Activities of Françoise GROSSETÊTE related to 2008/0261(COD)
Plenary speeches (1)
Falsified medicinal products (debate)
Amendments (28)
Amendment 57 #
Proposal for a directive – amending act
Recital 4 a (new)
Recital 4 a (new)
(4a) The European Union should support the drafting of an international agreement stepping up the penalties for falsifying medicinal product, and of an additional protocol to the Palermo Convention against Transnational Organised Crime.
Amendment 90 #
Proposal for a directive – amending act
Recital 8
Recital 8
(8) Any actor in the supply chain who packages 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 onlynot be permitted to remove, replace or cover these features under strict conditions. Except in exceptional cases governed by strict conditions as stipulated in paragraph (2) of Article 54a, the manufacturing authorisation holder may only place the original medicinal product container inside another package if this makes it possible to preserve intact the original container and the integrity and effectiveness of the initial safety arrangements throughout the entire distribution chain.
Amendment 93 #
Proposal for a directive – amending act
Recital 9
Recital 9
(9) These manufacturing authorisation holders shouldmust be held strictly liable for damages to patients caused by products placed by them on the market which are falsified in relation to their identity.
Amendment 99 #
Proposal for a directive – amending act
Recital 11 a (new)
Recital 11 a (new)
(11a) The Commission and the Member States should adopt measures such as awareness campaigns to inform the public more fully of the risks of purchasing pharmaceutical products online.
Amendment 100 #
Proposal for a directive – amending act
Recital 12
Recital 12
(12) Falsified active pharmaceutical ingredients pose the risk of sub-standard active pharmaceutical ingredients. This risk should be addressed. In particular, manufacturers of medicinal products should ensure either by themselves of through a body accredited for that purpos by combining an effective inspection system with a system ensuring the traceability of active pharmaceutical ingredients. In particular, manufacturers of medicinal products should themselves ensure that the supplying manufacturer of active pharmaceutical ingredients complies with good manufacturing practices.
Amendment 101 #
Proposal for a directive – amending act
Recital 13
Recital 13
(13) TIn order to ensure sufficient protection of public health the manufacture of active pharmaceutical ingredients should be subject to good manufacturing practices and should comply with the information submitted within, or supplied to, the Marketing Authorisation Application, irrespective of whether those ingredients were manufactured in the Community or imported. WTherefore, with regard to the manufacture of active pharmaceutical ingredients in third countries, it should be ensured that the rul intended for medicinal products marketed in the Union, it should be ensured through repeated, mandatory inspections and enforcement by the Union’s competent authorities for the manufacture of active pharmaceutical ingredients intended for export to the Community, including inspection and enforcement, provide for a level of protection of public health equivalent to that provided for by Community legislationby authorities with mutual recognition agreements covering active pharmaceutical ingredients in force, that manufacture is taking place in compliance with both of the above- mentioned requirements.
Amendment 114 #
Proposal for a directive – amending act
Recital 17 a (new)
Recital 17 a (new)
(17a) 36 months at the latest after entry into force of this Directive, the traceability procedure for medicinal products should be harmonised at EU level. Hence, each medicinal product should be unequivocally identified by means of a serial number on its individual packaging.
Amendment 169 #
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
Amendment 187 #
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) to assume legal liability for the accuracy of the findings of inspections and checks he has carried out or commissioned, without it being possible to delegate that liability.
Amendment 189 #
Proposal for a directive – amending act
Article 1 – point 4
Article 1 – point 4
Directive 2001/83/EC
Article 46b – paragraph 2 – introductory part
Article 46b – paragraph 2 – introductory part
2. Active substances used as starting material shallmay only be imported if:
Amendment 190 #
Proposal for a directive – amending act
Article 1 – point 4
Article 1 – point 4
Directive 2001/83/EC
Article 46b – paragraph 2 – point b
Article 46b – paragraph 2 – point b
(b) they are accompanied by a written confirmation from the exporting third country that the standards of good manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to those laid down by the Community, and that the planthave, in the past three years, successfully passed an inspection specifically covering active pharmaceutical ingredients carried out by a competent Community authority or an authority of a country with which a mutual recognition agreement is in force. The passing of the inspection shall be documented by a certificate is subject to control and enforcement ensuring that thoseed by a competent authority, attesting compliance with good manufacturing practices cannot be circumvented.
Amendment 211 #
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. 36 months at the latest after entry into force of this Directive, the traceability procedure for medicinal products should be harmonised at EU level. Hence, each medicinal product should be unequivocally identified by means of a serial number on its individual packaging.’
Amendment 217 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a - paragraph 1 - point a
Article 54a - paragraph 1 - point a
(a) verify authenticity by assessing overt, covert, or forensic devices;
Amendment 222 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a - paragraph 2 – introductory part
Article 54a - paragraph 2 – introductory part
2. The safety features referred to in point (o) of Article 54 shall not be partly or fully removed or covered-up, unless. If the following conditions are fulfilled: and justified for public health reasons, the manufacturing authorisation holder may place the original medicinal product inside another package while preserving intact its original safety feature.
Amendment 225 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a - paragraph 2 – point a
Article 54a - paragraph 2 – point a
(a) The manufacturing authorisation holder verifies, prior to partly or fully removing or covering-up the safety feature, the authenticity of the productmust leave the safety feature relating to the identification, authenticity and traceability of the product visible and usable;
Amendment 228 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a - paragraph 2 – point b
Article 54a - paragraph 2 – point b
(b) The manufacturing authorisation holder complies with point (o) of Article 54 by. Under no circumstances may he replacinge the safety feature with a safety feature which is equivalent as regards the possibility to ascertainapplied to the original container, which enables the identification, authenticity and uninterrupted traceability of the initial medicinal product, and without opening the immediate packaging as defined in Article 1(23) to be ascertained;
Amendment 239 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a - paragraph 2 – point c
Article 54a - paragraph 2 – point c
(c) The replacement of the safety feature is subject to supervision by the competent authoritymanufacturing authorisation holder is responsible for all the activities involved in the acts described in point 2.
Amendment 313 #
Proposal for a directive – amending act
Article 1 – point 13 – point a a (new)
Article 1 – point 13 – point a a (new)
Directive 2001/83/EC
Article 80 – point g
Article 80 – point g
(aa) Point (g) is replaced by the following: '(g) they must comply with the principles and guidelines of good distribution, trading and brokering practice for medicinal products as laid down in Article 84.'
Amendment 342 #
Proposal for a directive – amending act
Article 1 – point 15 – point -a (new)
Article 1 – point 15 – point -a (new)
Directive 2001/83/EC
Article 111 – paragraph 1
Article 111 – paragraph 1
(-a) Paragraph 1 is replaced by the following: '1. The competent authorities of the Member State concerned shall, under the Agency's coordination, ensure by means of repeated, and where necessary unannounced, inspections, that the legal requirements governing medicinal products are complied with, and shall, where appropriate, commission an official medicinal product test laboratory, or another laboratory designated for that purpose, to carry out sampling tests. Such inspections shall be carried out by officials representing the competent authority who shall be empowered to: (a) inspect manufacturing or commercial establishments and any laboratories entrusted by the holder of the manufacturing authorization with the task of carrying out checks pursuant to Article 20; (b) take samples; (c) examine any documents which relate to the object of the inspection, subject to the provisions in force in the Member States on 21 May 1975, and which place restrictions on these powers with regard to the descriptions of the method of preparation.'
Amendment 343 #
Proposal for a directive – amending act
Article 1 – point 15 – point a a (new)
Article 1 – point 15 – point a a (new)
Directive 2001/83/EC
Article 111 – paragraph 1 – subparagraph 2
Article 111 – paragraph 1 – subparagraph 2
(aa) In Article 111(1), subparagraph 2 is replaced by the following: '2. The competent authorities shall carry out repeated, and where necessary unannounced, inspections of the premises of producers, distributors or importers of active ingredients used as starting materials, the premises of manufacturing authorisation holders, the premises of medicinal product traders and brokers or the premises of excipient producers, importers and distributors where there are sound grounds for suspecting, on the basis of information available to the authorities or of previous cases, that legal obligations or the guidelines are not being complied with. Such inspections may also be carried out at the request of a Member State, the Commission or the Agency.'
Amendment 352 #
Proposal for a directive – amending act
Article 1 – point 16
Article 1 – point 16
Directive 2001/83/EC
Article 111a
Article 111a
The Commission shall adopt detailed guidelines laying down the principles for inspections referred to in Article 111 and, in particular, the Union or national bodies responsible for carrying out inspections.
Amendment 354 #
Proposal for a directive – amending act
Article 1 – point 16
Article 1 – point 16
Directive 2001/83/EC
Article 111b – paragraph 1 – introductory part
Article 111b – paragraph 1 – introductory part
1. The Commission shall, following a request from a third country and the satisfactory conclusion of the inspection by the body responsible pursuant to Article 111a, list that country by way of a Decision if its regulatory framework for active substances exported to the Community and the respective control and enforcement ensure a protection of public health equivalent to that in the Community. Particular account shall be taken of:
Amendment 357 #
Proposal for a directive – amending act
Article 1 – point 16
Article 1 – point 16
Directive 2001/83/EC
Article 111b – paragraph 3
Article 111b – paragraph 3
3. The Commission, in cooperation with the Agency and competent authorities of the Member States, shall verify regularly whether the conditions set out in paragraph 1 are fulfilled. The first verification shall take place no later than 3 years after the country has been listed in accordance with paragraph 1be conducted with a view to confirming compliance with the criteria set out in paragraph 1 and shall be followed by regular verifications at intervals of no less than 3 years.
Amendment 360 #
Proposal for a directive – amending act
Article 1 – point 17
Article 1 – point 17
Directive 2001/83/EC
Article 118b
Article 118b
1. Member States, in applying this Directive, shall take the necessary measures to ensure cooperation between competent authorities for medicinal products and customs authorities.’ In that connection, Member States, working in coordination with healthcare professionals, including the pharmaceuticals industry, shall take the necessary measures to encourage training for customs officers to help them deal with the phenomenon of falsified medicinal products. That coordination shall be strengthened by international cooperation programmes conducted by the Commission. 2. Member States shall take the necessary measures to ensure that customs officers are provided with the resources they need and shall supply, in particular, the technology essential to the work of detecting falsified medicinal products. 3. The Commission shall draw up a report on the relevant action taken 36 months after the publication of this Directive.
Amendment 364 #
Proposal for a directive – amending act
Article 1 – point 17
Article 1 – point 17
Directive 2001/83/EC
Article 118c a (new)
Article 118c a (new)
Article 118c a The Commission, working with the Member States, shall support the drafting, under the auspices of the United Nations, of an international convention on the combating of the falsification of medicinal products, with a view to ensuring that stiffer penalties are imposed on those guilty of such falsification.
Amendment 365 #
Proposal for a directive – amending act
Article 1 – point 17
Article 1 – point 17
Directive 2001/83/EC
Article 118c b (new)
Article 118c b (new)
Article 118c b The Commission, working closely with the Member States, shall take concerted measures with the competent authorities of third States which have transit areas in which medicinal products are stored. The Commission shall take the necessary measures to ensure that seizures of suspect products do not serve to hamper trade in legal generic medicinal products. In the context of international cooperation, the Commission shall authorise the impounding of suspect products so that the necessary checks can be carried out.
Amendment 366 #
Proposal for a directive – amending act
Article 1 – point 17
Article 1 – point 17
Directive 2001/83/EC
Article 118c c (new)
Article 118c c (new)
Article 118c c The Commission, working closely with the Member States, shall organise an information campaign aimed at the general public on the dangers of counterfeit medicinal products, including the Internet-related risks.
Amendment 372 #
Proposal for a directive – amending act
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)