Medical Transparency - Sunshine Acts Compliance

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Sunshine Acts Medical Transparency

Companies manufacturing drugs, medical devices and biological and medical supplies around the world promote their products to healthcare professionals who order and prescribe them.

Healthcare transparency acts (such as the US Sunshine Act or the French Loi Bertrand) aim to make the financial relationships between these manufacturers and healthcare professionals (HCPs) and organisations more transparent and uncover potential conflicts of interest.

Disclosure rules vary, but global transparency requirements have similarities.

HCP transparency requirements

Many countries require a higher level of compliance from the medical sector. To avoid abuse or undue influence, medical device and pharmaceutical manufacturers are subject to transparency requirements regarding their spending in healthcare.

Manufacturers and distributors of drugs and medical devices and supplies must annually and transparently report payments or transfers of value (ToV) above a certain amount made to HCPs.

In Europe, the European Federation of Pharmaceutical Industries and Association’s Disclosure Code serves as a framework. It is “[...] a code of conduct that requires all EFPIA member companies and companies that are members of EFPIA member associations to disclose transfers of value to HCPs and HCOs. [... and] the names of healthcare professionals and organisations that have received payments or other transfers of value from them. They will also have to disclose – by HCP or HCO – the total amounts of value transferred, by type of activity […]”. This voluntary code aims to avoid conflicting laws in different European countries.

In France, the legal requirements are stricter than in much of the rest of the European Union. The French Loi Bertrand requires that any payment or ToV exceeding €10 be disclosed on a central, public website. Contracts with recipients in the field must also be disclosed. Companies must provide structured reports relaying this information to the French authorities. In most other European countries, companies disclose these payments on their own websites.

Complying with HCP requirements

While specifics vary from country to country, the main requirements are as follows:

  • Companies which fall under the HCP requirements must have a tool for their employees to enter the details of an event, meeting or ToV with a healthcare professional or organisation.
  • They must also log these records in a report that they submit to the government or relevant surveillance authority.

In countries without medical transparency laws, industry associations (such as EFPIA or MedTech Europe) will encourage their members to report HCP spending. They will also help them set up the necessary reporting tools.

The reports must include:

  • The HCP's personal details (title, position, medical specialisation, address of the medical institution)
  • The event details (did the ToV take place as part of a dinner, meeting or conference, for example)
  • And, of course, the amount.

How mobilexpense supports HCP compliance

mobilexpense's Health Care Professional transparency solution helps customers in the medical sector report HCP spending in a compliant manner.

Users simply record their expenses in mobilexpense and add the beneficiary and event details.

There are three ways to add personal details for HCP attendees to an expense report.

  • Attendee details can be input manually by the user. This option is readily available to all customers. It is also the most tedious and prone to errors as users must enter all the information themselves.
  • The users can select the HCP from a company-approved list.
  • Or, the users can select the HCP from an online database to which the customer subscribes.

Customers can also combine the manual method with the company-approved list or online database.

The solution includes the creation of a report which mobilexpense sends to customers for them to provide as part of their compliance requirements to the authorities.

mobilexpense customers can choose from a variety of 3rd party databases such as MediSpend, Tucania, MedPro or IQVIA. The provider is then responsible for data quality and maintenance, making it a carefree solution for users.

Using an automated solution such as mobilexpense to ensure your medical requirement compliance gives you additional insights with which to make strategic decisions. Not only does it improve the process for employees, it also helps administrators properly track HCP spending. An automated T&E solution improves compliance and reduces fraud, thus reducing costs and improving productivity.

Companies operating in the medical field are subject to stringent transparency requirements. mobilexpense supports its customers' compliance with these regulations at a local level. We do this by including relevant HealthCare Professional information in the expenses, reports, and accounting files we produce for our customers. mobilexpense is a user-friendly solution for employees and companies alike to fulfill their compliance requirements. Even when those requirements are industry-specific.

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Posted on 23 Jul 2021