It is inevitable – and desirable – that pharmaceutical companies and healthcare professionals (HCPs) work closely together. Their cooperation can lead to medical advances and better healthcare provision, and ultimately to improved lives for patients. Yet, when unregulated, these relationships can be mined with conflicts of interest, opening opportunities for corruption.

We need improved disclosure codes around the world, to make transparent the relationships between pharmaceutical companies and HCPs. So far, regulatory progress around so-called ‘sunshine acts’ (legislation designed to shine a light on opaque practices) has been slow, with most advances being made in the US and Europe.

Weak codes of disclosure across the globe

There have been substantial efforts to regulate the relationships between the pharmaceutical industry and HCPs. In Chile, the NGO Médicos sin Marca (MSM, Doctors Without Brands) has been advocating for clearer divisions between doctors and pharmaceutical companies since 2012. Their lobbying resulted in the draft Medicines Act II (Ley Fármacos II), which would regulate and manage conflicts of interest; as of June 2021, the bill is in the final stages of parliamentary approval.

In Colombia, the European Union has supported anti-corruption and transparency initiatives to help strengthen the regulatory standards between HCPs and the pharma industry. This initiative also led to the formation of a Colombian branch of MSM.

In both the Asia-Pacific and Africa, the harmonisation of medical regulations across the APEC and African Union member countries is gaining momentum, with both initiatives promoting self-regulation in accordance with ethical guidance from global pharmaceutical associations.

Despite these initiatives, progress to increase transparency and accountability in the pharmaceutical industry is uneven, and often relies on self-regulation. For example:

• In the Middle East, the Saudi Food and Drug Authority launched its Pharmaceutical Company Payments Disclosure Initiative in 2016 but the wider Middle East and Africa Code of Promotional Practices encourages self-regulation in pharmaceuticals.
• In the Brazilian state of Minas Gerais donations or benefits to HCPs must be declared, but in most Latin American countries, conflicts of interest in the medical profession remain largely unregulated.
• In the Asia-Pacific region, Japan and Australia require member companies to disclose certain payments to HCPs and medical institutions on their websites. Many of these disclosure laws are informed by US and European legislation (explained below), which favour self-regulation and industry autonomy. However, the effectiveness of the US and European regulations is questionable.

Disclosure in the US and Europe

To guarantee that the relationships between pharmaceutical companies and HCPs do not threaten public health, we need to address gaps in transparency and strengthen accountability measures. A key step is to disclose all information about their relationships and make that information easier to access.

The US is leading on this front. Its Physician Payments Sunshine Act requires pharmaceutical companies to disclose any payments or other transfers of value made to physicians/HCPs or teaching hospitals to the Centers for Medicare and Medicaid Services (CMS). While an important step forward, the Sunshine Act is not enough to hold the industry and practitioners into account.

In contrast to the US approach, the EU has no centralised platform collecting disclosure data. The European Federation of Pharmaceutical Industries and Associations’ (EFPIA) Code of Conduct, which governs the disclosure of transfers of value between pharmaceutical companies and HCPs, recommends that transfers of value should be published on a “public platform”. These can either be on the pharmaceutical companies’ own websites or, in some countries, a centralised database.

The EFPIA Code covers 33 European countries; yet our research found that only 8 countries publish this information through central platforms (see Table 1 in the Annex below). These platforms’ data accessibility and quality differ greatly, which makes it difficult to judge their user-friendliness and utility. As a result, accessing information and holding pharmaceutical companies and HCPs accountable in Europe is challenging. For example, meals and drinks, small gifts and drug samples are often excluded from reports, and in some cases, HCPs can opt out from having their name publicly reported.

This is problematic for two reasons:

1. HCPs who obtain industry-sponsored meals, small gifts, and drug samples are more likely to prescribe the promoted brand drugs, which are often more expensive than generic brands.
2. Many HCPs consider the benefits of these interactions as an extra income, and as a result, they are more likely to opt-out from disclosing their relationships if given the chance.

Despite calls for a Europe-wide ‘Sunshine Act’, most national-level regulations in Europe rely on self-regulation and self-reporting of pharmaceutical payments. This is the industry’s favoured approach, as they claim it makes it easier to address local markets’ needs. However, a study found that in no country did self-regulation generate an accurate picture of financial relationships between pharmaceutical companies and HCPs.

Regulatory variation between countries creates loopholes, which can and are being exploited by the industry. The EFPIA Code of Conduct has been breached by multiple companies in the UK and Sweden without any serious consequence to revenue or reputation: European country regulations, lack ‘teeth’. This could be corrected by a Europe-wide legal framework that favours legal directives over self-regulation. It is only when we spread the sunshine equitably over Europe that transparency can lead to better accountability and health outcomes.

Why disclosure is important for public health

Engagement between the pharmaceutical industry and HCPs, when properly regulated, can lead to the discovery of new medicines, as well as improved treatments and care practices. When unregulated, conflicts of interest may arise, providing a fertile ground for corruption, especially in the form of bribery, informal payments and favouritism. Conflicts of interest may also contribute to the illegal promotion of unapproved medicines, as they may compromise HCPs’ objectivity in prescribing.

To mitigate this, pharmaceutical companies should follow strong codes of ethics and self-regulation policies (especially when there is no disclosure legislation in place). Improving transparency in these relationships is a means to an end: the goal is to ensure that future collaborations between HCPs and pharmaceutical companies can improve health outcomes instead of putting patients’ safety at risk.

Indeed, opaque relationships between pharmaceutical companies and HCPs can actively damage patients’ wellbeing. For instance, a meta-analysis found a correlation between pharma–HCP interactions and increased prescription rates, lower quality in prescriptions and/or increased prescription cost. All of these outcomes can increase inequities in healthcare access and outcomes for vulnerable groups, such as the chronically ill, unemployed and people suffering from substance use disorders.

In the US, researchers used CMS data to investigate the relationship between pharmaceutical marketing and medicine-induced overdoses. The study found that direct industry promotion of opioid medicine to physicians was positively associated with increased unnecessary prescriptions of opioid medicine and a rise in opioid overdoses. As new diseases emerge and healthcare costs rise, disclosure data can provide profound insights for policymakers on the impact that pharma–HCP relationships can have on public health.

Disclosure can help build trust, expose conflicts of interest, improve prescribing behaviour, and ensure patients’ needs are prioritised over profit. When this information is made fully transparent, patients can make more informed decisions, and industry and practitioners can be held accountable for their actions and their impact on public health. More can and should therefore be done to ensure that disclosure regulations are promoted and implemented in low- and middle-income countries, so they are better prepared to mitigate the corruption risks that can arise in the context of pharmaceutical companies and HCPs’ engagements.

Moving beyond disclosure

Clearly, transparency alone does not solve conflicts of interest or corruption, which is why it needs to be accompanied by other measures, such as educating HCPs on why and how to report, establishing sanction mechanisms, and improving public awareness. In the interest of transparency and accountability, it is important that independent auditors, researchers, journalists and the public can examine the relationship between HCPs and pharmaceutical companies. The fact that in many countries, the pharmaceutical industry can self-regulate their relationships with HCPs is concerning.

To ensure that patients’ needs, and care are at the centre of all engagements, countries must commit to strong transparency and accountability measures. Disclosure regulations are simply not enough.

Annex. A snapshot of ‘sunshine legislation’ in Europe

As described above, only 8 countries in Europe publish transfers-of-value information through a central database. Table 1 outlines these 8 frameworks for pharmaceutical payment disclosure to HCPs, with links to their respective databases (where these are available).