19 Amendments of Peter LIESE related to 2008/0261(COD)
Amendment 53 #
Proposal for a directive – amending act
Recital 3 a (new)
Recital 3 a (new)
(3a) In the light of this Directive the Commission should submit every year to the European Parliament and to the Council a statistical report with reliable and accurate data on the current situation, trends and developments in counterfeiting/falsified medicines, including details of where, how and by whom the counterfeit products were detected, the country from which they came, and the ‘counterfeit’ element itself (identity, source and/or ingredient/components) in the Member States.
Amendment 65 #
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/or 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 98 #
Proposal for a directive – amending act
Recital 11 a (new)
Recital 11 a (new)
(11a) European citizens should be made aware of the risks of ordering medicinal products from illegal suppliers. In particular, awareness campaigns should be promoted at Member States and EU level. The Commission together with the Member States should adopt measures to increase awareness among the general public of the risks related to purchasing medicinal products on the internet.
Amendment 116 #
Proposal for a directive – amending act
Recital 18 a (new)
Recital 18 a (new)
(18a) Member States should collaborate, including through Europol, to enforce existing restrictions on the illegal internet supply of medicines.
Amendment 120 #
Proposal for a directive – amending act
Recital 18 a (new)
Recital 18 a (new)
(18a) Counterfeit medicinal products are often found to have been supplied in response to orders placed over the Internet. In accordance with the provisions of the Treaty, particularly Article 168 of the TFEU, Member States are responsible for regulating the marketing of medicinal products at the last level of trade, particularly in pharmacies. This also includes regulating the marketing of medicinal products by mail order and over the Internet. The case law of the Court of Justice permits Member States to impose an absolute ban on the supply of prescription medicines by mail order, in accordance with the wide margin of discretion which they enjoy on account of the dangers associated with this method of marketing.
Amendment 173 #
Proposal for a directive – amending act
Article 1 – point 3 – point a
Article 1 – point 3 – point a
Directive 2001/83/EC
Article 46 – point f – subparagraph 1
Article 46 – point f – subparagraph 1
(f) to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials. To this end, the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself, another holder of a manufacturing authorisation obtaining the same material from this manufacturer or through a body accredited for this purpose by the competent authority of a Member State.
Amendment 179 #
Proposal for a directive – amending act
Article 1 – point 3 – point a a (new)
Article 1 – point 3 – point a a (new)
Directive 2001/83/EC
Article 46 – point f – subparagraph 2
Article 46 – point f – subparagraph 2
(aa) The second subparagraph of point (f) is replaced by the following: This point shall also be applicable to certain excipients, the list of which as well as the specific conditions of application of which shall be established by the Commission by means of delegated acts in accordance with Article 121a and subject to the conditions of Articles 121b and 121c. Only excipients which have been manufactured in accordance with the standards for quality control of ISO 9000/ISO 9001 should be used in medicinal products.
Amendment 185 #
Proposal for a directive – amending act
Article 1 – point 3 – point b a (new)
Article 1 – point 3 – point b a (new)
Directive 2001/83/EC
Article 46 – point h
Article 46 – point h
(ba) The following point (h) is added: h) In the light of this Directive the Commission shall submit to the European Parliament and to the Council a statistical report with reliable and accurate data on the current situation, trends and developments in counterfeiting/falsified medicines in the Member States on a yearly basis. That report shall clearly distinguish counterfeiting/falsified medicines from patent infringement.
Amendment 209 #
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, where the Commission decides that there is a risk that a medicinal product will be counterfeited due to the price or past incidences.
Amendment 219 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 1 – point b
Article 54a – paragraph 1 – point b
(b) identify individual packs by a single EU-wide standard;
Amendment 257 #
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
Article 54a – paragraph 4 – subparagraph 3 – point a
(a) the price and sales volume of the product;
Amendment 261 #
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 b
Article 54a – paragraph 4 – subparagraph 3 – point b
(b) the number of incidences of falsifications in third countries and within the Communityand frequency of past incidences of reported cases of counterfeited medicines within the Union and the evolution of those incidences in the past;
Amendment 264 #
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 c
Article 54a – paragraph 4 – subparagraph 3 – point c
Amendment 266 #
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 d
Article 54a – paragraph 4 – subparagraph 3 – point d
Amendment 268 #
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 e
Article 54a – paragraph 4 – subparagraph 3 – point e
Amendment 273 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 4
Article 54a – paragraph 4 – subparagraph 4
On the basis of these criteria, the requirementCommission may decide that the security features referred to in points (ao) and (bof Article 54 and the requirements in points (a) to (c) of paragraph (1)1 of this Article may be waived for certain products or product categoriesshall be applied to certain medicinal products subject to prescription that pose a high risk of being counterfeited.
Amendment 275 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54 a – paragraph 4 – subparagraph 4 a (new)
Article 54 a – paragraph 4 – subparagraph 4 a (new)
The safety features may be used voluntarily for all medicinal products irrespectively of their prescription status and it the marketing authorisation holders may employ the safety features on their products.
Amendment 281 #
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. The safety features shall not be used to transfer data apart from the necessary data to prevent counterfeiting and data related to social security systems. Especially the commercial treatment of data, that makes it possible to connect the pharmaceuticals with the patients, the doctors or the pharmacist has to be prevented.
Amendment 319 #
Proposal for a directive – amending act
Article 1 – point 13 – point b
Article 1 – point 13 – point b
Directive 2001/83/EC
Article 80 – point i – paragraph 2
Article 80 – point i – paragraph 2
Moreover, in cases where these infringements or suspected infringements relate to a falsified medicinal product, the holder of the marketing authorisation or of the trademark that has been falsified shall be informed.’ In the same way, the holder of a marketing authorisation or trademark shall inform other supply chain operators in case where counterfeit products are suspected of having infiltrated the legal supply chain.'