BETA

Activities of Julia REDA related to 2018/0161(COD)

Plenary speeches (1)

2016/11/22
Dossiers: 2018/0161(COD)

Shadow reports (1)

2016/11/22
Committee: JURI
Dossiers: 2018/0161(COD)
Documents: PDF(350 KB) DOC(162 KB)

Amendments (18)

Proposal for a regulation
Recital 3 a (new)

(3a) The Council, in its conclusions on strengthening the balance in the pharmaceutical systems in the Union and its Member States1a, and the European Parliament in its Resolution 2016/2057(INI) on Access to medicines, have underlined the importance of timely availability of generics and biosimilars in order to increase competition, to reduce prices, to facilitate patients' access to pharmaceutical therapies and to improve the sustainability of national health systems; _________________ 1a Council conclusions adopted in June 2016: https://www.consilium.europa.eu/en/press /press-releases/2016/06/17/epsco- conclusions-balance-pharmaceutical- system.

2018/11/28
Committee: JURI

Proposal for a regulation
Recital 3 b (new)

(3b) Supplementary Protection Certificates in the EU grant prolonged market exclusivity status upon the expiry of the patent term, the extension of exclusive rights beyond the patent terms, including Supplementary Protection Certificates, go beyond the mandatory requirements of the TRIPS agreement (‘TRIPS Plus’);

2018/11/28
Committee: JURI

Proposal for a regulation
Recital 3 c (new)

(3c) None of the studies commissioned by the European Commission and by Member States on the SPC system in 2018 found evidence that without SPCs, pharmaceutical companies lacked adequate protection to recoup Research and Development investments. Whereas the lack of such data calls for a more thorough evaluation and debate about the relevance of the SPC system, beyond the scope of the SPC manufacturing waiver subject of the present Regulation;

2018/11/28
Committee: JURI

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, as well as on the internal market from the day that the supplementary protection 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. Indirectly, it 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. 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

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 a supplementary protection certificate so as to allow making for the exclusive purpose of export to third countries , entering markets in the Union immediately upon expiry of the supplementary protection certificate and any related acts ~~strictly~~ necessary for making or for th~~e actual export itself~~ose purposes.

2018/11/28
Committee: JURI

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, 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~~, storing, the preparation of market entry or for export. 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.

2018/11/28
Committee: JURI

Proposal for a regulation
Recital 10

(10) The exception should not cover placing the product made for the exclusive purpose of export on the market in the Member State where a supplementary protection certificate is in force, either directly or indirectly after export, nor should it cover re-importation of the product to the market of a Member State in which a certificate is in force. Moreover, it should not cover any act or activity for the purpose of import of medicinal products, or parts of medicinal products, into the Union merely for the purposes of repackaging and re- exporting.deleted

2018/11/28
Committee: JURI

Proposal for a regulation
Recital 11

(11) By ~~limiting the scope of the exception to making for the purpose of export outside the Union and acts strictly necessary for such making or for the actual export itself~~applying strictly to acts necessary in order to allow the bringing to market of medicinal products in situations where no supplementary protection applies, 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

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

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

(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

Proposal for a regulation
Recital 20

(20) The Commission should carry out an evaluation of this Regulation. The merits of the present regulation deserve a thorough debate; the impact of the patent system, and of the SPC protection in particular, on generic competition, on healthcare budgets and on the access to medicines in Europe should be carefully assessed through a continuous evaluation of the SPC system. Given the paramount importance of access to and affordability of medicinal products for public health and public expenditure, a frequent evaluation cycle is justified. Pursuant to paragraph 22 of the Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making of 13 April 201643, that evaluation should be based on the five criteria of effectiveness, efficiency, relevance, coherence and added value and should provide the basis for impact assessments of possible further measures. The evaluation should take into account exports to outside the Union and the ability of generics and especially biosimilars to enter markets in the Union as soon as possible after a certificate lapses. In particular, this evaluation should review the effectiveness of the exception in the light of the aim to restore a global level playing field for generic and biosimilar firms in the Union and a swifter entry of generic and especially biosimilar medicines onto the market after a certificate lapses. It should also study the impact of the exception on research and production of innovative medicines by holders of certificates in the Union and consider the balance between the different interests at stake, including those of public health. _________________ 43 OJ L 123, 12.5.2016, p. 1. OJ L 123, 12.5.2016, p. 1.

2018/11/28
Committee: JURI

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 the ~~exclusive~~ purpose of export to third countries; or

2018/11/28
Committee: JURI

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

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

(ia) making for the purpose of entering markets in the Union on Day-1 after the expiry of the supplementary protection certificate; or

2018/11/28
Committee: JURI

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 ~~or for the actual export itself~~, storing, the preparation of market entry in the Union or export;

2018/11/28
Committee: JURI

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) 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 holddeleted the name and address of the the address, or addresses, of the the number of thate 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 export the number of the authorisation the intended start date of making an indicative list of the intended.

2018/11/28
Committee: JURI

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)].to existing certificates;

2018/11/28
Committee: JURI

Proposal for a regulation
Article 1 – paragraph 1 – point 3

Regulation (EC) No 469/2009
Article 21

~~No later than five years after the date referred to~~Every year, the Commission shall carry out an evaluation of the impact of patent protection, and in Apartic~~le 4(5), and every five years thereafter, the Commission shall carry out an evaluation of~~ular the SPC system including the SPC manufacturing waiver once introduced, on access to medicines and public health, Articles 4(2) to (4) and 11 and present a report on the main findings to the European Parliament, the Council and the European Economic and Social Committee.;

2018/11/28
Committee: JURI