Activities of Barbara WEILER 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 (11)
Amendment 16 #
Proposal for a directive – amending act
Recital 4 a (new)
Recital 4 a (new)
(4a) Citizens of the Union should be made aware of the danger to their health of ordering products from non-controlled internet websites or from the illegal supply chain. The Commission, together with the Member States and in cooperation with patients' and consumers´ organisations, should adopt measures to increase awareness among the general public of the risks involved in purchasing medicinal products via the internet.
Amendment 23 #
Proposal for a directive – amending act
Recital 8
Recital 8
(8) Any actor in the supply chain who packageslabels or packages medicinal products or makes changes to the labelling or packaging of medicinal products has to be a holder of a manufacturing authorization. In order for the safety features to be effective, the manufacturing authorization holder should only be permitted to remove, replace or cover these features under strict conditions. Those strict conditions should provide adequate safeguards against falsified medicinal products entering the distribution chain and reflect a strict duty of care owed by the manufacturing authorisation holders to the original manufacturer and by the marketing authorisation holder to consumers of the products.
Amendment 24 #
Proposal for a directive – amending act
Recital 8 a (new)
Recital 8 a (new)
(8a) 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 28 #
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83(EC)
Article 1 – point 2 a (new)
Article 1 – point 2 a (new)
-1) In Article 1, the following point 2a is inserted after point 2: "2a. Falsified medicinal product: Any medicinal product, ingredient, excipient or component thereof which is deliberately and / or fraudulently misrepresented with respect to: (a) its identity, including its packaging and labelling, name, composition in respect of any of its components and strength; and/or (b) its source, including the manufacturer, country of manufacture, country of origin, marketing authorisation holder; and/or (c) its history, including the records and documents relating to distribution channels. This definition is without prejudice to legislation on intellectual and industrial property rights."
Amendment 33 #
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 medicinal prescription as defined in Title VI. Safety features are mandatory for all medicines listed in a restricted list of medicinal products conceived and developed together by the Commission and the Member States in consultation with stakeholders, including patients' organisations.'
Amendment 35 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83(EC)
Article 54a – paragraph 1 – point c a (new)
Article 54a – paragraph 1 – point c a (new)
(ca) keep the additional costs as low as possible and spread additional costs along the supply chain.
Amendment 36 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83(EC)
Article 54a – paragraph 2 – point b a (new)
Article 54a – paragraph 2 – point b a (new)
(ba) Manufacturing authorisation holders clearly indicate on the outer packaging when original safety features have been partly or fully removed or covered up;
Amendment 42 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83(EC)
Article 54a – paragraph 4 – subparagraph 3 – point a a (new)
Article 54a – paragraph 4 – subparagraph 3 – point a a (new)
(aa) the complexity of the supply chain;
Amendment 49 #
Proposal for a directive – amending act
Article 1 – point 14
Article 1 – point 14
Directive 2001/83(EC)
Article 85 c (new)
Article 85 c (new)
Article 85c The Commission, together with the Member States, shall certify, and establish a register of accredited internet pharmacies. Such a register shall be accessible via a public database. The Commission shall establish a Community quality certification logo to be affixed on the webpages of the legitimate internet pharmacies. The Commission shall ensure that none of the non-accredited pharmacies use the Community logo, or trade in medicinal products in the internal market.
Amendment 50 #
Proposal for a directive – amending act
Article 1 – point 14
Article 1 – point 14
Directive 2001/83(EC)
Article 85 d (new)
Article 85 d (new)
Article 85d 1. The Commission and Member States shall adopt measures to increase awareness among the general public of the risks related to purchasing medicinal products on the internet, which may include: - warnings appearing at the top of the internet page in search engines in the event of a search for medicinal products on the internet; - information campaigns, in cooperation with the Member States and patients' and consumers' organisations; - providing an easily accessible list of accredited internet pharmacies; Those measures, designed to amend non- essential elements of this Directive by supplementing it, shall be adopted in accordance with the procedure referred to in Article 290 of the Treaty on the Functioning of the European Union.
Amendment 52 #
Proposal for a directive – amending act
Article 1 – point 17
Article 1 – point 17
Directive 2001/83(EC)
Article 118 b a (new)
Article 118 b a (new)
Article 118 ba The Commission shall establish a network between the Commission, the Agency and the competent authorities of the Member States and involve patients' and consumers' organisations in order to ensure the exchange of information on the measures taken to combat the falsification of medicinal products, including on the penalties systems in place.