Pharmaceutical companies, physicians, pharmacists, academicians, pricing and reimbursement officers... Each of these is an important stakeholder, who has a critical role in presenting the most effective treatments to patients. In that respect, all of these interact with each other under certain rules and regulations. One example is that pharmaceutical companies, who are the marketing authorisations holders of pharmaceutical products, need to receive professional assistance of healthcare professionals as well as key opinion leaders, academicians and other specialists (all will be referred to as "HCPs") in the process of developing medical content and disseminating such information to other HCPs.
The most frequent forms of the professional assistance received from HCPs are speaker services and advisory services. In the first one, HCPs attend scientific symposia and congresses to deliver speech and presentation on a scientific topic, while on the other such contribute in preparation of a medical content or material. In return of the professional services provided and the time allocated, a fee called "honorarium fee" is paid.
All over the world, interactions between HCPs and pharmaceutical companies is a debated area. To prevent any conflict of interest, official authorities and public expect more transparency. In that respect, governments do their best to minimise the financial interactions. As detailed below, this is also what has happened in Turkey as the Government through the law making process before the Turkish Parliament amended the legislation to prevent such interactions as much as possible.
Although it may be understandable why such a sceptical approach is taken, it should also be taken into account that such medical advisory services are necessary indeed not only for pharma companies and physicians but also in the ultimate plan the public, as public has the utmost right and benefit in developing the medical intellectual capacity in the pharmaceutical area.
Surely, also the pharma industry supports that this area is regulated by certain rules and regulations. In particular, originator pharmaceutical companies, which are foreign capital companies and in most cases do care about complying crossborder legislation such as FCPA, UK Anti-bribery Act, are willing to take all the necessary precautions to prevent any breach to the local legislation and ethics rules.
In the light of the foregoing, we have deemed necessary to provide information on the current legal status regarding honorarium payments.
1. Current Legal Framework in Turkey
Currently working conditions of HCPs and honorarium payments made to HCPs are stipulated under the Decree Law with No. 650 published in the Official Gazette on August 26, 2011. The Decree Law with No. 650 amended various laws including the following:
- Law on Public Servant, No. 657, Article 28: Public servants cannot operate bureaus, offices and private clinics to perform professional activity or self-employed work; neither can they work at workplaces of private entities or institutions in the nature of public institution or foundation universities.
- Law on Higher Education, No. 2547, Article 36: Academics (only professors and assistant professors) can perform professional work after working hours, provided that they do not receive revenue from the revolving fund administrations of their institutions.
- Law on Military Medicine Academy Law, No. 2955, Article 32: Academic personnel of the civil and armed forces (only professors and assistant professors) can perform professional work after working hours, provided that they do not provide services at their institutions regarding treatment of soldiers and they have obtained permission from the Turkish General Staff.
In accordance with the mentioned amendments, the Decree Law with No. 650 stipulated a restrictive approach with respect to HCPs working on his/her account. In summary, all public officers were prohibited from working on their own account both during and after working hours, however, physicians with academic status (civilian or soldier) could work on their own behalf provided that they do not generate income from revolving fund of the institution that they work and they performed such study after working hours. Another controversial dimension of the matter was related to copyright payments. We evaluate that copyright payments that could be made to HCPs should be literally interpreted, since an intellectual or artistic work must exist in order to make a copyright payment. We evaluate that in case HCPs who are public officers and HCPs with academic title who created a work, which has no relationship with the official duty of the HCP, copyright payment could be directly made to the HCP.
However, the Constitutional Court repealed the Decree Law with No. 650 a year after its publication, on July 2012. Nevertheless, the repeal decision is not yet published on the Official Gazette, and will enter into force one year following its publication. The grounds of the repeal decision are the procedural rationales. The Court did not state any evaluation with respect to substantial aspects of the Decree Law. Therefore, we evaluate that the decision did not change the current legal status with respect to payments made to HCPs.
2. Transparency with regard to the Relationships between Pharmaceutical Companies and HCPs
Meanwhile in Europe, the pursuit for transparency with regard to the relationships between pharmaceutical companies and HCPs has also been a topic of discussion. The Directive 2001/83/ EC of the European Parliament and the Council dated November 6, 2001 relating to Medicinal Products for Human Use ("Directive"), concentrates on many aspects of the promotion of medicinal products. However, the Directive does not comprise any provision regarding disclosure or reporting requirements on (honorarium) payments to HCPs. Therefore, EU member states are not required to regulate any such obligations in their national laws, but some European countries regulate this area. For instance, the French government enacted a transparency act, namely "La Loi Relative au Renforcement de la Sécurité Sanitaire du Médicament et des Produits de Santé" (The law relating to improvement of the health security of drugs and healthcare product) in December 2011 which was deemed as a major and comprehensive reform of the French healthcare system. This act stipulates reporting requirements and two main types of transparency rules; (i) public declarations of interest that HCPs must make concerning their relationship with pharmaceutical companies, and (ii) disclosure obligations imposed on pharmaceutical companies concerning their interactions with HCPs.
In the meantime, the European Federation of Pharmaceutical Industries and Associations (EFPIA), of which Association of Research-Based Pharmaceutical Companies (AIFD) is a member, released the Code on Interactions with Healthcare Professionals, which does not contain actual reporting or disclosure requirements. However, it encourages pharmaceutical companies to ensure that information, regarding donations, grants or benefits provided to institutions, organisations or associations comprised of HCPs, are publicly available. Furthermore, the EFPIA Code on Relationships with Patient Organisations contains reporting requirements. The requirements apply to activities initiated as of or ongoing on January 1, 2012, with the first reports to be made public by the end of the first quarter of 2013.
Finally and most recently, EFPIA Draft Code on Transparency of Payments to HCPs and Healthcare Organisations has been prepared and discussed. With the virtue of this Code of Transparency, EFPIA is preparing to require member associations to impose a requirement to document and disclose payments and other transfers of value directly or indirectly for the benefit of the HCPs and healthcare organisations. The Disclosure is designed to be made annually and standardised templates shall be used.
The Ministry of Health has recently mimicked the EFPIA's Draft Code of Transparency's approach. On October 14, 2012 the MoH published amendments on the Regulation on Promotional Activities of Human Medicinal Products and required HCPs to mention/disclose all sorts of sponsorships received at the end of each scientific article and/or at the beginning of every speech/ presentation.
As summarised above, we are in a transition period where the issue of honorarium payments seems to be debated for a further while. The legislation will be amended at some point in light of the Constitutional Court decision. However, we evaluate that there are already certain rules in place to be considered in determining the necessary actions to be taken. Therefore, it would be reasonable to follow the wording and the spirit of such rules and prefer to remain on the safe side to avoid any possible administrative and/or legal risk.