Recommendations for the ethical conduct of vaccination awareness campaigns by biopharmaceutical companies

Figures & data

Table 1. Guidance for disease awareness campaigns

	UK MHRA: DA^Citation8	Health Canada Policy: Help-seeking announcements including 1–800 numbers^Citation9	US FDA: Guidance for Industry 2004 (Withdrawn)^Citation7	Australian Pharmaceutical Industry (Medicines Australia): Code of Conduct- Edition 19 and CoC Guidelines (2016)^Citation10	Israel’s DA Guidance (#134)^Citation11,Citation12
Topic	Focus on disease instead of specific treatment options.		Disease or health condition specific.	Medical conditions and prescription treatments/focus on conditions instead of treatment options.
Audience	General public	General public.	Population at risk of or affected by disease or health condition.	General public.	Should be directed at adult members of the general public only.
Intent	Increase awareness of disease(s) and provide medical health information on disease and its management. Aid to recognize symptoms. Highlight appropriate source(s) of advice.		Enhance education.	Educational and should encourage patients to seek further information from HCPs.	Promoting education for patient health.
Responsible public health message	Structure of the information to be included: - symptoms or risk factors - general information on the disease - advice for the patient (refer to HCP).	For 1–800 numbers: The content is disease related rather than product related. The various treatment options (drug and nondrug) and their respective risks and benefits are discussed in an objective manner.	Information on prevention, diagnosis or treatment of a disease or condition.	DA must reflect severity and prevalence of disease in the community (not more serious/prevalent) and be consistent with current body of evidence.	Discuss disease states, their mechanism of action and impact on the human being, their diagnosis and shall not contain any reference to potential treatments.
Seek help	Patient advice and further information.		Refer consumers to qualified HCP for information.	Should be clearly stated that appropriate treatment is for HCP to decide, in consultation with the patient.	Promote with treating physician.
Style	Accurate, up to date, substantiable, comprehensive, balanced and fair, readable/accessible.		Clear and accurate. Avoid encouraging self-diagnosis and self-treatment.	Tone should not unnecessarily cause alarm or misunderstanding nor stimulate demand for prescription of a particular product. Information should be presented in a comprehensive, balanced and fair manner, with no emphasis on particular options or need to seek treatment.	Accurate, up to date, scientifically based, fair, accessible and referenced. The language of the campaign should not include frightening tactics in order to convince the public.
Product and Branding	May make reference to available treatment options but should not encourage to approach prescriber to request a particular medicinal option. Do not use brand names.	Help-seeking announcements: No specific drug is identified. There is no implication that a drug is the sole treatment available for the disease or condition. 1–800 numbers: No emphasis is placed on one drug product, e.g., excessive use of a brand name or description as a ‘breakthrough,’ and no emphasis is accorded to the merits of one drug product. No reference is made to an unauthorized drug beyond the mention that research is underway in a particular area, in which case, the regulatory status should be indicated (i.e., market authorization not yet obtained), and no reference is made to the availability of unauthorized drugs through the Special Access Programme.	Do not mention a particular drug or device. Do not include any representation or suggestion relating to a particular drug or device.	Therapeutic category including classes but no reference to a specific prescription product.	No mention of or hinting at the name of a product. The name of the internet site will not contain the trade or generic name of the medicinal product.
Sponsor name	Source should be clearly identified on the publication itself.	Help-seeking announcements: No drug manufacturer’s name is included.			Each web page should contain the text: ‘The information is provided as a service to the public sponsored by (name of Marketing Authorization Holder).’
Only one approved product	When only one, one leading or few medicinal treatments available, particular care is required and it is particularly important that these DA campaigns focus on health and disease education with details of where to get appropriate advice.		Where the company is the only manufacturer of a product for a particular disease or the company only manufactures one product, that company is not automatically disqualified from disseminating communications that discuss a disease related to the product.		Ministry of Health approval required in the case of DA campaigns conducted for diseases for which there is only one product approved, such as HIV or cancer.
Channel					Regulation defines permitted means of communication, including internet websites and social media networks and any other means of electronic communication.

Box 1. Key recommendations for Vaccination Awareness Campaigns (VACs)

• Be clear about the non-promotional intent, with messages addressing audience’s identified needs. • VACs should not be conducted concurrently with branded campaigns for HCPs. • Use lay language conveying relevant, accurate and balanced unbranded information. • Engage broadly and as early as possible to involve and inform patients, healthcare professionals and authorities, ensuring preparedness and local appropriateness. • Clearly and transparently acknowledge sponsorship. • Do not ‘product point’, i.e., refer to the specific characteristics of a product. • Collaborate with not-for-profit organizations when it adds benefit for the patient and society. • Do not exaggerate benefits or harms, be proportionate, and invite the target audience to seek advice from healthcare professionals. • Use digital metrics and surveys to measure the success of VACs.

Medicines and Healthcare products Regulatory Agency. Blue Guide, Advertising and promotion of medicines in the UK. Appendix 7: disease awareness campaign guidelines. Issued: Jul 2012; updated Nov 2020. [accessed 2020 Jul 2021]. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/956860/Appendix_7.pdf

 Google Scholar

Advertising Standards Canada. DTCI guide. 2020 [accessed 2020 Oct]. https://adstandards.ca/wp-content/uploads/2020/02/DTCIGuideEN2020.pdf

 Google Scholar

Food and Drug Administration. Guidance for industry: “Help-seeking” and other disease awareness communications by or on behalf of drug and device firms (draft guidance). January 2004 [accessed 2020 Oct]. https://www.hlregulation.com/files/2015/05/2004-draft-guidance-on-disease-awareness-activities.pdf

 Google Scholar

Medicines Australia. Code of conduct edition: 19. 2019 [accessed 2020 Nov]. https://www.medicinesaustralia.com.au/wp-content/uploads/2020/11/20200108-PUB-Edition-19-FINAL.pdf

 Google Scholar

Israeli Ministry of Health, Pharmaceutical Administration. Guidance document #134. Disease awareness campaigns - rules for accessibility of information to the general public funded or sponsored by the MA holder or a third party. 2014 [Accessed 2020 Nov]. https://www.health.gov.il/hozer/DR_134.pdf

 Google Scholar

Shani S. Prescription drugs communication to consumers in Israel - a new regulatory policy balancing between advertising and access to information. Med Law. 2016;35:25.

 Google Scholar