SFEE Disclosure Code October 2014 Good governance in the pharmaceutical sector Interactions between the pharmaceutical industry and health care professionals have a profound and positive influence on the quality of patient treatment and the value of future research. Both parties regularly join together, during early scientific research, clinical trials and medical education in the interests of delivering and advancing high quality patient care. Despite the distinct roles of the various shareholders, we are all committed to a common goal: to constantly improve the life of patients. The Disclosure Code is a step towards greater TRANSPARENCY and TRUST between the pharmaceutical industry, the medical community and society across Europe. Why this initiative? The reasons for introducing the Code • Part of a series of international actions for self-regulation: (a) Introduction of the EFPIA Disclosure Code (b) Tajani Initiative on Transparency and Corporate Social Responsibility in the Pharmaceutical Sector (c) Sunshine Act already in place in the US • Under the above, the details on interactions between health care professionals/healthcare organisations (HCPs/HCOs) and pharmaceutical companies must be fully transparent Objectives • Further strengthening of Transparency and Professional Ethics and Responsibility • Transparency in the interactions between HCPs/HCOs and pharmaceutical companies • Responding to society’s growing demand for more transparency and integrity What will change? Disclosure of data by pharmaceutical companies, based in Greece or abroad, on interactions and cooperation with: - Health Care Professionals (HCPs) resident in Greece - Health Care Organisations (HCOs) resident in Greece The following information will be disclosed: - Details of HCP/HCO (name and tax registration number) - Level and type of transfer of value (e.g. fees for consultancy services, cost of participation in events, honorary remuneration, etc.) 1 Jan. 2016 Start of effect with the disclosure of data referring to calendar year 2015 Data will be disclosed through a dedicated platform on the SFEE website (www.sfee.gr), freely accessible by THE PUBLIC AT LARGE Disclosure – Individual HCP Recipient Α. Events/Conferences/Symposiums/Boards Registration fees Travel and accommodation Β. Consultancy and other services Fees resulting from or related to agreements between Pharma Company and HCP for the provision of services such as: • Education/training • Non-medical consultancy (Commercial Advisory Boards or Expert panels on pharmacoeconomics) • Speeches/Lectures • General consultancy services Other fees and related expenses agreed in the contract will be disclosed separately Disclosure – Individual HCO Recipient Α. Events/Conferences/Symposiums/Board Cost of group registration (where HCPs are selected by a PCO) Cost of sponsorship Β. Consultancy and other services Fees resulting from or related to agreements between Pharma Company and HCO for the provision of any type of services Γ. Donations and grants In cash or in kind Disclosure - Aggregate Aggregate disclosure will apply to cases where: ► the recipient denies or revokes consent once given ► the transfer of value relates to R&D, such as: Α. Activities relating to the planning and conduct of: • non-clinical studies (as defined in OECD Principles on Good Laboratory Practice) • clinical trials (Phase I,II, III & IV, as defined in Directive 2001/20/EC) • non-interventional studies that are prospective in nature and that involve the collection of patient data from or on behalf of individual, or groups of, HCPs specifically for the study Β. Εvents related to R&D: • Investigator meetings • Advisory boards on clinical research • Steering committee meetings, consultancy meetings on clinical research (e,g. biostatistics, epidemiology, etc.) • Technical training on clinical research (e.g. laboratory processes, training on equipment and systems, etc. Requirements for Disclosure and Exemptions Requirements • Written consent of the partner HCP/HCO • Data will be disclosed per individual person, identified by the following details: • -Full name (for natural persons - HCPs) - Corporate/Institution name (for legal persons - HCOs) - Tax registration number • Once given, consent may only be revoked in writing and for serious reasons • If consent is not given or is revoked, the pharmaceutical company will disclose the relevant data on an aggregated basis Exemptions • Exempted from disclosure are the following: • • • • • Transfers of value exclusively relating to OTC medicines Working meals in the context of events or otherwise Samples of medicinal products Medical practice items of negligible value (<€15) Ordinary business transactions (pharmaceutical distribution chain) Applicability and sanctions The Disclosure Code applies to and binds all the member companies of SFEE In the event of non-compliance, the following sanctions will apply: Sanctions on SFEE member companies • If the First Degree Committee, after processing a report/complaint, decides that there is a breach of the Code, it may impose the following sanctions: - immediate publication of the decision on SFEE’s website; and - financial penalty In the event of noncompliance with the above decision, a Follow-up Review Committee may impose an additional financial penalty In the event of noncompliance or inadequate compliance with this second decision, the Follow-up Review Committee may impose a penalty of up to three times the initial penalty If the member still fails to comply, the Disciplinary Board may consider the expulsion of the member The Disclosure Code in Europe What about the other countries of the EU? In 2013, the General Assembly of EFPIA adopted the EFPIA Disclosure Code 26 out of 33 countries of the EU have transposed the Disclosure Code in line with their national law and regulation France, Portugal and Denmark have transposed the provisions of the EFPIA Disclosure Code into their legislation The objectives of the Ethics & Transparency Committee TRANSPARENCY IN ACTION Promoting Responsible Behaviour across the Industry Training all stakeholders on the fundamental articles of the Code and its provisions – These will in turn communicate with their members and provide them with training Commitment by all stakeholders to greater transparency and to taking concrete action to foster Ethical Behaviour Effective implementation of the Disclosure Code by all stakeholders (medical community, etc.) – Consensus Highlighting and promoting of positive effects from the implementation of the Disclosure Code Setting an example for change and combatting corruption Next steps within 2014 Information activities 15 October-15 November October - December June – October Information meetings with Health Care Stakeholders ● SFEE General Assembly ● Internal Workshop/ “Prepare our Members” campaign ● Public Information Event ► Direct Mail Campaign ► Online / Social Media Campaign ► Newsletters ►Awareness Campaign ►Section dedicated to the Disclosure Code on SFEE’s website Disclosure Code Month “Door to Door” Information to Health Care Professionals by medical reps of SFEE member companies The successful implementation of the SFEE Disclosure Code, which is aimed at maximum transparency is crucial for enhancing transparency and public confidence in the relations between HPCs/HCOs and pharmaceutical companies. Our engagement is necessary!