Activities of Vicky FORD 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 (15)
Amendment 48 #
Proposal for a directive – amending act
Recital 7
Recital 7
(7) In order to take account of new risk profiles, while at the same time ensuring the functioning of the internal market for medicinal products, safety features designed to ensure the identification, authentication and traceability of prescription medicinal products should be established at Community level. When introducing obligatory safety features for prescription medicinal products, due account should be taken of the particularities of certain products or categories of products, such as generic medicines or medicines that are delivered directly by producers, without the involvement of third parties, such as wholesale distributors, traders or brokers, to establishments at which the product is administered directly to the patient. This includes the risk of falsifications in view of their price and past incidences in the Community and abroad, as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated.
Amendment 52 #
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 54 #
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 55 #
Proposal for a directive – amending act
Recital 7 c (new)
Recital 7 c (new)
(7c) The use of technologies that allow the authentication and tracing of medicinal products at the level of individual dosage forms (e.g. the capsule, tablet or tamper- evident immediate packaging of liquids) can also be very valuable in allowing better monitoring of products on the market.
Amendment 68 #
Proposal for a directive – amending act
Article 1 – point -1 b (new)
Article 1 – point -1 b (new)
Directive 2001/83/EC
Article 1 – point 5 a (new)
Article 1 – point 5 a (new)
(-1b) 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 exipients 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 Member State authorities, update this definition on the basis of technical and scientific progress and international agreements. This definition is not related to infringements of legislation on intellectual and industrial property rights or patent rights. This definition does not include manufacturing errors.'
Amendment 72 #
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 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 on the internet'.
Amendment 87 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83/EC
Article 54 a – paragraph 2 – point b – subparagraph 1 a (new)
Article 54 a – 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 for duplication. When removing, replacing or covering the safety feature, this point should also be applicable to the new safety feature, unless the primary safety feature is a covert one and can therefore not be recognised.
Amendment 91 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83/EC
Article 54 a – paragraph 4 – subparagraph 1
Article 54 a – 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 on 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 94 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83/EC
Article 54 a – paragraph 4 – subparagraph 3 – point e a (new)
Article 54 a – paragraph 4 – subparagraph 3 – point e a (new)
(ea) if the product is delivered directly, without the involvement of third parties, such as wholesale distributors, traders or brokers, to a healthcare setting in which the product is administered directly to the patient.
Amendment 97 #
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 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 medical products are respected.
Amendment 98 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83/EC
Article 54 a – paragraph 4 a (new)
Article 54 a – 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 purposes referred to in paragraph 2 of this Article.
Amendment 102 #
Proposal for a directive – amending act
Article 1 – point 13 – point a
Article 1 – point 13 – point a
Directive 2001/83/EC
Article 80 – point e
Article 80 – point e
(e) they must keep records either in the form of purchase/sales invoices or on computer, or in any other form, giving for any transaction in medicinal products received, dispatched or, traded or brokered at least the following information: – date, – name of the medicinal product, – quantity received, supplied or, traded or brokered, – name and address of the supplier or consignee, as appropriate;’;
Amendment 106 #
Proposal for a directive – amending act
Article 1 – point 14
Article 1 – point 14
Directive 2001/83/EC
Article 85b – paragraph 1
Article 85b – paragraph 1
Persons trading or brokering medicinal products shall ensure that the traded or brokered medicinal products are covered by a marketing authorization granted pursuant to Regulation (EC) No 726/2004 or by the competent authorities of a Member State in accordance with this Directive. In addition, the requirements set out in Article 80(d) to (h) shall apply.
Amendment 110 #
Proposal for a directive – amending act
Article 1 – point 14 a (new)
Article 1 – point 14 a (new)
Directive 2001/83/EC
Article 97 – paragraph 5 a (new)
Article 97 – paragraph 5 a (new)
(14a) In Article 97, the following paragraph 5a is added: 5a. The Commission shall ensure, in cooperation with the Agency and national authorities, that manufacturers, importers, wholesale distributors, traders and brokers, either collectively or individually, promote public information campaigns in the various media (press, television, radio, Internet) to raise awareness of the risks connected with the purchase of falsified medicinal products on the Internet.
Amendment 114 #
Proposal for a directive – amending act
Article 2 – paragraph 1
Article 2 – paragraph 1
(1) Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [insert concrete date 186 months after publication] at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from [insert concrete date 186 months after publication + one day]. However, the Member States shall apply: (a) the provisions necessary to comply with Article 1(4) in so far as it relates to Articles 46b(2)(b) and 46b(3) of Directive 2001/83/EC as amended by this Directive from [insert concrete date 24 months after publication]; (b) the provisions necessary to comply with Article 1(6),(8) and (9) and (8) from [insert concrete date 48 months after publication]; (c) 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 concrete date 6 months after publication]; (d) 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 concrete date 48 months after publication]. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.