C-169/88

PRELLE v COMMISSION

OPINION OF MR ADVOCATE GENERAL TESAURO delivered on 12 October 1989 *

Mr President, On 13 June 1988 the Commission rejected Members of the Court, 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 1. In these proceedings, Maurice Prelle be regarded as a pharmaceutical product seeks the annulment of the implied decision and its cost was therefore not reimbursable rejecting his complaint, lodged in November under Section V of Annex I to the Rules on 1987, against the refusal of the office Sickness Insurance for Officials of the responsible for settling claims of the European Communities. Sickness Insurance Scheme to reimburse the cost of an organotherapeutic preparation.

That decision was notified to the applicant on 24 June. 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 However, on 17 June, in other words before application for the reimbursement of the receiving that late reply, Mr Prelle brought cost of an injectable organotherapeutic the present action seeking the annulment of product composed of extracts of organs and the implied refusal of the appointing novocaine which was intended to treat authority to uphold his complaint and an rheumatoid arthritis. It was produced by a order requiring the Commission to pay: homeopathic pharmaceutical laboratory to a prescription issued by Dr Jourdan.

3. The applicant puts forward two In the present case, consideration of the submissions in support of his application: memorandum of 2 September 1987 sent to infringement of Section V of Annex I to the the applicant by the office responsible for Community Rules on Sickness Insurance settling claims, which refers to 'services the and failure to provide a statement of cost of which is not reimbursable' together reasons pursuant to Article 25 of the Staff with the subsequent letter of 26 October Regulations. 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 4. I shall examine first the submission that the office responsible for settling claims no statement of reasons was provided. 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 It must be observed in that regard that, as provisions of the rules governing the Joint the Court has consistently held, in order to Sickness Insurance Scheme. 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 Moreover, the applicant appears to be the duty to state the reasons on which a perfectly well aware that that was the decision is based is both to permit the reason for the refusal since both in the person concerned to determine whether the complaint lodged on 4 November 1987 and decision contains a defect allowing its in the subsequent appeal to the Court of legality to be challenged and to enable it to Justice of 17 June 1988 he challenged the be reviewed by the Court; it follows that the Commission's interpretation of Section V of extent of that duty must be determined on Annex I to the Rules in question, which he the basis of the particular facts of each considered to be wrong. case. 1

Under the first paragraph of Section V, the cost of pharmaceutical products prescribed Let me say straight away that in the context by the practitioner is to be reimbursed at the of the present case there is certainly no rate of 85 %. assistance to be derived from the definition of a proprietary medicinal product con­ tained in Article 1, according to which, for the purposes of the directive, a proprietary However, the next paragraph states that medicinal product must be understood as mineral waters, tonic wines and beverages, any ready-prepared medicinal product infant foods, hair-care products, cosmetics, placed on the market under a special name special diet foods, hygiene products, and in a special pack. irrigators, thermometers, tisanes, aromath- erapeutic products and similar products and instruments are not considered to be phar­ maceutical products.

It is clear that that definition is extremely restrictive and that it is specifically intended The Commission claims that the product in to limit the scope of the directive to question is not a pharmaceutical product the industrial products with a view to cost of which is reimbursable pursuant to developing the pharmaceutical industry and Section V since it does not have curative or facilitating trade in such products. preventative properties or, at least, a sufficient degree of therapeutic benefit proven on the basis of current scientific knowledge.

Moreover, the inadequacy of that definition It is therefore necessary to consider, first, for the purposes of a health insurance whether organotherapeutic preparations are scheme is confirmed by the current covered by the general definition of a phar­ practice — both in the Member States and maceutical product in the first paragraph of in the Community institutions — of not Section V and then, if the answer to the ruling out in principle reimbursement of the first question is in the affirmative, whether cost of 'magistral' preparations which are they may be regarded as similar to the not covered by the above definition. products listed in the second paragraph and consequently excluded from reimbursement. 3 — OJ, English Special Edition 1965-66. p 20

Under those circumstances, and in view of However, in my opinion it is not reasonable the fact that organotherapeutic prepa­ to argue that organotherapeutic prepa­ rations, leaving aside the question whether rations must be regarded as products which there is firm scientific evidence of their are similar to those other products listed, effectiveness, are always presented for such as mineral waters, cosmetics, special treating or preventing disease in human diet foods and so forth. In fact, such beauty beings, the conclusion must be that such products and tonics, which are not used to preparations fit perfectly the definition of a treat a specific illness, were probably pharmaceutical product, as, moreover, do regarded by the persons who drafted the homeopathic preparations, which are in fact rules as not strictly necessary, almost

PRELLE v COMMISSION

luxuries, and as such not worthy of reim­ The administration did not in fact cite that bursement under the Community Sickness provision until late in the procedure; it is Insurance Scheme. not the basis of the decision in question and concerns circumstances which are different from that at issue in these proceedings.

In short, the cost of those products is not reimbursable not because their effectiveness 9. However, so that what I have said will is not proven but because of the special not be misconstrued, before I finish with nature of the products. 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.

OPINION OF MR TESAURO —CASE C-169/88

In that way they could comply both with claims that by forcing him to take legal the requirement that only the cost of action over a small amount of money and products which have been scientifically on account of a typically arbitrary decision, proven to be effective should be reimbursed the administration has caused him and with the equally fundamental non-material and material damage put at requirement that the legitimate expectations BFR 8 000. of members should be protected; members, who are not necessarily experts in pharma­ In my opinion this claim is unfounded. cology and are in possession of a doctor's prescription for a product to be purchased As I said above, the administration's from a pharmacy, legitimately expect the decision can be criticized because it is based amount paid to be reimbursed. on a wrong interpretation of a measure; however, in my opinion the decision is not 10. I need not linger over the claim for in any way vexatious, nor indeed is it clear damages submitted by Mr Prelle, who 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.