The Colombia Ministry of Health and Social Protection recently published a draft law which would require pharmaceutical and device manufacturers to disclose their payments and in-kind transfers to “those who participate in any manner in the provision, insurance, or education in the health sector.” The reports will be made public on a searchable database.
Columbia follows a long list of countries that have reporting laws, including the U.S. Sunshine Act, EFPIA in the European Union, and the French Sunshine Act.
View Columbia’s draft resolution (translated to English) here.
“[M]any pharmaceutical companies operating in Colombia already disclose information in their home countries and other countries in which they conduct their operations,” Columbia notes in their resolution (emphasis added). The draft does not specify whether the reporting obligations would be restricted to companies “operating in Colombia,” nor does it describe what is meant by “operating.”
If the draft resolution is finalized, the Ministry provides that “voluntary registration” and reporting of payments would start January 1, 2015. This initial disclosure would only relate to “general information about the payments.” Registration and reporting of payments would be mandatory starting January 1, 2016, and would require “information identifying the recipients.”
The draft resolution states that the “invitation to register” applies to manufacturers, distributors, importers, traders, or participants in the supply chain of drugs, supplies, devices, and medical equipment or any other health technology.
These parties must report on payments made to health practitioners that perscribe health services. Furthermore, the draft law requires reporting on payments made to virtually anyone remotely involved in healthcare: administrative staff that work in the health sector, professional organizations, associations, clinics, hospitals, universities, students in healthcare fields, patient organizations, and patients, among others.
Manufacturers and distributors must submit direct payments and transfers of value of any type, including those made in cash and in kind. The draft includes a non-exhaustive list, which includes:
- funding attendance at medical, academic, or scientific events
- funding for meals and other recreational events
- payments for patient monitoring
- funding for research
- medical continuing education activities
- medical equipment
Thus, Columbia’s law explicitly states that many transfers of value that are excluded under the U.S. Sunshine Act are to be reported on in Columbia. The only four exceptions are as follows (interestingly many dollar thresholds are in proportion to the minimum wage, which works out to a monthly wage of COL$589,500 (US$333)):
- Payments by parties obligated to register made to someone with a employment or contractual relationship to develop the social objective of the activity of the payer shall not be registered.
- Medical samples or diagnostic tests shall not be registered “unless their individual market value exceeds four minimum wages (SMLMV).”
- Printed promotional information shall not be registered unless it is part of a continuing education or recreational activity.
- Transfers of value of less than half (1/2) a monthly legal minimum wage need not be registered, unless they exceed one monthly legal minimum wage in one year.
Reporting entities must then consolidate their payments into categories (such as food and drink, research, gifts). These are almost identical to the US Sunshine Act categories. The reports must also include the “form” of payment–cash, in kind items, stocks.
As noted above, the current draft contemplate different stages for implementation. The first stage will last one year and include two registrations–first, payments made during the first half of 2015 will be completed before October 31, 2015. The second registration will cover payments made in the second half of 2015 and will be completed before April 30, 2016.
The second phase will be mandatory, and requires individual, non-aggregated payment reports. It is slated to begin January 2016 and its rules will remain in place going forward, with reports required before April 30 each year. Notably, “[t]he only payments that will not be individually identified are those given to patients and the registry will maintain the aggregate amount,” the draft states. “Those that are transferred to patient associations shall be reported individually.”
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We will continue to follow updates on Columbia’s disclosure law, as well as other Sunshine initiatives. View our coverage of the Open Payments release here.
In the meantime, Columbia provides a fairly succinct answer to most disclosure inquiries we could think of: “In case of a question as to whether a payment or transfer of value should or should not be registered, it shall be registered.”