Considerations on COM(2011)633 - Amendment of Directive 2001/83/EC, as regards information to the general public on medicinal products subject to medical prescription and as regards pharmacovigilance - Main contents
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| dossier | COM(2011)633 - Amendment of Directive 2001/83/EC, as regards information to the general public on medicinal products subject to medical ... |
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| document | COM(2011)633  |
| date | October 11, 2011 |
(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 making available of information from the marketing authorisation holder to the general public, including patients, 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 made available.
(3) On the basis of Article 88a of Directive 2001/83/EC, on 20 December 2007 the Commission submitted a Communication to the European Parliament and the Council on a 'Report on current practices with regard to the provision of information to patients on medicinal products' [5] . The report concludes that Member States have adopted divergent rules and practices with regard to the provision of information, resulting in a situation where patients and the public at large have unequal access to information on medicinal products. Such unjustifiable inequalities in accessing information that is publicly available in other Member States should be redressed.
(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 Union, and that this has also given rise to situations where the general public is exposed to disguised advertising. As a result, citizens in certain Member States may be denied the right to have access, in their own language, to high-quality, non-promotional information on medicinal products. The distinction between advertising and information should be clarified in order to be interpreted uniformly across all Member States so as to ensure patient safety.
(5) Those disparities in the interpretation of the Union rules on advertising, and between national provisions on information have a negative impact on the uniform application of Union rules on advertising, and on the effectiveness of the provisions on product information contained in the summary of products characteristics and the package leaflet. Although those rules are fully harmonised to ensure the same level of protection of public health across the Union, this objective is undermined if widely divergent national rules on the making available of such key information are allowed.
(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 make available information on medicinal products is not the same across Member States, while information made available in one Member State is 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 Union 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.
(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 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 rights and interests of patients. Patients should have the right to easily access certain information such as the summary of the product characteristics, the package leaflet and the assessment report.
(8) National competent authorities and health care professionals should remain the main sources of information on medicinal products for the general public. While there is already independent information on medicinal products, for example by national authorities or health care professionals, the situation differs very much between Member States and among medicinal products. Member States should facilitate the access of citizens to high-quality information through appropriate channels. Marketing authorisation holders may be an additional valuable 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.
(9) Third parties, such as patients and patients' organisations or the press, should be able to express their views on prescription-only medicinal products, and should therefore not be covered by the provisions laid down in this Directive, provided that they are acting independently from the marketing authorisation holder. To ensure transparency as to whether third parties act independently from marketing authorisation holders, when making available information, third parties should declare any financial or other benefits received from marketing authorisation holders.
(10) In accordance with the principle of proportionality, it is appropriate to limit the scope of this Directive to the making available of information on prescription-only medicinal products, as current Union rules allow the advertising to the general public of medicinal products not subject to prescription, under certain conditions.
(11) 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 made available. 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.
(12) In order to further ensure that patients have access to high-quality information and to distinguish non-promotional information from advertising, the types of information which may be made available by marketing authorisation holders should be defined. Marketing authorisation holders should be obliged to make available the approved and most recent contents of summaries of the product characteristics, labelling and package leaflet and the publicly accessible version of the assessment report. It is appropriate to allow marketing authorisation holders to also make available other well-defined medicinal product-related information.
(13) Whether obligatory or not, information to the general public on prescription-only medicinal products should only be provided through specific channels of communication, including Internet , to avoid that the effectiveness of the prohibition on advertising is undermined by unsolicited provision of information to the public. Where information is made available via television, radio or printed media, patients are not protected against such unsolicited information and such channels of information should therefore not be allowed.
(14) The Internet is of major importance with regard to the provision of information to patients and its importance is increasing. The Internet allows almost unlimited access to information disregarding national boundaries. Registered websites for objective and non-promotional information are therefore necessary and specific rules on the monitoring of those websites should be established to take account of the cross-border nature of information provided over the Internet and to allow cooperation between the Member States.
(15) Monitoring of information on prescription-only medicinal products should ensure that marketing authorisation holders only make available 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 being made available, unless the substance of the information has already been agreed by the competent authorities in the course of the marketing authorisation procedures, as it is the case for the summary of the product characteristics, labelling and package leaflet, and the publicly accessible version of the assessment report or any updated versions of these documents.
(16) This Directive enhances compliance with fundamental rights and is fully in line with the principles recognised by the Charter of Fundamental Rights of the European Union, in particular Article 11 thereof. In this regard, this Directive does not in any way prevent Member States from applying their constitutional rules relating to freedom of the press and freedom of expression in the media.
(17) As this Directive introduces for the first time harmonised rules on the provision of information on medicinal products subject to medical prescription to the general public, the Commission should assess its operation and the necessity for a review five years after its entry into force. Provision should also be made for the drawing up of guidelines by the Commission based on Member States' experience, in cooperation with stakeholders, in the monitoring of information.
(18) Recent pharmacovigilance events in the Union have shown the need for an automatic procedure at Union level in the cases of specific safety issues to ensure that a matter is assessed and addressed in all Member States where the medicinal product is authorised. The scope of different Union procedures concerning nationally authorised products should be clarified.
(19) In addition, voluntary action by the marketing authorisation holder should not lead to a situation where concerns related to benefits-risks of a medicinal product authorised in the Union are not properly addressed in all Member States. Therefore, provisions should be made for the marketing authorisation holder to inform competent authorities of the reasons for the withdrawal of a medicinal product, for interrupting the placing on the market of a medicinal product, for requests for revoking a marketing authorisation, or for not renewing a marketing authorisation.
(20) In order to clarify the information allowed, the power to adopt acts in accordance with Article 290 of the Treaty on the Functionning of the European Union should be delegated to the Commission. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and the Council.
In addition, the Commission should be empowered to adopt implementing measures on the quality criteria to be fulfilled by information by the marketing authorisation holder to the general public on medicinal products subject to prescription.
(21) Since the objective of this Directive to harmonise the rules on information on medicinal products subject to prescription across the Union cannot be sufficiently achieved by the Member States and can therefore be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve this objective.
(22) Directive 2001/83/EC should therefore be amended accordingly.