Life Science Compliance Update

October 02, 2014

Physician Payments Sunshine: Columbia Seeks to Join Global Transparency Trend

Columbia

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)):

  1. 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.
  2. Medical samples or diagnostic tests shall not be registered "unless their individual market value exceeds four minimum wages (SMLMV)."
  3. Printed promotional information shall not be registered unless it is part of a continuing education or recreational activity.
  4. 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."  

July 29, 2014

Medicines Australia Code of Conduct: Payment Reporting Starts October 1, 2015

Australia

Transparency is increasingly a global phenomenon. Australia is no exception. Medicines Australia, Australia's industry body, recently revamped the disclosure provisions of its Code of Conduct, and sent the reforms to the Australian Competition and Consumer Commission (ACCC) for approval. The new Code will require Medicines Australia's member companies to report on an individual basis a wide range of payments and transfers of value to healthcare professionals, as well as sponsorships of third party educational meetings and symposia. The Australian requirements are similar to the United States' Physician Payments Sunshine Act, but there are notable differences in the policies.

The new version of the Code—Edition 18—was unanimously adopted by Medicines Australia's members at a general meeting on June 17, 2014. The ACCC authorization process is expected to take around six months and, if authorized, the new Code will come into effect in January 2015, with the new transparency reporting starting October 1, 2015. The new Edition preserves the reporting requirements of Edition 17 of the Code until September 30, 2014, which require aggregate rather than individualized reporting at the healthcare professional level.

Under the new Code, the following activities would be reported by pharmaceutical companies for individual healthcare professionals, by name, with the amount of the payment or transfer of value:

  • Consulting fees and/or speaking fees at educational event.
  • Sponsorship of a healthcare professional to attend an educational event: airfares, accommodation and/or registration fees (whether held within or outside Australia).
  • Fees paid to healthcare professional consultants in Australia, or to their employers on their behalf, for specific services rendered by them: consulting fees, accommodation and airfares (whether within or outside Australia).
  • Fees paid to healthcare professionals in their role as Advisory Board members: sitting fees, accommodation and airfares (whether within or outside Australia).
  • Fees paid to healthcare professionals for the purpose of market research ONLY where the identity of the healthcare professional is known to the company.
  • Payment of an educational grant or sponsorship to a specific healthcare professional

The following would NOT be required to be reported:

  • Payments to consultants in relation to research and development work, including the conduct of clinical trials.
  • Hospitality (food and beverages): The cost of any meal (including drinks) provided by a company must be below the defined limit set in the Code ($120 for food and beverages)
  • Airport ground transfers, taxis, parking fees
  • Venue costs (e.g. room and/or audio-visual equipment hire)

Analysis

As you can see, while the Code requires broader reporting than the United States for speaking events, the Australian Code exempts clinical trials from reporting as well as providing for a much larger food limit ($120 compared to $10). After the recent revision to the Sunshine Act, the CME speaking events policy may not even give us the edge there.

We also noticed that Australia's definition of "Transfer of Value" includes both direct and indirect transfers, like the United States. However, the Australian Code defines indirect transfer of value as "one made by a third party on behalf of a company for the benefit of a recipient where the identity of the company is known to, or can be identified by, the recipient." (p. 94 of the revised code). This is an interesting standard, considering the onus is on the manufacturers to report the transfer of value. In the US, if a payment meets the definition of an indirect payment in § 403.902, then the payment can be excluded from the reporting requirements if the applicable manufacturer does not ''know'' the identity of the covered recipient.

Another interesting aspect of the Australian Code is the concept of informed consent from physicians. "Each company must establish a means to ensure informed consent and maintenance of records which comply with Australian Privacy legislation," the Code states. "Where recipients of transfers of value cannot be identified for legal reasons, the amount attributable to such transfers must be reported on an aggregate basis by each company. The number of recipients involved must be stated and the aggregate amount attributable to transfers of value to such recipients."

Medicines Australia will make publicly available on its website the completed reports provided by each Member Company within two months of the date on which the reports must be submitted to Medicines Australia. The first report is scheduled to be published on August 31, 2016. Like in the United States, companies must provide Australian healthcare professionals for whom they have collected information about payments the opportunity to review and submit corrections to the information during a 6-week period before the public disclosure.

Now that the US system is in its Dispute Resolution phase, perhaps the most striking difference between Codes is that in Australia, "[i]f a healthcare professional does not agree to the information being disclosed with their name, the expenditure will be reported in aggregate with the number of healthcare professionals it relates to." This is a completely different approach than the US Sunshine Act, which allows manufacturers to unilaterally dismiss complaints by healthcare professionals.

Resources:

The Code of Conduct, June 2014: http://medicinesaustralia.com.au/files/2010/01/20140701-Draft-Edition-18-Code-version-30-June-2014-final-no-mark-up.pdf

Medicines Australia's press release, July 2, 2014 http://medicinesaustralia.com.au/2014/07/02/ma-submits-new-transparency-reforms-to-accc/

Thanks to Health Market Science for the information leading to this article on Australia's new code.

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