Thursday, January 15, 2009

Three legislative proposals from the European Commission for safe, innovative and accessible medicines


IP/08/1924

Brussels, 10th December 2008

Safe, innovative and accessible medicines: a renewed vision for the pharmaceutical sector

The EU has been losing ground in pharmaceutical innovation. European patients still suffer from inequalities in the availability of information about medicines, whilst counterfeits are on the rise. To address these challenges, the Commission has tabled a package, consisting of four key parts:

1. A communication to launch reflections on ways to improve market access and to develop initiatives to boost EU pharmaceutical research.

2. A proposal to tackle the growing issues of counterfeiting and illegal distribution of medicines,

3. Proposals to enable citizens to have access to high-quality information on prescription-only medicines and

4. Proposals to improve patient protection by strengthening the EU system for the safety monitoring ('pharmacovigilance') of medicines.

Commission Vice President Günter Verheugen, responsible for enterprise and industry said: “Everything we are suggesting today builds on the needs and interests of patients European citizens should benefit from safe, innovative and accessible medicines. They should be best informed about available medicines and treatments – since their health is at stake. We wish to restore the EU's traditional role as the pharmacy of the world.

The pharmaceutical sector makes an important contribution to European and global well-being through the availability of medicines, economic growth and sustainable employment. It has been and remains a strategic sector for Europe. It employs more than 634,000 people and accounts for more than 17% of the EU Research and Development (R&D) expenditure. Most importantly, innovation in human medicines has enabled patients to benefit from treatments considered unimaginable a few decades ago. Much has been achieved. However, major health, economic and scientific challenges lie ahead:

- Increasing globalisation of the sector brings new opportunities but also challenges. New markets are opening up; counterfeit medicines are on the rise;

- Shortcomings exist in the EU pharmaceutical market which affect patients' access to medicines and to relevant information, but also hampers the competitiveness of the industry;

Today’s Communication outlines a series of legislative proposals, political initiatives and international collaboration projects:

1. Legislative proposals:
- to tackle the growing issues of counterfeiting and illegal distribution of medicines (see Memo)
- to enable citizens to have access to high-quality information on prescription-only medicines (see Memo).
- to improve patient protection by strengthening the EU system for the safety monitoring ('pharmacovigilance') of medicines (see Memo)
These proposals will now be transmitted to the European Parliament and the Council.

2. A political communication:
- to discuss with Member States ways to improve market access by making pricing/reimbursement decisions more transparent;
- to develop initiatives to boost EU pharmaceutical research.
- to intensify cooperation with major partners (US, Japan, Canada) to improve medicines’ safety worldwide;
- to strengthen cooperation with emerging partners (Russia, India, China).


More information

http://ec.europa.eu/enterprise/pharmaceuticals/index_en.htm


Source

http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/pharmpack_en.htm