Turkey: Promotion And Advertising Of Medical Devices In Turkey: How Many Shades Of Grey?

Last Updated: 13 February 2013
Article by Ozge Atilgan Karakulak and Ceren Aral

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.

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.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Ozge Atilgan Karakulak
Ceren Aral
Similar Articles
Relevancy Powered by MondaqAI
YukselKarkinKucuk Attorney Partnership
 
Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
YukselKarkinKucuk Attorney Partnership
Related Articles
 
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions