WRITTEN QUESTION P-0590/02

by Paolo Bartolozzi (PPE-DE) to the Commission

(25 February 2002)

Subject: Europeanisation of Italian law 107/90 on the production of blood derivatives

Italian law 107/90 requires the processing of plasma to be located entirely on Italian territory (currently about 500 000 litres a year). This law in fact safeguards a monopoly as only one company, Kedrion SpA, a member of the Marcucci Group, qualifies. This violation of the competition rules was condemned by the Competition and Market Authority on 26 January 1996. During the past parliamentary term efforts were made, without success, to enact an amendment to Law 107 which would have seemingly removed the monopoly. The proposal would have opened up access to the processing of Italian plasma by allowing industrial companies to carry out at least the first stage of the processing cycle (plasma fractioning) in Italy and then to complete the processing and packaging in Europe.

This proposal, which is still supported by a number of members of Parliament, would make it possible to move from a monopoly situation to a duopoly, excluding by law other European competitors with plasma fractioning and production plants in Member States of the EU.

The opening up of the production of blood derivatives from Italian plasma to the whole of Europe would allow all Italian companies to operate not only in Italy but also in Spain, Germany and the UK and would enable all European firms to compete in Italy in terms of output, technology and products.

It is also desirable that firms that undertake fractioning and the production of blood-derivative drugs should have facilities capable of carrying out the complete fractioning and production cycle for all blood-derivative products in Italian territory or in the territory of other Member States of the European Community. The absence of the complete cycle would put patient safety at risk, as was confirmed by the Director-General of the Italian Institute of Health in a statement to Committee XII of the Chamber of Deputies on 13 July 1995, when he said that monitoring of the production of blood derivatives is feasible if the plasma goes into a plant and comes out of it as a finished product, but this is not the case when plasma goes into one processing plant, comes out as paste, and is then sent elsewhere.

In the light of the above, will the Commission check whether Italian Law 107/90 on the production of blood derivatives complies with Community legislation and with the general principles of Community law and what measures will it take to restore absolutely fair conditions of competition, which are currently undermined by the legal effects of Law 107/90.

The Commission's attention is also drawn to decisions 5867/2001 and 10700/2000 of the Lazio Administrative Court, Chamber A, which on 27 September 2001, in the light of the opinion of the Italian Health Council and National Blood Transfusion Service, ruled that there are no grounds for upholding the constraints imposed by Article 10 of Law 107/90.

Answer given by Mr Bolkestein on behalf of the Commission

(19 April 2002)

In the light of the information provided by the Honourable Member, the Commission feels there is a need to conduct a detailed examination of the system laid down by Italian law with regard to plasma.

The question asked basically seeks to establish whether or not Italian law 107/90, which establishes a national monopoly for the processing/fractioning of blood and human plasma collected on Italian territory (mainly, but not exclusively, in order to produce blood-derivative medicinal products), complies with Community law.

In particular, the Commission considers that the analysis should focus on two, closely inter-related aspects.

First of all, it will examine the justification for a regulation which stipulates that the complete fractioning and production cycle for all or some specialised blood-derivative products be carried out within the one plant.

Then, given that reasons of public health have been invoked in this case, it will assess whether, and to what extent, the stipulation that this complete cycle be conducted entirely upon Italian territory complies with the demands of non-discrimination, necessity and proportionality and, therefore, whether or not this is compatible with the principles of the freedom of establishment and the freedom to provide services.

The Commission can already confirm that Title X (Article 109) on medicinal products derived from human blood and plasma in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(1) does not set out any rules, either for the (public or private sector) bodies responsible for the collection of blood or plasma as a raw material or for those responsible for processing/fractioning blood or plasma as a preliminary stage in the production of the medicinal product. Responsibility for these two types of activity lies therefore with the Member States. Article 1(10) of this Directive simply explains that medicinal products derived from human blood or human plasma are prepared industrially by public or private establishments.

(1) OJ L 311, 28.11.2001.