Opinion of the Economic and Social Committee on the "Proposal for a European Parliament and Council Directive on the Community code relating to medicinal products for human use (codified version)"

(1999/C 368/02)

On 4 October 1999 the Council decided to consult the Economic and Social Committee, under Article 262 of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for the Single Market, Production and Consumption, which was responsible for preparing the Committee's work on the subject, adopted its opinion on 7 October 1999. The rapporteur was Mr Braghin.

At its 367th plenary session (meeting of 20 October 1999) the Economic and Social Committee adopted the following opinion by 105 votes to one with three abstentions.

1. Introduction

1.1. The proposed directive under consideration is designed to codify and thus to supersede the various directives on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, from Council Directive 65/65/EEC of 26 January 1965 onwards. The purpose of codification is to simplify and clarify Community law so as to ensure transparency and correct interpretation, in accordance with the Commission's decision of 1 April 1987 and the Conclusions of the Presidency of the Edinburgh European Council (December 1992).

1.2. The new directive, which is intended to codify the rules expressly mentioned in Annex II, Part A, containing the list of repealed directives, with their successive amendments, must be adopted in full compliance with the normal Community legislative procedure as laid down in Article 251 of the Treaty, and must respect the substance of the codified texts, confining itself to collating them with only such formal amendments as are required by codification itself.

1.3. The Commission has also taken account of the fact that the European Agency for the Evaluation of Medicinal Products has been set up by Council Regulation (EEC) No 2309/93 (OJ L 214 of 24.8.1993) and that in parallel Directive 93/39/EEC (ibidem) has laid down the framework for European regulatory procedures.

1.4. The codification proposal concerning medicinal products for human use was drawn up in parallel with the codification proposal for directives relating to veterinary medicinal products, which are not covered by the text under consideration.

2. General comments

2.1. The Committee warmly welcomes this codification effort, which constitutes an essential reference point for the relevant authorities of the Member States. The proposed codification, reflecting a need felt for years, was finally included in the Commission's 1998 work programme and has now reached the proposal stage. The Committee hopes that the accelerated procedure, endorsed by the interinstitutional agreement of 20 December 1994, will make possible the rapid adoption of the codified legislation, so that the Directive can enter into force on 1 January 2000 as laid down in Article 131.

2.2. The codification in question is complete insofar as it also covers the directives and specific provisions relating to immunological medicinal products, radiopharmaceuticals, medicinal products derived from human blood or human plasma, and homeopathic medicinal products, as well the directives on wholesale distribution, classification, labelling and package leaflets, and advertising. The final part of the text is Annex I entitled "Analytical, Pharmacotoxicological and Clinical Standards and Protocols in respect of the Testing of Medicinal Products".

2.3. The codified text mostly retains the terminology used in the original directives and does not reflect developments which have occurred in the meantime, particularly as a result of the work of the International Conference on Harmonisation (ICH), which seeks to define standards applicable in the EU and the rest of the world. The Committee suggests the addition of another annex in which the technical terms which should be replaced by those finally adopted by the ICH are indicated.

2.3.1. The development of international terminology should in particular be reflected in the updating of the definitions in Article 1 in those languages where traditional terms no longer current internationally have remained in use (e.g. in Italian: "effetto collaterale negativo" rather than "reazione avversa"). The Committee feels that the incorporation of changes approved by the appropriate international organisations should be facilitated when transposing directives into national law.

2.3.2. The Committee also hopes that, for those few terms which in certain languages can be expressed in slightly different forms without changing the meaning, a single term could always be used (e.g. in English: "marketing authorisation holder" instead of "applicant", "holder" or "authorisation holder"), unless it is necessary in a specific context to bring out shades of meaning.

2.3.3. The text of Annex I includes a series of amendments as to the terms used, with some discrepancies between the different languages. It would be desirable to point out and justify these amendments in notes or in a specific annex, given the technical nature of the points and their importance for correct preparation of the registration dossier.

2.4. The various language versions do not always match, probably because of imperfect translation from the original stages of the document. The Committee suggests that the Commission could make use of the present codification exercise to amend the articles and take appropriate steps where they are inaccurately translated from the reference language.

2.5. Title IX tackles the subject of pharmacovigilance, a field in which debate is under way with a view to drawing up proposed amendments to Directive 75/319/EEC. The Committee hopes that these proposals will be put forward and discussed soon, in the interests of increasingly effective public health protection.

2.6. The Committee, aware of the importance of this codification to harmonisation of the rules governing the pharmaceutical sector, and of early transposition of the directive into national legislation, recommends that the Commission set up a panel of experts, if possible representing all the official languages of the EU, in order to standardise the use of technical terms, verify that they reflect official ICH findings and, where compatible, current usage, and compare the language versions to ensure that changes are standard.

2.6.1. The Committee would draw special attention to the need for consistent and uniform use of concepts such as:

- adverse reactions / negative collateral effects

- medicine / medicinal product / medicinal speciality

- holder of marketing authorisation / holder / authorisation holder / applicant

- active substance / active ingredients / components

- method of preparation / method of manufacture

- competent authorities / Member States

- Agency (EMEA) / Committee (CPMP).

2.7. As shown in the final part of the Commission communication on the Community marketing authorisation procedures for medicinal products (OJ C 229 of 22 July 1998), there are still diverging interpretations by national administrations, a certain reluctance to trust scientific assessments from other Member States, and lengthy national administrative procedures - all factors which have prevented full use of the advantages of the new authorisation procedures. The Committee hopes that the Commission will take advantage of the overall reassessment of the registration system due in 2001 to introduce the necessary adjustments to the present texts, assisted in this by the considerable and welcome effort of codification currently in progress.

3. Specific comments

3.1. The Committee would draw the Commission's attention to a number of specific points in which it has identified discrepancies, so that the excellent work of codification presented can be further improved.

3.2. The adaptation in whereas clause (14) would appear to alter the meaning of the second sentence slightly compared to the original version.

3.3. In the Italian language version of whereas clause (45), the verb "può" is missing before "incidere" (i.e. "could" before "affect").

3.4. Article 1 is of particular importance, since it defines the terms used. The various versions differ at several points, those of particular relevance being 11 (effet indésirable; adverse reaction; effetto collaterale negativo), 12, 13, 14 (specifications of point 11), 17 (professionnel habilité à cet effet; professional person qualified to make such a prescription; professionista autorizzato a prescrivere medicinali) and 26 (tout risque; all risks; un rischio: the Italian version is closest to the original texts).

3.4.1. A discrepancy running throughout the text is that in the English version the terms "side effects" and "undesirable effects" have been replaced with the now universally used "adverse reactions", while this has not been done for the other language versions.

3.5. Article 11(2) does not contain specific reference to the international common term recommended by the World Health Organisation, which provided technical clarification for the original text.

3.6. The English language version of Article 19(2) is the sole language version which does not contain the phrase "the basic ingredients and, if need be, its intermediate products or other constituent materials".

3.7. The English language version of Article 36(1) incorrectly refers to "products" instead of "procedures".

3.8. The term "agent" used in a number of articles [42(1); 46(d); fifth line of 51(3)], and the expression "persons responsible for inspecting them" [80(a)], should be replaced by the technically correct term "inspector".

3.9. The phrase "person authorised or entitled" to supply medicinal products to the public (Article 82) is truncated in a number of language versions, which refer solely to a "person authorised".

3.10. The English term "guidelines" is not translated by the usual "linee guida", but in some languages the phrase "linee direttrici" is employed, which may give the wrong impression that they can be imposed from above.

3.11. The English version of Article 85 wrongly talks of distribution of medicinal products to the public "for promotional purposes". The meaning must be "for non-promotional purposes".

3.12. The English version of Article 96(b) employs the term "prescribing agent": it would be more appropriate to use the term "prescriber", which reflects both the reference text and current usage.

3.13. In Article 103(a), some language versions fail to provide an accurate description of the function of "medical representatives". The Commission is asked to check that the term employed is that currently used in the different Member States to describe this professional function.

3.14. The English language version of Article 112 uses the term "person responsible for marketing a medicinal product" instead of "marketing authorisation holder" as employed in the reference text.

3.15. There is a typing error in the English version of Annex I, Part 2.D.1, third paragraph, giving "method or preparation" instead of the correct "method of preparation".

3.16. The Italian version of Annex I, Part 4.B.1.2, second paragraph, still uses the term "procedure di attuazione" ("implementation procedures") instead of "tecniche adottate" ("technical application") as in the other updated language versions.

3.17. Annex I (Part 4.F.1) talks of "treatment of the control groups". The Italian version wrongly uses the phrase "controllo delle prove" ("control of the samples"). It should be ensured that the correct phrase is used in all language versions.

3.18. In some language versions, other articles contain incorrect references. For instance, the English version of Article 33 refers to 34 instead of 32, and the Italian version of Article 55 refers to 55 instead of 54. The entire directive should be formally checked.

3.19. Some language versions only give "or" instead of "and/or", for instance Articles 41(a), 59(a), the third indent of 71(1), and 115 in the Italian version. This may change the meaning and the subsequent transposition to national law. The entire directive should be formally checked for this aspect.

3.20. Lastly, reference to Article 12(3) of Directive 92/28 is missing.

Brussels, 20 October 1999.

The President

of the Economic and Social Committee

Beatrice RANGONI MACHIAVELLI