BETA

37 Amendments of Michèle RIVASI related to 2012/0035(COD)

Michèle RIVASI

The European Parliament rejects the Commission proposal.

2012/10/22
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Recital 9

(9) Any measure to regulate, either directly or indirectly, the prices of medicinal products, as well as any measure to determine their coverage by public health insurance systems should be based on objective and verifiable criteria that are independent from the origin of the product ~~and should provide adequate legal remedies, including judicial remedies, to affected companies~~. These requirements should equally apply to national, regional or local measures to control or promote the prescription of specific medicinal products as such measures also determine their effective coverage by health insurance systems.

2012/10/22
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Recital 11

(11) The time-limits for the inclusion of medicinal products in the health insurance systems set out in Directive 89/105/EEC are mandatory as clarified by the case-law of the Court of Justice. Experience has shown that those time limits are not always respected and that there is need to ensure legal certainty and improve the procedural rules related to the inclusion of medicinal products in the scope of health insurance system. Therefore, an effective and rapid ~~remedies proc~~measures of reduress should be ~~put in place~~encouraged.

2012/10/22
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Recital 12

(12) In its Communication "Executive Summary of the Pharmaceutical Sector Inquiry Report" the Commission demonstrated that pricing and reimbursement procedures often unnecessarily delay the launch of generic medicines in Union markets. Approving the price of generic medicinal products and their coverage by the health insurance system should not require any new or detailed assessment when the reference product is essentially similar, within the meaning of Directive 2001/83/EC, and has already been priced and included in the health insurance system. It is therefore appropriate to lay down shorter time limits for generic medicinal products in those cases. If generic medicinal products display differences by comparison with the reference medicinal product, for example as regards their packaging or their therapeutic indications, Member States may provide for their assessment.

2012/10/22
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Recital 13

(13) The judicial remedies available in the Member States have played a limited role in ensuring compliance with the time limits due to the often lengthy procedures in national jurisdictions, which deter affected companies from initiating legal action. Therefore, effective mechanisms are necessary to control and enforce compliance with the time limits for pricing and reimbursement decisions.deleted

2012/10/22
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Recital 14

(14) TProof of the quality, safety and efficacy of medicinal products, including the bioequivalence of generic medicinal products with the reference product, ~~are ascertain~~is verified in the framework of marketing authorisation procedures. In the framework of pricing and reimbursement procedures, Member States should therefore not re- assess the e~~lements~~ssential elements (quality, safety, efficacy or biosimilarity) on which the marketing authorisation is based, including the quality, safety, efficacy or bioequivalence of the medicinal product. However, Member States must be guaranteed full access to the data used by the authorities responsible for granting the marketing authorisation so that they can assess the relative safety, efficiency and efficacy of a medicinal product in the context of its inclusion in the scope of the mandatory health insurance system. The competent authorities should also be able to include or generate additional relevant data for the purposes of assessing medicinal products.

2012/10/22
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 2 – point 4

~~4) “health technology” means a health technology as defined in point (l) of Article 3 of Directive 2011/24/EU of the European Parliament and of the Council;~~deleted

2012/10/22
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 2 – point 5

5) “health technology assessment” means an assessment of the relative efficacy or of the short- and long-term effectiveness of the medicinal product compared to other health technologies in use for treating the associated condition.deleted

2012/10/22
Committee: ENVI

Michèle RIVASI

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

Michèle RIVASI

Proposal for a directive
Article 3 – paragraph 3

3. Member States shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 690 days of the receipt of an application submitted, in accordance with the requirements laid down in the Member State concerned, by the holder of a marketing authorisation. ~~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 1530 days, provided that the price of the reference medicinal product has been approved by the competent authorities and that the generic product is essentially similar to the reference product, within the meaning of Directive 2001/83/EC of 6 November 2001.

2012/10/22
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 3 – paragraph 4

4. Member States shall establish in detail the categories of particulars and main documents to be submitted by the applicant.

2012/10/22
Committee: ENVI

Michèle RIVASI

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 of ~~the~~what detailed additional information is required and take their final decision within 690 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 1530 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 and that the generic product is essentially similar to the reference product, within the meaning of Directive 2001/83/EC of 6 November 2001.

2012/10/22
Committee: ENVI

Michèle RIVASI

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

Michèle RIVASI

Proposal for a directive
Article 4 – paragraph 3 – subparagraph 1

Member States shall ensure that a decision on an application submitted in accordance with the requirements laid down in the Member State concerned, by a marketing authorisation holder to increase the price of a medicinal product is adopted and communicated to the applicant within 690 days of its receipt.

2012/10/25
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 4 – paragraph 3 – subparagraph 2

In case of an exceptional number of applications, the time limit set out in this paragraph may be extended once only for a further 690 days. The applicant shall be notified of such an extension before the expiry of the time limit set out in this paragraph.

2012/10/25
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 4 – paragraph 4 – subparagraph 1

Member States shall establish in detail the categories of particulars and main documents to be submitted by the applicant.

2012/10/25
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 4 – paragraph 4 – subparagraph 2

The applicant shall furnish the competent authorities with adequate information, including details of those events intervening since the price of the medicinal product was last determined which in his opinion justify the price increase requested. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of ~~the~~what detailed additional information is required and take their final decision within 690 days of receipt of this additional information. Member States shall not request any additional information which is not explicitly required under national legislation or administrative guidelines.

2012/10/25
Committee: ENVI

Michèle RIVASI

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

Michèle RIVASI

Proposal for a directive
Article 5 – paragraph 3 – subparagraph 1

Member States shall ensure that a reasoned decision on an application referred to in paragraph 2 is adopted and communicated to the applicant within 690 days of the receipt of the application. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of ~~the~~what detailed additional information is required and take their final decision within 690 days of receipt of this additional information. If the derogation is granted, the competent authorities shall forthwith publish an announcement of the price increase allowed.

2012/10/25
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 5 – paragraph 3 – subparagraph 2

I~~f there is~~n case of an exceptional number of applications, the ~~relevant~~ time limit set out in this paragraph 3 may be extended once only for a further 690 days. The applicant shall be notified of such extension before the expiry of the time limit set out in paragraph 3.

2012/10/25
Committee: ENVI

Michèle RIVASI

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

Michèle RIVASI

Proposal for a directive
Article 7 – paragraph 3

3. Member States shall establish in detail the categories of particulars and main documents to be submitted by the applicant.

2012/10/25
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 7 – paragraph 4

4. Member States shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system, submitted by the marketing authorisation holder in accordance with the requirements laid down in the Member State concerned, is adopted and communicated to the applicant within 690 days of its receipt. ~~However, w~~With respect to ~~medicines for which Member States use health technology ass~~generic medicinal products, that time limit shall be 30 days, provided that the reference medicinal product is essment 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 systemially similar, within the meaning of Directive 2001/83/EC, and has already been included in the public health insurance system. If generic medicinal products display differences by comparison with the reference medicinal product, for example as regards their packaging or their therapeutic indications, Member States may provide for their re- assessment.

2012/10/25
Committee: ENVI

Michèle RIVASI

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 of ~~the~~what detailed additional information is required and take their final decision within 690 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 1530 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 guidelinesis essentially similar, within the meaning of Directive 2001/83/EC of 6 November 2001, and has already been included in the public health insurance system.

2012/10/25
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 7 – paragraph 6

6. Irrespective of the organisation of their internal procedures, Member States shall ensure that the overall period of time taken by the inclusion procedure set out in paragraph 5 of this Article and the price approval procedure set out in Article 3 does not exceed 1280 days. ~~However, w~~With respect to ~~the~~generic medicinal products for which Member States use health technology assessment as part of their decision-making process, the time limit shall not exceed 180 days. With respect to generic medicinal products, that time limit shall not exceed 30 days, provided that the reference medicinal product, that time limit shall be 30 days, provided that the reference medicinal product is essentially similar, within the meaning of Directive 2001/83/EC, and has already been included in the public health insurance system. Those time-limits may be extended in accordance with paragraph 5 of this Article or Article 3(5).

2012/10/25
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 7 – paragraph 7 – subparagraph 2

~~The~~Les deécisions ~~referred to in this paragraph shall also include any evaluation, expert opinion or~~visées au présent paragraphe contiennent également toute évaluation, tout avis d'expert ou toute recommeandation ~~on which they are based~~d'expert sur lesquels elles s'appuient. The applicant shall be informed of all remedies available, including judicial remedies, and ~~the remedies procedure set out Article 8,~~ of the time limits for applying for such remedies.

2012/10/25
Committee: ENVI

Michèle RIVASI

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

Michèle RIVASI

Proposal for a directive
Article 11 – paragraph 1

1. Paragraphs 2~~, 3~~ and 43 shall apply where a Member State adopts measures intended to control or promote the prescription of specific named medicinal products.

2012/10/25
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 11 – paragraph 4

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

Michèle RIVASI

Proposal for a directive
Article 13 – title

~~Additional p~~Proof of quality, safety, efficacy or bioequivalence

2012/10/25
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 13

In the framework of pricing and reimbursement decisions, Member States sh~~all~~ould not be seeking to re-assess the e~~lements on which the marketing authorisation is based, including the quality, safety, efficacy or bioequivalence of the~~ssential elements (quality, safety, efficacy or bioequivalence) on which the marketing authorisation is based. However, Member States must be guaranteed full access to the data used by the authorities responsible for granting the marketing authorisation so that they can assess the relative safety, efficacy and efficiency of a medicinal product in the context of its inclusion in the scope of the mandatory health insurance system. The competent authorities should also be able to include or generate additional relevant data for the purposes of assessing medicinal products.

2012/10/25
Committee: ENVI

Michèle RIVASI

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

Michèle RIVASI

Proposal for a directive
Article 16 – paragraph 1

1. Where Member States ~~intend to~~ adopt or amend any measure falling within the scope of this Directive, they shall ~~immediately~~ communicate the final text to the Commission ~~the draft measure envisaged,~~ , together with the reasoning on which the measure is based.

2012/10/25
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 16 – paragraph 3

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.deleted

2012/10/25
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 16 – paragraph 4

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.deleted

2012/10/25
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 16 – paragraph 5

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

Michèle RIVASI

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

1. 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