Ethical Code

STATUTE OF THE ETHICAL COMMITTE OF PHARMACEUTICAL INDUSTRY IN SLOVAKIA

2. Composition
The Ethical Committee consists of nine members, from which six members are internal (industry representatives) and three members are external. Six internal members of the Ethical Committee are nominated by member industrial associations ADL, GENAS, SAFS - two nominees for each association according to following rules and key:

2.1. Internal members of Ethical Committee are nominated by companies and delegated person is not replaceable.
Key:
ADL - 1 generic + 1 original producer
GENAS - 2 generic producers
SAFS - 2 original producers

2.2. There are three external members of the Ethical Committee: one person with the pharmaceutical expertise, one person active in the field of ethics or generally accepted opinion leader with the medical or pharmaceutical expertise, one medical doctor with active ambulatory and hospital practice. Every association shall nominate one nominee. External members for further periods will be nominated and agreed by the Ethical Committee members.

2.3. The chairman of the Ethical Committee is usually an external member of the Ethical Committee elected by the majority of members of the Ethical Committee. The chairman shall be elected for one year time period.

2.4. Rotation. The administration of the Ethical Committee shall be performed by the office of the member association for the period of two years, always starting from 1st January, in the following order: SAFS, ADL, GENAS. The administrator of the Ethical Committee shall be such an employee of the member association who is not an employee of a pharmaceutical company.

2.5. Data confidentiality. Members of the Ethical Committee and all empowered employees of member association offices dealing with the Ethical Committee agenda must keep strict confidentiality on processed cases and handle documentation on processed cases as confidential.

The Committee can ask other ADL, GENAS SAFS or non-association members to join the group for specific complaints when further expertise it required

3. Terms of Office
It is important to keep the continuity of work of the Ethical Committee. Out of six first internal members three would be elected for a one year term, the other three for a two years term. Further on, three members of the Ethical Committee would be elected for a two years term, what means to elect three new members of the Ethical Committee each year.
If the elected company representative resigns, the company shall nominate new member of the Ethical Committee until the end of the elective period.
It will be recommended to external members of the Ethical Committee to remain in the office for at least two years. External member of the Ethical Committee will confirm their willingness to continue work in the Ethical Committee every year.

4. Fees
External committee members would be paid a fee for their participation in the Ethical Committee that will be set commonly by the Boards of ADL, GENAS and SAFS. Every member association will pay fee for one external member of the Ethical Committee.

5. Intent
The activities of the Ethical Committee are not legally binding and should be seen to facilitate complaints being resolved, and to clarify situation so that similar problems can be avoided. Any involvement or decision made by the Ethical Committee in no way limits any member from taking their own independent action.

ADL, GENAS and SAFS members would sign a document stating they would take no legal action against ADL, GENAS or SAFS or individual members as a result of a decision taken by the Ethical Committee.

6. Quorum
For a meeting to continue there must be at least six committee members present, one of which is an external member.

7. EFPIA Code of Practice on the Promotion of Medicines and Ethical Code of Pharmaceutical Industry
The Ethical Committee shall follow the Code. The Code of Practice on the Promotion of Medicines of European Federation of Pharmaceutical Industries and Associations (EFPIA Code) is a base for establishment of the Code.
A copy of both Codes shall be available in Slovak and English to all members of ADL, GENAS and SAFS.
All ADL, GENAS and SAFS members shall sign a document confirming that they, their organisations and their licensee partners will follow the Code in their business practices in the Slovak Republic.
If the EFPIA Code is changed or if the Ethical Committee as a whole decides to change or modify the Code after further local experience then such modifications must be approved by a simple majority vote of the Ethical Committee members.

8. Complaints Procedure
Complaints Procedure forms a component part of this Statute.

9. Complaints against Committee Member
If the Ethical Committee member is the subject of a complaint then it should take no part in judgement of that complaint. The Ethical Committee can then decide to ask another ADL, GENAS or SAFS member to join the Committee.

10. The Appeal Board
The Appeal Board deals with appeals submitted against decisions of the Ethical Committee and consist of: three internal members of the Ethical Committee (one per every association ADL, GENAS and SAFS), two external members of the Ethical Committee and six representatives of the Boards of members associations (two per every member association). For a meeting to continue there must be at least seven committee members present, two of which are external members.

11. Advertising
Pharmaceutical Industry, healthcare professionals and the general public shall be informed aware that there is a procedure implemented to receive complaints in the pharmaceutical industry.

12. Training
Through the Ethical Committee, ADL, GENAS and SAFS would develop a training course for staff in ADL, GENAS and SAFS member companies to appreciate the Code and its implications in the marketing practice.

Basic principles
governing the Application of the Code

1. The Ethical Committee always seeks to consult with the member company, who is the subject of a complaint, in the course of a Committee meeting, to assist them in determining whether a violation has been committed or not.
2. Through the application of these procedures pharmaceutical industry is striving to ensure that all representatives of ADL, GENAS and SAFS member companies are aware of the limits of ethical behaviour under which they should operate. Where there are grey areas of interpretation of the Code then the Ethical Committee retains the right to establish appropriate guidelines for members.
3. The Ethical Committee retains the right to request that member companies who are found and agreed to be guilty of a severe or repeated breach make a public apology in a form determined by the Ethical Committee.
4. The ADL, GENAS and SAFS Boards, follows the recommendation of the Ethical Committee, retains the right to publish in the specialist and lay press, details of judgement that have been made against members companies breaching the Code.
5. The Ethical Committee retains the right to recommend the expulsion from the respective association of any member company who is found to be guilty of a severe or repeated breach. The decision to expel a member must be supported by The Board of the member association and than confirmed by a majority vote of members during General Assembly of the association, to which the offending member company will be invited.
6. The Code, its application and penalties are adopted on a voluntary basis by ADL, GENAS and SAFS member companies as a precondition of being a member of the association. In addition ADL, GENAS and SAFS members companies agree not to take legal action against ADL, GENAS or SAFS for any consequences resulting from the assessment of a complaint against a member company by the Ethical Committee.
7. Any judgement passed by the Ethical Committee has no force in law and should not prevent any member from taking appropriate and legitimate legal action regarding an activity which is already the subject of a complaint to the Ethical Committee.
8. The Ethical Committee will develop and publish examples of what would be considered minor, moderate and severe breach of the Code.
9. The Ethical Committee would normally meet every two months. In the case of alleged major offences a special meeting of the Ethical Committee would be convened within 2-3 weeks of the complaint being received in a form capable of being judged. The Committee shall undertake to communicate its judgement on a complaint to the accused company within two weeks of assessing the complaint.
10. The application of the Complaints Procedure by the Ethical Committee will at all times be driven by the motivation to educate members of ADL, GENAS and SAFS to improve their behaviour, rather than to punish or penalise offenders.
11. Any complainant who ultimately remains unsatisfied with the outcome of the treatment of their complaint submitted to the Ethical Committee has the right to meet with a special meeting of the Ethical Committee and ADL, GENAS and SAFS Board combined, in order to understand the full reasons for the decision.
    
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