Legal provisions of COM(2013)168 - Transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems

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dossier COM(2013)168 - Transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of ...
document COM(2013)168 EN
date March 18, 2013

Contents

Chapter I - Scope and definitions

Article 1 - Subject matter and scope

1. Member States shall ensure that any national, regional or local measure, whether laid down by law, regulation or administrative action, to control the prices of medicinal products for human use or to determine the range of medicinal products covered by public health insurance systems, including the extent and conditions of their coverage, complies with the requirements of this Directive. Member States shall also ensure that the national procedures related to the pricing of medicinal products and their inclusion in the health insurance systems are not duplicated at regional or local level in their respective territories.

2. This Directive shall not apply to the following:

(a) voluntary contractual agreements which are concluded between competent authorities and the marketing authorisation holder for a medicinal product which is not mandatory nor represents the only possibility for the medicinal product to be included in the health insurance systems, and which aims to include a medicinal product under the scope of a health insurance system while monitoring elements are agreed upfront among both parties relating to the effectiveness and/or relative efficacy of the given medicinal product, with a view to enabling the effective provision of that medicine to patients under specific conditions and during an agreed period of time.

          concluded between public authorities and the holder of a marketing authorisation for a medicinal product that have as their object to enable the effective provision of this medicine to patients under specific conditions;

(b) national measures intended to determine the prices or the coverage of medicinal products by public health insurance systems which are subject to national or Union legislation on public procurement, in particular Council Directive 89/665/EEC, Council Directive 92/13/EEC and Directive 2004/18/EC of the European Parliament and of the Council.

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. In accordance with Union and national law regarding business confidentiality, information regarding the name of the medicinal product and the name of the marketing authorisation holder included in contractual agreements or public procurement procedures shall be made publicly available once those agreements or procedures are concluded.

3. Nothing in this Directive shall permit the placing on the market of a medicinal product which has not received marketing authorisation as provided for in Article 6 of Directive 2001/83/EC.

This Directive shall be without prejudice to the marketing authorisation relating to a medicinal product granted in accordance with the procedure referred to in Article 6 of Directive 2001/83/EC and Article 3 of Regulation (EC) No 726/2004 of the European Parliament and of the Council.

Article 2 - Definitions

For the purposes of this Directive, the following definitions apply:

(1) “medicinal product” means a medicinal product as defined in Article 1 of Directive 2001/83/EC;

(2) “reference medicinal product” means a reference medicinal product as defined in point (a) of Article 10(2) of Directive 2001/83/EC;

(3) “generic medicinal product” means a generic medicinal product as defined in point (b) of Article 10(2) of Directive 2001/83/EC;

(4) “biosimilar medicinal product” means biological medicinal product which is similar to a reference biological medicinal product;

(5) “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;

(6) “health technology assessment” means an assessment which as a minimum includes of the assessment of the relative efficacy or of the short- and long-term effectiveness of the medicinal product compared to other health technologies or interventions in use for treating the associated condition.

Chapter II - Pricing of medicinal products

Article 3 - Price approval

1. Paragraphs 2 to 9 shall apply if the marketing of a medicinal product is permitted only after the competent authorities of the Member State concerned have approved the price of the product.

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 of the formal application for pricing within 10 days of its receipt.

Member States may provide the possibility to the applicant of a marketing authorisation to submit a request for informal negotiations on price approval when the Committee for Medicinal Products for Human Use established by Article 5 of Regulation (EC) No 726/2004 or the national competent authority has issued an opinion in favour of the granting of a marketing authorisation for the medicinal product concerned.

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 60 90 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 medicinal products 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 30 15 days, provided that the price of the reference medicinal product has been approved by the competent authorities.

Where Member States decide to include health technology assessment as part of their decision-making process on the pricing of medicinal products, such assessment shall be carried out within the time limits set out in the first subparagraph.

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

5. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 90 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 3015 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.

6. In the absence of a decision within the relevant time limit set out in paragraphs 3 and 5, the applicant shall be entitled to market the product at the price proposed.

7. If the competent authorities decide not to permit the marketing of the medicinal product concerned at the price proposed by the applicant, the decision shall contain a statement of reasons based on objective and verifiable criteria, including any evaluation, expert opinion or recommendation on which it is based. The applicant shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.

8. Member States shall publish in an appropriate publication and communicate to the Commission the criteria which the competent authorities must take into account when approving the prices of medicinal products. Member States shall make publicly available the information on those criteria and decision-making bodies at national or regional level.

9. If the competent authorities decide to reduce the price of a specific named medicinal product on their own initiative, the decision shall contain a statement of reasons based on objective and verifiable criteria, including any evaluation, expert opinion or recommendation on which it is based. The decision shall be communicated to the holder of the marketing authorisation, who shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies. The decision and summary of the statement of reasons shall be made publicly available by the competent authorities without delay, after deletion of any information of a commercially confidential nature.

Article 4 - Price increase

1. Without prejudice to Article 5, paragraphs (2) to (6) shall apply if an increase in the price of a medicinal product is permitted only after prior approval has been obtained from the competent authorities.

2. Member States shall ensure that an application to increase the price of the product can be submitted by the marketing authorisation holder in accordance with national law at any point in time. The competent authorities shall provide the applicant with an official acknowledgement of receipt of the application within 10 days of its receipt.

3. Member States shall ensure that a decision to approve or reject 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 90 60 days of its receipt.

In case of an exceptional number of applications, the time limit set out in this paragraph may be extended once only for a further 60 days. The applicant shall be notified of such an extension before the expiry of the time limit set out in this paragraph.

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

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 detailed additional information required and take their final decision within 90 60 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.

5. In the absence of a decision within the relevant time limit referred to in paragraphs 3 and 4, the applicant shall be entitled to apply the price increase requested.

6. If the competent authorities decide not to permit the whole or part of the price increase requested, the decision shall contain a statement of reasons based on objective and verifiable criteria and the applicant shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.

Article 5 - Price freeze and price reduction

1. In the event of a price freeze or price reduction imposed on all medicinal products or on certain categories of medicinal products by the competent authorities of a Member State, that Member State shall publish a statement of reasons for its decision based on objective and verifiable criteria, including, if applicable, a justification of the categories of products subject to the price freeze or price reduction. Once a year Member States shall assess whether the price freeze or the price reduction is still justified taking into account the macro-economic conditions and adopt necessary changes where appropriate.

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 of the formal applicationfor inclusion of the medicinal product in the health insurance system within 10 days of its receipt.

3. Member States shall ensure that a reasoned decision on an application referred to in paragraph 2 is adopted and communicated to the applicant within 90 60 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 detailed additional information required and take their final decision within 90 60 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.

If there is an exceptional number of applications, the relevant time limit set out in paragraph 3 may be extended once only for a further 60 days. The applicant shall be notified of such extension before the expiry of the time limit set out in paragraph 3.

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.

Chapter III - Coverage of medicinal products by public health insurance systems

Article 7 - Inclusion of medicinal products in health insurance systems

1. Paragraphs 2 to 8 9 shall apply if a medicinal product is covered by the public health insurance system only after the competent authorities have decided to include the medicinal product concerned in the scope of that system.

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. The competent authorities shall provide the applicant with an official acknowledgement of receipt of the application within 10 days of its receipt.

Member States may also provide the possibility to the applicant of a marketing authorisation to submit a request for informal negotiations on inclusion of a medicinal product in the scope of the publisc health insurance systems when the Committee for Medicinal Products for Human Use established by Article 5 of Regulation (EC) No 726/2004 or the national competent authority has issued an opinion in favour of the granting of a marketing authorisation for the medicinal product concerned.

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

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 90 60 days of its receipt. However, with respect to medicinal products 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 30 days, provided that the reference medicinal product has already been included in the public health insurance system.

Where Member States decide to include health technology assessment as part of their decision-making process on the pricing of medicinal products, such assessment shall be carried out within the time limits set out in the first subparagraph

5. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 90 60 days of receipt of the additional information. However, with respect to medicinal products 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 30 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.

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 120 180 days. However, with respect to the 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 60 days, provided that the reference medicinal product 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).

7. Any decision not to include a medicinal product within the scope of the public health insurance system shall contain a statement of reasons based upon objective and verifiable criteria. Any decision to include a medicinal product within the scope of the public health insurance system shall contain a statement of reasons justifying the decision, including the extent and conditions of the product’s coverage, on the basis of objective and verifiable criteria.

The decisions referred to in this paragraph shall also include any evaluation, expert opinion or recommendation on which they are based. 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.

8. Member States shall publish in an appropriate publication and communicate to the Commission the criteria which the competent authorities must take into account when deciding whether or not to include medicinal products within the scope of the public health insurance system. Member States shall make publicly available the information on those criteria and decision-making bodies at national or regional level.

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 procedures are available to the applicant in case of non-compliance with the time limits set out in Article 7 and are in accordance with their national law.

2. For the purposes of the remedies procedures referred in paragraph 1, Member States may designate a body and entrust it with the powers to 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.

3. The body in charge of the remedies procedures shall be independent of the competent authorities in charge of controlling the prices of medicinal products or in charge of determining the range of medicinal products covered by health insurance systems.

4. 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.

5. 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.

6. A decision not to grant interim measure shall not prejudice any other claim of the applicant seeking such measures.

7. Member States shall ensure that decisions taken by bodies responsible for remedies procedures can be effectively enforced.

8. 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.

9. 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.

Article 9 - Exclusion of medicinal products from health insurance systems

1. Any decision to exclude a medicinal product from the scope of the public health insurance system, or to modify the extent or the conditions of coverage of the product concerned, shall contain a statement of reasons based on objective and verifiable criteria. Such decisions shall include any evaluation, expert opinion or recommendation on which they are based. The applicant shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.

2. Any decision to exclude a category of medicinal products from the scope of the public health insurance system, or to modify the extent or the conditions of coverage of the category concerned, shall contain a statement of reasons based on objective and verifiable criteria and be published in an appropriate publication.

3. Any decision to exclude a medicinal product or a category of medicinal products from the scope of the public health insurance system shall be made publicly available, together with a summary of the statement of reasons, after deletion of any information of a commercially confidential nature.

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 remedies, and of the time limits for applying for such remedies.

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 and made available to the public.

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 remedies, and of the time limits for applying for such remedies.

Chapter IV - Specific requirements

Article 12 - Effectiveness of the time limits

1. 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 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.

2. If the decision making process involves negotiations between the marketing authorisation holder and the competent authority, provided that it is agreed by both parties, the time limits laid down in Articles 3, 4, 5 and 7 shall be suspended from the time the competent authority communicates its proposals to the marketing authorisation holder until the competent authority receives the response to its proposals from the marketing authorisation holder. Member States shall make available to the public the practical modalities for such suspension.

Article 13 - Additional proof of quality, safety, efficacy or bioequivalence

1. In the framework of pricing and reimbursement decisions, Member States shall not re-assess the elements on which the marketing authorisation is based, including the the quality, safety, efficacy, or bioequivalence, or biosimilarity of the medicinal product or the criteria for orphan designation which have already been assessed during the marketing authorisation procedure.

2. Paragraph 1 shall be without prejudice to the right of the competent authorities to request and have full access to data generated during the marketing authorisation process for the purpose of health technology assessment, so that they can assess the relative efficacy as well as the short- and long-term effectiveness, where appropriate, of a medicinal product.

3. The competent authorities shall also be able to use the available data or generate additional relevant data for the purpose of health technology assessment.

Article 14 - Non interference of intellectual property rights

1. Applications, decision-making procedures and decisions to regulate the prices of medicinal products in accordance with Article 3 or to determine their inclusion within the scope of public health insurance systems in accordance with Articles 7 and 9 shall be considered by Member States as administrative procedures which, as such, are independent from the enforcement of intellectual property rights.

2. The protection of intellectual property rights shall not be a valid ground to refuse, suspend or revoke decisions relating to the price of a medicinal product or its inclusion within the public health insurance system.

3. Paragraphs 1 and 2 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.

Chapter V - Transparency mechanisms

Article 15 - Consultation of interested parties

Where a Member State intends to adopt or amend any legislative measure falling within the scope of this Directive, it shall give civil society organisations, including patient and consumer groups, and other 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.

Article 16 - Transparency of decision-making bodies and prices

1. Member States shall ensure that the competent authorities controlling the prices of medicinal products or determining the coverage of medicinal products by public health insurance systems make publicly available a regularly updated list of the members of their decision-making bodies, together with their declarations of interest.

2. Paragraph 1 shall also apply to the body referred to in Article 8(2).

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.

Article 17 - Report on the implementation of the time limits

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:

(a) the number of applications received in accordance with Articles 3, 4 and 7 during the preceding year;

(b) the amount of time taken to issue a decision on each of the applications received in accordance with Articles 3, 4, and 7.

(c) an analysis of the main reasons for delays, if any, together with recommendations to bring decision-making processes into line with the time limits laid down in this Directive.

For the purposes of point (a) of the first subparagraph, a distinction shall be made between generic medicinal products subject to shorter time limits in accordance with Articles 3, 4 and 7 and other medicinal products.

For the purposes of point (b) of the first subparagraph, any suspension of the procedure to request additional information to the applicant shall be reported with a clear indication of the duration of the suspension and the detailed reasons for the suspension.

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

Chapter VI - Final provisions

Article 18 - Transposition

1. Member States shall adopt and publish, by [last day of the 12th 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.

They shall apply those provisions from [the day after the date set out in the first subparagraph.].

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

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.

Article 20 - Repeal

Directive 89/105/EEC is repealed from [the date set out in the second subparagraph of Article 18(1)].

The effects of Article 10 of Directive 89/105/EEC shall be maintained.

References to the repealed Directive shall be construed as references to this Directive.

Article 21 - Entry into force and application

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 16 shall apply from [insert the date - date set out in the second subparagraph of Article 18(1)].

Article 22 - Addressees

This Directive is addressed to the Member States.