Activities of Cristina GUTIÉRREZ-CORTINES related to 2008/0256(COD)
Shadow opinions (1)
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 (20)
Amendment 22 #
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 information.
Amendment 24 #
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, which shall ensure that such campaigns are not intended to serve as advertising.";
Amendment 27 #
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 but it shall require prior authorisation by the Member State, after having checked that such information complies with the requirements for marketing authorisation for the medicinal product. The information concerned may not contain any data on development studies for medicinal products, new prospects for their use or properties under investigation, or any other information which may create distortions or endow the medicinal product with properties or uses other than those contained in the current marketing authorisation for the medicinal product in question.
Amendment 29 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100a – paragraph 2 – point a
Article 100a – paragraph 2 – point a
(a) information relating to human health or diseases, provided that it is based on objective, realistic data supplied by the competent bodies and there is no reference, even indirect, to medicinal products;
Amendment 30 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100a – paragraph 2 – point b
Article 100a – paragraph 2 – point b
(b) material provided by the marketing authorisation holder to healthcare professionals for distribution to patients, which must be explicitly authorised by the Member States, taking account of what was authorised in the technical summary.
Amendment 31 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100b – point a
Article 100b – point a
(a) the summary of product characteristics, labelling and package 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; these versions and summaries shall require prior authorisation by the Member State before they are disseminated to the public;
Amendment 32 #
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; this publicly accessible version may not constitute a substantial change in the characteristics, properties, effects and reactions that the medicinal product might have;
Amendment 34 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100b – point d
Article 100b – point d
(d) medicinal product-related information about non-interventional scientific studies, or accompanying measures to prevention and medical treatment, or information which presents the medicinal product in the context of the condition to be prevented or treated. This information must have been evaluated in advance by the Member State, and such studies must be included in the registration dossier for the medicinal product. Scientific studies may not be submitted if they were carried out without complying with the legal requirements in force for clinical trials. Scientific studies may also not be submitted if they relate to properties of the medicinal product or a use of that product other than those for which it is currently authorised in the Member State.
Amendment 35 #
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, radio or any other instrument of dissemination to the general public, including Internet radio or television channels. It shall only be made available through the following channels:
Amendment 38 #
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) written health-related publications as defined by the Member State of publication, to the exclusion of unsolicited material actively distributed to the general public or members thereof; health-related publications shall mean those certified as such by the Member State, so that consumers can clearly identify those publications as having been endorsed and authorised by the Member State;
Amendment 39 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100c – point b
Article 100c – point b
(b) internet websites on medicinal products, explicitly authorised and regarded as such by the Member State, to the exclusion of unsolicited material actively distributed to the general public or members thereof; for this purpose, the Member States shall establish a system for authorising, supervising and monitoring Internet sites which may present the information referred to in this article. Furthermore, an early warning system shall be set up among the Member States to combat Internet sites which violate the provisions of this Directive;
Amendment 41 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100c – point c
Article 100c – point c
(c) written answersd oral answers, provided that the latter are duly recorded, to requests for information ofrom a member of the general public. These answers shall in all cases correspond to the package leaflet or technical summary for the authorised medicinal product and shall refer the requestor to the Member State's health authority and to medical or pharmaceutical healthcare staff, giving an explicit indication in the answer that it is no substitute for mandatory intervention by the above healthcare professionals. Furthermore, all these written and oral answers shall also be forwarded to the competent health authorities in the Member State for periodic supervision.
Amendment 45 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100d – paragraph 1 – point f
Article 100d – paragraph 1 – point f
(f) it must be understandable and perfectly legible for the general public orand members thereof; , paying particular attention to elderly people;
Amendment 46 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100d – paragraph 1 – point h a (new)
Article 100d – paragraph 1 – point h a (new)
(ha) it must be presented in such a way as to ensure that the dosage of the medicinal product is perfectly understandable, paying particular attention to those medicinal products whose correct administration is complex. This information shall indicate: (i) the exact dosage to be taken; (ii) the way in which it is to be measured and the instruments to be used for this purpose; (iii) the interval of time between each dose; (iv) the adjustment of the dosage to the weight and age of the individual patient.
Amendment 48 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100d – paragraph 2 – point d
Article 100d – paragraph 2 – point d
(d) a mail address or e-mail address allowing members of the general public to send comments to the marketing authorisation holder. Comments sent by private individuals and the replies from marketing authorisation holders shall be duly recorded and monitored.
Amendment 49 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100e – paragraph 2 a (new)
Article 100e – paragraph 2 a (new)
2a. The state or infra-state authorities responsible for health administration shall set up a telephone helpline providing individual advice to patients, staffed by healthcare professionals, that may be consulted on the interpretation of the information contained in the leaflet, and on compatibility with other medicinal products or with the patient's case history.
Amendment 50 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100f – paragraph 2 a (new)
Article 100f – paragraph 2 a (new)
2a. A harmonised procedure shall be established to determine the bases on which information provided on Internet websites and information points is regulated, in such a way as to guarantee the reliability of the data presented and its compliance with the authorisation and registration of the medicinal product, providing a guarantee for consumers that the site or information concerned is accurate and based on facts. A certification or qualification system shall be applied with respect to authorised sites. A list shall also be kept of Internet web pages and information points authorised to provide the information referred to in this Directive. That list shall be kept up- to-date and shall be accessible to consumers.
Amendment 52 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100h – paragraph 1 – subparagraph 1
Article 100h – paragraph 1 – subparagraph 1
1. Member States shall ensure that marketing authorisation holders register Internet websites containing information on medicinal products with the national competent authorities of the Member State of the country code Top Level Domain used by the website concerned, prior to making it available to the general public. Where the website does not use a country code Top Level Domain, the marketing authorisation holder shall select the Member State of registration. This information shall comply with the requirements laid down in this Directive and shall be in accordance with the registration dossier for the medicinal product.
Amendment 54 #
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-TV, podcasts, video streaming or any other digital information format not strictly authorised in accordance with this Directive and supervised by the Member State.
Amendment 58 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100k
Article 100k
Information on homeopathic medicinal products referred to in Article 14(1) that have been classified as prescription-only shall be subject to the provisions of this Title. The same shall apply to information on herbal medicinal products or any other compounds or therapies that have been classified as prescription-only.