By Anya Constantine
Messaging is a marketers most powerful tool.
It may be a bold statement to make but the proof is really in the pudding. Marketing agencies will spend multiple sessions talking about brand image, marketing mix, levels of product value, market segmentation and campaign strategies when in actuality they are subconsciously exploring the numerous ways to formulate a compelling message. What is even more interesting to see is how even in a highly professional space like medicine and pharmaceuticals, messaging overrules all logic.
Pharmaceutical companies drive the global economy through their research and development, which boosts health and the global quality of life. Therefore, they are almost essential to the progression of the human race. At the same time, most of these pharmaceutical companies live off the back of local governments and philanthropic organisations, resulting in a daily struggle to continue their work. To combat this precarious financial terrain and the continuous emergence of competing entities, many pharmaceutical companies have turned to the marketing of their drugs, some even in the most controversial of ways. Today, around 3.83 per cent of world trade is pharmaceutical products, and in 2021, the Observatory of Economic Complexity noted that pharmaceutical products were the 6th most globally traded product. While typically, the focus of international trade has been related to ensuring tariffs between countries remain at a minimum, an underlying aim in global trade has also been to prioritise the interests and safety of consumers. This is why trade has subsequently expanded to regulating the marketing or promotional aspects of the pharmaceutical sector.
What Do We Mean by Regulation?
Source: Fierce Pharma
If one was to take the example of Pfizer, today many are aware that this pharmaceutical brand has achieved success. Hence, Pfizer, the creator of some of the best-selling drugs in the world, almost no longer need to market at all. Pfizer’s marketing strategy that changed their position in the global industry was based on its product Viagra, a common drug prescribed today to treat erectile dysfunction. Viagra was marketing its product in such a way so as to convince men with erectile dysfunction, that they were not alone. Despite vigorous competition from other drugs and pharmaceutical companies, Pfizer used a very similar theme in their vastly different message that changed the formula ever so slightly to create one of the most successful drugs in the 1990s and 2000s. All they did was use a women’s perspective in their advertising. This tactic in the marketing efforts of Pfizer’s Viagra campaign was so successful that the drug saw 55 – 62 per cent of men admitting they would ask to be prescribed the little blue pill. It was certainly controversial and risky to introduce a female voice into an exclusively male sphere, but is this what we mean by advertising regulations? No. Regulating the pharmaceutical industry is based on ensuring what is advertised is correct and not misleading.
How Truthful Should Pharmaceutical Marketing Be?
If regulating pharmaceutical marketing is based on its truth, how truthful is a company required to be? Marketing takes many forms. Companies may use advertisements and commercials, or even adopt the traditional practice of sending their sales representatives to visit the doctor’s office and conduct coordinated marketing campaigns. With over 13,000 human drugs in the world, one can only imagine how to market each. Should it be educational? Informative? Advocated? Or… should it be enticing? Enticing enough for regular individuals to ask their local GP to prescribe them the drug. Most importantly, one of the key questions that have surfaced in this debate is whether promotional information and marketing activities support the appropriate use of medicines.
A research article by Lilia Ziganshina and Joel Lexchin cites numerous cases where the lack of regulation in pharmaceutical promotion led to drastic consequences. This included the promotion of a synthetic oestrogen called Diethylstilbestrol (DES) during the 1940s, which was advertised on the claim that it would prevent miscarriages as it supposedly made the babies stronger. In reality, however, the women that did take the drug resulted in them being subjected to a higher risk of getting breast cancer, whereas their daughters in utero developed reproductive tract abnormalities, with some of them being diagnosed with a rare form of vaginal cancer. The need for regulation further heightened when certain medicine were being promoted for unapproved conditions. For instance, in the 1990s, gabapentin was legally approved by the US as an additional epilepsy treatment for those whose prescribed medication no longer responded. However, pharmaceutical manufacturers started to market the pharmaceutical drug on the claim that it helped in controlling or curing other diseases. Not only was this misleading, but the consequences of taking such medicine could lead to one suffering from adverse effects, from mild to severe.
Who Regulates the Pharmaceutical Promotion?
Generally, each country has the sole authority to implement legislation to ensure unethical marketing strategies are not implemented in the pharmaceutical industry. Hence, while this means the regulations of each country may vastly differ, they typically include two common responsibilities. First, pharmaceutical promotions must be consistent with the approved product information, and second, they must not be deceptive or inaccurate. Approved product information refers to mentioning the purpose of the medicine (the more specific it is, the better), the right dosage and administration, and any warnings. Additionally, the product must also have a section that describes the potential adverse effects of using it or whether it is safe to administer the drug while taking other medicines. Further, companies have to take into account the World Health Organisation’s guidelines on Ethical Criteria for Medial Drug Promotion.
It should be noted that the physician or doctor has the freedom to prescribe any drug while abiding by their own code of ethics. However, what happens when a person gets prescribed a medicine whose product information does not note that it is used to treat that specific illness? This is called ‘off-label prescribing’. This is legal considering that it is a doctor that prescribes them – a person who one can reasonably believe has the best interest of the patient in mind – and also since there are many illnesses that do not have a specific medicine. Certain manufacturers may then try to apply and gain approval by a specific body permission to include in its label that the medicine is being used for that additional purpose. However, until it is approved by the governing body of the country, they are restricted from promoting it. Hence, off-label promotions are not allowed.
Other forms of unethical or prohibited forms of advertising in the pharmaceutical sector include direct-to-consumer advertising (DTCA) of prescribed medicine.
Does Sri Lanka Have Guidelines on Marketing or Promotional Material in the Pharmaceutical Industry?
The National Medicines Regulatory Authority has published a detailed guideline on advertising of medicine and medicinal products to the general public. Although it is a guideline, it complements the provisions of the National Medicine Regulatory Authority Act (NMRA) 2015, specifically S50(4) and S55:
No person shall label, package, re-pack, treat, process, sell, distribute, exhibit or advertise any medicine in a manner that is false, misleading, deceptive or likely to create an erroneous impression regarding efficacy, quality, composition or safety.
1) No person shall advertise or promote any medicine without prior written approval of the Authority.
2) No person shall advertise or promote any medicine to the general public as a treatment, prevention or cure for any of the prescribed diseases, disorders or abnormal physical states.
It should be noted that the said guideline only regulates marketing of pharmaceutical medicine for human use. In this sense, the medical product must first be registered as a ‘medicine’ under Schedule 1 of the NMRA prior to advertising it. The guideline goes on to explain what form of material amounts to advertising, extending it to any sponsorships, talks shows, vehicle wrappers, stationary material and more. Under this guideline, the Medicine Advertisements Sub-committee (MASC) reviews and approves a certificate for advertisements that meets the guidelines. Hence, whether a advertisement is approved will be a question of fact for the MASC. Accordingly, the MASC requires all information or claims made in an advertisement to not be stronger than what scientific evidence warrants, and that “every effort should be made to avoid ambiguity”.
The NMRA moreover contains a list of prohibited advertisements. This includes restricting manufacturing companies from publishing any form of advertisements that claim to the prevent, treat, alleviate, cure or diagnose diseases and conditions like cancer, deafness, kidney-related diseases, mental illnesses and more (the list contains 20). It also prohibits any marketing campaigns centred on practicing contraception among human beings, improving the condition or functioning of the human kidney or heart, or improving the sexual function or sexual performance of human beings. The guideline further recognises the need for social responsibility. Hence, celebrity endorsements, medical professional endorsements, and the use of client or user testimonials are highly restricted. For instance in the case of celebrities, a disclaimer noting that ‘The effect of the product may vary among individuals” needs to be present. On the other hand, advertisements are not allowed to have any audio and/or visual presentations of doctors, let alone anyone from the scientific community endorsing the product. User testimonials also require the same disclaimer as a celebrity to be inserted although the company must receive a consent letter of such users including their name, NIC/passport number, signature and contact information.
Even hyperboles which overestimate the value of the product is cautioned against in the guideline. Note that these guideline apply not only for those who promote medical drugs for diseases but also for anti-aging products, energy intensifying drugs to increase performance in sports or studies, and more. Even the use of the word ‘Natural Product’ or ‘Herbal product’ cannot be carelessly inserted. The guideline also goes on to offer advise on how awareness campaign, press releases, competitions, sponsorships, or even the advertisement of a free gift needs to be carried out by the company.
While traditionally marketers are not held to the same standard of journalists or reporters, marketers in the pharmaceutical industry have a high responsibility to safeguard the public from any harmful exposure. This responsibility is extended to any other individuals associated with the promotion of a product. In most cases, brands create compelling messages that lead to astounding ad campaigns and skyrocketing sales, all ignoring the gory underlying details. While Pfizer may argue that their campaigns, although may be distracting, still provide full disclosure on the risks of taking the drug, their intentional or unintentional attempts to hide the growing concerns over the side effects of Viagra for instance, certainly lacks the transparency required by medical standard. Particularly in the global trade of the pharmaceutical industry on which the survival of the human race is very dependant, Pfizer may have sold a successful drug as a “sex life enhancer”, but did they solve the real issue of erectile dysfunction and male impotency, or did they simply disguise several side effects in a strong message, a pretty face and a good time?
The views and opinions expressed in articles submitted to the Comparative Advantage Blog are those of the authors and do not necessarily reflect the views of The Moot Court Bench.