Repon for the Hearing in Case C-271/92

I — The relevant national provisions

1. Under Article 505 of the Code de la Santé Publique (Public Health Code, hereinafter ‘the Code’) no one may act as a retail optician and supplier of spectacles unless he holds the certificate of optician and supplier of spectacles, the diploma of certified pupil of the national professional schools, opticians and spectacle supply section, the certificate of the optical trades school or any other qualification designated by order of the Minister for National Education, the Minister for Trade, the Minister for Public Health and Population and the Minister for Finance and Economic Affairs.

2. Under Article 508 of that Code, commercial establishments whose main business is optical supplies and the supply of spectacles, their branches, and shop departments supplying optical appliances and spectacles may be run or managed only by a person fulfilling the conditions laid down for the exercise of the profession of optician and supplier of spectacles. The peddling of glasses to correct ametropia is prohibited. No corrective lens may be supplied to a person of less than 16 years of age without a medical prescription.

3. An infringement of these provisions renders the person liable to the criminal penalties provided for in Article 509 of that Code.

4. Under Article 512(1) of the Code, wholesale or retail sales of products for the maintenance of contact lenses or the supply of such products to the public are reserved to pharmacists. However, Article 521 of that Code provides that, as an exception to the pharmacists' monopoly, such products may also be sold to the public by opticians and suppliers of spectacles.

II — Facts and procedure

1. The Laboratoire de Prothèses Oculaires (Laboratory for Eye Prostheses, hereinafter ‘LPO’) markets contact lenses, intraocular implants and related products, on prescription by ophthalmologists, through its agents or distributors associated with it under lixence; the products are supplied to the persons concerned under seal, without employing the services of an optician, and must then be fitted by an ophthalmologist.

2. Considering itself to be the victim of machinations by a number of professional associations of opticians supplying spectacles, who sought to have it banned by the courts from selling those products on the basis of Articles 505 and 508 of the Code, LPO brought an action against the Syndicat des Opticiens Français Indépendants (SOFI) (Union of French Independent Opticians), the Groupement d'Opticiens-Lunetiers Détaillants (GOLD) (Association of Retail Opticians supplying Spectacles), the Union Nationale des Syndicats d'Opticiens de France (UNSOF) (National Federation of Opticians' Trade Unions in France) and the Syndicat National des Adaptateurs d'Optique de Contact (SNADOC) (National Union of Contact Lens Opticians) for a ruling that Articles 505 and 508 of the Code do not give qualified opticians supplying spectacles a monopoly on the distribution of contact lenses and that the various actions brought against it by those professional organizations constituted restrictive and discriminatory practices.

3. The Cour d'Appel de Paris (Paris Court of Appeal), in a decision of 15 April 1991, dismissed LPO's claim, upheld the professional organizations' counterclaim and enjoined LPO, subject to a penalty for infringement, from selling contact lenses to individuals at sales outlets which it controlled and which were run by persons who did not hold an optician's certificate (Diplôme de lunetier-opticien).

4. LPO applied for a review of that decision. It pointed out that all national rules which are capable of hindering, directly or indirectly, actually or potentially, intra-Community trade are to be regarded as measures incompatible with Article 30 of the Treaty even if they affect the sale of domestic products as well as imported products. LPO also argued that in the absence of Community rules on marketing a product, whatever its classification under domestic law, it is for the national courts to verify whether the marketing monopoly conferred on the holders of a particular qualification is necessary for the protection of public health or consumers and whether those two objectives cannot be achieved by less restrictive measures.

5. By judgment of 2 June 1992, the Cour de Cassation (Court of Cassation) decided to stay the proceedings until the Court had given a preliminary ruling on the following questions: (1) Must Article 30 of the Treaty be interpreted as applying to the sale of contact lenses and related products subject to conditions such as those laid down in Articles L-505 and L-508 of the Code de la Santé Publique reserving solely to holders of an optician's certificate (Diplôme d'opticien-lunetier) the sale of optical appliances and corrective lenses? (2) May such legislation be justified by mandatory requirements relating to the protection of consumers or human health and life, as referred to in Article 36 of the Treaty?

6. The order for reference dated 2 June 1992 was received at the Court Registry on 16 June 1992.

7. Pursuant to Article 20 of the Protocol on the Statute of the Court of Justice, written observations were submitted by LPO, represented by Defrenois and Levis, Advocates with the right of audience before the Conseil d'Etat and the Cour de Cassation; by the Syndicat des Opticiens Français Indépendants (SOFI) and the Groupement d'Opticiens Lunetiers-Détaillants (GOLD), represented by Lyon-Caen, Fabiani and Thiriez, Advocates with the right of audience before the Conseil d'Etat and the Cour de Cassation, and Mr Brueder (of Lafarge), Advocate with the right of audience before the Cour d'Appel de Paris; by the Union Nationale des Syndicats d'Opticiens de France (UNSOF) and the Syndicat National des Adaptateurs d'Optique de Contact (SNADOC), represented by Lemaître-Monod, Advocates with the right of audience before the Conseil d'Etat and the Cour de Cassation; by the French Government, represented by P. Pouzoulet and H. Duchene, of the Ministry of Foreign Affairs, acting as Agents; by the Greek Government, represented by F. P. Georgakopoulos, Assistant Legal Adviser in the State Legal Service, acting as Agent; and by the Commission of the European Communities, represented by R. Pellicer of its Legal Service and V. Melgar, a national civil servant seconded to the Legal Service of the Commission under the scheme for exchanges with national civil servants, acting as Agents.

8. Upon hearing the report of the Judge-Rapporteur and the views of the Advocate General, the Court decided to open the oral procedure without any preparatory inquiry and to assign the case to the Sixth Chamber.

III — Observations submitted to the Court

1. The plaintiff in the main proceedings, LPO, claims that in the present state of Community law, in which the rules on marketing medical devices have not been harmonized, the question whether such rules comply with Community law must be considered in the light of Articles 30 and 36 of the Treaty. It claims that contact lenses do not have to be altered when they are fitted since they are batch-produced or custom-made by laboratories, on prescription. Unlike corrective lenses, contact lenses are not processed by opticians but purchased from laboratories and retailed in sterile packs which are opened by the user or by the ophthalmologist when the lenses are fitted. LPO maintains that the monopoly on the sale of readymade contact lenses conferred on opticians under Articles 505 and 508 of the Code makes it more difficult and more costly to sell imported products and constitutes an obstacle to free trade. Many of the lenses sold to French users are imported from Member States of the Community. Studies on the lens-manufacturers' respective shares of the French market show that more than 40% of the contact lenses sold in France are produced by three large laboratories located in neighbouring Member States. The monopoly claimed by French opticians on the sale of contact lenses and products for their care therefore constitutes a measure having an effect equivalent to a quantitative restriction on imports within the meaning of Article 30 of the Treaty. On the question whether that monopoly may be justified by mandatory requirements, the plaintiff notes that the Court has consistently ruled that, in the absence of Community rules on the production and marketing of a product, it is for the Member States to regulate all aspects of the production, distribution and consumption of the product in question, provided that such legislation does not obstruct intra-Community trade. LPO considers, however, that national rules may derogate from the principles enshrined in Article 30 of the Treaty only if they can be shown to be necessary to satisfy mandatory requirements relating, in particular, to public health, fair trading and consumer protection. Such rules must also be proportionate to the aim to be achieved. Consequently, rules based on the requirement to protect public health must be confined to the measures necessary for that purpose. In that connection, LPO argues that it is impossible to regard the monopoly claimed by French opticians as necessary to the protection of public health. As far as contact lenses are concerned, that monopoly amounts to no more than a straightforward commercial transaction without any associated medical or technical services. Furthermore, this restriction on trade in contact lenses and the products for their care is unnecessary. Unlike spectacles, which require the services of an optician to select the frames and cut and set the corrective lenses, contact lenses are batch-produced or custom-made by laboratories, to an ophthalmologist's prescription, and do not have to be processed when they are fitted. Moreover, these prostheses are supplied by manufactures in sterile packs and do not even need to be repackaged by the retailer. Lenses sold on prescription are checked by the ophthalmologist when they are fitted, to ensure that they are in order. The plaintiff concludes that the restriction on intra-Community trade resulting from the French opticians' monopoly on the sale of contact lenses and the products for their care therefore appears to be unnecessary and disproportionate in relation to the objective of protecting public health, which is already secured by the ophthalmologists responsible for prescribing and fitting the contact lenses. Lastly, LPO considers that there is no proof that if the sale of contact lenses and the products for their care were reserved to opticians it would lead to any reduction in the incidence or gravity of the pathological conditions associated with the use of these prostheses. Inasmuch as ophthalmologists are responsible for prescribing and fitting contact lenses, to require those selling them readymade to hold an optician's certificate is unnecessary for the protection of public health and unconnected with that purpose. LPO therefore suggests that the reply to the first question should be that the distribution of contact lenses is not subject to conditions such as those laid down in Articles 505 and 508 of the Code de la Santé Publique reserving solely to holders of an optician's certificate (Diplôme d'opticien-lunetier) the sale of optical appliances and corrective lenses and any other interpretation would constitute a measure having an effect equivalent to a quantitative restriction on imports within the meaning of Article 30 of the Treaty, and that the reply to the second question should be that an interpretation of Articles 505 and 508 of the Code de la Santé Publique reserving to holders of an optician's certificate (Diplôme d'opticien-lunetier) the sale of contact lenses and the products for their care is not justified by mandatory requirements relating to the protection of consumers or human health and life, as referred to in Article 36 of the Treaty, and the French State and the opticians have not produced evidence to show that the sale of such products in places other than opticians' shops actually constitutes a risk to public health, and that, in the alternative, the Court should order an investigation to establish whether the pathological conditions associated with wearing contact lenses occur more frequently or are more serious in Community countries where there are no restrictions on the sale of these prostheses and the products for their care than in those with legislation restricting the distribution of such devices.

2. On the first question, the defendants in the main proceedings, SOFI and GOLD, contend that the Community provisions are not applicable in the present case. The Court has consistently held that, in the absence of any factor that is not purely national, Community law does not apply to a domestic situation. In the present case, LPO is a small business which neither produces nor imports contact lenses. The defendants also argue that the national legislation does not hinder intra-Community trade. The sale of contact lenses and corrective lenses is only reserved to qualified professionals, that is to say holders of the certificate of optician and supplier of spectacles, the diploma of certified pupil of the national professional schools, opticians and spectacle supply section, or the certificate of the optical trades school. In those circumstances, they maintain that Article 508 of the Code allows any commercial establishment to sell contact lenses, corrective lenses and related products, provided only that companies or departments supplying optical appliances and spectacles are run or managed by a person holding an optician's certificate. The legislation does not discriminate between domestic and imported products. It has neither the aim nor the effect of restricting the flow of trade so as to secure a special advantage for national production or the domestic market to the detriment of the production or trade of other Member States. In the alternative, SOFI and GOLD maintain that the provisions of the Code are necessary to satisfy mandatory requirements relating to the protection of human health and consumers. The national measures at issue may be exempt from the application of Article 30 of the Treaty, in the absence of Community rules, because the level of protection is not excessive or unreasonable and the measures themselves are necessary and proportionate to the aim to be achieved. The defendants consider, in this connection, that it is necessary to reserve the sale of contact lenses and related products solely to holders of an optician's certificate in order to achieve the objective of protecting public health and consumers. Moreover, in the absence of harmonization of the conditions governing access to the profession in question, Member States are entitled to define the knowledge and qualifications required to practise that profession. SOFI and GOLD point out, in this context, that contact lenses are placed directly on the eye and are liable to cause allergies, rejection symptoms, corneal ulcers, conjunctivitis, glaucoma, or substantial loss of visual activity. They consider that the nature of opticians, as medical auxiliaries, is defined by various tasks, namely verifying that prescriptions are technically correct and detecting any errors they may contain, which could not be performed by a person without the necessary qualifications and scientific knowledge of the subject. Moreover, in contact lens optics, a number of other parameters have to be taken into account in defining the lenses accurately, in particular the material, hydrophilic qualities, thickness, diameter, curvature of the inner surface, and possibly also colour. The defendants emphasize in this connection that an optician, who has aerial optics data at his disposal and has mastered the techniques of subjective refraction, is in a position to decide on reading the ophthalmologist's prescription whether the prescribed parameters are suitable in the case of the customer. It is all the easier for him to do this in that he has to consider the comfort of the wearer and assess the effects on his vision of fitting the contact lenses. Moreover, the sale of contact lenses always involves teaching the patient how to handle and care for them. This is essential to achieve and maintain visual correction and to prevent and deal with the various problems that may occur when contact lenses are used. As regards the products for preserving and disinfecting contact lenses and obviating the risk of infection, SOFI and GOLD explain that their complexity and diversity are such that they should be sold only by a person qualified to advise the patient, in particular as to whether they are suitable for the type of lens used, whether they are mutually compatible, and whether there is any risk of allergy. The defendants also contend that the French rules reserving the sale of contact lenses solely to holders of an optician's certificate are proportionate to the aim pursued. As far as the criterion of proportionality is concerned, that is to say the absence of a less restrictive alternative, the requirement of professional training cannot be replaced by any other measure that is equally effective and less harmful to the free movement of goods. On the second question, the defendants consider that the French legislation may be justified on grounds of the protection of human health and life and the protection of consumers, as referred to in Article 36 of the Treaty. In conclusion, SOFI and GOLD propose that the questions referred for preliminary ruling should be answered as follows: Primarily In the absence of any element that is not purely national in a specific case, the provisions of Community law relating to the free movement of goods do not apply. In the alternative The Treaty provisions on the free movement of goods cannot apply to activities if all the relevant elements of those activities are confined to a single Member State; whether or not that is the case depends on the facts, which it is for the national court to establish. Article 30 of the Treaty does not apply to the sale of contact lenses and related products subject to conditions such as those laid down in Articles 505 and 508 of the Code de la Santé Publique reserving solely to holders of an optician's certificate the sale of optical appliances and corrective lenses. The provisions of the Code de la Santé Publique reserving the sale of contact lenses to holders of an optician's certificate are necessary to satisfy mandatory requirements relating to the protection of human health and of consumers. The provisions of the Code de la Santé Publique reserving the sale of contact lenses to holders of an optician's certificate are necessary for the protection of public health or consumers, as referred to in Article 36 of the Treaty.

3. The defendants in the main proceedings, UNSOF and SNADOC, contend that in the absence of Community rules on the marketing of a product, it is for the Member States to regulate all aspects of the distribution of the product in question, provided that such legislation does not obstruct intra-Community trade. They also maintain that, in principle, rules requiring the trader concerned to have certain qualifications in order to sell a product can affect trade in such a product only if the conditions laid down are so difficult to meet that few sales outlets can offer it for sale. As regards the sale of contact lenses, UNSOF and SNADOC point out that there are no particular conditions for opening an optician's shop apart from the requirement that the person running it must hold an optician's certificate. In addition, there are no restrictions on producers, distributors or opticians' shops advertising contact lenses. Consequently the mere fact that sales outlets for contact lenses must be run by a qualified person cannot be held to mean that the traders concerned are obliged to adopt different marketing methods in the different Member States. The opticians' monopoly on the sale of contact lenses does not therefore appear likely to affect the flow of trade. The defendants also consider that, as contact lenses are not a medicinal product within the meaning of the national and Community definitions but a means of correcting vision, the national rules are justified for reasons relating to the protection of public health. With respect to that objective, UNSOF and SNADOC point out that opticians are medical auxiliaries. Their role is to verify the prescription and supervise the issuing of contact lenses, so as to ensure that they are appropriate to the vision and physiology of the customer and that the product supplied by the manufacturer does in fact correspond to the parameters set. There are no rules in France on the production of contact lenses. Anyone may set up as a manufacturer of these prostheses; they are not subject to quality control or inspection to ensure that they are effective, nor is any authorization such as marketing authorization required. Consequently, only a qualified professional can verify the quality of the product and only an optician has the necessary qualifications to read the parameters given in the ophthalmologist's prescription and issue the corresponding lenses. Thus, in their opinion, even if the rules reserving the sale of contact lenses and related products to opticians fall within the ambit of Article 30 of the Treaty, they are justified on grounds of the protection of public health and protection of the interests of consumers referred to in Article 36 of the Treaty.

4. The French Government notes, first, that there is no harmonization of the rules on marketing optical appliances within the Community. It therefore falls to the Member States to determine such rules, subject to compliance with the provisions of the Treaty. The French Government states that, in so far as it may, by restricting sales to certain channels, constitute a measure having an effect equivalent to a quantitative restriction on trade, legislation reserving to holders of an optician's certificate the sale of optical appliances and corrective lenses falls within the ambit of Article 30 of the Treaty. However, there is no evidence that such legislation favours the marketing of domestic products. The types of contact lenses marketed in France come from a wide variety of sources, some being produced by French companies or subsidiaries of large chemical or pharmaceutical combines, while others are imported. So far as concerns the applicability of Article 36 of the Treaty, the French Government claims that the purpose of the national legislation is to protect public health. It is necessary, in the users' interest, to take the precaution of reserving the distribution of contact lenses to retailers with special qualifications. That is why commercial establishments whose main business is optical supplies and the supply of spectacles must be run by a person who fulfils the conditions laid down for practising as an optician and supplying spectacles. In so far as it does not seriously obstruct imports, being concerned only with the method of distributing such goods, not with preventing their importation, such a requirement complies with the principles established by the Court in its case-law, notably the principle of proportionality. According to the French Government, the purpose of the legislation in question in requiring evidence of qualifications and conferring a certain responsibility on the retailer is to protect consumers and ensure that the contact lenses they receive are of the necessary quality to produce the desired therapeutic effect. Articles 505 and 508 of the Code comply with the abovementioned principles inasmuch as they are intended to protect the consumer without obstructing trade to an extent that is disproportionate in relation to the protection they afford. The French Government therefore suggests that the Court should reply that, as Community law now stands, it is still for the Member States to determine the rules governing the distribution of contact lenses and related products, subject to compliance with the provisions of the Treaty, in particular those on the free movement of goods. A monopoly, conferred on opticians, for the distribution of contact lenses and related products may constitute a barrier to imports. If a Member State elects to reserve the distribution of such products to opticians, such a barrier is justified on grounds of the protection of human health and life, as referred to in Article 36 of the Treaty, and by mandatory requirements relating to the protection of consumers.

5. The Greek Government notes that the national rules at issue concern the conditions laid down for practising as an optician. They define the qualifications required of members of that profession to ensure that it is practised in an equitable manner, that is to say without imposing any restriction on the products distributed or discriminating between them so as to give domestic products an advantage over products of Community origin. The Greek Government considers that the purpose of those national rules is to satisfy mandatory requirements in so far as they are intended to ensure the protection of consumers and human health. The criteria with respect to the professional qualifications required to practise as an optician, as defined, constitute the minimum conditions necessary to meet consumers' needs in an adequate, responsible and efficient manner. They also clearly contribute to the protection of public health in so far as they guarantee fulfilment of the minimum conditions laid down as to the professional training and experience a person must have in order to correct or treat sight defects safely and without danger to the patient. The Greek Government also considers that, in so far as such rules lay down the minimum conditions a person must fulfil in order to practise the profession in question safely and without danger, they clearly cannot be regarded as being contrary to the principle of proportionality, since there are no less restrictive measures that could be adopted in their stead. Consequently, they cannot be regarded as being in any respect contrary to Community law, there being no harmonizing directives on the subject. The Greek Government therefore proposes that the questions referred for a preliminary ruling should be answered as follows:

‘If Article 30 of the Treaty is interpreted as applying to the sale of contact lenses and related products subject to conditions such as those laid down in Articles 505 and 508 of the Code de la Santé Publique reserving solely to holders of an optician's certificate (Diplôme d'opticien-lunetier) the sale of optical appliances and corrective lenses, such legislation is absolutely justified by mandatory requirements relating to the protection of consumers and human health, as referred to in Article 36 of the Treaty’.

6. The Commission considers that in the present case no distinction can be drawn between contact lenses and related products; although they are different products, they are intrinsically too closely linked in marketing terms to be subject to different legal provisions. Fitting contact lenses necessarily entails instruction in the use of the related products for cleaning them. According to the Commission, moreover, the line of reasoning adopted by the Court in its case-law on the pharmacists' monopoly is applicable in this case, that is to the opticians' monopoly on the sale of contact lenses. Article 30 of the Treaty therefore applies to such legislation. As regards Article 36 of the Treaty, the Commission notes that it provides for exceptions to the principle of free movement of goods in cases where restrictions on imports, exports or goods in transit are justified on grounds of public morality, public policy, public security, or the protection of health and life of humans. The Commission adds that such prohibitions or restrictions must not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States. As regards human health and life, it is for the Member States to decide on the degree of protection which they wish to afford to public health and, in particular, on how strict a system of inspection they wish to establish. The measures taken must, however, be necessary to ensure effective protection and will not qualify for the exception provided for in Article 36 of the Treaty if health can be protected by provisions that have a less restrictive effect on Community trade. The Commission considers that the obligation requiring contact lenses to be issued by a specialist is justified by the requirement of health protection. The sale of such prostheses by a qualified person is likely to ensure that the lenses are used correctly. Moreover, merely to give ophthalmologists a monopoly on fitting lenses is not of itself sufficient to prevent the risk that patients who have obtained lenses through the post may fail to go back to the ophthalmologist to have them fitted. In the Commission's opinion, this restriction on the free movement of contact lenses and related products does not appear to be discriminatory, since it applies to all lenses, not just to those from other Member States. Nor does it appear to be disproportionate in relation to the aim to be achieved, namely that of protecting human sight. It is difficult to imagine any means of protecting patients' vision effectively that would have a less restrictive effect on trade than employing a specialist. The national measure is therefore justified by the requirement of public health protection laid down in Article 36 of the Treaty. The Commission therefore proposes that the questions referred for a preliminary ruling should be answered as follows:

‘(1) Article 30 of the Treaty is applicable to legislation which confers on opticians a monopoly on the marketing of contact lenses and related products, in that such a monopoly restricts sales to certain channels and is capable of affecting the possibilities of marketing imported products and may accordingly constitute a measure having an effect equivalent to a quantitative restriction on imports within the meaning of Article 30 of the Treaty.

2) However, such legislation is justified on the basis of the exception relating to the protection of public health referred to in Article 36 of the Treaty.’

M. Diez de Velasco

Judge-Rapporteur

1 Language of the case: French.