Activities of Ashley FOX 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 (10)
Amendment 31 #
Proposal for a directive – amending act
Recital 7
Recital 7
(7) In the light of the above and taking into account technological progress with regard to modern communication tools and the fact that patients throughout the European Union have become increasingly active as regards healthcare, it is necessary to amend the existing legislation in order to reduce differences in access to information and to allow for the availability of good-quality, objective, reliable and non -promotional information on medicinal products by placing emphasis on the interests of patients. They should have the right to easily access certain information such as a summary of product characteristics and the package leaflet in electronic and printed form.
Amendment 36 #
Proposal for a directive – amending act
Recital 12 a (new)
Recital 12 a (new)
(12a) The Internet is a major source of information for a growing number of patients. This trend is likely to increase in the coming years. In order to adapt to this development and to add to the growing importance of e-health, information on medicinal products should also be made available via national health Internet websites. These websites should be monitored by competent authorities in the Member States. Member States in cooperation with stakeholders such as health care professionals or patient organisations should be responsible for managing these websites.
Amendment 46 #
Proposal for a directive – amending actArticle 1 – point 5 Directive 2001/83/EC
Article 100 b – introductory part
Article 100 b – introductory part
1. The following types of information onmarketing authorisation holder shall, in respect of authorised medicinal products subject to medical prescription, may be disseminated by the marketing authoriske available to the general public or members thereof a summary of the 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. This information should be made available both in electronic and in printed form and in a format accessible to people with disabilities. 2. In addition, the following types of information may also be made availabler to the general public or members thereof by the marketing authorisation holder:
Amendment 47 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Amendment 49 #
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 wayway that is comprehensible to the general public or members thereof without jeopardising the quality or reliability of the information;
Amendment 51 #
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
(cb) information on the environmental imparelating to the disposal of unused medicinal products of ther waste derived from medicinal products, as well as reference to any collection system in place; information on prices and factual, informative announcements and reference material on a medicinal product, relating, for example, to pack changes or adverse- reaction warnings;
Amendment 57 #
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 publicCommission’s guidelines concerning the information allowed, such as booklets, leaflets, and other categories of printed information, to the exclusion of unsolicited material actively distributed to the general public or members thereof;
Amendment 60 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c a (new)
Article 100 c a (new)
Article 100ca 1. Member States shall ensure that the mandatory information as referred to in Article 100b(1) shall be made available through national health Internet websites in the official language(s) of the Member State where the website is registered. Such websites shall be monitored by a competent authority of the Member State or by a body assigned by the competent authority in accordance with Article 100g. The websites shall be administered and managed in cooperation with stakeholders such as health care professionals and patient organisations. 2. The information shall communicate both benefits and risks in a clear descriptive manner that is patient friendly and linked to the national medicinal products safety website. The Internet websites shall provide patients with the mandatory information on all available medicinal products in that Member State both centrally approved by the European Medicines Agency and locally approved in that Member State. 3. The Internet websites should also include general information about medicinal and non-medicinal treatment of various diseases, including rare diseases, in order to promote a high level of public health. They may also contain other information as referred to in Article 100b(2) and as defined by the Commission’s guidelines concerning information allowed.
Amendment 63 #
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 a (new)
Article 100 h – paragraph 2 – subparagraph 2 a (new)
Without prejudice to this prohibition, Internet websites registered in accordance with paragraph 1 can provide video content when it is aimed at supporting the safe and effective use of medicinal products in general and provided that it does not contain any promotional claims relating to medicinal products. Compliance with these two conditions shall be subject to monitoring in accordance with Article 100g.
Amendment 64 #
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 b (new)
Article 100 h – paragraph 2 – subparagraph 2 b (new)
The registered Internet websites shall display a notification at the top of each website page informing the public that the information contained therein is developed by a named marketing authorisation holder. A link to the EudraPharm database on medicinal products shall also be included in that notification.