By its very nature, public trust in healthcare professionals (“HCPs”) is at the heart of the patient – HCP relationship and is crucial for the continuity and reliability of healthcare services. Because patients must rely on the knowledge gained by HCPs in their graduate medical degrees, it is important that HCPs make unbiased decisions ethically when determining the right treatment for patients. This necessitates transparency in the relationships between HCPs, healthcare organizations (“HCOs”), private companies and public institutions. With this understanding, the disclosure of anything of value provided to HCPs and HCOs is deemed to be a requirement by law in different countries. In addition, pharmaceutical companies are also held liable to declare any kind of value that they provide to HCPs and HCOs by the rules of the international and regional pharmaceutical associations of which they are members, by way of a voluntary commitment that instructs them to disclose transfers of value to HCPs and HCOs.
According to the Code of Practice of the International Federation of Pharmaceutical Manufacturers & Associations (“IFPMA”) and the Code of Practice of the European Federation of Pharmaceutical Industries and Associations (“EFPIA”), the pharmaceutical industry must disclose any kind of direct or indirect, monetary, and nonmonetary value transferred to HCPs. Disclosure must be made regardless of whether transfers of value are made in return for promotional or non-promotional activities, such as sponsorships for participation in scientific congresses, or fees for service agreements such as speaker fees, consultancy, and advisory boards. Member pharma companies voluntarily publish all transfers of value related to, or that may be assumed as related to the development and commercialization of prescription-only pharmaceuticals. Disclosure of values transferred in a calendar year are published at the latest by the end of June in the following year.
The Disclosure System in Turkey
Turkey’s transparency practice differs dramatically from the EFPIA’s voluntary disclosure system. Article 11 of the Regulation on the Promotion of Human Medicinal Products published in the Official Gazette numbered 29405 (“Promotion Regulation”), states that pharma companies need only make their disclosures to the Turkish Medicines and Medical Devices Agency (“TMMDA”), the regulative and enforcement body of the Ministry of Health (“MoH”), and that their declaration will not be made public. Furthermore, there is no scope related to their disclosure, but pharma companies are required to report all transfers of value exceeding a certain threshold per transaction.
What is Considered a Transfer of Value?
According to the Promotion Regulation, anything of value may be transferred to HCPs and/or HCOs for various reasons. Pharma companies may support HCPs’ attendance at scientific congresses and meetings in ways such as paying registration fees, accommodation, transportation, meals, and visa expenses. Even though this support is provided through payments made to conference organizations or travel agencies, such support is accepted as indirect payment made to HCPs and is subject to disclosure.
Pharma companies may also support HCOs, which include all the healthcare institutions and non-profit patient and HCP associations:
- Pharma companies may provide a range of sponsorship support to scientific congresses hosted by HCOs. Although payments may be made to conference organization companies, and not directly to the HCOs, these sponsorships are, however, deemed as transfers of value to HCOs.
- Pharma companies may make donations to HCOs. Providing anything of value in the scope of a donation is made for non-promotional purposes, these donations can be monetary or nonmonetary assets, such as equipment and book donations.
Prerequisites for Transfers of Value
Turkey applies a no consent no contract principle as a prerequisite for Transfers of Value (including VAT) that exceed 10% of the monthly minimum gross wage. That is to say, any value transferred at one time that does not exceed 10% of the monthly minimum gross wage is not subject to disclosure and does not require any liability to obtain consent or to keep a record.
However, if a pharma company is willing to transfer a value exceeding this rate, first they must obtain written approval from HCPs and/or the authorized supervisors of HCOs, for acceptance and for the notification of the transfer of value to the MoH. In the absence of this written approval, transfers of value cannot be made by pharma companies. The pharma companies are also held liable to keep records of all information and documents regarding a transfer of value for five years. Since the burden of proof that consent has been provided is on pharma companies, this liability to keep records must not be overlooked.
Written consent for the notification of transfers of value can be given for a specific period. Pharma companies usually obtain these consents for three or five years, especially from HCPs with whom they regularly interact. An important issue to highlight here is that in contrast to the principle of withdrawing a given consent in data protection law, the consent given for a notification cannot be withdrawn after a transfer of value is made.
How Transfers of Value are Appraised
The Promotion Regulation requires pharmaceutical companies to declare any kind of value, monetary or nonmonetary, directly or indirectly, transferred to HCPs and/or HCOs that exceeds 10% of the monthly minimum gross wage.
Minimum wage is determined annually by the Ministry of Family, Work and Social Services. For 2021, the gross minimum wage is TRY 3,577.50, accordingly any transfer of value above TRY 357 to HCPs or HCOs should be reported to the MoH.
How Disclosures Are Made
Like the EFPIA system, any payments made in a particular year must be disclosed in the first six months of the following year. Notification can only be made through the official TMMDA “Electronic Application System”. Transfers of value to a specific HCP or HCO in the same period are added and notified together. An official TMMDA template form is used for these notifications.
A notification includes the pharma company’s name, tax ID, registered city and the HCP’s name-surname, ID number and business address information, or the HCO’s information, and any information regarding the transferred value; the contributions made to events such as registration fees, transportation, accommodation, and meal expenses, or in the case of fees for service agreements, the service and consulting fee, and any other transfer of value. It should also be noted that, in cases where a service or consultancy contract is structured tripartite and made between the pharma company, relevant HCP and the employer HCO, with fees paid to the HCO’s bank account, the notification must also include the name of the relevant HCP and all other expenses related to the HCP such as transportation, registration and hospitality.
Liability of disclosure is not only deemed to be a requirement for the pharma companies. HCPs are also obligated to declare any kind of support at the end of published articles for which they have received support for their research and development, and at the beginning of any presentation for which they have received sponsorship. In contrast to the pharma companies’ responsibility of direct notification to the MoH, HCPs’ declarations of support are made directly to the public.
With the ultimate aim of providing transparency, accountability and integrity in the healthcare industry, a mechanism has been created that can demonstrate all the factors that may have affected an HCPs' decisions. Therefore, any kind of support provided to HCPs and HCOs which may be perceived as a motive to prescribe particular pharmaceuticals or to make decisions in favor of pharmaceutical companies will be declared to the MoH.
Due to the fact that these notifications are based on the principle of a statement, pharma companies must duly keep internal records of all their transfers of value, as well as the mandatory details of these transfers. Any absence of information may result in a misleading notification, which may cause severe liability for pharmaceutical companies, and may even result in the suspension of their promotional activities for up to one year.
Kemal Altuğ Özgün