Activities of Bernadette VERGNAUD related to 2008/0260(COD)
Shadow opinions (1)
OPINION Proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use
Amendments (26)
Amendment 27 #
Proposal for a directive – amending act
Recital 12
Recital 12
(12) In order to ensure close cooperation between the Member States in the area of pharmacovigilance, the mandate of the coordination group set up by Article 27 of Directive 2001/83/EC should be enlarged to include the examination of based on the expertise of the pharmacovigilance systems of the Member States, a new coordination group should be set up with specific responsibility for these pharmacovigilance issues, to examine questions related to the pharmacovigilance of all medicinal products authorised by the Member States. In order to fulfil its new tasks, the new coordination group should be further strengthened through the adoption of clear rules as regards the expertise required, the adoption of opinions, transparency, independence and professional secrecy of its members, and the need for cooperation between Community and national bodies.
Amendment 29 #
Proposal for a directive – amending act
Recital 17
Recital 17
(17) To further increase the coordination of resources between the Member Statespharmacovigilance expertise at Community level, Member States should be authorised to delegate certain pharmacovigilance tasks tohave the option of arranging for their teams to be trained by the specialist teams of another Member State.
Amendment 30 #
Proposal for a directive – amending act
Recital 5
Recital 5
Amendment 31 #
Proposal for a directive – amending act
Recital 28
Recital 28
(28) In order to protect public health, there should be adequate funding of activities related to pharmacovigilance by the national competent authorities. It should be possible to ensure adequate funding for pharmacovigilance activities through the collection of feesThe indirect collection of additional resources should be possible for this purpose. However, the management of those collected funds should be under the permanent control of the national competent authorities in order to guarantee their independence.
Amendment 36 #
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2001/83/EC
Article 21 a – introductory part
Article 21 a – introductory part
Amendment 37 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83/EC
Article 22 – paragraph 3
Article 22 – paragraph 3
Continuation of the authorisation shall be linked to the annual reassessment of these conditions. The list of these conditions shall be made accessible to the public without delay, together with deadlines and dates of fulfilment.
Amendment 38 #
Proposal for a directive – amending act
Article 1 – point 10
Article 1 – point 10
Directive 2001/83/EC
Article 22 a (new)
Article 22 a (new)
1. After the granting of a marketing authorisation, the national competent authority may require a marketing authorisation holder to conduct a post- authorisation safety study if there are concerns about the risks of an authorised medicinal product. The requirement shall be made in writing, provide a detailed justification and include the objectives and timeframe for submission and conduct of the study. It shall be made public without delay. 2. The national competent authority shall provide the marketing authorisation holder with an opportunity to present explanations on the requirement within a time limit which it shall specify, if the marketing authorisation holder requests this, in writing and with a detailed justification, within 30- days of receipt of the written requirement. Such requests shall be made public without delay. 3. On the basis of explanations submitted by the marketing authorisation holder, the national competent authority shall withdraw or confirm the requirement. That decision shall be made public without delay. Where the national competent authority confirms the requirement, the marketing authorisation shall be varied to include the requirement as a condition of the marketing authorisation and the risk management system shall be updated accordingly.
Amendment 39 #
Proposal for a directive – amending act
Article 1 – point 14 – point a
Article 1 – point 14 – point a
Directive 2001/83/EC
Article 27 – paragraph 1
Article 27 – paragraph 1
“1. ATwo coordination groups shall be set up: (a) a coordination group for mutual recognition and decentralised procedures, responsible for the following purposetasks: (ai) the examination of any question relating to a marketing authorisation of a medicinal product in two or more Member States in accordance with the procedures laid down in Chapter 4; (bii) the examination of questions related to the pharmacovigilance of medicinal products authorisvariations to the terms of marketing authorisations granted by the Member States, in accordance with Articles 107c, 107e, 107g, 107l and 107r; (c) 35(1), with the examinaception of all questions related to the variations to the terms of marketing authorisations granted by the Member States, in accordance with Article 35(1)ing to pharmacovigilance. The Agency shall provide the secretariat of this coordination group. For the fulfilment of its pharmacovigilance tasks, the coordination group shall be assisted by the Pharmacovigilance Risk Assessment Advisory Committefor mutual recognition and decentralised procedures shall be assisted by the Committee for Medicinal Products for Human Use referred to in Article 56(1)(aa) of Regulation (EC) No 726/2004.
Amendment 40 #
Proposal for a directive – amending act
Article 1 – point 14 – point a
Article 1 – point 14 – point a
Directive 2001/83/EC
Article 27 – paragraph 1 – point a a (new)
Article 27 – paragraph 1 – point a a (new)
(aa) A coordination group for pharmacovigilance risk assessment shall be responsible for the following tasks: (i) the examination of questions relating to the pharmacovigilance of medicinal products authorised by the Member States, in accordance with Articles 107c, 107e, 107g, 107l and 107r; (ii) the examination of questions relating to the variations to the terms of marketing authorisations granted by the Member States, in accordance with Article 35(1), for all questions relating to pharmacovigilance. The Agency shall provide the secretariat of this coordination group.
Amendment 42 #
Proposal for a directive – amending act
Article 1 – point 14 – point b
Article 1 – point 14 – point b
Directive 2001/83/EC
Article 27 – paragraph 2
Article 27 – paragraph 2
“Members of the coordination groups and experts shall, for the fulfilment of their tasks, rely on the scientific and regulatory resources available to the national marketing authorisation bodiesbodies responsible for, respectively, issuing marketing authorisations and pharmacovigilance. Each national competent authority shall monitor the level of expertise of the evaluations carried out and facilitate the activities of nominated coordination group members and experts. Article 63 of Regulation (EC) No 726/2004 shall apply to the coordination groups as regards the transparency and independence of its membertheir members. Their members may be members only of one coordination group at a time. The members of the coordination group for pharmacovigilance risk assessment shall be hierarchically independent of the national marketing authorisation bodies.”
Amendment 43 #
Proposal for a directive – amending act
Article 1 – point 14 – point c
Article 1 – point 14 – point c
Directive 2001/83/EC
Article 27 – paragraph 4
Article 27 – paragraph 4
“4. The Executive Director of the Agency or his representative and representatives of the Commission shall be entitled to attend all meetings of the coordination groups.
Amendment 44 #
Proposal for a directive – amending act
Article 1 – point 14 – point c
Article 1 – point 14 – point c
Directive 2001/83/EC
Article 27 – paragraph 5
Article 27 – paragraph 5
5. The members of the coordination groups shall ensure that there is appropriate coordination between the tasks of thateir group and the work of national competent authorities, including, respectively, the consultative bodies concerned with the marketing authorisation and those concerned with the surveillance of medicinal products.
Amendment 45 #
Proposal for a directive – amending act
Article 1 – point 14 – point c
Article 1 – point 14 – point c
Directive 2001/83/EC
Article 27 – paragraph 6
Article 27 – paragraph 6
6. Save where otherwise provided for in this Directive, the coordination groups shall use itstheir best endeavours to take decisions by consensus. If such a consensus cannot be reached, the position of the majority of members shall prevail.
Amendment 46 #
Proposal for a directive – amending act
Article 1 – point 14 – point c
Article 1 – point 14 – point c
Directive 2001/83/EC
Article 27 – paragraph 7
Article 27 – paragraph 7
7. MemberDetailed agendas of the coordination group shall be required, even after their dmeetings shall be made public at the latest the day before the meeting concerned. Detailed minuties have ceased, not to disclose informof coordination group meetings, containing the decisions taken, details of votes and explanations of the kind covered by the obligation of professional secrecyvotes, including minority opinions, shall be made public in the month following the meeting.”
Amendment 53 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 103
Article 103
A Member State may not delegate any of the tasks entrusted to it under this Title to. It may request training and assistance from another Member State, subject to athe written agreement of the latter. The delegarequesting Member State shall inform the Commission, the Agency and all other Member States of the delegation in writing. The delegating Member State and the Agency shall make that informatand the training Member State shall submit a detailed and budgeted training and assistance plan to the Commission and the Agency, which shall finance it from the Union’s public funds.
Amendment 54 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 105
Article 105
Amendment 74 #
Proposal for a directive – amending act
Article 1 – point 1 – point a
Article 1 – point 1 – point a
Directive 2001/83/EC
Article 1 – point 11
Article 1 – point 11
11) adverse reaction: a response to a medicinal product which is noxious and Uunintended, and which occurs at doses normally used in the human body for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function.
Amendment 95 #
Proposal for a directive – amending act
Article 1 – point 1 – point d
Article 1 – point 1 – point d
Directive 2001/83/EC
Article 1 – point 28c
Article 1 – point 28c
(28c) Pharmacovigilance system: a system utilized bywhich marketing authorisation holders and by Member States to fulfil the tasks and responsibilities listed in Title IX and designed to monis it possible: (a) to collect information useful in the surveillance of medicinal products, with particular reference to adverse reactions in human beings, including in cases of misuse, medication abuse or medication error; (b) to assess this information scientifically in order to detect any change tor the safetyrisk- benefit balance of authorised medicinal products and detect any change to their risk-benefit balance. ; (c) for marketing authorisation holders and for Member States to fulfil the tasks and responsibilities listed in Title IX
Amendment 97 #
Proposal for a directive – amending act
Article 1 – point 1 – point d a (new)
Article 1 – point 1 – point d a (new)
Directive 2001/83/EC
Article 1 – points 32 a, 32 b and 32 c (new)
Article 1 – points 32 a, 32 b and 32 c (new)
(da) The following point 32a is inserted: “(32a) Medication error: a non- intentional omission or action relating to a medicinal product which can be the cause of a risk or of an adverse event for the patient. By definition, medication error is avoidable because it indicates what should have been done but was not done during the medical treatment of the patient. Medication error can concern one or more stages in the medicinal product’s cycle, such as formulary selection, prescription, dispensing, validation, preparation, storage, delivery, administration and therapeutic monitoring and information, but also its interfaces, such as communications and transcriptions.”
Amendment 98 #
Proposal for a directive – amending act
Article 1 – point 1 – point d a (new)
Article 1 – point 1 – point d a (new)
Directive 2001/83/EC
Article 1 – point 32 b (new)
Article 1 – point 32 b (new)
(da) The following point 32b is inserted: “(32b) Medication misuse: use of a medicinal product not in compliance with the recommendations in the summary of the product characteristics (SPC).”
Amendment 99 #
Proposal for a directive – amending act
Article 1 – point 1 – point d a (new)
Article 1 – point 1 – point d a (new)
Directive 2001/83/EC
Article 1 – point 32 c (new)
Article 1 – point 32 c (new)
(da) The following point 32c is inserted: “(32c) Medically justified use outside the approved indications: specific case of use deliberately not in compliance with the recommendations under the ‘indications’ section of the SPC but based on the assessment data.”
Amendment 100 #
Proposal for a directive – amending act
Article 1 – point 1 – point d a (new)
Article 1 – point 1 – point d a (new)
Directive 2001/83/EC
Article 1 – point 32 d (new)
Article 1 – point 32 d (new)
(da) The following point 32d is inserted: “(32d) Commercially confidential information: parts of documents, data or information are regarded as being commercially confidential, for a determined period which must be specified, if it is shown that divulging them is likely to cause disproportionate harm to the commercial interests of a marketing authorisation holder, except in cases in which, notwithstanding this damage, there is a major public-interest justification for divulgation. Information about public health, especially pre- clinical, clinical and pharmacovigilance data, can never be regarded as commercially confidential information. Data about sales volumes should also be made public as they are scientific data that make it possible to assess the level of exposure of the population to adverse reactions to a given medicinal product.”
Amendment 126 #
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2001/83/EC
Article 21a - introduction
Article 21a - introduction
Amendment 131 #
Proposal for a directive – amending act
Article 1 – paragraph 8
Article 1 – paragraph 8
Directive 2001/83/EC
Article 21a – point 4 – subparagraph 2
Article 21a – point 4 – subparagraph 2
The marketing authorisation shall lay down deadlines for the fulfilment of the conditions where necessary.
Amendment 170 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – paragraph 1 – point 1
Article 102 – paragraph 1 – point 1
(1) take all appropriate measures to encourage doctorpatients, doctors, hospitals, pharmacists and other health-care professionals to report suspected adverse reactions to the national competent authority or the marketing authorisation holder;
Amendment 204 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 105
Article 105