The FDA’s November 2009 hearing into the challenges of the internet and social media for pharma was followed closely by industry and regulators in the European Union. The hearing represented the first substantial public review by a regulator of the pharma industry’s uneasy relationship with the array of social media channels available in the digital space.
Although regulators in the EU have yet to tackle fully the use of social media channels by the pharma industry, the European Commission has acknowledged consumers’ hunger for online health information. Indeed, this is one of the drivers for the Commission’s proposals for new legislation to allow the provision by pharma companies of high quality health information to patients.
This article looks briefly at the Commission’s proposals, which although extensive do not go as far as to suggest the introduction of direct-to-consumer (DTC) advertising of prescription-only medicines in the EU. With those proposals – and the DTC prohibition - in mind, we go on to look at the legal and regulatory landscape in the EU that pharma companies need to navigate when engaging in social media channels, as well as the associated risks for pharma companies. Finally, we examine such guidance as there is currently from EU regulators, and consider briefly what the future might hold for pharma companies wishing to engage through social media channels in Europe.
The EU position
The main piece of legislation governing medicines in the EU is Directive 2001/83, also known as the Community Code. It is here, in Article 88(1), that you find the prohibition in Europe on the advertising of prescription-only medicines to the public.
In February 2008, the EC launched a public consultation on its proposals to introduce legislation to ensure that all patients throughout Europe have access to good quality, up-to-date and non-promotional information on prescription-only medicines. The apparent driver for the changes was a fundamental lack of harmonisation within the EU as to the level and quality of health information available to patients in different countries.
When the proposal was first launched, there was talk of it being an attempt to get DTC advertising in through the back door. While this is clearly not the case, the changes would represent a considerable new opportunity for pharma companies in Europe to interact with patients in a more meaningful way. More than two years after the consultation, however, the legislation remains some way from becoming a reality.
Despite the ban on DTC in Europe, the Commission’s information to patients proposals are very significant in the context of the opportunities available to the pharma industry through social media channels.
The dynamic challenge
All social media channels – be it Facebook, Twitter or any old blog – have at their heart user generated content (UGC). It is the dynamic nature of UGC that provides so many opportunities, for marketing, information provision and discussion. At the same time, this is the source of the real challenges for pharma in the social media space.
At a general level, there are a number of ways in which UGC may expose the host or sponsor of a social media channel to liability in the EU, including defamation – UGC may feature defamatory content; private and confidential information – UGC may contain information that is (or at least was) private and confidential to a third party; and copyright infringement – UGC may include material that infringes the copyright of a third party.
A company hosting a website needs to consider whether or not to moderate the content on the site to remove material that may, for example, be defamatory. On one level, pre-vetting UGC completely removes one of the key features of social media channels: the dynamic and spontaneous nature of the material they contain.
From a legal perspective, we need to consider the provisions of the EU Directive on e-commerce. It provides that a host of a website is not liable for information on that site where (among other things) the host has no knowledge of the illegal activity. Under English law at least, this provides the foundation for a reasonable argument that the host of a blog that permits the posting of unmoderated content should be able to rely on this defence if they had no control over, or knowledge of, the content.
As a result, you would expect companies hosting blogs to take the view that they should not – from either a legal or a commercial perspective – moderate UGC. The position in a heavy regulated industry such as pharma, however, is not so simple.
Many of the risks for pharma companies engaging in social media channels in the EU are the same as those in the US, such as outside-of-licence references. However, the EU prohibition on the advertising of prescription-only medicines to consumers adds a further level of risk compared to the US position.
The prohibition on DTC is even more troublesome when you view it in the context of how easily a pharma company can find itself responsible for the UGC on a website that, in the pharma company’s view at least, it has no control over. While it is difficult to generalise about the position throughout Europe, there is no doubt that there is at the very least a substantial risk that a pharma company will be deemed to be responsible for the contents of a website (including UGC on it) where it sponsors, advertises on or instigates the site. If you then imagine how easily UGC could contain promotional statements about one of the pharma company’s products – thereby putting the pharma company in breach of the prohibition on advertising such products to the public – it is understandable that European pharma companies are reluctant to enter the social media fray.
Current EU guidance
There is currently very little EU guidance that refers expressly to any social media channel. The UK’s Prescription Medicines Code of Practice Authority (PMCPA) – which is responsible for administering the Association of the British Pharmaceutical Industry’s Code of Practice for the Promotion of Prescription-Only Medicines (the UK Code) – has issued some brief guidance on blogs. The guidance states that if a pharma company were to sponsor a blog about a medicine or a therapy area, it would need to ensure that all information contributed to the blog complied with the UK Code. In other words, it would need to pre-vet all UGC on the blog.
The PMCPA goes further, and states that pharma companies should not sponsor websites that are intended, or could reasonably be expected, to discuss medicines and their uses “as it would be impossible to guarantee their compliance with the Code”. There is no doubt that it would be difficult to guarantee compliance with the UK Code for all material on the site.
In addition to the substantial resources required for a pharma company to pre-vet all the UGC on a website, imposing such a regime on a website would all but kill off the UGC on it. One possible way round the problem of pre-vetting is to take a step back and examine the situations in which a pharma company should in fact be regarded as being responsible for all material on a website. Indeed, this is an area that received substantial attention during the FDA’s November 2009 hearing, and it is hopefully one that EU regulators will address before long.
The European pharma industry body, EFPIA, has also published some guidelines on websites available to healthcare professionals, patients and the public, in its Code of Practice on the Promotion of Prescription-Only Medicines to, and interactions with, Healthcare Professionals, Annex B (October 2007). However, as becomes clear on reading the guidelines, websites containing UGC were not contemplated at the time the guidelines were written, so they offer little assistance in relation to social media channels.
Managing the risks
In the absence of any express guidance from EU regulators, there are a number of ways in which pharma companies can attempt to manage the risks of engaging in social media in the meantime. These are generally no different from the steps that a pharma company would take in the US, and it is important to note that not all of them can be applied to all social media channels, since a pharma company will not, for example, be able to exert a sufficient level of control in relation to third party sites.
They also include transparency – making clear statements as to the intended audience (e.g. patient or healthcare professional), the pharma company’s involvement and any jurisdictional limitations; and third party sites – informing users when they are leaving a page for which the pharma company is responsible and linking through to a third party site. Indeed, this is an express requirement under the UK Code.
What next in Europe?
The European Commission already recognises the growing role of the internet as a tool for the provision of information about medicines to patients. Although its attempt to harmonise the law in the EU to allow for the provision of high-quality, non-promotional information by pharma companies to patients is proceeding slowly, it continues to represent an opportunity for the industry and regulators to discuss and formulate guidance on how information can be disseminated using the internet. It clearly makes sense for those discussions to go a step further and consider social media channels specifically, as the FDA has in the US.
In reality, there is unlikely to be any further substantial guidance in the EU until the FDA issues its guidance on pharma, the internet and social media. Even once the FDA guidance emerges, there will be a period of review when regulators and industry consider how that guidance might be translated into a different regulatory environment, in particular one which does not permit DTC.
In the meantime, pharma companies in the EU are likely to remain reluctant to enter the social media fray in any meaningful way. The biggest issue as matters stand is the fact that pharma companies will be held to be responsible for content, including UGC, that they can’t control – and if they do put in place mechanisms to control content to the extent required, they will fundamentally undermine the dynamic nature of social media. The degree of control is a point that was examined in detail at the FDA hearing, and one that received considerable attention in the written submissions from pharma companies. This element of any FDA guidance will be of particular interest in the EU, and is likely – more so than any other parts of the FDA guidance – to influence the approach taken in Europe.
Tim Worden heads Taylor Wessing’s Pharmaceutical Regulatory Practice in the UK.