CELEX: 62008CJ0262
Language: en
Date: 2010-06-10
Title: Judgment of the Court (Third Chamber) of 10 June 2010.#CopyGene A/S v Skatteministeriet.#Reference for a preliminary ruling: Østre Landsret - Denmark.#Sixth VAT Directive - Exemptions - Article 13A(1)(b) - Hospital and medical care - Closely related activities - Duly recognised establishments of a nature similar to hospitals or centres for medical treatment or diagnosis - Private stem cell bank - Services of collection, transportation, analysis and storage of umbilical cord blood of newborn children - Possible autologous or allogeneic use of stem cells.#Case C-262/08.

Case C-262/08
      CopyGene A/S
      v
      Skatteministeriet
      (Reference for a preliminary ruling from the Østre Landsret)
      (Sixth VAT Directive – Exemptions – Article 13A(1)(b) – Hospital and medical care – Closely related activities – Duly recognised establishments of a nature similar to hospitals or centres for medical treatment or diagnosis – Private stem cell bank – Services of collection, transportation, analysis and storage of umbilical cord blood of newborn children – Possible autologous or allogeneic use of stem cells)
      Summary of the Judgment
      1.        Tax provisions – Harmonisation of laws – Turnover taxes – Common system of value added tax – Exemptions provided for in the
            Sixth Directive – Exemption for hospital and medical care and closely related activities
      (Council Directive 77/388, Art. 13A(1)(b))
      2.        Tax provisions – Harmonisation of laws – Turnover taxes – Common system of value added tax – Exemptions provided for in the
            Sixth Directive – Exemption for hospital and medical care and closely related activities
      (European Parliament and Council Directive 2004/23; Council Directive 77/388, Art 13A(1)(b))
      1.        The concept of activities ‘closely related’ to ‘hospital and medical care’ within the meaning of Article 13A(1)(b) of Sixth
         Directive 77/388 on the harmonisation of the laws of the Member States relating to turnover taxes is to be interpreted as
         meaning that it does not cover activities consisting in the collection, transportation and analysis of umbilical cord blood
         and the storage of stem cells contained in it, when the medical care provided in a hospital environment to which those activities
         are merely potentially related has not been performed, commenced or yet envisaged.
      
      Indeed, it is established that, whatever the precise figures derived from the current state of scientific knowledge may be,
         in the case of the majority of the recipients of the activities concerned, there is not and probably never will be a principal
         service coming within the concept of ‘hospital and medical care’ within the meaning of Article 13A(1)(b) of the Sixth Directive.
         It is only in the double eventuality that, first, the state of medical science enables or requires use of cord stem cells
         for the treatment or prevention of a given illness and, second, that illness presents or is likely to present in a specific
         case that a sufficiently close link would exist between, on the one hand, the hospital and medical care which would constitute
         the principal service and, on the other, the activities concerned. In those circumstances, even accepting that those activities
         could have no purpose other than that of using the cord stem cells thus preserved in connection with medical care provided
         in a hospital environment and could not be diverted to other uses, those activities cannot be regarded as actually being supplied
         as services ancillary to the hospital or medical care received by the patients in question and constituting the principal
         service.
      
      (see paras 47-49, 52, operative part 1)
      2.        If the services of stem cell banks are performed by professional medical personnel, when such stem cell banks, although authorised
         by the competent health authorities of a Member State, within the framework of Directive 2004/23 on setting standards of quality
         and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissue and
         cells, to handle human tissue and cells, do not receive any support from the public social security scheme and when the payment
         for those services is not covered by that scheme, Article 13A(1)(b) of Sixth Directive 77/388 on the harmonisation of the
         laws of the Member States relating to turnover taxes does not preclude the national authorities from deciding that such stem
         cell banks are not ‘other duly recognised establishments of a similar nature’ to ‘hospitals [and] centres for medical care
         or diagnosis’ within the meaning of Article 13A(1)(b) of Sixth Directive 77/388. Nor, however, can that provision be interpreted
         as requiring, in itself, the competent authorities to refuse to treat a private stem cell bank as an establishment ‘duly recognised’
         for the purposes of the exemption in question. To the extent that it is necessary, it is for the referring court to determine
         whether the refusal of recognition for the purposes of the exemption provided for in Article 13A(1)(b) of Sixth Directive
         77/388 is compatible with European Union law and, in particular, with the principle of fiscal neutrality.
      
      It is, in principle, for the national law of each Member State to lay down the rules according to which recognition under
         Article 13A(1)(b) of Sixth Directive 77/388 may be granted to establishments that request it. When a taxable person seeks
         the status of an establishment duly recognised for the purposes of that article, it is for the competent authorities to observe
         the limits of the discretion conferred upon them by the latter provision in applying the principles of European Union law,
         in particular the principle of equal treatment which, in the field of value added tax, takes the form of the principle of
         fiscal neutrality. In that regard, in order to determine which establishments should be ‘recognised’ under that provision,
         the national authorities must, in accordance with European Union law and subject to review by the national courts, take into
         consideration a number of factors, including the public interest of the activities of the taxable person in question, the
         fact that other taxable persons carrying on the same activities already have similar recognition, and the fact that the costs
         incurred for the treatment in question may be largely met by health insurance schemes or other social security bodies.
      
      In that regard, the mere fact that the services supplied by a taxable person are furnished by qualified health professionals
         does not in itself prevent the national authorities refusing to grant to that taxable person the recognition which would entitle
         it to the exemption under Article 13A(1)(b) of the Sixth Directive. Also, the national authorities are entitled to take into
         account the fact that a taxable person’s activities receive no support from and are not covered by the public social security
         scheme in order to determine whether an entity should be recognised. However, that does not mean that the exemption concerned
         must be systematically excluded when the services supplied are not reimbursed by the social security authorities. It is rather
         a factor which must be weighed in the balance, and which could be outweighed, for example, by the necessity to ensure equal
         treatment. If a taxable person’s situation is comparable to that of other operators providing the same services in comparable
         situations, the mere fact that the cost of those services is not fully covered by the social security authorities does not
         justify a difference in the treatment of providers for valued added tax purposes. Finally, the fact that a taxable person
         has been authorised by the competent health authorities to handle cord stem cells under the national legislation implementing
         Directive 2004/23, may be a factor tending to support the argument that such service provider is, in any case, ‘duly recognised’
         within the meaning of Article 13A(1)(b) of the Sixth Directive. However, if the national authorities are not to be deprived
         of the discretion which that provision confers upon them, the mere fact that they have authorised such activities, in accordance
         with the European Union’s prescribed standards of quality and safety in the sector concerned, cannot lead, by itself and automatically,
         to recognition from the point of view of Article 13A(1)(b) of the Sixth Directive. Obtaining such authorisation is a necessary
         condition to carrying on the activity of a private stem cell bank. However, the granting of such authorisation is not, in
         itself, synonymous with recognition for the purposes of Article 13A(1)(b) of the Sixth Directive.
      
      (see paras 63-65, 68-69, 71, 74-75, 81, operative part 2)
JUDGMENT OF THE COURT (Third Chamber)
      10 June 2010 (*)
      
      (Sixth VAT Directive – Exemptions – Article 13A(1)(b) – Hospital and medical care – Closely related activities – Duly recognised establishments of a nature similar to hospitals or centres for medical treatment or diagnosis – Private stem cell bank – Services of collection, transportation, analysis and storage of umbilical cord blood of newborn children – Possible autologous or allogeneic use of stem cells)
      In Case C‑262/08,
      REFERENCE for a preliminary ruling under Article 234 EC from the Østre Landsret (Denmark), made by decision of 13 June 2008,
         received at the Court on 19 June 2008, in the proceedings
      
      CopyGene A/S
      v
      Skatteministeriet,
      THE COURT (Third Chamber),
      composed of J.N. Cunha Rodrigues, President of the Second Chamber, acting for the President of the Third Chamber, P. Lindh,
         A. Rosas, A. Ó Caoimh (Rapporteur) and A. Arabadjiev, Judges,
      
      Advocate General: E. Sharpston,
      Registrar: R. Şereş, Administrator,
      having regard to the written procedure and further to the hearing on 14 May 2009,
      after considering the observations submitted on behalf of:
      –        CopyGene A/S, by A. Hedetoft and M. Andersen, advokater,
      –        the Danish Government, by B. Weis Fogh, acting as Agent, and D. Auken, advokat,
      –        the Greek Government, by K. Georgiadis, I. Bakopoulos, G. Kanellopoulos and I. Pouli, acting as Agents,
      –        the Commission of the European Communities, by H. Støvlbæk and D. Triantafyllou, acting as Agents,
      after hearing the Opinion of the Advocate General at the sitting on 10 September 2009,
      gives the following
      Judgment
      1        This reference for a preliminary ruling concerns the interpretation of Article 13A(1)(b) of Sixth Council Directive 77/388/EEC
         of 17 May 1977 on the harmonisation of the laws of the Member States relating to turnover taxes – Common system of value added
         tax: uniform basis of assessment (OJ 1977 L 145, p. 1; ‘the Sixth Directive’).
      
      2        The reference was made in the course of proceedings between CopyGene A/S (‘CopyGene’) and the Skatteministeriet (Ministry
         of Taxation) concerning the refusal of the Danish tax authorities to exempt from value added tax (‘VAT’) services offered
         by CopyGene consisting in the collection, transportation, analysis and storage of blood from the umbilical cord (‘cord blood’)
         for the purpose of using stem cells from that blood for possible future medical treatment, either ‘autologous’ or, as the
         case may be, ‘allogeneic’.
      
       Legal context
       European Union law
       The Sixth Directive
      3        Article 2(1) of the Sixth Directive makes ‘the supply of goods or services effected for consideration within the territory
         of the country by a taxable person acting as such’ subject to VAT.
      
      4        Article 13A(1)(b) and (c) of the Sixth Directive provide:
      
      ‘Without prejudice to other Community provisions, Member States shall exempt the following under conditions which they shall
         lay down for the purpose of ensuring the correct and straightforward application of such exemptions and of preventing any
         possible evasion, avoidance or abuse:
      
      …
      (b)      hospital and medical care and closely related activities undertaken by bodies governed by public law or, under social conditions
         comparable to those applicable to bodies governed by public law, by hospitals, centres for medical treatment or diagnosis
         and other duly recognised establishments of a similar nature;
      
      (c)      the provision of medical care in the exercise of the medical and paramedical professions as defined by the Member State concerned;
      …’
      5        Article 13A(2)(a) of the Sixth Directive provides that Member States may make the granting to bodies other than those governed
         by public law of the exemption provided for in paragraph (1)(b) of that article subject, in each individual case, to one or
         more of the conditions it lays down.
      
      6        Article 13A(2)(b) provides:
      
      ‘The supply of services or goods shall not be granted exemption as provided for in (1)(b), (g), (h), (i), (l), (m) and (n)
         above if:
      
      –        it is not essential to the transactions exempted,
      –        its basic purpose is to obtain additional income for the organisation by carrying out transactions which are in direct competition
         with those of commercial enterprises liable for value added tax.’
      
       Directive 2004/23/EC
      7        In the words of Article 1 of Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting
         standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution
         of human tissues and cells (OJ 2004 L 102, p. 48), that directive ‘lays down standards of quality and safety for human tissues
         and cells intended for human applications …’.
      
      8        Recital 1 in the preamble to that directive states that the transplantation of human tissues and cells ‘is a strongly expanding
         field of medicine offering great opportunities for the treatment of as yet incurable diseases’. Recital 7 in the preamble
         states that the directive should apply to umbilical cord stem cells.
      
      9        Article 3(p) and (q) of the directive define allogeneic use as cells or tissues removed from one person being applied to another,
         and autologous use as cells or tissues being removed from and applied in the same person.
      
      10      Under Article 6(1) of Directive 2004/23, Member States are to ensure that all tissue establishments where activities of testing,
         processing, preservation, storage or distribution of human tissues and cells intended for human applications are undertaken
         have been accredited, designated, authorised or licensed by a competent authority for the purpose of those activities.
      
       National legislation
      11      It is common ground in the main proceedings that Paragraph 13(1)(1) of the Law on VAT (momsloven) must be interpreted in accordance
         with Article 13A(1)(b) of the Sixth Directive.
      
      12      Directive 2004/23 was transposed into Danish law by the Law on the requirement for quality and safety in handling human tissues
         and cells (vævsloven).
      
      13      The activities of stem cell banks are regulated in Denmark by, in particular, the Law on the marketing of health services
         (lov om markedsføring af sundhedsydelser), the Law on the protection of personal data (persondataloven) and the Law on patients’
         rights (lov om patienters retsstilling). It is apparent from the Court file that the last-mentioned law has been supplemented
         by several administrative guidelines, including Guidelines No 83 of 22 September 1998 on biobanks in the health sector: patients’
         rights and official requirements (vejledning nr. 83 of 22 September 1998 om biobanker inden for sundhedsområdet: Patientrettigheder
         og mydighedskrav).
      
       The main proceedings and the questions referred for a preliminary ruling
      14      The Østre Landsret (Eastern Regional Court) explains that stem cells are immature cells capable of reproducing themselves
         and of renewing other specialised cells in the body. They can be extracted from embryos, cord blood, bone marrow or peripheral
         blood, and are used to treat diseases in which special cells are absent or have been destroyed. That court states that stem
         cells from cord blood (‘cord stem cells’) have been used since 1988.
      
      15      In the long term, according to the referring court, it should be possible to use stem cells in treatments for diabetes, rheumatism,
         cancer, Parkinson’s and Alzheimer’s diseases and cystic fibrosis. It adds that research is being carried out worldwide into
         further development of their possible therapeutic uses. However, the decision for reference states that not all kinds of stem
         cell can be used to treat all types of disease. In some cases, cord stem cells are preferable.
      
      16      CopyGene is described in the decision for reference as being ‘Scandinavia’s largest privately owned biobank’. It offers to
         prospective parents the collection, transportation, analysis and storage of cord blood of newborn children with a view to
         using the cord stem cells contained in it to treat the child in the event of serious disease. Those services are not covered
         or reimbursed by the Danish public health insurance scheme.
      
      17      First, the future parents sign a contract with CopyGene for the blood to be collected, transported and analysed. The blood
         is drawn off immediately after birth by authorised medical personnel who are also contractually bound to CopyGene. It is next
         transported to CopyGene’s laboratory and then analysed to establish whether there are sufficient live stem cells to justify
         their storage. If there are, the parents can conclude a further renewable contract with CopyGene for the cryopreservation
         (freezing) and storage of the cells.
      
      18      The stem cells in question can be used only for hospital care. The blood is the property of the child, represented by its
         mother. CopyGene does not own the stem cells and has no right to use them for research, transplantation or other purposes.
      
      19      In accordance with the Law on the requirement for quality and safety in handling human tissues and cells, CopyGene is authorised
         to handle cord stem cells for ‘autologous’ use. Following the purchase of another Danish biobank, which is authorised to handle
         stem cells for both autologous and allogeneic use, CopyGene entered into negotiations with the Danish authorities about unifying
         the systems of the two stem cell banks so that all the stem cell samples, both previously frozen and new, would undergo the
         same process of analysis and could be used both autologously and allogeneicly. CopyGene stated in its written observations
         that it expected to obtain an authorisation to do so in the course of 2009.
      
      20      By decision of 1 July 2004, the Told- og Skattestyrelsen (Customs and Tax Directorate) rejected an application for exemption
         from VAT for the services at issue in the main proceedings. CopyGene’s complaint against that decision was dismissed on 21
         October 2005 by the Landsskatteretten (National Tax Tribunal).
      
      21      CopyGene appealed to the referring court against the refusal to grant the exemption applied for, arguing that its supplies
         of services should be regarded as being ‘closely related’ to hospital and medical care and, consequently, should be exempted
         from VAT under Article 13A(1)(b) of the Sixth Directive.
      
      22      In those circumstances, the Østre Landsret decided to stay the proceedings and to refer the following questions to the Court
         for a preliminary ruling:
      
      ‘(1)      Is the term activity “closely related” to hospital care in Article 13A(1)(b) of the Sixth Directive to be interpreted as implying
         a temporal requirement so that the hospital care to which the service is closely related must exist or be specifically performed,
         commenced or envisaged, or is it sufficient that the service will potentially be closely related to possible, but as yet non-existent
         or undetermined future hospital care, so that the services supplied by a stem cell bank, consisting in the collection, transportation,
         analysis and storage of umbilical cord blood from newborns for autologous use, are covered by it?
      
      In that connection, is it relevant that the services described cannot be performed at a later time than the time of delivery?
      (2)      Is Article 13A(1)(b) of the Sixth Directive to be interpreted as covering general preventive services where the services are
         supplied before the hospital or medical care takes place and before the hospital or medical care is required in both temporal
         and health terms?
      
      (3)      Is the term “other duly recognised establishments of a similar nature” in Article 13A(1)(b) of the Sixth Directive to be interpreted
         as covering private stem cell banks where the services – which are performed and supplied by professional health personnel
         in the form of nurses, midwives and bioanalysts – consist in the collection, transportation, analysis and storage of umbilical
         cord blood from newborns with a view to autologous use in connection with possible future hospital care where the stem cell
         banks concerned do not receive support from the public heath insurance scheme and where the expenditure on the services provided
         by these stem cell banks is not covered by the public health insurance scheme?
      
      In that connection, is it relevant whether or not a private stem cell bank has obtained authorisation from a Member State’s
         competent health authorities to handle tissue and cells – in the form of processing, preserving and storing stem cells from
         umbilical cord blood for autologous use – pursuant to national legislation which implements Directive 2004/23 …?
      
      (4)      Is the answer to Questions 1 to 3 affected by whether the above services are supplied with a view to possible allogeneic use
         and provided by a private stem cell bank which has obtained authorisation from a Member State’s competent health authorities
         to handle tissue and cells – in the form of processing, preserving and storing stem cells from umbilical cord blood for autologous
         use – pursuant to national legislation which implements Directive 2004/23 …?’
      
       The questions referred
       Preliminary observations 
      23      Under the Sixth Directive, the scope of VAT is very wide in that Article 2 thereof, which concerns taxable transactions, refers
         not only to imports of goods but also to the supply of goods or services effected for consideration within the territory of
         the country by a taxable person acting as such (see, in particular, Case C‑255/02 Halifax and Others [2006] ECR I‑1609, paragraph 49; Case C‑401/05 VDP Dental Laboratory [2006] ECR I‑12121, paragraph 22; and Case C-88/09 Graphic Procédé [2010] ECR I‑0000, paragraph 15). Article 13 of the Sixth Directive nevertheless exempts certain activities from VAT.
      
      24      It is settled case-law that the exemptions referred to in Article 13 of the Sixth Directive constitute independent concepts
         of European Union law whose purpose is to avoid divergences in the application of the VAT system as between one Member State
         and another (see, in particular, Case C-349/96 CPP [1999] ECR I‑973, paragraph 15, and Case C‑473/08 Eulitz [2010] ECR I‑0000, paragraph 25). 
      
      25      The Court has also consistently held that the exemptions in Article 13A of the Sixth Directive are not aimed at exempting
         from VAT every activity performed in the public interest, but only those which are listed and described in great detail in
         it (see, in particular, Case 107/84 Commission v Germany [1985] ECR 2655, paragraph 17; Case C‑307/01 D’Ambrumenil and Dispute Resolution Services [2003] ECR I‑13989, paragraph 54; and Eulitz, paragraph 26, and the case-law cited).
      
      26      The terms used to specify the exemptions in Article 13 of the Sixth Directive are to be interpreted strictly, since they constitute
         exceptions to the general principle that VAT is to be levied on all goods and services supplied for consideration by a taxable
         person. Nevertheless, the interpretation of those terms must be consistent with the objectives pursued by those exemptions
         and comply with the requirements of the principle of fiscal neutrality inherent in the common system of VAT. Thus, the requirement
         of strict interpretation does not mean that the terms used to specify the exemptions referred to in Article 13 should be construed
         in such a way as to deprive the exemptions of their intended effect (see, in particular, Case C‑445/05 Haderer [2007] ECR I‑4841, paragraph 18, and the case-law cited, and Eulitz, paragraph 27, and the case-law cited).
      
      27      As regards medical services, it is clear from the case-law that Article 13A(1)(b) of the Sixth Directive covers all services
         supplied in a hospital environment while Article 13A(1)(c) thereof covers medical services provided outside such a framework,
         both at the private address of the person providing the care and at the patient’s home or at any other place (see, to that
         effect, Case C‑141/00 Kügler [2002] ECR I‑6833, paragraph 36). It follows that Article 13A(1)(b) and (c) of the Sixth Directive, which have separate fields
         of application, are intended to regulate all exemptions of medical services in the strict sense (see Kügler, paragraph 36, and Case C‑106/05 L.u.P. [2006] ECR I‑5123, paragraph 26).
      
      28      It follows, as the Court has previously ruled, that the concept of ‘medical care’ in Article 13A(1)(b) of the Sixth Directive
         and that of ‘the provision of medical care’ in Article 13A(1)(c) are both intended to cover services which have as their purpose
         the diagnosis, treatment and, in so far as possible, cure of diseases or health disorders (see Case C‑45/01 Dornier [2003] ECR I‑12911, paragraph 48, and the case-law cited, and L.u.P., paragraph 27).
      
      29      Whilst ‘medical care’ and ‘the provision of medical care’ must have a therapeutic aim, it does not necessarily follow that
         the therapeutic purpose of a service must be confined within a particularly narrow compass (see Case C‑76/99 Commission v France [2001] ECR I‑249, paragraph 23, and Case C‑212/01 Unterpertinger [2003] ECR I‑13859, paragraph 40).
      
      30      Thus the Court has already ruled that medical services effected for prophylactic purposes may benefit from exemption under
         Article 13A(1)(b) or (c) of the Sixth Directive. Even in cases where the persons who are the subject of examinations or other
         medical intervention of a prophylactic nature are not suffering from any disease or health disorder, the inclusion of those
         services within the meaning of ‘medical care’ and ‘the provision of medical care’ is consistent with the objective of reducing
         the cost of healthcare, which is common to both the exemption under Article 13A(1)(b) of the Sixth Directive and that under
         (c) of that paragraph (see, to that effect, L.u.P., paragraph 29, and the case-law cited). Accordingly, medical services supplied for the purpose of protecting, including maintaining
         or restoring, human health may benefit from the exemption under Article 13A(1)(b) and (c) of that directive (see, to that
         effect, Unterpertinger, paragraphs 40 and 41, and D’Ambrumenil and Dispute Resolution Services, paragraphs 58 and 59).
      
      31      It is in the light in particular of those considerations that the questions referred must be answered.
      
       The first and second questions, read in conjunction with the fourth question
      32      By its first two questions, read in conjunction with the fourth question, the referring court seeks, in essence, to determine
         whether the collection, transportation, analysis and storage of cord blood with a view to the possible use of the stem cells
         in it for the purposes of future autologous medical treatment can be covered by the exemption from VAT under Article 13A(1)(b)
         of the Sixth Directive, as an activity ‘closely related’ to ‘hospital and medical care’ within the meaning of that provision.
      
      33      In that context, by its first question, the referring court is asking, in essence, whether the concept of activities ‘closely
         related’ to ‘hospital and medical care’ within the meaning of Article 13A(1)(b) of the Sixth Directive is to be interpreted
         as meaning that it can cover activities such as those at issue in the main proceedings, even though the possible hospital
         care in question has not necessarily been performed, commenced or yet envisaged. The second question seeks more particularly
         to ascertain, in essence, whether Article 13A(1)(b) of the Sixth Directive encompasses, as preventive services, activities
         such as those at issue in the main proceedings. The fourth question concerns also, particularly, the point whether the possibility
         of a taxable person such as CopyGene being authorised to supply services with a view to both autologous and allogeneic uses
         has any bearing on the reply to be given to those first two questions. 
      
      34      As regards, first of all, the point, raised by the second question, whether Article 13A(1)(b) of the Sixth Directive encompasses,
         as preventive services, activities such as those at issue in the main proceedings, it is already clear from paragraph 30 of
         the present judgment that preventive medical services can come within the meaning of ‘medical care’ for the purposes of that
         provision.
      
      35      However, in the present case, neither the referring court nor any of the parties which have submitted observations to the
         Court has suggested that the activities at issue in the main proceedings come themselves within the meaning of ‘medical care’
         in Article 13A(1)(b) of the Sixth Directive.
      
      36      In any event, while the detection of illness may admittedly be one of the possible purposes for collecting cord stem cells,
         it appears, from the file before the Court, that the services provided by CopyGene seek only to ensure that a particular resource
         will be available for medical treatment in the uncertain event that it becomes necessary, but they do not constitute, as such,
         activities seeking to avert, avoid or prevent disease, injury or health problems, or to detect latent or incipient conditions.
         Were that the case, which it is, where necessary, for the referring court to determine, activities such as those at issue
         in the main proceedings could not be regarded as being, by themselves, preventive.
      
      37      On the other hand, if the referring court concluded that the analysis of cord blood actually has a medical diagnostic purpose
         and does not merely form part of the tests to determine whether the stem cells are viable, the conclusion would follow that
         there was a supply of diagnostic care within the exemption laid down in Article 13A(1)(b) of the Sixth Directive, subject
         to compliance with the other requirements laid down by that provision and by that directive.
      
      38      As regards, next, the concept of activities ‘closely related’ to ‘hospital and medical care’ within the meaning of Article
         13A(1)(b) of the Sixth Directive, it is apparent from the very terms of that provision that it does not envisage services
         which are unrelated to hospital care for the patients receiving those services or to any medical care which they might receive
         (see Dornier, paragraph 33, and Joined Cases C‑394/04 and C‑395/04 Ygeia [2005] ECR I‑10373, paragraph 17).
      
      39      Accordingly, the Court ruled that services fall within the concept of ‘activities closely related’ to hospital or medical
         care appearing in Article 13A(1)(b) of the Sixth Directive only when they are actually supplied as a service ancillary to
         the hospital or medical care received by the patients in question and constituting the principal service (see Ygeia, paragraph 18).
      
      40      In that regard, it follows from the case-law that a service may be regarded as ancillary to a principal service if it does
         not constitute an end in itself, but a means of better enjoying the supplier’s principal service (see Commission v France, paragraph 27; Dornier, paragraph 34; Ygeia, paragraph 19; and Case C‑434/05 Horizon College [2007] ECR I-4793, paragraph 29, and the case-law cited). As regards medical services, the Court has stated that, taking
         account of the objective pursued by the exemption provided for in Article 13A(1)(b) of the Sixth Directive, only the supply
         of services which are logically part of the provision of hospital and medical-care services, and which constitute an indispensable
         stage in the process of the supply of those services to achieve their therapeutic objectives, is capable of amounting to ‘closely
         related activities’ within the meaning of that provision (see, to that effect, Ygeia, paragraph 25).
      
      41      In this case, it appears from the Court file that, by reason of among other things the relevant Danish legislation and the
         contract between CopyGene and the client parents, the cord stem cells concerned by the activities at issue in the main proceedings
         can be used only for medical treatment, namely transplants, to the exclusion of all other purposes, for example that of research.
      
      42      It is apparent from the file before the Court that such treatment involves the carrying-out of complex medical interventions
         which are usually, if not always, performed in a hospital environment. Since such treatment is intended to treat and, in so
         far as possible, to cure diseases or health disorders, it comes within, as follows from paragraph 28 of the present judgment,
         the concept of ‘medical care’ in Article 13A(1)(b) of the Sixth Directive.
      
      43      The Danish and Greek Governments as well as the Commission of the European Communities argue however, in essence, that the
         activities at issue in the main proceedings present, in the current state of scientific knowledge, so distant and hypothetical
         a link with the possible future hospital care of the persons concerned that there can be no question of their being activities
         closely related to hospital and medical care within the meaning of Article 13A(1)(b) of the Sixth Directive.
      
      44      In that regard, as is clear from paragraph 24 of the present judgment, the exemptions referred to in Article 13 of the Sixth
         Directive constitute independent concepts of European Union law. Therefore, it is not appropriate in this case to base the
         interpretation of Article 13A(1)(b) of that directive principally on the ‘current’ state of scientific knowledge, all the
         more so as it is clear from the contents of the file before the Court that, in the field subject to this reference for a preliminary
         ruling, the state of scientific knowledge is constantly developing. It is very difficult for courts to evaluate that state
         with confidence in a field such as that at issue in the main proceedings.
      
      45      Further, the exemption provided for in Article 13A(1)(b) of the Sixth Directive does not impose what the referring court describes,
         in its first question, as a ‘temporal requirement’. Neither the purpose of that exemption nor the general scheme of the Sixth
         Directive requires that provision to be interpreted as if there were such a requirement. Thus, the possibility put forward
         in that question that there could be a long period of time between the collection of the cord stem cells concerned and their
         possible future use for the purposes of hospital or medical care does not, as such, preclude activities such as those at issue
         in the main proceedings from coming within that exemption, all the more so since, as the referring court points out in the
         second part of the first question, it is impossible to collect blood containing cord stem cells otherwise than at birth.
      
      46      However, it does not follow that the activities at issue in the main proceedings could be regarded as being services which
         are ‘closely related’ to ‘hospital and medical care’ within the meaning of Article 13A(1)(b) of the Sixth Directive.
      
      47      In that regard, it is established that, whatever the precise figures derived from the current state of scientific knowledge
         may be, in the case of the majority of the recipients of the activities at issue in the main proceedings, there is not and
         probably never will be a principal service coming within the concept of ‘hospital and medical care’ within the meaning of
         Article 13A(1)(b) of the Sixth Directive. Thus, the first question is based on the premiss that, when services such as those
         at issue in the main proceedings are supplied, there is usually no hospital or medical care which has been performed, commenced,
         necessitated or determined, or even envisaged in its major aspects.
      
      48      Indeed, it is only in the double eventuality that, first, the state of medical science enables or requires use of cord stem
         cells for the treatment or prevention of a given illness and, second, that illness presents or is likely to present in a specific
         case that a sufficiently close link would exist between, on the one hand, the hospital and medical care which would constitute
         the principal service and, on the other, the activities at issue in the main proceedings.
      
      49      In those circumstances, even accepting that the activities at issue in the main proceedings could have no purpose other than
         that of using the cord stem cells thus preserved in connection with medical care provided in a hospital environment and could
         not be diverted to other uses, those activities cannot be regarded as actually being supplied as services ancillary to the
         hospital or medical care received by the patients in question and constituting the principal service.
      
      50      Therefore, those activities do not fall within the concept of activities ‘closely related’ to ‘hospital and medical care’
         within the meaning of Article 13A(1)(b) of the Sixth Directive. Indeed, since the hospital and medical care have not been
         performed, commenced or yet envisaged, activities such as those at issue in the main proceedings are merely liable, if certain
         eventualities come to pass, to be closely related to medical care provided in a hospital environment.
      
      51      As regards, finally, the possibility raised in the fourth question, namely the allogeneic rather than autologous use of the
         cord stem cells, it is sufficient to observe that that circumstance has, as a rule, no bearing on the conclusions set forth
         in paragraphs 34 to 50 of the present judgment.
      
      52      Having regard to the foregoing, the reply to the first, second and fourth questions referred, read together, is that the concept
         of activities ‘closely related’ to ‘hospital and medical care’ within the meaning of Article 13A(1)(b) of the Sixth Directive
         is to be interpreted as meaning that it does not cover activities such as those at issue in the main proceedings consisting
         in the collection, transportation and analysis of cord blood and the storage of stem cells contained in it, where the medical
         care provided in a hospital environment to which those activities are merely potentially related has not been performed, commenced
         or yet envisaged.
      
       The third question, read in conjunction with the fourth question
      53      The third question is intended, in essence, to ascertain whether, in circumstances such as those at issue in the main proceedings,
         national authorities may legitimately decide that taxable persons such as CopyGene are not ‘other duly recognised establishments
         of a similar nature’ to ‘hospitals [and] centres for medical treatment or diagnosis’ within the meaning of Article 13A(1)(b)
         of the Sixth Directive.
      
      54      In that context, the referring court is asking in particular whether, if the services of stem cell banks such as those at
         issue in the main proceedings are performed by professional medical personnel, where such stem cell banks, although authorised
         by the competent health authorities of a Member State within the framework of Directive 2004/23 to handle human tissue and
         cells, do not receive any support from the public health insurance scheme and where the payment for those services is not
         covered by that scheme, Article 13A(1)(b) of the Sixth Directive precludes the national authorities from deciding that taxable
         persons such as CopyGene are not ‘other duly recognised establishments of a similar nature’ to ‘hospitals [and] centres for
         medical care or diagnosis’ within the meaning of Article 13A(1)(b) of the Sixth Directive.
      
      55      The fourth question concerns, particularly, the point whether the possibility of a taxable person such as CopyGene being authorised
         to supply services with a view to both autologous and allogeneic uses could have any bearing on the reply to be given to the
         third question.
      
      56      In the words of Article 13A(1)(b) of the Sixth Directive, Member States are to exempt from VAT the supply of services coming
         within that provision where those services are ‘undertaken by bodies governed by public law or, under social conditions comparable
         to those applicable to bodies governed by public law, by hospitals, centres for medical treatment or diagnosis and other duly
         recognised establishments of a similar nature’.
      
      57      In this respect, it should be noted that the rules for interpreting the exemptions in Article 13 of the Sixth Directive set
         out in paragraph 26 of the present judgment apply to the specific conditions laid down for those exemptions to apply and in
         particular to those concerning the status or identity of the economic agent performing the services covered by the exemption
         (see Eulitz, paragraph 42, and the case-law cited).
      
      58      As regards Article 13A(1)(b) of the Sixth Directive, it is clear from the Court’s settled case-law that that provision covers
         duly recognised establishments pursuing social purposes, such as the protection of human health (see, to that effect, Dornier, paragraph 47).
      
      59      As regards, as a preliminary point, the concept of ‘other … establishments of a similar nature’ to ‘hospitals [and] centres
         for medical treatment or diagnosis’ within the meaning of Article 13A(1)(b) of the Sixth Directive, the Danish and Greek Governments
         maintain that CopyGene cannot be likened to hospitals or centres for medical treatment or diagnosis.
      
      60      Where necessary, it is for the referring court to determine whether an operator such as CopyGene is ‘of a similar nature’
         to hospitals and centres for medical treatment or diagnosis. It should be noted, as the Court has already ruled, that since
         diagnostic medical tests, in the light of their therapeutic purpose, come within the concept of ‘medical care’ as referred
         to in Article 13A(1)(b) of the Sixth Directive, a laboratory governed by private law and undertaking analyses must be regarded
         as being an establishment ‘of a similar nature’ to ‘hospitals’ and ‘centres for medical treatment or diagnosis’ within the
         meaning of that provision (see L.u.P., paragraphs 18 and 35). That being so, in the present case, CopyGene, in answer to a question at the hearing before the Court,
         stated in essence that, usually, it analyses cord stem cells solely in order to ascertain whether there are sufficient ‘viable’
         cells to justify the preservation of the sample in question.
      
      61      As regards the meaning of ‘duly recognised establishments’, that is to say the only one of the requirements set out in paragraph
         56 of the present judgment which was addressed in detail either in the decision for reference or in the observations submitted
         to the Court, it is clear from the case-law that the recognition of an establishment for the purposes of Article 13A(1)(b)
         of the Sixth Directive does not presuppose a formal recognition procedure and that such recognition need not necessarily be
         derived from national tax law provisions (see, to that effect, Dornier, paragraphs 64, 65, 67 and 76).
      
      62      Therefore, the fact that the Kingdom of Denmark has not exercised the right, provided for by Article 13A(2)(a) of the Sixth
         Directive, to make the granting to bodies other than those governed by public law of the exemption provided for in Article
         13A(1)(b) subject, in each individual case, to one or more of the conditions referred to later in paragraph 2, does not affect
         the possibility that an establishment may be recognised for the purposes of granting the exemption referred to in Article
         13A(1)(b) of the Sixth Directive (see, by analogy, Dornier, paragraph 66).
      
      63      It is thus, in principle, for the national law of each Member State to lay down the rules according to which such recognition
         may be granted to establishments which request it. The Member States enjoy a discretion in this regard (Dornier, paragraphs 64 and 81, and L.u.P., paragraph 42).
      
      64      Where a taxable person seeks the status of an establishment duly recognised for the purposes of Article 13A(1)(b) of the Sixth
         Directive, it is for the competent authorities to observe the limits of the discretion conferred upon them by the latter provision
         in applying the principles of European Union law, in particular the principle of equal treatment which, in the field of VAT,
         takes the form of the principle of fiscal neutrality (see, to that effect, Dornier, paragraph 69, and L.u.P., paragraph 48).
      
      65      In that regard, in order to determine which establishments should be ‘recognised’ under that provision, the national authorities
         should, in accordance with European Union law and subject to review by the national courts, take into consideration a number
         of factors, which include the public interest of the activities of the taxable person in question, the fact that other taxable
         persons carrying on the same activities already have similar recognition, and the fact that the costs incurred for the treatment
         in question may be largely met by health insurance schemes or other social security bodies (see, to that effect, Kügler, paragraphs 57 and 58; Dornier, paragraphs 72 and 73; and L.u.P., paragraph 53).
      
      66      In the present case, it is common ground that the Kingdom of Denmark has not laid down any specific rules or procedure implementing
         Article 13A(1)(b) of the Sixth Directive which would apply to service providers which are not bodies governed by public law.
         Contrary to CopyGene’s suggestion at the hearing, the mere fact that several other Member States have systematically exempted
         the services of private cord stem cell banks can have no bearing on the reply to the third question referred. As is clear
         from paragraphs 63 and 64 of the present judgment, the Danish authorities have a discretion in this respect, subject to complying
         with European Union law, including, in particular, the principle of fiscal neutrality.
      
      67      It is apparent from the wording of the third question that the factors which the referring court considers to be of possible
         relevance in that regard include, in particular, the fact that, first, the services provided by CopyGene are performed by
         professional medical personnel, second, those services are not supported or covered by any public social security scheme and,
         third, CopyGene has been authorised by the competent health authorities to handle cord stem cells under the national legislation
         implementing Directive 2004/23.
      
      68      As regards, first of all, the fact that CopyGene’s services are supplied, within the framework of contracts concluded with
         it, by professional medical personnel, that is to say nurses, midwives and bioanalysts, the documents before the Court do
         not reveal for which activities those personnel are ‘professionally qualified’ under the relevant national legislation, the
         content of which is also not apparent from those documents. That being so, it should be pointed out that, in any event, the
         mere fact that they are qualified health professionals does not prevent, as such, the Danish authorities refusing to grant
         to a taxable person such as CopyGene the recognition which would entitle it to the exemption under Article 13A(1)(b) of the
         Sixth Directive.
      
      69      As regards, next, the fact that CopyGene’s activities at issue in the main proceedings receive no support from and are not
         covered by the public social security scheme, it is clear from the case-law cited in paragraph 65 of the present judgment
         that the national authorities are entitled to take that factor into consideration in order to determine whether an entity
         should be recognised for the purposes of Article 13A(1)(b) of the Sixth Directive.
      
      70      That same fact is also a matter which can be taken into account in the determination, which is not the subject of this request
         for a preliminary ruling, of whether a taxable person supplies its services ‘under social conditions comparable to those applicable
         to bodies governed by public law’ within the meaning of that provision.
      
      71      It should, however, be made clear that the considerations set forth in paragraphs 69 and 70 of the present judgment do not
         mean that the exemption under Article 13A(1)(b) of the Sixth Directive must be systematically excluded when the services supplied
         are not reimbursed by the social security authorities. It is rather a factor which must be weighed in the balance, and which
         could be outweighed, for example, by the necessity to ensure equal treatment. Indeed, it is also apparent from the case-law
         that, if, for example, a taxable person’s situation is comparable to that of other operators providing the same services in
         comparable situations, the mere fact that the cost of those services is not fully covered by the social security authorities
         does not justify a difference in the treatment of providers for VAT purposes (see, to that effect, Dornier, paragraph 75).
      
      72      Furthermore, contrary to the Greek Government’s suggestion, the mere fact that a taxable person such as CopyGene is an establishment
         governed by private law does not automatically mean that such a taxable person’s activities could not come within the exemption
         under Article 13A(1)(b) of the Sixth Directive. When the Community legislature intended to restrict the grant of the exemptions
         under Article 13A(1) of the Sixth Directive to certain non-profit-making or non-commercial entities, it said so expressly,
         as is clear from subparagraphs (l), (m) and (q) thereof (see Case C‑498/03 Kingscrest Associates and Montecello [2005] ECR I-4427, paragraph 37).
      
      73      In addition, it is important to note that, having regard particularly to the principle of fiscal neutrality, the approach
         adopted by the tax authorities when they examine competing comparable establishments must be consistent. On that point, CopyGene’s
         Counsel confirmed at the hearing that there was no other private stem cell bank in Denmark.
      
      74      As regards, finally, the fact that CopyGene has been authorised by the competent health authorities to handle cord stem cells
         under the national legislation implementing Directive 2004/23, it is true that, to a certain extent, that factor tends to
         suggest that CopyGene carries on activities dealing with hospital and medical care. Such authorisation can therefore be a
         factor tending to support the argument that CopyGene is, in any case, ‘duly recognised’ within the meaning of Article 13A(1)(b)
         of the Sixth Directive.
      
      75      However, if the national authorities are not to be deprived of the discretion which that provision confers upon them, the
         mere fact that they have authorised activities such as those at issue in the main proceedings, in accordance with the European
         Union’s prescribed standards of quality and safety in the sector concerned, cannot lead, by itself and automatically, to recognition
         from the point of view of Article 13A(1)(b) of the Sixth Directive. As the Danish Government maintains, obtaining such authorisation
         is a necessary condition to carrying on the activity of a private stem cell bank. However, the granting of such authorisation
         is not, in itself, synonymous with recognition for the purposes of Article 13A(1)(b) of the Sixth Directive.
      
      76      The same applies as regards the other provisions of the Danish rules on private stem cell banks cited by CopyGene, which are
         referred to in paragraph 13 of the present judgment.
      
      77      It follows that Article 13A(1)(b) of the Sixth Directive does not therefore, by itself, preclude the Danish tax authorities
         from refusing to treat CopyGene as a ‘duly recognised’ establishment for the purposes of the exemption at issue in the main
         proceedings.
      
      78      That said however, neither can that provision be interpreted as requiring, as such, the competent authorities to refuse to
         treat a taxable person such as CopyGene as an establishment ‘duly recognised’ for the purposes of that exemption.
      
      79      In those circumstances, it would be for the national court, in so far as necessary, to determine whether the refusal of recognition
         for the purposes of the exemption provided for in Article 13A(1)(b) of the Sixth Directive complies with the requirements
         of the case-law set forth in paragraphs 63 to 65 of the present judgment, and in particular with the principle of fiscal neutrality.
         To that end, it would be appropriate to take into consideration, for example, established administrative practice and other
         practices adopted as regards the status of paramedical establishments and exemptions from VAT in sectors comparable to that
         in question in the main proceedings.
      
      80      As regards the fourth question, it is sufficient to observe that the nature of the envisaged treatment, whether autologous
         or allogeneic, is irrelevant to the reply to be given to the third question.
      
      81      In the light of the foregoing, the reply to the third and fourth questions referred, read together, is that, if the services
         of stem cell banks such as those at issue in the main proceedings are performed by professional medical personnel, where such
         stem cell banks, although authorised by the competent health authorities of a Member State, within the framework of Directive
         2004/23, to handle human tissue and cells, do not receive any support from the public social security scheme and where the
         payment for those services is not covered by that scheme, Article 13A(1)(b) of the Sixth Directive does not preclude the national
         authorities from deciding that taxable persons such as CopyGene are not ‘other duly recognised establishments of a similar
         nature’ to ‘hospitals [and] centres for medical care or diagnosis’ within the meaning of Article 13A(1)(b) of the Sixth Directive.
         However, neither can that provision be interpreted as requiring, as such, the competent authorities to refuse to treat a private
         stem cell bank as an establishment ‘duly recognised’ for the purposes of the exemption in question. To the extent that it
         is necessary, it is for the referring court to determine whether the refusal of recognition for the purposes of the exemption
         provided for in Article 13A(1)(b) of the Sixth Directive complies with European Union law and, in particular, with the principle
         of fiscal neutrality.
      
       Costs
      82      Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court,
         the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs
         of those parties, are not recoverable.
      
      On those grounds, the Court (Third Chamber) hereby rules:
      1.      The concept of activities ‘closely related’ to ‘hospital and medical care’ within the meaning of Article 13A(1)(b) of Sixth
            Council Directive 77/388/EEC of 17 May 1977 on the harmonisation of the laws of the Member States relating to turnover taxes
            – Common system of value added tax: uniform basis of assessment is to be interpreted as meaning that it does not cover activities
            such as those at issue in the main proceedings consisting in the collection, transportation and analysis of umbilical cord
            blood and the storage of stem cells contained in it, where the medical care provided in a hospital environment to which those
            activities are merely potentially related has not been performed, commenced or yet envisaged.
      2.      If the services of stem cell banks such as those at issue in the main proceedings are performed by professional medical personnel,
            where such stem cell banks, although authorised by the competent health authorities of a Member State, within the framework
            of Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and
            safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissue and cells,
            to handle human tissue and cells, do not receive any support from the public social security scheme and where the payment
            for those services is not covered by that scheme, Article 13A(1)(b) of Sixth Directive 77/388 does not preclude the national
            authorities from deciding that taxable persons such as CopyGene A/S are not ‘other duly recognised establishments of a similar
            nature’ to ‘hospitals [and] centres for medical care or diagnosis’ within the meaning of Article 13A(1)(b) of Sixth Directive
            77/388. However, neither can that provision be interpreted as requiring, as such, the competent authorities to refuse to treat
            a private stem cell bank as an establishment ‘duly recognised’ for the purposes of the exemption in question. To the extent
            that it is necessary, it is for the referring court to determine whether the refusal of recognition for the purposes of the
            exemption provided for in Article 13A(1)(b) of Sixth Directive 77/388 complies with European Union law and, in particular,
            with the principle of fiscal neutrality.
      [Signatures]
      * Language of the case: Danish.