Pharmaceutical Industry Support of US Patient Advocacy Organizations: An International Context

Abstract

Objectives. To examine whether the share of pharmaceutical industry funds allocated to patient advocacy organizations (PAOs) is disproportionately large in the United States relative to other industrialized countries and to compare pharmaceutical companies’ disclosure practices across industrialized countries.

Methods. We examined funding of PAOs among the 10 largest pharmaceutical companies in 2016. We compared funding allocated to organizations across 8 large industrialized countries and pharmaceutical companies’ disclosure practices in each country.

Results. Only 6 of the 10 largest pharmaceutical companies disclosed their financial transactions with PAOs in the United States. All 10 companies disclosed transactions in France, Germany, and the United Kingdom, with varying levels of disclosure in other countries. In 2016, the 6 companies that disclosed transactions in the United States allocated 74% of their patient advocacy funding ($88 million) in the United States.

Conclusions. The disproportionate funding of US PAOs in the absence of any disclosure requirements suggests that the United States should consider adoption of regulatory actions to enhance the transparency of relationships between the pharmaceutical industry and PAOs, and to ensure the integrity of public health decision-making.

Patient advocacy organizations (PAOs) exist in almost every industrialized country, performing valuable functions such as educating patients, providing social support, and raising public awareness about particular diseases.¹ Recently, there has been increased scrutiny of PAOs that seem to take positions contrary to patients’ interests.² One study showed that more than 80% of large US PAOs receive funding from the pharmaceutical and biotechnology industries, but only 5% of them offer information on the exact amount received.³ However, the magnitude of financial support provided to US PAOs relative to that in other industrialized countries remains unclear.

We conducted a retrospective analysis to explore whether the share of industry funds supporting PAOs is disproportionately large in the United States. We also examined pharmaceutical companies’ disclosure practices in the United States and other industrialized countries, and we discuss policy options to improve the transparency of the relationship between the industry and PAOs.

METHODS

We identified the 10 largest pharmaceutical companies according to global revenue: Pfizer, Novartis, Roche, Sanofi, Merck, AbbVie, Amgen, Gilead, Janssen, and GlaxoSmithKline. These companies accounted for 41% of pharmaceutical industry revenues in 2016.⁴ We focused on 8 industrialized countries—Canada, France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States—that together account for more than two thirds of the global pharmaceutical market.⁵

We examined the Web sites of each company and collected data on individual transactions disclosed in 2016 patient organization funding reports and grants and donation reports. Two of the authors (S. K. and L. K.) independently reviewed the purpose and grantee of each transaction to ensure that only grants related to patient advocacy were included. We compared funding amounts across countries for each company that disclosed transactions in the United States. Then we aggregated data for entire countries by summarizing the contributions of each company. We also compared funding amounts according to 3 measures: population size, gross domestic product (GDP), and pharmaceutical revenue across countries. The annual average exchange rate for 2016 was used to convert funding amounts expressed in foreign currencies to US dollars.⁶ We used Microsoft Excel, version 15.24 (Redmond, WA), in our data analysis.

RESULTS

AbbVie, Merck, Novartis, Roche, Sanofi, and Pfizer disclosed details of funding transactions with PAOs in the United States. The four other companies—Gilead, GlaxoSmithKline, Janssen, and Amgen—disclosed details of funding transactions with PAOs in some non-US countries, most commonly Germany, France, and the United Kingdom. Unlike the United States, each of these countries has a legal or self-regulatory framework requiring pharmaceutical companies to disclose their financial relationships with PAOs.

In aggregate, the 6 companies that disclosed details of funding transactions with US PAOs provided $120 million in PAO funding in the 8 countries and reported 6729 transactions. US organizations received 74% of total funding ($88 million). By company, the share of funding provided to US PAOs ranged from 64% for Merck to 89% for Sanofi (Table 1). Our analysis did not reveal any correlations in the 8 countries between the distribution of PAO funding and population size, GDP, or pharmaceutical revenue.

TABLE 1—

Distribution of Patient Advocacy Funding in 8 Countries in 2016, by Company

Country	Sanofi, $	Roche, $	Pfizer, $	Novartis, $	AbbVie, $	Merck, $	Total, $
United States	23 415 679	17 556 020	16 299 712	14 135 583	14 013 060	2 871 846	88 291 900
Canada	513 254	3 968 595	…	1 362 316	…	652 197	6 496 362
United Kingdom	900 021	1 124 586	6 132 755	1 470 715	795 176	118 672	10 541 925
Italy	393 078	790 079	703 284	2 010 891	1 868 224	352 242	6 117 799
France	375 421	316 755	367 295	1 218 529	270 377	89 442	2 637 819
Germany	242 260	434 111	684 861	552 270	568 383	282 663	2 764 548
Spain	429 640	465 392	1 817	745 985	681 575	140 080	2 464 488
Japan	124 003	135 741	…	178 176	…	…	437 920
Total	26 393 356	24 791 279	24 189 725	21 674 465	18 196 794	4 507 142	119 752 761

Even though some companies provided data on their financial support of PAOs in the United States, there were significant barriers to accessing and identifying the relevant information as a result of variations in companies’ reporting styles. Some of the companies disclosed funding to US PAOs as part of their medical and scientific grant reports. However, in European countries, notably France, Germany, Spain, and the United Kingdom, companies have created easily accessible PAO funding reports and adopted consistent standards regarding disclosure vehicle, format, and content.

DISCUSSION

We found that only 6 of the 10 largest pharmaceutical companies disclosed their financial transactions with PAOs in the United States, whereas all 10 companies disclosed them in France, Germany, and the United Kingdom. In 2016, the 6 companies that disclosed transactions in the United States allocated 74% of their funding to PAOs in the United States.

We did not detect any association between pharmaceutical companies’ financial support and a country’s population size, pharmaceutical revenue, or GDP. Our hypothesis was that one of these factors would be correlated with funding levels, but they were not. One possible reason for the concentrated funding of US PAOs is that the activities of PAOs in the United States have significant implications for a drug’s commercial performance both domestically and globally. US Food and Drug Administration approval can foster better access to the global market, and the United States typically sets the reference price for drugs because it is often the first country to commercialize a given drug.³ Currently, there are no guidelines, regulations, or legislation in place to address potential conflicts of interest associated with industry funding of PAOs in the United States.⁷

A first step is voluntary disclosure by pharmaceutical companies. The European Federation of Pharmaceutical Industries and Associations code of practice requires member companies in 33 European countries to disclose standardized details of their transfers of value to PAOs each year.⁸ Trade associations also have comprehensive guidelines in accordance with local laws.⁹ The US pharmaceutical trade association (Pharmaceutical Research and Manufacturers of America) does not have any comparable guidelines in place despite the larger funding of US-based organizations.

However, voluntary compliance may not be sufficient. The primary challenge associated with voluntary disclosure is the difficulty in ensuring universal compliance with comparable data. Some companies have chosen not to disclose PAO funding despite trade association guidelines or have provided the data in different formats.

A more comprehensive approach is the implementation of a legal disclosure requirement. This can be done via the framework created in the Physician Payments Sunshine Act.² The French government requires detailed disclosure of industry sponsorship of PAOs and imposes sanctions on companies that fail to report.¹⁰ The Canadian province of Ontario and the US state of Nevada have also adopted mandatory disclosure. Mandatory disclosure can ensure comparability of reporting and help discern conflicts of interest.

The main limitation of our study is that the 10 pharmaceutical companies we examined do not necessarily represent the entire industry. Our results, however, suggest the potential magnitude of the difference between the United States and other industrialized countries with respect to pharmaceutical companies’ PAO funding. Also, we did not examine the nature and purpose of the contributions, which may have been an important factor in determining the extent of ethical concerns related to financial relationships.

PUBLIC HEALTH IMPLICATIONS

Disclosure of pharmaceutical company financial contributions to PAOs is an important step in ensuring PAOs’ accountability to their patients and the public.² The disproportionate funding of US PAOs in the absence of any disclosure requirements highlights concerns about PAOs making recommendations to policymakers and public health authorities without full disclosure of their funding sources. Our study suggests the legitimate need for exploring a range of options to require disclosure of funding for PAOs, preferably legislative action expanding the Sunshine Act to include PAOs or industry-wide self-regulatory guidelines as an intermediary step.

Increased transparency regarding the nature and scope of industry relationships with PAOs would help policymakers and the public discern potential conflicts of interest.² Such requirements could also motivate PAOs to consider their financial relationships and their positions on public health issues.¹¹ In light of the influential roles played by PAOs in health policy-making, regulations requiring disclosure of relationships between PAOs and the pharmaceutical industry have become a global phenomenon.^8–11 PAOs’ financial independence is essential to prioritize public health interests and ensure the integrity of public health decision-making.