WRITTEN QUESTION E-2295/02 by Avril Doyle (PPE-DE) to the Commission. Pharmaceutical products for human use.
Date: 2002-07-25
Institutions: European Parliament, Provisional data
Subjects: approximation of laws, budget, data protection, drug surveillance, impact study, intellectual property, market approval, medicinal product, pharmaceutical legislation, public health

5.12.2002

EN

Official Journal of the European Communities

C 301 E/267

Answer given by Mrs Diamantopoulou on behalf of the Commission

(27 August 2002)

The Commission would refer the Honourable Member to its answers to written questions E- 1505/02 by
Mr Xarchakos (1) and E-1495/02 by Mr Hatzidakis (2).

(1) OJ C 277 E, 14.11.2002, p. 220.
(2) OJ C 277 E, 14.11.2002, p. 216.

(2002/C 301 E/286)

WRITTEN QUESTION E-2295/02

by Avril Doyle (PPE-DE) to the Commission

(25 July 2002)

Subject: Pharmaceutical products for human use

In its proposal (1) to amend the Community Code relating to pharmaceutical products for human use
(amending Directive 2001/83/EC (2)), the European Commission has put forward a harmonised 10-11 year
data exclusivity period during which all applications for an essential similar generic medicine are
prohibited.

Could the European Commission please indicate:

1. What economic criteria and analysis did the European Commission use in selecting a 10-year period

rather than a 6-year period as applied in Ireland and six other EU Member States?

2. Did the European Commission carry out any assessment of the impact on health care budgets caused

by the increase in this period of protection for:

(a) EU Member States currently applying a 6-year data exclusivity period and

(b) applicant countries, most of who have indicated their preference for a 6-year data exclusivity

period?

(1) COM(2001) 404 final, OJ C 75 E, 26.3.2002, p. 216.
(2) OJ L 311, 28.11.2001, p. 67.

Aswer given by Mr Liikanen on behalf of the Commission

(26 August 2002)

In preparation of its proposal to amend the pharmaceutical legislation (1), the Commission initiated an
evaluation of the authorisation procedures by external experts. The final report by CMS Cameron McKenna
and Andersen Consulting of November 2000 (2) analyses in detail the issue of data protection, taking into
account economic criteria and impact on health care budgets.

on behalf of the Commission, a further report on ‘Global competitiveness in pharmaceuticals (cid:1) A
European perspective’ was prepared by Gambardella, Orsenigo and Pammolli (3) and presented in
November 2000. This report, too, addresses the deficiencies in the current legislation’s lack of sufficient
protection of intellectual property rights.

In particular the ‘McKenna’ report revealed a very strong support for harmonising the periods of data
protection of currently 10 years for centrally and at least 6 years for nationally authorised medicines (see
section 5.3.9.2 of the report).

Regarding the precise level of data protection, 79 % of all respondents were in favour of a harmonised
period of 10 years. This included innovative industry, regulators and other respondents, but also generic
companies, of which 56 % supported a harmonised protection of 10 years (section 5.3.9.2 of the report).

C 301 E/268

Official Journal of the European Communities

EN

5.12.2002

Based on this report as well as on other publicly available figures, the Commission considers that a period
of 10 years strikes the most appropriate balance between providing sufficient rewards for innovation while
at the same time promoting generic competition. This assessment was also underlying the adoption of
Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the
authorization and supervision of medicinal products for human and veterinary use and establishing a
European Agency for the Evaluation of Medicinal Products (4) which grants such a 10-year data protection
to all centrally authorised medicines.

The reflection leading to the current proposal extended of course to the expected impact of this proposal
on the healthcare budget of current and future Member States. Basic information was again collected and
summarised in the ‘McKenna’ report (see in particular section 5.3.9.1).

A precise prediction of the impact however is not possible for a number of reasons. The first and
fundamental reason is the interdependence of expenditure for medicines on the one hand and in- and out-
patient care on the other. Medicines account for about 15 % of the total healthcare expenditure, whereas
the in-patient care accounts for about 42 % and out-patient care for about 43 % (according to Organisation
for Economic Cooperation and Development Health Data 2001). It is to be expected that a favourable
climate for innovation in Europe will improve the availability of innovative medicines. This could lead to
an increase in public expenditure for medicines, but it has great potential for reducing significantly the
expenditure for in- and out-patient care. This could finally help to cut down the public expenditure.

In addition, there are a number of other factors which will also contribute to the total healthcare budget.
First, the Commission’s proposals contain a number of improvements for generic medicines which aim at
reinforcing generic competition after the expiry of data protection. Second, a number of developments
outside the ongoing revision, like the arrival of ‘tailor-made’ medicines relying on the latest knowledge of
the human genome or expected improvements in health conditions in candidate countries, will also have a
strong impact on the total healthcare budget.

(1) COM(2001) 404 final.
(2) Available on the web site http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2000/nov/reportmk.pdf.
(3) http://pharmacos.eudra.org/F3/g10/docs/comprep_nov2000.pdf.
(4) OJ L 214, 24.8.1993.

(2002/C 301 E/287)

WRITTEN QUESTION P-2313/02

by Edward McMillan-Scott (PPE-DE) to the Commission

(18 July 2002)

Subject: Closure of Selby coalfield

With regard to the enormous public investment by the EU and other public authorities in the development
of the mines and associated infrastructure in the area, what funds are now available to deal with the
human consequences of the recently announced closure of Selby coalfield?

(2002/C 301 E/288)

WRITTEN QUESTION E-2397/02

by Richard Corbett (PSE) to the Commission

(5 August 2002)

Subject: Closure of Selby coal mines and EU structural funding

Will the Commission give active consideration to redeploying structural funding to Yorkshire to take
account of new developments, and in particular, the announcement of the closure of the Selby coal mines
with the loss of thousands of jobs?