Opinion of Mr Advocate General Tesauro delivered on 12 October 1989. - Maurice Prelle v Commission of the European Communities. - Officials - Meaning of term "pharmaceutical products" - Reimbursement. - Case C-169/88.



European Court reports 1989 Page 04335



Opinion of the Advocate-General

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Mr President,

Members of the Court,

1 . In these proceedings, Maurice Prelle seeks the annulment of the implied decision rejecting his complaint, lodged in November 1987, against the refusal of the office responsible for settling claims of the Sickness Insurance Scheme to reimburse the cost of an organotherapeutic preparation .

2 . The facts of the case are as follows : on 14 July 1987, Mr Prelle, a former employee of the Commission, submitted to the office responsible for settling claims in Brussels an application for the reimbursement of the cost of an injectable organotherapeutic product composed of extracts of organs and novocaine which was intended to treat rheumatoid arthritis . It was produced by a homeopathic pharmaceutical laboratory to a prescription issued by Dr Jourdan .

By a decision of 2 September 1987, the office responsible for settling claims refused to reimburse the cost of that product .

In October 1987, after having requested clarification of the reasons for the refusal, the applicant received a copy of the opinion of the medical officer attached to the office responsible for settling claims, which stated : "ointment the cost of which is not reimbursable ( organotherapy )".

On 13 June 1988 the Commission rejected the complaint lodged by Mr Prelle on 4 November 1987 pursuant to Article 90(2 ) of the Staff Regulations, on the ground that the organotherapeutic preparation could not be regarded as a pharmaceutical product and its cost was therefore not reimbursable under Section V of Annex I to the Rules on Sickness Insurance for Officials of the European Communities .

That decision was notified to the applicant on 24 June .

However, on 17 June, in other words before receiving that late reply, Mr Prelle brought the present action seeking the annulment of the implied refusal of the appointing authority to uphold his complaint and an order requiring the Commission to pay :

( 1 ) 85% of the equivalent in Belgian francs of FF 400 ( the cost of the product in question );

( 2 ) interest on that sum at the statutory rate from 11 November 1987, the day following acknowledgement of the receipt of the complaint;

( 3 ) the sum of BFR 8 000 in damages, together with all the costs of the case .

3 . The applicant puts forward two submissions in support of his application : infringement of Section V of Annex I to the Community Rules on Sickness Insurance and failure to provide a statement of reasons pursuant to Article 25 of the Staff Regulations .

4 . I shall examine first the submission that no statement of reasons was provided .

It must be observed in that regard that, as the Court has consistently held, in order to decide whether the requirements of Article 25 of the Staff Regulations have been satisfied it is appropriate to take into consideration not only the contested decision but also the circumstances surrounding its adoption . The purpose of the duty to state the reasons on which a decision is based is both to permit the person concerned to determine whether the decision contains a defect allowing its legality to be challenged and to enable it to be reviewed by the Court; it follows that the extent of that duty must be determined on the basis of the particular facts of each case . ( 1 )

The Court has also had occasion to explain that the duty to state the grounds on which a decision is based, under the second paragraph of Article 25 of the Staff Regulations, is satisfied if the circumstances in which the disputed measure was adopted and notified to those concerned and the staff memoranda and other communications accompanying it make it possible to recognize the essential factors which guided the administration in its decision . ( 2 )

In the present case, consideration of the memorandum of 2 September 1987 sent to the applicant by the office responsible for settling claims, which refers to "services the cost of which is not reimbursable" together with the subsequent letter of 26 October 1987, which refers to "ointment the cost of which is not reimbursable ( organotherapy )" makes it sufficiently clear - leaving aside the fact that the medical officer attached to the office responsible for settling claims made an error in referring to an ointment instead of an injectable product - that the reason for the refusal was that the product in question was not a pharmaceutical product within the meaning of the relevant provisions of the rules governing the Joint Sickness Insurance Scheme .

Moreover, the applicant appears to be perfectly well aware that that was the reason for the refusal since both in the complaint lodged on 4 November 1987 and in the subsequent appeal to the Court of Justice of 17 June 1988 he challenged the Commission' s interpretation of Section V of Annex I to the Rules in question, which he considered to be wrong .

In my opinion, therefore, despite its brevity the statement of the reasons for the decision refusing reimbursement enabled the applicant to be aware of the administration' s reasoning, even if no account is taken of the administration' s explanatory - albeit late - reply, which the applicant did not receive until 24 June 1988 .

In other words, the administration' s reasoning may not have pleased Mr Prelle, but it was sufficiently clear to him .

In my view, therefore, that submission must fail .

5 . The submission that the administration wrongly applied Section V of Annex I to the Community Rules on Sickness Insurance, upon which it based its refusal, is more difficult to assess .

Under the first paragraph of Section V, the cost of pharmaceutical products prescribed by the practitioner is to be reimbursed at the rate of 85 %.

However, the next paragraph states that mineral waters, tonic wines and beverages, infant foods, hair-care products, cosmetics, special diet foods, hygiene products, irrigators, thermometers, tisanes, aromatherapeutic products and similar products and instruments are not considered to be pharmaceutical products .

The Commission claims that the product in question is not a pharmaceutical product the cost of which is reimbursable pursuant to Section V since it does not have curative or preventative properties or, at least, a sufficient degree of therapeutic benefit proven on the basis of current scientific knowledge .

It is therefore necessary to consider, first, whether organotherapeutic preparations are covered by the general definition of a pharmaceutical product in the first paragraph of Section V and then, if the answer to the first question is in the affirmative, whether they may be regarded as similar to the products listed in the second paragraph and consequently excluded from reimbursement .

6 . With regard to the first point, some of the definitions contained in Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products ( 3 ) might be of assistance in defining more closely the concept of a pharmaceutical product .

Let me say straight away that in the context of the present case there is certainly no assistance to be derived from the definition of a proprietary medicinal product contained in Article 1, according to which, for the purposes of the directive, a proprietary medicinal product must be understood as any ready-prepared medicinal product placed on the market under a special name and in a special pack .

It is clear that that definition is extremely restrictive and that it is specifically intended to limit the scope of the directive to industrial products with a view to developing the pharmaceutical industry and facilitating trade in such products .

Moreover, the inadequacy of that definition for the purposes of a health insurance scheme is confirmed by the current practice - both in the Member States and in the Community institutions - of not ruling out in principle reimbursement of the cost of "magistral" preparations which are not covered by the above definition .

In defining a pharmaceutical product for the purposes of the Joint Sickness Insurance Scheme the definitions of "medicinal product" and "substance" are more enlightening and useful .

A "medicinal product", for the purposes of Directive 65/65/EEC, is any substance or combination of substances presented for treating or preventing disease in human beings ( or animals ) ( see Article 1(2 ) ).

The directive then goes on to state that a "substance" must be interpreted as "any matter irrespective of origin which may be ... animal, e.g . ... parts of organs" ( see Article 1(3 ) ).

Going beyond terminology which is not always consistent, in my opinion it is the concept of "medicinal product", as defined in the directive, which must be regarded as synonymous with a "pharmaceutical product" for the purposes of the Joint Sickness Insurance Scheme . That definition, broad though it may be, provides guidelines which are sufficiently clear and precise .

Under those circumstances, and in view of the fact that organotherapeutic preparations, leaving aside the question whether there is firm scientific evidence of their effectiveness, are always presented for treating or preventing disease in human beings, the conclusion must be that such preparations fit perfectly the definition of a pharmaceutical product, as, moreover, do homeopathic preparations, which are in fact generally reimbursed, provided, of course, that they are prescribed by a practitioner and purchased from a pharmacy .

If, on the contrary, a different definition were to be accepted according to which a preparation was not a pharmaceutical product unless its effectiveness was undisputable, there would be a serious risk that members could never be sure whether they would be reimbursed for the cost of a product purchased from a pharmacy in accordance with a doctor' s prescription .

7 . Having said that, it remains to be considered whether reimbursement of the cost of an organotherapeutic preparation may be refused under the second paragraph of Section V, which lists those products which "shall not be considered as pharmaceutical products ".

There is no doubt in my mind that the list in question is not, by its very nature, exhaustive, since the paragraph refers to a certain number of products which are specifically mentioned, "and similar products and instruments ".

However, in my opinion it is not reasonable to argue that organotherapeutic preparations must be regarded as products which are similar to those other products listed, such as mineral waters, cosmetics, special diet foods and so forth . In fact, such beauty products and tonics, which are not used to treat a specific illness, were probably regarded by the persons who drafted the rules as not strictly necessary, almost luxuries, and as such not worthy of reimbursement under the Community Sickness Insurance Scheme .

In short, the cost of those products is not reimbursable not because their effectiveness is not proven but because of the special nature of the products .

The second paragraph of Section V thus cannot be so interpreted as to cover organotherapeutic preparations, which, though their effectiveness may be debatable, possess no characteristics which would enable them to be placed on an equal footing with the products listed in that paragraph .

In my view, therefore, under the present wording of Section V of Annex I to the Rules on Sickness Insurance, the cost of organotherapeutic preparations prescribed by a practitioner and purchased from a pharmacy must be reimbursed, since they are to be regarded as pharmaceutical products and do not belong in the class of products similar to those listed in the second paragraph of Section V .

8 . Nor, incidentally, do I regard as relevant the administration' s reference to Section XV(2 ) of Annex I, under which expenses relating to treatment considered by the office responsible for settling claims, after its medical officer has been consulted, to be non-functional, superfluous or unnecessary are not to be reimbursed .

The administration did not in fact cite that provision until late in the procedure; it is not the basis of the decision in question and concerns circumstances which are different from that at issue in these proceedings .

9 . However, so that what I have said will not be misconstrued, before I finish with this point I would like to set out my thoughts more clearly and at the same time reply to some of the other observations made by the administration .

The Commission claimed that the preparation in question did not merit reimbursement because of the lack of scientifically valid evidence of its effectiveness and also that the cost of such products is not reimbursable in the Member States .

Those considerations are, no doubt, valid in themselves; however, they are not, in my view, relevant for the purposes of settling this dispute .

As I said above, in view of the present wording of the Rules the Commission cannot refuse to reimburse the cost of organotherapeutic preparations as such .

However, there is nothing to stop the persons responsible for drafting the Rules, in the light of the foregoing considerations, from amending Section V and including organotherapeutic preparations in the class of products which are not considered to be pharmaceutical products .

In that way they could comply both with the requirement that only the cost of products which have been scientifically proven to be effective should be reimbursed and with the equally fundamental requirement that the legitimate expectations of members should be protected; members, who are not necessarily experts in pharmacology and are in possession of a doctor' s prescription for a product to be purchased from a pharmacy, legitimately expect the amount paid to be reimbursed .

10 . I need not linger over the claim for damages submitted by Mr Prelle, who claims that by forcing him to take legal action over a small amount of money and on account of a typically arbitrary decision, the administration has caused him non-material and material damage put at BFR 8 000 .

In my opinion this claim is unfounded .

As I said above, the administration' s decision can be criticized because it is based on a wrong interpretation of a measure; however, in my opinion the decision is not in any way vexatious, nor indeed is it clear what further damage the applicant suffered .

11 . In conclusion, I therefore suggest that the Court should annul the contested decision, order the Commission to pay 85% of the equivalent in Belgian francs of the sum of FF 400 plus interest on that sum at the statutory rate from 11 November 1987, the day following acknowledgment of the receipt of the complaint ( as requested by the applicant ), order the Commission to pay the costs and dismiss the remainder of the application .

(*) Original language : Italian .

( 1 ) See the judgment of 21 June 1984 in Case 69/83 Lux v Court of Auditors (( 1984 )) ECR 2447, paragraph 36 .

( 2 ) Judgment of 17 December 1981 in Case 791/79 Demont v Commission (( 1981 )) ECR 3105, paragraph 12 .

( 3 ) OJ, English Special Edition 1965-66, p . 20 .