51 Amendments of Daniel BUDA related to 2023/0130(COD)
Amendment 46 #
Proposal for a regulation
Recital 3
Recital 3
(3) Medicinal products, especially . in particular . those that are the result of long, costly research will not continue to be developed in the Union unless they are covered by favourable rules that provide for sufficient protection to encourage such research. However, it is challenging to establish a clear link between SPC protection and the location of R&D, because many other factors unrelated to the SPC play a significant role in the location of R&D.
Amendment 48 #
Proposal for a regulation
Recital 5
Recital 5
(5) That this situation leads to a lack of protection which penalises pharmaceutical research , and there is a risk that research centres situated in the Member States relocate to countries that offer greater protection, despite it is challenging to establish a clear link between SPC protection and the location of R&D.
Amendment 49 #
Proposal for a regulation
Recital 8
Recital 8
Amendment 52 #
Proposal for a regulation
Recital 9
Recital 9
(9) To avoid overprotection, it should be provided that no more than one certificate, whether national or unitary, may protect the same product, in a Member State. Therefore it should be required that the product, or any therapeutically equivalent derivative such as salts, esters, ethers, isomers, mixtures of isomers, complexes or biosimilars, should not have already been the subject of a prior certificate, either alone or in combination with one or more additional active ingredients, whether for the same therapeutic indication or for a different one.
Amendment 53 #
Proposal for a regulation
Recital 11
Recital 11
Amendment 55 #
Proposal for a regulation
Recital 13
Recital 13
(13) Where the marketing authorisation submitted in support of the application for a certificate for a biological medicinal product identifies that product by means of its International Nonproprietary Name (INN), the protection conferred by the certificate should extend to all therapeutically equivalent, subject to the limits of the protection conferred by the basic patent, to all biosimilar products having the same International Nonproprietary Name as the product referred to in the marketing authorisation, irrespective of possible minor differences between a subsequent biosimilar and the product authorised, which are usually unavoidable given the nature of biological products.
Amendment 57 #
Proposal for a regulation
Recital 15
Recital 15
(15) The duration of the protection granted by the certificate should be such as to provide adequate effective protection. For this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of 154 years of exclusivity from the time the medicinal product in question first obtains an authorisation to be placed on the market in the Union .
Amendment 58 #
Proposal for a regulation
Recital 17
Recital 17
(17) In order to promote the development of paediatric medicinal products, it should be possible to extend the period of overall maximum exclusivity of 154 years and the maximum period of validity of the certificate of 5 years where the paediatric extension provided for in Article 36 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council22 applies. _________________ 22 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).
Amendment 59 #
Proposal for a regulation
Recital 24
Recital 24
(24) The Office should have the possibility to charge a fee for the centralised application for a certificate and for an application for the extension of duration of certificates in the case of the paediatric medicinal productsextension provided for in Article 36 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council, as well as other procedural fees such as a fee for opposition or appeal. The fees charged by the Office should be laid down by an implementing act.
Amendment 62 #
Proposal for a regulation
Recital 28
Recital 28
(28) To guarantee a fair and transparent process, ensure legal certainty and reduce the risk of subsequent validity challenges, third parties should have the possibility, after the publication of the centralised application, to submit within 3 months observations to the Office while the centralised examination is being performed. Third parties should have the possibility to make observations also in opposition and appeal proceedings. These third parties allowed to submit observations should also include Member States. This, however, should not affect the rights of third parties to initiate invalidity proceedings before the body responsible under national law for the revocation of the corresponding basic patent. These provisions are necessary to ensure involvement of third parties both before and after the grant of certificates.
Amendment 71 #
Proposal for a regulation
Recital 60
Recital 60
(60) To ensure transparency, a register should be set up that can serve as a single access point providing information on applications for certificates under the centralised procedure, including on certificates granted on that basis by competent national authorities, which should share with the Office any related information. The register should be available in all official languages of the Union. The register shall not be used for practices of patent linkage, such as conditioning any regulatory or administrative decisions related to generic or biosimilar medicinal product, such as marketing authorisations, pricing and reimbursement decisions or tender bids to the existence of the SPC.
Amendment 72 #
Proposal for a regulation
Article 2 – paragraph 1 – point 12 a (new)
Article 2 – paragraph 1 – point 12 a (new)
(12 a) ‘economically linked’ means, in respect of different holders of two or more basic patents protecting the same product, that (i) one holder, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with another holder, (ii) that the different holders have concluded tacit or explicit agreements in relation to the basic patents, in relation to applications for a certificate on the product or in relation to an authorisation to place the product on the market as a medicinal product or (iii) that they otherwise exercise concerted practices concerning the placing of the product on the market as a medicinal product.
Amendment 74 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. TSubject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.
Amendment 78 #
Proposal for a regulation
Article 8 – paragraph 1 – point a a (new)
Article 8 – paragraph 1 – point a a (new)
(a a) information on all direct financial support received for research related to the development of the product for which the SPC is applied for.
Amendment 80 #
Proposal for a regulation
Article 8 – paragraph 1 – point d a (new)
Article 8 – paragraph 1 – point d a (new)
(d a) a consent in accordance with Art. 6(2), if applicable.
Amendment 82 #
Proposal for a regulation
Article 11 – paragraph 1 a (new)
Article 11 – paragraph 1 a (new)
1 a. information on all direct financial support received for research related to the development of the product for which the SPC is applied for.
Amendment 83 #
Proposal for a regulation
Article 15 – paragraph 1 – point a
Article 15 – paragraph 1 – point a
(a) the certificate it was granted contrary to the provisions of Articles 3 or 6;
Amendment 85 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. Any person may submit an application for revocation of the extension of the duration granted under this Chapter to the body responsible under national law for the revocation of the corresponding basic patent or before a competent court of a Member State.
Amendment 86 #
Proposal for a regulation
Article 18 – paragraph 2 a (new)
Article 18 – paragraph 2 a (new)
2 a. Full transparency shall be ensured throughout the whole appeal proceeding, which shall be open, whenever possible, to public participation.
Amendment 88 #
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
If the centralised application complies with Article 22, or if an application for an extension of the duration of certificates complies with Article 33(2), the Office shall publish the application, without undue delay, in the Register and anyway no later than five working days after.
Amendment 89 #
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
1. The Office shall assess the application on the basis of all the conditions in Articles 3(1), 3(3) and 6(2) for each of the designated Member States.
Amendment 90 #
Proposal for a regulation
Article 24 – paragraph 2
Article 24 – paragraph 2
2. Where the centralised application for a certificate and the product to which it relates comply with Articles 3(1), 3(3) and 6(2) in respect of all or some of the designated Member States, the Office shall adopt a reasoned positive examination opinion in respect of such Member States. The Office shall notify that opinion to the applicant.
Amendment 91 #
Proposal for a regulation
Article 24 – paragraph 3
Article 24 – paragraph 3
3. Where the centralised application for a certificate and the product to which it relates does not comply with Articles 3(1), 3(3) and 6(2) in respect of all or some of the designated Member States, the Office shall adopt a reasoned negative examination opinion in respect of such Member States. The Office shall notify that opinion to the applicant. and publish it on the Register immediately and anyway no later than five working days after the opinion is issued.
Amendment 93 #
Proposal for a regulation
Article 25 – paragraph 3
Article 25 – paragraph 3
3. Third party observations shall be submitted within 3 months after publication of the centralised application in the Register. Third party observations may also be submitted in opposition and appeal proceedings.
Amendment 96 #
Proposal for a regulation
Article 26 – paragraph 2
Article 26 – paragraph 2
2. Opposition may only be filed on the grounds that one or more of the conditions set out in Articles 3 or 6 are not fulfilled for one or more of the designated Member States.
Amendment 97 #
Proposal for a regulation
Article 26 – paragraph 4 – point c a (new)
Article 26 – paragraph 4 – point c a (new)
(c a) any evidence that is relied upon by the opponent.
Amendment 98 #
Proposal for a regulation
Article 26 – paragraph 6
Article 26 – paragraph 6
6. If the opposition panel notes that the notice of opposition does not comply with paragraphs 2, 3 or 4, it shall reject the opposition as inadmissible, and communicate this to the opponent with reasons as soon as practicable after the filing of the notice of opposition, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1.
Amendment 99 #
Proposal for a regulation
Article 26 – paragraph 7 – subparagraph 2
Article 26 – paragraph 7 – subparagraph 2
Amendment 100 #
Proposal for a regulation
Article 26 – paragraph 9
Article 26 – paragraph 9
9. The Office shall issue a decision on the opposition within 6 months, unless the complexity of the case requires a longer period. The decision shall include detailed reasons.
Amendment 101 #
Proposal for a regulation
Article 26 – paragraph 9 a (new)
Article 26 – paragraph 9 a (new)
9 a. If more than one opposition is filed in respect of the same examination opinion, the Office shall hear the oppositions jointly and issue a common decision.
Amendment 102 #
Proposal for a regulation
Article 26 – paragraph 11
Article 26 – paragraph 11
11. If the opposition panel considers that at least oneno ground for opposition prejudices the maintenance of the examination opinion, it shall adopt an amended opinreject the opposition, and the Office shall mention thispublish its full decision in the Register.
Amendment 103 #
Proposal for a regulation
Article 26 – paragraph 12 a (new)
Article 26 – paragraph 12 a (new)
12 a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation.
Amendment 108 #
Proposal for a regulation
Article 28 – paragraph 3 – point a
Article 28 – paragraph 3 – point a
Amendment 113 #
Proposal for a regulation
Article 29 – paragraph 3
Article 29 – paragraph 3
3. Notice of appeal shall be filed in writing at the Office within 2 months of the date of notification of the decision. The notice shall be deemed to have been filed only when the fee for appeal has been paid. In case of an appeal, a written statement setting out the grounds of appeal, together with any evidence relied upon, shall be filed within 4 months of the date of notification of the decision.
Amendment 116 #
Proposal for a regulation
Article 29 – paragraph 4 a (new)
Article 29 – paragraph 4 a (new)
4 a. The examination and/or opposition panels should also be amenable to representing themselves and defending their examination opinion as a party to the appeal proceedings.
Amendment 118 #
Proposal for a regulation
Article 29 – paragraph 5
Article 29 – paragraph 5
5. Where an appeal before the Boards of Appeal of the Office results in a decision which is not in line with the examination opinion and is remitted to the Office, the decision of the Boards mayshall annul or alter that opinion before transmitting it to the competent national authorities of the designated Member States.
Amendment 121 #
Proposal for a regulation
Article 32 – paragraph 1
Article 32 – paragraph 1
1. After the period during which an appeal or an opposition may be filed has expired without any appeal nor opposition being filed, or after a final decision on the merits any appeal or opposition (including, where applicable, any appeal to the General Court or the Court of Justice) has been issued, the Office shall transmit the final examination opinion and its translations to the competent national authority of each designated Member State.
Amendment 122 #
Proposal for a regulation
Article 33 – paragraph 4
Article 33 – paragraph 4
4. Third parties may also submit observations or an opposition in respect of a centralised application for an extension of the duration of certificates.
Amendment 125 #
Proposal for a regulation
Article 35 – paragraph 2 – point j a (new)
Article 35 – paragraph 2 – point j a (new)
(j a) information on all direct financial support received for research related to the development of the product for which the unitary SPC is applied for.
Amendment 127 #
Proposal for a regulation
Article 35 – paragraph 2 – point j b (new)
Article 35 – paragraph 2 – point j b (new)
(j b) where applicable, any third party observation and any related documents;
Amendment 128 #
Proposal for a regulation
Article 35 – paragraph 2 – point k
Article 35 – paragraph 2 – point k
(k) any documents from the examination procedure and the date and a copy summary of the examination opinion in respect of each of the designated Member States;
Amendment 129 #
Proposal for a regulation
Article 35 – paragraph 2 – point m
Article 35 – paragraph 2 – point m
(m) where applicable, the date and a summarcopy of the examination opinion relating to an application for an extension of the duration of athe certificates;
Amendment 131 #
Proposal for a regulation
Article 35 – paragraph 2 – point n
Article 35 – paragraph 2 – point n
(n) where applicable, the filing of an opposition, and its outcome, includingits status, any documents from the opposition procedure, its outcome, a copy of the decision and where applicable a summarcopy of the revised examination opinion;
Amendment 132 #
Proposal for a regulation
Article 35 – paragraph 2 – point o
Article 35 – paragraph 2 – point o
(o) where applicable, the filing of an appeal, and the outcome of the appeal proceedings, includingits status, any documents from the appeal proceedings, its outcome, a copy of the decision and where applicable a summary of the revised examination opinion;
Amendment 133 #
Proposal for a regulation
Article 35 – paragraph 2 – point r – point 1 (new)
Article 35 – paragraph 2 – point r – point 1 (new)
1) where applicable, the filing of an action to the General Court or the Court of Justice of the European Union, its status, a copy of the decision and where applicable a copy of the revised examination opinion;
Amendment 134 #
Proposal for a regulation
Article 35 – paragraph 2 – point s a (new)
Article 35 – paragraph 2 – point s a (new)
(s a) any documents and communications between the Office and any party in the proceedings.
Amendment 135 #
Proposal for a regulation
Article 35 – paragraph 9 – point b
Article 35 – paragraph 9 – point b
(b) maintaining the Register and making it available for inspection by public authorities and economic operators;
Amendment 137 #
Proposal for a regulation
Article 35 – paragraph 11 a (new)
Article 35 – paragraph 11 a (new)
11 a. The existence on the Register of a granted or applied for supplementary protection certificate shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of a medicinal product or its inclusion within the public health insurance system, or the public and private procurement of medicinal products.
Amendment 141 #
Proposal for a regulation
Article 44 – paragraph 2
Article 44 – paragraph 2
Amendment 143 #
Proposal for a regulation
Article 44 – paragraph 3
Article 44 – paragraph 3
3. Oral proceedings before an examination panel, an opposition panel or the Boards of Appeal, including delivery of the decision and, as the case may be, of a revised opinion, shall be public, unless the examination panel, the opposition panel or the Boards of Appeal decide otherwise in cases where admission of the public to all or a part of the oral proceedings could have serious and unjustified disadvantages, in particular for a party to the proceedings.
Amendment 150 #
Proposal for a regulation
Article 57 – paragraph 2
Article 57 – paragraph 2
2. By [OP, please insert: five years after the date of application], and every 5 years thereafter, the Commission shall also carry out an evaluation of the application of Chapter IIIother provisions of Chapter I and II as well as of the application of Chapter III. and present a report on the main findings to the European Parliament, the Council and the European Economic and Social Committee. The evaluation should assess in particular whether the objectives of those provisions have been achieved, with particular regard to whether research centres situated in the Member States relocate and medicinal products, especially those that are the result of long, costly research continue to be developed in the Union.