As COVID-19 outbreak has occurred in Wuhan in China and started to affect the daily life of the people worldwide, the practices in the healthcare sector have been either amended or suspended by Turkish Medicines and Medical Devices Agency(“TMMDA”) until further notice, in order to ensure the safety of the sector employees. In this context, the activities of Product Promotion Representatives as to their visits to physicians, dentists, and pharmacists in all health institutions/organizations including pharmacies had been suspended until further notice. In the meantime, the promotional activities of the product promotion representatives were allowed to be done electronically via e-mail, video conferencing, and similar methods.
Since the normalization process has started on June 1, 2020, the measures taken for the promotional activities of Product Promotion Representatives have also been re-evaluated by TMMDA upon the demands of the marketing authorization holders and the sector representatives and TMMDA has recently issued a new notification explaining that the promotional activities may resume under certain condition.
As per the notification, provided that the marketing authorization holders ensure that the training of their Product Promotion Representatives, on certain subjects such as infection control, reduction of contamination, etc. are completed, the promotional activities may be conducted in accordance with the below timeline and by fulfilling the respective requirements.
As of June 8, 2020, promotional activities may be started to be conducted in the primary healthcare institutions providing primary diagnosis and treatment services such as family health centers, pharmacies, community health centers, etc., provided that the below-mentioned requirements are fulfilled and maintained:
1. The visiting days and hours should be determined by the authorized person of these centers and the visits should be made when the patient density is rather low.
2. During the visits, Product Promotion Representatives shall use masks and shall comply with social distance and hygiene rules.
3. The promotion materials and printed promotional materials shall not be given during the visits.
4. The visits should last as short as possible.
5. The information of the physician, dentist, and pharmacist visited by the Product Promotion Representatives such as name, surname, institution, date of visit, and branches should be recorded.
As of June 15, 2020, promotional activities may be started to be conducted by visits of Product Promotion Representatives to physicians, dentists and pharmacists working in other hospitals, except for the hospitals where patients diagnosed with COVID-19 are treated, provided that the below-mentioned requirements are fulfilled and maintained:
1. The visiting days and hours should be determined by the authorized person of these centers and the visits should be made when the patient density is rather low.
2. During the visits, Product Promotion Representatives shall use masks and shall comply with social distance and hygiene rules.
3. No visit should be paid to inpatient services.
4. The promotion materials and printed promotional materials shall not be given during the visits.
5. The visits should last as short as possible.
6. The information of the physician, dentist, and pharmacist visited by the Product Promotion Representatives such as name, surname, institution, date of visit, and branches should be recorded.
7. If the decision to restrict the visit (branch and hospital-based) was made by the chief physicians of the hospital, this decision should be followed.
8. If a decision is made by the chief physicians of the hospital to restrict the visits (either branch or hospital-based), the decision should be complied with.
The promotion activities of Product Promotion Representatives in hospitals where patients diagnosed with COVID-19 are treated must continue to be carried out in the electronic form until further notice.
In addition, to the physicians, dentists, and pharmacists who do not prefer to be promoted through the visits of Product Promotion Representatives, the activities of the product promotions can only be made electronically on the conditions that the whole activity to be carried by the Product Promotion Representatives and without any information to be evaluated within the scope of the product promotion meeting such as product expert speech and/or speech video, etc.
Promotion to be conducted electronically may be done towards the lone physician, dentist, or pharmacist, as well as towards a group of physicians, dentists, and pharmacists who are working in the same health institution/institution.
The marketing authorization holders are indicated to be responsible for the acts of their Product Promotion Representatives and therefore they should follow the process carefully.
TMMDA has also provided certain contents for training and information materials to be utilized in training for Product Promotion Representatives, which marketing authorization holders should ensure that their Product Promotion Representatives should complete prior to initiating the promotional activities.
As the daily life and the sectoral practices begin to continue as in the times of pre-COVID-19 outbreak, we may expect that new notifications are yet to come in order to ensure both the continuance of the necessary promotional activities and the safety of the stakeholders of the healthcare sector.
Firstly published in Lexology on June 10, 2020.