Suppliers regularly interact with a range of individuals and groups to share information about their products and promote their use. In an effort to expand the use of these products to increase their profits and expand their market share, suppliers may use corrupt marketing practices, while unethical healthcare providers may see these interactions as an opportunity to solicit payments.
From explicit gifts and implicit research grants, to suppliers distorting the presentation of evidence relating to the benefits and harms of products, suppliers can influence healthcare providers so they use and prescribe their products rather than those of their competitors.
Suppliers may also encourage healthcare professionals to act as spokespeople for specific products, which is a particularly effective way for suppliers to market their products. A healthcare professional can effectively promote a product is they are respected in the healthcare community and appear as impartial to their peers, particularly if a conflict of interest is not declared.
Across the world, marketing interactions between suppliers and healthcare providers are controlled by a mixture of government regulation and self-regulation. A range of industry association codes have set the marketing practices expected of suppliers, while initiatives can be introduced that encourage members to disclose online the gifts and hospitality they have provided to healthcare professionals. For example, the European Federation of Pharmaceutical Industries and Associations (EFPIA) introduced a Disclosure Code in 2014, with reporting commencing in 2016. In the US, the Physician Payments Sunshine Act requires healthcare suppliers to disclose financial relationships with doctors. However, in most of the world this is not mandatory, and penalties are minimal.
A driving force for marketing malpractice are the incentives offered to sales representatives by suppliers. Bonuses can encourage or pressure sales representatives to increase their sales in any way possible, disregarding codes of conduct and policies that mandate ethical marketing. This becomes a greater risk if a sales representative’s salary is driven largely by bonuses.
Suppliers can improperly market their products using more implicit means such as by setting the curriculum of continuing education programmes, using post-marketing studies to actually promote their products, or widening the diagnostic boundaries of illnesses. It is arguably harder to tackle these practices as they are often well hidden and involve the production and dissemination of medical knowledge.
“In one country I was in the sales reps were giving services in kind to physicians; offering to pick up kids after school and a little extra tutoring, all sorts of things that were not considered bribery as such.”
— Deirdre Dimancesco - Technical Officer, World Health Organisation
Inducements can be explicit such as gifts or holidays that directly relate to the healthcare professional using or purchasing the product. But even this can be difficult to uncover as inducements can be made through agents, by using offshore accounts or by being given to the family and friends of a healthcare provider.
Inducements can be implicit and attempt to build a relationship with a healthcare professional. Examples include sponsoring attendance at a conference, invitations to be on an advisory board or funding medical research. Therefore, this corruption type has strong links to other types of corruption.
A key challenge with this corruption type is that the relationship between healthcare professionals and suppliers may be critical in the development of medicines and health technologies. Added to this, healthcare professionals often do not accept that they may be influenced by these inducements, despite research showing that even small gifts can influence a doctor’s decision-making process. In cultures where gift giving is widespread, healthcare workers may even expect gifts from suppliers and their sales representatives.
When seeking to influence health facilities so they purchase or place a product on a product list, a supplier may offer a range of inducements. Bribes may be paid to public officials or employees of private facilities responsible for the decision, such as cash transfers or holidays for them and their families. Alternatively, suppliers may offer secretive discounted prices to get health facilities to use a particular product, and then this is used as a promotional tool to encourage other facilities or even countries to buy it.
Patient organisations and professional associations are expected to support the interests of the groups they represent. They affect health policy and governance through their advocacy work with government and politicians. However, if patient organisations or professional associations accept funding or other advantages from a supplier, it may unduly influence their behaviour. Rather than acting in the best interests of the people they represent and wider public health goals, they may support the interests of a supplier.
For example, a patient organisation may campaign for drugs that actually have little or no benefit over previous medicines, or may advocate for a medicine to enter a market or be added to national reimbursement lists more quickly. This may have the effect of reducing the amount of funding available for other treatments and services in a health system. It may also increase the potential harm to patients, for example through the use of medicines for which the risks are not well known.
Similarly, a professional association may develop clinical practice guidelines that call for the treatment of conditions using products from a funder or funders with a lack of evidence to support the decision. Funding from multiple sources may mean the association advocates for quick use of a product or treatment when an appropriate clinical decision would be to watch and wait to see how a condition develops. If conflicts of interest are not declared and the funding sources are not made explicit, corruption can flourish.
In many countries healthcare professionals are required to complete accredited continuing education. However, by funding continuing professional education companies can use this as an opportunity to market their products. By developing the curriculum and choosing speakers the harm of products can be downplayed, the benefits amplified and off-label uses encouraged. This is of particular concern if conflicts of interest are not declared and funding sources are not made explicit.
As many governments subsidise a small proportion of continuing education there are risks. If training opportunities are limited, supplier-funded continuing education may be the only form of continued training available for some healthcare providers. Care must be taken to ensure that the funding sources do not compromise the objectivity of the information, thereby impacting on patient care.
After a product has been released into a health system for use it must be monitored to ensure there are no unknown risks and safety issues. For medicines, the pharmaceutical industry voluntarily conducts most of the post-market surveillance. Arguably, there is a potential conflict of interest if suppliers are conducting trials on their own products, as they may be encouraged to hide risks and promote the product through the design and conduct of the trial/study.
Termed ‘off-label marketing’, suppliers can market a product to healthcare providers outside the uses for which it has been approved by regulators and what is stated on the product label. This can be extremely profitable for suppliers, as increased use of their products will generate more revenue. A healthcare professional may prescribe off-label, for example, to patients in a different age group to those a product was tested on, to prescribe a different dose or duration, or to use a different mode of administration. This is extremely common for population groups that are often excluded from clinical trials, such as pediatrics or geriatrics.
Off-label marketing is an issue for many regulatory authorities. In the US, off-label marketing has resulted in large fines by the Department of Justice using the False Claims Act. In other parts of the world, this behaviour often can go unchallenged.
Off-label marketing can be dangerous for patients if the unapproved use that is promoted has not been shown to be safe and effective using robust evidence. There are also concerns that if the bar were lowered to allow such marketing practices, this would obviate the need for large scale clinical trials to get a drug approved by the regulators.
Disease mongering has also been termed the corporate construction of disease or the medicalisation of society. It involves the widening of the diagnostic boundaries of illnesses and aggressively promoting their public awareness in order to expand the markets for treatment. While a condition may exist and be an issue for a selection of the population, suppliers are able to exaggerate the incidence, prevalence and severity of a condition to increase the use of a product. This means a common condition can evolve into a disease that requires treatment.
This is achieved in collaboration with supporting healthcare professionals and patient groups that are able to act as informal thought-leaders. The use of direct-to-consumer advertising, unnecessary screening tests or awareness raising campaigns can also be used to increase public support for the treatment of the condition.
Unnecessary procedures and overtreatment can cause negative patient health outcomes, in terms of adverse effects, as well as mental concern and fear. It also increases the cost of healthcare, as payers fund these procedures at the expense of other services.