2002/65/EC: Commission Decision of 25 January 2002 on the national provisions concerning HIV testing kits notified under Article 95(4) of the EC Treaty by the United Kingdom as regards Directive 98/79/EC on in vitro diagnostic medical devices (Text with EEA relevance) (notified under document number C(2002) 297)
Date: 2002-01-25
Institutions: European Commission
Subjects: AIDS, United Kingdom, approximation of laws, artificial reproduction, medical device, national law

29.1.2002

EN

Official Journal of the European Communities

L 25/47

COMMISSION DECISION

of 25 January 2002

on the national provisions concerning HIV testing kits notified under Article 95(4) of the EC
Treaty by the United Kingdom as regards Directive 98/79/EC on in vitro diagnostic medical devices

(notified under document number C(2002) 297)

(Text with EEA relevance)

(2002/65/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

2. The notified national provisions

Having regard to the Treaty establishing the European
Community and in particular Article 95(6) thereof,

(5)

Whereas:

I. FACTS

(6)

1. Community legislation: Directive 98/79/EC

devices (1)

Directive 98/79/EC of the European Parliament and of
the Council of 27 October 1998 on in vitro diagnostic
rules
medical
concerning the safety, health protection an performance,
characteristics and authorisation procedures for in vitro
diagnostic medical devices, with a view to their placing
on the market and putting into service.

harmonised

down

lays

Directive 98/79/EC stipulates in Article 2 that
the
Member States shall take all necessary steps to ensure
that devices may be placed on the market and/or put
into service only if they comply with the requirements
laid down by the Directive when duly supplied and
properly installed, maintained and used in accordance
with their intended purpose.

(7)

Directive 98/79/EC stipulates in Article 4 that
the
Member States shall not create any obstacle to the
placing on the market or the putting into service within
their territory of devices bearing the EC marking indi-
cating that they are considered to meet the requirements
set out in the Directive.

Directive 98/79/EC, in Annex I, contains specific label-
ling requirements related to the product and its charac-
teristics, including instructions for a proper and safe use.
These requirements aim, among others, to inform users
of the residual risks in relation with the product, as also
the
to provide information on the identification of
device, on any special microbiological state, particular
storage or handling conditions, particular operating
instructions and appropriate precautions to take.

(1) OJ L 331, 7.12.1998, p. 1.

(1)

(2)

(3)

(4)

The United Kingdom intends to maintain in force
national provisions concerning HIV testing kits. These
provisions are set out in the HIV testing kits and services
regulations 1992 (SI 1992/460 — 1992 Regulations)
and apply since 1 April 1992.

The notification of the United Kingdom relates to ‘those
provisions of
the 1992 Regulations that potentially
relate to the free movement of goods’. These are,
according to the notification, the provisions, that make
it an offence within the UK, to sell, supply or advertise,
for sale or supply, a HIV testing kit or any component
part of such a kit to a member of the public (Article 2 of
the Regulations) and also these, that make it an offence
to sell or supply a HIV testing kit that is not accompa-
nied at the time of sale or supply in the United Kingdom
by a notice indicating that it may not be supplied to a
member of the public (Article 3(2)(a) of the Regulations),
that a positive test should not be relied upon unless
confirmed by at least one other test result, and that a
negative test may not have detected recently acquired
HIV (Article 3(2)(b) and (c) of the Regulations).

The United Kingdom justifies its request by referring to
the protection of life and public health. They consider it
necessary to ensure the quality of HIV Testing Services
and to underpin Government public health policy on
HIV. In that context, individuals taking HIV tests should
have the opportunity to receive pre-test discussion and
post (positive) test counselling with a trained health care
professional. Such discussions allow for the impact and
consequences of a positive HIV test to be dealt with and
for the communication of
important advice on the
prevention of transmission.

II. PROCEDURE

(8)

Directive 98/79/EC of the European Parliament and of
the Council was adopted on 27 October 1998. Member
States has to adopt and publish the national provisions
necessary to comply with the Directive before 7
December 1999 and to apply them with effect from 7
June 2000.

L 25/48

EN

Official Journal of the European Communities

29.1.2002

(9)

(10)

Article 95(4) of the Treaty reads as follows: ‘If, after the
adoption by the Council or by the Commission of a
harmonisation measure, a Member State deems it neces-
sary to maintain national provisions on grounds of
major needs referred to in Article 30, or relating to the
protection of the environment or the working environ-
ment, it shall notify the Commission of these provisions
as well as the grounds for maintaining them’.

By letter of 31 July 2001, the United Kingdom Perma-
in
nent Representation informed the Commission,
accordance with Article 95(4) of the EC Treaty, that the
United Kingdom intends to maintain in force the HIV
Testing Kits and Services Regulations 1992. This noti-
fication was received on 1 August 2001.

(11) According to Article 95(6) of the Treaty, the six months
period for the examination of the notification under
Article 95(4) starts on 2 August 2001, the day following
the one when the notification was received.

III. ASSESSMENT

(12)

The notification submitted by the United Kingdom
authorities on 31 July 2001 intends to maintain in force
national provisions after the adoption of Directive 98/
79/EC, which constitutes a harmonisation measure
adopted on the basis of Article 95 of the Treaty (ex
Article 100A).

(13) Directive 98/79/EC provides for the prohibition of any
restriction regarding the placing on the market or the
putting into service of devices complying with the
Directive. Article 2 of the Regulations introduce restric-
tions to the distribution of HIV testing kits, limiting their
availability to the medical profession. Directive 98/79/
EC does not contain any rules concerning the distribu-
tion of in vitro diagnostic medical devices after their
placing on the market or their putting into service.
Consequently, the national measure corresponding to
Article 2 of the Regulations does not fall under the
scope of Directive 98/79/EC.

(14)

The labelling requirements of Directive 98/79/EC, are
related to the product and its characteristics. They
concern, among others, its proper and safe use, partic-
ular storage or handling conditions, instructions for use
and particular operating instructions and also any other
relevant information related to the product. The notified
national measures, as far as they require a notice indi-
cating that the product must not be sold or supplied to a
intend to give information
member of
regarding restrictions to the distribution of
the HIV
testing kits. Directive 98/79/EC does not contain neither
any provisions regarding the distribution of in vitro diag-
nostic medical devices, nor any labelling requirements
regarding their distribution and marketing. Conse-
quently, this national measure, corresponding to Article

the public,

(15)

3(2)(a) of the Regulations, does not fall under the scope
of Directive 98/79/EC.

The labelling requirements of Directive 98/79/EC aim,
among others, to inform users of the residual risks in
relation with the product. They impose information on a
proper and safe use, on appropriate precautions to take.
This should include the possibility of false positive or
false negative result. The notified national measures, as
far as they require a warning, drawing the attention of
the users to a possible fault positive or negative result,
intend to give information concerning the risks related
to the product. Consequently, the national measures,
corresponding to Article 3(2)(b) and (c) of the Regula-
tions,

implement Directive 98/79/EC.

IV. CONCLUSION

(16) Article 95(6) of the EC Treaty, aims at approving or
rejecting a national measure that derogates from a
harmonisation measure. National provisions that are
either falling outside the scope of a harmonisation
Directive or intended to implement such a Directive
cannot be assessed under this procedure.

(17)

regards

the compatibility of

In the light of the above considerations and without
prejudice to any assessment that the Commission can
make as
the notified
national measures with the EC Treaty, the Commission
is of the opinion that the notification of the United
Kingdom for maintaining the measures in the HIV
Testing Kits and Services Regulations 1992, as submitted
on 31 July 2001, with reference to Article 95(4) of the
Treaty,

is inadmissible,

HAS ADOPTED THIS DECISION:

Article 1

The notification concerning the maintenance of the notified
measures in the HIV Testing Kits and Services Regulations
1992, which the United Kingdom submitted to the Commis-
sion on 31 July 2001, on the basis of Article 95(4) of the
Treaty,

is hereby declared inadmissible.

Article 2

This Decision is addressed to the United Kingdom of Great
Britain and Northern Ireland.

Done at Brussels, 25 January 2002.

For the Commission

Erkki LIIKANEN

Member of the Commission