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INTERVENTION BY HIS EXCELLENCY MONS. DIARMUID MARTIN
TO
THE PLENARY COUNCIL OF THE WORLD TRADE
ORGANIZATION ON TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS*
Wednesday, 20 June 2001
INTELLECTUAL PROPERTY AND ACCESS TO BASIC MEDICINES
1. The AIDS crisis, together with the worrying return and
diffusion of older infectious diseases, such as malaria and tuberculosis,
constitutes a global disaster of dramatic magnitude. Most poor people
suffering from these diseases receive only very inadequate health care. In so
many of the poorest countries, lack of basic medicines together with poor
health infrastructures, prevents an appropriate response to urgent public
health needs. A heavy burden of disease has considerable negative effects on
economic development. A reduction in disease, on the other hand, promotes
human well-being, with a consequent improvement in the quality of those human
resources which are the essential driving force of the what should be the
fundamentally pro-development stance of the WTO.
2. The Holy See is aware that the availability of medicines is
not the only aspect of access to health. It is, however, an essential aspect.
Without access to essential medicine, there is no cure at all! Access to basic
medicines depends on a series of factors, such as efficient infrastructure and
logistics, informed drug choice and use, adequately controlled production,
research and development aimed at specific diseases. Accessible price,
however, always remains a determinant factor.
3. The high price of new drugs seems to be determined both by
the burden of research and development of the product itself and by the role
each medicine plays in the maintenance of a complex research and development
structure. It is not possible, however, ethically to justify a rationale of
fixing the highest possible prices in order to attract investors and to
maintain and strengthen research, while leaving aside consideration of
fundamental social factors. To condition the international reaction to any
other natural or human-made disaster (such as earthquakes, floods, accidents
or terrorism) on the victims being able to pay for the treatment and to
contribute to the research and development of new assistance devices, would
rightly be considered a crime.
4. The legal protection of Intellectual property, especially
through patents, gives to the patentees monopoly rights over the product or
process, during the patent life-span. Such a right may indeed allow a patentee
to produce and supply the product only when and where it is possible to
recover, through pricing policies, the costs of the investments contained in
its development, as well as the expected revenues, while disregarding those
who cannot afford the product prices. Within a open free trade system,
intellectual property rights constitute an exceptional monopoly regime. As an
exception within a legal regime, its use must be narrowly interpreted and must
take due account of and, where necessary be subordinated to, other important
principles. IP legal theory and practice have, in fact, created regimes, such
as compulsory licences, to curb social/patent abuses. Compulsory licenses have
thus been included in the TRIPS framework, to be used as remedies in
situations of national emergency or other circumstances of extreme urgency,
provided that such mandatory uses respect the rule of law and preserve some
essential rights of the patent owner.
5. It must, of course, be recognized that prices are not the
only component contributing to the lack of access to health, and that IP
protection is necessary for progress and for the just compensation of
researchers and producers. But in order to cope with a world health emergency,
IP regimes must be integrated into a broader framework. The unity of humankind
and the universality of human rights (among which the right to health)
requires that all the economic and political actors involved (international
organizations, governments, private foundations, corporations and NGOs) work
together, pooling their differentiated responsibility for resolving a global
crisis, leaving aside narrow individual or sectorial interest.
6. In the case of medicines, the supply stakeholders
(scientific institutions, pharmaceutical companies and the governments of
developed countries) should work together to ensure an adequate supply of
urgently needed drugs at prices adequate to the cost of living in a particular
country, especially LDCs or HIPCs countries. They should also be open and
flexible in an equitable manner to the granting of voluntary licenses for
import, production and distribution of basic drugs. They should not create
obstacles to national production of drugs in third countries; they should
where possible help them, rather, to develop such production in ways that are
consistent with their IP duties. Compulsory licenses and other safeguards, as
worded in TRIPS, should however be maintained, because they are a national
safeguard against eventual imperfections of the IP enforcement.
7. Full and efficient universal access to basic medicines will
most likely require the enactment of an innovative differential pricing
system, which can still preserve the incentive for future research and
development. Luxury and non essential pharmaceutical products, for
example, such as cosmetics, could well share a greater part of the
burden of research and development of essential medicines.
8. A broad-based commitment of solidarity is the best way
to prevent poor countries from falling into the temptation of weakening the
Intellectual Property rights framework.
9. The solution to the problem of access to basic medicines is
far beyond the mandate and the means of the Council for TRIPS. It is the
common responsibility of many other international organizations as well as
national governments, and in an appropriate manner also of the private sector.
However, the Council for TRIPS could make a fundamental contribution, by means
of an authoritative interpretation of the TRIPS rules,
- consistent with a unified vision of law,
- based on respect for human rights,
- and applying those articles of the WTO treaty that call for
a pro-development interpretation of the whole legal body.
10. Such a legal interpretation might affirm
- that any TRIPS clause should not be understood in a way that
becomes a practical obstacle to rapid, efficient and universal access to basic
medicines, for those who are the victims of the actual dramatic health
emergency, and
- that nothing in the TRIPS should prevent countries,
including small countries with limited domestic manufacturing ability, from
implementing sound health policies.
This would contribute to a broad and not restrictive
interpretation of articles 30 and 31, which allow that licensing fees may be
fixed in accordance with the real purchasing capacity of the poorest
countries, balanced with a system that blocks the re-exports of the licensed
products to the original markets.
11. The Holy See, consistent with the traditions of Catholic
social thought, underlines that there is a "social mortgage" on all
private property, namely, that the reason for the very existence the
institution of private property is to ensure that the basic needs of every man
and woman are met and sustained. This "social mortgage" on private
property must also be applied today to "intellectual property" and
to "knowledge" (John Paul II, Message to the "Jubilee 2000
Debt Campaign" Group, September 23, 1999). The law of profit alone
cannot be applied to that which is essential for the fight against hunger,
disease and poverty. Hence, whenever there is a conflict between property
rights, on the one hand, and fundamental human rights and concerns of the
common good, on the other, property rights should be moderated by an
appropriate authority, in order to achieve a just balance of rights.
*L'Osservatore Romano. Weekly Edition in English n.28 pp. 9, 10.
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