ECHA policy for prevention of conflicts of interest EP workshop 21 February 2013 Geert Dancet Executive Director ECHA
INTERNAL 2/21/2013 2
Driving Legislation for ECHA REACH adopted in December 2006 ECHA established on 1 June 2007 REACH entry into force June 2008 Registration of chemicals [ substances ] Evaluation of selected registered substances Authorisation of (certain) Chemicals Restriction of (certain) Chemicals CLP entry into force Jan 2009 Classification, Labelling & Packaging of substances and mixtures INTERNAL 2/21/2013 3
Driving Legislation for ECHA NEW TASKS Biocides entry into force 17 July 2012 entry into operation on 1 September 2013 PIC entry into force 16 Aug 2012 entry into operation on 1 March 2014 INTERNAL 2/21/2013 4
Main Activities of ECHA Managing REACH & CLP processes (Biocides & PIC) Disseminating information on chemicals Developing scientific IT tools Providing regulatory assistance to industry, i.e. ECHA Helpdesk & Guidance Co-ordination of national enforcement Advice on chemical safety to EU Institutions & Member States Assisting EU s international activities (UNEP & OECD; accession countries) http://echa.europa.eu INTERNAL 2/21/2013 5
ECHA s strategic aims 2013-2018 I. Maximise the availability of high quality data to enable the safe manufacture and use of chemicals. II. Mobilise authorities to use data intelligently to identify and address chemicals of concern. III. Address scientific challenges by serving as a hub for building the scientific and regulatory capacity of Member States, European institutions and other actors. IV. Embrace current and new legislative tasks efficiently and effectively, while adapting to upcoming resource constraints. INTERNAL 2/21/2013 6
ECHA s Organisation Management Board (appointment Council, EP & COM) Secretariat led by Executive Director (appointment MB) 529 ECHA staff (1 February 2013) Committees with national delegates Member State Committee (appointment MS) Committee for Risk Assessment (appointment MB) Committee for Socio-economic Analysis (appointment MB) Forum for Exchange of Information on Enforcement (appointment MS) Board of Appeal Independent from the Secretariat (appointment MB) INTERNAL 2/21/2013 7
How ECHA reduces risks of CoI Independent and impartial opinion and decisionmaking is more than avoidance of CoI: Multi-disciplinary teams work on the dossiers Public consultations Unanimous or majority-based decision-making (reducing influence of individual members) Science-based, peer-reviewed opinions and decisions Transparency of working methods: Transparent procedures Detailed minutes of meetings published Stakeholder observers in Committee meetings Publication of non-confidential versions of decisions INTERNAL 2/21/2013 8
Cornerstones of ECHA CoI policy Transparency Annual declarations of Interest of all members of ECHA bodies and of ECHA managers published on ECHA website Awareness Induction and regular training Robust policies and procedures INTERNAL 2/21/2013 9
ECHA Policy for prevention of CoI Since the start in 2007 prevention of CoI was a key aspect of Agency s governance Incorporated into REACH (and Staff Regulations) First ever (interim) Executive Director decision concerned Guidance on conflicts of interest and invitations and gifts, as well as declarations of commitment and confidentiality and interest (ED/01/2007) INTERNAL 2/21/2013 10
Legal Basis REACH Regulation Recital (95): The Agency should be central to ensuring that chemicals legislation and the decision-making processes and scientific basis underlying it have credibility with all stakeholders and the public. [ ] The confidence in the Agency of the Community institutions, the Member States, the general public and interested parties is therefore essential. For this reason, it is vital to ensure its independence, high scientific, technical and regulatory capacities, as well as transparency and efficiency. 11
Legal Basis (cont.) Article 88(2) REACH: Members of the Management Board, the Executive Director and members of the Committees and of the Forum shall make a declaration of commitment to fulfil their duties and a declaration of interests which could be considered to be prejudicial to their independence. These declarations shall be made annually in writing and, without prejudice to paragraph 1, be entered in a register held by the Agency which is accessible to the public, on request, at the Agency's offices. 12
Legal Basis (cont.) Article 88(3) REACH: At each of their meetings, members of the Management Board, the Executive Director, members of the Committees and of the Forum and any experts participating in the meeting shall declare any interests which could be considered to be prejudicial to their independence with respect to any points on the agenda. Anyone declaring such interests shall not participate in any voting on the relevant agenda point. 13
Legal Basis (cont.) Similar provisions for Board of Appeal (Art. 90 REACH) Similar provisions foreseen for future Biocidal Products Committee (see Biocides Regulation) ECHA staff: Staff Regulations, Title II (Rights and obligations) and ECHA staff implementing rules thereto 14
Legal Basis (cont.) Rules of Procedure of Management Board, Committees and Forum ECHA Policy for Managing potential Conflicts of Interest (MB/45/2011 final) 15
ECHA CoI Policy Main responsibilities outlined Main procedure for identifying and handling potential CoI outlined Conflict of Interest Advisory Committee established 16
Special report ECA Audit took place when ECHA was transiting from simple system to an advanced system ECA audited the old system and found it inadequate The new ECHA CoI policy and the new system under development was not audited All-encompassing new system, addressing the recommendations of the ECA, is now in place and audits on the new system will start this year 17
ECHA CoI Policy Prevention and management of potential conflicts of interests: I. Before engagement II. During engagement III. After engagement 18
I. Before engagement Eligibility criteria for members of RAC, SEAC and BoA (appointed by ECHA Management Board) Guidelines for eligibility for members of MB, MSC, BPC and Forum (appointed by MS, Council, COM or EP) CoI check included in recruitment procedure of ECHA managers 19
II. During engagement Detailed annual and ad hoc declarations of interest Documented CoI checks before assignment of task/file or during meetings Mitigating measures imposed where necessary 20
Annual declarations of interest Template annexed to CoI Policy To be renewed annually by all staff and all members of ECHA bodies Inclusive for members of household (spouse, partner and/or dependent children) Timeframe defined at past 5 years 21
Annual declarations of interest (cont.) Interests to be declared include: o Employment, consultancy, legal representation and advice o Membership of a Managing Body, Scientific Advisory Body or equivalent structure o Other membership or affiliation o Research funding 22
Annual declarations of interest (cont.) Interests to be declared include: o Investments o Intellectual Property o Public Statements and positions o Other relevant information 23
III. After engagement Certain duties continue to apply (independence/loyalty/confidentiality) Post-employment procedure for ECHA staff (application for approval for any new employment within 2 years) External experts (non-staff): limited impact, as ECHA not employer 24
Conclusions ECHA s own risk analysis confirms high sensitivity and potential impact of CoI ECHA applies proactively high standards of prevention of CoI Apply workability and proportionality in setting up procedures So far no CoI incidents ECHA and EU Agencies Network would welcome an EU standard or guidelines that set a minimum standard 25
Thank you! Geert.Dancet@echa.europa.eu