The long awaited Regulation on Promotional Activities of Medicinal Products for Human Use (New Regulation) is eventually published in the Official Gazette dated August 26, 2011. This New Regulation deals with the principles and limitations in relation to the promotion of medical products that are used by humans including biological products, enteral nutrition products, medical infant food, traditional herbal medical products, and natural or synthetic origin drug substances including immunological products (product) to physicians, dentists, pharmacists, nurses and other related healthcare professionals (HCPs). In general, the New Regulation clarifies many of ambiguous issues which were tried to be solved by interpretation of the rules in the past and adopts the common practice that used to be accepted and applied by the implementers.
The provisions of the New Regulation are examined under different headings below in order to provide a better view of the changes which are introduced.
General Principles about Promotional Activities
The promotional activities are defined as a compromise of publications distributed/sold to HCPs or publications in medical-professional scientific journals; scientific meetings organized or sponsored by marketing authorization (MA)/permission holders and visits of the promotion personnel. Visits by product promotion personnel1 to promote the products are limited to physicians, dentists and pharmacists unless the administration and side effects of products are to be explained.
The New Regulation explicitly forbids;
- Direct and indirect promotion of products to public through mass-media, as was accepted in common practice. This prohibition reveals itself also in the liability provision which assigns the chief of health institutions to take the precautions in order to keep the promotional material out of patient vision. As an additional note for promotional materials, their financial value shall not exceed the limit that is to be announced within the official website of the Ministry of Health (MoH).
- The HPCs, associations and foundations to have an active role in any kind of promotional activity unless the MoH permits.
- The promotion of the products, which are not duly licensed or permitted according to the related legislation. In line with the practice and interpretation of the Regulation on Promotional Activities of Medicinal Products for Human Use dated 2003 (Old Regulation2), activities within the scope of international congresses held in Turkey are explicitly exempted from this rule.
- To promise or give personal incentives to physicians, dentists and pharmacists similarly with the Old Regulation.
One of the major changes introduced with the New Regulation is that the frame of donations to public institutions is strictly drawn. It is not very clear whether the MoH aimed to forbid donations to private institutions, associations or foundations by setting these rules. On the other hand and notwithstanding with its aim, from a hierarchy of rules principle point of view providing such limitation on donations between private real and legal persons which are regulated by laws with a regulation is not possible. Therefore, said rules only sets common rules for donating to public institutions.
One of the specifications worth to be mentioned here is the requirement of permission of the superior administration of the public institution, organization or family health centre to which the donation will be done. This rule requires the MA/permission holders to apply to the related institution to get an approval before making the donation. This requirement seems to create problems for multinational MA/permission holders who limit a proactive approach in their international standard operation procedures.
Scientific and Educational Activities
The New Regulation makes a distinction between the promotional meetings and scientific meetings. According to the wording of the Regulation, the MA/permission holders shall not meet transportation and accommodation expenses of the participants to the meetings for promoting a product.
The outstanding principles with regard to local and international scientific meetings such as symposium and conferences are provided in detail with the New Regulation. The distinctive difference that will be brought by the New Regulation is the limitation of number of meetings that can be sponsored by an MA/permission holder per HCP. Accordingly, an HCP can be sponsored for five meetings at maximum within the same year while only two of these participations can be sponsored by the same MA/permission holder.
Attendance of the HCP to the national or international investigator meetings of clinical trials that are sponsored by the MA/permission holder is not considered as congress or symposium participation which will be counted in the above mentioned scope. Therefore the sponsor shall notify such nature of the support to the MoH.
A limit for free samples is adopted with the New Regulation and accordingly the amount of the distributed free samples cannot exceed the 5 % of the annual sale amount of the previous year for that product, however the year following the grant of the MA is not subject to this limit.
Product Promotion Personnel
The most significant change regarding promotion personnel is about their on the job trainings. The New Regulation obliges the promotion personnel to be subject to on the job trainings which are certified by the MoH. The certificates obtained as result of these trainings will be valid for three years. Details with regard to these certified trainings are expected to be determined with the announcements of the MoH, because it should be clarified whether in house trainings will be sufficient or the MoH will grant certification to some institutions in order to give training services. If the promotion personnel acts in contradiction with the principles set forth in the New Regulation, their training certificates are cancelled and they are banned from trainings for a year.
The promotional visit hours which were tried to be kept under control through circulars during the Old Regulation period are regulated in the New Regulation. Accordingly it is not possible for the promotion personnel to pay visits to HCPs during policlinic hours when patients are examined and in emergency services. The hours of the visits will be determined by the chief of the institution as not to disrupt health services.
Responsibilities of the MA/Permission Holder
The MA/permission holder shall establish a science service and assign a responsible person for each product to be placed on the market.
In case launch of a product is planned to be announced by press release, permission of the MoH is required. This activity, which is not regarded as promotion, could be done only once for each product.
Apart from the general rules such as the provisions of the Turkish Criminal Code, specific heavy sanctions are introduced by the New Regulation. In case a promotional activity contrary to the provisions of the New Regulation is conducted, the MA/permission holder is warned and the promotional activity is ceased; in case of repetition marketing activities for the concerned product are suspended for three months and for a year if the irregularity is continued.
The provisions of the New Regulation are envisaged to enter into force at different dates in order to grant a certain period of time to the firms in order for them to adopt themselves to the new provisions and make the necessary arrangements. Most of the provisions of the New Regulation are to become effective on December 31st, 2011 at the earliest.
At first sight the New Regulation seems to clarify many issues which were under discussion in the past. However, as always, when the word comes to the legal aspect of the situation there are still some questions which will need interpretation and clarification. Additionally, such detailed provisions and special sanctions which are regulated for cases of incompliance with the aforesaid principles demonstrate that the MoH is getting prepared to conduct more rigid audits on promotional activities and the outcome of such audits is likely to shed light on the interpretation and implementation of the New Regulation by the MoH.
1. In practice commonly named as "sales representatives" or "field force".
2. Even though this regulation is defined with the "old" adjective; it should be noted that it is currently applied and would continue to be in effect until all of provisions of the new Regulation enter into force.
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.