Conflicts of interest in the relationship between medical professionals and the pharmaceutical industry

Renata Fialho de Oliveira

Veirano, São Paulo

renata.oliveira@veirano.com.br

Beatriz Marconi

Veirano, São Paulo

beatriz.marconi@veirano.com.br

Introduction

The relationship between medical professionals and the pharmaceutical industry, in one way or another, has always been in the spotlight due to ethical concerns arising from potential conflicts of interest. These conflicts may arise when financial or other economic incentives (in a broader sense) may interfere in the impartiality of healthcare professionals to choose and prescribe the treatment or therapy (if any) that is the most appropriate to a given patient, potentially impacting their individual care or creating an unnecessary burden on the healthcare system as a whole. To address these concerns, regulatory measures have been implemented worldwide. This article explores  regulatory measures adopted in Brazil in that sense in recent times.

The nature of conflicts of interest

Conflicts of interest refer broadly to situations where an individual’s personal, financial or other external interests may interfere with, or appear to interfere with, their duty to act impartially and in the best interests of those they serve.

They can arise in any professional field, but they are particularly sensitive in the medical profession due to the potential impact on patient care and public health. In the context of relationships between medical professionals and the pharmaceutical industry, conflicts of interest occur when interactions – whether financial or otherwise – create the possibility that a physician’s clinical judgment could be unduly influenced by external incentives. Examples of such incentives include the receipt of gifts, sponsorship for educational events, research funding or travel reimbursements, all of which can subtly shape attitudes or preferences toward certain products or treatments.

The boundary between ethical and unethical conduct in interactions between medical professionals and the industry can be remarkably thin, particularly when it comes to hospitality provided by pharmaceutical companies. Offering hospitality, such as funding for attendance at conferences or covering travel and accommodation costs, can be a legitimate way to foster research, professional development and collaboration. However, depending on their particular features and circumstances, such practices may cross into unethical territory, creating an implicit expectation that a physician will favour a company’s products or services in consideration for material gains.

To address these concerns, robust regulatory frameworks and transparent disclosure practices are essential so that legitimate professional interactions do not undermine trust, nor compromise the integrity of medical decisions. It is critical for both medical professionals and industry stakeholders to remain vigilant, recognising the difference between fostering professional development and exerting undue influence that could harm patients or erode public confidence in the healthcare system.

The Brazilian regulatory framework

At a national level, there is no express legal or regulatory provision governing specifically the relationship between pharmaceutical companies and medical professionals. Despite that fact, certain practices may be considered irregular by law enforcement authorities, especially if the relationship results or are perceived as an inducement of prescription or a disguised promotional activity.

Resolution RDC No 96/08 issued by Brazilian health regulatory agency Anvisa, which primarily regulates the promotion and marketing of drugs, also contains provisions concerning the interaction of pharmaceutical companies with physicians and the general public. Although not specifically focused on relationships between healthcare professionals and pharmaceutical companies, its Article 5 could be arguably used as a good practice guideline, which reads: ‘companies cannot grant, offer, promise or distribute gifts, benefits and advantages to prescribers or dispensers, those who sell the product directly to the consumer, as well as to the general public’.

Additionally, the Medical Code of Ethics (Resolution CFM No 2.217/2018) issued by the Federal Council of Medicine (CFM) contains provisions that directly regulate the conduct of medical professionals. Specifically, it establishes that physicians are prohibited from:

‘Exercising their profession in interaction with or dependence on pharmacies, pharmaceutical industries, optical shops or any organisation dedicated to the manufacture, manipulation, promotion or marketing of products subject to medical prescription, regardless of their nature […] Allowing pecuniary, political, religious or other interests of their employer, hierarchical superior, or public or private health assistance financer to interfere in the choice of the best scientifically recognised means of prevention, diagnosis, or treatment available in the interest of the patient’s or society’s health.’

It is important to emphasise that the obligations provided for in the Medical Code of Ethics are binding exclusively on medical professionals and do not create corresponding obligations or sanctions for the pharmaceutical industry.

Finally, the Association of the Research Pharmaceutical Industry (Interfarma) Code of Conduct contains specific rules on the interaction between the industry and medical professionals. This code of conduct is mandatory for Interfarma’s members and generally accepted as a good practice standards. Following it can be used as a defence in case of challenges by law enforcement authorities.

The ‘Sunshine Act Mineiro’

While federal legislation does not directly regulate the relationship between medical professionals and the pharmaceutical or medical device industries, the state of Minas Gerais has enacted a statute imposing rules that may prevent improper interactions with healthcare professionals.

The statute requires companies to disclose their expenditures involving healthcare professionals registered in the state of Minas Gerais, including payments, gifts or other forms of value transfer. This obligation aims to promote transparency but could inadvertently discourage some companies from maintaining legitimate relationships due to the administrative burden or fear of reputational risks associated with public disclosure.

The ‘Sunshine Act Mineiro’ is a pioneering piece of legislation in Brazil. It is inspired by the United States Physician Payments Sunshine Act, which requires companies to report payments and transfers of value to healthcare professionals or organisations, including sponsorships for medical events, consulting fees and research funding. These disclosures are then compiled in a publicly accessible database.

CFM Resolution No 2,386/2024

Recently, the CFM recently issued Resolution No 2,386/2024 to address conflicts of interest on a national scale. This resolution establishes guidelines for the ethical conduct of medical professionals in their relationships with the pharmaceutical industry, emphasising transparency and prioritising patient welfare.

It requires physicians to disclose connections with health-related industries, such as employment contracts, consulting agreements, participation in research projects or lectures, through the CRM-Virtual platform managed by the different regional councils of medicine (CRMs) in each state of Brazil.

Additionally, the Resolution prohibits the acceptance of benefits related to products that lack registration with Anvisa, except in cases of research protocols that have received prior approval. Physicians are also required to disclose their ‘conflicts of interest’ in interviews, debates or in any events aimed at laypersons, as well as in medical events. Physicians who fail to comply with these new requirements will be subject to sanctions imposed by the CRMs.

The Resolution will come into force in March 2025. As above, this is an obligation applicable exclusively to medical professionals and does not create corresponding obligations or sanctions for the pharmaceutical industry (even if their marketing strategies will need to be reviewed in light of the new regulation).

Despite its intent to increase transparency, there is a significant discussion about the constitutionality of the Resolution. The Federal Constitution grants professional councils regulatory authority within the bounds of existing legislation. Imposing mandatory disclosure of affiliations and prohibiting certain benefits without a legal basis may be deemed an overreach of regulatory authority. The existence of pending federal bills, such as Bills No 204/2019 and 7990/2017, underscores the complexity of the issue and suggests that it requires broader legislative debate and public input rather than unilateral action by a professional council.

Given these constitutional and legal uncertainties, the resolution could face judicial challenges. Industry associations, unions and affected physicians might file lawsuits to contest the resolution’s validity. These efforts would aim to ensure that any regulatory framework for physician–industry relationships complies with constitutional principles and existing legal norms.

The path ahead

The Sunshine Act Mineiro and Resolution No 2,386/2024 are part of a growing movement in Brazil to enhance transparency and accountability in healthcare. These initiatives align with global efforts to address conflicts of interest, fostering a healthcare system that prioritises patient wellbeing and ethical practice.

As the regulatory landscape evolves, stakeholders must work collaboratively to implement these measures effectively, balancing the benefits of industry collaboration with the need to maintain trust and impartiality in medical care.