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Document 52017PC0013

Proposal for a COUNCIL DECISION on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning an amendment to Annex II (Technical Regulations, Standards, Testing and Certification) and Annex XVII (Intellectual Property) to the EEA Agreement (Paediatric Regulation)

COM/2017/013 final - 2017/05 (NLE)

Brussels, 13.1.2017

COM(2017) 13 final

2017/0005(NLE)

Proposal for a

COUNCIL DECISION

on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning an amendment to Annex II (Technical Regulations, Standards, Testing and Certification) and Annex XVII (Intellectual Property)
to the EEA Agreement

(Paediatric Regulation)


EXPLANATORY MEMORANDUM

1.CONTEXT OF THE PROPOSAL

Reasons for and objectives of the proposal

The draft Decision of the EEA Joint Committee (annexed to the proposed Council Decision) aims to amend Annex II (Technical regulations, standards, testing and certification) and Annex XVII (Intellectual Property) to the EEA Agreement in order to incorporate the Paediatric Regulation 1 and the SPC Regulation 2  into the Agreement on the European Economic Area (EEA Agreement).

The EEA EFTA States (Iceland, Liechtenstein and Norway) are requesting adaptations which go above the level of mere technical adjustments. Therefore, in conformity with Article 1(3) of Council Regulation (EC) No 2894/94 3 , the EU position on this EEA Joint Committee Decision shall be established by the Council.

Consistency with existing policy provisions in the policy area

The annexed draft Joint Committee Decision extends the already existing EU policy to the EEA EFTA States.

Consistency with other Union policies

The extension of the EU acquis in the EEA EFTA States, through their incorporation into the EEA Agreement is conducted in conformity with the objectives and principles of this Agreement aiming at establishing a dynamic and homogeneous European Economic Area, based on common rules and equal conditions of competition.

These efforts cover all policies in the area of the free movement of goods, persons, services and capital, as well as flanking and horizontal policies specified in the EEA Agreement.

2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

Legal basis

The legislation to be incorporated into the EEA Agreement is based on Article 114 of the Treaty on the Functioning of the European Union.

Article 1(3) of Council Regulation (EC) No 2894/94 concerning arrangements for implementing the EEA Agreement provides that the Council establishes the position to be adopted on the Union’s behalf on such Decisions, on a proposal from the Commission.

The Commission in cooperation with the EEAS submits the draft Decision of the EEA Joint Committee for adoption by the Council as the Union’s position. The Commission would hope to be able to present it in the EEA Joint Committee at the earliest possible opportunity.

Subsidiarity (for non-exclusive competence)

The proposal complies with the subsidiarity principle for the following reason.  

The objective of this proposal, namely to ensure the homogeneity of the Internal Market cannot be sufficiently achieved by the Member States and can therefore, by reason of the effects, be better achieved at Union level.

Proportionality

In accordance with the principle of proportionality, the proposal does not go beyond what is necessary in order to achieve its objective – to ensure the homogeneity of the Internal Market.

Choice of the instrument

In conformity with Article 98 of the EEA Agreement, the chosen instrument is the EEA Joint Committee Decision. The EEA Joint Committee shall ensure the effective implementation and operation of the EEA Agreement. To this end, it shall take decisions in the cases provided for in the EEA Agreement.

3.RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

Collection and use of expertise

In the framework of the preparation of the legislation in question the Commission has widely consulted all interested parties.

Impact assessment

In the framework of the preparation of the legislation in question the Commission has carried out a detailed impact assessment, analysing a wide range of various policy options.

The attached EEA Joint Committee Decision merely aims to extend the current system to the EEA EFTA States.

4.BUDGETARY IMPLICATIONS

Incorporation of this legislation into the EEA Agreement has no budgetary implications.

5.OTHER ELEMENTS

Justification of the main requested adaptations and proposed solution

Adaptations to the Paediatric Regulation

(1)Article 36(3)

Article 36(3) of the Paediatrics Regulation reads as follows:

“Where the procedures laid down in Directive 2001/83/EC have been used, the six-month extension of the period referred to in paragraph 1 shall be granted only if the product is authorised in all Member States.”

Under the terms of this Article, the extension of a supplementary protection certificate under the Paediatric Regulation is subject to the condition that the underlying medicinal product has been authorised in all Member States. However, in accordance with point 15q of Chapter XIII of Annex II of the EEA agreement Liechtenstein is not obliged to participate in the common procedures laid down in Directive 2001/83/EC. The proposal for the adaptation text takes this into account.

Proposed adaptation text:

“The application of Article 36(3) shall not be made dependant on an authorisation of the medicinal product in Liechtenstein.”

(2)Article 49(3) (as amended by Regulation (EC) No 1902/2006)

In view of the two-pillar structure characterising the EEA Agreement, an adaptation text is suggested foreseeing that in the cases where the marketing authorisation holder of a centrally authorised product is established in an EFTA State, the EFTA Surveillance Authority will impose the financial penalties. However, due to the special circumstances, notably that the Commission grants marketing authorisations for centrally authorised products, that the infringements affect the Union and its interests and the complex and technical nature of the infringement procedures, the EFTA Surveillance Authority shall cooperate closely with the Commission and await the Commission’s assessment and proposal for action before taking a decision regarding financial penalties to the holders of marketing authorisations established in an EFTA State.

Adaptations to the SPC Regulation:

Articles 7 and 21 of Regulation (EC) No 469/2009

Justification:

The proposal for an adaptation text concerns the fact that the extension of the supplementary protection certificates (‘SPC’) established by Regulation (EC) No 1901/2006 and codified by Regulation (EC) No 469/2009 enters into force in the EEA EFTA States at a later stage than in the EU Member States and that the six months period shall constitute a direct extension of the SPC.

The same situation occurred when Regulation (EEC) No 1768/1992 was incorporated into the EEA Agreement, see point 6c of Annex XVII to the EEA Agreement. The proposal for an adaptation text is based on the same scheme as the current adaptation text to Article 19 of Regulation (EEC) No 1768/1992.

(1)New paragraphs 6 and 7 added to Article 7 of Regulation (EC) No 469/2009

According to Article 7(5) of Regulation (EC) No 469/2009, the application for an extension of the duration of the SPC shall, for a period of five years following the entry into force of Regulation (EC) No 1901/2006, be lodged not later than six months before the expiry of the SPC. In an EEA EFTA context there is a need for an adaptation on this point in such a way that the five years period shall be counted from the date where the regulation entered into force for the concerned EFTA state, see our proposal for Paragraphs 6 and 7 of Article 7 in Regulation (EC) No 469/2009.

(2)New paragraph 3 added to Article 21 of Regulation (EC) No 469/2009

There was also a need for an adaptation for situations where a SPC expires less than six months prior to the entry into force of Regulation (EC) No 469/2009 in an EEA EFTA state. Where a SPC expires earlier than six months prior to the entry into force of the regulation in an EFTA state, the extension will not have effect in the concerned EEA EFTA State, see our proposal for a new paragraph 3 to be added to Article 21 of Regulation (EC) No 469/2009. The reason for this is that the extension period shall follow as a direct prolongation to the SPC period. Where an SPC expires less than six months prior to the entry into force of Regulation (EC) No 1901/2006 and Regulation (EC) No 469/2009 in an EEA EFTA state, the possible extension should have effect for the period that remains of the six months extension period (counted from the expiry of the SPC) at the time where the Regulations enters into force in a concerned EEA EFTA state provided that the application for extension is published at this time.

(3)New paragraph 4 added to Article 21 of Regulation (EC) No 469/2009

For the situations where the SPC expires earlier than seven months after the entry into force of the Regulations in the EEA EFTA state concerned, we propose that the application for an extension of the duration of an SPC shall be lodged no later than one month after the entry into force of the Regulations in the EEA EFTA state concerned (see our proposal for a new paragraph 4 to be added to Article 21 of Regulation (EC) No 469/2009). According to our proposal the extension will take effect only with respect to the time following the date of publication of the application for an extension. Where the SPC expires after the entry into force of the Regulations in the EEA EFTA state concerned it will be possible to obtain the extension as a direct prolongation of the SPC. Where the SPC expires prior to the time of entry into force of the Regulations it will be possible to obtain that the remainder of the extension period take effect from the date the Regulations enter into force, provided that the application has already been lodged and the mention of it has been published. The extension will only have effect for the period that remains of the six months extension period (counted from the expiry of the SPC) at the time where the regulations enter into force in a concerned EFTA state and the application for extension is published.

(4)New paragraph 5 added to Article 21 of Regulation (EC) No 469/2009

According to our proposal for transitional arrangements a situation can occur where the protection first expires and then takes effect at a later stage, i.e. when the Regulations enter into force. For these situations we outline a provision on continued prior use below. A similar adaptation text was introduced as paragraph 5 to Article 19 of Regulation (EEC) No 1768/92 when this act was made part of the EEA Agreement.



Other adaptations proposed:

The Paediatric Committee should be inserted into the introductory text of Chapter XIII of Annex II to the EEA Agreement.

In view of the patent union between Liechtenstein and Switzerland, Liechtenstein does not deliver any supplementary protection certificates. In line with the practice of the EU since 2004 in the Treaty of Accession of new Member States the following text has been included as adaptation (d) to Regulation (EC) No 469/2009:

“(c)    In view of the patent union between Liechtenstein and Switzerland, Liechtenstein shall not deliver any supplementary protection certificates for medicinal products as laid down in this Regulation.”



2017/0005 (NLE)

Proposal for a

COUNCIL DECISION

on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning an amendment to Annex II (Technical Regulations, Standards, Testing and Certification) and Annex XVII (Intellectual Property)
to the EEA Agreement


(Paediatric Regulation)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 in conjunction with Article 218(9) thereof,

Having regard to Council Regulation (EC) No 2894/94 of 28 November 1994 4 concerning arrangements for implementing the Agreement on the European Economic Area, and in particular Article 1(3) thereof,

Having regard to the proposal from the European Commission,

Whereas:

(1)The Agreement on the European Economic Area ('the EEA Agreement') entered into force on 1 January 1994.

(2)Pursuant to Article 98 of the EEA Agreement, the EEA Joint Committee may decide to amend, inter alia, Annex II (Technical Regulations, Standards, Testing and Certification) and Annex XVII (Intellectual Property) to the EEA Agreement.

(3)Regulation (EC) No 1901/2006 of the European Parliament and of the Council 5  is to be incorporated into the EEA Agreement.

(4)Regulation (EC) No 1902/2006 of the European Parliament and of the Council 6  is to be incorporated into the EEA Agreement.

(5)Regulation (EC) No 469/2009 of the European Parliament and of the Council 7 is to be incorporated into the EEA Agreement.

(6)Commission Regulation (EU) No 488/2012 of 8 June 2012 8 , is to be incorporated into the EEA Agreement.

(7)Regulation (EC) No 469/2009 repeals Council Regulation (EEC) No 1768/92 9 which has been incorporated into the EEA Agreement and which is therefore to be repealed under the EEA Agreement.

(8)Commission Regulation (EC) No 658/2007 10 lays down rules concerning the application of financial penalties to the holders of marketing authorisations granted under Regulation (EC) No 726/2004. Marketing authorisations are granted by the Commission and the EFTA States shall simultaneously and within 30 days take corresponding decisions. Due to the special circumstances, notably that the Commission grants marketing authorisations, that the infringements affect the Union and its interests and the complex and technical nature of the infringement procedures, the EFTA Surveillance Authority shall cooperate closely with the Commission and await the Commission’s assessment and proposal for action before taking a decision regarding financial penalties to the holders of marketing authorisations established in an EFTA State.

(9)Annex II (Technical Regulations, Standards, Testing and Certification) and Annex XVII (Intellectual Property) to the EEA Agreement should therefore be amended accordingly.

(10)The position of the Union within the EEA Joint Committee should therefore be based on the attached draft Decision,

HAS ADOPTED THIS DECISION:

Article 1

The position to be adopted, on behalf of the Union, within the EEA Joint Committee on the proposed amendment to Annex II (Technical Regulations, Standards, Testing and Certification) and Annex XVII (Intellectual Property) to the EEA Agreement, shall be based on the draft decision of the EEA Joint Committee attached to this Decision.

Article 2

This Decision shall enter into force on the date of its adoption.

Done at Brussels,

   For the Council

   The President

(1) Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004.
(2) Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (Codified version).
(3) OJ L 305, 30.11.1994, p. 6–8
(4) OJ L 305, 30.11.1994, p. 6–8.
(5) Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004, (OJ L 378, 27.12.2006, p. 1).
(6) Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use, (OJ L 378, 27.12.2006, p. 20).
(7) Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (Codified version), (OJ L 152, 16.6.2009, p. 1).
(8) Commission Regulation (EU) No 488/2012 of 8 June 2012 amending Commission Regulation (EC) No 658/2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council, (OJ L 150, 9.6.2012, p. 68).
(9) OJ L 182, 2.7.1992, p. 1.
(10) Commission Regulation (EC) No 658/2007of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council, (OJ L 155, 15.6.2007, p. 10–19).
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Brussels, 13.1.2017

COM(2017) 13 final

ANNEX

to the

proposal for a

Council Decision

on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning an amendment to Annex II (Technical Regulations, Standards, testing and Certification) and Annex XVII (Intellectual Property)
to the EEA Agreement

(Paediatric Regulation)


DECISION OF THE EEA JOINT COMMITTEE
No


of


amending Annex II (Technical Regulations, Standards, Testing and Certification) and Annex XVII (Intellectual Property) to the EEA Agreement

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (“the EEA Agreement”), and in particular Article 98 thereof,

Whereas:

(1)Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 1  is to be incorporated into the EEA Agreement.

(2)Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use 2  is to be incorporated into the EEA Agreement.

(3)Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (Codified version) 3  is to be incorporated into the EEA Agreement.

(4)Commission Regulation (EU) No 488/2012 of 8 June 2012 amending Commission Regulation (EC) No 658/2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council 4 , as corrected by OJ L 338, 12.12.2012, p. 44, is to be incorporated into the EEA Agreement.

(5)Regulation (EC) No 469/2009 repeals Council Regulation (EEC) No 1768/92 5 which has been incorporated into the EEA Agreement and which is therefore to be repealed under the EEA Agreement.

(6)Commission Regulation (EC) No 658/2007 lays down rules concerning the application of financial penalties to the holders of marketing authorisations granted under Regulation (EC) No 726/2004. Marketing authorisations are granted by the Commission and the EFTA States shall simultaneously and within 30 days take corresponding decisions. Due to the special circumstances, notably that the Commission grants marketing authorisations, that the infringements affect the Union and its interests and the complex and technical nature of the infringement procedures, the EFTA Surveillance Authority shall cooperate closely with the Commission and await the Commission’s assessment and proposal for action before taking a decision regarding financial penalties to the holders of marketing authorisations established in an EFTA State.

(7)Annexes II and XVII to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

Chapter XIII of Annex II to the EEA Agreement shall be amended as follows:

1.The following text is inserted after the words “Committee on Orphan Medicinal Products (COMP)” in the 13th paragraph of the introductory text:

‘, the Paediatric Committee’

2.The following indent is added in points 15q (Directive 2001/83/EC of the European Parliament and of the Council) and 15zb (Regulation (EC) No 726/2004 of the European Parliament and of the Council):

‘-32006 R 1901: Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 (OJ L 378, 27.12.2006, p. 1).’

3.The adaptation text of point 15zb (Regulation (EC) No 726/2004 of the European Parliament and of the Council) is replaced by the following:

‘The powers vested in the European Commission in relation to the infringement procedure foreseen in Article 84(3), including the power to impose financial penalties on the holders of marketing authorisations, shall, in the cases where the marketing authorisation holder is established in an EFTA State, be carried out by the EFTA Surveillance Authority in close cooperation with the Commission. Before the EFTA Surveillance Authority takes a decision regarding financial penalties, the Commission shall provide it with its assessment and a proposal on how to act.’

4.The text of point 15zj (Commission Regulation (EC) No 658/2007) is replaced by the following:

32007 R 0658: Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 155, 15.6.2007, p. 10), as amended by:

-32012 R 0488: Commission Regulation (EU) No 488/2012 of 8 June 2012 (OJ L 150, 9.6.2012, p. 68), as corrected by OJ L 338, 12.12.2012, p. 44.

The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation:

The powers vested in the European Commission in relation to the infringement procedure, including the power to impose financial penalties on the holders of marketing authorisations, shall, in the cases where the marketing authorisation holder is established in an EFTA State, be carried out by the EFTA Surveillance Authority in close cooperation with the Commission. Before the EFTA Surveillance Authority takes a decision regarding financial penalties, the Commission shall provide it with its assessment and a proposal on how to act.’

5.The following point is inserted after point 15zo (Commission Implementing Regulation (EU) No 198/2013):

‘15zp. 32006 R 1901: Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1), as amended by:

-32006 R 1902: Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 (OJ L 378, 27.12.2006, p. 20).

The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:

(a)The application of Article 36(3) shall not be made dependant on an authorisation of the medicinal product in Liechtenstein.

(b)The powers vested in the European Commission in relation to the infringement procedure foreseen in Article 49(3), including the power to impose financial penalties on the holders of marketing authorisations, shall, in the cases where the marketing authorisation holder is established in an EFTA State, be carried out by the EFTA Surveillance Authority in close cooperation with the Commission. Before the EFTA Surveillance Authority takes a decision regarding financial penalties, the Commission shall provide it with its assessment and a proposal on how to act.’

Article 2

The text of point 6 (Council Regulation (EEC) No 1768/92) of Annex XVII to the EEA Agreement is replaced by the following:

32009 R 0469: Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (Codified version) (OJ L 152, 16.6.2009, p. 1).

The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:

(a)The following paragraphs shall be added to Article 7:

"6.Paragraph 5 shall not apply to the EFTA States.

7.Notwithstanding paragraph 4, for five years following the entry into force of Regulation (EC) No 1901/2006 in the EFTA State concerned, the application for an extension of the duration of a certificate already granted shall be lodged not later than six months before the expiry of the certificate."

(b)The following paragraphs shall be added to Article 21:

"3.An application for an extension of the duration of a certificate can only be granted in an EFTA State where the certificate expires less than 6 months prior to the entry into force of Regulation (EC) No 1901/2006 in the EFTA state concerned. In cases where the certificate expires prior to the entry into force of Regulation (EC) No 1901/2006 in the EFTA state concerned, the extension shall take effect only with respect to the time following after both such entry into force in the EFTA state concerned and the date of the publication of the application for the extension. However, paragraph 3 of Article 13 shall apply as to the calculation of the duration of the extension.

4.Notwithstanding paragraph 7 of Article 7, in cases where a certificate expires earlier than seven months after the entry into force of Regulation (EC) No 1901/2006 in the EFTA state concerned, the application for an extension of the duration of a certificate shall be lodged no later than one month after such entry into force in the EFTA state concerned. In these cases the extension takes effect only with respect to the time following the date of publication of the application for an extension. However, paragraph 3 of Article 13 shall apply as to the calculation of the duration of the extension.

5.An application for an extension of the duration of a certificate lodged in accordance with paragraphs 3 and 4 shall not prevent any third party who, between the expiry of the certificate and the publication of the application for an extension of the duration of the certificate, in good faith has commercially used the invention or made serious preparation for such use, to continue such use.

(c)In view of the patent union between Liechtenstein and Switzerland, Liechtenstein shall not deliver any supplementary protection certificates for medicinal products as laid down in this Regulation.’

Article 3

The texts of Regulations (EC) No 1901/2006, (EC) No 1902/2006, (EC) No 469/2009 and Commission Regulation (EU) No 488/2012, as corrected by OJ L 338, 12.12.2012, p. 44, in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 4

This Decision shall enter into force on […], provided that all the notifications under Article 103(1) of the EEA Agreement have been made 6*.

Article 5

This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, […].

   For the EEA Joint Committee

   The President
   […]

       The Secretaries
   to the EEA Joint Committee
   […]

(1) OJ L 378, 27.12.2006, p. 1.
(2) OJ L 378, 27.12.2006, p. 20.
(3) OJ L 152, 16.6.2009, p. 1.
(4) OJ L 150, 9.6.2012, p. 68.
(5) OJ L 182, 2.7.1992, p. 1.
(6) [Constitutional requirements indicated.]
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