[ParlTrack]

Proposal for a directive
Recital 16

(16) Member States have frequently amended their health insurance schemes or adopted new measures falling within the scope of Directive 89/105/EEC. It is therefore necessary to establish information mechanisms intended, on the one hand, to ensure the consultation of interested stakeholders and, on the other hand, to facilitate preventive dialogue with the Commission as regards the application of this Directive.deleted

2012/10/22
Committee: ENVI

Milan CABRNOCH

Proposal for a directive
Recital 18

(18) In accordance with the Joint Political Declaration of Member States and the Commission on explanatory documents of 28 September 2011, Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified.deleted

2012/10/22
Committee: ENVI

Milan CABRNOCH

Proposal for a directive
Article 1 – paragraph 2 – subparagraph 2

~~The provisions of this Directive shall apply to measures intended to determine which medicinal products may be included in contractual agreements or public procurement procedures.~~deleted

2012/10/22
Committee: ENVI

Milan CABRNOCH

Proposal for a directive
Article 3 – paragraph 2

2. Member States shall ensure that an application to approve the price of the product can be introduced by the marketing authorisation holder at any point in time. ~~The competent authorities shall provide the applicant with an official acknowledgement of receipt.~~

2012/10/22
Committee: ENVI

Milan CABRNOCH

Proposal for a directive
Article 3 – paragraph 5

5. If the information supporting the application is inadequate, the competent authorities shall ~~forthwith~~ notify the applicant without undue delay of the detailed additional information required and take their final decision within 60 days of receipt of this additional information. However, with respect to medicines for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be in all events 15 days, provided that the price of the reference medicinal product has been approved by the competent authorities. Member States shall not request any additional information which is not explicitly required under national legislation or administrative guidelines.

2012/10/22
Committee: ENVI

Milan CABRNOCH

Proposal for a directive
Article 4 – paragraph 2

2. Member States shall ensure that an application to increase the price of the product can be submitted by the marketing authorisation holder at any point in time. ~~The competent authorities shall provide the applicant with an official acknowledgement of receipt.~~

2012/10/22
Committee: ENVI

Milan CABRNOCH

Proposal for a directive
Article 5 – paragraph 2

2. Marketing authorisation holders may apply for a derogation from a price freeze or price reduction if this is justified by particular reasons. The application shall contain an adequate statement of reasons. Member States shall ensure that applications for a derogation can be introduced by the marketing authorisation holder at any point in time. ~~The competent authorities shall provide the applicant with an official acknowledgement of receipt.~~

2012/10/25
Committee: ENVI

Milan CABRNOCH

Proposal for a directive
Article 6

Article 6 Controls on profits Where a Member State adopts a system of direct or indirect controls on the profitability of persons responsible for placing medicinal products on the market, the Member State concerned shall publish the following information in an appropriate publication and communicate it to the Commission: (a) the method or methods used in the Member State concerned to define profitability: return on sales and/or return on capital; (b) the range of target profit currently permitted to persons responsible for placing medicinal products on the market in the Member State concerned; (c) the criteria according to which target rates of profit are accorded to an individual responsible for placing medicinal products on the market, together with the criteria according to which they will be allowed to retain profits above their targets in the Member State concerned; (d) the maximum percentage profit which any person responsible for placing medicinal products on the market is allowed to retain above his target in the Member State concerned. The information referred to in the first subparagraph shall be updated once a year or when significant changes are made. Where, in addition to operating a system of direct or indirect controls on profits, a Member State operates a system of controls on the prices of certain types of medicinal products which are excluded from the scope of the profit control scheme, Articles 3, 4 and 5 shall, where relevant, apply to such price controls. However, those Articles shall not apply where the normal operation of a system of direct or indirect controls on profits results exceptionally in a price being fixed for an individual medicinal product.deleted

2012/10/25
Committee: ENVI

Milan CABRNOCH

Proposal for a directive
Article 7 – paragraph 2

2. Member States shall ensure that an application to include a medicinal product in the scope of the public health insurance system can be introduced by the marketing authorisation holder at any point in time. If the public health insurance system comprises several schemes or categories of coverage, the marketing authorisation holder shall be entitled to apply for the inclusion of its product in the scheme or category of its choice. ~~The competent authorities shall provide the applicant with an official acknowledgement of receipt.~~

2012/10/25
Committee: ENVI

Milan CABRNOCH

Proposal for a directive
Article 7 – paragraph 5

5. If the information supporting the application is inadequate, the competent authorities shall ~~forthwith~~ notify the applicant without undue delay of the detailed additional information required and take their final decision within 60 days of receipt of this additional information. However, with respect to medicines for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 15 days, provided that the reference medicinal product has already been included in the public health insurance system. Member States shall not request any additional information which is not explicitly required under national legislation or administrative guidelines.

2012/10/25
Committee: ENVI

Milan CABRNOCH

Proposal for a directive
Article 8

Article 8 Remedies procedure in case of non- compliance with the time limits related to the inclusion of medicinal products in health insurance systems 1. Member States shall ensure that effective and rapid remedies are available to the applicant in case of non- compliance with the time limits set in Article 7. 2. For the purposes of the remedies procedure Member States shall designate a body and entrust it with the powers to: (a) take, at the earliest opportunity and by way of interlocutory procedures, interim measures with the aim of correcting the alleged infringement or preventing further damage to the interests concerned; (b) award damages to the applicant in case of non-compliance with time limits set in Article 7 where damages are claimed, unless the competent authority may prove that the delay is not imputable to it; (c) impose a penalty payment, calculated by day of delay. For the purposes of point (c), the penalty payment shall be calculated depending on the seriousness of the infringement, its duration, the need to ensure that the penalty itself is a deterrent to further infringements. Member States may provide that the body referred to in the first subparagraph may take into account the probable consequences of potential measures taken under the present paragraph for all interests likely to be harmed, as well as the public interest, and may decide not to take such measures when their negative consequences could exceed their benefits. 3. A decision not to grant interim measure shall not prejudice any other claim of the applicant seeking such measures. 4. Member States shall ensure that decisions taken by bodies responsible for remedies procedures can be effectively enforced. 5. The body referred to in paragraph 2 shall be independent of the competent authorities in charge of controlling the prices of medicinal products for human use or in charge of determining the range of medicinal products covered by health insurance systems. 6. The body referred to in paragraph 2 shall state reasons for its decision. Furthermore, where that body is not judicial in character, provision must be made to guarantee procedures whereby any allegedly illegal measure taken by the independent body or any alleged defect in the exercise of powers conferred on it can be subject to judicial review or review by another body which is a court or tribunal within the meaning of Article 267 of the Treaty on the Functioning of the European Union and independent of both the competent authority and the body referred to in paragraph 2. The members of the body referred to in paragraph 2 shall be appointed and leave office under the same conditions as members of the judiciary as regards the authority responsible for their appointment, their period of office, and their removal. At least the president of that body shall have the same legal and professional qualifications as members of the judiciary. That body shall take its decisions following a procedure in which both sides are heard, and these decisions shall, by means determined by each Member State, be legally binding.deleted

2012/10/25
Committee: ENVI

Milan CABRNOCH

Proposal for a directive
Article 10

Article 10 Classification of medicinal products in view of their inclusion in health insurance systems 1. Paragraphs 2, 3 and 4 shall apply where medicinal products are grouped or classified according to therapeutic or other criteria for the purpose of their inclusion within the scope of the public health insurance system. 2. Member States shall publish in an appropriate publication and communicate to the Commission the objective and verifiable criteria according to which medicinal products are classified in view of their inclusion in the public health insurance system. 3. For the medicinal products subject to such grouping or classification, Member States shall publish in an appropriate publication and communicate to the Commission the methodologies used to determine the extent or conditions of their inclusion in the public health insurance system. 4. At the request of the holder of a marketing authorisation, the competent authorities shall specify the objective data on the basis of which they have determined the arrangements of coverage for their medicinal product, in application of the criteria and methodologies referred to in paragraphs 2 and 3. In such a case, the competent authorities shall also inform the marketing authorisation holder of all remedies available, including judicial, and of the time limits for applying for such remedies.deleted

2012/10/25
Committee: ENVI

Milan CABRNOCH

Proposal for a directive
Article 11

Article 11 Measures to control or promote the prescription of specific medicinal products 1. Paragraphs 2, 3 and 4 shall apply where a Member State adopts measures intended to control or promote the prescription of specific named medicinal products. 2. Measures referred to in paragraph 1 shall be based on objective and verifiable criteria. 3. Measures referred to in paragraph 1, including any evaluation, expert opinion or recommendation on which they are based, shall be published in an appropriate publication. 4. At the request of the holder of a marketing authorisation whose interests or legal position are affected by the measures referred to in paragraph 1, the competent authorities shall specify the objective data and criteria on the basis of which these measures have been taken with respect to its medicinal product. In such a case, the competent authorities shall also inform the marketing authorisation holder of all remedies available, including judicial, and of the time limits for applying for such remedies.deleted

2012/10/25
Committee: ENVI

Milan CABRNOCH

Proposal for a directive
Article 12

The time limits laid down in Articles 3, 4, 5 and 7 shall be construed as the period between the receipt of an application or additional information, as the case may be, and the ~~effective entry into force of the corresponding~~issuing of the decision. All expert evaluations and administrative steps necessary for taking the decision and bringing it into effect shall be carried out within the prescribed time limits.

2012/10/25
Committee: ENVI

Milan CABRNOCH

Proposal for a directive
Article 15

Article 15 Consultation of interested parties Where a Member State intends to adopt or amend any measure falling within the scope of this Directive, it shall give interested parties the opportunity to comment on the draft measure within a reasonable period. The competent authorities shall publish the rules applicable to consultations. The results of consultations shall be made publicly available, with the exception of confidential information in accordance with Union and national legislation regarding business confidentiality.deleted

2012/10/25
Committee: ENVI

Milan CABRNOCH

Proposal for a directive
Article 16

Article 16 Notification of draft national measures 1. Where Member States intend to adopt or amend any measure falling within the scope of this Directive, they shall immediately communicate to the Commission the draft measure envisaged, together with the reasoning on which the measure is based. 2. Where appropriate, Member States shall simultaneously communicate the texts of the basic legislative or regulatory provisions principally and directly concerned, if knowledge of such texts is necessary to assess the implications of the measure proposed. 3. Member States shall communicate the draft measure referred to in paragraph 1 again if they make changes to the draft that have the effect of significantly altering its scope or substance, or shortening the timetable originally envisaged for implementation. 4. The Commission may send its observations to the Member State which has communicated the draft measure within three months. The observations of the Commission shall be taken into account as far as possible by the Member State concerned, in particular if the observations indicate that the draft measure may be incompatible with Union law. 5. When the Member State concerned definitively adopts the draft measure, it shall communicate the final text to the Commission without delay. If observations have been made by the Commission in accordance with paragraph 4, this communication shall be accompanied by a report on the actions taken in response to the observations of the Commission.deleted

2012/10/25
Committee: ENVI

Milan CABRNOCH

Proposal for a directive
Article 17 – paragraph 1 – subparagraph 1 – introductory part

1. Do 31. By 31 January of […] [insert a date - the year following the date referred to in the first subparagraph of Article 18(1)], and by 31 January ~~and 1 July~~ of every year thereafter, Member States shall communicate to the Commission and publish in an appropriate publication a detailed report providing the following information:

2012/10/25
Committee: ENVI

Milan CABRNOCH

Proposal for a directive
Article 17 – paragraph 2

2. The Commission shall publish ~~every six months a report~~a report once a year on the information submitted by Member States according to paragraph 1.

2012/10/25
Committee: ENVI

Milan CABRNOCH

Proposal for a directive
Article 18 – paragraph 1 – subparagraph 1

Member States shall adopt and publish, by [last day of the 124th month following publication of this Directive in the Official journal of the European Union] at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.

2012/10/25
Committee: ENVI

Milan CABRNOCH

Proposal for a directive
Article 19

Article 19 Report on the implementation of this Directive 1. Member States shall send a report to the Commission on the implementation of this Directive by [insert date - within two years after the date referred to in the second subparagraph of Article 18(1)] and every three years thereafter. 2. By [insert date - within three years after the date referred to in the second subparagraph of Article 18(1)], the Commission shall submit a report to the European Parliament and the Council on the implementation of this Directive. The report may be accompanied by any appropriate proposals.deleted

2012/10/25
Committee: ENVI

Activities of Milan CABRNOCH related to 2012/0035(COD)

Shadow reports (1)

Amendments (20)

ParlTrack - 2011-2024