This is an interpretative document on social media and the ethical rules for the pharmaceutical industry (LER) drawn up by LIF’s secretariat. We present some examples of social media and various situations as well as questions and answers to assist the pharmaceutical companies in evaluating when the use of these media is appropriate or not in terms of LER.
Please note that the final decision whether procedures are appropriate or not will be taken by IGM (the Swedish Pharmaceutical Industry Information Examiner) and NBL (the Information Practices Committee) after examining a complaint. This document is to be considered a living document and may be updated. Last updated: October 26, 2010.
On social media
Social media are digital forms of communication where we share experiences, opinions and content. Communication takes place through dialogue and conversation by way of chats, blogs, micro blogs, social networks, uploading and sharing of photos, music and videos, emails, virtual worlds and wikis. Most well-known are Facebook, Twitter and Youtube.
The question is how to define the relationship between social media and the pharmaceutical industry’s ethical framework (LER). Some examples of social media, various situations and questions and answers will be presented here to assist you in evaluating when the use of these media is appropriate with regard to LER. Please note that the final decision whether a procedure is appropriate or not will be taken by IGM (the Swedish Pharmaceutical Industry Information Examiner) and NBL (the Information Practices Committee) after examining a complaint.
We also refer to our document from September 2004, “Established practice and recommendations for various kinds of information on the Internet according to the ethical rules for the pharmaceutical industry”, only available in Swedish.
In the 2000s, the importance of social media along with the number of users have skyrocketed and will probably continue to evolve at a rapid pace. Conse-quently, this is a relatively new platform for drug information and practice has so far not yet been established. It is therefore of vital importance that the pharmaceutical companies apply the ethical rules for the pharmaceutical industry (LER) also in these forums. Indeed, information distributed in digital media is not part of an unregulated grey area. LER and its media neutral regulations shall apply in all contexts, regardless of channels used by the companies.
In social media, high ethics and transparency are basic core values of equal significance to which the pharmaceutical companies should attach great importance. It is true that social media make it possible to create “unethical” and anonymous accounts or to make anonymous contributions. Of course LIF strongly disclaims this kind of conduct. LIF is confident that our member companies’ products are marketed in a correct, scientific and ethical way in accordance with LER. It must always be clear who is the messenger behind information or a professional opinion provided in social media.
Some basic aspects:
If a company helps to diffuse an individual idea on blogs etc, the company is responsible for this.
Advertising of prescription drugs to the general public is forbidden as well as contributing to spread information on prescription drugs to the public.
Healthcare personnel can only convey information on a prescription drug when in direct contact with a patient, not in any other way.
Healthcare personnel must not give advice or information that could be construed as recommending a particular treatment.
A statement from an individual about a drug treatment with subjective ratings may be perceived as a patient statement if the information is disseminated or published in any other way by a pharmaceutical company.
If a company chooses to follow the debates, for instance on a patient forum, they may also have an obligation to report possible side effects which are discussed in connection with the company's products. The company should have a policy for handling adverse reaction cases where information about the reporter or the patient is incomplete.
Google AdWords is certainly not a social medium but is in this context still worth mentioning. Its mechanism in brief is that Google pays when an Internet user clicks on a link that Google has put up (this is called PPC, Pay Per Click). The advertiser informs Google what words or concepts are to lead to activation of their link (e.g. diabetes) as well as the maximum amount that the advertiser is willing to pay.
What makes it all more complicated is that the system has evolved into what Google calls Placement Targeted Advertisement. This means that an advertiser can first specify what concepts are relevant, for instance dating and fashion, followed by the domain name, such as Blondinbella or Aftonbladet Klick!, then topics such as pregnancy, then a demographic profile for example, women age 15-35. Google makes an objective analysis of the websites, blogs, micro blogs, etc that are relevant to the advertiser’s keywords, and then places the company's advertisements on these pages. This is called cost per impression (CPI).
This is done automatically via Google's databases and software programs and it is not done through manual intervention by Google employees. The problem then is that you do not have full information about what the objectives are and the Google software programs do not know the word “ethics”. However, there is a possibility for manual intervention from the company, but this requires constant monitoring of the system.
LIF is not opposed to the use of Google AdWords, but since this software program does not know what ethics means it is quite possible that your link will show up on inappropriate sites. LIF therefore recommends member companies to regularly go through gross lists where their links appear and remove any inappropriate pages. An example was the website www.fasse.se (no longer a problem), where some LIF member companies appeared through Google AdWords. Also note that links may only apply to websites or hybrid pages oriented towards therapy and education. If someone is looking, for instance, for information about a disease, linking (pull) may be at hand to any of these above sites. However, the person may not by linking be routed (push) into a web page that directly deals with a prescription drug.
Advertisements for prescription drugs through AdWords is contrary to the LER. According to article 114, information about prescription drugs may not be actively disseminated on a pre-approved website. This means that pharmaceutical companies may not sponsor links to this page or actively promote the website in question.
Facebook is a community of about 500 million users worldwide. On Facebook, anyone can create a group where all or some users in the forum can become members. There are groups for various diseases such as multiple sclerosis and breast cancer. A member of a group can start a “market survey” and ask questions to all members of the group. Of course, participants should always be transparent with their business affiliation. According to Article 114, drug information must be selective and only directed to recipients who may need or be interested in the information in question. It would for instance be possible for a company to ask certain questions to the members of a group about for instance the design of syringes. In these contexts it is important to give information about who you are and what is the purpose of your questions. Note, however, that making questions or disseminating information on prescription drugs is not allowed (Article 102).
Patientslikeme.com is a website (USA) where patients post and share information about themselves and how they feel about their illness, medications and side effects. The information is accessible to all. You can also read summaries on how patients on this forum are experiencing their own medicine, their dose regime or what side effects they experience. This page collects the information posted and resells it to pharmaceutical and insurance companies. There is to our knowledge no Swedish equivalent, but of course also patients from Sweden may register on this website.
Consider, however, that you cannot link directly to a person's private information, as this can be interpreted as a violation of Article 108 stating that testimonials from individual patients may not be cited as documentation. Case studies shall be formulated as typical cases so that the identity of the individual patient is kept anonymous and the studies shall remain free from the patient’s subjective evaluations. To this can be added the possible violation of Article 102 and the prohibition of advertising prescription drugs to the general public, i.e. you cannot link directly to the summary of a company’s products. Disclaimers cannot exclude the company from its liability. However, it should be quite possible to link to the main forum page when it is neutral, compare hybrid page.
Wikipedia is a popular source of information where anyone has the opportunity to update or create a new subject with no preview. Here a company can post information about the company and its non-prescription products. However, it is important to do this in a serious, scientific and ethical way. Most likely, the posting of information about prescription drugs would violate the prohibition on advertising to the general public, so this is not possible.
There is a possibility that the information already exists and you can of course consider whether the information is correct and if necessary update it with correct information. But this also means that it is possible for a company to create an anonymous user and "spice up" some details such as exaggerating the results of a treatment, rule out important information such as side effects or to post information about prescription drugs. Such a procedure is obviously rejected by LIF.
As an example, according to Wikipedia (USA) and "Wiki Scanner", a pharmaceutical company has been accused of having deliberately edited and biased articles relating to their area. Such a procedure harms the entire industry's confidence and reputation. It is quite another thing to correct obvious false claims with scientifically based facts. For instance, someone may claim that a double dose of a particular drug is more efficacious although this is not true and in fact only leads to an increased risk of side effects. In this case, however, the company should be cautious, as otherwise this could easily be perceived as advertising. Alternatively, an appropriate procedure could be to state for instance "For accurate information about our products, contact the company NN” and give contact information or refer to Fass.se.
Questions and answers
Can our company post a PIL (patient information leaflet) or SPC for a product on Wikipedia?
Answer: No, not by "cut and paste" from Fass.se, as it is important that the information is updated, which can easily be forgotten. However, a suitable solution is linking to for instance a patient information leaflet or Patient-Fass on Fass.se.
Can we go in and correct factual errors about our prescription products in Wikipedia using the applicable catalogue text according to Fass? We have of course an account showing who we are and our contact information.
Answer: Yes in order to correct obvious false claims with scientifically based facts. For instance, someone may claim that a double dose of a particular drug is more efficacious although this is not true and in fact only leads to an increased risk of side effects.
On Twitter, blogs and Facebook: Information may be spread by Bookmark & Share features. If there are articles about one of our drugs in the newspapers, can we send them on through these functions?
Answer: No, this is contrary to the advertising ban of prescription drugs. See also question 10.
Can our company have a restricted meeting place on Facebook where we invite key doctors and discuss drugs for which we have marketing approval in Sweden (only approved members get access)?
Answer: No. In many cases a website, for instance Twitter, “owns” the information on those who join and Twitter among others say that they have the right to pass on information on the users and may also quote from the blogs in advertisements. (”Twitter collects personally identifiable information about its users and shares it with third parties. The service considers that information an asset, and reserves the right to sell it if the company changes hands. While Twitter displays no advertising, advertisers can target users based on their history of tweets and sometimes may quote tweets in ads”).
Although Facebook does not own the information and does not have the right to disseminate information, restricted meeting places for healthcare personnel are associated with general difficulties. If doctors for example begin to discuss off-label prescription of your drugs, you may be convicted for this. A pharma-ceutical company must not allow healthcare professionals to participate in drug information and act as a guarantor for a particular medicine or recom-mend a particular treatment. If the forum provides too much information about a particular drug, this could indirectly be interpreted as promotion of your medicines. This would mean that your company must monitor the forum and edit out inappropriate messages which is time consuming, as probably most posts are published in the evenings and on weekends, etc.
May our company have an open forum on Facebook where we invite the general public to ask questions about our products? (No personal health advice, of course, we refer that to healthcare professionals).
Answer: No, it easily becomes a form of patient testimonial in violation of Article 108 and/or marketing where the merits/benefits of the product are pointed out. However, there is the possibility of a product-neutral forum for questions on your website, where questions are not made in real-time and cannot be diffused as under question 4 above. If a company provides an open discussion forum (via a disease informative website) where questions are asked in real-time, this may be perceived as testimonials from individual patients.
Under the Product Liability Act/Product Safety Act pharmaceutical companies are required to reply to questions about their products. But there is obviously a difference in asking a question and receiving a reply in a forum, compared with direct contact by e-mail or telephone. To reply to questions received via Facebook’s email function ought to be OK.
May we take part and comment on what journalists write about our products or our company? The possibility to post comments is often offered.
Answer: No, not in the case of prescription drugs. This is important because you could be convicted for attempt of marketing. However, in our view there is the possibility to correct factual errors, see question 2.
However, in a forum for professionals, as for instance the home page of Dagens Medicin, you should be able to use comment boxes to a greater extent as these are not addressed to the general public.
Can we be held responsible if someone blogs about our products on for example twitter (eg by linking to the company X)?
Answer: If a private individual giving his name would blog about one of your products or even link to your company, you cannot be held responsible for this. However, it can at worst be perceived/believed that this person is a "front" for your company, but it depends on the circumstances and is often difficult to prove.
May we comment on other people’s tweets?
Answer: No, but we reckon it is possible to correct obvious factual errors if this can be done in the limited space available. To comment on product neutral tweets should be OK.
If we put something up on Youtube (OTC), are we then responsible for any comments?
Answer: The same risk of suspicion of a patient statement with subjective evaluations of excellent properties may arise.
There are therapy-oriented websites where companies only provide information about a disease and not on products, a room designated for the general public. These pages usually have or may have a place "for healthcare personnel" where this category must click to reach a pop-up to confirm that they are professionals in order to go further. Product information can be provided in the therapy room for healthcare personnel.
As I understand it you are not allowed to have Facebook icons for the medical part, but is it OK to post Facebook icons for the therapy-oriented part which is for the general public (but which also contains a room with a pop-up for healthcare personnel)?
Answer: Since a company may advertise its disease informative websites in the newspapers, it should consequently be OK to post Facebook icons for the therapy-oriented part open to the general public.
On the other hand, there is a risk that people who use Facebook and forward information and links, also in this context add allegations and subjective evaluations on their own or on any other drug treatment contrary to Article 108. A company contributing to the diffusion of subjective evaluations of any kind is responsible for this under Articles 127 and 128. The company would then need to have complete control over what is said in this context, which is impossible. In addition, since most disease informative websites contain some information on the treatment of a disease, drug information should be selective and aimed solely at those who may need it or be interested in it (Article 114).
Conclusion: It is therefore difficult to give a comprehensive answer to this question.
Would we be allowed to have an app on our site for patients to download to access an instructional video for the preparation and administration of one of our products?
Answer: Yes, assuming that the data to be downloaded only contain pure handling instructions and no information on the product’s benefits or effectiveness. Thus, it should be possible to download this information from a so-called hybrid site open to the general public, but also from a so-called password-protected website aimed at patients. However, it is not appropriate to have such an app on a so-called therapy-oriented website, as this site should be problem-oriented, product neutral and only mention the therapy groups.
We are developing an app which aims to be an aid to veterinarians on dispensing medicine from a number of parameters. This app will be posted on App Store which of course is widely available. It will be possible to download the app free of charge. It will be marketed in trade magazines and in connection with sales calls. Can the app include advertisements, for instance a tab with product photos and target points (which of course follow the regulations)?
Answer: An application posted on App Store can be downloaded by anyone, also the general public. In this case you must point out very clearly that the app is aimed at veterinarians, or it might be considered that you are marketing prescription drugs to the general public (Article 102). There would also be a greater risk for violation of Article 102 if the app contains advertising and target points and is free of charge to download.
You would also have to consider that a software product (app) for a dispensing tool for drugs for human use can be seen as a medical device. This requires CE-marking and for these directives you would need to refer to experts in the field.
Where patient apps are concerned, I wonder if it is possible, according to the regulations, to create a patient app with information about the drug? It would contain information on the drug, i.e. equivalent to patient information which would be easier for patients to understand than the way in which Patient Fass works. Upon downloading, a query could "pop up" where you have to confirm that you have a prescription for the drug x in order to take advantage of the information.
Answer: In this case you would have to regard the app as a "patient brochure" but in app format. These may only be handed over by the physician to the patient with a prescription. The problem with apps is that they are downloaded from a public site where anyone can download them, not only patients but also the general public and consequently, they can not be personally handed over. To certify that you are a patient is not enough, and this would be interpreted as marketing of a prescription drug to the general public (Article 102).
You might possibly envisage an app where you would have to enter your batch number in order to get hold of further information. Compare in this connection password-protected websites for prescription drugs where you can reach information in such a way. However, this scheme has not yet been reviewed by IGM/NBL where apps are concerned and if, despite the uncertain outcome of IGM/NBL’s decision, you would like the question to be examined, such an app, its contents and the information obtainable must be reviewed by IGM as mandatory samples.
a) This is a question concerning non-prescription drugs on Facebook. During the cold season I would like, for example, to strike a blow for our cold medications which are traditional herbal medicines or herbal products. But do I then have to include the whole "mandatory text"?
Answer: Yes, this will be considered as marketing and therefore it will be necessary to include the minimum required information (Article 117). If, for example, you have a company page on Facebook where you would like to present your various non-prescription drugs for colds, this would mean that you write a "status update" mentioning an OTC-product and then the minimum required information must be included. In addition, it would probably be best to include the minimum required information in each "status update" where you mention the OTC product. The minimum required information must be easy to find and therefore it should apply to all status updates - also if this information is already available elsewhere on the site in connection with another status update. Status updates on Facebook often treat very different things and can thus be seen as separate "ads". Furthermore, of course all the other articles in LER, e.g. 102, 104 also apply.
Answer: Yes, probably, because of the risk that this can be perceived as a testimonial from a patient which is not allowed (Article 108).
In their recruitment strategy, can clinics in the future in their applications for clinical trials complete their advertising for applications on Facebook (as a supplement to newspapers which is already approved since you see ads in newspapers regularly) and on the clinic's already existing website, and complement this with Facebook advertisements (with the advertisement link leading directly to the clinic's website where all information and the application form is to be found (as they are already today)?
Answer: Yes, it is possible to recruit applicants to studies/clinical trials via social media. In your application to the Ethics Committee you must state which channels you plan to use for advertising, such as newspapers, radio, television or social media. Similar advertisements and terms can then be used independently of the medium used - but a shorter version may be used for social media. The ad design is to be neutral/informative and to focus on the study and the disease. If this is not the case, it risks violating LER and the marketing of prescription drugs to the general public.