What is the Transparency Code? It is a self-regulatory directive that ensures the transparency of the transfers of value between the pharmaceutical industry and healthcare professionals, healthcare organisations and healthcare service providers, and it applies to the disclosure of specific types of benefits as determined by the European Federation of Pharmaceutical Industries and Associations (EFPIA). The Hungarian Transparency Code (TC) is the equivalent of the relevant EFPIA Code. The member companies of the AIPM and the companies that joined the Transparency Cooperation consider the spirit and the regulations contained within obligatory for themselves. Due to its nature, the TC, serving the purposes of self-regulation, defines stricter requirements than legislation.
All participants have the same goals: to heal efficiently, safely and effectively, to prevent diseases and to restore health by the power of science. Therefore, it is very important for everyone to understand: the continuous relationship between the developers of medicinal products and physicians is the key to ensuring the most advanced patient care and the use of state-of-the-art knowledge. On the other hand, transparency improves the efficacy and recognition of the joint work, and helps spreading the innovative medicinal products.
Self-regulation – Social responsibilities
During the first half of 2016 all the companies that joined to the TC all over Europe will disclose the amounts of the financial funding they disbursed based on their contracts with doctors, pharmacists and healthcare institutions. The disclosure will reveal the financial conditions of the 2015 cooperations and contracts, which, on one hand, supported the continuing education of doctors, and on the other hand used their feedback and expertise for creating and developing new innovative medicines.
The member companies of the Association of Innovative Pharmaceutical Manufacturers (AIPM) formed the independent Transparency Cooperation in April 2015. From this date, the Transparency Code, initiated by the European Federation of Pharmaceutical Industries and Associations (EFPIA) in 2012 and adopted to the Hungarian legal environment by the Association of Innovative Pharmaceutical Manufacturers at the end of 2013, opened up for every participant of the Hungarian pharmaceutical industry to join. Thus, now it is possible for any pharmaceutical company operating in Hungary to join this independent self-regulating platform provided that it accepts the spirit and the regulations contained within the code binding upon themselves.
The Hungarian Medical Chamber and the Hungarian Hospital Association supports the introduction and application of the TC in Hungary.
What is considered to be a benefit according to the Transparency Code?
Every transfer of value given directly or indirectly to any doctor or healthcare organisation/service provider, being either a financial compensation or payment in kind, in connection with the development and sales of prescription-only medicinal products exclusively for human use.
To organisations/service providers:
- donations and funding given to support healthcare or research
- contributions to the costs of events, including the funding of the participation of healthcare professionals in the events (agreements regarding the event, administration fees, travel and accommodation expenses); such events include events promoting the safe and economically feasible supply and provision of information of medicinal products and medical aids, or professional scientific events
- benefits regarding service or consultation agreements (providing any kind of service or consultation to pharmaceutical companies)
- contribution to the cost of their participation in an event (registration fees, travel and accommodation expenses); for the definition of an event, see above
- benefits regarding service or consultation agreements (scientific cooperation, presenting papers, professional consultation, research and development activities, clinical trials in particular)
Based on the first experiences regarding the creation and application of the TC, the majority of doctors and other healthcare professionals accepts the disclosure obligation contained in the document.
Further information about the Transparency Cooperation and the Transparency Committee can be found here on the organisation’s website.
There is nothing to hide
It is a fact that the benefits to be disclosed are provided explicitly for extra work carried out by the parties concerned (as the compensation of such activities has been a natural practice in other industries for a long time). The research and development activity of the innovative pharmaceutical manufacturers focuses on the development of more effective and safer medications and procedures, which could improve the standard of healthcare and patients' quality of life. Within the framework of the cooperation between pharmaceutical manufacturers and doctors, which serve as the basis for the funding and benefits, Hungarian doctors take an active part in these developments and have the ongoing opportunity to learn about the most advanced innovative therapies and technologies.
Recently, there has been a significant progress in the treatment of several diseases due to innovative medicines, and further breakthroughs are expected, which can alter the previous therapeutic practices and professional guidelines. The pharmaceutical companies in Hungary spend more than HUF 2 billion annually for the funding of professional events, which means a great help for Hungarian doctors so that they can remain in the forefront of science. Industry representatives agree that the doctors use the knowledge acquired at these conferences and trainings extremely well in their everyday work, and this knowledge helps them keep up with the fast progress of the solutions developed by medicine, healing practices and the pharmaceutical industry. There is no way for doctors and healthcare professionals alone to raise the money needed for financing the trainings, which can ensure that their knowledge is up-to-date.
Hence, it is essential for the benefit of patients that the developers of medicinal products and the doctors carrying out the therapeutic work cooperate in various forms.
More detailed information about the Transparency Cooperation and the Transparency Code can be found here.