[ParlTrack]

Proposal for a regulation
Recital 7

(7) The aim of this Regulation is to ensure that manufacturers established in the Union are able to compete effectively in those third country markets where supplementary protection does not exist or has expired. It is intended to complement the efforts of the Union’s trade policy to ensure open markets for Union-based manufacturers of medicinal products. I~~ndirectly, i~~t is also intended to put those manufacturers in a better position to enter the Union market immediately after expiry of the relevant supplementary protection certificate, i.e. day-1 entry. It would also help to serve the aim of fostering access to medicines in the Union by helping to ensure a swifter entry of generic and biosimilar medicines onto the market after expiry of the relevant certificate.

2018/11/12
Committee: INTA

Bolesław G. PIECHA, Kosma ZŁOTOWSKI

Proposal for a regulation
Recital 8

(8) In those specific and limited circumstances, and in order to create a level playing field between Union-based manufacturers and third country manufacturers, it is appropriate to ~~restrict the protection conferred by~~overcome the above mentioned unintended effects deriving from a supplementary protection certificate so as to allow making for the exclusive purposes of (i) export to third countries and any related acts strictly necessary for making or for the actual export itself and (ii)enter the Union market immediately after expiry of the relevant supplementary protection certificate and any related acts.

2018/11/12
Committee: INTA

Bolesław G. PIECHA, Kosma ZŁOTOWSKI

Proposal for a regulation
Recital 9

(9) That exception should cover the making of the product, including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a Member State, for the exclusive purpose of export to third countries and/or day-1 entry, as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker, where such acts would otherwise require the consent of the certificate-holder, and are strictly necessary for making for the purpose of export or for the actual export itself or for day-1 entry. For instance, such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds, or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations or day- 1 entry.

2018/11/12
Committee: INTA

Bolesław G. PIECHA, Kosma ZŁOTOWSKI

Proposal for a regulation
Recital 11

(11) By limiting the scope of the exception to making for the purposes of day-1 entry and of export outside the Union and acts strictly necessary for such making or for the actual export itself, the exception introduced by this Regulation will not ~~unreasonably~~ conflict with normal exploitation of the product in the Member State where the certificate is in force, nor ~~unreasonably~~ prejudice the legitimate interests of the certificate- holder, taking account of the legitimate interests of third parties.

2018/11/12
Committee: INTA

Bolesław G. PIECHA, Kosma ZŁOTOWSKI

Proposal for a regulation
Recital 12

(12) Safeguards should accompany the exception in order to increase transparency, to help the holder of a supplementary protection certificate to enforce its protection in the Union and to reduce the risk of illicit diversion onto the Union market during the term of the certificate. deleted (Regulation (EC) No 469/2009) Or. en (Recital 12 Regulation (EC) No 469/2009)

2018/11/12
Committee: INTA

Bolesław G. PIECHA, Kosma ZŁOTOWSKI

Proposal for a regulation
Recital 13

(13) To this end, this Regulation should impose a once-off duty on the person making the product for the exclusive purpose of export, requiring that person to provide certain information to the authority which granted the supplementary protection certificate in the Member State where the making is to take place. The information should be provided before the making is intended to start for the first time in that Member State. The making and related acts, including those performed in Member States other than the one of making in cases where the product is protected by a certificate in those other Member States too, should only fall within the scope of the exception where the maker has sent this notification to the competent industrial property authority (or other designated authority) of the Member State of making. The once-off duty to provide information to the authority should apply in each Member State where making is to take place, both as regards the making in that Member State, and as regards related acts, whether performed in that or another Member State, related to that making. The authority should be required to publish that information, in the interests of transparency and for the purpose of informing the holder of the certificate of the maker’s intention. deleted (Regulation (EC) No 469/2009) Or. en (Recital 13, Regulation (EC) No 469/2009)

2018/11/12
Committee: INTA

Kosma ZŁOTOWSKI

Proposal for a regulation
Recital 7

(7) The aim of this Regulation is to ensure that manufacturers established in the Union are able to compete effectively in those third country markets where supplementary protection does not exist or has expired. It is intended to complement the efforts of the Union’s trade policy to ensure open markets for Union-based manufacturers of medicinal products. I~~ndirectly, i~~t is also intended to put those manufacturers in a better position to enter the Union market immediately after expiry of the relevant supplementary protection certificate, i.e. day-1 entry. It would also help to serve the aim of fostering access to medicines in the Union by helping to ensure a swifter entry of generic and biosimilar medicines onto the market after expiry of the relevant certificate.

2018/11/28
Committee: JURI

Bolesław G. PIECHA, Kosma ZŁOTOWSKI

Proposal for a regulation
Recital 14

(14) In addition, this Regulation should impose certain due diligence requirements on the maker as a condition for the exception to operate. The maker should be required to inform persons within its supply chain, through appropriate means, in particular contractual means, that the product is covered by the exception introduced by this Regulation and is intended for the exclusive purpose of export. A maker who failed to comply with these due diligence requirements would not benefit from the exception, nor would any third party performing a related act in the same or a different Member State where a certificate conferring protection for the product was in force, and the holder of the relevant certificate would therefore be entitled to enforce its rights under the certificate. deleted (Regulation (EC) No 469/2009) Or. en (Recital 14, Regulation (EC) No 469/2009)

2018/11/12
Committee: INTA

Kosma ZŁOTOWSKI

Proposal for a regulation
Recital 8

(8) In those specific and limited circumstances, and in order to create a level playing field between Union-based manufacturers and third country manufacturers, it is appropriate to ~~restrict the protection conferred by~~overcome the above mentioned unintended effects deriving from a supplementary protection certificate so as to allow making for the ~~exclusive~~ purposes of export to third countries and any related acts strictly necessary for making or for the actual export itself and enter the Union market immediately after expiry of the relevant supplementary protection certificate and any related acts.

2018/11/28
Committee: JURI

Bolesław G. PIECHA, Kosma ZŁOTOWSKI

Proposal for a regulation
Recital 15

(15) Furthermore, this Regulation should impose labelling requirements on the maker, in order to facilitate, by means of a logo, identification of the product as a product exclusively intended for the purpose of export to third countries. The making and related acts should only fall outside the protection conferred by a supplementary protection certificate if the product is labelled in this manner. This labelling obligation would be without prejudice to labelling requirements of third countries. deleted (Regulation (EC) No 469/2009) Or. en (Recital 15, Regulation (EC) No 469/2009)

2018/11/12
Committee: INTA

Bolesław G. PIECHA, Kosma ZŁOTOWSKI

Proposal for a regulation
Recital 19

(19) In order to ensure that holders of supplementary protection certificates already in force are not deprived of their acquired rights, the exception provided for in this Regulation should only apply to certificates that are granted on or after a specified date after entry into force, irrespective of when the application for the certificate was first lodged. The date specified should allow a reasonable time for applicants and other relevant market players to adjust to the changed legal context and to make appropriate investment and manufacturing location decisions in a timely way. The date should also allow sufficient time for public authorities to put in place appropriate arrangements to receive and publish notifications of the intention to make, and should take due account of pending applications for certificates. deleted (Regulation (EC) No 469/2009) Or. en (Recital 19, Regulation (EC) No 469/2009)

2018/11/12
Committee: INTA

Kosma ZŁOTOWSKI

Proposal for a regulation
Recital 9

(9) That exception should cover the making of the product, including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a Member State, for the ~~exclusive~~ purposes of export to third countries and day-1 entry, as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker, where such acts would otherwise require the consent of the certificate-holder, and are strictly necessary for making for the purpose of export or for the actual export itself or for day-1 entry. For instance, such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds, or temporary storage of the product or advertising for the ~~exclusive~~ purposes of export to third country destinations or day-1 entry.

2018/11/28
Committee: JURI

Bolesław G. PIECHA, Kosma ZŁOTOWSKI

Proposal for a regulation
Recital 21

(21) It is necessary and appropriate for the achievement of the basic objective, of providing a level playing field for generic and biosimilar manufacturers with their competitors in third country markets where protection does not exist or has expired, to lay down rules restricting the exclusive right of a supplementary protection certificate holder to make the product in question during the term of the certificate~~, and also to impose certain information and labelling obligations on makers wishing to take advantage of those rules~~. This Regulation complies with the principle of proportionality, and does not go beyond what is necessary in order to achieve the objectives pursued, in accordance with Article 5(4) of the Treaty on European Union.

2018/11/12
Committee: INTA

Bolesław G. PIECHA, Kosma ZŁOTOWSKI

Proposal for a regulation
Recital 22

(22) This Regulation respects fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union. In particular, this Regulation seeks to ensure full respect for the right to property in Article 17 of the Charter by maintaining the core rights of the supplementary protection certificate, ~~by confining the exception to certificates granted on or after a specified date after entry into force of this Regulation and by imposing certain conditions on the application of the exception~~the right to health care in Article 35 of the Charter by making medicines more accessible to EU patients, and the principle of proportionality in Article 52 of the Charter,

2018/11/12
Committee: INTA

Bolesław G. PIECHA, Kosma ZŁOTOWSKI

Proposal for a regulation
Article 1 – paragraph 1 – point 1

Regulation (EC) No 469/2009
Article 4 – paragraph 2 – point a – point i

(i) making for either: a. the exclusive purpose of export to third countries; or b. the exclusive purpose of selling or offering to sell in the Union market immediately after expiry of the certificate;

2018/11/12
Committee: INTA

Bolesław G. PIECHA, Kosma ZŁOTOWSKI

Proposal for a regulation
Article 1 – paragraph 1 – point 1

Regulation (EC) No 469/2009
Article 4 – paragraph 2 – point a – point ii

(ii) any related act that is strictly necessary for that making, including keeping, or for the actual export itself;

2018/11/12
Committee: INTA

Kosma ZŁOTOWSKI

Proposal for a regulation
Recital 11

(11) By limiting the scope of the exception to making for the purposes of day-1 entry and export outside the Union and acts strictly necessary for such making or for the actual export itself, the exception introduced by this Regulation will not ~~unreasonably~~ conflict with normal exploitation of the product in the Member State where the certificate is in force, nor ~~unreasonably~~ prejudice the legitimate interests of the certificate- holder, taking account of the legitimate interests of third parties.

2018/11/28
Committee: JURI

Bolesław G. PIECHA, Kosma ZŁOTOWSKI

Proposal for a regulation
Article 1 – paragraph 1 – point 1

Regulation (EC) No 469/2009
Article 4 – paragraph 2 – point a – point iii (new)

(ii a) (iii) sale, and offer for sale, for the exclusive purpose of export to third countries; or

2018/11/12
Committee: INTA

Kosma ZŁOTOWSKI

Proposal for a regulation
Recital 12

(12) Safeguards should accompany the exception in order to increase transparency, to help the holder of a supplementary protection certificate to enforce its protection in the Union and to reduce the risk of illicit diversion onto the Union market during the term of the certificate.deleted

2018/11/28
Committee: JURI

Bolesław G. PIECHA, Kosma ZŁOTOWSKI

Proposal for a regulation
Article 1 – paragraph 1 – point 1

Regulation (EC) No 469/2009
Article 4 – paragraph 2 – point a – point iv (new)

(ii b) (iv) importing for the purposes of (i)

2018/11/12
Committee: INTA

Bolesław G. PIECHA, Kosma ZŁOTOWSKI

Proposal for a regulation
Article 1 – paragraph 1 – point 1

Regulation (EC) No 469/2009
Article 4 – paragraph 2 – point b

(b) the authority referred to in Article 9(1) of the Member State where that making is to take place (‘the relevant Member State’) is notified by the person doing the making (‘the maker’) of the information listed in paragraph 3 no later than 28 days before the intended start date of making in that Member State;deleted

2018/11/12
Committee: INTA

Kosma ZŁOTOWSKI

Proposal for a regulation
Recital 13

(13) To this end, this Regulation should impose a once-off duty on the person making the product for the exclusive purpose of export, requiring that person to provide certain information to the authority which granted the supplementary protection certificate in the Member State where the making is to take place. The information should be provided before the making is intended to start for the first time in that Member State. The making and related acts, including those performed in Member States other than the one of making in cases where the product is protected by a certificate in those other Member States too, should only fall within the scope of the exception where the maker has sent this notification to the competent industrial property authority (or other designated authority) of the Member State of making. The once-off duty to provide information to the authority should apply in each Member State where making is to take place, both as regards the making in that Member State, and as regards related acts, whether performed in that or another Member State, related to that making. The authority should be required to publish that information, in the interests of transparency and for the purpose of informing the holder of the certificate of the maker’s intention.deleted

2018/11/28
Committee: JURI

Bolesław G. PIECHA, Kosma ZŁOTOWSKI

Proposal for a regulation
Article 1 – paragraph 1 – point 1

Regulation (EC) No 469/2009
Article 4 – paragraph 2 – point c

~~(c) the maker ensures that a logo, in the form set out in Annex -I, is affixed to the outer packaging of the product or, if there is no outer packaging, to its immediate packaging;~~deleted

2018/11/12
Committee: INTA

Bolesław G. PIECHA, Kosma ZŁOTOWSKI

Proposal for a regulation
Article 1 – paragraph 1 – point 1

Regulation (EC) No 469/2009
Article 4 – paragraph 2 – point d

~~(d) the maker complies with the requirements of paragraph 4.~~deleted

2018/11/12
Committee: INTA

Bolesław G. PIECHA, Kosma ZŁOTOWSKI

Proposal for a regulation
Article 1 – paragraph 1 – point 1

Regulation (EC) No 469/2009
Article 4 – paragraph 3

~~3. The information for the purposes of paragraph 2(b) shall be as follows: (a) the name and~~deleted the address, of the maker; (b) premises where the making is to take place in the relevant Member State; (c) granted in the relevant Member State, and identification of the product, by reference to the proprietary name used by the holder of that certificate; (d) granted in accordance with Article 40(1) of Directive 2001/83/EC or Article 44(1) of Directive 2001/82/EC for the manufacture of the corresponding medicinal product or, in the absence of such authorisation, a valid certificate of good manufacturing practice as referred to in Article 111(5) of Directive 2001/83/EC or Article 80(5) of Directive 2001/82/EC covering the premises where the making is to take place; (e) in the relevant Member State; (f) third country or third countries to which the product is to be exportr addresses, of the the number of the certificate the number of the authorisation the intended start date of making an indicative list of the intended.

2018/11/12
Committee: INTA

Kosma ZŁOTOWSKI

Proposal for a regulation
Recital 14

(14) In addition, this Regulation should impose certain due diligence requirements on the maker as a condition for the exception to operate. The maker should be required to inform persons within its supply chain, through appropriate means, in particular contractual means, that the product is covered by the exception introduced by this Regulation and is intended for the exclusive purpose of export. A maker who failed to comply with these due diligence requirements would not benefit from the exception, nor would any third party performing a related act in the same or a different Member State where a certificate conferring protection for the product was in force, and the holder of the relevant certificate would therefore be entitled to enforce its rights under the certificate.deleted

2018/11/28
Committee: JURI

Bolesław G. PIECHA, Kosma ZŁOTOWSKI

Proposal for a regulation
Article 1 – paragraph 1 – point 1

Regulation (EC) No 469/2009
Article 4 – paragraph 4

4. The maker shall ensure, through appropriate means, that persons in a contractual relationship with the maker who perform acts falling within paragraph 2(a)(ii) are fully informed and aware of the following: (a) that those acts are subject to the provisions of paragraph 2; (b) import or re-import of the product might infringe the certificate referred to in that paragraph where, and as long as, that certificate applies.deleted that the placing on the market,

2018/11/12
Committee: INTA

Bolesław G. PIECHA, Kosma ZŁOTOWSKI

Proposal for a regulation
Article 1 – paragraph 1 – point 1

Regulation (EC) No 469/2009
Article 4 – paragraph 5

5. Paragraph 2 shall apply in the case only of certificates granted on or after [OP: please insert the date of the first day of the third month that follows the month in which this amending Regulation is published in the Official Journal)].;only to activities carried out after the entry into force of the present Regulation

2018/11/12
Committee: INTA

Kosma ZŁOTOWSKI

Proposal for a regulation
Recital 15

(15) Furthermore, this Regulation should impose labelling requirements on the maker, in order to facilitate, by means of a logo, identification of the product as a product exclusively intended for the purpose of export to third countries. The making and related acts should only fall outside the protection conferred by a supplementary protection certificate if the product is labelled in this manner. This labelling obligation would be without prejudice to labelling requirements of third countries.deleted

2018/11/28
Committee: JURI

Bolesław G. PIECHA, Kosma ZŁOTOWSKI

Proposal for a regulation
Article 1 – paragraph 1 – point 2

Regulation (EC) No 469/2009
Article 11 – paragraph 4

~~(2) in Article 11, the following paragraph is added: ‘ 4. authority as referred to in Article 4(2)(b) shall be published by that authority within 15 days of receipt of the notification.; ’~~deleted The notification sent to an

2018/11/12
Committee: INTA

Kosma ZŁOTOWSKI

Proposal for a regulation
Recital 19

(19) In order to ensure that holders of supplementary protection certificates already in force are not deprived of their acquired rights, the exception provided for in this Regulation should only apply to certificates that are granted on or after a specified date after entry into force, irrespective of when the application for the certificate was first lodged. The date specified should allow a reasonable time for applicants and other relevant market players to adjust to the changed legal context and to make appropriate investment and manufacturing location decisions in a timely way. The date should also allow sufficient time for public authorities to put in place appropriate arrangements to receive and publish notifications of the intention to make, and should take due account of pending applications for certificates.deleted

2018/11/28
Committee: JURI

Kosma ZŁOTOWSKI

Proposal for a regulation
Recital 21

(21) It is necessary and appropriate for the achievement of the basic objective, of providing a level playing field for generic and biosimilar manufacturers with their competitors in third country markets where protection does not exist or has expired, to lay down rules restricting the exclusive right of a supplementary protection certificate holder to make the product in question during the term of the certificate~~, and also to impose certain information and labelling obligations on makers wishing to take advantage of those rules~~. This Regulation complies with the principle of proportionality, and does not go beyond what is necessary in order to achieve the objectives pursued, in accordance with Article 5(4) of the Treaty on European Union.

2018/11/28
Committee: JURI

Kosma ZŁOTOWSKI

Proposal for a regulation
Recital 22

(22) This Regulation respects fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union. In particular, this Regulation seeks to ensure full respect for the right to property in Article 17 of the Charter by maintaining the core rights of the supplementary protection certificate, ~~by confining the exception to certificates granted on or after a specified date after entry into force of this Regulation and by imposing certain conditions on the application of the exception,~~the right to health care in Article 35 of the Charter by making medicines more accessible to EU patients, and the principle of proportionality in Article 52 of the Charter.

2018/11/28
Committee: JURI

Kosma ZŁOTOWSKI

Proposal for a regulation
Article 1 – paragraph 1 – point 1

Regulation (EC) No 469/2009
Article 4 – paragraph 2

(i) making for either: a. making a product, or a product to be placed on the market as a medicinal product, for the exclusive purposes of export to third countries and/or storage to enter the market of Member States as and from day-1; or

2018/11/28
Committee: JURI

Kosma ZŁOTOWSKI

Proposal for a regulation
Article 1 – paragraph 1 – point 1

Regulation (EC) No 469/2009
Article 4 – paragraph 2 – point ii

(ii) any related act that is strictly necessary for that making in the Union or for the actual export and/or storage itself;

2018/11/28
Committee: JURI

Kosma ZŁOTOWSKI

Proposal for a regulation
Article 1 – paragraph 1 – point 1

Regulation (EC) No 469/2009
Article 4 – paragraph 2 – point a – point ii a (new)

(iia) sale, and offer for sale, for the purpose of export to third countries; or

2018/11/28
Committee: JURI

Kosma ZŁOTOWSKI

Proposal for a regulation
Article 1 – paragraph 1 – point 1

Regulation (EC) No 469/2009
Article 4 – paragraph 2 – point a – point ii a (new)

(iia) importing for the purposes of (i);

2018/11/28
Committee: JURI

Kosma ZŁOTOWSKI

Proposal for a regulation
Article 1 – paragraph 1 – point 1

Regulation (EC) No 469/2009
Article 4 – paragraph 2 – point c

~~(c) the maker ensures that a logo, in the form set out in Annex -I, is affixed to the outer packaging of the product or, if there is no outer packaging, to its immediate packaging;~~deleted

2018/11/28
Committee: JURI

Kosma ZŁOTOWSKI

Proposal for a regulation
Article 1 – paragraph 1 – point 1

(d) the number of the authorisation granted in accordance with Article 40(1) of Directive 2001/83/EC or Article 44(1) of Directive 2001/82/EC for the manufacture of the corresponding medicinal product or, in the absence of such authorisation, a valid certificate of good manufacturing practice as referred to in Article 111(5) of Directive 2001/83/EC or Article 80(5) of Directive 2001/82/EC covering the premises where the making is to take place;deleted

2018/11/28
Committee: JURI

Kosma ZŁOTOWSKI

Proposal for a regulation
Article 1 – paragraph 1 – point 1

Regulation (EC) No 469/2009
Article 4 – paragraph 3 – point f

~~(f) an indicative list of the intended third country or third countries to which the product is to be exported.~~deleted

2018/11/28
Committee: JURI

Kosma ZŁOTOWSKI

Proposal for a regulation
Article 1 – paragraph 1 – point 1

Regulation (EC) No 469/2009
Article 4 – paragraph 5

5. Paragraph 2 shall apply in the case only of certificates granted on or after [OP: please insert the date of the first day of the third month that follows the month in which this amending Regulation is published in the Official Journal)].only to activities carried out after the entry into force of the present Regulation;

2018/11/28
Committee: JURI

Kosma ZŁOTOWSKI

Proposal for a regulation
Annex I

~~THIS SUBHEADING IS MISSING. THANK YOU FOR USING ANOTHER LANGUAGE. Logo null ’~~deleted

2018/11/28
Committee: JURI

42 Amendments of Kosma ZŁOTOWSKI related to 2018/0161(COD)

ParlTrack - 2011-2024