NTNU har uttalt seg positivt om EUs patentdirektiv. I høringsuttalelsen sies det bla.:
«[
] det er ingen motsetning
mellom at bioteknologisk forskning
har en markedsverdi, og at den er
samfunnsnyttig. Det er snarere en
sammenheng.»
Uttallelsen ble som nevnt, se
http://www.itk.ntnu.no/ansatte/Andresen_Trond/n-d/nye/0167.html
ikke behandlet i kollegiet, men ble satt bort til noen av NTNUs professorer i
bioteknologi.
Vedlagte klipp fra Le Monde Diplomatique skulle illustrere at det på langt nær
er så enkelt som skissert i det naive ("ingen motsetning") sitat ovenfor.
Trond Andresen
*******************************************************
DEFINING THE WORLD'S PUBLIC PROPERTY
Le Monde diplomatique
January 2000
A GLOBAL PUBLIC GOOD
Who does knowledge belong to? When intellectual property increases the
price of vital drugs ten fold, sentencing millions of sick Africans to
death, this is not just a hypothetical question. The future of the world
economy and of part of humanity now hangs on the answer. Computing,
agro-industry, biotechnology, pharmaceuticals and communications lead the
way in the "information revolution". The rise of these activities has
brought with it an ever greater need for a check to be kept on new
inventions. If such a virtual product as knowledge, which is by nature
copiable, is to be turned to profit, its dissemination must be controlled
and an artificial scarcity created that allows a price to be set. Such is
the primary objective of intellectual property law, together with a
concern to protect the "moral" rights of authors over the future of their
works (literary and artistic property), to protect the consumer (trade
marks) or to limit recourse to industrial secrecy by publishing the detail
of inventions (patents).
In an attempt to keep pace with these developments, following the trend in
the United States the World Trade Organisation and the World Intellectual
Property Organisation have launched themselves into a frenzy of legal
activity to "strengthen" the rights of owners in order to ensure they get
a return on their investment and thereby, in theory, stimulate world
growth.
But a number of factors stand in the way of this. First, as the United
Nations Development Programme points out, many of today's developed
nations which are so keen to see intellectual property rights strengthened
had very vague rules when their own national industries were being built.
They only changed their tune when they became exporters of technology. By
amassing intellectual property rights over the whole of knowledge (from
photographic archives to the human genome, from software to drugs), the
richest countries, which are also the ones with the most highly developed
legal systems (the US employs one third of the world's lawyers) are making
sure they have control over vast swathes of future output.
Secondly, the appropriation of knowledge by private firms is not always
legitimate. Both technological research and cultural production feed
primarily on knowledge shared by the whole of society. But there are for
the most part no mechanisms for promoting and defending the public domain
of knowledge, little thought having been given to what might be called
"global public goods" (1).
Current thinking about the ownership of this common wealth of humanity is
embryonic. The American lawyer James Boyle compares it to 1950s thinking
on the environment: a few commentators are sounding the alarm about
particular issues but are not yet in a position to make a connection
between them (2). But the matter needs to be discussed urgently if we are
to put a stop to the sequestration of knowledge by private interests (see
articles by Philippe Queau and Martine Bulard).
(1) Inge Kaul, Isabelle Grunberg, Marc A. Stern (ed.), Global Public
Goods: International Cooperation in the 21st Century, UNDP - Oxford
University Press, New York and Oxford, 1999.
(2) James Boyle, "A Politics of Intellectual Property: Environmentalism
for the Net?", http://www.wcl.american.edu/pub/faculty/boyle/
***************
DEFINING THE WORLD'S PUBLIC PROPERTY
by MARTINE BULARD * Journalist
Apartheid of pharmacology
Twenty-two million people in Africa are seropositive - 65% of all the
people infected with the Aids virus world wide. South Africa, which is
particularly 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.
Sleeping sickness, which is transmitted by the tsetse fly, is making a
comeback, 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 Roussel
has finally agreed to transfer marketing rights to the World Health
Organisation (WHO). But the WHO lacks the resources to manufacture it.
After three years of talks, the French humanitarian agency Medecins sans
frontires (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
chloramphenicol 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 Association 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 guarantee 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 Pecoul, 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 carried 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 patients - 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 seconds (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 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. 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 Franois Bricaire, head of
the parasitology and tropical diseases department of the Pitie-Salpetriere
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 disease 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 virtually 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 requiring 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
Bernard 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 foundations. But his conclusion is nevertheless final: "I don't
see why special effort 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
outside initiative. Before the first half of 1998 Thailand had only one
drug, fluconazole, to treat cryptococcal meningitis, a fatal disease often
associated 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 expensive 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 Technology
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
tenacity, 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
industry.
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 excessively 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
corporations 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
undermine 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
industry journal Pharmaceutiques says that "the reforms and the
liberalisation that are under way are opening up new prospects for
pharmaceutical laboratories" (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 Argentina in the space of four years.
But the pharmaceutical lobbies are hoping to use the WTO to get all
exceptions to patent rights abolished. At the same time, they want greater
access, 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 materials 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,
Professor 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
knowledge 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 information 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 laboratories 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 monopoly
on life and have seized control of genetic diversity. There is a great
danger that the rich countries will officially become a technological and
financial 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
dangers. If they differ on strategy, all are agreed that at the very least
the exceptions 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 exception". 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
devastating the peoples of the poor countries? Prices could be cut quickly
to make drugs accessible without jeopardising the financial health of the
pharmaceuticals 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 Velasquez, 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 Rhone Poulenc, or the current link-up between
Switzerland'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 Pecoul, propose that a tax should therefore be levied on the
pharmaceuticals 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,
international 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 nothing 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
indication 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".
****
(1) Bernard Pecoul, 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 Medecins sans frontieres, 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 assembly,
"Looking ahead for WHO after a year of change", World Health Report, 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 Andre Ferron,
Philippe Herzog, Bernard Marx, "Pour un controle social du cycle du
Millenaire 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
pharmaceutiques", Pharmaceutiques, Paris, no. 53, January 1998.
(9) Jean-Paul Marechal, "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: realites economiques 1999", document
published by the Syndicat national de l'industrie pharmaceutique (SNIP),
88 rue de la Faisanderie, Paris.
(13) German Velasquez, Sarah Bennett and Jonathan D. Quick, "Rles des
secteurs public et prive dans le domaine pharmaceutique. Incidences sur
l'equite en matire d'accs et sur l'usage rationnel des medicaments", WHO,
Geneva, 1997.
(14) Amartya Sen, "Health and development", keynote address to the 52nd
world health assembly, Geneva, May 1999.
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