Life Science Compliance Update

May 06, 2015

New Medicines Australia Code Tightens Transparency Provisions

Australia

On April 24, 2015, the Australian Competition Consumer Commission (ACCC) granted authorization of Edition 18 of the industry trade group, Medicines Australia’s, Code of Conduct. If Medicines Australia members accept the authorization and the conditions, Edition 18 will come into effect on May 16, 2015. The latest Code provisions tighten the transparency requirements for Medicines Australia member companies starting October 1, 2015, and will require physician payment reporting every six months. The Code provisions are similar in policy to the United States Open Payments program, though there are some differences in specifics. 

In Edition 18, Medicines Australia proposed a new reporting regime which requires reporting of "transfers of value" (such as speaking fees, advisory board fees, or sponsorships to attend a conference) made to individual healthcare professionals. 

The ACCC reviewed Medicines Australia's first stab at a reporting law--the Commission both commended the trade group for its transparency initiative, but noted some weaknesses in the law. “Having taken this crucial step, it is important to ensure that the significant benefits of the regime are realised," ACCC stated. "In this context, the ACCC is requiring the regime to be strengthened to ensure that all relevant transfers of value are reported and that the data is accessible." 

Under the new version, the ACCC has imposed a condition that enables reporting of all relevant transfers of value. "This addresses the ACCC’s concern in its draft determination that if a doctor did not consent to the reporting then the individual payment would only be reported in aggregate," states the Commission. "It also avoids healthcare professionals withdrawing their consent to reporting their details after receiving a transfer of value." ACCC states that "Medicines Australia must amend the Code before 1 October 2016 to require the reporting of all transfers of value."    

The ACCC is also requiring the transparency reports compiled by Medicines Australia member companies to be published in a common accessible format and to be available for at least three years. The ACCC also put the onus on the trade group to "establish a central reporting system" for the transfers of value. 

Notably, Australia's Code has a meal cap that excepts from reporting meals under $120.The ACCC said requiring companies to continue to report spending on food and beverages would impose a "significant administrative burden" on companies, but warned that it could reconsider the need for reporting on food and beverage spending if it became aware of "significant (and unreasonable) increases" in such spending. News outlets have focused on this apparent weakness in the reporting categories due to this exception. 

Code Provisions

As noted above, Medicines Australia has a number of updates before the October 1 deadline, but the Code has the following provisions currently:

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

  • Consulting fees and/or speaking fees
  • Sponsorship of a healthcare professional to attend an educational event, including 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:

  • 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, exclusive of goods and services tax (GST)).
  • Airport ground transfers, taxis, parking fees.
  • Venue costs (e.g. room and/or audio-visual equipment hire).

Companies will be required to indicate the following information:

  • Date of the event or provision of service
  • Name of the healthcare professional
  • Type of healthcare professional (i.e. medical practitioner, pharmacist, nurse practitioner);
  • Principal Practice Address of the healthcare professional;
  • Description of the service (i.e. speaker, Advisory Board member, Chairperson at educational meeting etc);
  • Description of the event (i.e. company sponsored meeting in Australia; independent meeting held in Australia; independent meeting held overseas; etc)
  • Whether the payment was made to the healthcare professional or a third party;
  • The amount of the payment or transfer of value, subdivided into (where relevant) registration fees, travel and accommodation, and fees for service.

We will continue to provide updates to the Australian transparency law, as well as other international reporting requirements. 

April 29, 2015

“Encouraging Continuing Medical Education For Physicians” Incorporated Into Newly Updated 21st Century Cures Discussion Draft

Notable updates to January's Draft include bipartisan concessions: New provisions to increase NIH funding; removal of provisions for increased exclusivity periods. 

Ladd email

Today, the House Energy and Commerce Committee released an updated discussion draft of 21st Century Cures legislation (view the legislative text, whittled from 400 pages to 199 pages since January); a section-by-section explainer; and a 1-page summary). “The yearlong 21st Century Cures listening session explored the complete cycle of cures – from the discovery of clues in basic science, to the development of new treatments, to the delivery of those cures, and back again to further discovery,” the House notes in the press release for the new bill.

Unlike January’s release of the draft, which Democrats did not formally endorse, today's document  is issued as a bipartisan bill by Chairman Fred Upton (R-MI), Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-CO), Full Committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairman Joe Pitts (R-PA), and Health Subcommittee Ranking Member Gene Green (D-TX).

Concessions: NIH Funding In; Market Exclusivity Out

One of the most notable new aspects of the bill—clearly evidenced as the lead off provision—is that the 21st Century Cures bill would raise NIH funding to $31.8 billion in 2016 and to $34.85 billion in 2018. The bill would also create an NIH Innovation Fund of $2 billion per year to support “precision medicine” and “young emerging scientists.”

Another important change is the absence of provisions which extended the marketing exclusivity. The January version of the bill included a 15-year marketing exclusivity for “dormant therapies,” defined as medicine that “is being investigated or is intended to be investigated for an indication to address one or more unmet medical needs…”  The old bill also sought more exclusivity for “New Therapeutic Entities” and “Orphan Products.” View Title 1, Subtitles L, M, and N in the old bill’s language, not found in the new version. 

Encouraging Continuing Medical Education for Physicians

Most interesting to Policy and Medicine readers likely concerns the status of the continuing medical education provision in the new bill. The language is updated considerably from the first go-round. 

Subtitle C—Encouraging Continuing Medical Education for Physicians:Exempting from manufacturer transparency reporting certain transfers used for educational purposes.  

Updates to the Sunshine Act reporting requirements are included in red. 

Transparency Reports and Reporting of Physician Ownership or Investment Interests, Sec. 1128G. [42 U.S.C. 1320a-7h]

(B) Exclusions.—An applicable manufacturer shall not be required to submit information under subsection (a) with respect to the following:

  • (iii) Educational materials that directly benefit patients or are intended for patient use, including peer-reviewed journals, journal reprints, journal supplements, and medical textbooks;
  • (xiii) In the case of a covered recipient who is a physician, an indirect payment or transfer of value to the covered recipient 
    • (I) for speaking at, or preparing educational materials for, an educational event for physicians or other health care professionals that does not commercially promote a covered drug, device, biological, or medical supply; or
    • (II) that serves the sole purpose of providing the covered recipient with medical education, such as by providing the covered recipient with the tuition required to attend an educational event or with materials provided to physicians at an educational event.

This language is much clearer than previously set forth. CME Coalition Senior Advisor, Andy Rosenberg, was encouraged by the language in the new bill, and commended the bipartisan effort set forth in the 21st Century Cures initiative.  

Sharing Off-Label Data and Social Media

Also of note, the original draft's provision encouraging FDA to consider a new regulatory approach to social media has been dropped from the final bill. This could be in recognition of the fact that FDA has agreed to align their guidances concerning scientific exchange with the First Amendment. 

This new bill includes an important section entitled "Facilitating Dissemination of Health Care Economic Information," which offers some regulatory leniency concerning communications with payors and formulary committees. This is especially significant given the more prominent decision-making role payors play in the current health care environment. 

Other Highlights in the Bill 

The Energy and Commerce Committee ran down a short list of provision highlights in the bill, which, in addition to increasing the flow of funds to NIH, also:

  • Incorporate the patient perspective in the discovery, development, and delivery process.
  • Foster development of treatments for patients facing serious or life-threatening diseases.
  • Repurpose drugs for serious or life-threatening diseases and conditions.
  • Modernize clinical trials.
  • Break down barriers to increased collaboration and data sharing among patients, researchers, providers, and innovators.
  • Help the development of personalized and precision medicines so the right patient can receive the right treatment at the right time.
  • Provide for continued work in the telehealth space.
  • Advance a truly interoperable health care system.
  • Provide clarity for developers of software products used in health management and medical care.

We will continue to cover this important legislation as it makes its way through Congress. 

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