Activities of Marina YANNAKOUDAKIS related to 2008/0256(COD)
Shadow reports (1)
REPORT Report on the proposal for a directive of the European Parliament and of the Council amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use PDF (693 KB) DOC (1020 KB)
Amendments (9)
Amendment 36 #
Proposal for a directive - amending act
Recital 3
Recital 3
(3) On the basis of Article 88a of Directive 2001/83/EC, on 20 December 2007 the Commission submitted a Communication to the European Parliament and the Council on a "Report on current practices with regard to the provision of information to patients on medicinal products". The report concludes that Member States have adopted divergent rules and practices with regard to the provision of information, resulting in a situation where patients and the public at large have unequal access to information oin medicinal productsthe package leaflet and in the summary of product characteristics. Such unjustifiable inequalities in accessing information that is publicly available in other Member States should be redressed.
Amendment 48 #
Proposal for a directive - amending act
Recital 8
Recital 8
(8) National competent authorities and health care professionals should remain importantthe main sources of information on medicinal products for the general public. Member States should facilitate the access of citizens to high-quality information through appropriate channels. Marketing authorisation holders may be a valuable source of non promotional information on their medicinal products. This Directive should therefore establish a legal framework for the disseminationmaking available of specific information on medicinal products by marketing authorisation holders to the general public in the context of a wider "information to patients" strategy. The ban on advertising to the general public for prescription-only medicinal products should be maintained. The provisions of this Directive concerning the making available of information by marketing authorisation holders are without prejudice to the relationship between patients and their doctors and should contribute to ensuring that patients are better informed. The quality and accuracy of information should be increased with a view to better informing patients and therefore to achieving better health outcomes for patients. This information must be based on scientific criteria.
Amendment 73 #
Proposal for a directive - amending act
Recital 12
Recital 12
(12) Information to the general public on prescription-only medicinal products should only be provimade available by the marketing authorisation holdedr through specific channels of communication, including Internet and health-related publications, to avoid that the effectiveness of the prohibition on advertising is undermined by unsolicited provision of information to the public. Where information is disseminated via television or radiomade available by the marketing authorisation holder via television, internet sites, radio, or newspapers, magazines and similar publications, patients are not protected against such unsolicited information and such disseminmaking available of information should therefore not be allowed.
Amendment 81 #
Proposal for a directive - amending act
Recital 15 a (new)
Recital 15 a (new)
(15a) The Commission should consult patient organisations and healthcare professionals on issues relating to the implementation of this Directive and its application by the Member States.
Amendment 107 #
Proposal for a directive - amending act
Article 1 – point 2
Article 1 – point 2
2001//83/EC
Article 88 – paragraph 4
Article 88 – paragraph 4
4. The prohibition set out in paragraph 1 shall not apply to vaccination campaigns and other information campaigns in the interest of public health carried out by the industry and approved by the competent authorities of the Member States, where national authorities deem there to be a severe risk.
Amendment 168 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – introductory part
Article 100 c – introductory part
Information on authorised medicinal products subject to medical prescription disseminatedmade available by the marketing authorisation holder to the general public or members thereof shall not be made available on television or radio, internet sites, radio or newspapers, magazines and similar publications. It shall only be made available through the following channels:
Amendment 197 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 d – paragraph 2 – point d
Article 100 d – paragraph 2 – point d
d) a maipostal address or e-mail address allowing members of the general public to send comments to, or request for further information from, the marketing authorisation holder.
Amendment 251 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 1 – subparagraph 2
Article 100 h – paragraph 1 – subparagraph 2
After registration of the Internet website, the information on a medicinal product contained therein may be provided by the marketing authorisation holder on other Internet websites throughout the Community if the contents are identicalregistered by the marketing authorisation holder in accordance with the provisions of the first subparagraph throughout the Community if the contents are identical. These websites shall be linked to the website which will be created by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use .
Amendment 262 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 2 – subparagraph 2
Article 100 h – paragraph 2 – subparagraph 2
Internet websites registered in accordance with paragraph 1 shall not allow the identification of members of the general public which have access to those websites or the appearance therein of unsolicited material activelycontent distributed to the general public or members thereof. ThoseInternet websites shall not contain web-TVmay provide video content if it is useful for the safe and effective use of the medicine.