18 Amendments of Philippe JUVIN related to 2008/0256(COD)
Amendment 28 #
Proposal for a directive – amending act
Recital 2
Recital 2
(2) In the area of information, Directive 2001/83/EC lays down detailed rules on the documents to be annexed to the marketing authorisation and intended for information purposes: the summary of product characteristics (distributed to health-care professionals) and the package leaflet (inserted in the product’s packaging when it is dispensed to the patient). On the other hand, as regards the disseminationmaking available of information from the marketing authorisation holder to patients and the general public, the Directive only provides that certain information activities are not covered by the rules on advertising, without providing for a harmonised framework on the contents and the quality of non -promotional information on medicinal products or on the channels through which this information may be disseminated.made available. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 29 #
Proposal for a directive – amending act
Recital 4
Recital 4
(4) Experience gained from the application of the current legal framework has also shown that certain restrictions on the possibilities of pharmaceutical companies to providmake information available to patients and the general public result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the Community. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout)
Amendment 30 #
Proposal for a directive – amending act
Recital 5
Recital 5
(5) Those disparities in the interpretation of the Community rules on advertising, and between national provisions on information have a negative impact on the uniform application of Community rules on advertising, and on the effectiveness of the provisions on product information contained in the summary of products’ characteristics and the package leaflet. Although those rules are fully harmonised to ensure the same level of protection of public health across the Community, this objective is undermined if widely divergent national rules on the disseminationmaking available of such key information are allowed. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout)
Amendment 32 #
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. MWithout prejudice to the importance of the role played by national competent authorities and health care professionals in better informing patients and the general public, marketing authorisation holders may be a valuablen additional 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. The ban on advertising to the general public for prescription-only medicinal products should be maintained.
Amendment 34 #
Proposal for a directive – amending act
Recital 11
Recital 11
(11) In order to further ensure that marketing authorisation holders disseminatmake available only high-quality information and to distinguish non-promotional information from advertising, the types of information which may be disseminatedmade available should be defined. It is appropriate to allow marketing authorisation holders to disseminatmake available the contents of the approved summaries of product characteristics and package leaflets, information that is compatible with those documents without going beyond their key elements, and other well-defined medicinal product-related information. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 35 #
Proposal for a directive – amending act
Recital 12
Recital 12
(12) Information to the general public on prescription-only medicinal products should only be provided through specific channels of communication, including the Internet and health-related publications, to avoidensure that the effectiveness of the prohibition on advertising is not undermined by unsolicited provision of information to the public. Where information is disseminatedmade available via television or radio, patients are not protected against such unsolicited information and such disseminationmaking available should therefore not be allowbe prohibited.
Amendment 39 #
Proposal for a directive – amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 4
Article 86 – paragraph 2 – indent 4
– information made available by the marketing authorisation holder to the general public on medicinal products subject to medical prescription, which is subject to the provisions of Title VIIIa.
Amendment 40 #
Proposal for a directive – amending act
Article 1 – point 2
Article 1 – point 2
Directive 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 campaigns in the interest of public health carried out by the industry and approved by the competent authorities of the Member States.
Amendment 41 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 a – paragraph 1
Article 100 a – paragraph 1
1. Member States shall allow the marketing authorisation holder to disseminatmake available, either directly or indirectly through a third party, information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this Title. Such information shall not be considered advertising for the purposes of the application of Title VIII. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout)
Amendment 43 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
1. Without prejudice to the importance of the role played by national competent authorities and health care professionals in better informing patients and the general public on authorised medicinal products subject to medical prescription, Member States shall allow the marketing authorisation holder to disseminatmake available, either directly or indirectly through a third party, information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this Title. Such information shall not be considered advertising for the purposes of the application of Title VIII.
Amendment 45 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – introductory part
Article 100 b – introductory part
The following types of information on authorised medicinal products subject to medical prescription may be disseminatedmade available by the marketing authorisation holder to the general public or members thereof: (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 50 #
Proposal for a directive - amending act
Recital 8
Recital 8
(8) National competent authorities and health care professionals shouldmust 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. MWithout prejudice to the importance of the role played by national competent authorities and health care professionals in better informing patients and the general public, marketing authorisation holders may be a valuablen additional 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. The ban on advertising to the general public for prescription-only medicinal products should be maintained.
Amendment 50 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point b
Article 100 b – point b
(ba) information which does not go beyond the elements of the summary of product characteristics, labelling and the package leaflet of the medicinal product, and the publicly accessible version of the assessment report drawn up by the competent authorities, but presents them in a different waya patient-friendly way, without prejudice to the comprehensive and impartial nature of the information made available;
Amendment 58 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – point b
Article 100 c – point b
(b) imarketing authorisation holders’ Internet websites on medicinal products, to the exclusion of unsolicited material actively distributed to the general public or members thereof;
Amendment 62 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 g – paragraph 1 – subparagraph 3
Article 100 g – paragraph 1 – subparagraph 3
The methods may include the voluntary control of information on medicinal products by self-regulatory or co- regulatory bodies and recourse to such bodies, if proceedings before such bodies are possible in addition to the judicial or administrative proceedings available in the Member States.
Amendment 114 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 a – paragraph 1
Article 100 a – paragraph 1
1. Without prejudice to the importance of the role played by national competent authorities and health care professionals in informing the patients and the general public on authorised medicinal products subject to medical prescription, Member States shall allow the marketing authorisation holder to disseminate, either directly or indirectly through a third party, information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this Title. Such information shall not be considered advertising for the purposes of the application of Title VIII.
Amendment 144 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point b
Article 100 b – point b
b) information which does not go beyond the elements of the summary of product characteristics, labelling and the package leaflet of the medicinal product, and the publicly accessible version of the assessment report drawn up by the competent authorities, but presents them in a different waypatient-friendly way, without prejudice to the comprehensive and impartial nature of the information made available;
Amendment 242 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 g – paragraph 1 – subparagraph 3
Article 100 g – paragraph 1 – subparagraph 3
The methods may include the voluntary control of information on medicinal products by self-regulatory or co- regulatory bodies and recourse to such bodies, if proceedings before such bodies are possible in addition to the judicial or administrative proceedings available in the Member States.