Who’s Watching? Why You Should Care About Global Promotional Material Review

Recently, there have been two notable cases regarding pharmaceutical advertising code violations based on LinkedIn content. It was announced that Danish drugmaker Novo Nordisk has been suspended by the Association of the British Pharmaceutical Industry (ABPI) for over two years due to "serious breaches" of the ABPI code of practice. According to the ABPI allegations, Novo Nordisk sponsored weight management courses on LinkedIn for health professionals without disclosing its involvement. The complaint deemed this action as an attempt to bribe health professionals to prescribe the company's products. This incident emphasizes the significance of transparency in pharmaceutical marketing and the necessity for companies to adhere to ethical codes of conduct.

In two recent rulings issued by the Prescription Medicines Code of Practice Authority (PMCPA), which regulates the marketing code of pharmaceutical firms in the UK, it was identified that two companies were found to have violated three PMCPA clauses each:

• AstraZeneca breached three PMCPA clauses. The LinkedIn post in question was made by an academic researcher discussing the recently published PRESERVED-HF trial on Forxiga, also known as Farxiga in the U.S. The employee liked this post and commented “Congratulations.” The panel found that this action violated AZ’s own social media policy, which prohibits employees from engaging with certain types of posts. The PMCPA also stated the activity breached PMCPA rules.
• Novartis breached three PMCPA clauses. The issue revolved around a website for Novartis' heart drug Entresto, particularly the "Starting and Monitoring Entresto" page of the Entresto promotional website, which failed to adequately display the potential safety risks of the medication. The PMCPA identified three rule violations: a breach of Clause 6.1, "Providing misleading information," a breach of Clause 5.1, "Failing to maintain high standards," and a breach of Clause 2, "Bringing discredit upon and reducing confidence in the pharmaceutical industry."

The codes of conduct include guidelines that encourage pharmaceutical companies to act responsibly and ethically when promoting their products, thereby avoiding practices that could be considered inappropriate or misleading. The ABPI collaborates closely with the UK government, healthcare professionals, patient groups, and other stakeholders to promote the interests of the pharmaceutical industry, and to ensure that patients in the UK receive the best possible care.

Global Promotional Review – Codes of Practice

The advertising and promotion of pharmaceutical products in the UK are regulated by a combination of laws, regulations, and codes of practice. The following are some of the key regulatory bodies that apply to advertising and promotion of pharmaceutical products in the UK and other countries in the EU:

1. Medicines and Healthcare products Regulatory Agency (MHRA): The MHRA is the UK's regulatory agency responsible for ensuring that medicines and medical devices are safe and effective. They oversee the approval and licensing of medicines and regulate their advertising and promotion.
2. The Prescription Medicines Code of Practice Authority: The Prescription Medicines Code of Practice Authority (PMCPA) is the self-regulatory body which administers the Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry, independently of the ABPI. The Authority is responsible for the provision of advice, guidance and training on the Code, handling the complaints procedure. In addition, it facilitates conciliation between companies upon request and regularly scrutinizes advertising and meetings
3. The Association of the British Pharmaceutical Industry (ABPI): The ABPI has a code of practice that sets out guidelines for the promotion of medicines by its members. The code is designed to ensure that pharmaceutical companies act responsibly and ethically when promoting their products, and that they do not engage in practices that could be considered inappropriate or misleading.
4. The Advertising Standards Authority (ASA): The ASA is responsible for regulating advertising in the UK. They enforce the UK Code of Non-broadcast Advertising, Sales Promotion, and Direct Marketing, which covers advertising across all media.
5. EFPIA Code of Practice: The EFPIA Code comprises a collection of ethical rules agreed upon by EFPIA members for the Promotion of Medicinal Products to healthcare professionals (HCPs) and the interactions with HCPs, healthcare organisations (HCOs) and patients' organisations (POs), with the intent of guaranteeing that these activities are conducted while respecting the most stringent ethical principles of professionalism and responsibility. This Code applies to all types of communication and interaction, including traditional and digital channels.
6. The IFPMA Code of Practice: The IFPMA Code covers interactions with HCPs, medical institutions and patient organizations, and the promotion of pharmaceutical products. Where direct promotion to the public is allowed, this is covered by local laws, regulations and/or relevant codes of practice. Member companies should comply with these local laws, regulations and/or codes.

It is crucial for pharmaceutical companies to be aware of these promotional review regulatory bodies and their respective laws, regulations and codes of practice to ensure that their advertising and promotional activities are compliant. Failure to comply can result in enforcement actions, fines, and damage to a company's reputation.

Promotional Review Codes of Practice Enforcement Actions

Codes of practice cover a wide range of activities, including advertising, sponsoring events and meetings, and providing information to healthcare professionals. The enforcement of these codes and requirements is taken very seriously and there are a few measures in place to ensure compliance. For example, if the company is found to have breached the code, the ABPI can take a number of enforcement actions. These may include:

1. Public reprimand: The ABPI can issue a public reprimand to the company, which is published on the ABPI website and in the trade press.
2. Fines: The ABPI can impose fines on member companies for breaches of the code. The fines can range from a few thousand pounds to tens of thousands of pounds.
3. Suspension: The ABPI can suspend a member company from the association for a period of time. During the suspension, the company will not be able to access the benefits of membership.
4. Expulsion: In serious cases, the ABPI can expel a member company from the association. This is a rare and extreme measure and is only taken in cases of repeated or serious breaches of the code.

General Promotional Material Review Guidelines

To avoid suspension from industry associations and regulatory bodies, pharmaceutical companies must adhere to strict ethical and legal standards when promoting their products. Here are some general guidelines that pharmaceutical companies can follow:

1. Be transparent: It is essential to clearly disclose any financial or other relationships with healthcare professionals, institutions, or patient organizations. This includes disclosing any payments, gifts, or sponsorships.
2. Adhere to laws, regulations, guidance, and industry codes of conduct: Pharmaceutical companies should follow the codes of conduct established by industry associations, such as the ABPI, which outlines guidelines for marketing and promotional activities.
3. Provide accurate information: All information provided by pharmaceutical companies about their products must be truthful and not misleading. Claims made about the efficacy and safety of a product must be supported by scientific evidence.
4. Avoid unethical practices: Companies should avoid unethical practices such as paying healthcare professionals to prescribe their products, offering incentives or kickbacks, or misrepresenting their products.
5. Train employees: Pharmaceutical companies must train their employees on the importance of ethical conduct, compliance with regulations, and the company's policies and procedures.

Companies also have a responsibility to conduct thorough reviews of these materials to ensure that they comply with relevant regulations. The typical promotional review involves input and approval from medical affairs, regulatory affairs, and legal or compliance professionals who collaborate with the marketing team to ensure adherence to all the regulations, codes and requirements and keep companies out of trouble. The purpose of the review is to confirm the medical accuracy of communications and marketing materials, ensure adherence to regulatory requirements, and prevent any violations of existing laws.

Exceptional Global Promotional Review Services

ProPharma plays a vital role in assisting pharmaceutical companies in ensuring compliance with advertising and promotion regulations through our expert consulting services. Here are some ways in which ProPharma can help:

• Audit and assessment: Conduct audits and assessments of a company's advertising and promotion practices to identify areas of potential non-compliance. Review promotional materials and procedures and provide recommendations for improvement.
• Training: Provide training to company employees on regulations and codes of practice related to advertising and promotion. This can help ensure that all employees are aware of the rules and guidelines and know how to comply with them.
• Compliance monitoring: Monitor a company's advertising and promotion practices on an ongoing basis to ensure ongoing compliance. This can include reviewing promotional materials, attending events and meetings, and conducting mystery shopping exercises to identify potential breaches.
• Regulatory and Medical Review support: Provide support and guidance to companies for the review of all commercial and medical materials as well as serving as an expert, work with regulatory authorities on promotional enforcement actions, preparing for regulatory inspections, and navigating complex regulatory promotional requirements.
• Process improvement: Help companies improve their processes and procedures for advertising and promotion to ensure ongoing compliance. This can include developing policies and procedures, implementing new technologies, and providing ongoing support and advice.

ProPharma provides valuable support to pharmaceutical, biotech, vaccine and medical device companies in achieving compliance with advertising and promotion regulations. By collaborating with our experienced consultants, companies can mitigate the risk of non-compliance, avoid enforcement actions, investigations, fines and safeguard their reputation. Learn more about our global promotional review capabilities or contact an expert today.