CELEX: 62013CC0310
Language: en
Date: 2014-06-11 00:00:00
Title: Opinion of Advocate General Szpunar delivered on 11 June 2014.#Novo Nordisk Pharma GmbH v S.#Request for a preliminary ruling from the Bundesgerichtshof.#Reference for a preliminary ruling — Directive 85/374/EEC — Consumer protection — Liability for defective products — Material scope of the directive — Special liability system existing on the date of notification of that directive — Permissibility of a national liability system enabling information on the adverse effects of pharmaceutical products to be obtained.#Case C‑310/13.

OPINION OF ADVOCATE GENERAL
      SZPUNAR
      delivered on 11 June 2014 (
            1
         )
      
         Case C‑310/13
      
      
         Novo Nordisk Pharma GmbH
      
      
         v
      
      
         S.
      
      
         (Request for a preliminary ruling from the Bundesgerichtshof (Germany))
      
      ‛Consumer protection — Liability for defective products — Scope of Directive 85/374/EEC — Exclusion of special liability systems existing on the date of notification of that directive — Permissibility of a national liability system enabling, inter alia, information on the side effects of pharmaceutical products to be obtained’
      
         Introduction
      
      
               1.
            
            
               This case gives the Court an opportunity to supplement its interpretation of Article 13 of Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products. (
                     2
                  ) For the first time, that interpretation will relate to a system of liability which is in fact ‘a special liability system existing at the moment when [that] Directive is notified’ for the purposes of that provision. The Bundesgerichtshof (Federal Court of Justice; or ‘the referring court’), the highest court of the Federal Republic of Germany, refers a question about remedying the harm caused by the defectiveness of a medicinal product.
            
         
               2.
            
            
               However, in order to give the referring court a reply that will be of assistance in resolving the dispute before it, it will be necessary to undertake an analysis which goes beyond an interpretation of Article 13 of Directive 85/374 and to consider the nature of the harmonisation that has come about as a result of the provisions of that directive, and the ambit thereof.
            
         
         Legal background
      
      
         EU law
      
      
               3.
            
            
               According to the first and second recitals in the preamble to Directive 85/374:
               ‘… approximation of the laws of the Member States concerning the liability of the producer for damage caused by the defectiveness of his products is necessary because the existing divergences may distort competition and affect the movement of goods within the common market and entail a differing degree of protection of the consumer against damage caused by a defective product to his health or property;
               … liability without fault on the part of the producer is the sole means of adequately solving the problem, peculiar to our age of increasing technicality, of a fair apportionment of the risks inherent in modern technological production.’
            
         
               4.
            
            
               The final sentence of the 13th recital to the directive states:
               ‘… in so far as effective protection of consumers in the sector of pharmaceutical products is already also attained in a Member State under a special liability system, claims based on this system should similarly remain possible.’
            
         
               5.
            
            
               The 18th recital in the preamble to the directive states:
               ‘Whereas the harmonisation resulting from this [directive] cannot be total at the present stage, but opens the way towards greater harmonisation …’
            
         
               6.
            
            
               Articles 1, 4 and 13 of Directive 85/374 provide:
               
                  ‘Article 1
               
               The producer shall be liable for damage caused by a defect in his product.
               …
               
                  Article 4
               
               The injured person shall be required to prove the damage, the defect and the causal relationship between defect and damage.
               …
               
                  Article 13
               
               This Directive shall not affect any rights which an injured person may have according to the rules of the law of contractual or non-contractual liability or a special liability system existing at the moment when this Directive is notified.’
            
         
         German law
      
      
               7.
            
            
               Directive 85/374 was transposed into German law by the Produkthaftungsgesetz vom 15. Dezember 1989 (
                     3
                  ) (Law on product liability of 15 December 1989; ‘the ProdHaftG’). However, Paragraph 15(1) of the ProdHaftG excludes liability for medicinal products from the scope of that law, providing:
               ‘If, as a result of having been administered a medicinal product intended for human use, a person dies or the body or health of a person is adversely affected, the present Law shall not apply where the product at issue has been supplied to the consumer under the Law on medicinal products [Arzneimittelgesetz of 24 August 1976; “the AMG”] and is subject to compulsory marketing authorisation or has been exempted by regulation from that requirement.’
            
         
               8.
            
            
               Liability for defective medicinal products administered to humans is governed by another legal act, that is to say, the Arzneimittelgesetz vom 24 August 1976 (
                     4
                  ) (Law on medicinal products of 24 August 1976; ‘the AMG’). Under Paragraph 84 of the AMG in the version applicable in the main proceedings:
               ‘1.   If, as a result of having been administered a medicinal product intended for human use, a person dies or the body or health of a person is adversely affected to a substantial degree, the pharmaceutical undertaking which placed the medicinal product on the market under the present Law shall be required to compensate the injured party for the resulting damage, where the product at issue has been supplied to the consumer under the present Law and is subject to compulsory marketing authorisation or has been exempted by regulation from that requirement. Liability to provide compensation shall apply only where:
               
                        (1)
                     
                     
                        when used as intended, the medicinal product has harmful effects in excess of what is considered acceptable in the light of current medical knowledge; or
                     
                  
                        (2)
                     
                     
                        the damage has occurred as a result of labelling, or specialist information or instructions for use which do not reflect current medical knowledge.
                     
                  2.   If, in the circumstances of an individual case, the medicinal product administered is capable of causing the damage, a presumption shall arise to the effect that the damage was caused by that medicinal product. In each case, the question whether the medicinal product is capable of causing the damage shall be determined in the light of the product’s composition and the dosage administered, the intended manner and duration of use, the relationship in time between the dose administered and the damage, the nature of the damage and the state of health of the person adversely affected at the time when the product was administered and all other circumstances which, in the individual case, suggest that the product did, or did not, cause the damage. That presumption shall not apply if, in the circumstances of an individual case, the damage may well be attributable to a different factor. However, the administration of additional medicinal products capable, in the circumstances of the individual case, of causing the damage concerned shall not be considered to constitute such a factor unless, in relation to the administration of those medicinal products, no claims may be brought under this provision for reasons other than the lack of causality.
               3.   Where the circumstances indicate that the damaging effect of the medicinal product is not attributable to its development or manufacturing process, the pharmaceutical undertaking shall not be liable under point 1 of the second sentence of subparagraph 1.’
            
         
               9.
            
            
               Paragraph 84a of the AMG provides:
               ‘1.   Where the facts suggest that a medicinal product has caused the damage, the injured party may require the pharmaceutical undertaking to provide him with information unless such information is unnecessary for the purposes of establishing whether damages may be claimed under Paragraph 84. That request for information may relate to the effects, adverse effects and interactions known to the pharmaceutical undertaking, to suspected cases of adverse effects and interactions brought to its attention and to any other factor which may be of significance for the purposes of assessing whether the adverse effects are acceptable. Articles 259 to 261 of the German Civil Code (Bürgerliches Gesetzbuch) shall apply by analogy. There shall be no right to obtain disclosure where statutory provisions require that the information remain confidential or where non-disclosure is justified by an overriding interest of the pharmaceutical undertaking or of a third party.
               2.   In the circumstances specified in subparagraph 1, the injured party may also require information to be disclosed by the authorities responsible for the authorisation and supervision of medicinal products. Those authorities shall be under no obligation to disclose the information where statutory provisions require that the information remain confidential or where non-disclosure is justified by an overriding interest of the pharmaceutical undertaking or of a third party.’
            
         
               10.
            
            
               The presumption of a causal relationship established under Paragraph 84(2) of the AMG and the right to obtain disclosure of information pursuant to Paragraph 84a of the AMG were introduced pursuant to the Law of 19 July 2002 amending the law on compensation (Zweites Schadensersatzrechtsänderungsgesetz), (
                     5
                  ) which entered into force on 1 August 2002.
            
         
         Facts, procedure and questions referred
      
      
               11.
            
            
               While residing in Germany, S. sustained damage to her health after using from 2004 to 2006 a medicinal product marketed by Novo Nordisk Pharma GmbH (‘Novo Nordisk’) under the name ‘Levemir’.
            
         
               12.
            
            
               Consequently, S. brought an action against Novo Nordisk before the Landgericht Berlin (Regional Court, Berlin), seeking damages and disclosure of information pursuant to Paragraph 84a(1) of the AMG. By partial judgment of 25 August 2010, the Landgericht Berlin granted the application for disclosure of information. By judgment of 30 August 2011, the Kammergericht Berlin (Higher Regional Court, Berlin) dismissed the appeal brought by Novo Nordisk against that judgment. Novo Nordisk thereupon brought before the Bundesgerichtshof an appeal on a point of law which, in common with the judgments at first instance and on appeal, concerned the right to obtain disclosure of information.
            
         
               13.
            
            
               The Bundesgerichtshof is uncertain whether Paragraphs 84(2) and 84a of the AMG are compatible with Directive 85/374. On the view that the resolution of the dispute before it depends on the interpretation of Article 13 of that directive in relation to the right to obtain disclosure of information under Paragraph 84a of the AMG, the Bundesgerichtshof decided to stay proceedings and to refer the following question to the Court of Justice for a preliminary ruling:
               ‘Must Article 13 of Directive [85/374] be interpreted as meaning that, as a “special liability system”, the German system of liability for pharmaceutical products is in general not affected by that directive, with the result that the national system of liability for pharmaceutical products may be further developed,
               or
               must that provision be interpreted as meaning that no extension is permitted to the situations covered by the liability system for pharmaceutical products existing at the point in time at which the directive was notified (30 July 1985)?’
            
         
               14.
            
            
               The order for reference was received at the Court Registry on 6 June 2013. Observations were submitted by S., the Czech Government, the German Government and the European Commission. Representatives of S., the German Government and the Commission attended the hearing on 26 March 2014.
            
         
         Analysis
      
      
               15.
            
            
               Although divided into alternative parts, the question referred must be considered as a whole. It concerns the interpretation of Article 13 of Directive 85/374. Before that interpretation can be attempted, however, it is necessary to undertake a more general analysis of the scope of the harmonisation, brought about by the directive, of the law on liability for defective products as it stands in the various Member States. In order to give the referring court a reply which will be of assistance in resolving the dispute before it, it is also necessary, in my view, to examine — in the light of that directive — provisions of national law that are akin to the provisions of German law under consideration in the main proceedings, that is to say, provisions relating to the right of injured persons to obtain disclosure of certain information from the producer of a defective product.
            
         
         Objective and nature of the harmonisation undertaken by Directive 85/374
      
      Objective of Directive 85/374
      
               16.
            
            
               According to the first recital in the preamble thereto, Directive 85/374 was adopted, as regards EU law, in order to prevent distortion of competition, adverse effects on the movement of goods within the common market, and differences in the level of consumer protection against damage caused by defective products. According to that recital, those adverse phenomena come about because of divergences in the laws of the Member States concerning the liability of producers for damage caused by the defectiveness of their products.
            
         
               17.
            
            
               The fact that Directive 85/374 was adopted with that objective in mind is also indicated by the choice of Article 100 of the EEC Treaty (now Article 115 TFEU) as the legal basis for that directive, it being possible under that provision to adopt directives ‘for the approximation of such provisions laid down by law, regulation or administrative action in Member States as directly affect the establishment or functioning of the common market’ (now the internal market).
            
         
               18.
            
            
               As regards the axiological and economic considerations prevailing when Directive 85/374 was adopted, the latter was to bring about an appropriate spread of the risk which arises in today’s world from the mass industrial production of goods. The aim is not only to place that risk on the manufacturers of those goods rather than those who might be injured in using them, but also to do so in a manner which does not hamper technical development or deny customers access to an increasingly broad range of relatively cheap goods. That is why the first characteristic of the system of liability established by the directive is that it allows the risk to be transferred from the individual injured consumers to the manufacturers of the goods and the second is that it enables those manufacturers to spread that risk across all consumers by incorporating in the cost of their products the costs of that liability and, where appropriate, the cost of insurance. (
                     6
                  )
            
         
               19.
            
            
               To my mind, it is clear that, in order to attain those objectives, account has to be taken of the various interests that may come into play in this connection. As the Court has found, ‘the limits set by the [EU] legislature to the scope of … Directive [85/374] are the result of a complex balancing of different interests. As is clear from the first and ninth recitals in the preamble to the Directive, those interests include guaranteeing that competition will not be distorted, facilitating trade within the common market, consumer protection and ensuring the sound administration of justice’. (
                     7
                  ) I believe it possible to apply that finding not only to the scope of the directive but also to the rights and obligations arising from it. (
                     8
                  )
            
         
               20.
            
            
               This leads to the conclusion that consumer protection in general, and the attainment of the highest level of protection in particular, is not the only — or even the principal — objective of Directive 85/374. It is only one out of a number of considerations of equal weight which enter into the balance that the legislature sought to strike by means of that legal act. (
                     9
                  )
            
         Nature of the harmonisation undertaken by Directive 85/374
      
               21.
            
            
               According to the 18th recital to Directive 85/374, the harmonisation brought about by that directive is not total, but opens the way to further harmonisation. The Court has consistently held, however, that that finding must apply to the range of issues covered by the harmonisation. On the other hand, that does not mean that the Member States are free to lay down provisions which depart from those laid down in the directive. The Court has held that Directive 85/374 ‘seeks to achieve, in the matters regulated by it, complete harmonisation of the laws, regulations and administrative provisions of the Member States’. (
                     10
                  ) The primary points in favour of that view are the following: the legal basis for Directive 85/374 (Article 100 of the EEC Treaty) does not permit the Member States to derogate from the harmonising acts based on that directive; the directive lays down no standard provisions permitting the Member States to adopt, in their national law, more far-reaching provisions; or, lastly, the fact that the directive makes provision for alternative action to be taken in certain circumstances, which would not be necessary if the Member States were generally empowered to derogate from the directive. (
                     11
                  )
            
         
               22.
            
            
               The Court went on to find that ‘[a]lthough Directive 85/374 … seeks to achieve, in the matters regulated by it, complete harmonisation of the laws, regulations and administrative provisions of the Member States, it does not, however, as is apparent from the 18th recital in the preamble thereto, seek exhaustively to harmonise the field of liability for defective products beyond those matters’. (
                     12
                  )
            
         
               23.
            
            
               What inferences are to be drawn from the above case-law as regards the nature of the harmonisation brought about by Directive 85/374? I see no need in the present case to analyse the relationship between complete, total, exhaustive and maximum harmonisation — no doubt of great theoretical interest — particularly because, in academic writings, those legal concepts are not construed consistently. (
                     13
                  ) Suffice it to say that Directive 85/374 lays down a series of principles on which Member States should base ‘product liability’ systems, entailing, that is to say, the liability of producers (and, to a lesser extent, certain other persons), regardless of fault, for the harm caused by defects in their products. Save in the cases expressly provided for in the directive, Member States may not introduce derogations from those principles in their national legislation; nor may they apply rules that are more stringent or less stringent to one or other of the categories of person concerned by the directive. At the same time, however, for that system of liability to function, other provisions of national law must be applied.
            
         
               24.
            
            
               There is no doubt that an injured person who asserts his rights in a Member State invokes not only the provisions transposing the directive but also other rules in force in that State. To my mind, rules of the latter kind fall into two categories. First, in certain cases, Directive 85/374 itself provides for the possibility of applying provisions of national law which remain outside the scope of harmonisation. That is the position, for instance, as regards provisions on joint and several liability (Article 5), remedies (Articles 5 and 8(1)), damage contributed to by the injured person (Article 8(2)), and the suspension or interruption of time bars (Article 10(2)). Secondly, however, I have no doubt that, even where Directive 85/374 does not expressly provide for reference to be made to the law of the Member State, it may be necessary to apply provisions of national law. That would be the position, for instance, as regards provisions (substantive and procedural) relating to the quantification of the damage, to presumptions of fact, to the transferability of the right to compensation, including the permissibility of succession to such a right, and to the measures which a national court may take to prevent harm. That being so, it must be found that the harmonisation provided for in Directive 85/374 is not ‘complete’, in the sense that the provisions transposing it do not govern all aspects of liability for harm caused by defective products. (
                     14
                  )
            
         
               25.
            
            
               It is therefore necessary to examine the role played by Article 13 of Directive 85/374 in the logic and scheme of that directive and, on that basis, to interpret that provision in the context of the question referred for a preliminary ruling by the national court.
            
         
         Interpretation of Article 13 of Directive 85/374
      
      
               26.
            
            
               Article 13 of Directive 85/374 governs the relationship between the provisions of that directive and the other systems of defective product liability that may be in force in the Member States. There are three types of liability: contractual liability; non-contractual liability, which differs from the no-fault liability established by the directive (in practice, this may essentially be liability based on the principle of fault); (
                     15
                  ) and the ‘special liability system existing at the moment when this Directive is notified’. It is common ground — as, moreover, the Commission confirmed at the hearing — that the final part of Article 13 of Directive 85/374 actually relates only to the German system of liability for defective products, as established by the AMG, which was already in force at the time when Directive 85/374 was notified. (
                     16
                  ) It is that final part of Article 13 of the directive that the Court is called upon to interpret.
            
         
               27.
            
            
               The referring court essentially seeks to establish whether Article 13 of Directive 85/374 has the effect of wholly excluding the German system of liability for defective products from the scope of the harmonisation effected by that directive. It seems to me that, as both the wording and the logic of Article 13 of the directive suggest, to argue for such an approach would be to go too far.
            
         The provision made under Article 13 of Directive 85/374
      
               28.
            
            
               Article 13 of Directive 85/374 begins with the words ‘This Directive shall not affect any rights which an injured person may have according to …’ In my view, this demonstrates the complementary nature of the liability systems referred to in that directive in relation to the system established by the directive itself. Article 13 does not allow derogations in favour of other liability systems, but merely allows injured persons to rely on rights arising from other systems, irrespective of the rights conferred on them by the directive. That is quite evident in relation to contractual liability and non-contractual liability based on a principle of liability other than that established by the directive.
            
         
               29.
            
            
               This expression also applies to the German system of liability in relation to pharmaceutical products and I see no reason to interpret it differently in this case. The equal treatment of all liability systems referred to in Article 13 of Directive 85/374 is further confirmed by the 13th recital, according to which ‘… claims based on this system [that is to say the special liability system laid down in the AMG] should similarly [like claims based on the system of contractual and non-contractual liability] remain possible’. Neither Article 13 of Directive 85/374 nor the 13th recital suggests that the system established by that directive be replaced by a pre-existing system; they merely maintain the rights conferred on injured persons by that system. Accordingly, although Article 13 of Directive 85/374 states that that directive ‘shall not affect any rights which an injured person may have according to’, (
                     17
                  ) inter alia, the German liability system laid down in the AMG, that expression must be construed literally and strictly, and not understood as permitting a general derogation from that directive.
            
         
               30.
            
            
               Another essential element of Article 13 of Directive 85/374 as regards the special liability system is the statement that it concerns a system ‘existing at the moment when this Directive is notified’. That reservation relates only to that special liability system and not to the systems of contractual and non-contractual liability which are also referred to in Article 13. This means that the rights conferred by a system of contractual or non-contractual liability remain unaffected, regardless of whether that system was established before or after the directive was notified. These systems — based on a principle of liability other than no-fault liability — fall outside the scope of the directive which establishes a system of no-fault liability. (
                     18
                  ) However, the rights conferred by a special liability scheme — based on the no-fault principle like the system established by the directive — remain unaffected only if that system predates the directive. To me this solution appears evident: to permit the parallel existence in national law of a different system of no-fault liability would render meaningless the provisions of the directive.
            
         
               31.
            
            
               However, as I pointed out at points 28 and 29 of this Opinion, the derogation provided for in Article 13 of Directive 85/374 does not relate to the liability systems referred to therein but to the right of injured persons conferred by those systems. Consequently, the provision concerning a special liability system must be interpreted as concerning not only the system existing at the moment when the directive is notified, but also the rights conferred by that system at that time.
            
         
               32.
            
            
               I am, furthermore, unconvinced by the argument of the German Government and the Commission, in their observations, that the legislature’s use in Article 13 of Directive 85/374 of the term ‘liability system’ indicates that it means all the rules which form part of that system, irrespective of whether they were in force at the moment when the directive was notified or were introduced later. That provision must be interpreted having regard to its overall content. It clearly refers to the rights conferred by the system existing at the moment when the directive is notified.
            
         Nature of the authorisation conferred by Article 13 of Directive 85/374
      
               33.
            
            
               What then does Article 13 of Directive 85/374 authorise the Federal Republic of Germany to do? The judgment in González Sánchez throws light on this matter. (
                     19
                  ) That case concerned a system of liability for damage caused by products and services which was in force in Spain before Directive 85/374 was notified. That system, like the system established by the directive, was based on the principle of no-fault liability. After the Kingdom of Spain had acceded to the European Communities and that Member State had transposed the directive, the previous system, which was regarded as more favourable to injured persons, (
                     20
                  ) was kept in force, with the exception, however, of products covered by the directive. The applicant in the main proceedings challenged that solution on the grounds that it restricted consumers’ rights in comparison with the situation before the transposition of the directive and claimed the benefit of the previous provision. In her view, under Directive 85/374 that option was justified by Article 13. The Court excluded that possibility. It found, first, that the Spanish liability system was neither a system of contractual or non-contractual liability nor a special liability system, for such a system must be limited to a given sector of production, whereas the Spanish system was of a general nature. The existence of such a system in parallel with the system under the directive could not be permitted. (
                     21
                  ) Summing up, the Court ruled that ‘… the rights conferred under the legislation of a Member State on the victims of damage caused by a defective product under a general system of liability having the same basis as that put in place by … directive [85/374] may be limited or restricted as a result of the Directive’s transposition into the domestic law of that State’. (
                     22
                  ) Therefore, despite having a product liability system which predated Directive 85/374, the Kingdom of Spain had to exclude the application thereof to products covered by that directive.
            
         
               34.
            
            
               On the other hand, the system under the AMG falls within the ambit of Article 13 of Directive 85/374, for it is limited to a given sector of production and it did not, therefore, have to be repealed or adapted following the transposition of the directive into German law. Article 13 of Directive 85/374 thus allowed Germany not to restrict the rights of injured persons conferred by the system established by the AMG and going beyond the rights laid down in the directive. That was precisely the purpose of introducing that part of Article 13 of Directive 85/374, which allows a special liability system to be maintained. That is because, at the moment when the directive was notified, a system of liability for medicinal products, established as a result of dramatic events, (
                     23
                  ) was already in force in Germany and the Community legislature had no intention of restricting the rights of injured persons conferred by that system.
            
         
               35.
            
            
               In the light of that interpretation of Article 13 of Directive 85/374, uncertainty may remain as to the consistency with that provision of Paragraph 15(1) of the ProdHaftG, under which the provisions of that law are not to apply to adverse effects resulting from the administration of a medicinal product. (
                     24
                  ) However, I do not consider that it is necessary to be so categorical and regard that solution as contrary to the directive. Covering the same products with two systems based on no-fault liability functioning in parallel would give rise to complications both for producers and injured persons. On the other hand, it is difficult to find clear benefits arising from such a situation, given that injured persons will generally choose that of those two systems that gives them greater rights.
            
         
               36.
            
            
               The solution adopted in German law must therefore be regarded as rational. However, in my view, that does not mean that the rules on liability for defective medicinal products in Germany are excluded from the harmonisation carried out by Directive 85/374. The provisions of the AMG concerning that liability, in so far as they are covered by the directive, are a means of attaining the objectives set out in that directive, in the same way as the provisions of the ProdHaftG ensure that the objectives of the directive are attained in relation to other categories of product. The sole difference lies in the fact that, under Article 13 of Directive 85/374, the Federal Republic of Germany has the right to maintain the rights of injured persons enjoyed by the latter under the provisions of the AMG in force at the moment when the directive was notified and going beyond the rights conferred by the directive.
            
         
               37.
            
            
               To accept the interpretation proposed by the German Government and the Commission in their written observations, that the Federal Republic of Germany has complete freedom to go on developing the liability system arising from the AMG, would mean that one sector of production alone, in one Member State alone, is excluded from the harmonisation carried out by Directive 85/374. As the parties to the proceedings correctly point out, Article 13 of the directive does not allow a special liability system to be extended to new sectors of production or such special systems to be created in other Member States. What then would be the rationale of a provision which allows new rights to be conferred on injured persons as part of a pre-existing system but which does not allow such rights to be conferred in other sectors of production or in other Member States? In my view, such an interpretation would defy all logic. The justification for the derogation laid down in Article 13 of Directive 85/374 was solely historical in nature and its scope must also remain historical, that is to say, limited to rights already existing at the moment when that directive was notified.
            
         
               38.
            
            
               Special treatment of the medicinal products sector could possibly be justified by the specific nature of those products whose defects can have more far-reaching adverse effects for the health and lives of injured persons than the defects of other types of product. In that case, however, that special treatment is not to be reserved to Member States in which there already, more precisely in 1985, existed a system of liability for such defective products, that is to say, reserved de facto to one Member State only. Furthermore, it should be recalled that the Union legislature had occasion to depart from the general principles of the system of liability for defective medical products in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. (
                     25
                  ) However, that directive makes express provision in Articles 5(4) and 47(2) for the application of Directive 85/374 to medicinal products.
            
         
               39.
            
            
               Nor am I convinced by the argument put forward by the German Government and the Commission that Article 13 of Directive 85/374 must mean allowing free alteration of the special liability system referred to therein, for if it were otherwise that system could not evolve in step with changes in social and economic circumstances, and proper customer protection would not be safeguarded.
            
         
               40.
            
            
               Nor, it should first be noted, has the system established by Directive 85/374 evolved in practice since that directive was adopted. Despite the wording of the 18th recital in the preamble and the review clause contained in Article 21, Directive 85/374 has been amended only once. Directive 1999/34/EC of the European Parliament and of the Council of 10 May 1999 amending Council Directive 85/374/EEC on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (
                     26
                  ) introduced into Directive 85/374 a definition of ‘product’ and removed the possibility of Member States’ excluding agricultural produce from its ambit. The legislature did not, therefore, judge it necessary for the liability system established by the directive to evolve, except for defining one of its terms and removing the possibility of limiting its ambit. (
                     27
                  )
            
         
               41.
            
            
               Secondly, as I pointed out at point 20 of this Opinion, consumer protection is not the only or principal objective of Directive 85/374. The legislature weighed up the individual interests at issue and laid down the principles of product liability which it had not deemed appropriate to amend hitherto. Therefore, if in Article 13 of Directive 85/374 the legislature allowed certain rights of injured persons under the special liability system going beyond the rights conferred by that directive to be maintained, merely increasing the level of consumer protection cannot justify further strengthening of those rights in a manner which departs yet further from the principles laid down in that directive.
            
         
               42.
            
            
               However, I recall that the harmonisation carried out by Directive 85/374 is not ‘complete’ (see points 21 to 24 of this Opinion). The principles laid down in the directive are supplemented and specified pursuant to the rules of law in force in the Member States which arise from both legislation and judicial practice. Those rules may be amended in order, in particular, to be adapted to changes in social and economic circumstances, provided that the system of product liability remains consistent with the principles of such liability laid down in Directive 85/374. In my view, the same applies to the special liability system referred to in Article 13 of that directive. The rights of injured persons conferred by that system may go beyond the scope of the rights provided in that directive only in so far as they did so when it was notified. None the less, the principles governing the functioning of that special system, which relate to issues not governed by the directive, may evolve.
            
         
               43.
            
            
               Consequently, Article 13 Directive 85/374 must to my mind be interpreted as meaning that, with regard to the matters governed by that directive, it allows, as part of a special liability system within the meaning of that provision, the rights of injured persons going beyond the level of protection conferred by the directive to be preserved only if those rights were already in existence when the directive was notified.
            
         
         Problem of the right to obtain disclosure of information
      
      
               44.
            
            
               As is clear from the order for reference and as I pointed out at point 12 of this Opinion, the dispute in the main proceedings concerns to right of the injured person to obtain disclosure of certain information by the producers of a medicinal product. That right is laid down in Paragraph 84a of the AMG. It seems to me that, in order to provide the referring court with an answer which will be of use to it and enable it to determine the case before it, it is necessary to conduct, in addition to a general interpretation of Article 13 of Directive 85/374, an analysis of whether it is permitted to introduce in national legislation an instrument such as the right to obtain disclosure of information provided for by Paragraph 84a of the AMG.
            
         
               45.
            
            
               Directive 85/374 does not directly govern this question of the right to obtain disclosure of information. That right is, however, an instrument intended to make it easier for an injured person to demonstrate the defect of the medicinal product which caused the damage sustained by that person. The question of proof is governed by Article 4 of the directive.
            
         
               46.
            
            
               Under Article 4 of Directive 85/374, the injured person is to be required to prove the defect of the product, the damage sustained, and the causal relationship between defect and damage. However, that provision does not stipulate how such proof is to be adduced. It is clear that in the field of product liability, as in other kinds of legal relations between consumers and economic operators, there is a considerable imbalance as regards access to information, to the detriment of consumers. Consequently, the conventional mechanisms of civil-law liability based on formal equality of the parties and the principle of actori incumbit probatio may prove insufficient to enable consumers to assert their rights effectively against economic operators. The right to obtain disclosure of information laid down in Paragraph 84a of the AMG is intended to rectify that imbalance. It does not lead to a reversal of the burden of proof but merely allows the injured person to obtain disclosure of information about the objective circumstances relating to the product suspected of causing the damage. That information can then help the injured person demonstrate the conditions that render the producer liable.
            
         
               47.
            
            
               The right to obtain disclosure of information is not, therefore, covered by Article 4 of Directive 85/374. It must be found that that issue is one of the aspects not regulated by that directive as referred to in the Court’s case-law cited at point 22 of this Opinion. It is therefore for the national legislation of the Member States to regulate the matter, which is not one of the aspects harmonised by the directive.
            
         
               48.
            
            
               In those circumstances, it must be found that Directive 85/374 does not preclude a Member State from introducing, in its national law, an instrument, such as the right to obtain disclosure of information laid down in Paragraph 84a of the AMG, intended to make it easier to adduce evidence. This applies also to a special liability system within the meaning of Article 13 of the directive. The right to obtain disclosure of information not being one of the aspects harmonised by Directive 85/374, the latter does not preclude the introduction of such a right, even if that right did not exist, as part of that special system, at the moment when the directive was notified.
            
         
         Conclusion
      
      
               49.
            
            
               In the light of the foregoing, I propose that the following answer be given to the question referred by the Bundesgerichtshof:
               
                        (1)
                     
                     
                        Article 13 of Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products must be interpreted as meaning that, with regard to the matters governed by that directive, it allows, as part of a special liability system within the meaning of that provision, the rights of injured persons going beyond the level of protection conferred by the directive to be preserved only if those rights already existed at the moment when the directive was notified.
                     
                  
                        (2)
                     
                     
                        Directive 85/374 does not preclude a Member State from introducing, in its national law, an instrument, such as the right to obtain disclosure of information laid down in Paragraph 84a of the Arzneimittelgesetz, intended to make it easier to adduce evidence. The possibility of introducing such instruments also holds good for a special liability system within the meaning of Article 13 of the directive.
                     
                  
         (
            1
         )	Original language: Polish.
      (
            2
         )	OJ 1985 L 210, p. 29.
      (
            3
         )	BGBl. I, p. 2198.
      (
            4
         )	Consolidated text published on 12 December 2005 (BGBl. I, p. 3394).
      (
            5
         )	BGBl. I, p. 2674.
      (
            6
         )	See the second recital in the preamble to Directive 85/374. See also Taschner, H.C., ‘Product liability: basic problems in a comparative law perspective’, in: Fairgrieve, D., (ed.), Product liability in comparative perspective, Cambridge, 2005, p. 155.
      (
            7
         )	Judgments in Commission v France, C‑52/00, EU:C:2002:252, paragraph 29, and Commission v Greece, C‑154/00, EU:C:2002:254, paragraph 29.
      (
            8
         )	See, to the same effect, judgment in Dutrueux, C‑495/10, EU:C:2011:869, paragraphs 22, 23 and 31.
      (
            9
         )	See, to the same effect, for example, Łętowska, E., Europejskie prawo umów konsumenckich, Warsaw, 2004, pp. 111, 112.
      (
            10
         )	Judgments in Commission v France, EU:C:2002:252, paragraph 24; Commission v Greece, EU:C:2002:254, paragraph 20; Dutrueux, EU:C:2011:869, paragraph 20.
      (
            11
         )	Judgments in Commission v France, EU:C:2002:252, paragraphs 14 to 20; Commission v Greece, EU:C:2002:254, paragraphs 10 to 16. See, in greater detail on that matter, Advocate General Geelhoed in his Opinion in Commission v France, C‑52/00, EU:C:2001:453, points 22 to 56.
      (
            12
         )	Judgment in Moteurs Leroy Somer, C‑285/08, EU:C:2009:351, paragraph 25.
      (
            13
         )	See, for example: Dubouis, L., Blumann, C., Droit matériel de l’Union européenne, 5th edition, Montchrestien, 2009, p. 320; Kowalik-Bańczyk, K., commentary on Article 114 TFEU in: Wróbel, A., (edit.), Traktat o funkcjonowaniu Unii Europejskiej. Komentarz Lex, Vol. II, Warsaw, 2012, p. 521 et seq.
      (
            14
         )	See, to the same effect, for example, Łętowska, E., referred to in footnote 9 above, p. 103.
      (
            15
         )	See, in particular, judgment in González Sánchez, C‑183/00, EU:C:2002:255, paragraph 31.
      (
            16
         )	This is also confirmed in the 13th recital in the preamble to Directive 85/374. Despite certain differences on this point in the various language versions, it clearly concerns a system of liability relating to medical products which already exists (that is to say at the moment when the directive is notified) in a Member State (that is to say Germany).
      (
            17
         )	Emphasis added.
      (
            18
         )	See, to the same effect: Commission v France, EU:C:2002:252, paragraph 22; Commission v Greece, EU:C:2002:254, paragraph 18; González Sánchez, EU:C:2002:255, paragraph 31.
      (
            19
         )	EU:C:2002:255.
      (
            20
         )	González Sánchez, EU:C:2002:255, paragraph 12.
      (
            21
         )	Ibidem, paragraphs 31 to 33.
      (
            22
         )	Ibidem, paragraph 34.
      (
            23
         )	A medical product called Contergan (Thalidomide) given to pregnant women caused deformations in around 2500 infants in Germany. The related compensation proceedings ended with the conclusion of an agreement but at the same time provided the impetus for work on a system of liability for defective medical products and, more broadly, on a system for controlling such products. See, for example, Borghetti, J.S., La responsabilité du fait des produits. Étude de droit comparé, LGDJ, 2004, p. 134.
      (
            24
         )	Moreover, these uncertainties have been raised in academic legal writings: Jagielska, M., Odpowiedzialność za produkt, Zakamycze, 1999, p. 190.
      (
            25
         )	OJ 2001 L 311, p. 67.
      (
            26
         )	OJ 1999 L 141, p. 20.
      (
            27
         )	Moreover, the second point was merely a return to the Commission’s original proposal which had made no provision for the exclusion of agricultural produce from the scope of that directive (see Proposal for a Council Directive relating to the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products of 9 September 1976, OJ 1976 C 241, p. 9).