MEPS vote against advertising but ask for clarity on the provision of information
In early November 2003 the Parliament’s Environment Committee began to discuss its response to the review of the Pharmaceutical’s legislation.
There are three proposals under consideration:
Regulation 2309/3 concerns the provision of a legislative framework for medicinal products.
2 Directives: 2001/83 on human medicine, and 2001/82 concerning vetinary medicines
The Committee retabled amendments rejected by the Council concerning the definition of medicines, generic, biological etc.
On the contentious issue of Direct to Consumer Advertising (DTCA), this was rejected by the Committee. Although the MEPs asked the Commission, after consulting patients, doctors, consumers and pharmacists organizations, to provide a clearer distinction between what constitutes publicity and what is genuine information.
The Environment Committee also voted to broaden the scope of the centralised authorization procedure from biotech products to also include medicines for:
HIV/AIDS
cancer
diabetes
neurodegenerative disorders
On the issue of data protection, the Council had wanted to extend the period before which generics could come onto the market. The Committee rejected this in regard to medicinal products for humans, but agreed to a compromise in certain circumstances known as the 8+2+1. This would mean that certain generic drugs could only be marketed after 11 years instead of the usual 10.
Parliament is due to complete its second reading of the Pharmaceticals review in Strasbourg (15th - 18th December 2003).
For more information about DTCA click here
