Explanatory Memorandum to 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

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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 ...
source COM(2011)633 EN
date 11-10-2011
The Commission presents an amended proposal for a Directive of the European Parliament and of the Council on information to the general public on medicinal products subject to medical prescription. Incorporated within the amended proposal are amendments proposed by the European Parliament at its first reading which are acceptable to the Commission.

Contents

1.

1. Background


On 10 December 2008, the Commission adopted a proposal for a Directive of the European Parliament and of the Council on information to the general public on medicinal products subject to medical prescription. This proposal was forwarded to the European Parliament and the Council on 10 December 2008.

The Economic and Social Committee gave its opinion on 10 June 2009 and the Committee of the Regions, 7 October 2009.

The European Parliament adopted a legislative resolution at its first reading on 24 November 2010.

2.

2. Objective of the Commission's proposal


The general policy objectives of the proposals to amend Directive 2001/83/EC and Regulation (EC) No 726/2004 are in line with the overall objectives of the EU pharmaceutical legislation. These are intended to ensure the proper functioning of the internal market for medicinal products for human use and to better protect health of EU citizens. Following this line, the proposals aim specifically to:

· Provide for a clear framework for provision of information by marketing authorisation holders about their prescription-only medicines to the general public with a view to enhancing the rational use of these medicines, while ensuring that the legislative framework continues to prohibit direct-to-consumer advertising of prescription-only medicines.

This aim shall be achieved by:

· Ensuring the high quality of information provided by coherent application of clearly defined standards across the EU.

· Allowing information to be provided through channels addressing needs and capabilities of different types of patients.

· Allowing marketing authorization holders to provide in an understandable way objective and non-promotional information about the benefits and the risks of their medicines.

· Ensuring that monitoring and enforcement measures are in place to ensure that information providers comply with the quality criteria, while avoiding unnecessary bureaucracy.

This amended proposal is in line with those objectives and further reinforces the rights of patients. In particular, the marketing authorisation holders will have the obligation, and no longer just the possibility, to make available certain information, such as the labelling and the package leaflet.

3. Commission opinion on the amendments adopted by the European Parliament:

On 24 November 2010, the European Parliament adopted 78 amendments on the proposal for a Directive on information to the general public on medicinal products subject to medical prescription. The Commission considers that a majority of the European Parliament's amendments are acceptable in full, in principle, or in part, as they maintain the aims and overall scheme of the proposal.

The Commission therefore accepts in full or in part, the following amendments of the European Parliament:

3.

3.1. Amendments of a general nature


Some of the amendments of the European Parliament, in particular 1, 4 13 and 70, provide for the replacement of the words 'disseminate' by 'making available' the information. These changes have been incorporated within the whole revised text (recitals and articles) as foreseen by the amendments.

Amendment 2 modifies recital 2 in order to stress that inequalities in accessing information are not acceptable and should be adjust. The Commission introduces these changes within recital 3.

Amendment 3, that the amended proposal incorporates, modifies recital 4 calling for a distinction between advertisement and information in order that all citizens have access to information in all Member States.

Amendments 6 and 7 share the same aim which is to recognise that although some information is made available by national competent authorities and healthcare professionals, marketing authorisation holders may be an additional source of information. The Commission modifies accordingly recital 8.

3.2. Scope of title VIII 'Advertising' (Article 86(2))

Article 86 i of Directive 2001/83/EC, as currently in force, identifies types of information which are not covered by the Directive's title on advertising.

Amendment 20 adds to the list in Article 86 i correspondence needed to answer a specific question about a medicinal product, and amendment 21 adds some factual, informative announcements. The Commission agrees in principle; however, it is not necessary to specifically mention these aspects as they are already covered by the general indent on 'information by the marketing authorisation holder to the general public on medicinal products subject to medical prescription, which shall comply with the provisions of Title VIIIa'.

Amendments 22 and 23 clarify the elements listed in the Commission proposal as not covered by the advertisement title. In particular, amendment 23 adds, to the fact that information to the general public should comply with Title VIIIa, the requirement for such information to be approved by the authorities and to respect quality criteria. As these requirements are included in Title VIIIa, it is not necessary to repeat them.

Amendment 24 adds to the list of elements which should not be covered by the advertisement title, factual, informative announcements for investors and employees on significant business developments provided they are not used to promote the product to the general public. This amendment is incorporated in the amended proposal; it is further specified that, however, if the information concerns individual medicinal products, the conditions of Title VIIIa should apply to ensure that the provisions of information to investors and employees is not used to circumvent the provisions of the Directive.

Amendment 25 clarifies that in cases not covered by the advertising title, the marketing authorisation holder and any third party acting on behalf of the marketing authorisation holder making available the information should be identified as such. This has been introduced in Article 100a for all activities covered by the Directive's title on information. .

4.

3.3. Exception to advertising (Article 88(4))


Amendment 87 provides conditions that must be fulfilled by industry in order to be authorised to conduct advertising on vaccination campaigns.

Directive 2001/83/EC provides that the prohibition of advertising does not apply to vaccination campaigns carried out by industry and approved by the competent authorities of the Member States. The original proposals extended this exception to public health campaigns in general. Amendment 87 deletes this proposed extension and imposes further requirements on possible vaccination campaigns. The amended proposal incorporates these changes; however the information should refer only to the vaccines and not to the diseases concerned as the scope of Directive 2001/83/EC is limited to medicinal products.

5.

3.4. Advertising to healthcare professionals (Article 94)


Amendment 27 modifies Article 94 which regulates the advertising to healthcare professionals. It specifies that the rules should apply to direct or indirect promotion by marketing authorisation holder or a third party acting on its behalf or following its instructions. The Commission supports this clarification, which should not be restricted to one specific article. It should concern all Articles on advertising. Therefore the change is introduced in Article 86 at the beginning of the Title VIII on advertising.

3.5. Scope of the new title VIIIa 'Information to the general public on medicinal products subject to medical prescription' (Article 100a)

Article 100a defines the scope of the title of the Directive on information. Amendment 84, modifying Article 100b on the content of the information, makes the distinction between information that marketing authorisation holders should make available and information that he may make available. By creating this distinction, the European Parliament re-orientates the text from the right of marketing authorisation holders to make available some information to the right of the patients to have information. This re-orientation should also be reflected in Article 100a. Furthermore, requirements added by this amendment regarding identification of the marketing authorisation holder and control mechanisms do not have to be specified in this Article as they are provided for in specific articles.

Amendment 29 provides that healthcare professionals who deliver information on medicinal products during public events should declare their financial interests with marketing authorisation holders. The Commission supports this amendment, which can however only concern medicinal products and not medical devices in view of the scope of the Directive. This amendment is covered by the introduction within the amended proposal of the obligation for any person making available information to the public to declare any financial or other benefits from marketing authorisation holders.

Amendment 31 modifies the list of types of information which should not be covered by the Directive's title on information. The Commission supports this amendment to the extent that it is consistent with Article 100b on the content of information that may be made available.

Amendments 8 and 32 exclude from the scope of the Directive information made available by third parties acting independently from the marketing authorisation holder in order for them to express their views on prescription-only medicinal products. The Commission supports this exclusion. In addition, in order to ensure transparency about information provided by third parties, they should declare their interests when making available information on medicinal products.

6.

3.6. Content of the information (Article 100b)


Amendments 10 and 84 (modifying Article 100b) make the distinction between information that marketing authorisation holders should make available and information that they may make available. Such a distinction was not included in the original proposal, where no mandatory obligations were created. The Commission accepts these amendments.

However, regarding the list of information that can be made available, Directive 2010/84/EU amending Directive 2001/83/EC as regards pharmacovigilance provides within Article 106a requirements applicable to public announcements by marketing authorisation holders relating to information on pharmacovigilance. Therefore, information regarding adverse-reaction warnings should be excluded from the scope of the Directive's Title on information, as it is specifically addressed by the Title on pharmacovigilance.

Lastly, requirements linked to channels of information, persons with disabilities and control (also contained in the amendment) do not have to be specified in this Article as they are provided for in specific Articles.

7.

3.7. Channels of information (Article 100c)


Amendments 12 and 34 delete the possibility to make available information through health-related publications and provide that it cannot be made available through newspapers, magazines and similar publications. However, the amendments introduce the possibility to make available information through printed materials about a medicinal product prepared by marketing authorisation holders upon specific request by a member of the general public. The Commission accepts these changes; however it is the issuing of these printed materials that should be on request, not their drafting.

8.

3.8. Quality criteria and statements (Article 100d)


Amendments 35, 36 and 37 modify some of the quality criteria applicable to the information.

Amendments 39, 40, 41, 42 and 43 modify the statements that must be available with the information and add two others: a statement containing contact information allowing members of the public to contact competent authorities, and a statement containing a reference to the most recent package leaflet or an indication as to where that text can be found. These amendments have been included in Article 100d. The elements of amendment 41 which relate to monitoring are not included in the amended Article 100d, but are added in the specific Article on monitoring. The elements of amendment 43 referring to internet websites are included in Article 100h.

Amendment 44 requires a statement encouraging the report of undesirable effects to doctors, pharmacists, healthcare professionals and competent authorities. Although the Commission supports this proposal, it considers that a specific statement to encourage this reporting of undesirable effects is not necessary. Indeed, Directive 2010/84/EU already introduces such a statement within Article 59 of Directive 2001/83/EC on information to be included within the package leaflet.

Paragraph 3 of Article 100d provides the elements that the information should not include, such as comparisons between medicinal products. Amendment 46 adds the inducement to or the promotion of the consumption of the medicinal product. Although the Commission supports this principle, the text does not need to be modified to reflect this aspect as this follows already from the provisions of the Directive (Article 86). Indeed, all information that can be made available under Title VIIIa should not induce or promote the consumption of medicinal product.

Amendment 48 aligns to the Treaty of Lisbon the granting to the Commission of the power to adopt measures necessary for the implementation of Article 100d. The acts adopted by the Commission should be implementing acts and not delegated acts, as they are limited to the implementation of the quality criteria which are laid down in the proposal.

9.

3.9. Language aspects (Article 100e)


Amendments 49, 50 and 52 refer to Article 100e on languages; however the modifications concern other aspects and therefore have been introduced, if not already provided for, in the corresponding Articles on quality criteria (Article 100d), monitoring (Article 100g), control (Article 100j) and internet websites (Article 100h).

10.

3.10. Persons with disabilities (Article 100f)


Amendment 53 aligns with the Treaty of Lisbon the delegation to the Commission to amend the Article to take account of technical progress.

11.

3.11. Control of the information (Article 100g)


Amendments 9, 11, 56 and 96 provide for the pre-control of the information by competent authorities, including through the marketing authorisation process, and delete the possibility for Member States to opt for voluntary control by self-regulatory or co-regulatory bodies. A derogation from the system of pre-control is foreseen for Member States which have implemented other type of control mechanisms before 31 December 2008.

The Commission accepts this principle of pre-control and the possibility for derogations. For the latter, in addition to the derogation for pre-existing systems foreseen by the amendments, an additional derogation should be included for cases where Member States cannot introduce a system of pre-control for constitutional reasons related to the principles of freedom of expression and of the press. However, the Commission should not be tasked to verify and approve alternative national systems.

As the possibility to opt for voluntary control by self-regulatory or co-regulatory bodies are deleted in the new proposal, the provisions for a code of conduct adopted by the Commission has been deleted, while maintaining provisions for Commission guidelines.

The Commission acknowledges that a number of Member States have expressed concerns in relation to the conformity with their national constitutions. The Commission is prepared to enter into a dialogue with those concerned to find suitable solutions while fully respecting the objectives of this Directive. As regards this Directive, apart from the control mechanism, as some of the provisions introduced by this Directive may interfere with national constitutional rules relating to freedom of the press and freedom of expression in the media, the Commission introduces recital 16 clarifying that this Directive does not prevent Member States from applying these constitutional rules.

12.

3.12. Internet websites (Article 100h)


Article 100h lays down rules for marketing authorisation holders' internet websites making available information on medicinal products under prescription status.

Amendment 58 clarifies that the information available on these websites shall comply with the requirements of the Directive and that it shall be in accordance with the marketing authorisation of the medicinal product. Although the Commission agrees with this, it is not necessary to specify it, as this already follows from other provisions of the Directive.

Amendment 59 foresees the identification of the marketing authorisation holder in the websites. However this identification is already provided for within Article 100d, paragraph 2.

Amendment 60 provides that any update of the information is subject to the monitoring without leading to a re-registration of the website. It should also be stated that the new information is also subject to the requirement of control provided by Article 100g.

Amendment 61 deals with the possibility of including video content on internet websites. The modification of Article 100d i by amendment 84 (allowing still or moving images of technical nature demonstrating the proper way of using the product) is sufficient in this regard.

The Commission agrees to the linkage of marketing authorisation holder websites to EU databases and portals on medicinal products, introduced by amendment 62. However, it is more appropriate to link marketing authorisation holder websites to the EU medicines web-portal established by Regulation (EU) No 1235/2010 than to the EudraPharm database, as that portal is intended to become the central point of access to information on medicines. Furthermore, the identification of marketing authorisation holders providing the information is already required in Article 100d i; therefore the Commission considers that a reference to this Article is sufficient.

13.

3.13. Penalties (Article 100i)


Article 100i on penalties is modified in order to provide for the possibility to publish the name of marketing authorisation holders who have published information on a medicinal product which is non-compliant with the Directive (amendment 67), to lay down the right of appeal of marketing authorisation holders and to introduce the suspension of the dissemination of the information while the proceedings are on-going (amendment 69).

14.

3.14. Monitoring of the information (Article 100j)


Article 100j refers to marketing authorisation holders' obligations to allow the monitoring of the information provided. Amendment 52, modifying Article 100e, to keep replies available for inspections by national competent authorities, should therefore be introduced within Article 100j.

15.

3.15. Consultation (Article 100ka)


Amendments 16, 90, 92, 93 and 94 refer to the consultation of all relevant stakeholders such as independent patient, health and consumer organisations on issues relating to the implementation of the Directive and its application by the Member States. The consultation of appropriate stakeholders is part of the inter-institutional agreement on better law making (2003/C321/01) and therefore it is not necessary to mention each time examples of these stakeholders, neither to provide for a stand-alone article on that matter.

16.

3.16. Information provided by other sources than the marketing authorisation holder (Articles 21 and 106)


Amendment 79 provides for information about diseases and health conditions and the prevention of such diseases and conditions. The Commission recognises the need for such broader information, however, this cannot be addressed within the Directive which covers medicinal products only.

The part of the amendment intended to task Member States with ensuring that objective, unbiased information is available to general public or members thereof has been introduced in Article 106. This Article following amendment of Directive 2001/83/EC by Directive 2010/84/EU already provides a key tool to fulfil the objective of the amendment (the creation of medicines web portals in every Member States).

17.

3.17. Comitology alignment (Article 100k)


Amendments 15, 75 to 77 are intended to include in Directive 2001/83/EC, in view of the entry into force of the Treaty of Lisbon, general provisions on the granting of delegated powers to the Commission. However, these Articles have been introduced into the Directive by Directive 2010/84/EU. It is only necessary to adapt Article 121a on the exercise of the delegation to include the reference to Article 100f, paragraph 2 which provides for delegated acts.

18.

3.18. Pharmacovigilance


In addition to the changes introduced on the basis of the European Parliament resolution regarding the Commission proposal on information to patients, the Commission considers that certain changes to Directive 2001/83/EC in the area of pharmacovigilance should be introduced.

Directive 2001/83/EC has been recently amended by Directive 2010/84/EU to revise the EU pharmacovigilance system. Directive 2010/84/EU having as legal basis Article 168(4)(c) of TFUE; the amended proposal should also be based on Article 168(4)(c) of TFUE. Directive 2010/84/EU substantially strengthens the legal framework for the surveillance of medicinal products authorised by the Member States, with provisions to reinforce the coordinating role of the Agency, the possibilities for signal detection, and the operation of coordinated procedures at European level to respond to safety concerns. However, in view of recent pharmacovigilance events in the EU, the Commission has detected certain areas where the legislation could be further strengthened. Therefore:

· Articles 107i is modified in order to provide for an automatic procedure at European level in the cases of specific serious safety issues with nationally authorised products, with a view to ensuring that the matter is assessed and addressed in all Member States where the medicinal product is authorised. Articles 31 and 34 are also modified to clarify the respective scopes of this provision and the revised automatic procedure, as well as the links between these procedures and procedures involving medicinal products authorised in accordance with Regulation (EC) No 726/2004.

· Articles 23a and 123 are modified to avoid that the voluntary withdrawal of a marketing authorisation or product by the holder could lead to safety issues not being addressed in the EU, by clarifying information obligations for the marketing authorisation holder.

19.

4. Conclusion


Having regard to Article 293 of the Treaty on the functioning of the European Union, the Commission modifies its proposal as follows: