Activities of Gilles PARGNEAUX 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 (58)
Amendment 28 #
The European Parliament rejects the Commission proposal.
Amendment 35 #
Proposal for a directive – amending act
Recital 3
Recital 3
Amendment 38 #
Proposal for a directive – amending act
Recital 3 a (new)
Recital 3 a (new)
(3a) In the area of scientific information, Directive 2001/83/EC lays down transparency obligations for National competent authorities, but experience gained from the application of the current legal framework has also shown certain restrictions on the possibilities for the general public to access information from their National competent authorities due to a too extensive interpretation of commercial confidentiality.
Amendment 41 #
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 Communitythe distinction between the notions of advertising and information is not clear across the Community, resulting in exposure of the general public is disguised advertising.
Amendment 43 #
Proposal for a directive – amending act
Recital 6
Recital 6
(6) The different national measures are also likely to have an impact on the proper functioning of the internal market for medicinal products, as the possibility for marketing authorisation holders to disseminate informationcommunicate on medicinal products is not the same across Member States, while information disseminatedcommunications in one Member State isare likely to have effects in other Member States. This impact will be greater in the case of medicinal products whose product information (summary of product characteristics and package leaflet) is harmonised at Community level. This includes medicinal products authorised by the Member States under the mutual recognition framework of Chapter IV of Title III of Directive 2001/83/EC.
Amendment 44 #
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 productsrelevant, independent and comparative health information and to protect patients from misleading or biased information.
Amendment 51 #
Proposal for a directive – amending act
Recital 8
Recital 8
(8) National competent authorities and health care professionals should remain importantthe main sources of information on medicinal products for the general public. Member States should facilitate the access of citizens to high-quality information through appropriate channels. Marketing authorisation holders may be a valuable source of non promotional information on their medicinal products. This Directive should therefore establish a legal framework for the dissemination of specific information on medicinal products by marketing authorisation holders to the general public. The ban on advertising to the general public for prescription-only medicinal products should be maintained.
Amendment 59 #
Proposal for a directive – amending act
Recital 10
Recital 10
(10) Provisions should be established to ensure that only high-quality non- promotionalreliable and comparative information about the benefits and the risks of medicinal products subject to medical prescription may be disseminated, notably using the Community database referred to in Articles 57(1)(l) and 57(2) of Regulation (EC) No 726/2004 (hereinafter "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 63 #
Proposal for a directive – amending act
Recital 11
Recital 11
(11) In order to further ensure that marketing authorisation holders disseminate only high-qualityvalidated information and to distinguish non-promotional information from advertising, the types of information which may be disseminated should be defined. I, it is appropriate to allow marketing authorisation holders to disseminate the contentsmake available the last updated version 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 informationof the approved package leaflet.
Amendment 71 #
Proposal for a directive – amending act
Recital 12
Recital 12
(12) InformCommunication to the general public on prescription-only medicinal products by marketing authorisation holders should only be provided in writing through specific channels of communication, including Internet and health-related publications, to avoid that the effectiveness of the prohibition on advertising is undermined by unsolicited provision of informcommunication to the public. Where information is disseminated via television, web TV, video broadcast materials, newspapers, magazines and similar publications, or radio, patients are not protected against such unsolicited informcommunication and such dissemination should therefore not be allowed.
Amendment 78 #
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 make 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 86 #
Proposal for a directive – amending act
Article 1 – point 1
Article 1 – point 1
- the labelling which shall always at least specify the International Non-proprietary Name and the accompanying package leaflets, which are subject to the provisions of Title V;
Amendment 87 #
Proposal for a directive – amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 2 a (new)
Article 86 – paragraph 2 – indent 2 a (new)
“- correspondence, possibly accompanied by material of a non- promotional nature, needed to answer a specific question including those of media organisations about a particular medicinal product;”
Amendment 92 #
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 information on the environmental risk of the medicinal product, availability, pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claims and do not induce to or promote the consumption of the medicinal product;
Amendment 97 #
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
- information by the marketing authorisation holder to the general publicofficially approved documents on medicinal products subject to medical prescription, which is subject to the provisions of Title VIIIa..
Amendment 98 #
Proposal for a directive – amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 4 a (new)
Article 86 – paragraph 2 – indent 4 a (new)
- factual, informative announcements for investors and employees on significant business developments, provided they are not use to promote the product to the general public;
Amendment 99 #
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 2 a (new)
Article 86 – paragraph 2 a (new)
(1a) In Article 86, the following paragraph shall be inserted: “(2a) When exemptions to advertising referred to in paragraph 2 are made available, the marketing authorisation holder and any third party acting on behalf of the marketing authorisation holder shall be identified as such.”
Amendment 101 #
Proposal for a directive – amending act
Article 1 – point 1 b (new)
Article 1 – point 1 b (new)
Directive 2001/83/EC
Article 86 – paragraph 2 b (new)
Article 86 – paragraph 2 b (new)
(1b) In Article 86, the following paragraph shall be inserted: “2b. To this end, the statement "Conflict of interest: This information has been compiled and disseminated by [the name of the company] which is the producer of [the name of the medicinal product]" shall be included.”
Amendment 106 #
Proposal for a directive – amending act
Article 1 – point 2
Article 1 – point 2
2001//83/EC
Article 88 – paragraph 4
Article 88 – paragraph 4
Amendment 115 #
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 disseminatmake available, either directly or indirectly through a third party, information identified as acting on behalf of the marketing authorisation holder, officially approved documents or factual, informative announcement 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 122 #
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 123 #
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
Amendment 130 #
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 141 #
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 147 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point b a (new)
Article 100 b – point b a (new)
ba) the package leaflet;
Amendment 148 #
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 155 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point c a (new)
Article 100 b – point c a (new)
ca) the periodic safety update reports;
Amendment 159 #
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 164 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point d a (new)
Article 100 b – point d a (new)
da) the pre-clinical and clinical data on their product.
Amendment 166 #
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 174 #
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 187 #
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 191 #
Proposal for a directive – amending act
Article 1 – point 5 – introductory part
Article 1 – point 5 – introductory part
Directive 2001/83/EC
Article 100 d – paragraph 2 – introductory part
Article 100 d – paragraph 2 – introductory part
2. Any information shall include: factual, informative announcements on authorised medicinal products subject to medical prescription referred to in Article 86(2) disseminated by the marketing authorisation holder to the general public shall include:
Amendment 193 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 d – paragraph 2 – point b
Article 100 d – paragraph 2 – point b
b) a statement indicating that the informationannouncement is intended to support, not to replace, the relationship between patient and health professionals and that a health professional should be contacted if the patient requires clarification on the information provided;
Amendment 194 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 d – paragraph 2 – point c
Article 100 d – paragraph 2 – point c
c) a statement starting with the indicationg that the informationannouncement is disseminated by or on behalf of a marketing authorisation holder;
Amendment 204 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 d – paragraph 3 – introductory part
Article 100 d – paragraph 3 – introductory part
3. The informationse factual, informative announcements shall not include:
Amendment 206 #
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 209 #
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 a (new)
Article 100 d – paragraph 3 – point a a (new)
aa) any inducement to, or promotion of, the consumption of the medicinal product;
Amendment 211 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 d – paragraph 4 a (new)
Article 100 d – paragraph 4 a (new)
Amendment 212 #
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 information on medicinal products subject to medical prescreproduce the last updated version as approved by the competent authoription reproducees of the summary of product characteristics and of the package leaflet of the medicinal products concernedsubject to medical prescription they commercialise in the official languages of the Member States where they are authorised.
Amendment 218 #
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 of the Internet website of the marketing authorisation holders that refers to a medicinal product subject to medical prescription links 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 219 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 e – paragraph 1 b (new)
Article 100 e – paragraph 1 b (new)
Amendment 224 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 e – paragraph 1 b (new)
Article 100 e – paragraph 1 b (new)
Amendment 226 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 e – Paragraph 1 c (new)
Article 100 e – Paragraph 1 c (new)
In Article 100 e, the following paragraph shall be inserted: 1c. The summary of the European Public Assessment Reports referred to in Article 13 of Regulation (EC) No 726/2004 shall be hyperlinked with the corresponding studies in in the clinical trials database provided for in Article 11 of Directive 2001/20/EC (hereinafter ‘the EudraCT database’).
Amendment 228 #
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 replies shall be kept available for inspections by national competent authorities.
Amendment 229 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 f – paragraph 1
Article 100 f – paragraph 1
1. Member States shall, without creating a disproportionate burden for the marketing authorisation holder, ensure that marketing authorisation holders make information provided in accordance with this Title accessible to persons with disabilities.
Amendment 232 #
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 shall ensure that there are adequate and effective methods of monitoring to avoid misuse when informationannouncements on authorised medicinal products subject to medical prescription is disseminatedare made available by the marketing authorisation holder to the general public or members thereof.
Amendment 234 #
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 – introductory part
Article 100 g – paragraph 1 – subparagraph 2 – introductory part
Such methods shall be based on the control of informationannouncements prior to itstheir dissemination, unless
Amendment 237 #
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 241 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
2001/838/EC
Article 100 g – paragraph 1 – subparagraph 3
Article 100 g – paragraph 1 – subparagraph 3
Amendment 245 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 g – paragraph 2
Article 100 g – paragraph 2
After consulting the Member States, patients and consumers organisations, social health insurance organisations and healthcare professionals, the Commission shall draw up guidelines concerning informationannouncements allowed under this Title, the elaboration of the package leaflets, publication of clinical trial results promotional practices toward prescribers, and containing a mandatory code of conduct and dissuasive sanctions for marketing authorisation holders providing information to the general public or members thereof on authorised medicinal products subject to medical prescripthat do not respect the code of conduct. The guidelines shall also contain provisions to ensure that members of the public may lodge complaints with competent authorities regarding misleading practices in the making available of information. The Commission shall draw up these guidelines on the entry into force of this directive and update them regularly on the basis of the experience gained.
Amendment 253 #
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 264 #
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. or video broadcast materials.
Amendment 273 #
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 marketing authorisation holder shall send the new contents and changes to the competent authorities of the Member State where the Internet website has been registered shall be responsible forfor prior approval before making available the monitoring of the contents disseminated on thator changes on its website.
Amendment 277 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 5
Article 100 h – paragraph 5
5. Member States shall allowrequire 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 Directivemessage at the top of each website page informing the public that information contained therein is developed by the marketing authorisation holder and is therefore subject to monitoring in order to avoid advertising of prescription medicines. 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. and include a link to the EudraPharm database specifying that validated information is available there.
Amendment 297 #
Proposal for a directive – amending act
Article 1 – point 5 (new)
Article 1 – point 5 (new)
Article 100 la) Under the coordination of the Agency, national competent authorities shall organise independent health and treatment literacy campaigns on the following topics: - Rational use of medicines: what is the INN; what does a risk and harm-benefit balance mean; what is an adverse drug reaction; what to do when experiencing an ADR; how to report an ADR; what is compliance; - Good governance: what is a conflict of interest; what is transparency; - Patient and Consumer Rights in Clinical trials: what is a clinical trial; what is informed consent; what are your rights as a participant; what are surrogate endpoints.
Amendment 298 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 l b (new)
Article 100 l b (new)
Article 100 lb Under the coordination of the Agency, national competent authorities shall organise independent preventive health information, notably on health determinants, notably by supporting public campaigns on how to deal with an addiction, risk of alcohol addiction and dependence from addictive substances (tobacco, narcotics, etc.), why to opt for a healthier diet, or to do physical exercise on a regular basis, etc.
Amendment 300 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 l c (new)
Article 100 l c (new)
Article 100 lc Member States shall make sure that undergraduate education of healthcare professionals ensures the development of their communications skills and their understanding of the basics of evidence based medicine. Member States shall grant financial support to independent drug information centres, encourage the development of independent continuing education programmes for health professionals and the development of their critical appraisal skills. Within three years of the entry into force of this Directive, the Commission shall, following a public consultation with Member States and continuing education programs for health professionals, establish a comprehensive report on best practices among Member States.