1. What is the FSA Code of Transparency?
The FSA Transparency Code requires all member companies of FSA disclose payments and other transfers of value made to Healthcare Practitioners and Healthcare Organisations (HCPs and HCOs) in certain categories. The transactions disclosed could consist of, for instance, a grant to an HCO, or a consultancy fee for an HCP speaking engagement.
2. Where did the Code come from – who created it?
EFPIA, as the representative body for the research-based pharmaceutical industry in Europe, has a number of codes and guidelines in place to support transparency in the pharmaceutical sector, including payments made to patient advocacy organisations. The EFPIA Disclosure Code – in full, the EFPIA Code on Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations – was created in order to enhance the transparency surrounding relationships between the pharmaceutical industry and HCPs/HCOs.
3. What is the pharmaceutical industry’s objective with the Transparency Code?
The collaboration of the pharmaceutical industry with healthcare professionals is a decisive factor towards improving the care of patients. The pharmaceutical industry developed codes of conduct in parallel to the physician associations’ codes of conduct, which create a transparent and ethically-sound basis for collaboration, in order to guarantee that the patient’s well-being is the sole focus of all cooperation. Voluntary self-regulation has been successful up to now. However, societal expectations are continually increasing – in particular, the expectations of the system for transparency are rising. The pharmaceutical industry is responding to this development with the Transparency Code, by becoming increasingly more transparent and endeavouring to make its activities as consistent as possible, in order to thus foster a better understanding of the collaboration between pharmaceutical companies and healthcare professionals.
4. Why does the pharmaceutical industry need to interact with HCPs/HCOs?
It is essential for the development of new innovative drugs and improvement of existing treatments that the industry interact regularly with HCPs and HCOs. As the primary point of contact with patients, the medical profession can offer invaluable and expert knowledge on patients’ behaviour and management of diseases. This plays a big part in informing the pharmaceutical industry’s efforts to improve patient care and treatment options – and is essential to improving patient outcomes. A healthy working relationship between the pharmaceutical industry and HCPs/HCOs is in the best interests of patients. Of course, it is only fair to compensate HCPs and HCOs for the valuable insights and time they offer.
5. When will this information be available?
The first disclosures required under this new Code will made in 2016 and will convey information about payments and transfers of value made in 2015.
6. Where will this information be available?
This information will be published on the member companies' own websites.
7. Who has to abide by the code? What do you mean by HCP/HCO?
The FSA Transparency Code defines HCPs as any member of the medical, dental, pharmacy or nursing professions or any other person who, in the course of his or her professional activities, may prescribe, purchase, supply or administer a medicinal product. Medical institutions are defined as companies from the fields of health, medicine and research, as well as organizations such as hospitals, clinics, foundations, universities and other teaching institutions based in Germany.
8. Doesn’t this infringe on the privacy rights of the doctors and healthcare organisations involved? What is the HCP/HCO does not consent to disclosure?
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 in each case be checked at the national level by the member company prior. Companies must obtain consent from HCPs prior to disclosure.
9. Where will the Code apply? What happens in cases of non-compliance?
The Code applies to all FSA member companies including their domestic subsidiaries.
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.
10. Will the new system cover all payments made to healthcare professionals?
Yes, with the Transparency Code of Conduct, the FSA member companies will be making public all direct and indirect payments and benefits in kind made to healthcare professionals and medical institutions.
The FSA Transparency Code provides for the following categories:
- Donations and other unilateral payments,
- Payments in connection with further training events,
- Fees for service or consultancy contracts,
- Payments in connection with Research & Development.
11. What happens if a healthcare professional does not agree with the disclosures made by a company?
If a healthcare professional does not agree with the disclosures made by a company, he should directly contact the company and request clarification of the matter. The type, scope and remuneration of all collaboration between pharmaceutical companies and healthcare professionals must be documented according to the FSA Code of Conduct Healthcare Professionals, in order to enable any discrepancies to be quickly resolved.
12. Whom can a healthcare professional contact in case he has any questions?
In case of questions, the healthcare professional should contact the company with which he is collaborating. For general questions on the Transparency Code of Conduct, the FSA is also pleased to provide information.
13. Can healthcare professionals also state that they have no paid relationships to the industry?
Currently, there is no publication procedure for healthcare professionals who do not receive any payments.