Activities of António Fernando CORREIA DE CAMPOS related to 2008/0256(COD)
Shadow opinions (2)
OPINION 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
OPINION 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
Amendments (19)
Amendment 21 #
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 authorised medicinal products subject to medical prescription may be disseminatedmade available. 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 authorised prescription-only medicinal products should comply with a set of quality criteria. (Replacing the term 'disseminated' with 'made available' applies throughout the text. Adopting this amendment will necessitate corresponding changes throughout.)
Amendment 23 #
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 86 – paragraph 1 – indent 1 a (new)
Article 86 – paragraph 1 – indent 1 a (new)
(-1) The following indent shall be inserted after the first indent of Article 86(1): "- drawing the general public's attention to a specific medicinal product, using therapeutic indications or signs and symptoms,"
Amendment 28 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100a – paragraph 1
Article 100a – paragraph 1
1. 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 33 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100b – point b
Article 100b – 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 way, provided that it clearly contains an accurate representation of the risks and benefits of the medicinal product;
Amendment 33 #
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 authorised medicinal products subject to medical prescription may be disseminatedmade available. 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. (The replacement of the word ‘disseminated’ with the term ‘made available’ applies to the text as a whole. Adopting this amendment will necessitate corresponding changes throughout)
Amendment 36 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100c – introductory part
Article 100c – introductory part
Information on authorised medicinal products subject to medical prescription disseminated by the marketing authorisation holder to the general public or members thereof shall not be made available on television or radio, or in general newspapers and magazines or in the form of inserts or supplements to them. It shall only be made available through the following channels:
Amendment 37 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100c – point a
Article 100c – point a
(a) health-related publications as defined by the Member State of publictechnical and scientific magazines in the field of health, or magazines addressed to the general public whose main content is in the field of health, brochures, leaflets and other categories of printed information, to the exclusion of unsolicited material actively distributed to the general public or members thereof;
Amendment 38 #
Proposal for a directive – amending act
Article 1 – point 1
Article 1 – point 1
(-1) In paragraph 1 of Article 86, after the first indent, the following indent is inserted: “– drawing the attention of the general public to medicinal products by means of references to therapeutic indications or to signs and symptoms,”
Amendment 42 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100d – paragraph 1 – point b
Article 100d – paragraph 1 – point b
(b) it must take into accoube geared to the patient, the general needs and expectations of patiento better meet his or her needs;
Amendment 42 #
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 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 43 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100d – paragraph 1 – point c
Article 100d – paragraph 1 – point c
(c) it must be based on evidence, be verifiable and include a statement on the level of evidence; Does not affect the English version)
Amendment 47 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100d – paragraph 2 – point c
Article 100d – paragraph 2 – point c
(c) a statement indicating that the information is disseminated by a marketing authorisation holder and naming the holder;
Amendment 48 #
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 wayand more readily comprehensible way, provided that it manifestly constitutes an accurate representation of the risks and benefits associated with the medicinal product;
Amendment 51 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100g – paragraph 1 – subparagraph 3
Article 100g – 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 55 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100h – paragraph 2 – subparagraph 2
Article 100h – 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-TVdisseminate video material.
Amendment 55 #
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 publicscientific and technical journals or magazines aimed at the general public with mainly health-related content, booklets, leaflets, and other categories of printed information, to the exclusion of unsolicited material actively distributed to the general public or members thereof;
Amendment 56 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100h – paragraph 3
Article 100h – paragraph 3
3. The Member State where the Internet website has been registered shall be responsible for the monitoring of the contents disseminated on that website in relation to medicinal products subject to medical prescription.
Amendment 57 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100h – paragraph 5
Article 100h – paragraph 5
5. Member States shall allow mrequire that: (a) Marketing authorisation holders which have registered Internet websites in accordance with paragraphs 1 to 4 to include a statement therein to the effect that the site has been registered and is subject to monitoring in accordance with this Directive. The statement shall identify the national competent authority monitoring the website concerned. It shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval; (b) Registered Internet websites include on each of their pages, in a prominent position, a hyperlink to the web page of the Eudrapharma database, together with an explanatory note informing users that this is the official database developed by the European Medicines Agency.
Amendment 59 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
(c) written answers to requests for information ofrom a member of the general public. Verbal questions must be recorded.