WRITTEN QUESTION E-2567/00 by Imelda Read (PSE) to the Commission. Experimental use and testing for generic medicines prior to patent-expiry.
Date: 2000-08-01
Institutions: European Parliament, Provisional data
Subjects: European patent, generic drug

C 89 E/208

Official Journal of the European Communities

EN

20.3.2001

The Commission has also written to the International Monetary Fund (IMF) informing it of the problems
posed by Korea(cid:146)s practices in this area and drawing its attention to the monitoring such practices require.

Although the Agreed Minutes do not contain any binding provisions for sanctions, they still constitute an
international agreement binding both parties legally. Korea has repeatedly expressed its intention to apply
all the Agreement(cid:146)s provisions in full. The second consultation meeting in September will show whether
Korea(cid:146)s goodwill gestures at the first meeting will be transformed into practical solutions. In any case the
Commission will remain vigilant regarding the implementation of Korea(cid:146)s commitments. Korea is perfectly
aware that if the results of the consultations do not fulfil the Community(cid:146)s expectations, the European
industry will probably lodge a complaint under the Trade Barriers Regulation (TBR) (1). This procedure
could, if necessary, lead to World Trade Organisation (WTO) action to penalise the Korean use of subsidies
and dumping, and to remedy the situation.

The Commission does not plan to extend aid for contracts. However, Council Regulation (EC) No 1540/98
of 29 June 1998 establishing new rules on aid to shipbuilding (2) covers aid for modernisation, allowing
support for the European industry(cid:146)s efforts to adapt to world competition.

(1) Council Regulation (EC) No 3286/94 of 22 December 1994 laying down Community procedures in the field of the
common commercial policy in order to ensure the exercise of the Community(cid:146)s rights under international trade
rules,
(OJ L 349,
31.12.1994).

in particular those established under the auspices of the World Trade Organisation (WTO)

(2) OJ L 202, 18.7.1998.

(2001/C 89 E/235)

WRITTEN QUESTION E-2567/00

by Imelda Read (PSE) to the Commission

(1 August 2000)

Subject: Experimental use and testing for generic medicines prior to patent-expiry

On 16 April 1996 the European Parliament passed a resolution on the (cid:145)Industrial policy for the
pharmaceutical sector(cid:146) (A4-0104/96 (1)) asking the European Commission and Member States to introduce
legislation that would enable generic medicines to be tested and registered in preparation for the expiry of
the original product(cid:146)s market monopoly (so-called (cid:145)bolar(cid:146) provisions).

Since that date the European Commission has commissioned a study on (cid:145)Policy relating to generic
medicines in the OECD(cid:146) (20/12/1998) that showed that without such provisions the EU active ingredient
industry alone will lose 13 000 jobs.

At the TABD in November 1997 the Commission acknowledged that the EU generic industry was at a
competitive disadvantage to the manufacturers outside the EU who benefit from such provisions. In its
Communication on the Single Market in Pharmaceuticals (COM(98) 588) the Commission indicated that
the licensing process should operate speedily to ensure that consumers have access to low-priced generic
medicines as soon as possible after the patent protection of the originator product expires.

The call for such provisions was also made at the TACD meeting in February in Washington.

Most recently a WTO Panel Ruling in EU v. Canada (WT/DS114/R) of 17 March 2000 clarified that these
Bolar provisions are compatible with TRIPS and are therefore in line with the EU(cid:146)s international obligations
with respect to intellectual property protection.

In view of these developments could the Commission explain what is being done to introduce such
provisions into EU law?

(1) OJ C 141, 13.5.1996, p. 63.

20.3.2001

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Official Journal of the European Communities

C 89 E/209

Answer given by Mr Bolkestein on behalf of the Commission

(27 September 2000)

for establishing a Community patent (1). The
The Commission has recently agreed on a proposal
discussions in the Council and the Parliament on this proposal will certainly address the issue of the so-
called (cid:145)Bolar type(cid:146) exception to patent rights. The Commission will take note of the positions taken on this
issue in respect of the Community patent and will,
if necessary, then consider whether any further
initiatives should be taken in relation to the national patent systems in the Community.

(1) COM(2000) 412 final.

(2001/C 89 E/236)

WRITTEN QUESTION E-2572/00

by Florence Kuntz (UEN) to the Commission

(1 August 2000)

Subject: Legislation applicable to homeopathy in the European Union

Can the Commission provide information on the legislation currently applicable to homeopathy and
homeopathic medicines within the European Union and can it provide full references for the relevant texts
(directives, etc.)?

Can it say whether this legislation applies to all fifteen Community countries and, if that is not the case,
what reasons are given for exempting certain Member States from the application of legislation on
homeopathy?

Does it consider that the single market in the homeopathy sector is a reality and, if not, can it say what
initiatives it will take?

Can it say, in particular, what measures it will propose to ensure that the products listed on homeopathic
prescriptions can be obtained in all the countries of the European Union, in order to ensure that citizens of
the various countries can be certain, when travelling within the Community, that they will be able to
obtain homeopathic medicines and protect their health while enjoying free movement and travel?

Answer given by Mr Liikanen on behalf of the Commission

(28 September 2000)

Community legislation governing homeopathic medicines is contained in Council Directive 92/73/EEC of
22 September 1992 widening the scope of Directives 65/65/EEC and 75/319/EEC on the approximation
of provisions laid down by law, regulation or administrative action relating to medicinal products and
laying down additional provisions on homeopathic medicinal products (1).

The Member States were required to take the necessary measures to comply with the Directive no later
than 31 December 1993. This legislation therefore applies throughout the European Union.

The Directive, which provides for the possibility of a special, simplified registration procedure, also
stipulates, however, that the Member States may decide not to implement the procedure, on condition
that they inform the Commission accordingly. In this event, the Member States must allow the use on their
territory of medicines which have been registered in other Member States using the simplified procedure.

Similarly, the Directive allows a Member State to introduce or apply special rules on testing requirements,
in line with the principles and rules governing homeopathic medicines in that Member State.