Регулирование рекламы лекарственных средств в интернете

Mobile websites

Mobile websites are considered as full desktop websites and as they must be submitted to prior approval to ANSM.

4. What are the main requirements for online promotional materials according to corporate standards?

See sanofi ITS global intranet http://internet.sanofi-aventis.com/Pages/Home_Page_en_en_US.aspx

5. What role does self-regulation of pharmaceutical industry and advertising play in your country? What is the role of Sanofi in self-regulation?

Self-regulation of pharmaceutical industry

the Leem association is the union of pharmaceuticals industries in France. The Leem includes several workshops and committees, including a regulatory instance.The Leem writes and gives recommendations and guidelines to its members. http://www.leem.org

Role of Sanofi in self-regulation

Sanofi has several Department (Digital and multichannel, Regulatory affairs, Quality, Information technology, Promotional charter department) which emit recommendations in form of guidelines, white papers, procedures related to Digital.

At the local level of the France affiliate a committee named "Digital incubator" communicates recommendations to marketing teams. This committee validates all digital projects. (Permanent members of this committee are Digital and multichannel, Digital regulatory affairs, External Communication, Legal Affairs, Pharmacovigilance)

At the Global level, all websites projects and social networks must be submitted for validation to the IVC (Internet Validation Committee) prior the Go live/online. It is also a transversal committee that emits some Digital recommendations and validates digital projects.

6. Please, provide some examples of successful online promotion of drugs by your company.

· Synvisc Multichannel project:

o www.sanofi-arthrose.fr

o www.retrouverlemouvement.fr

o App Arthmouv:

· Lovenox Multichannel:

o www.agir-thrombose.fr

o www.thromboseval.fr

o App Caprini:

· Diabetes Multichannel:

o www.sanofi-diabete.fr

o App Mon Glucocompteur :

o www.diabeteanalytics.fr

o www.diabplus-equilibre.fr

o www.toujeo.fr

· Novanuit Social Media platform: Team de Nuit

o www.teamdenuit.fr

o Facebook: https://www.facebook.com/Teamdenuit-918555641537741/

o Twitter:

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Интервью с Shanna Kijko, Digital Marketing Solutions, ITS (Sanofi-Aventis, Германия)

· Расскажите, пожалуйста, чем Вы занимаетесь в Санофи.

IST (Information Technology & Solutions) Manager Digital Marketing, проектный менеджмент проектов в сфере Multi Channel Solutions and Digital Marketing Solutions в Германии и Европе

· Разрешена ли реклама лекарственных препаратов в Интернете в Вашей стране? Существуют ли какие-либо ограничения?

http://www.iclg.co.uk/practice-areas/pharmaceutical-advertising/pharmaceutical-advertising-2015/germany

· Какие диджитал инструменты продвижения лекарственных препаратов используются в Вашей стране и в компании?

В стране:

В компании:

· Social Media - Content Page

· Social Media - Ads

· Live E-detailing

· Self E-detailing

· Mobile Ads

· Newsletter / Email Marketing

· Transactional Email

· Mobile Application

· Search Engine Optimization

· Display Retargeting

· Pay Per Click

· Website

· Webinar

· Как регулируется реклама лекарственных препаратов в Интернете в Вашей стране (законы, этические кодексы, международные соглашения)?

P.1 http://www.iclg.co.uk/practice-areas/pharmaceutical-advertising/pharmaceutical-advertising-2015/germany

· Какие требования предъявляются различными документами к рекламе лекарственных препаратов в Интернете?

P8. http://www.iclg.co.uk/practice-areas/pharmaceutical-advertising/pharmaceutical-advertising-2015/germany

· Расскажите, каким основным требованиям должен соответствовать рекламный онлайн материал по внутрикорпоративным стандартам?

· Уделяется ли внимание саморегулированию фармацевтической отрасли в Вашей стране? Если да, то какова его роль и участвует ли в нем Санофи?

P1. http://www.iclg.co.uk/practice-areas/pharmaceutical-advertising/pharmaceutical-advertising-2015/germany

Да, FSA ("Voluntary Self-regulation of the Pharmaceutical Industry" (Freiwillige Selbstkontrolle fьr die Arzneimittelindustrie e.V. - FSA) и AKG ("Pharmaceuticals and Cooperation in the Health Care Sector" (Arzneimittel und Kooperation im Gesundheitswesen e.V. - AKG). Санофи - член обоих организаций http://transparency.efpia.eu/countries/10/30/Germany

· Приведите, пожалуйста, пример(ы) успешного онлайн продвижения лекарственных препаратов Санофи в Вашей стране.

Приложение 6

Интервью с Maria-Teresa Essen-Mцller, Digital Marketing Manager Nordics&Baltics (Sanofi, Швеция)

· Please, tell few words about your work at Sanofi (position, responsibilities, projects, etc.).

My responsibility is Digital Marketing Manager, for the therapeutic areas CV and Diabetes, and I am situated in Sweden.

· Is advertising of medical drugs allowed on the Internet in your country? Are there any restrictions?

Prescription drugs are not allowed to be marketed to the general public at all. Marketing of Rx drugs to HCPs is allowed but very regulated by the National Drug Association, an industry association.

Non-prescription drugs may be marketed to the public (but also regulated by the industry association).

· What digital tools in the promotion of medical drugs are used in your country and in the company?

Rx to HCPs: websites and email marketing.

Rx to public: websites (only one exception, so called “pre-approved websites” with drug information (see e.g. Multaq.se), pre-approved by industry association and basically only containing the information in the SPC.)

Non-prescription drugs: websites, social media, digital adverts.

· What are the rules governing advertising of medical drugs on the Internet in your country (laws, ethical codes, international agreements, etc.)?

1. Marketing Law (Marknadsfцringslagen)

2. Pharmaceutical law (Lдkemedelslagen)

3. Code of ethics from the industry organization (LER)

4. International agreements - European Federation of Pharmaceutical Industries and Associations (EFPIA), International Federation of Pharmaceutical Manufacturers Association (IFPMA)

5. ICC rules for marketing and market communication

· What are the requirements of various documents to the advertising of medicines on the Internet?

The online requirements are not different to those for offline communication, only we have to find ways of applying these requirements in an online setting. For guidance we look at cases where communication has been fined by the Industry Association or the legal entities/courts.

· What are the main requirements for online promotional materials according to corporate standards?

Since the online requirements are not different from the general marketing requirements - the difference lies more in HOW this is executed - it is difficult to briefly describe this here (everyone working with marketing in the pharma industry need to go through a 3-day course to cover all aspects of marketing and to pass a 5 hour exam…)

The main points are:

· Good marketing practice, not inappropriate (aggressive or misleading)

· Clear sender

· No marketing of un-approved drugs

· No marketing towards children (under 18)

· No marketing of prescription drugs (exception: vaccination campaigns)

· Up to date, correct and balanced presentation

· What role does self-regulation of pharmaceutical industry and advertising play in your country? What is the role of Sanofi in self-regulation?

A very large role. The industry association is striving to be more restrictive than the legal courts and frequently fine member organizations.

· Please, provide some examples of successful online promotion of drugs by your company.

www.praluent.se - lunched in January. The reason that we call this promotion to HCPs successful is that the visitors to the website are spending a considerable amount of time (+ 11 minutes on average) to read the extensive product information (information only the target group of specialists would be interested in). From this we draw the conclusion that we are reaching the small and specified target group of CV specialists and lipidologists. However, we have no way of telling exactly WHO the Drs visiting the websites are, since we are not allowed to track this kind of data according to Privacy laws.

Compared to other industries the pharmaceutical industry is EXTREMELY regulated and EXTREMELY far behind.

Hope this answers to your questions. If you want to read more about what applies for Sweden, please check out http://www.lif.se/en/ where some information on the above is available in English.

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Интервью с Sushil Katdare, Regional Marketing APAC и Ambuj Mudgal, Digital Project Manager APAC (Sanofi, Singapore)

Sushil Katdare

· Please, tell few words about your work at Sanofi (position, responsibilities, projects, etc.). I head APAC Marketing for Sanofi Pasteur for the Dengvaxia (Dengue vaccine)

· Is advertising of medical drugs allowed on the Internet in your country? Are there any restrictions? Since I look after the region, the regulations vary per country. But in general I can say, for prescription products DTC is restricted to education/ awareness and also is typically unbranded

· What digital tools in the promotion of medical drugs are used in your country and in the company? In Dengue Co we are using various digital tools. It depends on the objective and audience and list may be too long to reproduce here. However examples could be - Mobile apps, social listening, CLM, website, videos for youtube, twitter etc.

· What are the rules governing advertising of medical drugs on the Internet in your country (laws, ethical codes, international agreements, etc.)? mostly we advise the countries to follow internal compliance documents, DVC guidelines and local regulations

· What are the requirements of various documents to the advertising of medicines on the Internet? I am not sure I understand your question here. Requirement for whom?

· What are the main requirements for online promotional materials according to corporate standards? SP has guidelines available, please visit the MySanofi resources online.

· What role does self-regulation of pharmaceutical industry and advertising play in your country? Does it help to cope with violations? What is the role of Sanofi in self-regulation? I reckon we are aligned to IFPMA code and internal guidelines from compliance department. At the country level, every project needs to be validated by local validation committee (regulatory, legal, compliance etc.)

· Please, provide some examples of successful online promotion of drugs by your company. We mostly do disease education and not online promotion of drugs online with consumers. Please visit Mr. Dengue on facebook.

Ambuj Mudgal

· Please, tell few words about your work at Sanofi (position, responsibilities, projects, etc.). I am a DPM , digital project manager in Sanofi ITS , APAC. I project manage implementations of websites , ecommerce solutions and other online marketing tools

· Is advertising of medical drugs allowed on the Internet in your country? Are there any restrictions? There are different regulations in different countries. The local country teams work to ensure that the rules are being following

· What digital tools in the promotion of medical drugs are used in your country and in the company? ( Websites, ecommerce stores , Apps , SEO / SEM campaigns)

· What are the rules governing advertising of medical drugs on the Internet in your country (laws, ethical codes, international agreements, etc.)? There are different regulations in different countries. The local country teams work to ensure that the rules are being following

· What are the requirements of various documents to the advertising of medicines on the Internet? Internally in sanofi APAC, we have to go thru IVC (internal validation committee) and MLR - Medical legal review

· What are the main requirements for online promotional materials according to corporate standards? (All promotional material is reviewed by MLR and for anything which goes online, we need to go thru a IVC committee)

· What role does self-regulation of pharmaceutical industry and advertising play in your country? Does it help to cope with violations? What is the role of Sanofi in self-regulation? I do not have clear visibility into this

· Please, provide some examples of successful online promotion of drugs by your company. www.lactacyd.com.myLactacyd.jp, rashikusupport.jp, lantusxr.jp . These are some example of sites we have launched as part of overall digital strategy ( please be aware that lactacyd is a CHC product)

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