Activities of Carl SCHLYTER related to 2008/0256(COD)
Shadow reports (1)
REPORT Report on the 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 PDF (693 KB) DOC (1020 KB)
Amendments (47)
Amendment 29 #
The European Parliament rejects the Commission proposal.
Amendment 31 #
Proposal for a directive - amending act
Recital 1
Recital 1
(1) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use establishes harmonised rules on the advertising of medicinal products for human use. In particular, it prohibits the advertising to the general public of medicinal products subject to medical prescription in order to protect human health.
Amendment 37 #
Proposal for a directive - amending act
Recital 3 a (new)
Recital 3 a (new)
Amendment 61 #
Proposal for a directive - amending act
Recital 10
Recital 10
(10) Provisions should be established to ensure that only high-quality non- promotionofficial information about the benefits and the risks of authorised medicinal products subject to medical prescription may be dissemmade available, notably through the Community database referred to in Articles 57(1)(l) and 57(2) of Regulation (EC) No 726/2004 (hereinaftedr ‘the Eudrapharm database’). 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.
Amendment 66 #
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. Ivalidated statutory information, it is appropriate to allow marketing authorisation holders to disseminate the contents ofmake available the approved summaries of product characteristics and the approved package leaflet, information that is compatible with those documents without going beyond their key elements, and other well-defined medicinal product- related information.
Amendment 79 #
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 informationmake available material which is in compliance with Title VIIIa of Directive 2001/83/EC. Member States should adopt rules establishing effective independent monitoring mechanisms and allowing effective enforcement in cases of non-compliance. 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 83 #
Proposal for a directive – amending act
Article 1 – point – 1 a (new)
Article 1 – point – 1 a (new)
Directive 2001/83/EC
Article 86 – paragraph 1
Article 86 – paragraph 1
(-1a) Article 86(1) shall be replaced by the following: “1. For the purposes of this Title, ‘advertising of medicinal products’ shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products; it shall include in particular: - the advertising of medicinal products to the general public, including posts on blogs and websites, social media (so called ‘buzz marketing’) by the marketing authorisation holders either directly or indirectly through a third party; - advertising of medicinal products to persons qualified to prescribe or supply them, - visits by medical sales representatives to persons qualified to prescribe medicinal products, - the supply of samples, - the provision of inducements to prescribe, […]supply or, for citizens, patients and their carers, use medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal, - drawing the general public's attention to a specific medicinal product or to a therapeutic class of medicinal products using therapeutic indications or signs and symptoms, - sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products, - sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith.”
Amendment 89 #
Proposal for a directive – amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 1a (new)
Article 86 – paragraph 2 – indent 1a (new)
– correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product;
Amendment 90 #
Proposal for a directive – amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 2
Article 86 – paragraph 2 – indent 2
- factual, informative announcements and reference material relating, for example, to availability, pack changes, adverse- reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claimsinformation on the environmental risk of the medicinal product and information relating to the disposal of unused medicinal product or waste derived from medicinal products as well as reference to any collection system in place, provided they include no product claims and they do not induce to or promote the consumption of the medicinal product;
Amendment 93 #
Proposal for a directive – amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 3
Article 86 – paragraph 2 – indent 3
- information relating to human health or diseases, provided that it is based on scientific evidence and that there is no reference, even indirect, to medicinal products;
Amendment 96 #
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
- informationofficially approved documents 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 102 #
Proposal for a directive – amending act
Article 1 – point 1 a (new)
Article 1 – point 1 a (new)
Directive 2001/83/EC
Article 88 – paragraph 2
Article 88 – paragraph 2
(1a) Article 88(2) is replaced by the following: "2. Medicinal products may be advertised to the general public, except on television, which, by virtue of their composition and purpose, are intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary."
Amendment 103 #
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
(2) Article 88(4) is replaced by the following: “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.”;deleted.
Amendment 110 #
Proposal for a directive – amending act
Article 1 – point – 4 a (new)
Article 1 – point – 4 a (new)
Directive 2001/83/EC
Article 94 – paragraph 1
Article 94 – paragraph 1
(4a) Article 94(1) shall be replaced by the following: "1. Where medicinal products are being promoted directly or indirectly by a marketing authorisation holder or a third party acting on its behalf or following its instructions to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons […]."
Amendment 113 #
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 thereofto make available on their website official documents on authorised medicinal products subject to medical prescription provided that it is in the official languages of the Member States where they are authorised. Member States shall also allow the marketing accordance with the provisions of this Title. Such information shall not be considered advertising for the purposes of the application of Title VIIIuthorisation holder to make available on their websites information on authorised medicinal products subject to medical prescription as listed in Article 86(2). When such information is made available, the marketing authorisation holder and any third party acting on behalf of the marketing authorisation holder shall be clearly identified.
Amendment 119 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 a – paragraph 1 a (new)
Article 100 a – paragraph 1 a (new)
1a. Health professionals who deliver information on pharmaceutical products or medical devices during a public event, in print and/or broadcast media shall declare publicly their interests, i.e. any financial ties with marketing authorisation holders or with third parties working on their behalf. This also includes the provision of consulting services and technical advice about the product(s) in question.
Amendment 121 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 a – paragraph 2 – point a
Article 100 a – paragraph 2 – point a
Amendment 125 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 a – paragraph 2 – point b
Article 100 a – paragraph 2 – point b
b) material provided by the marketing authorisation holder to healthcare professionals for distribution to patients.
Amendment 131 #
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 informationdocuments on authorised medicinal products subject to medical prescription may be disseminatedmade available by the marketing authorisation holder to the general public or members thereof:.
Amendment 136 #
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 most recent 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;
Amendment 139 #
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 149 #
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
Amendment 157 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point d
Article 100 b – 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.eleted
Amendment 167 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c
Article 100 c
Amendment 172 #
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
Amendment 188 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 d – paragraph 1
Article 100 d – paragraph 1
Amendment 198 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 d – paragraph 2 – point d a (new)
Article 100 d – paragraph 2 – point d a (new)
da) a mail address or e-mail address allowing members of the general public to send comments to the national competent authorities;
Amendment 202 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100d – paragraph 2 – point d b (new)
Article 100d – paragraph 2 – point d b (new)
"db) A statement indicating that members of the general public should report all suspected adverse reactions to their doctor, pharmacist, healthcare professional or to the national competent authority."
Amendment 205 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 d – paragraph 3 – point a
Article 100 d – paragraph 3 – point a
Amendment 214 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 e – paragraph 1
Article 100 e – paragraph 1
1. Member States shall ensure that marketing authorisation holders' Internet websites for the dissemination of informationmaking available of documents on medicinal products subject to medical prescription faithfully reproduce the summary of product characteristics and the package leaflet of the medicinal products concerned in the official languages of the Member States where they are authorised.
Amendment 216 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 e – paragraph 1 a (new)
Article 100 e – paragraph 1 a (new)
1a. Member States shall ensure that each webpage from marketing authorisation holders referring to a medicinal product subject to medical prescription contains a prominent link to the corresponding webpage of the Community database referred to in Articles 57(1)(l) and 57(2) of Regulation (EC) No 726/2004 (hereinafter ‘the Eudrapharm database’).
Amendment 221 #
Proposal for a directive – amending act
Article 1 – point 5 (new)
Article 1 – point 5 (new)
Directive 2001/83/EC
Article 100 e – paragraph 1 b (new)
Article 100 e – paragraph 1 b (new)
1 b. Member States shall make available on the website of the national competent authorities the approved and updated version of the summary of product characteristics, labelling and package leaflet of the medicinal product, the publicly accessible version of the assessment report and its summary where applicable. The relevant websites of the national competent authorities shall include a link to the Eudrapharm web site.
Amendment 227 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/ec
Article 100 e – paragraph 2
Article 100 e – paragraph 2
2. Member States shall ensure that requests for information to a marketing authorisation holder on a medicinal product subject to medical prescription by a member of the general public may be drafted in any of the official languages of the Community which are official languages in the Member States where the medicinal product is authorised. The reply shall be drafted in the language of the request. The request and the reply shall be kept by the marketing authorisation holder for 10 years following the request and be made available to the competent authorities upon their request.
Amendment 235 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100g – paragraph 1 – subparagraph 2 – indent 1
Article 100g – paragraph 1 – subparagraph 2 – indent 1
- the content of the informationdocuments hasve already been approved by the competent authorities; or.
Amendment 236 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 g – paragraph 1 – subparagraph 2 – indent 2
Article 100 g – paragraph 1 – subparagraph 2 – indent 2
Amendment 240 #
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
Amendment 250 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 1 – subparagraph 2
Article 100 h – paragraph 1 – subparagraph 2
Amendment 254 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 1 – subparagraph 2 a (new)
Article 100 h – paragraph 1 – subparagraph 2 a (new)
After registration of the Internet website, any amendments to the content relating to medicinal products subject to medical prescription shall be subject to monitoring in accordance with paragraph 3.
Amendment 258 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 2 – subparagraph 1
Article 100 h – paragraph 2 – subparagraph 1
2. Internet websites registered in accordance with paragraph 1 shall not contain links to other marketing authorisation holder websites unless they have also been registered in accordance with that paragraph. Those websites shall identify the competent authority which granted the marketing authorisation and its website address.
Amendment 263 #
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-TV, web-radio, pod casts, video streaming or any other digital information format not strictly authorised in accordance with this Directive.
Amendment 269 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 3
Article 100 h – 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. marketing authorisation holder shall send the new contents and changes referred to in paragraph 1 to the competent authorities of the Member State where the Internet website has been registered for prior approval, before making available the new contents or changes on its website. The marketing authorisation holder shall remain fully responsible and liable for all the information it disseminates to the general public.
Amendment 283 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 5 a (new)
Article 100 h – paragraph 5 a (new)
5a. Member States shall require marketing authorization holder to add the following statements to the registered web site: - [the name of the marketing authorisation holder] is responsible for the information provided in this web site. - “If you believe that the information provided is not in compliance with the law, please contact the national competent authority”. - “You are encouraged to report negative side effects of prescription drugs to your doctor, pharmacist, health care professional or to the national competent authorities”. - “You can find information on prescription medicines authorised in the community on the following web site: [link to Eudrapharm]."
Amendment 289 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 j – point c
Article 100 j – point c
c) supplyprovide the authorities or bodies responsible for monitoring information on medicinal products with the information, the financial resources and assistance they require to carry out their responsibilities;
Amendment 291 #
Proposal for a directive – amending act
Article 1 – point 5 (new)
Article 1 – point 5 (new)
Directive 2001/83/EC
Article 100 j – point c a (new)
Article 100 j – point c a (new)
ca) put in place complaint-handling systems and efficient redress mechanisms to deal with consumer complaints and to ensure fair compensation of victims.
Amendment 292 #
Proposal for a directive – amending act
Article 1 – point 5 (new)
Article 1 – point 5 (new)
Directive 2001/83/EC
Article 100 j – subparagraph 1 a (new)
Article 100 j – subparagraph 1 a (new)
Member States shall provide for the possibility to publish the name of a marketing authorisation holder responsible for disseminating non- compliant information on a medicinal product.
Amendment 294 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 k
Article 100 k
Information on homeopathic and herbal medicinal products referred to in Article 14(1) that have been classified as prescription-only shall be subject to the provisions of this Title.
Amendment 296 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 l – paragraph 1 a (new)
Article 100 l – paragraph 1 a (new)
Within 12 months following the entry into force of this Directive, the Commission shall, following a public consultation, involving patient and consumer organisations, doctors' and pharmacists' organisations, present to the European Parliament and the Council an assessment report regarding the readability and the accuracy of the summaries of product characteristics and the packaging leaflets and their value to the general public and healthcare professionals. Following a data analysis and a systematic review of evidence, the Commission shall, if appropriate, put forward proposals to improve the layout and content of the summaries of product characteristics and of the package leaflet to ensure they are a valuable source of information for the general public and for healthcare professionals.