EN Official Journal of the European Union CE 84/39

(2004/C 84 E/0043)

WRITTEN QUESTION E-2808/03

by Albert Maat (PPE-DE) to the Commission

(19 September 2003)

Subject: Risks of hormone therapies

At the beginning of August the British journal The Lancet published findings which demonstrated the existence of a link between certain hormone therapies and breast cancer. The findings were particularly concerned with hormone therapies for problems associated with the menopause or osteoporosis using estrogens and the synthetic hormone tibolon, and with preparations combining estrogens and progestogens.

Moreover, research by the University of Groningen has shown that the use of hormones after the menopause can also increase the risk of cardiovascular diseases, whereas previously it was assumed that hormone therapies actually afforded protection against cardiovascular diseases and osteoporosis.

What is the Commission doing to protect citizens of the Union and consumers of such products against these recently demonstrated risks, and to inform them of the dangers?

Answer given by Mr Liikanen on behalf of the Commission

(15 October 2003)

Hormone Replacement Therapy (HRT) products are authorised for the treatment of menopausal symptoms. Some products are also authorised for the prevention of osteoporosis.

The increased risk of breast cancer with HRT has been recognised for some time. New data regarding the risks of breast cancer, as well as data suggesting an increased risk of cardiovascular disease have recently become available.

A working group on HRT with experts from the Member States, of the Mutual Recognition Facilitation Group (MRFG) has been updating a European ‘core’ Summary of Product Characteristics (SPC) for the last few years. An SPC has two functions. Firstly it is part of the Marketing Authorisation of a product and secondly it is a communication document to inform healthcare professionals about a particular product and how to use it safely. Because most HRT products are authorised nationally a European ‘core’ SPC was developed. This is used as a template by the Member States as the basis for the national HRT SPCs. The European ‘core’ SPC contains clear warnings about the risks of breast cancer and cardiovascular disease. Hence these warnings appear in national SPCs. The HRT Working Group of the MRFG meets at the European Agency for the Evaluation of Medicinal Products (EMEA) and takes advice from the Committee for Proprietary Medicinal Product's- (CPMP) Pharmacovigilance Working Party.

In light of the new data on the risks of HRT, national competent authorities in the Member States have communicated with healthcare professionals and users of HRT with information about the risks of HRT therapy. At a European level, the EMEA has made available funds for a new CPMP ad-hoc working group on HRT. This working group will build on the work already done by the MRFG Working Group and will advise CPMP what further action, if any, is required to protect the citizens of the Union from the risks of HRT. In addition, the Community under its three consecutive ‘Europe against Cancer’ programs has helped to set up a system of cancer surveillance through the European Network of Cancer Registries (ENCR) as well as a large European prospective investigation into cancer and nutrition (EPIC), which studies among 522 000 volunteers, of which about 320 000 are women, risk factors for cancer related to diet, lifestyle and physical activity. This prospective study is also expected to contribute evidence on the relative risks for breast cancer related to hormone replacement therapy.