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 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).

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.