Marco Ricolfi


BIOETHICS MARKETS AND MORALS: THE CASE OF BIOTECHNOLOGICAL PATENTS



Footnotes
1. The field of moral reasoning, which usually is referred to as bioethics, is specifically linked with the kind of choices which have appropriately been characterized as tragic (1) to show that a conflict between ultimate values is involved in them. When one of the most authoritative scholars in the field (2) in recent times tried to give "a first account of the areas in which choices at the frontiers of life are made", he presented a catalogue which indeeed appears exemplary: "to procreate or not; to intervene on the procreative process or not; to be informed of one's own genetic characters or not; to extend the term of life or not; to live or to die". It is by no means a chance that around a list of this kind the structure of this conference has, so to say, shaped itself of its own accord.
In each of the areas encompassed, the conflict, it may be easily seen, concerns values or - in other terms - moral perspectives. Accordingly, it appears appropriate to speak about "moral dilemmas" whenever a choice has to be made between such values: e.g. in connection with the situations in which a child is claimed simultaneously by the "surrogate mother" and by the couple who has so to say "contracted" (3) for it, a choice between the "right to parenthood" of the couple and the "right to motherhood" of the surrogate mother or, in connection with terminal patients, between the professional duties of the phisician and the rules against the "unproportionate use of therapeutic means" (5).
I am not certain however that we are faced with a merely moral dilemma when we consider questions as the ones just referred to; and even more so, when we consider the range of problems which is linked to organ transplants. Even though one of the most adamant supporters of the liberalisation of the rules governing this area (6) has endeavoured to establish the exquisitely moral character of the dilemma, there is enough evidence to support the conclusion that, on the recipients' side, strong claims are made not only in the name of a value which is indeed embedded in the Western tradition, the "right to life", but also on behalf of well organized economic interests and well established markets (in the field of medical services and allied industries); and the significance of both for the debate cannot be neglected, except by those intellectul approaches which, under the cover of banning "ideology", may have chosen to jettison in bulk all the legacy of realistic thought.
What seems beyond dispute is, however, that there is at least a single area - the one concerning the question of patentability of life forms - in which the heart of the matter lies not at the "noble" level of the conflict between moral values but at the even more significant and dramatic, albeit "lower", level of a conflict between ethical imperatives on the one side and interests on the other, or, if one prefers, between morals and markets. In this case, we are faced with a specific problem: we have to seek a trade off between ultimate goals (values; moral perspectives) on the one side and a different goal, the quest for optimal allocation of resources in scientific and technologic innovation, on the other side, which surely is of paramount importance for our societies but clearly is only subordinate, in that allocative efficiency belongs to the realm of means and not of ends.
I shall try to outline the contours of this conflict; to set forth the legal techniques which are available to solve it and, finally, to examine the institutional background - under EEC law, Italian legislation being subject to it - against which the question has to be looked at.


2. - It is well known that in the last decades biotechnological research has proved remarkably successful in various directions and has been moving along lines foreshadowing advancements in the areas of genetic engineering in connection with plants, animals and man which seem very promising indeed. Virus resistant and insect repellent plant varieties have been developed (7); by appropriate genetic manipulation sheep have been turned into "animal factories" for the large scale production of an important chemical as human factor VIII (essential in the treatment of haemophilia) (8). In the human field biotechnology has enabled large scale production of insulin by means of RDNA, the preparation of interpherons against cancer and leukemia, of vaccines, of tissue plasminogen activator (TPA) against heart attacks; in recent times promising perspectives seem to have been opened up in the therapy of diseases like adenosin-deaminase (ADA) and perhaps also of sickle cells anemia, cystic fibrosis and muscular distrophy (9).
It is not difficult to single out the main actors of this extraordinary momentum in biotechnological advancement. Surely, public research institutions have not abdicated their pivotal role in basic research; but to a large extent a tight web of allegiances between the private sector and public research has dictated the timing and the priorities even of the latter (10). Therefore it might be accurate to say that, in this domain more than in others, it has been private businesses, both large and small, which dominated the process. In the agricultural field, while the role played by traditional plant breeders has been extremely limited, the leadership has passed into the hands of agro-chemical and veterinary firms (11); in the human field, multinational firms active in the chemical and pharmaceutical areas, along with a panoply of small but highly innovative firms, have taken the lead (12).
Private business as the ones just indicated have certainly not shied away from posing one of the most appropriate questions relating to any innovative process: what is the kind of legal protection available to those who obtain first access to a new technology? It is also hardly surprising that in the Western world and in Europe (13) the reply favoured by those asking the question has been found in the resort to the patent system, which, after all, is traditionally considered capable of providing an incentive to industrial research through the temporary monopoly afforded by patentee's exclusive rights.
However, the idea of extending patent protection to biotechnological innovation has immediately raised serious questions. As these fall into two categories, the one intrinsec to the logic of the patent monopoly, the other extrinsec to it, it appears advisable to keep them analytically separate.
For the present purpose, it appears sufficient to observe that the problems falling in the first category are rooted in the circumstance that the patent system originates from the mechanic field and, while it has adapted itself with some twists and turns to new areas as chemical and pharmaceutical innovation, it now seems to face greater difficulties when called to extend its reach to situations in which the protection should cover living and self reproducing matter (14).
The problems falling into the second category, which are directly relevant to the questions raised above, have to deal with the fact that the extension of patent monopoly to biotechnology may conflict with a) the preservation of biological and genetical diversity existing in nature; b) the need of greater fairness in the industry/agriculture and North/South relations; c) the right of the individual - and of the future generations - that human genetic characteristics are not tampered with.


3. - What are the forms taken by the conflict between patent protection of technology and the values and constrainst listed above?
A) The environmental balance of our planet is based on the preservation of genetic diversity in the vegetal field.
Such diversity has been kept through the centuries by agriculture and, more specifically, by local agricultural techniques employed in cloisterd areas in the Third world and by plant breeders. It is presently fostered by legislation on plant varieties protection (1961 UPOV Convention) which, in the effort of providing a protection mechanism compatible with the characters of living matter, grants a research exemption (15) and the right to protection to whomever may breed a new variety even though the same is obtained from matter for which another subject has obtained prior protection.
According to the views held by scholars with different academic backgrounds (16) and shared by environment protection groups (17), the extension of patent protection to biotechnology would increase the dependence of agriculture on chemical industry and would lead to a drastic erosion of genetic diversity. There is some empirical evidence confirming this alarming prospect: it may be easily proved that "the stock of vegetal species necessary to sustain genetic diversity decreases, as plant varities marketed by multinationals replace, in ever increasing lots of land, local cultivars of undeveloped countries and thereby homogeneize the genetic characters of harvests" (18); and it is easy to see how such homogeneity of the harvests enhances their "vulnerability to parassytes and pathogens" (19): it is well known that bio-diversity is a form of self-insurance against epidemics and famine.
More arduous it may seem to explain why access to patenting for genetic engineering relating to plants should increase the dependence of agricolture on chemical industry and thereby contribute to the erosion of bio-diversity. In this regard, some characters of the patent system should be considered: for patent purposes, it is sufficient that one character of a certain seed or seed group is transformed by chemical or genetic means for the patent monopoly to extend to the altered seed at large and its offspring (20). In turn, in its present form the patent system does not provide for a mechanism equivalent to the research exemption afforded by the UPOV Convention in connection with those situations in which the new plant variety is generated on the basis of a patented plant or seed instead of a plant variety protected under UPOV. Therefore, resort to patent protection may prevent plant breeders, who are believed to give a substantial contribution to bio-diversity through their cross-breeding efforts (21), from marketing their new varieties unless consent by patent holders in the originating variety is obtained - which, it is submitted, is not forthcoming short of the payment of possibly substantial licensig fees or royalties.
B) The extension of the patent mechanism might well lead to an additional form of "unequal exchange" between the North and the South of the world.
A moment ago reference was made to genetic engineering carried out in connection with seeds or plants. It should now be added that usually the process entails insertion of genes obtained by biotechnological research onto spontaneous germoplasm or, in other words, vegetal species preserved in their pristine forms by the most backward and sheltered agricultural systems. Presently no constraint is foreseen on the free use of preserved germoplasm. Therefore, a situation may arise in which, while Third World countries have no way to oppose the free exploitation by the rest of the world economy of the germoplasm preserved by them, its patenting in a genetically modified form gives birth to a monopoly which the patentee may enforce as a barrier against agricultural exports incorporating the patented characteristic even though they originate from the same Third world country which preserved the corresponding germoplasm. It is therefore hardly surprising that Third World countries, hit by a severe deterioration of the overall trading terms of their production (22), are considering to resort to germoplasm embargo (23). Such an adverse impact of the extension of patent protection to biotechnology on the terms of North/South trade is the ultimate outcome of a mechanism whereby the protection available to patentees concerns not only propagating material (seeds, genes) but also the products deriving therefrom (24), including - according to the provisions of draft legislation pending (25) - all subsequent generations of protected living matter.
C) Genetic engineering relating to germ cells not only affects the individual concerned but also his (or her) offspring; its patenting risks therefore to collide with the - individual and collective - right to freedom from genetic manipulation (26).



4. - When we rest for a moment to consider the kind of conflict arising in the above situations from the perspective of a purely ethical judgement, we cannot escape the conclusion that only one of the conflicting terms should prevail. While it is beyond dispute that there is a collective interest that biotechnological research is fostered and there may be a reasonable - albeit not unchallenged (27) - degree of consensus on the appropriateness of the patent monopoly to attain such a goal, there is no way to refute the argument that, at least for purposes of ethical reasoning - the underlying quest for optimal allocation of resources has a lower ranking than claims, as the ones referred to in lett. A) and C) above, which, according to an eminent scholar (28), belong to the third and fourth "generation" of fundamental rights and the value of distributive justice, as described in lett. B). In case of conflict, efficiency should give way to claims and values of such a standing.
To be sure, in connection with the area which I referred to under C) (patenting of genetic engineering on germ cells) there has been dispute both on the status of the claim to genetic integrity and on the very possibility that it may conflict with patent protection.
Is seems however that the argument that claims to genetic integrity may be waived by the free consent of interested parties (29) misses the point that intervention on germ cells affects not only the party directly concerned but also his (or her) offspring and, a fortiori, the future generations. In such a situation, it seems appropriate to doubt that decisions may be made by (present) political majorities (30), let alone by the immediately affected individuals.
The argument has also been put forward that patenting of genetic engineering relating to germ cells does not conflict with any value because it does not entail by itself authorisation to its actual use: after all, patenting of weapons is clearly admissible because the very limited circumstances in which they may be employed are painstakingly defined by law. It should nevertheless be noted that, while certainly there are instances in which resort to weapons may be legitimate (e.g.: use by police in given circumstances, self-defense and even hunting), no such exceptions are to be found in connection with manipulation of germ cells; and we cannot easily forget that a rule in favour of patenting would provoke a flow of financial resources in the field of research on genetic engineering relating to germ cells large enough to ultimately endanger the preservation of prohibitions to its use.
It seems therefore reasonable to stick to the conclusions previously reached on both counts. However, it is apparent that the legislative process leads to an outcome at variance with the choices mandated by ethical reasoning: in short market interests systematically prevail over moral values.
This result is hardly surprising in the European matrix: except in exceptional cases - which may present themselves when extraordinary mobilisations transform values into interests (31) - a legislative process which confers law-making powers on executive bodies like the EEC Commission and the Council and marginalizes the Parliament, the reasons of power are bound to prevail over the powers of reason.



5. - In making the last point, I do not want to suggest that ethical reasoning is of no relevance in this field. On the contrary, the question of the patenting of biotechnology seems to hold in store a wider lesson concerning the difficulties to be found when a coordination between markets and morals is attempted. It seems that, when the ones conflict with the others, it is not enough to show that the moral principles invoked are valid (are rationally founded) and overriding (have an axiologic priority ove the market interests) but an additional step is to be made, to prove that the relevant principles are implemented through the choice of the one alternative among all theoretically possible competing approaches which minimizes the potential for adverse impact on efficiency (32).
How can such a condition be satisfied? In principle, this may happen to the extent the values referred above under letters A), B) and C) are implemented through means consistent with market mechanisms and specifically with the functioning of the patent system.
The task thus set is to show in detail which particular solutions may satisfy the criterion just set forth in each of the conflict areas previously described.




6. - A first step towards the setting up of rules favouring the preservation of bio-diversity (lett. A above) may be made by establishing a legal license mechanism in favor of any party who may wish to incorporate a biotechnological patent into a new vegetal variety. The corresponding rule may have a positive impact on bio-diversity in that it plays a role similar to the research exemption in the UPOV system and avoids that plant breeders who contribute to biodiversity by creating new plant varieties are placed at the mercy of holders of blocking biotechnological patents. To achieve this aim, the rule enables plant breeders to incorporate a biotechnological invention into their (new) varieties even before obtaining the patent holder's consent, provided they pay the latter a royalty at a rate set by legislation and proportional to the end-sale price of the patent incorporating plants or seeds. While the corresponding amount may be easily transferred forward by the well known cost-translation mechanisms (33), the flow of remuneration to patentees thus generated would at the same time provide a reasonable reward for biotechnological research. It has to be stressed, however, that this kind of outcome may be obtained only through a genuine legal license (34), as the same entails that the need for patentee's authorisation to plant breeders is replaced by payment of the flat royalty rate. This purpose is not achieved, on the contrary, by the compulsory license provisions of the present text of the draft directive (35), as past experience shows that this latter mechanism is of no practical avail (36) as its smooth functioning rests on the heroic assumption that the parties be in principle prepared to reach an agreement on the terms and conditions (including royalty rate) of the license.



7. - If we pass to consider the questions connected with biotechnolgy patents' impact on North/South "unequal exchange" (lett. B above), we must at the onset note that problems of this import may not be dealt with by simple adjustments of characters and scope of patent protection. However, a few steps in the right direction may be made also in this very limited perspective. If we consider that in this connection the aim is to prevent that patents are exploited to build additional artificial barriers to the flow of trade originating from Third World countries, we readily realize that a few rules may be fashioned to approach this goal. First of all, the rules concerning the exaustion of the patent right should clarify that patent monopoly does not extend to those generations of living matter which do not keep the essential characters for which patent protection was granted in the first place. Additionally, an extension by international Treaty of the legal license mechanism - as described in the previous paragraph - from the EEC level to plant varities originating from Third world countries would certainly contribute to keeping the gates open to agricultural trade. Solutions of this kind are certainly tentative and of low profile. They certainly must be supplemented by a comprehensive array of additional measures of Third World countries, which supply germoplasm free of charge to the rest of humankind. Such measures are currently being debated at international level. Moreover, the steps I just described seem to me to be mandated by the Rio de Janeiro Convention and specifically by the third and fifth section of art. 16 (37). The first provision establishes that developing countries which "supply genetic resources" should have "access to technology intended for the exploitation of said resources... including patented technology"; the second is intended to prevent that patents may be used to create "obstacles to the achievment of the objectives of the Convention" including, per art. 1, "the fair and equitable apportionment of the advantages flowing from the exploitation of genetic resources". I should add that failure to adopt corresponding measures - including the first steps I described above - would not just mean an obtuse entrenchement in the present status quo but would amount to behaviour warranting resort to germoplasm embargo by Third World countries under Sec. 4 of Art. 21 of the Convention itself.



8. A straightforward and clearcut solution seems appropriate in connection with the questions above indicated under lett. C). In this regard, it should be provided that: "Inventions relating to human germ cells, genetic engineering processes relating thereto and any and all kinds of means whereby genetic identity of future generations may be altered are not patentable". Such a rule entails an absolute and unconditional ban on patenting of any form of genetic engineering relating to germ cells. In this regard, the argument - underlying the text accepted by a Resolution of the European Parliament (38) - whereby patentability should be admitted when genetic engineering, albeit concerning germ cells, has therapeutic aims and respects human dignity (39), seems unsound: threading on the downward slope of "therapeutic" aims we are bound to meet, sooner or later, the sinister claims of "enhancement engineering" (e.g. in the so called "cure" of depressions) which ring an ominous bell to those who believe in liberal values.



9. - We are now in a position to perceive that in pursuing goals which go beyond allocative efficiency the alternatives selected appear, on each of the counts considered, consistent with the basic features of the market oriented patent law system. It is true that in some instances the rules have been fashioned after the example set by the UPOV Convention: but this approach, which certainly is appropriate when protection concerns living - as opposed to inanimate - matter, also leads to provisions (relating to legal licenses and exaustion) which are consistent with the patent law system and the doctrines which marked its evolution in the centuries. More specifically, both the provision of a legal license and the simultaneous resort to the same and to a re-definition of exaustion, while seem apt to strike a balance between the legitimate interest of the patent holders and collective goals as the preservation of bio-diversity and fairness in North-South exchange, are taken from the traditional tools to which intellectual protection has made resort when confronted with novel realities. In turn, the ban on patenting of genetic engineering relating to germ cells is not repugnant to a body of law which, in the area of patent protection, has recurrently incorporated significant limitations to patentability for reasons of public interest. It appears therefore that the proposals here put forward may be able to satisfy the requiremets set before and that, at least in the instance before us, nothing prevents that aims framed in terms of justice may be achieved through means which are compatible with the constrainsts posed by the search for efficiency. It might well be said that is is not impossible that the same set of rules is able to apportion different categories of public goods - here optimal allocation on the one side, environmental balance, distributive fairness and genetic integrity on the other side - in accordance with the logics which pertain to each of them (40).



10. - Normative approaches as the one here advocated are usually countered by the objection that they lead to forms of protection to inventors which are weaker than the ones presently afforded to technological advances by the North American and Japanese legal systems. A similar line of reasoning disregards that the boundaries of patent protection are quite uncertain also for the other legal systems and moreover ignores that increased protection at the EEC level would certainly benefit more American and Japanese firms than their European competitors (41). More to the point, it should be remebered that, in the area we are considering, the goal of legislation is not confined to creating a competitive advantage on behalf of European firms over their American and Japanese counterparts. Such a narrow approach would run counter the provisions of the Rome Treaty setting up the EEC, which provide that the aims of the Community include, inter alia, "a harmonious development of economic activities" and "an accelerated raising of the standard of living" (art. 2) and clarify that resort to competitive efficiency is but one of the means designed to reach those purposes (art. 3, lett. f). In this perspective, the task of EEC legislation is not just to engage in a sterile competitive race and to bring down our relevant rules to the level set by U.S. and Japanese standards but to use of all the imagination and of all the realism we are capable of in the search for solutions - as the ones here suggested - which may prove apt to combine fairness and efficiency while respecting the moral values underpinning our societies.



Footnotes (1) For the use of this terminology see G. CALABRESI and P. BOBBIT, Tragic choices, it. ed. Scelte tragiche, Giuffré, Milano, 1986
(2) S. RODOTA', Repertorio di fine secolo, Bari, 1992, 214. The chapter concerning bioethics is significantly devoted to "The frontiers of life" (p. 210 ff.).
(3) See, for Italy, Trib. Monza, October 27, 1989, in Foro It., 1990, I, 298 ff. and, for the U.S., New Jersey Court of Appeals, March 31, 1987 (in re Baby M.), in Foro It., 1988, IV, 97 and ff. with note by G. PONZANELLI, Il caso Baby M., la "surrogate mother" e il diritto italiano" and New Jersey Supreme Court, February 3, 1988 (in the matter of Baby M.), in Foro It., 1989, IV, 293 ff. with comments of G. PONZANELLI, Ancora sul caso Baby M.: l'illegittimità dei contratti di "sostituzione di maternità" and of R. CLARIZIA, Inseminazione artificiale, contratto di sostituzione di maternità, interesse del minore.
(4) I here use the word right in its wider (and, for those who reserve the term to the classic instances of jus perfectum, ambiguous) meaning, illustrated and discussed by N. BOBBIO, L'età dei diritti, Torino, 1990, XVI e segg.
(5) In the terminology adopted by the Sacra Congregazione per la dottrina della fede in its Dichiarazione sull'eutanasia of 1980. See also S. RODOTA', Repertorio, cit., 228 ff.
(6) H.T. ENGELHARDT Jr., Il corpo in vendita: dilemmi morali della secolarizzazione, in (a cura di S. RODOTA'), Questioni di bioetica, Bari, 1993, 123 ff.
(7) For a review of this kind innovation see A. ALBERTINI, Biotecnologie e paesi in via di sviluppo, in Questioni di bioetica, cit., 289 ff.
(8) R. WHAITE-N. JONES, Biotechnological Patents in Europe: The Draft Directive, in 5 EIPR, 1989, 145 ff. at 146.
(9) See Y. KO, An Economic Analyisis of Biotechnology Patent Protection, in 102 Yale L. J., 1992, 777 ff., at 783-4, where, at notes 46-8, additional references and R.M. HENIG, Gene Therapy: Medicine's New Frontier, in Dialogue, 1992, 51 ff.
(10) See, also for additional references, Y. KO, op. cit., 794 and n. 115 and, in a critical perspective, R.C. LEWONTIN, The Dream of the Human Genome, in New York Review of Books, May 28, 1992, 31 ff., at 38.
(11) According to A. ALBERTINI, op. cit., 299, "the twenty larger agrochemical and veterinary firms have invested in 1990 sums in the range of 300 million dollars in biotechnological R. & D.".
(12) See Y. KO, op. cit., 794-5 and n. 120.
(13) See the Joint Position adopted by the EEC Council concerning the Draft Directive on legal protection of biotechnological inventions issued on February 23, 1994.
(14) For an overview see also my paper La brevettabilità della materia vivente: fra mercato e nuovi diritti, in Giur. It., 1993, IV, 292 ff. and, with specific reference to patentability and infringement, Y. KO, op. cit.
(15) See art. 5 (3) of the UPOV Convention of 1961. The relevant rules have been modified in a more restrictive direction by art. 14 (5) of the new Convention signed on March 19, 1991.
(16) Among others J.J. HARDON, Industrial Patents, Plant Breeding and Genetic Resources: A Plant Breeder's View, in Patenting Life Forms in Europe, Proceedings of an International Conference at the European Parliament, Brussels, 7-8 February 1989, Barcelona, 1989, 34 ff.; P. KENNEDY, Preparing for the 21st Century: Winners and Losers, in New York Review of Books, February 11, 1993, 32 ff., at 42 and A. ALBERTINI, op. cit., 298 ff.
(17) See the positions expressed in this respect by H. HOBBELINK for the GRAIN group in European Parliament, Public Hearing on the Legal Protection of Biotechnological Inventions, May 11, 1990, PE 141.102 (55/89), 34 ff. and by the Genetics Forum in the brochure Patent Concern. Patenting of Plants and Animals, London, 1990, 3.
(18) A. ALBERTINI, op. cit., 299.
(19) Ibid..
(20) See G. GHIDINI-S. HASSAN, Biotecnologie, novità vegetali e brevetti, Milano, 1990.
(21) It should, however, be noted, that the views on the impact of plant breeders on biological diversity widely differ. According to the Report of the EEC Commission and to the statements of the AIPPI (in the Nouveeau Rapport revisé etabli par le Bureau del l'OMPI, Comité d'experts sur les inventions biotechnologiques et la proprieté industrielle. Quatrieme session, Geneve, October 24-28, 1988, Biot/CE/IV/2, 46), the research exemption might have an adverse impact as it is apt to divert plant breeders' investments towards small variations of preexisting plant stock and not towards true basic improvements.
An opposite opinion is expressed by AIPH (ivi, 49 e 65) as well as by R. WHAITE-N. JONES, op. cit., 145, 146.
(22) For some recent data see F. PRAUSSELLO, E' possibile un commercio "equo e solidale", in Il mulino, 1994, 125 ff., especially at 127 ff. and S. ZAMAGNI, Sviluppo, efficienza e solidarietà: per un mondo non ineguale, Il mulino, 1993, 394 ff. and the data and estimates at 399.
(23) A Report on Germoplasm Embargoes, Rural Advancement Fund International, 1988, quoted in Patent Concern, cit., 3 e 6. See also, in the same direction, J.P. CHIARADIA BOUSQUET, Plant Genetic Resources: Protection of Rights, in Patenting Life Forms, cit., specially at 47. Recent information on the subject are to be found in C. GRANDE, Variabilità genetica, Non rubare i semi d'altri: in pericolo troppe specie locali, in La Stampa, TuttoScienze, October 14, 1993, p. 3.
(24) As provided by patent law (see art. 1 of Royal decree n. 1127 of June 29, 1939 and subsequent amendments, as revised by Presidential decree n. 338 of June 22, 1979) but not by plant variety protection legislation (see art. 4 of Presidential decree n. 974 of August 12, 1974, as amended by Presidential decree n. 338 of June 22, 1979 and by Act n. 620 of October 14, 1985).
(25) Art. 10 of the Joint position.
(26) On this kind of issues see, in addition to the brief but remarkable notes by N. BOBBIO, L'età dei diritti, cit., XV, the outstanding pages by W. ROTHLEY, Report Problemi etici e giuridici della manipolazione genetica e della fecondazione artificiale umana, Parlamento Europeo, Commissione giuridica e per gli affari dei cittadini, Lussemburgo, 1990, 27 ff. specially at 36 ff. and S. RODOTA', Repertorio, cit., 223.
The final resolution of the fifth Conference on bioethic of the seven most industrialized countries (1988) states: "the delegates have established that at this stage there are neither medical grounds nor moral reasons which warrant intentional genetic manipulation of human germ cells".
In connection with the - indeed sinister - possibility of the pursuit of goals of "enhancement engineering" see R.M. HENNIG, op. cit., p. 54 and, in much stricter terms, F.D. BUSNELLI, Opzioni e principi normativi per una disciplina normativa delle biotecnologie avanzate, in Riv. crit. dir. priv., 1991, 283 ff. at 291-2.
Suggestions favourable to a more flexible approach in this regard are made by J. HARRIS, Regolazione bioetica e legge, in Questioni di bioetica, cit., 331, specially at 335 and by M. MORI, La "novità" della bioetica, ivi, 397 e segg. at 412.
(27) Indeed, three decades ago prof. F. MACHLUP (An Economic Review of the Patent System, Study n. 15, Subcommittee on Patents, Trademarks and Copyright of the Committee of the Judiciary, U.S. Senate, 85 th Congress, Second Session, Washington D.C, 1958) reached the conclusion that it is not possible to establish whether the allocative costs of the patent system outweigh its benefits.
For a more optimistic view see, however, in specific connection to biotechnology, F.K. BEIER-J. STRAUS, Patents in a Time of Rapid Scientific and Technological Change, in the OCSE Report (edited by F.K. Beier, R.S. Crespi and J. Straus) Biotechnology and Patent Protection. An International Review, 1985, 15 and, in general terms, M. LEHMAN, Property and Intellectual Property: Property Rights as Restrictions on Competition in Furtherance of Competition, in 20 I.I.C., 1989, 1 ff.
An excellent discussion of economic litterature in the field is in E. KAUFER, The Incentives to Innovate under Alternative Property Rights Assignments with Special reference to the Patent System, in 142 Zeitschrift fuer die gesamte Staatswissenschaft-Journal of Institutional and Theoretical Economics, 1986, 210 ff. and now in Y. KO, op. cit., 791 ff. (28) N. BOBBIO, L'età dei diritti, cit., XIV f.
It easy to understand that claims relating to the environment are amenable to a variety of philosophical foundations: for a persuasive perspective see now S. MAFFETTONE, La questione ambientale: metafisica e politica, in Questioni di bioetica, cit., 235 ff. and, for a fascinating account, H. JONAS, Il principio responsabilità. Un'etica per la società tecnologica, Torino, 1990.
(29) Put forward, for instance, by B. LEMENNICIER, Le corps humain: proprété de l'Etat ou propriété de soi, in Droits, 13, 1991, 112. For a critical evaluation of this perspective see F.D. BUSNELLI, op. cit., p. 286.
(30) For a similar point see S. RODOTA', Introduzione a Questioni di bioetica, cit., XI, who rightly remarks that in this event the decision might turn out to be unreversible even though a subsequent majority might change its mind.
(31) As envisaged by A. PIZZORNO, Sulla teoria dei movimenti collettivi, in Le radici della politica assoluta e altri saggi, Milano, 1993, 129 ff.
(32) Accordingly, arguments in this kind of areas may not resort to the traditional techniques of demonstrative reason and must fall back on those categories of proofs which, by an approach which simultaneously rejects moral rationalism and the application of analytical tools to ethics, are indicated as "non demonstrative": for the initial highliting of the roads accessible to non demonstrative reason for purpose of normative choices see C. PERELMAN-L. OLBRECHTS-TYTECA, Trattato dell'argomentazione. La nuova retorica, Vol. I, Torino, 1976, 3 e segg.
(33) As illustrated, for instance and with specific regard to patent licensing, by M. WHEELER, A Reexamination of Antitrust Law and Exclusive Territorial Grants by Patentees, in 119 U. Pa. L. Rev., 1971, 642 ff. at 655.
(34) In accordance with the wording advanced at n. 36 of my work La brevettabilità, cit.
(35) Art. 14 of the Joint position, cit.
(36) See, with specific regard to the field, R. WHAITE-N. JONES, op. cit., at 151 and 153.
(37) The text of the Convention on Biologic Diversity of June 5 1992, which is being adopted also by the EEC, is attached to the Council's proposal relating to the adoption of the Convention published December 21, 1992, in COM(92) 509 def.
(38) Doc. A 2-327/88, n. 25. Se however the appropriate critical remarks by S. RODOTA', Modelli culturali e orizzonti della bioetica, in Questioni di bioetica, cit., 421 f.
(39) Such is the proposal advanced by the Amendment of Representativa Merz at the European Parliament (PE 150.463/Em. 44 Or. PAN) and adopted January 20, 1992 by the Commission for legal Affairs and Citizens' Rights of the same European Parliament and thereafter by lett. b) of n. 3 of art. 2 of the Joint position.
(40) For the corresponding theoretical framework see M. WALZER, Sfere di giustizia, Milano, 1987, 15-60 and 312-20.
(41) In accordance to data presented by I. KRETSCHMER (Biotechnologie: Vorschlag einer EG-Richtlinie, in GRUR, 1988, 890 e segg., 892), patent applications at the pending at the UPO were, at the time, originating for 45% from the U.S., 15% from Japan and only 10% from Germany.