Activities of Paolo BARTOLOZZI related to 2008/0261(COD)
Plenary speeches (1)
Explanations of vote
Amendments (9)
Amendment 69 #
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. 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 84 #
Proposal for a directive – amending act
Recital 7 a (new)
Recital 7 a (new)
(7a) Member States, in consultation with stakeholders, should be free to determine the particular aspects of technologies for combating counterfeiting of pharmaceuticals which they consider most appropriate for their pharmaceutical distribution systems, taking account of the authentication seal adopted by this Directive.
Amendment 94 #
Proposal for a directive – amending act
Recital 11 a (new)
Recital 11 a (new)
(11a) The European public should be made aware of the risks run when purchasing pharmaceuticals through illegal channels. In particular, information campaigns should be promoted at both national and European level. The Commission, in conjunction with the Member States, should adopt effective measures to improve public awareness of the risks arising from purchases of pharmaceuticals over the internet.
Amendment 119 #
Proposal for a directive – amending act
Recital 18 a (new)
Recital 18 a (new)
Member States should cooperate with each other, and with Europol, to step up the existing restrictions on the illegal supply of pharmaceuticals over the internet.
Amendment 205 #
Proposal for a directive – amending act
Article 1 - point 8
Article 1 - point 8
Directive 2001/83/EC
Article 54 - point o
Article 54 - point o
‘o) safety features making it possible to ascertain identification, authenticity and traceability of medicinal products, other than radiopharmaceuticals, subject to medical prescription as defined in Title VI.’
Amendment 251 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 1 a (new)
Article 54a – paragraph 4 – subparagraph 1 a (new)
Before formulating a specific proposal, the Commission shall perform an impact assessment of the costs and benefits of the anti-counterfeiting systems currently in force and seek the views of those involved in the implementation and use of such authenticating seals.
Amendment 289 #
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 a (new)
Article 54 a – paragraph 4 – subparagraph 5 a (new)
Member States shall ensure that the ownership and confidentiality of the data generated by using technology to combat counterfeiting of pharmaceutical products are respected.
Amendment 329 #
Proposal for a directive – amending act
Article 1 – point 14
Article 1 – point 14
Directive 2001/83/EC
Article 85 a (new)
Article 85 a (new)
Article 85a Member States, in cooperation with the Commission and after consulting interested parties, shall devise an information strategy concerning the reliability of suppliers of pharmaceuticals. This strategy should take into account the various national laws regulating the supply of pharmaceuticals and the risks linked to certain methods of supply of pharmaceuticals, such as illegal internet channels.
Amendment 370 #
Proposal for a directive – amending act
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
2a. This Directive shall not in any way alter the right of Member States to restrict or prohibit the sale of prescription pharmaceuticals over the internet.