Out with the old! On with the new.
The pandemic has altered buyers’ behaviors across sectors. In healthcare, for example, it has heightened digital nativity with ramifications that include fewer in-person interactions between healthcare professionals (HCP) and sales reps. Nearly half of HCPs expect decreased in-person engagements with the sales teams.
The voluminous and sometimes compelling health information online has led patients to reduce their dependence on doctors, as they are increasingly willing to take greater control of their health.
These ground shifts in healthcare have forced pharmaceutical companies to enter the digital domain and ramp up their marketing. But the transition is more than creating a footprint in the digital space. We are talking about the marketing of pharmaceuticals, so there are precautions to heed. While we must promote every type of product ethically, medicines are hazardous when pitched out of context or promoted driven by profits. Healthcare authorities constantly monitor pharma marketers’ content, information, and advertisements.
The pharma industry is a critical contributor to society’s well-being and is a profit-driven industry. So, the greater the volume of medicines sold, the greater the return on investment for the drug manufacturing company. And to drive sales, promotion is indispensable.
Healthcare professionals and the public are exposed to various promotional approaches daily. Given that pharmaceuticals are highly regulated products, their promotions must be similarly regulated to ensure only the correct information, understanding, and awareness are provided to the public in the interest of safety.
Laws governing pharmaceutical promotion must contain two criteria:
- The promotion must be consistent with the approved product information.
- The information must not mislead, make inflated claims of efficacy, withhold critical information or be inaccurate.
Pharmaceuticals are highly regulated products. They result from years of research and development, clinical trials, scientific scrutiny, and peer reviews. Every aspect of their usage is mentioned in the product information, such as indications, dosages, administration, precautions, warnings, contra-indications, adverse effects, and interactions. This depth and volume of product information is a buyer’s right to know, and any marketing promotion or campaign must only be based on the integrity of the product profile. It must not, at any stage, go beyond the product’s purpose, usage, and result.
Regulatory standards can sometimes go beyond the presence or absence of information in a marketing campaign. There is a requirement in the US that the drug’s benefits, and risks, be presented in a ‘fair balance’. It means that apart from extolling its curative properties, every part of the advertisement must also contain information about its side effects. The lack of this provision means a medicine’s risks are not always disclosed in advertising in many countries.
Key differences in regulation
The different capacities of countries to regulate medicines have led to varying regulations on pharmaceutical promotions. According to a WHO survey, fewer than one-sixth of countries have a well-developed regulatory system for pharmaceutical products, and one-third do not have any. The number of countries regulating pharmaceutical promotion is slightly less than half (89).
How it works in the United States
The government directly regulates pharmaceutical promotion in the US. The FDA regulates only prescription drug advertising, and the Food and Drug Administration’s Division of Drug Marketing, Advertising and Communication (FDA DDMAC) cannot pre-approve advertising. Still, companies must submit advertisements as soon as they start a campaign, irrespective of whether the ads are aimed at healthcare providers or consumers.
The DDMAC sends an ‘Untitled Letter’ to the company if its advertisement violates US law, explaining why the promotion is illegal. If the misinformation is serious, a second stage ‘Warning Letter’ might be issued, which may require the offending pharmaceutical company to undertake costly and time-consuming correction campaigns and send ‘Dear Health Professional’ letters to doctors.
In the case of over-the-counter drugs, the FDA is not responsible for their advertising; it’s the responsibility of the Federal Trade Commission (FTC).
It is also essential that drug companies use language that is clear and understandable to the public. The law stipulates that companies clearly explain all the risks to consumers. There may be instances when it is challenging for pharma companies to express scientific and medical language in more straightforward terms without changing the meaning, and these are treated as exceptions.
What claims can pharma ads make in the US?
- The drug must have at least one approved use.
- The drug’s generic name.
- The risks of using the drug.
- Under certain circumstances, ads can state only the crucial risks.
What are ads not required to tell in the US?
- Cost of the drug.
- Information about the drug’s generic version.
- Whether there is a similar drug with fewer or different risks that can treat the condition.
- Lifestyle changes that help your condition (such as diet and exercise). Sometimes this information is required; it depends on the prescribing information for the drug
- The number of people with the condition the drug treats.
- How the drug works.
- The drug’s efficiency. (However, if the ad claims the drug works quickly, it must explain what ‘quickly’ means).
- The number of people, the drug will help.
How it works in the United Arab Emirates
The main regulatory board is the UAE’s Ministry of Health (MoH), and the main laws governing pharmaceuticals marketing and advertising in the UAE are:
- Dubai Executive Council Decision No. 7 of 2007 regulates health advertisements in the Emirate of Dubai.
- Abu Dhabi Decision No. 37 of 2019 governs health information and advertising in Abu Dhabi.
- UAE Federal Law No. 2 of 2019 (Health Data Protection Law).
- Cabinet Decision No. 32 of 2020 and Federal Law No. 2 of 2019 regulate information and communication technology use in health fields.
- Ministerial Decision No. 321 of 2020 on the Usage of Data and Information of Innovative Pharmaceutical Products.
The MoH’s approval is required to advertise medical and pharmaceutical products through any medium, including print, radio, television, internet, and others. The pharmaceutical marketing team must ensure the following while planning, crafting, and implementing marketing communications and advertisements:
- Governmental pre-approval. It is a must for all pharmaceutical advertising.
- Adverts comparing products are usually not permitted and are subject to criminal liability for defamation/harm to reputation (under UAE laws).
- As a rule, advertisements cannot violate UAE customs, values, traditions, public morals, or decency.
- A medical advertisement cannot be false, misleading, or intentionally misrepresent the quality or type of treatment or product offered.
- Advertising certain medications, therapies, or protocols cannot mislead potential patients about their effectiveness or state they are risk-free.
- A medical or healthcare advertisement cannot offer sales incentives to healthcare workers.
- Telemedicine advertising must clearly state what services the company is licensed or authorized to provide. The advertising of products or services aimed at children is prohibited.
You can get more information here.
According to a survey conducted by Ipsos in collaboration with the National Council on Patient Information and Education (NCPIE) and Pfizer, two-thirds of people believe they could be making more decisions about personal health and wellness on their own. More than 85 percent of patients said they were confident to take responsibility for their health and knew how to access online resources. It underlines the significance of pharmaceutical companies engaging digitally with patients and healthcare professionals with accurate and compelling campaigns. It helps consumers make evaluations conducive to a pharma company’s success.
The pharmaceutical industry must follow the guidelines of the regulatory authorities in implementing its marketing practices, so health outcomes are enhanced, and the company’s reputation is not damaged.