Notice Of Rules Of Procedure For Pharmaceutical Damage Appeals Tribunal.

Original Language Title: Bekendtgørelse om forretningsorden for Lægemiddelskadeankenævnet

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Overview (table of contents)



Chapter 1



Pharmaceutical injury Supreme tasks and composition





Chapter 2



Preparation of cases





Chapter 3



The holding of the meeting, etc.





Chapter 4



Decision, etc.





Chapter 5



Various provisions



The full text of the Ordinance on the rules of procedure for Pharmaceutical damage Appeals Tribunal.

Under section 56, paragraphs 2 and 5, of the law on complaint and redress access within the health system, see. lovbekendtgørelse nr. 1113 of 7. November 2011 and after negotiation with the pharmaceutical damage Appeals Tribunal determined: Chapter 1 Pharmaceutical injury Supreme tasks and composition section 1. Pharmaceutical injury Appeals Board appeal body for decisions is taken by the patient Insurance Association in cases concerning compensation for the damage.

(2). The victim, the Ministry of health and prevention, as well as others with a legal interest in the matter may refer the complaint to the pharmaceutical damage Appeals Board in accordance with paragraph 1.

§ 2. Pharmaceutical injury Appeals Tribunal consists of a President and eight appointed members, see. § 56, paragraph 1, of the law on complaint and redress access within the health service.

(2). The Board may appoint from among its members a Vice-Chairman, in the Chair's absence, to carry out the President's duties under this Ordinance.

(3). Upon the recommendation of the authorities, etc., referred to in section 56 (1) (8). 2-7 of the law on complaint and redress access within the health service, is appointed an alternate for each of the 6 groups for Pharmaceutical damage Appeals Board.

Chapter 2 Preparation of cases section 3. Appeals against the decisions referred to in paragraph 1 may be brought before the Appeals Board has the final Pharmaceutical injury administrative decision see. section 57, paragraph 1 of the law on complaint and redress access within the health service.

(2). The Chairman or a Vice-Chairman shall decide whether the complainant has sufficient legal interest in the matter, and about the deadline for the submission of the complaint are respected without prejudice. section 57, paragraph 2 of the law on complaint and redress access within the health service. The time limit is exceeded, and there is no particular reason for doing so, if the appeal is rejected without prejudice. section 57, paragraph 3 of the law on complaint and redress access within the health service.

§ 4. Patient and complaints provides secretarial services available to Drug damage Appeals Tribunal, see. § 56, paragraph 6, of the law on complaint and redress access within the health service.

(2). The Secretariat determines the order for the processing of the complaints.

(3). The Secretariat is responsible for the information of the case, obtaining the necessary expert assessment and the preparation of the draft decision.

(4). Reviews of claims for damages in accordance with the applicable rules on compensation for the damage, are sent to the Patient and complaints shall be deemed filed with the proper authority at the time they are received by the Patient and complaints. Reviews will be forwarded immediately to the Patient insurance referred to in article 6. paragraph 60 (a) of the law on complaint and redress access within the health service.

§ 5. When a complaint is received, a confirmation will be sent to the complainant with an indication of the expected processing procedure.

(2). The complaint will be sent prior to the submission of the Board to the patient Insurance Association, which sends the Committee the case file, together with an opinion of the submitted complaint. The Secretariat may fix a time limit for Patient Insurance response in cases where special considerations dictate this.

(3). When special interests grounds, the President may, subject to article 20. section 57, paragraph 1 of the law on complaint and redress access within the health service at the request of a complainant is entitled to decide that the appeal in whole or in part must have suspensory effect with regard to the payment of any amount of compensation. The decision must be taken within 14 days from the date of receipt of the request.

Chapter 3 the holding of the meeting, etc.

§ 6. The Board operates in the meetings, including Conference calls or similar, see. However, sections 10 and 11.

(2). Committee meetings shall be convened by the Secretariat with reasonable notice. The call to be attached to an agenda of the issues to be addressed at the meeting, a draft decision of the Board of each of the cases and the dossier, which is necessary for the Committee to decide in each case.

§ 7. The President directs the Committee meeting.

(2). Pharmaceutical injury Appeals Board is quorate when the Chairman and at least one member from each of the of the law on complaint and redress access in healthcare section 56 (1) (8). 2-7, person referred to groups are present.

§ 8. Committee meetings are not public.

(2). The Board's President can see. section 56 (2) of the law on complaint and redress access within the health system, provide that special experts or others may participate without the right to vote in the Board's treatment of cases.

Chapter 4 Decision, etc.

§ 9. The Board's decisions shall be taken by majority vote. Event of a tie, the casting vote.

(2). The Board's decisions are introduced into a decision-making Protocol, as signed by the President.

(3). In cases where a decision cannot be taken by a unanimous vote, Committee members can request that their særstandpunkter card shall be indicated in the draft Protocol. In these cases, the Committee members also require observation about their særstandpunkter included in the decision itself with justification for respectively the majority and the minority's positions and with indication of the number of votes for the respective positions.

§ 10. The President may, on behalf of the Board take a decision in cases that are not deemed to pose a doubt.

(2). The following case categories falls typically within the authorisation granted in paragraph 1:1) Cases that only relates to the compensation calculation.

2) cases in which the damage falls outside the scope of the Act.

3) cases concerning the request for the resumption of the resolved cases, the absence of new and for the decision of essential information.

4) cases in which the complaint was lodged by a non complaint justified.

5) proceedings relating to a complaint about freedom of information issues.

6) cases in which the conditions for recognition of liability in accordance with the law shall be deemed clearly met, and moreover is uncomplicated.

7) matters concerning exceedances of appeals or limitation under the law.

(3). Decisions of the President will, along with the decisions of the Tribunal could be brought before the Court.

(4). The Board's other members can be informed about the decisions taken by the President.

§ 11. Matters which the Chairman deems fit for the written assessment, can be distributed to the Committee members with the recommendation on the decision. If a member so requests, however, these matters must be discussed at a meeting.

§ 12. The Board's decisions can have the following content: 1) to the Board, modifies or repeals the patient Insurance Association's joining decision, 2) that the Board refer the case back to the decision in the patient Insurance Association, the Tribunal rejects the appeal, 3) to or 4) that the Committee shall consider complaints about freedom of information issues relating to matters dealt with in the patient Insurance Association.

§ 13. The Board's decisions shall be sent to the injured person, the patient Insurance Association, the Danish Medicines Agency and, as appropriate, others with a legitimate interest in the matter.

(2). Ministry of the Interior and health and pharmaceutical manufacturer or importer concerned shall be informed of the decisions in which Pharmaceutical damage Appeals Board has determined that the injured party is entitled to compensation and/or compensation.

(3). Patient and complaints shall pay compensation and reimbursement in accordance with Patient Insurance and Pharmaceutical injury Supreme decisions.

(4). The compensation shall be paid by the Patient and complaints pursuant to section 54, paragraph 2, of the law on complaint and redress access within the health service and on the basis of Decree No. 428 of 9. May 2011 on the administration of matters relating to pharmaceutical injury compensation.

§ 14. Pharmaceutical injury Appeals Tribunal is in its business independently of the instructions on the individual case processing and decision.

(2). The Board's decisions cannot be brought before another administrative authority referred to in article 6. section 57, paragraph 1 of the law on complaint and redress access within the health service.

§ 15. Resulting in a matter that the Tribunal has decided, new and for the decision of essential information, the Tribunal may decide to take the matter up for reconsideration and decision. The same applies if there are committed significant errors in the handling of the case.

Chapter 5 miscellaneous provisions § 16. Pharmaceutical injury Supreme members and others participating in the Committee's work, is in the exercise of their activities to the Board subject to the obligation of professional secrecy, without prejudice to article. Executive Law § 27.

§ 17. Pharmaceutical injury Supreme members in connection with their work for the Tribunal will be subject to administrative law rules on disqualification.

(2). A Committee member has a duty to inform the Committee about conditions which may lead to his disqualification, like any of the Board's other members, who are familiar with such conditions, have the duty to inform the Board accordingly.

(3). A Committee member may not participate in the consideration of a specific case of among others the following situations: 1) if the Committee members have close personal relationships with one of the parties to the proceedings, 2) if the Committee member has participated in the treatment of the same subject in another institution, for example, the medico-legal Council or the patient Insurance Association, 3) If an injured person at any time has been examined or treated by Committee member,
4) if there exist specific circumstances, as may be appropriate to arouse doubts about his/her impartiality.

(4). If a Committee member is in doubt as to his capacity, can the issue be discussed with the Secretariat.

(5). The Tribunal determines whether a member may participate in any proceedings. Member must not participate in the examination and determination of the question of his disqualification. In the event of a tie the President's vote is decisive.

§ 18. The Committee shall deliver an annual report on its activities, which shall be sent to the Minister for health and prevention. The statement shall be prepared by the Secretariat.

(2). Decisions that are of fundamental importance and is suitable as a guide for the Committee's practice, published in anonymous and possibly summarised form.

§ 19. The notice shall enter into force on the 1. February 2012.

(2). At the same time repealed Executive Order No. 195 of 11. March 1997 on the rules of procedure for Pharmaceutical damage Appeals Board.

The Ministry of health and prevention, 20. January 2012 Pia Olsen Dyhr/Anne Marie Hertzum