33 Amendments of Miroslav MIKOLÁŠIK related to 2008/0256(COD)
Amendment 34 #
Proposal for a directive - amending act
Recital 2
Recital 2
(2) In the area of information, Directive 2001/83/EC lays down detailed rules on the documents to be annexed to the marketing authorisation and intended for information purposes: the summary of product characteristics (distributed to health-care professionals) and the package leaflet (inserted in the product's packaging when it is dispensed to the patient). On the other hand, as regards the disseminationmaking available of information from the marketing authorisation holder to patients and the general public, the Directive only provides that certain information activities are not covered by the rules on advertising, without providing for a harmonised framework on the contents and the quality of non promotional information on medicinal products or on the channels through which this information may be disseminated.made available. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 42 #
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 providmake information available to patients and the general public result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the Community. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 46 #
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 49 #
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 authorisatWhile there is already a lot of independent information on pharmaceuticals, for example by national authorities or health care professionals, the situation differs very much between Member States and among the different products available. Member States and Commission shoulders to the general public. The ban on advertising to the general public for prescription-only medicinal products should be maintained take much more efforts to facilitate the access of citizens to high-quality information through appropriate channels.
Amendment 53 #
Proposal for a directive - amending act
Recital 8 a (new)
Recital 8 a (new)
(8a) Without prejudice to the importance of the role played by national competent authorities and health care professionals in better informing patients and the general public, marketing authorisation holders may be an additional source of non-promotional information on their medicinal products. This Directive should therefore establish a legal framework for the making available 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 54 #
Proposal for a directive - amending act
Recital 9
Recital 9
(9) In accordance with the principle of proportionality, it is appropriate to limit the scope of this Directive to the supply of information on prescription-only medicinal products that has been approved by the competent authorities by the marketing authorisation holder, as current Community rules allow the advertising to the general public of medicinal products not subject to prescription, under certain conditions.
Amendment 58 #
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 medicinal products subject to medical prescription may be disseminated. 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 criteriabe approved in advance by the competent authorities und should be supplied only in the approved form.
Amendment 64 #
Proposal for a directive - amending act
Recital 11
Recital 11
(11) In order to further ensure that marketing authorisation holders disseminatmake available only high-quality information and to distinguish non-promotional information from advertising, the types of information which may be disseminatedmade available should be defined. It is appropriate to allow marketing authorisation holders to disseminatmake available 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. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 67 #
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 andcompetent authority- approved high-quality information in approved form and in order 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 leaflets, information that is compatible with those documents without going beyond their key elements, and other well-defined medicinal product- related informationcluding the "drug-fact-box".
Amendment 72 #
Proposal for a directive - amending act
Recital 12
Recital 12
(12) Information to the general public on prescription-only medicinal products that has been approved by the competent authorities should only be provided through specific channels of communication, including Internet and health-related publications, by the marketing authority holder to avoid that the effectiveness of the prohibition on advertising is undermined by unsolicited provision of information to the public. Where information is disseminated via television or radioby the marketing authority holder via television, radio or newspapers, magazines and similar publications, patients are not protected against such unsolicited information and such disseminsupply of information should therefore not be allowed.
Amendment 74 #
Proposal for a directive - amending act
Recital 12 a (new)
Recital 12 a (new)
(12 a) The internet is a major source of information for a growing number of patients. This trend is likely 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 independent national health internet websites. These websites should be monitored by competent authorities in the Member States. Member States in co- operation with stakeholders such as health care professionals or patient organisations should be responsible for managing these websites.
Amendment 75 #
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 which is in compliance with Directive 2001/83/EC. Member States should adopt rules establishing effective 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 thesupply. Only such information thas already been agreedt has been approved in advance by the competent authorities or if there is a different mechanism in place to ensure an equivalent level of adequate and effective monitoringshould be provided, and it should be provided in the approved form only.
Amendment 88 #
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 95 #
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 holderon medicinal products that has been approved by the competent authorities in the Member States and that has been made available to the general public oin medicinal productapproved form by the marketing authorisation holder and that is subject to medical prescription, which is subject to the provisions of Title VIIIa.
Amendment 108 #
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.
Amendment 111 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 - a (new), to be inserted before Article 100a
Article 100 - a (new), to be inserted before Article 100a
Article 100 -a Member States and the European Commission shall support independent information on medical products to the general public. To this end the Member States shall present a national program on information to patients following consultation with stakeholders such as health care professionals and patient organisations. Information shall be presented in electronic as well as in printed form. The Commission shall provide assistance and organise the exchange of best practice. Member States and the Commission 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.
Amendment 112 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 - a a (new), to be inserted before Article 100a
Article 100 - a a (new), to be inserted before Article 100a
Amendment 116 #
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 that is acting in the name of the marketing authorization holder, information that has been approved by the competent authorities to the general public or members thereof on authorised medicinal products subject to medical prescription provided that ithis information and the way it is supplied 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. When such information is made available, the marketing authorisation holder and any third party shall be identified, and any third party that acts on behalf of the marketing authorisation holder shall be clearly identified as such.
Amendment 129 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – introductory part and point a
Article 100 b – introductory part and point a
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 authorisation holder available to the general public or members thereof: 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;. A drug-fact-box shall be added to the package leaflet. The information provided in the drug-fact-box shall be presented in a form that is clearly legible, prominent and clearly distinguishable from the rest of the text. This drug-fact-box shall contain a short description of the necessary facts of the medicinal product in order to enable the patient to understand the utility and the possible risks of the medicinal product and in order to apply the medicinal product safely and in the right way. It shall also contain a short summary of the results of the clinical trials. Before supplying it, the drug-fact-box shall be approved by the competent authorities; and prior to such approval, patient organizations shall be heard in an appropriate way in order to guarantee a form that is suitable to the patients. This information shall be made available both in electronic and printed form in all languages of the EU and in a format accessible to people with disabilities.
Amendment 146 #
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 way;
Amendment 162 #
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. Such information which presents the medicinal product in the context of the condition to be prevented or treatedshall be vetted by the Agency prior to its being made available in accordance with Article 20 b (1) of Regulation EC (No) 726/2004.
Amendment 165 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – introductory part
Article 100 c – introductory part
Information on authorised medicinal products subject to medical prescription disseminatedthat has been approved by the competent authorities and is made available by the marketing authorisation holder to the general public or members thereof shall not be made available on television or radio. It, radio or newspapers, magazines and similar publications. The marketing authorisation holder shall be allowed to supply the information approved in Article 100b on the internet. This information shall not be supplied to the general public or members thereof unasked or actively and shall only be made available through the following channels:
Amendment 182 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – point b
Article 100 c – point b
b) marketing authorisation holders' internet websites on medicinal products, to the exclusion of unsolicited material actively distributed to the general public or members thereof;
Amendment 190 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 d – paragraph 1 a (new)
Article 100 d – paragraph 1 a (new)
1a. Within one year of the entry into force of this Directive, the Commission shall, following a public consultation with patient and consumer organisations, doctor and pharmacist organisations, Member States and other interested parties, 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 an analysis of the above data, the Commission shall, if appropriate, put forward guideline proposals to improve the layout and the content of the summaries of product characteristics and of the packaging leaflet to ensure they are a valuable source of information for the general public and healthcare professionals.
Amendment 231 #
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 information on authorised medicinal products subject to medical prescription is disseminated by the marketing authorisation holder to the general public or members thereofmisuse is avoided by securing that only the marketing authorisation holder supplies information, and only such information which has been approved by the competent authorities about approved medicines subject to medical prescription, and in the form which has been approved for the dissemination to the general public or members thereof. By way of derogation Member States may continue those types of control mechanism which they have been implemented before 31.12.2008. The Commission verifies and approves these systems.
Amendment 248 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 1 – subparagraph 1
Article 100 h – paragraph 1 – subparagraph 1
1. Member States shall ensure that marketing authorisation holders register Internet websites containing authority- approved 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.
Amendment 259 #
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 without their explicit prior consent or the appearance therein of unsolicited material actively distributed to the general public or members thereof. Those websites shall not contain web-TVInternet websites may provide video content if it is useful for the safe and effective use of the medicine. Video contents shall only reflect the package leaflet, the summary of the characteristics and the drug-fact-box and hints how to use this medicine safe and effectively. Before publication video contents must be approved by the competent authorities.
Amendment 267 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 2 a (new)
Article 100 h – paragraph 2 a (new)
2a. 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 authorization holder. A link to the EudraPharm database on medicinal products shall also be included in that notification.
Amendment 274 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 4 – point a
Article 100 h – paragraph 4 – point a
(a) If a Member State has reasons for doubts as to whether the translation of the reproduced information is correct, it may require a marketing authorisation holder to provide for a certified translation of the authority-approved information disseminated on the Internet website registered with the national competent authority of another Member State.
Amendment 275 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 4 – point b
Article 100 h – paragraph 4 – point b
(b) If a Member State has reasons for doubts as to whether the authority- approved information disseminated on an Internet website registered with the national competent authorities of another Member State complies with the requirements of this Title, it shall inform that Member State of the reasons for its doubts. The Member States concerned shall use their best endeavours to reach agreement on the action to be taken. If they fail to reach an agreement within two months, the case shall be referred to the Pharmaceutical Committee set up by Decision 75/320/EEC. Any necessary measures may only be adopted after an opinion has been delivered by that Committee. Member States shall take account of opinions delivered by the Pharmaceutical Committee and shall inform the Committee of how its opinion has been taken into account.
Amendment 279 #
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 allow 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.
Amendment 288 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 j – point a
Article 100 j – point a
a) keep available for the competent authorities or bodies responsible for monitoring information on medicinal products that have approved the information in advance, a sample of all information disseminatedmade available in accordance with this Title and information on its volume of disseminatprovision, together with a statement indicating the persons to whom it is addressed, the method of disseminatprovision and the date of first disseminatprovision,
Amendment 295 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 l
Article 100 l
By [insert specific date five years from the entry into force of amending directive] at the latest, the Commission shall publish a report on the experience acquired in the implementation of this Title after consulting the patient organisations and the members of health care professions and shall also assess the need for a review thereof. The Commission shall submit this report to the European Parliament and to the Council.