AUTH/3430/11/20 - Complainant v AstraZeneca

Promotion of unlicensed Covid-19 Vaccine on LinkedIn

  • Received
    24 November 2020
  • Case number
  • Applicable Code year
  • Completed
    14 December 2021
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A complainant who described him/herself as a concerned UK health professional, complained about the pre-licence promotion of a Covid-19 vaccine by AstraZeneca UK Limited on LinkedIn.

The complainant provided a screenshot of, and a link to, a named AstraZeneca employee’s LinkedIn profile which stated:

‘While this is just a start, I am thankful for all those who have worked tirelessly on this vaccine program. It offers new hope to nations around the world.’

Below this was a number of hashtags including #happythanksgiving, #vaccines, #astrazeneca, #covidinnovation, #immunization and #proudemployee followed by an image of a virus and link to a press release entitled ‘AZD1222 vaccine met primary efficacy endpoint in preventing COVID-19’.

The complainant noted that AstraZeneca was a UK-based company and that the post had been ‘liked’ by staff in the UK and appeared on his/her LinkedIn feed. The complainant alleged that it appeared that extremely senior staff had little interest in the rules they chose to follow.

The complainant alleged that the post promoted a medicine prior to having any sort of licence being granted and it promoted to the public.

The complainant noted that this was not the first time that AstraZeneca had undertaken this activity and so alleged a breach of its undertaking related to Cases AUTH/3011/1/18 and AUTH/3248/9/19.

The detailed response from AstraZeneca is given below.

The Panel noted AstraZeneca’s submission that the LinkedIn post was outside the jurisdiction of the UK. In the Panel’s view, the post at issue came within the scope of the ABPI Code because it had been placed by a senior employee of a company located in the UK (AstraZeneca Global), albeit that the employee in question was based in the US.

The Panel noted that it was an established principle under the Code that UK-based global or other such companies were subject to the Code. If such entities were not members of the ABPI, or on the list of non-member companies that otherwise complied with the Code, the UK company had to take responsibility for their acts and omissions under the Code.

Regardless of the US-based global employee’s actions, the Panel further noted AstraZeneca’s submission that nine UK-based AstraZeneca employees had engaged with (‘liked’) the LinkedIn post in question. In that regard, the Panel considered that the nine UK employees’ act of liking the post, which, on the balance of probabilities, would have been proactively disseminated to their connections within the UK, brought it within the scope of the UK Code. The Panel further noted that the associated press release referred to clinical trials of AZD1222 in the UK which, in the Panel’s view, also brought the press release within the scope of the UK Code in its own right.

The Panel noted that the press release linked to from the post was dated November 2020 and was housed in the media section of the global corporate AstraZeneca website.

The Panel considered that there was a difference between making a press release available within the media section of a company’s website or only to the press, to be published or not, and linking to it on a social media platform with the expectation that a wider audience would read it.

The Panel considered that the LinkedIn post had drawn attention to medical research regarding the prevention of Covid-19 at a time when there would be much public interest in the work being done by pharmaceutical companies and others to investigate possible treatments and vaccines for the disease. Companies must ensure that any materials and activities related to the current public health emergency and which fell within the scope of the Code, were compliant with it; there were no exemptions in that regard.

The Panel noted that the first paragraph of the press release stated ‘Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine’. It further stated ‘AstraZeneca will now immediately prepare regulatory submission of the data to authorities around the world that have a framework in place for conditional or early approval. The Company will seek an Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries’.

The press release contained a quote from an investigator of the Oxford Vaccine Trial:

‘These findings show that we have an effective vaccine that will save many lives. Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply.’

The press release also contained the prominent quotation from a senior AstraZeneca executive:

‘Today marks an important milestone in our fight against the pandemic. This vaccine’s efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency. Furthermore, the vaccine’s simple supply chain and our no-profit pledge and commitment to broad, equitable and timely access means it will be affordable and globally available, supplying hundreds of millions of doses on approval.’

The Panel noted that the LinkedIn post included the title of the press release and considered that the title and content of the press release clearly referred to the clinical success of AZD1222 against Covid-19.

The Panel noted that AZD1222, was not classified as a prescription only medicine when the post and press release were posted by the global AstraZeneca employee and ‘liked’ by the nine UK-based employees. Clause 26.1 only applied to prescription only medicines. On that very narrow technical point, the Panel ruled no breach of the Code.

However, the Panel considered, noting their content, that the post and associated press release, which appeared on the global AstraZeneca employee’s LinkedIn profile and, on the balance of probabilities, its proactive dissemination to the nine AstraZeneca UK employees’ connections as a result of them liking it, constituted promotion of an unlicensed medicine and a breach of the Code was ruled.

The Panel considered that high standards had not been maintained in that regard and a breach of Clause 9.1 was ruled.

The Panel understood that employees might feel inclined to endorse articles related to their senior colleagues on LinkedIn but noted that depending on the content such activity might or might not fall within the scope of the Code; companies would be well advised to cover the possibility of that activity in their social media policies.

The Panel noted AstraZeneca’s submission that the senior US-based global executive had made the LinkedIn post using his/her own personal account at his/her own discretion and the post was in line with the US social media guidance, as written in the US Policy Handbook. The Panel noted, however, that the US policy handbook stated ‘employees are not permitted to post original content that is product related (AZ products, product class or competitors) with the exception of members of the North America Leadership Team with the guidance and approval of Corporate Affairs’. It further stated that employees could only ‘like’ and share ‘product‐related social media messages from official US Corporate AstraZeneca channels and product‐related social media messages from personal social media channels of members of the North America Leadership Team such as a product‐related LinkedIn post from the North American Executive Vice President’.

The Panel further noted that the AstraZeneca Global Standard employee use of personal social media document, which was applicable to all global employees, stated in bold under Key Principles: ‘…you must not post self-created product-related or disease education/awareness content on your personal channels, or engage with (liking, sharing, commenting on) this type of content from 3rd-party sources’. In that regard, it appeared to the Panel that both the senior global executive and the nine UK-based employees had breached the company’s global standard document. It further stated that engaging with product-related content from official AstraZeneca social media channels was only allowed in very few countries and readers should always familiarize themselves with country specific rules. The Panel noted that AstraZeneca did not provide any UK-specific social media guidance and made no submission in that regard.

The Panel noted that the supplementary information to Clause 2 included promotion prior to the grant of a marketing authorisation as an example of an activity that was likely to be in breach of that clause. The Panel noted its comments and ruling above. The Panel noted that a senior AstraZeneca global executive had proactively posted product-related material on to a personal social media account which contravened the company’s global standard document and which the company acknowledged would be visible to the public. Furthermore, nine UK-based employees had engaged with the post resulting in its likely subsequent proactive dissemination to all of their LinkedIn connections which would, on the balance of probabilities, be a predominately UK audience. Although AstraZeneca had not commented on the seniority of the nine UK-based employees, the Panel was concerned that ‘liking’ the original LinkedIn post was clearly not an isolated occurrence. The Panel considered that in promoting the unlicensed vaccine, including to members of the UK public, AstraZeneca had brought discredit upon, and reduced confidence in, the pharmaceutical industry and a breach of Clause 2 was ruled.

With regard to the alleged breach of undertaking in relation to Cases AUTH/3011/1/18 and AUTH/3248/9/19, the Panel noted that Case AUTH/3011/1/18 did not involve the distribution of the press release via social media. The complaint now at hand, Case AUTH/3430/11/20, was in relation to dissemination of information on LinkedIn. The Panel considered that Case AUTH/3430/11/20 where, in its view, an unlicensed medicine had been promoted was also different to Case AUTH/3248/9/19 which involved promotion of a licensed medicine for an unlicensed indication.

The Panel thus considered that the matters at hand in the current case were different to Case AUTH/3011/1/18 and Case AUTH/3248/9/19 such that there was no breach of the undertaking given in either of those cases. The Panel therefore ruled no breach of Clause 29 and consequently no breach of Clause 2 in relation to each.