American laboratory=20
Pfizer under the name Triflucan. It was effective, but extremely expensive:=
=20
12,000 bahts (around $330) for a pack of 50 tablets. For a patient starting=
=20
treatment, that meant a monthly outlay of 15,000 bahts, one and a half=20
times an executive's salary. Finally, two Thai companies managed to put on=
=20
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.=
=20
Six months later sales were banned: alerted by Pfizer, the United States=20
government had threatened the Thai authorities that it would impose a duty=
=20
on their main exports (timber, jewellery, microprocessors) if they did not=
=20
stop making fluconazole.

South Africa almost suffered the same fate. In 1997 the government passed=
=20
some health laws allowing local firms to produce treatments for Aids or to=
=20
import them bypassing the big corporations' patents. At once the big=20
American pharmaceutical companies, some of which have subsidiaries in=20
the Cape, complained, then pressed their government to take reprisals of=20
the same kind as inflicted on Thailand. Vice-president Al Gore, head of the=
=20
US-South Africa Binational Commission, took the matter in hand himself.

As soon as the confrontation began, the Aids organisations (Act Up-New=20
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=20
public meeting for the presidential election without being questioned on th=
e=20
subject. This campaign, coupled with the South African government's te-
nacity, resulted in the Clinton administration abandoning all proceedings=
=20
and retaliatory measures in September. The laboratories rushed to withdraw=
=20
their complaints. True, it will probably be some time before South Africa=
=20
produces its first generic medicine, but the first battle has been won.=20

To measure the scale of the victory, we must look at the changes made to=20
the world trade rules since the World Trade Organisation (WTO) was set=20
up (5). Up until 1994 every country was free to make its own health policy=
=20
and produce generic medicines without waiting for the patent to fall into=
=20
the public domain. India, Egypt and Argentina, for example, were able to=20
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=20
Trips agreements on trade-related aspects of intellectual property rights.=
=20
Under this agreement it is, in general, no longer possible to manufacture a=
=20
drug or buy it abroad without the permission (granted in return for payment=
=20
of royalties) of the owner of the invention, who holds this power for 20=20
years. As a result of pressure from countries like Spain and Canada (6),=20
however, the Trips do contain exception clauses: in the event of a medical=
=20
emergency or hindrances to competition (inventor's refusal to sell or exces=
-
sively high prices), every government is entitled to have recourse to=20
"compulsory licences" and parallel imports. Compulsory licences allow a=20
product to be manufactured without the inventor's consent, while parallel=
=20
imports allow it to be bought wherever it is sold the cheapest.=20

South Africa, where according to the WHO one adult in six is seropositive,=
=20
is an obvious case of medical emergency. The big pharmaceuticals corpo-
rations know that. But, as Pharmaceutical Research and Manufacturers of=20
America (PhRMA) spokesman Jeffrey Trewhitt bitterly comments, these=20
South African laws "could set a very, very bad precedent that could un-
dermine legitimate patent protection around the world. The potential harm=
=20
from these recent developments can be expected to reach into many other=20
developing countries" (7).

Furthermore, all the emergent nations are subject to unbelievable pressures=
=2E=20
Under WTO rules, India, where only one third of the population has access=
=20
to drugs, should abandon price controls and the production of generic=20
medicines. It is easy to see that this would result in small firms closing=
=20
down and even fewer people having access to medical care. Yet the indus-
try journal Pharmaceutiques says that "the reforms and the liberalisation=
=20
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 agreement=
s.=20
But we already know the damage that was caused when the countries of=20
Latin America were forced to deregulate in 1988. According to the WHO,=20
drug prices escalated by 44% in Mexico, 24% in Brazil and 16.6% in Ar-
gentina in the space of four years.=20

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=20
countries, since knowledge of their genomes is one of the keys to future=20
medicines. In other words, they want complete control over the raw mate-
rials and ever tighter protection for the discoveries made from those plant=
s,=20
making them inaccessible to the countries they came from (9).

In addition patents are being filed further and further upstream, which, Pr=
o-
fessor Axel Kahn, former chairman of the French National Consultative=20
Committee on Ethics, explains, is "a considerable handicap on freedom to=20
create". Until recently, he argues, "a distinction was made between knowl-
edge that is discovered and belongs to us all and products or processes tha=
t=20
are invented and can be patented" (10). Protecting earlier reduces the scop=
e=20
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=
=20
for than is freely accessible in the public domain. As a result, a number o=
f=20
American doctors and researchers say in an open letter, the use of patents=
=20
or the exorbitant cost of licences to prevent doctors and medical laborato-
ries from conducting genetic tests is restricting access to care, lowering
its=20
quality and pushing up costs unreasonably (11).=20

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 gre=
at=20
danger that the rich countries will officially become a technological and f=
i-
nancial directorate, a sort of "G8" for drugs, deciding everything, from th=
e=20
level of research to whether or not a particular product will be launched.=
=20
That would make the imbalances even worse: the developed countries, with=20
plenty of money to spend, would have the latest treatments, very expensive=
=20
and protected by intellectual property rights. The others could benefit fro=
m=20
them when the patent rights were exhausted - 20 years and several hundred=
=20
thousand deaths later.

Non-governmental organisations, associations of people suffering from=20
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=
=20
the millennium round talks. This basic minimum could, MSF suggests, give=20
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=20
would be perfectly sensible to decide that human genome and biodiversity=20
research should be "global public goods". Monuments like the Angkor Wat=20
temple or cities such as Venice are considered part of human heritage. Why=
=20
not human genetics? Likewise, a stop must be put to the plundering of the=
=20
third world: not only should a fee be paid for using plants originating in=
=20
those countries, but they should all be guaranteed the benefit of treatment=
s=20
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=
=20
drugs accessible without jeopardising the financial health of the pharma-
ceuticals corporations: those based in France, for example, spend nearly as=
=20
much on advertising and promotion as on research: 11.3% as against 14%=20
of turnover respectively (12).

German Vel=E1squez, Sara Bennett and Jonathan Quick, who have been=20
studying health care systems for the WHO for a long time, say that, unlike=
=20
the rest of health care, the pharmaceuticals sector is experiencing serious=
=20
problems owing to the lack of competition (13). This has an effect on=20
prices. In fact two thirds of the world market are in the hands of about 20=
=20
large groups. And concentration is proceeding apace, as evidenced by the=20
merger of HMR and Rh=F4ne Poulenc, or the current link-up between Swit-
zerland's Novartis and US giant Monsanto. Of the 25 drugs most widely=20
sold, 20 are American. There is more or less a single world price, based on=
=20
those charged in the US, which are among the highest in the world. Some,=20
like Dr P=E9coul, propose that a tax should therefore be levied on the phar=
-
maceuticals companies' profits, the proceeds of which would go into a fund=
=20
to pay for research into tropical diseases and the production of essential=
=20
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.=20
France, at least, has shown some signs of action: it has taken part in the=
=20
United Nations Programme on HIV/Aids (UNAids); it was behind the=20
creation of the International Therapeutic Solidarity Fund, which has=20
brought a lot of hope to the poorer countries. But these programmes have=20
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=20
"compulsory licences", but it is still far behind what is needed. It remain=
s=20
prisoner to an opaque method of operating and an outdated view of its role.=
=20
This hampers its ability to innovate and formulate new objectives for world=
=20
health. Of course the lack of funding is just as crucial. But it would be=
=20
possible to design emergency programmes making drugs available to health=20
care professionals in the poor countries at cost price or less. The
difference=20
would be paid by the pharmaceuticals companies, the governments of the=20
countries concerned and by the developed countries. After all, such a model=
=20
was adopted in the 1950s and 1960s to fight smallpox, which has been=20
eradicated since 1977.

"Financial prudence is not the real enemy," Nobel Prize-winning economist=
=20
Amartya Sen explains, but "the use of public resources for purposes where=
=20
the social benefits are very far from clear, such as the massive expenses=
=20
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=20
schoolteacher or the nurse feels more threatened by financial conservatism=
=20
than does the general and the air marshall" (14). And he adds: "the price o=
f=20
inaction and apathy can be illness and death".

* Journalist

(1) Bernard P=E9coul, Pierre Chirac, Patrice Trouille, Jacques Pinel, "Acce=
ss=20
To Essential Drugs In Poor Countries. A Lost Battle?", Journal of the=20
American Medical Association, Chicago, vol. 281, 27 January 1997. See=20
also the dossier in the journal Messages, no. 102, January-February 1999,=
=20
published by M=E9decins sans fronti=E8res, 16 rue Saint Sabin, 75011 Paris.=
=20
http//www.msf.org/

(2) Figures provided by the WHO. Note that 98.8% of victims live in third=
=20
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=
=20
Region, Geneva, June 1999.

(5) See Le Monde diplomatique, November 1999. See also Andr=E9 Ferron,=20
Philippe Herzog, Bernard Marx, "Pour un contr=F4le social du cycle du=20
Mill=E9naire =E0 l'OMC", L'Option de Confrontations, Montreuil, November=20
1999.

(6) Spain did not fully recognise the patenting system for drugs until 1992=
,=20
Canada in 1993.

(7) Quoted by Mike McKee, "Tripping over Trips", IP Magazine, San=20
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=E9chal, "Making merchandise of biodiversity", Le Monde=20
diplomatique, English edition, July 1999.

(10) Axel Kahn, Et l'homme dans tout cela, NIL, Paris, to be published in=
=20
February 2000.

(11) See The Guardian, London, 15 December 1999.

(12) "L'industrie pharmaceutique: r=E9alit=E9s =E9conomiques 1999", documen=
t=20
published by the Syndicat national de l'industrie pharmaceutique (SNIP),=20
88 rue de la Faisanderie, Paris.

(13) German Vel=E1squez, Sarah Bennett and Jonathan D. Quick, "R=F4les des=
=20
secteurs public et priv=E9 dans le domaine pharmaceutique. Incidences sur=
=20
l'=E9quit=E9 en mati=E8re d'acc=E8s et sur l'usage rationnel des m=E9dicame=
nts", WHO,=20
Geneva, 1997.

(14) Amartya Sen, "Health and development", keynote address to the 52nd=20
world health assembly, Geneva, May 1999.

                          Translated by Malcolm Greenwood