WRITTEN QUESTION P-0590/02 by Paolo Bartolozzi (PPE-DE) to the Commission. Europeanisation of Italian law 107/90 on the production of blood derivatives.
Date: 2002-02-25
Institutions: European Parliament, Provisional data
Subjects: EU law, Italy, biology, blood transfusion, competition law, freedom to provide services, medicinal product, research body, restriction on competition, right of establishment

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Official Journal of the European Union

EN

6.2.2003

Answer given by Mr Solbes Mira on behalf of the Commission

(22 April 2002)

The debt to the gross domestic product (GDP) ratio in Greece is among the highest in the Community and
far above the threshold of 60 % of GDP set in the EC Treaty. A rapid reduction in the debt ratio is essential
in particular in order to ensure the long-term sustainability of public finance. Greece has made significant
progress in recent years in correcting fiscal imbalances but the reduction in the debt ratio has been much
smaller than the rapid increase in nominal GDP, the achievement of high and increasing primary surpluses
and the reduction in interest rates would have implied. To some extent this was explained by exchange
rate movements before the entry of Greece in the euro zone, given that a large part of the government
debt was denominated in foreign currencies. However, according to the 2001 update of the stability
programme, unspecified factors hold back the decline in the debt ratio to the tune of 4 % of GDP for the
period 2002-2004 despite the projected use of privatisation receipts (averaging above 1 % of GDP) to pay-
off public debt.

The 2001 update of the stability programme compares the outcome of the stock of debt at the end of
2001 with the projections included in the budget for 2001. The total increase in the stock of debt is
estimated at EUR 6,55 billion while the budget projected an increase of EUR 4,78 billion. Factors other
than the deficit and the burden from foreign exchange amount to EUR 6,35 billion instead of EUR 3,20
billion as calculated in the budget. Of these, only a small part was due to higher military borrowing while
no information is provided for the other factors that caused the faster than projected increase in the stock
of debt. In addition, DEKA (a state-owned holding company which is not part of the general government)
paid off public debt for an amount equal to EUR 4,46 billion instead of EUR 2,20 billion projected in the
budget for 2001.

Against this background, the Commission considers that the multiplication in recent years of operations
which do not appear in the deficit but influence debt developments and the fact that the 2001 updated
stability programme projects the continuation of such operations in the medium-term, providing no clear
information on their purpose, represents a lack of transparency which raises difficulties in assessing the
quality of the budgetary adjustment proposed in the stability programme.

(2003/C 28 E/041)

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.

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Official Journal of the European Union

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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.