Alignment of Agencies for Transparency and Ethics in Corruption Elimination

November 27, 2013 1

Imperative need for the alignment of the two agencies (EOF-SFEE) towards the same direction for the purposes of eliminating corruption with specific propositions in compliance with the principles of Transparency and Ethics Acknowledgment of EOF s initiative and reinforcement thereof with the circular (September 1, 2013) as well as with the new Code of Ethics of SFEE Alignment of EOF-SFEE to the direction of cutting down the promotional expenses and towards Transparency Commitment of all members of SFEE for greater Transparency and assumption of specific actions that will support ethical conduct SFEE s initiative for the evaluation of domestic conferences in accordance with the standards of EFPIA 2

It is permitted to offer devices/applications of medical/training use of insignificant value, up to Euro 15 (per item) VAT included, which are directly associated with the conduct of daily activities Informational & educational material and medical use material must be communicated to EOF. The use of the brand name of the product is prohibited, however the use of the corporate logo is possible. From January 1, 2014 no gimmicks bearing the company s logo or products such as pens, stickers, stationery, mouse pads, PC mouse are not permitted. 3

It is permitted to offer devices/applications of medical/training use of insignificant value, up to Euro 15 (per item) VAT included, which are directly associated with the conduct of daily activities of HCPs such as: Applications for mobile phones/computers which are not characterised due to their nature as medical technology products Anatomy and/or physiology models (physical or electronic) Anatomy charts (physical or electronic ) Training material for the patient via the HCP as supporting material Printed or digital publications with guidelines of Scientific Companies provided that they do not concern use not stipulated by the approved indications and dosage 4

Antiseptic fluids Surgical gloves/ scrub hats/cloths Catheters Syringes/ needles/tourniquets Ultrasound gel CPRs Mp3 Stethoscopes Formularies ECG recording tape Any personal objects Schedules, notebooks etc. Any stationery PC accessories From January 1, 2014 no gimmicks bearing the company s logo or products such as pens, stickers, stationery, mouse pads, PC mouse are not permitted. 5

Provision of books and subscriptions of a cost of up to Euro 100 (including VAT) per year, per HCPs per Pharmaceutical Company Books and subscription of higher value only by means of donation to institutions and scientific societies (unincorporated (non- profiteering) legal entities). 6

Private clinics can organise conferences provided that they have hospitalisations centres (over 50 beds) and multiple specialties (or ISO). Greece-wide conferences are realised not more than once per year and per recognised specialty agency. They last for at least 3 days with a daily scientific programme of at least 8 hours. Type A scientific events cannot be exclusively sponsored by only one pharmaceutical company. 7

SFEE may conduct audits in scientific Type A events via its bodies or external associates, in order to verify the compliance of the companies-members thereof with the provisions of this Code. The results of the audits will be communicated to the 1st Degree Committee for the Observance of the Code of Ethics of SFEE, which will set about in case of violation. Domestic type A conferences are evaluated by the competent committee of for conferences of SFEE and are posted at SFEE s e-platform (scientific.events.sfee.gr). Companies-members are recommended to take into account the evaluation from SFEE s committee for each conference, before they decided to participate in any manner. 8

Harmonization with EOFs circular Accommodation cost must not exceed Euro 140 (VAT included) for domestic conferences. Scientific events must not be held in touristic destinations during the respective touristic (high) seasons, i.e. for the summer (20/8 to 15/9), winter (15/12 to 15/1) and in no case to skiing destinations for the period from 15/12 to 15/3. 9

Conditions for the participation of HCPs in domestic conferences The place were each scientific event is held must be central and with easily accessible. The area is clearly of business nature and has a conference hall corresponding the needs of the event. The conduct of conferences held in Greece and accommodation of HCPs in 5-star hotels is prohibited. Strictly business 5-star hotels located in the capitals of Greece prefectures are excluded and in exceptional cases, hotels located outside the capital of a prefecture, if they serve the needs of the conference, following the positive opinion that will be granted by the Conference Committee of SFEE. 10

The maximum limit for the annual fee per HCP and pharmaceutical company cannot exceed Euro 5,000 (excluding VAT and further legal withholdings). Fees paid for services paid abroad and paid by foreign companies are not included. 11

Business meals with HCPs in the context of the scientific events is permitted. the cost per meal cannot exceed on a daily bases Euro 70, including VAT. It is permitted to organise business meals outside the scope of scientific events in areas appropriate for the purpose of the meeting. The same limits as for meals in the scope of scientific events apply in this case. 12

When the collection of data, in the context of a market research, is performed by a pharmaceutical ESOMAR/EphMRA must be observed and no fee is provided for HCPs participating in the research. company, the principles of When pharmaceutical companies enter into contracts with market research companies, they may grant a reasonable compensation with regard to the time spent, which in no case can exceed two hours. 13

Companies-members may file their complaints for any violation by mail, personally or via email at complaints@sfee.gr. Complaints may either be eponymous or anonymous. 14

Rules of good practice for the preparation of promotional material so that these will be accurate, documented and balanced. Rules of good practice for the use of new technologies in the promotion of medicinal products (e-mailing, newsletters, websites, social media) Main conditions that must be met in relation to the Patients Training Programmes 15

It provides for the detailed disclosure in relation to the nature and scale of interactions between the pharmaceutical industry and the HCPs and HCOs. Enforces obligations as to the disclosure of transfers to HCPs and HCOs (Medical Societies and Hospitals, clinics etc.), with disclosure in 2016 of the relevant transfers effected in the calendar year 2015. Disclosure will be performed at SFEE s website and free and public access will be granted to the data disclosed. 16

Transfers of value which: Are related to meals and drinks (article 19 ), medical samples (article 14), items of insignificant value (article 15) Are part of the ordinary transactions between a pharmaceutical company and an HCP. Who sells medicinal products by profession (such as for example, pharmacists, wholesalers) and/or an HCO i.e. financial transactions within within the distribution string for medicinal products do not fall into the scope of application of the disclosure. 17

Benefits-Transfers of value to HCOs related to any of the following categories: Donations and grants Contribution in costs associated to Events Fees for Consulting and other Services. Benefits-Transfers of value to HCPs Contribution in costs associated to Events Fees for Consulting and other Services. 18

Transfers of value that concern Research and Development activities for each Reference Period will be disclosed by each Member Company on an aggregated basis. Costs related to events that are auxiliary to activities falling into the scope of application of Research and Development activities (e.g. investigator meetings) may be disclosed in the aggregate. Application and Sanctions. The provisions of this Code are binding for the Member Companies. Violations of the said provisions entail the imposition of sanctions provided for in CHAPTER B of the SFEE s Code of Ethics. 19

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The transmission of informational or educational materials is permitted provided it is: (i) inexpensive ; (ii) directly relevant to the practice of medicine or pharmacy; and (iii) directly beneficial to the care of patients. The transmission of such materials or items shall not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer a Medicinal Product. Items of medical utility aimed directly at the education of healthcare professionals and patient care can be provided if they are inexpensive and do not offset routine business practices of the recipient. EFPIA and Member Associations shall provide guidance on the meaning of the term inexpensive , as used in this Article 9. Companies must comply with any relevant guidance provided under this Section 9.03 or in connection with any Applicable Code(s). 21