15 Amendments of Nessa CHILDERS related to 2008/0256(COD)
Amendment 32 #
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 dissemination of information from the marketing authorisation holder to 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. in the context of a wider information to patients’ strategy. Furthermore, the Directive does not provide channels through which this information may be disseminated and does not provide for a package leaflet which is patient-friendly and responds to the real needs of patients. The package leaflet should therefore be transformed into a patient leaflet.
Amendment 40 #
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 provide information result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the Community. Each notion should be defined and should be interpreted uniformly across all EU Member States so to ensure patient safety.
Amendment 56 #
Proposal for a directive - amending act
Recital 9
Recital 9
(9) In accordance with the principle of proportionality, it is appropriate to limit the scope of this Directive to the making available of information on prescription- only medicinal products by the marketing authorisation holder, as current Community rules allow the advertising to the general public of medicinal products not subject to prescription, under certain conditions. The provisions of this Directive are without prejudice to the right of any other person or organisation, in particular the press or patients and patient organisations, to express their views on prescription only medicinal products, provided that they are acting independently and not directly or indirectly on behalf of, on the instructions of, or in the interest of the marketing authorisation holder and provided that they disclose the source of information.
Amendment 57 #
Proposal for a directive - amending act
Recital 10
Recital 10
(10) Provisions should be established to ensure that only high-quality non- promotional information about the benefits and the risks of medicinal products subject to medical prescription may be disseminated. The information should take into account patients needs and expectations in order to empower patients, allow informed choices and enhance the rational use of medicinal products. Therefore, any information to the general public on prescription-only medicinal products should comply with a set of quality criteria: objective and unbiased, patient-oriented, evidence-based, up-to- date, reliable, understandable, accessible, transparent, relevant, consistent with statutory information.
Amendment 65 #
Proposal for a directive - amending act
Recital 11
Recital 11
(11) In order to further ensure that marketing authorisation holders disseminate only high-quality information and to distinguish non-promotional information from advertising, the types of information which may be disseminated should be defined. It is appropriate to allow marketing authorisation holders to disseminate the contents of the approved summaries of product characteristics and package leaflet, information that is compatible with those documents without going beyond their key elements, and other well-defined medicinal product- related informationtient leaflet.
Amendment 70 #
Proposal for a directive - amending act
Recital 12
Recital 12
(12) Information to the general public on prescription-only medicinal products should only be providedbe made available through specific channels of communication, including Internet and health-related publications,health professionals, officially validated Internet websites, information booklets and medical journals 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, 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 77 #
Proposal for a directive - amending act
Recital 14
Recital 14
(14) Monitoring of information on prescription-only medicinal products should ensure that marketing authorisation holders only disseminate information which is in compliance with Directive 2001/83/EC. Member States should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non-compliance. These rules should be harmonized at European level so as to ensure consistency. Monitoring should be based on the control of information prior to its dissemination, unless the substance of the information has already been agreed by the competent authorities or if there is a different mechanism in place to ensure an equivalent level of adequate and effective monitoring.
Amendment 82 #
Proposal for a directive – amending act
Article 1 – point – 1 a (new)
Article 1 – point – 1 a (new)
Directive 2001/83/EC
Article 1 – paragraph 26
Article 1 – paragraph 26
Amendment 117 #
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 disseminate, either directly or indirectly through a third party, information that has been officially approved by national or European competent authorities 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. When such information is made available, the marketing authorisation holder and any third party shall be identified, and any third party acting on behalf of the marketing authorisation holder shall be clearly indentified as such.
Amendment 135 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point a
Article 100 b – point a
a) the summary of product characteristics, labelling and packagetient leaflet of the medicinal product, as approved by the competent authorities, and the publicly accessible version of the assessment report drawn up by the competent authorities; and the publicly accessible version of the assessment report drawn up by the competent authorities. This information should be made equally available in all Member States, both in electronic and printed format, and in a format accessible to people with disabilities. Representative patients’ organisations shall be involved in developing this information and making it available to patients.
Amendment 140 #
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
Amendment 153 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point c
Article 100 b – point c
c) information on the environmental impact of the medicinal product, prices and factual, informative announcements and reference material relating, for example, to pack changes or adverse-reaction warnings;
Amendment 178 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – point a
Article 100 c – point a
a) health-related publications as defined by the Member State of publicationEuropean Guidelines concerning information allowed, to the exclusion of unsolicited material actively distributed to the general public or members thereof;
Amendment 233 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 g – paragraph 1 – subparagraph 1
Article 100 g – paragraph 1 – subparagraph 1
1. Member States and European Commission shall ensure that there are adequate and effective methods of monitoring to avoid misuse when information on authorised medicinal products subject to medical prescription is disseminated by the marketing authorisation holder to the general public or members thereof.
Amendment 261 #
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 actively distributed to the general public or members thereof. Those websites shall not contain web-TVvideo delivery of information relating to the characteristics or usage of the medicinal product.