In June 2013, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has adopted the “code on disclosure of transfers of value from pharmaceutical companies to healthcare professionals and healthcare organisations” in an effort to further self-regulate the way pharmaceutical companies can work and interact with healthcare professionals and their organisations when a value transfer is involved. Healthcare professionals and healthcare organisations provide Medivir with independent and expert knowledge derived from their clinical and management experience and Medivir compensates them fairly for the services provided.
With the implementation of this new Disclosure Code, transparency of pharmaceutical company interactions with healthcare professionals will now be taken a step further. Meetings support and other payments made to healthcare professionals or healthcare organisations during the course of 2015 will be made public in mid-2016 and annually from then onwards.
The EFPIA (European Federation of Pharmaceutical Industries and Associations) Disclosure Code is a formal code of conduct that requires all EFPIA member companies and companies which are members of EFPIA member associations to disclose transfers of value to healthcare professionals (HCPs) and healthcare organisations (HCOs). As an EFPIA Member Company Medivir has to disclose the names of healthcare professionals and organisations that have received payments or other transfers of value from Medivir. Medivir will also have to disclose – by HCP or HCO – the total amounts of value transferred, by type of transfer or value which could consist of, for instance, a grant to an HCO, a consultancy fee for speaking, payment for travel, or registration fees to attend a medical education congress.
The EFPIA General Assembly formally adopted the EFPIA Disclosure Code on June 24, 2013. The Code applies to all EFPIA members including: Corporate Member Companies; Members of EFPIA Specialised Groups: (i) European Bio-pharmaceutical Enterprises (EBE) and Vaccines Europe (VE); and Member Companies of Member Associations that are not directly members of EFPIA. This includes most major pharmaceutical companies operating in Europe. You can find a list of EFPIA Member Companies, Member Associations and the countries they operate in, at: www.efpia.eu/about-us/membership.
What?
Medivir will disclose transfers of value made to health professionals such as sponsorship to attend meetings, speaker fees, consultancy and advisory boards. More specifically, donations and grants (to organisations only; grants and donations are not allowed to individual healthcare professionals under the EFPIA Code), coverage of costs to participate in events (including registration fees, travel and accommodation), fees-for-service & consultancy, where a contract is in place for activities such as speaking at, or chairing meetings, attending advisory boards and media consultancy and research & development transfers of value, which are disclosed in aggregate.
Examples of Transfers of Value covered under Fee for Service and Consultancy agreements according to EFPIA:
When?
Transfers of Value made from Medivir to health professionals are recorded throughout the year and publically disclosed by the 30 June, of the following year. The first disclosures will be made by 30 June 2016, for payments made in 2015. This information will be published on Medivirs company web site and with a link from LIF.se.
Currency
Transfer of value is reported in EUR.
Honorarium, fees and expenses
Honorarium paid as salary will be reported as gross salary, excluding social costs. Honorarium invoiced by a company will be reported excluding VAT. Other expenses in connection with the assignment will be reported excluding VAT. If small expenses and not able to separate from the honorarium it will be included in the honorarium.
Compensation received by market research conducted in accordance with the LER (Pharmaceutical Industry Ethical Rules) reported as remuneration only when the respondent is known for the sponsoring pharmaceutical company
What will be reported as HCP?
HCP means healthcare professionals. Transfer of value as salary to individuals as well as expenses in connection with the assignment will be reported under HCP.
What will be reported as HCO?
HCO means healthcare organization. Honorarium, fees and expenses invoiced by sole trader, trading company, limited company and limited partnership will be reported under the HCO. For assignment performed in-service the transfer of value paid to the organization/clinic or health care unit reports under HCO. Donations and sponsorship to healthcare organization also reports under HCO.
What includes in “Other"?
For payment of salary and for payment to sole trader, consent is required before publishing according to the Personal Data Act (PUL). In cases where consent is not granted, the transfer of value will be reported as unspecified in a total number under “Other”. The number of recipients not giving their consent will be shown together with the percentage of the total number of recipients.
What is reported R & D (total sum?)
With the transfer of value for research and development refers to transfer of value to the recipient associated with the planning or execution of (i) non-clinical study (defined in the OECD Principles of Good Laboratory Practice), (ii) clinical trial, or (iii) non-interventional study involving collection of patient data from healthcare professionals or on their behalf.
What is reported Sponsorship?
With sponsorship meant financial or other support, and includes a market return, such as, for example, exhibit space or other exposure. Pharmaceutical companies may only offer sponsorship to healthcare organizations or association, to cover the actual documented, reasonable and direct costs necessary for the professional elements such as:
Any sponsorship at international congresses in Sweden will be reported in the country where the organizer has its registered office. Examples of activities that should as a minimum be covered under “Sponsorship Agreements” according to EFPIA:
United Kingdom in English 2016