WRITTEN QUESTION P-2808/98

by Bernard Lehideux (PPE) to the Commission

(9 September 1998)

Subject: European directives preventing the recognition of hospital pharmacy as a discipline in its own right

Despite the many specific tasks assigned to it - manufacturing medicines from blood products, supervising clinical trials, epidemiology, sterilisation, chemical pharmacy and so forth - hospital pharmacy has not been granted the recognition as a discipline in its own right accorded to branches of medicine, surgery or biology.

Hospital pharmacists would like to see eligibility to practise pharmacy in hospitals or clinics restricted to holders of a special diploma. As matters stand, at the end of their internship they receive a university degree, the DES (Diplôme d'Études Supérieures), yet other branches of the medical profession are still entitled to practise hospital pharmacy.

The French Ministry of Health and the trade unions concerned apparently support granting hospital pharmacy more specialised status. However, France's National Trade Union Federation of Pharmacy Interns contends that certain European directives stand in the way of such a move.

1. Do the provisions of Community law applicable to hospital pharmacy practised in the Member States prevent its being recognised as a discipline in its own right open exclusively to holders of a special diploma?

2. If so, what is the purpose of the said provisions, and could thought be given to amending them, thereby removing the obstacles to recognition of the specific nature of hospital pharmacy?

Answer given by Mr Monti on behalf of the Commission

(5 October 1998)

1. Council Directive 85/432/EEC of 16 September 1985 concerning the coordination of provisions laid down by law, regulation or administrative action in respect of certain activities in the field of pharmacy(1) lays down the minimum training requirements which all basic diplomas in pharmacy issued by the Member States must meet.

Under this Directive the Member States may not make the right to take up the profession of hospital pharmacist conditional on the holding of a diploma other than the basic diploma in pharmacy. Article 1(1) of the Directive provides that the Member States must ensure that holders of a basic diploma in pharmacy issued by another Member State in accordance with the conditions laid down in the Directive are entitled at least to take up and pursue the activities referred to in Article 1(2). These activities include " ... the preparation, testing, storage and dispensing of medicinal products in hospitals", i.e. the activities of hospital pharmacists. In other words, Directive 85/432/EEC establishes the principle that the basic diploma in pharmacy constitutes the sole and sufficient condition governing the right to take up and pursue the activities listed under Article 1(2). This principle is referred to as the "indivisibility of diplomas".

The only derogation from this rule concerns the possibility for the Member States to make the right to take up and pursue one or more of these activities contingent on additional professional experience (cf. Article 1(1)).

However, the Directive does not prohibit the establishment of specialist training in hospital pharmacy (or in any other branch of pharmacy such as industrial pharmacy or dispensing pharmacy) or of a diploma corresponding to specialist training in hospital pharmacy in so far as such training does not constitute a condition governing the right to take up the activity in question but is merely a condition governing the right to use the title of specialist.

2. The aforementioned provisions of Directive 85/432/EEC are designed to give useful effect to the Directive in question and to Directive 85/433/EEC of 16 September 1985 concerning the mutual recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy, including measures to facilitate the effective exercise of the right of establishment relating to certain activities in the field of pharmacy(2), namely to guarantee free movement for pharmacists between the Member States.

Given the fact that Directive 85/432/EEC merely coordinates the basic training of pharmacists, as opposed to pharmaceutical specialities, if these provisions had not been included, the Member States would be able effectively to bypass the "pharmacy" Directives by reserving the various branches of pharmaceutical activity for specialist pharmacists. If that were the case, and given that Community law does not provide for the automatic recognition of specialist training in pharmacy, the automatic mutual recognition of the basic diploma enshrined in Directive 85/433/EEC would be no more than formal recognition since it would not guarantee access to a minimum field of activity. In addition, when the "pharmacy" Directives were adopted, it was decided that holders of the basic diploma in pharmacy had acquired skills and knowledge which were quite sufficient to pursue the activities listed under Article 1(2) of Directive 85/432/EEC.

The issue of pharmaceutical specialities has been exhaustively discussed by the body which, as provided for in Article 6 of Directive 85/432/EEC and Article 20 of Directive 85/433/EEC, assists the Commission in respect of the "pharmacy" Directives, namely the Pharmaceutical Committee set up under Decision 75/320/EEC(3). These discussions revealed that no consensus existed between the Member States on this subject.

Accordingly, the Commission has no plans to present proposals to amend the "pharmacy Directives" which would undermine the principle of the indivisibility of diplomas. The Commission takes the view that this principle works very much to the benefit of pharmacists in the Community in that it effectively guarantees their right of free movement within the internal market.

(1) OJ L 253, 24.9.1985.

(2) OJ L 253, 24.9.1985.

(3) OJ L 147, 9.6.1975.