Ten facts about the Transparency Code
In 2016, FSA member companies will make public details of payments and transfers of value or in kind made to healthcare professionals (HCPs) and healthcare organisations (HCOs) during 2015. The first disclosures will be made in 2016 and will convey information about payments and transfers of value made in 2015.
In recent years there has been growing public interest in the pharmaceutical industry's relationships with HCPs and HCOs. Critically, the public want to know that such relationships do not influence clinical decisions and that they can trust their HCP to recommend, administer or purchase appropriate care and treatments based solely on clinical evidence and experience. This demand will be supported by this push towards transparency, which in turn will create greater trust.
By creating greater transparency around industry's collaborations and partnerships with HCPs/HCOs, FSA Transparency Code aims to strengthen the legitimate relationship between pharmaceutical companies and healthcare professionals by making these better understood by patients and other stakeholders.
As the primary point of contact with patients, the medical profession can offer invaluable and expert knowledge on patient's behaviour and management of diseases. It is therefore essential that the industry interact regularly with healthcare professionals and organisations (HCPs and HCOs). This plays a big part in increasing the pharmaceutical industry's efforts to improve patient care and treatment.
The FSA believes healthcare professionals and healthcare organisations should be fairly compensated for the legitimate expertise and services they provide to the industry. At the same time, these relationships need to be handled in an open and transparent manner.
Disclosures are made based on the national code of the country where the HCP/HCO receiving payment or transfer of value has their principal practice. The physical address where the HCP practices or HCO is located should be used as the reference when determining in which country the data should be disclosed.
For example, if an Italian affiliate of an EFPIA member company engages with a HCP whose practice is in Spain for an activity in Germany, this transfer of value will have to be disclosed under the name of the recipient HCP in Spain (following the applicable laws, regulations and the national code in Spain). This ensures that the patient or interested stakeholder can easily find the information regarding transfers of value to an HCP/HCO he/she has an interest in.
Member companies must comply with applicable data protection and other laws, which may impose certain limitations on their ability to make disclosures on an individual basis. Data privacy requirements must be checked at national level (i.e. the jurisdiction of the HCP/HCO receiving payment or transfer of value) by member company. This must be done prior to any disclosure. Companies are encouraged to obtain consent from HCPs/HCOs prior to disclosure, and the FSA and its member companies are working together with HCPs/HCOs to raise their awareness and prepare for the implementation of the Transparency Code.
The code applies to all FSA member companies including their domestic subsidiaries and other affiliated companies. You can receive information on these companies here: http://www.fsa-pharma.de/der-fsa/mitgliedschaft/mitgliederuebersicht/
As with the other codes, the FSA arbitration board can impose up to 400,000 Euros financial penalties on companies which violate the code. The money is donated to a charitable cause. Furthermore, the arbitration board can publish the name of the company on the internet.
"Healthcare Professionals" shall mean physicians and pharmacists based in Europe and exercising their professional activities there on a full-time basis as well as any member of the medical, dental, pharmacy or other nursing professions or any other person who in the course of his or her professional activities may prescribe or apply or lawfully trade in medicinal products for human use. These include employees of government agencies or employees of health insurance funds responsible at such agencies for prescribing, procuring, supplying or administering medicinal products or deciding on their eligibility for reimbursement, as well any employee of a member company who, besides their work for the member company, work on a full-time basis as practising physicians, pharmacists or other Healthcare Professionals who work on a full-time basis for member companies.