WRITTEN QUESTION P-0064/00 by Peter Skinner (PSE) to the Commission. Definition of fundamental change in pharmaceutical products.
Date: 2000-01-18
Institutions: European Parliament, Provisional data
Subjects: EU policy, market approval, medicinal product

C 280 E/168

Official Journal of the European Communities

EN

3.10.2000

that they satisfy the conditions laid down (cid:129) in particular that they are provided direct to final consumers
and are covered by the list of eligible sectors.

The Council changed the Commission(cid:146)s proposal (2) by introducing an exhaustive list which in the building
sector covers only services consisting of the renovation and repairing of private dwellings, excluding
materials which form a significant part of the value of the service supplied.

Following the Council(cid:146)s decision, work to repair historic buildings will qualify for VAT reductions, but only
where the buildings contain private dwellings and the Member State has made a request. The Member
States that have made requests are Belgium, Spain (for masonry work only), France, Italy, the Netherlands
(for painting and plastering only), Portugal and the United Kingdom (for the Isle of Man only).

(1) OJ C 102, 13.4.1999.
(2) COM(99) 705 final.

(2000/C 280 E/191)

WRITTEN QUESTION P-0064/00

by Peter Skinner (PSE) to the Commission

(18 January 2000)

Subject: Definition of fundamental change in pharmaceutical products

Commission Regulation (EC) No 541/95 (1) states that certain changes to the terms of a pharmaceutical
product marketing authorisation are fundamental and as such require that a new, complete scientific
evaluation be conducted (such as in the case of replacement of the active substance by a different salt/ester.

Can the Commission confirm that:

1.
The rationale for defining fundamental changes and requiring them to be the subject of new
applications rather than variation applications was that special scrutiny of the research data relating to
that change would be required by the competent authorities before it could properly be concluded that the
public health criteria of quality, safety and efficacy were still met for the production in question, and

In principle the same cautious approach should apply if the same fundamental differences exist
2.
between two products where it is claimed that one is a generic copy of the other and that that copy can be
authorised on the basis of the research data generated for the first product?

(1) OJ L 55, 11.3.1995, p. 7.

Answer given by Mr Liikanen on behalf of the Commission

(11 February 2000)

Commission Regulation (EC) No 541/95 of 10 March 1995 concerning the examination of variations to
the terms of a marketing authorisation granted by a competent authority of a Member State, and
Commission Regulation (EC) No 542/95 of 10 March 1995 concerning the examination of variations to
the terms of a marketing authorisation falling within the scope of Council Regulation (EEC) No 2309/
93 (1), as amended (2), lay down rules governing the examination of variations to a marketing authorisation
granted for a medicinal product by either of the following Community procedures: the mutual recognition
procedure or the centralised procedure.

The Regulations provide for three types of variation to the terms of a marketing authorisation, depending
on their importance and the time allowed for their assessment: minor variations (type I), listed in Annex I,
major variations (type II) and changes which fundamentally alter the terms of the authorisation. The latter

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must be approved by a complete assessment procedure similar to that for new applications for marketing
authorisation and the assessment period (210 days) is exactly the same as that for new applications. Such
changes are listed in Annex II. They include changes to the active substance(s), the therapeutic indications
or the strength, pharmaceutical form and route of administration. However, it should be noted that even
these are always variations to an authorisation which has already been granted for a given medicinal
product.

With regard to the examination of data, the same criteria of quality, safety and efficacy must be met in all
cases.

The same assessment criteria of quality, safety and efficacy apply to generic products. The applicant can be
exempted from safety and efficacy trials only if he can show that the product for which the authorisation
has been requested is essentially the same as another products which already has a marketing authorisa-
tion.

(1) OJ L 55, 11.3.1995.
(2) OJ L 159, 3.6.1998.

(2000/C 280 E/192)

WRITTEN QUESTION E-0069/00

by Bart Staes (Verts/ALE) to the Council

(24 January 2000)

Subject: Checks on data exchange and telecommunications in the EU Member States

As part of the annual Ilets (International Law Enforcement Telecommunications Seminar) consultation
process the police forces of the fifteen Member States are working on the sophisticated interception
practices of the National Security Agency (NSA), the American secret service responsible for telecommu-
nications and data exchange. At the request of the NSA, Lotus, Microsoft and Netscape have lowered the
security level of their Internet and e-mail programmes for users outside the United Status. The interception
facilities are used mainly for industrial espionage.

In the EU report (cid:145)Interception capabilities 2000(cid:146) Duncan Campbell says that the result is that virtually
every computer in Europe has, as a built-in standard feature, a system that enables the NSA alone to crack
the user(cid:146)s code and to read secured messages. The messages are intercepted at US Internet nodes or are
picked up by the Echelon espionage network of the US, UK, Canada, New Zealand and Australia (the
(cid:145)UKUSA(cid:146) group).

The NSA bases its interception practices on the Communications Assistance for Law Enforcement Act
(Calea) which was adopted by Congress in 1994. Since then American telecommunications forms have
been obliged to build interception facilities into all digital satellite and mobile communications media.
In January 1995 the Council adopted a (non-binding) resolution which is virtually identical to Calea.
Approval of the use of these radical measures has never been subject to any parliamentary scrutiny.

1.

Can the Council give me a copy of the (non-binding) Calea resolution, as adopted in January 1995?

If not:

(a) why not, and

(b) does this refusal not violate the principle of parliamentary accountability in a constitutional state

governed by the rule of law?