How to navigate regulatory hurdles for compliant social media use in Europe
Despite an increase in the popularity and use of social media among various business sectors, pharma has been slow to embrace the social media wave
However, the utilisation of social media by the industry has huge potential. It could improve control of information related to products and services, enhance patient and physician engagement, contribute to the design of clinical programmes and facilitate the identification of key opinion leaders.
Still, strict compliance with regulatory guidance is essential for pharma to fully exploit the advantages of social media.
Regulatory hurdles to social media use
In Europe, while social media use by pharmaceutical companies has received a lot of attention, there are no official regulations in place. Europe’s rules and exceptions are not as well-defined as those in the US, where the FDA has issued clear guidelines for social media compliance.
Nevertheless, the UK body responsible for pharma regulations - the Prescription Medicines Code of Practice Authority (PMCPA) – does create some hurdles to social media use.
The PMPCA is a not-for-profit sub-division of the Association of the British Pharmaceutical Industry (ABPI), which is responsible for providing training, guidance, and ensuring compliance with their Code of Practice.
One of the main regulations emphasised in the ABPI code is the prohibition against advertising prescription medicines. Furthermore, in the UK - and in Europe as whole - pharmaceutical companies should enforce strict vigilance over the effectiveness and clinical outcomes of their products. Ultimately, if there is discussion on social media about a drug, then the side-effects of the drug need to be mentioned, otherwise there will be fines.
Social media tips: Smart steps to take for regulatory compliance
To better utilise social media, it is recommended that pharma companies enforce strict compliance with the regulations of the EMA and the PMCPA. More specifically, they should:
Have a legal team explore the laws and regulations regarding use of social media and any amendments to these official guidelines.
Create and implement a dedicated social media policy for all pharma employees, including providing training so that the policy is properly adhered to.
Avoid the use of blogs or forums, as these platforms encourage discussions of drugs that could eventually result in breach of the ABPI code if deemed advertorial. Moreover, pharmaceutical companies are considered liable not only for what they communicate, but also for the comments of other users. Therefore, if a user scrutinises a drug from another brand, then the pharma company can be accused of unfair competition.
Attentively monitor and adhere to any legally required information prior to any digital publication originating from the pharma company.
Collaborate with other companies in the industry to mitigate risks and share expertise regarding regulations and nuances in the market to establish clearly defined rules regarding social media use.
It’s worth jumping those hurdles!
Despite the hurdles and the lack of transparent guidance from EU regulatory bodies, pharma companies should aim for strict compliance with the ABPI code and communicate any issues and recommendations with their counter parties and the regulatory bodies themselves.
This is the only way forward for pharma, not only to define compliance rules for digital communication but also to harvest all the benefits of social media – and harvesting these benefits is certainly worth it.
Indeed, it could be argued that by bowing down to regulatory hurdles, pharma will be losing sight of its key stakeholder – the patients.