There have been specific rules governing the promotion of medicinal products in Turkey since the beginning of the 90's. The Regulation on Promotion of Medicinal Products for Human Use ("The Medicinal Products Promotion Regulation") of the Ministry of Health ("MoH") provides specific rules on promotion of medicinal products through interactions with health care professionals (HCPs) in areas such as sharing of information and material by product representatives, product samples, congress sponsorship, whilst advertising to public is strictly prohibited. The Medicinal Products Promotion Regulation also deals with donations, although donations cannot be used as a promotion tool.
The Medicinal Products Promotion Regulation does not cover medical devices ("MD or MDs") and there are no specific rules for MDs from the perspectives of neither interactions with HCPs nor advertising to the public. The promotion of medical devices through interaction with HCPs is governed by the law applicable to civil servants, predominantly ethics rules preventing the civil servant HCPs to demand or receive benefits for the exercising of the public service. On the other hand, advertising to public is governed by general rules, i.e. under consumer protection, advertising and unfair competition law.
Despite the lack of applicable provisions specific to medical devices, it was observed that in practice when it came to interaction with HCPs, the MoH did not in principle differentiate medical devices from medicinal products. The MoH expected the medical device manufacturers/distributors to comply with almost the same standards applied to medicinal products.
In 2011 the MoH wanted to clarify the grey areas and provide a regulatory framework for the promotion of MDs. The MoH was already engaged in the process of revising The Medicinal Products Promotion Regulation and most probably considered that it would be practical to also include MDs within the scope of the revised version. Accordingly, the MoH opened The Draft Regulation on Promotion of Medicinal Products for Human Use and Medical Devices and Health Declarations Provided for Promotions of Products for comments and suggestions from the industry.
The inclusion of MDs within this draft regulation was not welcomed by the industry. It almost seemed like the term MD had been included within the draft which was originally designed only to be for medicinal products. Therefore the regulation in the overall did not make much sense for MDs.
Medicinal products and MDs differed substantially on some important points like channels of trade, users, market entry conditions, classification, license/approval requirements. Therefore the application of the exact same product rules for medical devices was too strict for the nature of some types of MDs and thus not practical.
For example, just as in the case of medicinal products, the draft regulation prevented advertising of medical devices altogether irrespective of the medical device being subjected to the professional use of HCPs or everyday use of patients or consumers.
Moreover, the draft regulation provided significant quotas on sample products for MDs. Sample products are of significant importance for medicinal products, but medical devices are mostly promoted through demo products. There was uncertainty as to whether demo products could still be provided and if so, whether the same quotas would be applicable to them too.
To sum up, this drastic change from no specific provisions to having provisions applicable to medicinal products did not gain much support from both public and private entities within the health care sector. Eventually, it was unofficially confirmed by the MoH that specific provisions would be introduced for promotion and advertising of medical devices. Such provisions would not be formulated within the same document as medicinal products but as a seperate regulation covering medical devices only, taking into account their nature and specifics.
The MoH then moved on to publish the amended "Medicinal Product Promotion Regulation" on August 26, 2011 without any reference to medical devices within its scope1. The MoH subsequently opened the Draft Regulation on Advertising and Promotion of Medical Devices ("The New Draft Regulation") to comments and suggestions from the industry. The New Draft Regulation allowed advertising of non-professional medical devices to the public pursuant to both general advertising rules and some specific provisions arising from the nature of medical devices. It further set almost the same standards for the promotion of medical devices to HCPs, where under a few specific provisions the medical devices were subjected to lighter requirements compared to medicinal products. The New Draft Regulation was expected to be published before the beginning of 2012 and enter into force one year from its publication. However, as of today the MoH has not published this legislation yet.
At the current stage the real problem arises from the fact that the interactions with HCPs for pharmaceutical companies are strictly regulated, whereas there is still no regulation for medical devices. Even though at the first glance this may seem liberating for the medical device companies, the industry often finds itself faced with obstacles as there exists many grey areas of practice which can result in the risk of the MoH holding medical device companies responsible by relying on general provisions.
For example, relating to sponsorships, The Medicinal Products Promotion Regulation sets forth a rule commonly referred to as 3-2-1 rule. Under this rule an HCP can receive maximum three congress sponsorships from pharmaceutical companies. A maximum of two of these sponsorships may come from the same pharmaceutical company and a maximum of one of them can be an international congress. Furthermore, as the mere reflection of the global transparency rules in Turkey, the pharmaceutical companies are obliged to submit all the details in relation to the congress sponsorship to MoH's online database and obtain approval before the attendance takes place. Under the current regulatory framework, the medical device companies are not legally bound to make such online notification and obtain an approval. However in case they sponsor the HCP above the HCP's quota, the HCP and the MD company may be held responsible by the MoH. It gets significantly important where the same entity operates both in the areas of medicinal products and MDs.
On the other hand, regarding advertising to public, though it is not an official statement, it is known that in 2012 the MoH shared its view with the industry during its sector meetings that when the Draft Medical Device Promotion Regulation is published, the advertising of MDs will be prohibited altogether. This point of view was later confirmed by official letters sent by the industry associations. This was not supported, as prohibiting advertisement of all MDs including the ones that require no HCP intervention for selection and application would not protect the patients or consumers but would result in detriment caused to their access to information. In this respect, it is known that a Turkish medical association presented a suggestion to the MoH where the advertising of the MDs will be evaluated based on whether the device is for the use of health care professionals or patients. In this respect, for the professional devices that are prescribed and/or exclusively applied by the HCPs, the advertising to public would be forbidden and only promotion to HCPs would be permitted. For the non-professional devices that do not require any kind of intervention of an HCP and/or a prescription, the advertising would be possible without any specific limitations.
As of today, the issue remains unclear. However it can be said that the MD industry wishes to actually have the promotion and advertising of MDs regulated in order to overcome these many shades of grey. It is expected that the issue will get some clarity in 2013 with solutions that are hoped to be in a practical and reasonable manner.
Footnotes
1.This regulation was again amended on October 14, 2012.
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