44 Amendments of Jorgo CHATZIMARKAKIS related to 2008/0261(COD)
Amendment 47 #
Proposal for a directive – amending act
Recital 6 a (new)
Recital 6 a (new)
(6a) 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 51 #
Proposal for a directive – amending act
Recital 7 a (new)
Recital 7 a (new)
(7a) Member States, in cooperation with stakeholders, should be permitted to regulate the particular aspects of authentication of medicines in the way which they consider most appropriate for their market in medicinal products, taking account of the safety features established in accordance with this Directive.
Amendment 57 #
Proposal for a directive – amending act
Recital 10
Recital 10
(10) In order to increase reliability in the distribution chain, wholesale distributors should verify, either by themselves or through a body accredited for that purpose, that their suppliers comply with good distribution practices. In order to ensure that the distribution chain is also traceable for a medicinal product marketing authorisation holder, wholesalers should in addition provide him with information about the orders they receive.
Amendment 58 #
Proposal for a directive – amending act
Recital 11 a (new)
Recital 11 a (new)
(11a) European citizens should have their attention drawn to the risks which arise when medicinal products are ordered from illegal suppliers. In particular, public information measures should be promoted in the Member States and throughout Europe. The Commission and Member States should adopt measures to increase awareness among the general public of the risks related to purchasing medicinal products on the Internet.
Amendment 59 #
Proposal for a directive – amending act
Recital 4 a (new)
Recital 4 a (new)
(4a) A legitimate mail order pharmacy should be connected to a legally registered pharmacy, thereby ensuring that a legitimate mail order pharmacy must comply with all legal requirements for any pharmacy establishment in the Member State where it is legally based. The identification of the chief pharmacist should be a legal requirement for all legitimate mail order pharmacies. A mail order pharmacy can only dispense an ordered prescription medication if the original prescription has been obtained by the respective mail order pharmacy in advance. Member States should ensure that all mail order provision for pharmaceutical products is continuously regulated by designated national agencies.
Amendment 60 #
Proposal for a directive – amending act
Recital 4 b (new)
Recital 4 b (new)
(4b) European citizens should be made aware of the health risks associated with ordering products from illegal websites. The Commission, in co-operation with the Member States, should adopt measures to increase awareness among the general public of the risks associated with purchasing medicinal products on the internet from any websites other than legitimate mail order pharmacies. Public awareness campaigns should inform citizens about how to identify legitimate mail order pharmacies and the risks related to buying from illegal websites.
Amendment 63 #
Proposal for a directive – amending act
Recital 6 a (new)
Recital 6 a (new)
(6a) 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 TFEU, particularly Article 168 thereof, 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 63 #
Proposal for a directive – amending act
Recital 18 a (new)
Recital 18 a (new)
(18a) The Member States should cooperate to enforce existing restrictions on illegal trading in medicinal products over the Internet, including by means of Europol.
Amendment 66 #
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2a (new)
Article 1 – point 2a (new)
(-1) In Article 1, the following point 2a is inserted after point 2: ‘2a. Falsified medicinal product means any medicinal product which has been deliberately falsified with regard to its: (a) properties, including packaging, labelling, designation and formulation, as regards both the active pharmaceutical ingredients and their dosage; (b) production, including the manufacturer, the country of manufacture, the country of origin and the marketing authorisation holder; (c) its origin, including the records and documents relating to identification of the distribution chain. The Commission shall adapt this definition in accordance both with technical and scientific progress and with international agreements. This definition shall not concern violations of the legislation on industrial property rights. This definition shall not include production faults.'
Amendment 70 #
Proposal for a directive – amending act
Article 1 – point 1 a (new)
Article 1 – point 1 a (new)
Directive 2001/83/EC
Article 1 – point 17 b (new)
Article 1 – point 17 b (new)
(1a) In Article 1, the following point 17b is inserted after point 17a: '17b. Persons authorised to supply medicinal products means persons or rights-holders who possess a wholesale distribution authorisation for medicinal products, without detriment to persons or rights-holders who are exempt from the authorisation requirement.'
Amendment 71 #
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 or any other technical measure 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 and well-established use products. 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 73 #
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. The provisions of this Directive shall be without prejudice to the right of the Member States to restrict or prohibit trading in prescription medicinal products over the Internet.'
Amendment 83 #
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, which on account of their specific properties are not suitable for marketing by wholesalers and pharmacies and therefore are supplied by the manufacturer direct to clinics, where they are directly administered to the patient – subject to medical prescription as defined in Title VI.’
Amendment 85 #
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2001/83/EC
Article 54 – point o – subparagraph 1 a (new)
Article 54 – point o – subparagraph 1 a (new)
These safety features shall be applied without discrimination among marketing channels.
Amendment 88 #
Proposal for a directive – amending act
Recital 7 a (new)
Recital 7 a (new)
(7a) Member States, in cooperation with stakeholders, should be permitted to regulate the particular aspects of authentication of medicines in the way in which they consider most appropriate for their market in medicinal products, taking account of the safety features established in accordance with this Directive.
Amendment 93 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83/EC
Article 54 a – paragraph 4 – subparagraph 2 a (new)
Article 54 a – paragraph 4 – subparagraph 2 a (new)
Before the Commission adopts a measure to implement Article 54(o), it shall perform a public impact assessment of the costs and benefits of the existing safety features and consult all parties involved in implementing and using such safety features.
Amendment 96 #
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 both the ownership and the confidentiality of the data elicited in applying the safety features for the purpose of identifying medicinal products are respected.
Amendment 97 #
Proposal for a directive – amending act
Recital 11 a (new)
Recital 11 a (new)
(11a) European citizens should have their attention drawn to the risks which arise when medicinal products are ordered from illegal suppliers. In particular, public information measures should be promoted in the Member States and throughout Europe. The Commission and Member States should adopt measures to increase awareness among the general public of the risks related to purchasing medicinal products on the Internet.
Amendment 100 #
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) For a transitional period of 3 years, safety features shall be regarded as equivalent if they make it equally possible to ascertain the identity, authenticity and uninterrupted traceability of the medicinal product, without its being necessary to open the immediate packaging, or they make it equally difficult to counterfeit the product. If a safety feature is removed, replaced or covered, this point should also be applicable to the new safety feature, provided that the primary safety feature is not hidden and cannot be recognised.
Amendment 103 #
Proposal for a directive – amending act
Article 1 – point 13 – point b a (new)
Article 1 – point 13 – point b a (new)
Directive 2001/83/EC
Article 80 – paragraph 1 – point j (new)
Article 80 – paragraph 1 – point j (new)
(ba) the following point (j) shall be added: '(j) they must inform a medicinal product marketing authorisation holder, at the latter's request, about the orders they have received for medicinal products. The information pursuant to the first sentence must at the minimum include the name and address of the party placing the order and the particulars listed in point (e), first to fourth indents.'
Amendment 109 #
Proposal for a directive – amending act
Article 1 – point 14 a (new)
Article 1 – point 14 a (new)
Directive 2001/83/EC
Article 88 b (new)
Article 88 b (new)
Article 88b Member States, in cooperation with the Commission and after consultation with representatives of stakeholders, shall devise an information strategy relating to the safety of consignments of medicinal products. The strategy shall take account of the various national legal provisions concerning the supply of medicinal products and the risks associated with certain types of supply of medicinal products and with illegal trading on the Internet.
Amendment 112 #
Proposal for a directive – amending act
Recital 17
Recital 17
(17) In particular the Commission should be empowered to adopt measures regarding safety featuresdelegated acts in accordance with Article 290 TFEU in respect of safety features or any other technical instrument able to confirm the authenticity of the drug that shall appear on the packaging of medicinal products subject to medical prescription and to adopt detailed rules for medicinal products introduced without being placed on the market. Since those measures are of general scope A stand are designed to amend non-essential elements by supplementing it, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/ECdised form of safety feature or a standardised safety measure within the Union should be found.
Amendment 115 #
Proposal for a directive – amending act
Recital 18 a (new)
Recital 18 a (new)
(18a) The Member States should cooperate to enforce existing restrictions on illegal trading in medicinal products, including by means of Europol.
Amendment 127 #
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 - paragraph 1 - introductory part (new)
Article 1 – point 2 a - paragraph 1 - introductory part (new)
-1) In Article 1, the following point 2a is inserted after point 2: 2a. Falsified medicinal product: Any medicinal product which has been deliberately falsified with regard to its:
Amendment 135 #
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 - paragraph 1 - point a (new)
Article 1 – point 2 a - paragraph 1 - point a (new)
(a) properties, including packaging, labelling, designation and formulation, as regards both the active pharmaceutical ingredients and their dosage;
Amendment 138 #
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 - paragraph 1 - point b (new)
Article 1 – point 2 a - paragraph 1 - point b (new)
(b) production, including the manufacturer, the country of manufacture, the country of origin and the marketing authorisation holder;
Amendment 147 #
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 - paragraph 1 - point c (new)
Article 1 – point 2 a - paragraph 1 - point c (new)
(c) its origin, including the records and documents relating to identification of the distribution chain.
Amendment 153 #
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 - paragraph 2 (new)
Article 1 – point 2 a - paragraph 2 (new)
The Commission shall adapt this definition in accordance both with technical and scientific progress and with international agreements. This definition shall not concern infringements of legislation on industrial property rights. This definition shall not include production faults.
Amendment 160 #
Proposal for a directive – amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 1 – point 17 a
Article 1 – point 17 a
‘17a. Trading of medicinal products: 'All activities consisting of negotiating independently on behalf of another person the sale or the purchase of medicinal products, or billing or brokering medicinal producactive pharmaceutical ingredients or billing medicinal products or active pharmaceutical ingredients, apart from supplying medicinal productsthem to the public, and not falling under the definition of wholesale distribution.'
Amendment 163 #
Proposal for a directive – amending act
Article 1 – point 1 a (new)
Article 1 – point 1 a (new)
Directive 2001/83/EC
Article 1 – point 17 b (new)
Article 1 – point 17 b (new)
(1a) In Article 1, the following point 17b is inserted after point 17a: 17b. Persons authorised to supply medicinal products: Persons or entities in possession of a wholesale distribution authorisation without prejudice to persons or entities exempt from holding an authorisation to supply medicinal products.
Amendment 164 #
Proposal for a directive – amending act
Article 1 – point 1 a (new)
Article 1 – point 1 a (new)
Directive 2001/83/EC
Article 1 – point 17 b (new)
Article 1 – point 17 b (new)
(1a) In Article 1, the following point 17b is inserted after point 17a: 17b. Brokering: All activities in relation to sale or purchase of medicinal products or active pharmaceutical ingredients except for retail supply and wholesale distribution as defined in point 17 of this Article, that do not include physical handling and that consist of mediating independently and on behalf of another legal or natural person.
Amendment 167 #
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. The provisions of this Directive shall be without prejudice to the right of the Member States to restrict or prohibit trading in prescription medicinal products over the Internet.
Amendment 171 #
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 and distributed in accordance with the detailed guidelines on good manufacturing and distribution practices 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 or through a body accredited for this purpose by the competent authority of a Member State.
Amendment 194 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 47 – paragraph 3
Article 47 – paragraph 3
The principles of good manufacturing and distribution practices for active substances used as starting materials referred to in point (f) of Article 46 and in Article 46b shall be adopted in the form of detailed guidelines.
Amendment 198 #
Proposal for a directive – amending act
Article 1 - point 7
Article 1 - point 7
Directive 2001/83/EC
Article 52a
Article 52a
Importers and, manufacturers and distributors of active substances used as starting materials established in the Community shall notify their address to the competent authority of the Member State where they are established.
Amendment 201 #
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 VIwhich, because of their particular characteristics, are not suitable for marketing by wholesalers and pharmacies and are therefore supplied by the manufacturer directly to clinics, where they are administered directly to patients – subject to medical prescription as defined in Title VI. For generic and well-established use medicines, subject to medical prescription as defined in Title VI, safety features are mandatory if the Commission considers this to be necessary on a risk-based approach in accordance with Article 54a(4). The risk-based approach shall be performed with a so-called opt-in procedure.
Amendment 212 #
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. Those safety features shall be applied without discrimination through marketing channels.
Amendment 253 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 2 a (new)
Article 54a – paragraph 4 – subparagraph 2 a (new)
Before the Commission adopts a measure to implement point (o) of Article 54, it shall perform a public impact assessment evaluating the costs and benefits of the existing safety features and consult all parties involved in the implementation and use of such safety features.
Amendment 277 #
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. For a transitional period of three years, safety features shall be regarded as equivalent if they make it equally possible to ascertain the identity, authenticity and uninterrupted traceability of the medicinal product, without its being necessary to open the immediate packaging, or they make it equally difficult to counterfeit the product. If a safety feature is removed, replaced or covered, this point should also be applicable to the new safety feature, provided that the primary safety feature is not hidden and cannot be recognised.
Amendment 290 #
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 both the ownership and the confidentiality of the data elicited when applying the safety features for the purpose of identifying medicinal products are respected.
Amendment 331 #
Proposal for a directive – amending act
Article 1 – point 14 a (new)
Article 1 – point 14 a (new)
Directive 2001/83/EC
Title VII a (new) – Article 85 c (new)
Title VII a (new) – Article 85 c (new)
(14a) The following Title VII a and Article 85c are inserted after Article 85b: 'TITLE VII a INTERNET SALES Article 85c 1. The Commission shall adopt a EU logo for the front page of the websites of all legitimate mail-order pharmacies ensuring the general public that the respective website offering to sell medicinal products is compliant with EU legislation and is connected to a registered pharmacy. The logo shall be linked to a central website at Member State level, to be established by the Member State, that allows the visitor to check the authenticity of the logo and provides detailed information on the legality of the respective mail-order pharmacy, points of contact for further information and complaints as well as further advice on the identification of a legitimate mail- order pharmacy, e.g. by identifying the chief pharmacist. Legitimate mail-order pharmacies that are legally based in the Union and operate in the internal market must be listed in a European database to which the central website at Member State level shall be linked. Those measures shall be adopted by the Commission by means of delegated acts in accordance with Article 121a and subject to the conditions of Articles 121b and 121c. 2. Member States shall take the appropriate measures, including punitive measures, to ensure that all legitimate mail-order pharmacies within their territory display the EU logo referred to in paragraph 1 and to prevent illegal websites selling medicinal products from using the logo and linking to the central website referred to in paragraph 1.'
Amendment 335 #
Proposal for a directive – amending act
Article 1 – point 14 b (new)
Article 1 – point 14 b (new)
Directive 2001/83/EC
Article 85 d (new)
Article 85 d (new)
Amendment 338 #
Proposal for a directive – amending act
Article 1 – point 14 c (new)
Article 1 – point 14 c (new)
Directive 2001/83/EC
Article 85 e (new)
Article 85 e (new)
(14c) The following Article 85e is inserted: 'Article 85e Member States shall ensure that all legitimate mail-order pharmacies operating in the internal market adhere to professional standards and guidance for internet pharmacy services, including a specific code of ethics. All mail-order pharmacies are obliged to clearly display the code of conduct on their websites and display contact details for complaints. Member States shall ensure that the internet is continuously monitored by a designated body with regards to the selling of medicinal products and shall take legal actions, including punitive measures, in the event of non-compliance with this Directive.'
Amendment 340 #
Proposal for a directive – amending act
Article 1 – point 14 e (new)
Article 1 – point 14 e (new)
Directive 2001/83/EC
Article 88a a (new)
Article 88a a (new)
(14e) The following Article is inserted: 'Article 88aa Member States, in cooperation with the Commission and after consultation with representatives of stakeholders, shall devise an information strategy relating to the safety of consignments of medicinal products. The strategy shall take account of the various national legal provisions concerning the supply of medicinal products and the risks associated with certain types of supply of medicinal products and with illegal trading on the internet.'