Acceso usuarios
Malcolm MacLaren
I. Introduction [1] On 9 October 2001, the European Court of Justice dismissed (1) a challenge by the Netherlands with the support of Italy and Norway against the Community Directive on the legal protection of biotechnological inventions. (2) Although the Biotech Directive relates to a wide range of public concerns and the Application for its annulment was based on a half-dozen different pleas, the following article will focus on the case as it relates to European Community treaty limitations. It will critically examine the perspectives on the principles of harmonisation and subsidiarity presented in the Application, the Advocate General's Opinion and the Court's Judgment within the broader context of the Community/Union's past and future development. The examination will reveal that in this case the Court has foregone a good opportunity to delimit 'positive integration'. (3) It could have made an important contribution to the on-going discussion about power-sharing between the national and supranational levels. While the judgment does strongly affirm the positive integration paradigm, the margins of the EU's legislative policy competences remain blurred due to its oft-opaque reasoning. The judgment raises, directly and indirectly, as many questions as it answers.
[2] This outcome from the proceedings is unfortunate: it is "of the essence" of a regulatory order such as the EU's "that the powers exercisable at the centre be clearly demarcated." (4) A greater degree of clarity in the EU's policy competences would be desirable not only according to the well-known principle of legal certainty but also from the political perspective of legitimacy. A widespread suspicion exists even in traditionally more positive member states about the EU's ambition of "an ever-closer union". (5) Many people fear the extension of the integrationists' project into all walks of life, "gobbl[ing] up everything that gives substance to our sense of having separate national identities." (6) The extent of the EU's potential legislative reach is accordingly not an abstract issue; it is a live and sensitive one. Specifically, as regards biotechnological innovation, widespread concerns remain about the patenting of biological materials, particularly with respect to the propriety of patenting animals, plants and materials of human origin. (7) Given the failure of the European Court of Justice in cases such as the Biotech decision to address popular concerns, extra-judicial means, specifically revisions to the constitutive Treaties, may be the only means of providing a desirable degree of legal clarity in the EU's policy competences.
II. The Provisions of the Biotech Directive [3] The Biotech Directive harmonises patent law among member states regarding biotechnology and ensures that the products of modern biotechnology are patentable throughout the Community. The Directive does so by establishing a detailed set of rules that apply to the patenting of biotechnological products and processes (including those involving materials of human origin) and to the scope of protection offered by those patents. It requires the Member States, through their patent laws, to protect biotechnological inventions according to these rules, whilst complying with their international obligations. (8) [4] Approved by the Council and the European Parliament in July, 1998, after a decade-long debate, the Directive attempts both to encourage biotechnology innovation in Europe and to meet ethical concerns. The compromise struck failed to satisfy all member states. At the Council meeting convened for its approval, the Netherlands voted against the Directive, and Belgium and Italy abstained, but the proposal passed by a qualified majority. Four months after its publication, the Netherlands brought an action under Article 173 of the EC Treaty (now, after amendment, Article 230 EC) for its annulment. (9) Italy and Norway were subsequently granted leave by the Court to intervene in support of the Netherlands.
III. Harmonisation and Subsidiarity [5] As noted, the Netherlands put forward six pleas. It pleaded that the Directive is incorrectly based on Article 100a of the EC Treaty (now Article 95 EC); it is contrary to the principle of subsidiarity laid down by Article 3b EC Treaty (now Article 5 EC); it infringes the principle of legal certainty; it is incompatible with obligations in international law; it breaches the fundamental right to respect for human dignity; and it was not properly adopted. The first two pleas relate specifically to Community treaty limitations, as the principles of harmonisation and subsidiarity concern the division of powers between the national and supranational levels. Although these were 'technical' grounds of challenge, they were motivated by broader concerns that the irresponsible pursuit of biotechnological research may have ethically unacceptable consequences. Indeed, the fact that the Netherlands proceeded on largely technical grounds speaks significantly to the nature and dynamic of Community legislation. (10) [6] The principles of harmonisation and subsidiarity have played a strong, formative role in the development of the Community/Union to date and look to influence its character in future. Article 100a of the EC Treaty had its origins in the efforts in the mid-1980s to complete the internal market. Member states agreed to embark on a massive harmonisation programme designed to provide common standards of protection of vital interests. In order to accelerate the legislative process, Article 100a was introduced into the EC Treaty. It provides for the harmonisation of provisions in Member States that have as their object the establishing and functioning of the internal market. The related Community measures are to be enacted by qualified majority vote in the Council, rather than by unanimity as heretofore under Article 100 of the EC Treaty (now Article 94 EC). Put otherwise, Article 100a was "designed to break through the perceived previous legislative impasse to completing the internal market." (11) As one observer noted, the harmonisation programme has been "largely successful." (12) Indeed, it was in a sense too successful: its effects caused constraints to be be placed on its operation. "The power ceded by Member States under Article 100a (new 95) EC proved wider than was anticipated, and more controversial." (13) Concern about a loss of national sovereignty and democratic legitimacy concomitant with a transfer of powers to the Community/Union has led Member States to be reluctant to commit themselves to further harmonisation, especially by qualified majority voting, and to be dilatory in implementing EC legislation. Subsidiarity, introduced into the EC Treaty at Maastricht as a general principle, is perhaps the most tangible manifestation of the new attitude to achieving the single market.
[7]While by now a well-known word, the precise meaning of subsidiarity remains uncertain and much debated. It may perhaps be best seen as composed of three elements: (a) attribution of powers, (b) subsidiarity per se, and (c) proportionality. (14) The first concerns the existence and extent of Community powers, the latter their exercise. (15) Briefly stated, the first paragraph of Article 3b of the EC Treaty (now Article 5 EC), namely "the Community shall act within the limits of the powers conferred upon it by the Treaty and the objectives assigned to it therein", confirms that the Community's powers are, in principle, limited and that such powers given it are to further specific objectives. In the context of a legal challenge to Community action, "[i]t is always necessary to know what is the legal basis of a Community measure, to make sure the objective in question can validly be pursued under that provision." (16) Where the Community may take action but does not have exclusive competence, supranational action must only be preferred to national action if this will bring demonstrable advantages. The subsidiarity principle is "to guide the decision whether the powers given to the Community should actually be used, in cases where the objective in question can also be pursued by the Member States individually, using their own powers." (17) Lastly, the so-called proportionality principle in the third paragraph of the Article is "about the intensity of the action the Community should take." (18) In particular, rather than prescribing their obligations in minute detail, the Community is simply to provide the outline, which the Member States are then to fill in.
IV. The Pleas Relied on in the Application, the Advocate General's Opinion (19) and the Judgment of the Court [8] The pleas relating to Community treaty limitations will be consecutively considered as each was submitted by the Applicant, disputed by the Advocate General and settled by the Court. The intention is to uncover the legal justifications for the Community legislation.
A. Harmonisation 1. The Application [9] In its application, the Netherlands claimed that the former Article 100a of the EC Treaty could not serve as the legal basis for the Directive as the Directive was not aimed at harmonising the internal market. The Directive ought to have been approved under Article 235 of the EC Treaty (now Article 308 EC) instead. This latter source of legal authority enables the Council to take appropriate measures where Community action is found necessary to attain, in the course of the operation of the common market, one of the objectives of the Community, and no specific power under the the Treaty is available for the purpose. The political significance in the selection of the legal basis for the harmonising measure lies in the different voting procedures: the former Article 100a requires the Council to adopt measures by qualified majority; the former Article 235 requires unanimity.
[10] Specifically, the Netherlands submitted that the Directive does not fall within the definition of measures for the approximation of the provisions laid down by law, regulation or administrative action in the Member States, which have as their object the establishment and functioning of the internal market, and was therefore incorrectly adopted. (20) The differences in the laws and practices of the Member States and the likelihood of their increasing and creating barriers to trade do not exist or only concern secondary issues that do not justify harmonisation, according to the Netherlands. (21) The obstacles to trade cited in recitals five and six in the preamble of the Directive would at most be to trade with the United States and Japan, not within the internal market. (22) "In the absence of any evidence of differences in national laws or of effect on trade, harmonisation by way of a directive cannot be justified." (23) Second, "if the application by the Member States of the relevant provisions of international law left a measure of legal uncertainty [per recital 9 in the Directive preamble], it should have been removed not by Community harmonisation but by renegotiation of international legal instruments [i.e. the European Patent Convention or 'EPC']" in order to clarify the provisions. (24) Third, the Directive allegedly exceeded the definition of a measure for harmonisation of national legislation, as it creates "a new type of property right distinct in several respects from the rights previously covered by existing patent law." (25) Last, the Italian Government claimed that the Directive should have been adopted on the basis of Articles 130 and 130f (now Articles 157 and 163, all EC Treaty) since the principal aim is to support the industrial development of the Community and scientific research in the genetic engineering sector. (26) In the alternative, Italy contended that the former Article 100a could not be the legal basis for a harmonising measure in a field involving fundamental interests such as health and the environment unless the contents of the proposal conform to the former Article 100a(3) of the EC Treaty (now Article 95(3) EC), which requires the Commission to take as a base a high level of protection in its proposals. This high level had allegedly not been taken as a base. (27) 2. The Opinion [11] AG Jacobs took the view as regards the Netherlands' first argument - i.e. that obstacles to trade had not been shown - that the Council and Parliament were entitled to consider that a harmonising measure was necessary to deal with disparities between Member States' laws concerning the patent protection of biotechnological inventions. Referring to the Court's rulings in Spain v Council as well as Germany v Parliament and Council, (28) the Advocate General asserted that recourse to the former Article 100a is justified where "harmonising measures are necessary to deal with disparities between the laws of the Member States in areas where such disparities are liable to create or maintain distorted conditions of competition (or) in so far as such disparities are liable to hinder the free movement of goods within the Community" and thus directly affect the establishment and functioning of the internal market. (29) The Advocate General qualifed the preceding to the extent that the emergence of such obstacles must be likely and that the proposal must designed to prevent them. (30) Applying this qualified principle to the legal protection of industrial and intellectual property rights, the Opinion claimed that the Court had already recognised that, in the absence of harmonisation, different levels of legislative protection for an identical product would lead to the fragmentation of the market into national markets where the product would be protected and others where it would not: "the common market would not be a single environment for the economic activities of undertakings." (31) The supplementary objective of avoiding any obstacles to trade with the United States and Japan can also lawfully guide the Community's action. Indeed, the desire to improve the competitive position of European undertakings internationally may be said to underlie the entire internal market programme. (32) [12] The Advocate General likewise did not accept the second Dutch argument that Community harmonisation was inappropriate and ineffective. The Opinion began by noting that harmonisation at Community level often takes place against a background of international conventions whose parties include Member States and third countries. "The existence of that context does not [...] deprive the Community institutions of the competence in the area conferred upon them by the Treaty." (33) Moreover, in this particular instance, the Advocate General strongly doubted that amendent of the EPC would be feasible and that if feasible, it would guarantee harmonisation, as "important areas of patent law governed by the Directive are outside its scope" and as the Convention provides for no means of ensuring uniform interpretation of regulations in those areas covered. (34) The Directive would accordingly prove more effective than the Convention. The fact that the Directive leaves scope for non-harmonised national rules regulating in particular public health, safety and environmental protection does not militate against its effectiveness in contributing to the free movement of the products concerned: "a patent is a right merely to prevent others from infringing the patent and does not confer any absolute entitlement on the proprietor to exploit the patent: exploitation is always subject to national regulation." (35) [13] The third Dutch argument was that the Directive creates a specific right by requiring Member States to protect biotechnological inventions under their patent law and therefore that it cannot be said simply to harmonise national principles. The Advocate General found that "the patentability of living material is not an innovation introduced by the Directive but the recognition of what is actually happening in conformity with national law." (36) Citing instances at the national, continental and international levels, the Opinion showed that applications for such patents have for decades been recognized and regulated by Member States. It cautioned in any event that the Dutch use of the term "patent on life" was "unhelpful and unclear" as it implies a right of ownership and unfettered rights to exploit. The Directive explicitly recognises numerous limits to patentability in line with national laws and international conventions as well as the ongoing obligation of patent-holders to comply with national regulatory requirements. (37) [14] Last, Italy sought to characterize the Directive as not so much intended to ensure the smooth functioning of the internal market as to support industrial development and scientific research in the Community. It should therefore have been adopted on the basis of Article 130 and 130f (now Articles 157 and 163, all EC Treaty) and not the former Article 100a. The Advocate General reviewed the measure's aim and content as they appeared from its wording so as to ascertain its legal basis. (38) The Opinion observed that while some of the recitals in the preamble to the Directive refer to the importance of biotechnological inventions for the Community's industrial development and so forth, the emphasis was on the need to eliminate differences in national law and practice. (39) The Opinion noted further that the need could already be objectively seen in Member States' divergent approachs in this area. (40) For its part, the content of the Directive - in particular Article 1(1), which unequivocally requires Member States to adjust their national patent law to take account of its provisions - supported the conclusion that the principal aim was harmonisation. Inasmuch as the provisions of the Directive "will affect industrial development in the Community [...] the impact [...] is indissociably linked with its harmonising effect." (41) As the principal aim of the Directive was, the Opinion concluded, harmonisation, this aim was decisive in determining the correct legal basis, namely the former Article 100a. In any event, stated the Advocate General, the former Articles 130 and 130f do not confer any legislative power on the Community, even if measures taken under other Treaty provisions simultaneously pursue objectives falling within the Articles' scope. Recourse to the former Article 235 may only be had where the Treaty has not elsewhere provided the necessary powers to legislate. The Treaty has done so, however, under the former Article 100a. The Opinion dismissed the alternative argument that the proposal was not in line with the high level of protection required by the former Article 100a(3), stating that the Directive did not fall within the scope of the Article. Although biotechnological research and resultant inventions may have significant implications on these matters, "the proposal did not seek to regulate such research or use from the standpoint of health, safety or environmental or consumer protection"; this regulation was expressly left to other authorities. (42) 3. The Judgment [15] As regards the Netherlands' first argument under this heading, the Court's statement of the appropriate test to be applied is relatively simple and straightforward: "recourse to Article 100a as a legal basis is possible if the aim is to prevent the emergence of future obstacles to trade resulting from multifarious development of national laws provided that the emergence of such obstacles is likely and the measure in question is designed to prevent them." (43) Applying this test, the Court found not only that the proper operation of the internal market was threatened by the risk of divergent trends in practice and case-law but also that "marked differences with significant consequences were already apparent between national laws" in this area. (44) The Court held that by requiring the Member States to protect biotechnological inventions by means of their national patent law, the Directive does in fact aim to prevent the emergence of such future obstacles.
[16] The Court dismissed as unfounded the argument that any legal uncertainty resulting from Member States' application of the relevant provisions of international law should have been removed not by Community harmonisation but by renegotiation of the relevant instruments (e.g. the EPC). "The purpose of harmonisation is to reduce the obstacles, whatever their origin, to the operation of the internal market." Even if the obstacles derive from differing interpretations of international legal instruments, "there is nothing to prevent recourse to adoption of a Directive as a means of ensuring uniform interpretation." (45) In this instance, the Court observed, such an approach does not appear inconsistent with the Member States' honouring their obligations under the EPC, is suitable for achieving its objective of uniformity in patentability and, given the "more indirect and unpredictable approach of seeking to amend the wording of the EPC", may well be preferable. (46) [17] As regards the third Dutch argument, the Court began by noting the Community's competence to harmonise national laws in the field of intellectual property pursuant to the former Articles 100 and 100a (now Articles 94 and 95, all EC Treaty). Moreover, the Community may create new rights superimposed on national rights, as it did with the Community trade mark. (47) The Court found that the patents to be issued under the Directive are national patents, "issued in accordance with the procedures applicable in the Member States and deriving their protective force from national law." (48) The creation of a Community patent is neither the Directive's purpose nor effect, notwithstanding the fact that some of the inventions concerned were not previously patentable in certain Member States and that the scope of patent protection has been variously clarified and derogated. Recourse to the legal basis afforded by the former Article 235 was therefore not required.
[18] Last, the Court agreed with Italy that the legal basis on which an act must be adopted should be determined according to its principal aim. (49) It also agreed that the Directive is intended to promote biotechnological research and development in the Community. Where the Court disagreed with Italy was the relative importance to be placed on the harmonisation of national legislation that the Directive effects. It argues that the way in which research and development are to be promoted is by removing the legal obstacles within the single market. Harmonisation is "therefore not an incidental or subsidiary objective of the Directive but is its essential purpose." The fact that research and development are to be promoted does not "make it inappropriate to use Article 100a of the Treaty as the legal basis of the Directive." (50) B. Subsidiarity 1. The Application [19] In conjunction with its submissions as regards to harmonisation, the Netherlands claimed as its second plea in law that the Biotech Directive infringed upon the Subsidiarity Principle. The second paragraph of the fomer Article 3b states that in areas that do not fall within its exclusive competence, the Community is to act only and insofar as the objectives of the proposed action cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale or effects of the proposed action, be better achieved by the Community. The Netherlands submitted that if the objectives of the Directive are to clarify the legal protection of biotechnological inventions in view of existing national differences, this objective should be effected through amending the EPC. "[N]ational patent law has been almost entirely harmonised by the [EPC...]. The Member States are thus perfectly able to achieve that objective." (51) [20] In the alternative, the Netherlands claimed that the Directive does not state sufficient reasons to establish that the second paragraph of the former Article 3b was taken into account per the former Article 190 of the EC Treaty (now Article 253 EC). This article provides that measures jointly adopted by the Parliament and Council "shall state the reasons on which they are based and shall refer to any proposals or opinions which were required to be obtained pursuant to this Treaty." 2. The Opinion [21] The Advocate General found no infringement of the principle of subsidiarity. As explained in the context of the first plea, the Directive was necessary in order to harmonise Member States' legislation. This harmonisation could be effected only by the Community, as amendment of the EPC would be "inappropriate, ineffective and possibly not feasible." (52) Moreover, the Community has exclusive competence in the approximation of national rules concerning the establishment and functioning of the internal market. (53) [22] Although the Advocate General admitted that the Directive did not make express reference to the principle of subsidiarity, that the principle was respected is allegedly apparent in the preamble. Jurisprudence makes clear that "in such circumstances it is not necessar for the legislation to make express reference." (54) The alternative argument regarding subsidiarity was thus in the Advocate General's view groundless.
3. The Judgment [23] The Court found that the principal aim of the Directive, the removal of the legal obstacles to the smooth functioning of the single market, "could not be achieved by action taken by the Member States alone." (55) As the scope of the protection of biotechnological inventions has an immediate impact on intra-Community trade, "it is clear that, given the scale and effects of the proposed action, the objective in question could be better achieved by the Community." (56) The principle of subsidiarity was thus not breached. Indeed, compliance with the principle of subsidiarity is, in the Court's view, necessarily implicit in the recitals of the preamble of the Directive, which state that, in the absence of action at Community level, the development of national laws and practices impedes the proper functioning of the internal market. "It thus appears that the Directive states sufficient reasons on that point." (57) V. Analysis [24] In filing its application, the Netherlands was acting at the express request of the national Parliament, "in light of the opposition expressed there to genetic manipulation involving animals and plants and to the issuing of patents for the products of biotechnological procedures liable to promote such manipulation." (58) It is unlikely that the approach taken by the Court to biotechnological innovation will assuage the Dutch Parliamentarians' concerns, regardless of how well reasoned the judgment is perceived to be. For those who will brook no compromise of their ethical and social concerns, the judgment must appear wrong-headed, if not positively offensive.
[25] The original impetus for the Directive was to address competition from abroad by "harmonising the technical patent law issues necessary to create a robust biotech industry." (59) Although the European Parliament was subsequently able to introduce ethical elements into the Directive, the Directive remains predominantly influenced by the Commission's original conception of harmonisation. The elucidation of the 'ordre public' or morality exception and the clarification of the application of patent standards to biotechnological innovations do not alter the fundamental nature of the Directive. (60) The Court has essentially followed the Commission's approach in characterizing the Directive: it has considered biotechnological innovation as primarily an industrial and not an ethical and social issue. Put otherwise, the starting point of its analysis of the Directive's validity is the state of the biotechnological industry in Europe rather than the role of biotechnology in society. The Court's approach is manifested at different turns in the judgment. The Court held variously that biotechnological innovation was fit for regulation under a conventional intellectual property regime, that the Directive's primary intent was harmonisation for the well-functioning of the internal market and that harmonisation was effected only by clarifying existing national legislation. If an ethics-based approach to biotechnological innovation is taken, however, the issue appears in a different light. At each turn in the judgment, the alternative approach casts a shadow over the validity of the Directive.
[26] First, it may well be the case, as the Court states, that the Community is competent under the former Article 100a to harmonise intellectual property laws. (61) If so, this provision would provide a better legal basis for the Directive than the former Article 235. This reasoning presumes, however, that biotechnological innovation is a matter fit for regulation under a conventional intellectual property regime. To what degree it is is a question precedent that the Court never addresses. A good counter-argument may be ventured that in view of the ethical and social concerns involved, biotechnological innovation should not be regulated like other intellectual property: inventions involving materials of human origin should be handled differently than those involving bits and bytes. Article 7 and Recital 44 of the Directive foresee a periodic review by an expert group of ethicists, the European Group on Ethics in Science and New Technologies, of the basic ethical aspects of biotechnology including in respect of patent law. The Directive confers only advisory power on this group. Expansion of its mandate to oversee developments in the area and to bring ethical considerations into policymaking would, for example, constitute an alternative regulatory mechanism.
[27] Following on the above, it is jurisprudentially clear that the former Article 100a provided a legal basis for Community action where the primary intent of that action was to harmonise measures of Member States so as to eliminate or prevent distortions in the internal market. The question then is the proper judicial characterization of the impugned Community action. This characterization, which will inevitably involve an element of subjectivity, is to be made in light of the proposal's aim and content: "a measure must be seen to be about contributing to the well-functioning of the internal market mechanism; and not about something else, however worthy". (62) The means cannot, however, be collapsed into the end: the Court is to judge the direct and incidental impact of the measure on the functioning of the internal market to ensure that the measure in fact pursues the objectives stated by the Community legislature. (63) In short, if a measure that has as its object the functioning of the market mechanism is likely to have a direct impact on the functioning of that market, then harmonisation is permissible. It may at this point, however, be asked whether the Court in this analysis risks giving priority to the well-functioning of the market mechanism over all other considerations. As a measure may have a dual working, there is the possibility that its impact on other aspects of Community life may be greater than its impact on the functioning of the market mechanism - however direct the latter impact may be. In this case, is harmonisation really the appropriate legal basis for legislation? The former Article 100a(3) does provide for a high level of protection where health, safety, environmental protection and consumer protection is concerned. However, this qualification neither circumscribes all the conceivable effects of a measure nor does it prevent the Community from legislating in the first place. (64) It is also true that a broad legal basis of the kind in Article 100a may be indispensible in order to "cater for the multifarious problems of ensuring an open
