Transparency reporting requirements for life sciences companies are increasing all over the world.
The United States was the first country to enact comprehensive transparency reporting requirements for life sciences companies as part of the Patient Protection and Affordability Care Act in 2010. Known as Open Payments, the law requires annual reporting by applicable manufacturers to the Centers for Medicare and Medicaid Services (CMS).
Shortly after the enactment of Open Payments, on December 29, 2011, France enacted the Loi Bertrand Act, commonly referred to as the French Sunshine Act. Like Open Payments, Loi Bertrand established a comprehensive reporting scheme mandated by French law. Thereafter, in an attempt to avoid a patchwork of conflicting European laws, the European Federation of Pharmaceutical Industries and Associations (EFPIA) passed a voluntary disclosure code (EFPIA Disclosure Code). The first period of reporting under the EFPIA Disclosure Code took place in 2015.
Unlike CMS’ Open Payments, the EFPIA Disclosure Code* (full title: EFPIA Disclosure Code of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organizations) is a voluntary commitment that instructs all EFPIA member companies to disclose transfers of value to healthcare professionals (HCPs) and healthcare organizations (HCOs). EFPIA represents the pharmaceutical industry operating in Europe and has direct membership of 36 national associations and 39 leading pharmaceutical companies. Obviously, the voluntary commitment of members is one of the biggest differences compared to the legal requirement of Open Payments.
Under the EFPIA Disclosure Code, EFPIA member companies voluntarily publish all direct and indirect, monetary and non-monetary transfers of value related to the development and commercialization of prescription-only human pharmaceuticals. Disclosure of payments made in the previous calendar year are published at the latest by the end of June in the current year and this process is repeated every year. From that perspective, it is similar to federal reporting in the United States (US), where reporting takes place on an annual basis, although the reporting deadline in the US is earlier. Reporting in the US is due by March 31st, which only allows companies three months to gather accurate and complete data for the previous year. This tighter deadline can create the requirement for greater resources during the reporting season.
Another difference between the EFPIA Disclosure Code and Open Payments is the requirement for HCP consent. Specifically, the EFPIA Disclosure Code requires pharmaceutical companies to collect the affirmative consent from the HCP to allow the company to disclose the HCPs transfers of value. HCP consent is not required for disclosing HCP and HCO transfers of value pursuant to Open Payments as the US lacks the comprehensive privacy regulation existing in Europe. For reporting under EFPIA, companies need to collect consent from HCPs before disclosing the transfers of value that concern them.
Furthermore, US Open Payments reporting contains three different spend reports: general, research and ownership. The EFPIA reporting is done using one template with a separate section for aggregated transfers of value related to research and development.
Whether it is EFPIA regulating the pharmaceutical industry in Europe or MedTech Europe regulating medical device companies, numerous industry associations outside of the US have chosen to include transparency requirements in their codes of conduct. This is true in Japan, Australia, the Middle East, Mexico, Canada and Europe, with exceptions like France, Belgium and Portugal. Perhaps the hope being that it is less likely for the government to enact a legal requirement if self-regulation is in place. However, reporting requirements described in codes are only applicable for members companies and, overall, seem less detailed or complicated when compared to the legal requirements we have seen.
Nonetheless, a recent trend is showing an increase in laws over codes with reporting regulations being released in Colombia, South Korea and Saudi Arabia among others. One thing is for sure, we should prepare ourselves for many more regulations to come.
*In the meantime, EFPIA consolidated its three EFPIA codes: HCP, PO and Disclosure into one simplified code. The new code is available here: link. “Member associations are asked to transpose the revised code provisions by June 30, 2020 and must implement it by no later than December 31, 2020.