Promotion essentially means informing of healthcare professionals (physicians, pharmacists and dentists) by market authorisation holders (i.e. pharma companies) on the medical features of pharmaceutical products to enable the recipients develop sufficient technical information. Both physicians and dentists are the ones who prescribe products to patients, while pharmacists prepare and dispense such medications. Promotion is a sensitive issue, as it several important aspects including patient health, public spending, ethics & compliance and last but not least the commercial sustainability. At the end of the day, promotion is not necessary for pharma companies to better introduce their products, but also crucial for healthcare professional to keep up to date on the new treatments and the new features of the existing medications.
In Turkey, while there are some laws that have applicable provisions, the most relevant legislation on promotion is the Promotion of Pharmaceutical Products ("Promotion Regulation"). The Promotion Regulation was renewed the Ministry of Health ("MoH") and entered into force at the end of 2011. Some of its provisions will become effective in the 2013 and following years. In the meantime, in October 2012, various provisions of the Promotion Regulation were amended. MoH also published some guidelines and circulars to detail the rules of the implementation and these days the pharmaceutical industry and the other stakeholders are in the process of digesting this new legislation piece and taking their precautions to provide compliance.
Furthermore, also the pharmaceutical industry has some rules and regulations on the promotion, in particular from the perspective of ethics. Among the industry associations, the Association of Research Based Pharmaceutical Companies ("AIFD") is the professional body of the originator pharma companies, which is the Turkish extension of the European Federation of Pharmaceutical Industries and Associations ("EFPIA"). AIFD updated the Code of Good Promotional Practice and Good Communication ("AIFD Code") in light of the renewed Promotion Regulation and made it effective starting from 1st of July 2012.
Following such introduction on what has happened during the last year in the legislation and industry rules on the pharmaceutical product promotion, we would like to mention some of the significant changes introduced by such new regulations:
I. The Amendments on the Promotion Regulation
The most significant amendments can be summarised as follows:
Certification: The Document of Competency has been introduced by a definition under Article 4. With the new provision, in order to qualify as a product promotion representatives ("PPR") a certificate, which is valid for 4 years, must be obtained from the MoH. From January 1, 2015, potential PPRs are to apply for a document of competency. The minimum entry requirement for the document of competency is a high school graduation certificate and a document demonstrating successful results in the examination held by the MoH. However, university graduates of medical advertising and marketing programmes are eligible to obtain this document without any prior evaluation.
PPRs: Pharmaceutical companies shall register PPRs on the MoH's electronic record system. Furthermore, companies shall issue ID cards for their PPRs which will be mandatory to work in the field. Companies shall notify the MoH within 20 days when a PPR leaves or starts his/her work. At the beginning of the visit each PPR shall be required to display his/her ID card and to indicate which marketing authorisation holder he/ she represents to the healthcare professionals ("HCPs").
Reminder Materials: "Modest monetary value" used within the Regulation's definition of reminder materials has been determined in a more concrete way. Pursuant to this new provision, reminder materials' value cannot exceed 2.5% of the relevant year's gross minimum wage.
Educational Activities: Each HCP will be entitled to participate pharmaceutical company sponsored events for a maximum of 3 times a year, 2 of which can be sponsored by the same MA holder company. Another restriction is that HCPs can only attend only 1 event abroad.
Support: HCPs shall disclose all sorts of sponsorship received at the end of each scientific article and/or at the beginning of every speech/ presentation.
Free Samples: The quantity of free samples shall not exceed 5% of the previous year's total sale in the 1st and 2nd years and 3% of the total sales of the previous year for 3rd, 4th and 5th years and 1% thereafter.
II. The New AIFD Code
The main changes stipulated with the new Code are summarised below:
Promotion: The rule stipulates that promotion can only be aimed at healthcare professionals HCPs. It is possible to give specific information to other HCPs such as nurses and pharmacy technicians. In case of the breach of the Code, PPRs and the company will be jointly liable. It is also stipulated that pharmaceutical companies should provide service trainings to the PPRs.
Promotion Materials: The new Code abolished the positive list which was applied during 2004- 2011. However, the negative list is still applicable. Although a financial limit regarding medical scientific publications that can be distributed to HCPs is not stipulated in the law, the law states that companies should avoid extortionate payments which may lead to misinterpretation. Furthermore, the new Code stipulates detailed provisions on free samples, in parallel with the Regulation and the EFPIA Rules.
Donations: The Code states that direct or indirect donations cannot be made to HCPs. However, donations to public institutions are acceptable, provided that the conditions stipulated under the Regulation and the Code are met. The new regulation also specifies the conditions that donations can be made to non-profit organisations, institutions, and foundations that are established by the HCPs.
Educational Activities: The code states that large scale international congresses are an exception to the promotion ban concerning unlicensed pharmaceuticals. In promotions aimed at such organisations, it should be noted that such products are not licensed. As stated in the rules, large scale organisations can only be set up by specialised institutions.
Internet Usage: The Regulations also stipulated certain provisions on internet, digital platforms and social media concerning promotion of pharmaceuticals.
In light of the recent changes in Promotion Regulation and AIFD Code, it can be stated that the promotion area has become much more regulated and the official authorities have more tools to follow such activities more closely. Obviously, public has a certain level of interest that pharmaceutical product promotion activities are carried out in compliance with such regulations and ethics principles. Without doubt, the foremost benefits are the rational use of medications and access to new treatments. While the industry is working hard to improve its level of compliance with new rules, governmental agencies should also do their best in order to enable marketing authorisation holders to access HCPs and deliver their promotional messages and materials in the most appropriate way that would allow scientific content sharing.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.