Life Science Compliance Update

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36 posts from June 2014

June 30, 2014

Physician Payments Sunshine Act: CMS Will Not Enforce Penalties for Submissions Done By July 7

Open Payment System

According to an official email companies from the Centers for Medicare and Medicaid Services (CMS), CMS will not enforce penalites for reporting non compliance until after July 7th.

We had previously reported that CMS help desk had sent an email to one company stating that CMS extended the deadline to July 7.  The deadline remains at June 30th but companies will not be penalized for reporting before July 7, 2014.  

Companies should not delay reporting as this is a very detailed process in which your data may be rejected due to mistakes in submission of the data.

CMS encourages companies to  visit the Open Payments website. If you have any questions, you can submit an email to the Help Desk at openpayments@cms.hhs.gov.

Live Help Desk support is available by calling 1-855-326-8366, Monday through Friday, from 7:30 a.m. to 6:30 p.m. (CT), excluding Federal holidays. (Note: Please be prepared to experience longer wait times as there may be an increase in the volume of calls received.)

Thank you to the CMS press office and Michael Georgi, JD Regulatory Compliance Advisor at G&M Health, LLC for the information. 

 

EFPIA Launches “Pharma Disclosure” Website; Provides Template Disclosure Form

Starting in 2016, European Federation of Pharmaceutical Industries and Associations (EFPIA) member companies will make public the details of payments and transfers of value made to healthcare professionals (HCPs) and healthcare organizations (HCOs). The first disclosures will be made in 2016 and will convey information about payments made in 2015. As companies prepare for reporting, EFPIA has launched a new website—Pharmadisclosure.eu—to highlight the new disclosure rules, follow best practices in the implementation of EFPIA's Code, and monitor compliance in the 33 countries involved in the initiative.

EFPIA's Code on Transfers of Value

EFPIA's "Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organizations," agreed to in July 2013, requires its members to disclose any direct payments or other forms of support made to healthcare professionals. This information will be published on a public platform, which could be on a company's own website or a central platform. According to EFPIA, "[i]t must be possible for the public to easily find and access the disclosed information in the country where the relevant HCP/HCO practices."

According to the Pharma Disclosure resources, "[t]he move to introduce the new transparency code in Europe mirrors the introduction in the US of 'Physician Financial Transparency Reports' under the Sunshine Act."

Unlike the Sunshine Act, however, EFPIA covers 33 separate countries.

EFPIA states that each member company will decide how to organize its disclosures. Disclosures should be publicly accessible in the country where the HCP/HCO receiving a transfer of value or payment from industry has their practice. The physical address where the HCP practices or HCO is located should be used as the reference when determining in which country the data should be disclosed. EFPIA states, for example, "if an Italian affiliate of an EFPIA Member Company engages with a HCP whose practice is in Spain for an activity in Germany, this Transfer of Value will have to be disclosed under the name of the recipient HCP in Spain (following the applicable laws, regulations and the national code in Spain)."

While EFPIA seeks to standardize the procedure across borders, member companies must comply with applicable data protection and other laws, which may impose certain limitations on their ability to make disclosures on an individual basis. EFPIA notes that "[d]ata privacy requirements must in each case be checked at the national level (i.e. the jurisdiction of the HCP/HCO receiving payment or transfer of value) by the member company prior. This must be done prior to any disclosure. Companies are encouraged to obtain consent from HCPs/HCOs prior to disclosure, and EFPIA and its Member Associations and Companies are working together with HCPs/HCOs to prepare for the implementation of the Disclosure Code."

Furthermore, the EFPIA Disclosure Code defines HCPs as any member of the medical, dental, pharmacy or nursing professions or any other person who, in the course of his or her professional activities, may prescribe, purchase, supply or administer a medicinal product. Some countries have different policies on what professionals may prescribe products.

Template Disclosure Report

EFPIA recently provided a template for disclosure reports, which provides a nice snapshot of what companies must track. Click here for a clear image of the template.

June 27, 2014

Clinical Trial Transparency Update: Eli Lilly, Bayer, Boehringer, and BMS Join Pharmaceutical Companies Sharing Patient-Level Clinical Trial Data

Eli Lilly, Bayer Healthcare, and Boehringer Ingelheim have announced their plans to increase access to their clinical trial data. All three are using the website ClinicalStudyDataRequest.com (which currently is down until July 1st) to share clinical study reports and de-identified patient-level data with researchers upon request. They will join GlaxoSmithKline, Novartis, Roche, Sanofi, and ViiV Healthcare, who also use the same portal to manage data requests. Separately, Bristol-Myers Squibb announced that they will be collaborating with Duke University to expand access to their trial data.

Clinical Study Data Request: How the database works

Clinical Study Data Request provides a secure internet portal for researchers to request patient-level anonymized clinical trial data provided by sponsor organizations.

After creating an account on the website, researchers can submit a single research proposal which is then reviewed by an independent review panel who decides whether access should be provided. The panel reviews the proposed science, publication plans, conflicts of interest and the qualifications of the research team. Following approval by the independent review panel, researchers are asked to sign a data sharing agreement.

Eli Lilly's announcement highlights the differences from previous data-sharing sites. "The new portal, www.clinicalstudydatarequest.com, differs…in that access will only be granted after approval of a research proposal by an independent scientific review panel. Lilly will not be involved in the decisions made by the independent scientific review panel."

YODA Project

Medtronic and Janssen, the pharmaceutical company of Johnson and Johnson use Yale's Open Data Access (YODA) as the intermediary for clinical trial data requests. The YODA Project performs independent scientific reviews of investigator requests for Janssen's and Medtronic's clinical trial data, including both Clinical Study Reports and participant-level data.

Duke Clinical Research Institute

Bristol-Meyers Squibb on June 24 announced that they would expand their access to clinical trial data through a collaboration with Duke University.

PhRMA Principles for Responsible Clinical Trial Data Sharing

In January of this year, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) jointly created a new policy that sought to enhance public health through responsible sharing of clinical data. Companies that follow the policy certify that they have established policies and procedures to implement the data sharing commitments. The following list identifies the companies that have provided such certifications to PhRMA as of May 28, 2014:

Clinical Trial Transparency: List of Individual Company Information

Abbvie

Bayer Healthcare

Biogen

Bristol-Meyers Squibb (New- June 24, 2014)

Boehringer Ingelheim

Calgene

Eli Lilly

GlaxoSmithKline

Novartis

Novo Nordisk

Pfizer

Roche

Sanofi

Shire

Takeda

UCB

ViiV Healthcare

If we failed to list your company, please send us the link to your information and we will be glad to add it to this list.

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