General approaches

EC independent Scientific Committees

ECDC

ECHA

EMA

Main requirements:
The scientific advice delivered by the Committees must not be influenced by any consideration other than the scientific assessment of the risks in question. This principle implies in particular the independence from any external economic or political interests, but also from bias related to political, economic, social, philosophical, ethical or any other non-scientific considerations. The principle of independence refers to the organisation and results of the process, including in particular the independence criteria and conditions and arrangements for the participation of members, advisors and experts. [§ 3.2 of Rules of Procedure]

The stakeholder dialogue procedure shall apply when and as compatible with the fundamental requirement to ensure the full independence and autonomy of the Scientific Committees in elaborating, determining and deciding the contents and conclusions of their opinions and to preserve the integrity of the process for the establishment of scientific advice. The Secretariat shall suspend the application of the procedure in a particular case if there is any risk to the independence and integrity of the process and shall alert the Commission of the nature and extent of such risk. No aspect of the stakeholder procedure and its actual application may be invoked as a reason to delay the adoption of, modify or reconsider a scientific opinion. [§ 8.3 of Rules of Procedure]

Approach:
While the stakeholder dialogue procedures contribute to the implementation of the principle of transparency and are part of the Commission's efforts to engage with stakeholders in a spirit of openness and accountability, it should be clear that the work of the Commission Scientific Committees is, and must remain, independent of any influence. These procedures must therefore, not be seen as, and must not be used to interfere with the internal work of the Committees, claiming a right or trying to be involved in such work or exerting pressure on Committees' members. The overall aim of these procedures is to contribute to ensure the highest quality of the scientific opinions adopted by the Committees. In case of any evidence of significant risks for the independence of the committees due to the application of these procedures, the Commission will discontinue their application in part or in total as appropriate. [Annex IV of Rules of Procedure]

The practical arrangements regarding the ensurance of independence regarding relations with stakeholders are laid down in § 5 and Annex II of the Rules of Procedure.

In order to put its founding principles of transparency, efficiency and independence into practice and to meet and go beyond the direct legal requirements governing the issue, ECHA wants to develop efficient channels of communication, dialogue and engagement with its stakeholders. This policy of openness and engagement is part of the fundamental corporate philosophy of ECHA.

For more details on the provisions concerning the integrity and independence of the Committees and the Forum, please see the document ‘ Proactive engagement with all ECHA stakeholders’, approved by the ECHA Management Board. This document also refers to the code of conduct for stakeholders, endorsed by the ECHA Management Board.

Main requirements:
According to Article 6(1) of the Founding Regulation of ECDC (EC) No 851/2004 of the European Parliament and of the Council: "the Centre shall provide independent scientific opinions, expert advice, data and information."

Approach:
All scientific opinions are discussed in the ECDC Advisory Forum before they are issued by the ECDC Director. The Advisory Forum includes public health experts from all Member States, the Commission, the WHO, learned societies, and patient organisations.

All the members of the Advisory Forum can give their views on the final opinion. However, they only advice the Director: no consensus is needed, and the Director does not have to take any views into consideration.

A policy on interactions with pharmaceutical industry, including regular update meetings at ECDC premises on a pre-defined topic set up in collaboration with industry umbrella organizations is currently developing. This has no impact on the work of the scientific panels.

Main requirements:
Please see the Annex II of the Procedural Advice to CHMP members: Committee for Medicinal Products for Human Use (CHMP) Members Interactions with Applicants/Marketing Authorisation Holders during the Centralised Procedure.

Approach:
In the case of applicants/marketing authorisation holders the relation is limited to the dossier of the applicants.
In the case of health care professionals or patients it’s on a case by case basis. For patients in very few cases specific meetings have been set up. For others than industry e.g. patients organisations it’s very rare and on a case by case basis.

The Secretariat shall be responsible for providing scientific and administrative support necessary to facilitate the efficient functioning of the Scientific Committees, to monitor compliance with the rules of procedure, particularly in relation to the requirements for excellence, independence and transparency, to ensure communication on the Committees’ activities and the appropriate stakeholder dialogue, including in particular organisation of hearings on the activities of the Committees, and publication of the opinions and other public documents. Moreover, the Secretariat shall provide support to the Committees and organise and apply quality control of the opinions, as provided for in the rules of procedure, as far as completeness, consistency, clarity, correspondence with requests and with editorial standards are concerned. [Chapter 5, §3 of Commission Decision 2008/721/EC]

See documents referred to above in ‘independence’

Performance Indicators agreed with Industry association:

http://www.ema.europa.eu/pdfs/conferenceflyers/EMEA_EFPIA_Info_Day-24-02-09.pdf
http://www.ema.europa.eu/pdfs/conferenceflyers/EMEA-EFPIA_24Feb2009/Lisette_Vromans-Performance_Indicators.pdf