Activities of Thomas ULMER related to 2008/0261(COD)
Plenary speeches (3)
Explanations of vote
Explanations of vote
Explanations of vote
Amendments (43)
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 73 #
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, and 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 78 #
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 and homeopathic 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. No later than five years after the date of entry into force of this Directive, the Commission should submit to the European Parliament and to the Council an assessment report on the application of the safety features referred to in point (o) of Article 54 of Directive 2001/83/EC and their estimated contribution to the reduction of the number of falsified medicines in the legal supply chain in Europe. The report should include an assessment of the safety features of other categories of medicines, including medicinal products not subject to medical prescription as defined in Title VI of Directive 2001/83/EC.
Amendment 86 #
Proposal for a directive – amending act
Recital 7 a (new)
Recital 7 a (new)
(7a) Member States, working together with stakeholders, should be free to determine the particular aspects of medicines authentication which they consider most appropriate for their medicine distribution system, taking into account the safety features adopted pursuant to this Directive.
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 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 102 #
Proposal for a directive – amending act
Recital 13
Recital 13
(13) The manufacture of active pharmaceutical ingredients should be subject to good manufacturing practices irrespective of whether those ingredients were manufactured in the Community of imported. With regard to the manufacture of active pharmaceutical ingredients or excipients in third countries, it should be ensured that the rules for the manufacture of active pharmaceutical ingredients or excipients 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 legislation.
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 121 #
Proposal for a directive – amending act
Recital 18 a (new)
Recital 18 a (new)
Amendment 122 #
Proposal for a directive – amending act
Recital 18 a (new)
Recital 18 a (new)
(18b) It is necessary for the operation of the internal market to establish EU-wide harmonised safety features for medicinal products. The technical implementation of these features and the design of the test methods should, however, be left to the Member States in accordance with the principle of subsidiarity.
Amendment 126 #
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 that has been deliberately falsified in relation to its:
Amendment 132 #
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) identity, including its packaging, labelling, name and composition in terms of both ingredients, including excipients and active ingredients, and the dosage thereof;
Amendment 143 #
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) source, including the manufacturer, the country of origin and the marketing authorisation holder;
Amendment 145 #
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) history, including the registers and documents enabling the distribution chain to be identified.
Amendment 152 #
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 be empowered to update this definition on the basis of technical and scientific progress and international agreements. This definition is not related to infringements of legislation on intellectual and industrial property rights or patent rights. This definition does not include manufacturing errors.
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 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 180 #
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
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 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 207 #
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, and authenticity and traceability of medicinal products, other than radiopharmaceuticals, subject to medical prescription as defined in Title VI.’
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 213 #
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. Homeopathic medicinal products are exempt in accordance with Article 1(5). Where a medicinal product, such as a homeopathic medicinal product, is not subject to medical prescription, the safety features may be applied on a voluntary basis.
Amendment 230 #
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 replacing the safety feature with a safety feature which is equivalent as regards the possibility to ascertain identification, authenticity and uninterrupted traceabil and authenticity of the medicinal product, and without opening the immediate packaging as defined in Article 1(23);
Amendment 234 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 2 – point b - subparagraph 1 a (new)
Article 54a – paragraph 2 – point b - subparagraph 1 a (new)
Safety features shall be considered equivalent where they are equally efficient in identifying, authenticating, tracing and preventing tampering with medicinal product, and where they are equally technical difficult to duplicate. This paragraph shall also apply to the removal, replacement or covering up of new safety features unless the primary safety feature is a covert one and cannot be recognised.
Amendment 241 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 2 - point c a (new)
Article 54a – paragraph 2 - point c a (new)
(c a) The safety features referred to in point (o) of Article 54 shall be applied without discrimination between distribution channels.
Amendment 247 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 1
Article 54a – paragraph 4 – subparagraph 1
Amendment 280 #
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 ofat least all of the following: (a) the cost-effectiveness of the system, in order to guarantee that any measure that is applied is based on a cost-benefit analysis; (b) the proportional application of costs related to the measures to all participants in the supply chain and the linking of those costs to the price of the medicinal product concerned; (c) the independence of the system and the legitimate interests to protect information of a commercially confidential nature and of the protection of industrial and commercial property rights and personal data.
Amendment 283 #
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. It has to be ensured that no collection or commercial processing of data takes place that would enable a link to be made between the medicinal products provided and the corresponding patients or pharmacies.’
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 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.'
Amendment 341 #
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 88a a is inserted: 'Article 88aa Member States with the collaboration of the Commission and following consultation with stakeholders should develop an information strategy regarding the reliability of medicinal products suppliers. The strategy shall take into account the different national legislation regulating the supply of medicinal products as well as the risks of certain ways of supplying medicines, such as through illegal internet traders.
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 373 #
Proposal for a directive – amending act
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
2a. Nothing in this Directive shall affect the right of Member States to restrict or prohibit the sale of prescription medicines through the internet.