Activities of Ashley FOX related to 2008/0261(COD)
Shadow opinions (1)
OPINION Proposal for a directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source
Amendments (12)
Amendment 21 #
Proposal for a directive – amending act
Recital 7 a (new)
Recital 7 a (new)
(7a) Member States, working together with stakeholders, should be free to determine the particular aspects of medicines authentication which they believe are most appropriate for their medicine distribution system, taking into account the safety features adopted pursuant to this Directive.
Amendment 22 #
Proposal for a directive – amending act
Recital 7 b (new)
Recital 7 b (new)
(7b) In order to provide patients with timely protection from the risks of falsified medicinal products, a manufacturing authorisation holder who partly or fully removes or covers up safety features that are applied on a voluntary basis should be required to replace such safety features with equivalent safety features designed to ensure the identification, authentication and traceability of prescription medicinal products as soon as this Directive enters into force.
Amendment 31 #
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83(EC)
Article 1 – point 5 a (new)
Article 1 – point 5 a (new)
-1) In Article 1, the following point 5a is inserted after point 5: "5a. Falsified medicinal product: Any medicinal product that has been deliberately falsified in relation to its: (a) identity, including its packaging, labelling, name or composition in terms of both ingredients, including excipients and active ingredients, or the dosage thereof; (b) source, including the manufacturer, the country of manufacture, the country of origin or the marketing authorisation holder; (c) history, including the registers or documents enabling the distribution chain to be identified. The Commission shall, in cooperation with the Agency and the authorities of the Member States , update this definition on the basis of technical and scientific progress and international agreements. This definition is without prejudice to legislation on intellectual and industrial property rights. This definition does not cover manufacturing errors."
Amendment 32 #
Proposal for a directive – amending act
Article 1 – point 2 a (new)
Article 1 – point 2 a (new)
Directive 2001/83(EC)
Article 2 – paragraph 3 a (new)
Article 2 – paragraph 3 a (new)
(2a) In Article 2, the following paragraph 3a is inserted after paragraph 3: "3a. Nothing in this Directive shall affect the right of Member States to restrict or prohibit the sale of prescription medicines via the internet."
Amendment 39 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83(EC)
Article 54a – paragraph 2 - point b – subparagraph 1 a (new)
Article 54a – paragraph 2 - point b – subparagraph 1 a (new)
Safety features shall be considered equivalent when they offer the same level of efficacy for ascertaining identification, authentication, traceability and absence of tampering, as well as the same level of technical difficulty of duplication. When removing, replacing or covering up the safety feature, this condition shall also apply to the new safety feature, unless the primary safety feature is a covert one and can therefore not be recognised.
Amendment 41 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83(EC)
Article 54a – paragraph 4 – subparagraph 1
Article 54a – paragraph 4 – subparagraph 1
(4) The Commission shall adopt the measures necessary for the implementation of point (o) of Article 54 and of paragraphs (1) and (2) of this Article. Before a specific measure is proposed in accordance with point (o) of Article 54, the Commission shall carry out a public impact assessment of the costs and benefits of existing safety features, as well as a consultation with the parties involved in the implementation and use of such safety features.
Amendment 46 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83(EC)
Article 54a – paragraph 4 – subparagraph 5
Article 54a – paragraph 4 – subparagraph 5
The measures referred to in this paragraph shall take due account of the legitimate interests to protect information of a commercially confidential nature and of the protection of industrial and commercial property rights. Member States shall ensure that the ownership and confidentiality of data generated by the use of safety features to authenticate medicinal products shall be respected.
Amendment 48 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83(EC)
Article 54a – Paragraph 4 a (new)
Article 54a – Paragraph 4 a (new)
(4a) Paragraphs 2 and 3 shall also apply to a manufacturing authorisation holder who partly or fully removes or covers-up safety features that are applied on a voluntary basis to medicinal products that are subject to medical prescription by the original manufacturer for the purposes referred to in paragraph (2) of this Article.
Amendment 53 #
Proposal for a directive – amending act
Article 2 – paragraph 1 – subparagraph 3 – point -a (new)
Article 2 – paragraph 1 – subparagraph 3 – point -a (new)
(-a) the provisions necessary to comply with Article 1(9) in so far as it relates to Article 54a(5) and Articles 54a(2) and 54a(3) to the extent they are referred to 54a(5) of Directive 2001/83/EC as amended by this Directive from [insert actual date 6 months after publication];
Amendment 54 #
Proposal for a directive – amending act
Article 2 – paragraph 1 – subparagraph 3 – point b
Article 2 – paragraph 1 – subparagraph 3 – point b
(b) the provisions necessary to comply with Article 1(6), (8) and (98) from [insert concrete date 48 months after publication].
Amendment 55 #
Proposal for a directive – amending act
Article 2 – paragraph 1 – subparagraph 3 – point b a (new)
Article 2 – paragraph 1 – subparagraph 3 – point b a (new)
(ba) the provisions necessary to comply with Article 1(9) except in so far as it relates to Article 54a(5) and Articles 54a(2) and 54a(3) to the extent they are referred to 54a(5) of Directive 2001/83/EC as amended by this Directive from [insert actual date 48 months after publication].
Amendment 279 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54 a – paragraph 4 – subparagraph 5
Article 54 a – paragraph 4 – subparagraph 5
The measures referred to in this paragraph shall take due account ofat least all of the following: (a) the cost-effectiveness of the system, in order to guarantee that any measure that is applied is based on a cost-benefit analysis; (b) the proportional application of costs related to the measures to all participants in the supply chain and the linking of those costs to the price of the medicinal product concerned; (c) the independence of the system and the legitimate interests to protect information of a commercially confidential nature and of the protection of industrial and commercial property rights and personal data.