Based on the Regulation on Promotional Activities of Pharmaceutical Products for Human Use issued by the Turkish Ministry of Health (the "Ministry") dated August 26, 2011 (the "Regulation"), Guidelines on Principles and Procedures and the Implementation Timeline for Training of Medical Sales Representatives (the "Guidelines") has been published on June 29, 2013. This Guideline sets forth the implementation timeline, and principles and procedures for training of product promotion representatives. The new training and certification requirements imposed by the Regulation on Guidelines will be effective in one year from now, on January 01, 2015, though the medical sales representatives are expected to take the examination in 2014.
According to the Regulation, medical sales representative ("MSR") is defined as any person holding a qualification certificate who promotes products to physicians, dentists or pharmacists through direct visits. According to the Regulation, MSR shall be equipped with full and adequate scientific data and knowledge necessary on the products promoted.
Product promotion representative training and examination
In order to ensure that MSRs are well-informed, the Regulation foresees that i) persons graduated from universities' "Medical Promotion and Marketing Programs" or ii) persons who are at least holding a high school degree, are provided with basic and essential Ministry-approved in-service training and are successful in the examination prepared by the Ministry shall be entitled to have a MSR certificate. As mentioned above the Regulation postponed the application of these provisions until January 01, 2015, until an adequate training and examination system is implemented.
Qualification certificates issued to graduates of the aforementioned universities' programs do not need to renew their certification, since a certification will be directly issued upon the submission of their diploma, without further examination. On the other hand, persons who are not graduated from these programs and are at least high school graduates shall need to take an examination in order to get a certification; and renew the certification every four year by retaking the examination. It is required to complete the training in order to take the examination.
The Regulation provides that the persons who are not successful in the examination until January 01, 2015, shall not be hired as a MSR or if they are already working as a MSR they shall not continue their work in that position.
As clearly specified in the Regulation and the Guideline, the training and examinations would be held four times during 2014 and at least twice yearly after 2014. The Ministry has signed a protocol with Yıldırım Beyazıt University in Ankara, which will give the training and organize the examinations. Therefore the Ministry would act as an intermediary at this stage. For the following years, the Ministry has planned to increase the number of the Universities enabling this training and examination.
The training will be provided using distance learning methodology based on a curriculum determined by the Ministry. As for the form of the examination, it has been determined that the questions would be multiple choices and drawn from a pool of questions in which the industry would have an input.
It has been confirmed by the industry that due to the expected large number of applications to the examination, not many make-up examinations would be offered in 2014. However, the number of application is expected to decline in subsequent years; thus allowing make-up examinations to be offered more frequently.
The certified MSRs will first be registered in the Ministry's electronic registration database by their employer and then a MSR ID card will be issued by their employer, in a format prescribed therefore by the Ministry.
The ID cards will be used by the MSRs in order to introduce themselves to the healthcare professionals. Although the format of the ID cards is not yet determined, the industry is expecting that the Ministry will most probably decide that a computer readable format shall be required since it has been known as a fact that the Ministry wishes to integrate a system to keep track of the MSRs. As it has been determined by the Regulation that marketing authorization holders and MSR shall jointly be responsible for the promotional activities carried out by MSRs, a MSR tracking system may be a solution to reduce any kind of illegal promotional activity.
Although it is foreseen in the Regulation that MSRs may work for more than one marketing authorization holders, the liability shall be resting with the marketing authorization holders, reserving any corporate contractual rights of marketing authorization holders.
Another liability of marketing authorization holders is to notify the Ministry within twenty days after a MSR leave working for them for any reason. This Regulation allows the Ministry to be updated on the status of the MSR as well. In such case the MSR will not be able to use his/her ID card prepared by this specific employer anymore and will have to wait to be hired by another employer in order to get an ID card issued.
The provisions in the Regulation and the Guideline have been brought in order to improve and regulate the promotional activities of MSRs. However, the industry has been debating whether the fee of the training and examination shall be paid by the employers or by the MSRs themselves since it is a work related examination. In addition, according to the Regulation, the MSRs who do not pass the examination will not be able to practice their profession as a MSR. In this context, this regulation, is directly affecting the MSRs' labour rights, due to the obligation brought to the employers who may have to make some of their employees redundant in order to be in compliance with the law. The implications on Turkish labour law requirements such as whether this would constitute a just cause for dismissal, the principle of "use of dismissal as a last resort" and substantial changes in the working conditions in case unqualified ones are employed at other positions must be carefully assessed by the industry.
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