Life Science Compliance Update

November 30, 2017

ACCME Introduces Guidance for CME Providers on MEDTECH, APACMed and China Codes


Recently, MedTech Europe, the Advanced Medical Technology Association (AdvaMed), and the Asia Pacific Medical Technology Association (APACMed) introduced changes to their respective codes of conduct relating to professional development activities, including continuing medical education (CME). As such, the Accreditation Council for Continuing Medical Education (ACCME) has offered guidance for CME providers with respect to the changes.  

Starting in 2018, it is expected that the revised codes will require member manufacturers to discontinue making direct payments to clinicians to fund their attendance at professional development activities. However, the manufacturers may continue to support the engagement of physicians in professional development and CME activities through grants that are given to health systems and employers, and through grants to accredited CME providers.  

Following the longstanding procedure, organizations that are accredited in the ACCME system may accept financial support for their educational activities from commercial entities (I.e., device manufacturers) under the revised codes and maintain independence from industry by following ACCME's Standard 3: Appropriate Use of Commercial Support.  

Standard 3 can be met by an accredited organization following the below criteria when accepting funding from commercial interests: 

  • Make all decisions regarding the use of the support, independent of any company or companies; 
  • Have a signed written agreement with the company that includes the specific terms and conditions of the support; 
  • Use the funds only for the educational activity and to offset the cost of participation to the learners as a whole;  
  • Not pay for travel, lodging, honoraria, or personal expenses for any non-teacher or non-author participants of the supported educational activity; and 
  • Disclose to all learners the source (and if in-kind, the nature) of the commercial support.  

The revised codes and ACCME requirements can be aligned together by ensuring that funds received from companies by organizations accredited in the ACCME system are not used to pay for any travel, lodging, honoraria, or personal expenses for any non-teacher or non-author participants. This ensures the accredited organization does not act as an intermediary to establish a relationship between an ACCME-defined commercial interest and the learners in an accredited activity, as well as helping to ensure clinicians' prescribing or device usage patterns are not inappropriately influenced.  

If an international learner receives funding from his or her hospital or other commercial entity not affiliated with the ACCME-accredited organization to participate in the education, the accredited organization is not prohibited from accepting that learner's registration and participation in the education.  

In a press release announcing the changes and the ACCME guidance, ACCME applauded the change, "since they bring industry standards in closer alignment with those that have existed here in the United States since 1992, and in doing so support greater transparency and independence in global medical education. ACCME also noted that the standards and principles in the revised codes are aligned even with the ACCME's own Standards for Commercial Support, which have been internationally recognized as a benchmark for independent medical education and adopted by other healthcare continuing education accreditors throughout the world.  

October 11, 2017

MedTech Europe Changes Ethical Code


MedTech Europe represents the medical technology industries as a joint venture between EDMA and Eucomed and promotes a balanced policy environment that helps the medical technology industry meet Europe’s growing healthcare needs and expectations.

In 2015, MedTech Europe implemented a revised version of the 2008 Code of Ethical Business Practice to regulate interactions between members of the group and healthcare professionals. To help implement the code, in 2012, MedTech Europe created the Conference Vetting System. The Conference Vetting System attempted to address MedTech Europe members’ divergent interpretation of the Code and to reduce the risks associated to industry sponsorship of healthcare providers to third-party educational events.

The new MedTech Europe Code of Ethical Business Practice sets strict, clear and transparent rules for the industry’s relationship with Healthcare professionals (HCPs) and Healthcare Organizations (HCOs), including company-organized events, arrangements with consultants, research and financial support to medical education.

The Code of Ethical Business Practice has six big changes: (1) the phasing out of direct sponsorships; (2) transparency of educational grants; (3) creating a common chapter on general criteria for events; (4) creating a new chapter on demonstration products and samples; (5) agreed definitions; and (6) a common independent enforcement mechanism.

According to MedTech Europe, the new Code is a message from the medical technology industry to safeguard and protect the relationship with healthcare professionals by adopting clear and strict self-regulations.

The largest change coming from the new educational grant system is that it adds a significant amount of work onto the shoulders of the healthcare organization.

  1. Conferences supported by medical device companies will need to apply and be in compliance with the Ethical Vetting System;
  2. Healthcare organizations will need to write and submit grant requests to each medical device company that sponsors delegations to their medical meeting;
  3. Once awarded the grant, healthcare organizations will be responsible for choosing the healthcare providers that will receive support, following the guidelines as set forth on the grant requested;
  4. Healthcare organizations will be responsible for the management of the sponsored healthcare providers, including figuring out how to contact them, gather their information, manage their travel requirements, etc.; and
  5. Healthcare organizations and medical device companies will need to submit reconciliation and disclosure reports to MedTech Europe.

The rules will change in several ways, including: by forcing the public disclosure of grants, ensuring increased transparency of the funds allocated to medical education; by requiring conferences to comply with specific requirements and the Conference Vetting System; by allowing grants to be provided only to legal entities and never individuals, requiring a written contract and other related documentation; by allowing companies to define the types of recipients eligible for the grants; and by requiring companies to have internal and independent processes based on objective criteria to assess grant requests.

While most of the changes will affect European meetings, the most important change for the United States medical meeting industry is that MedTech Europe member companies will not be able to directly sponsor a healthcare provider, neither as a delegate nor as a speaker.

As of 2018, MedTech Europe will require all meetings to be vetted through its Conference Vetting System, and only these meetings will be eligible to receive funds from MedTech Europe member companies — and only through educational grants.

Healthcare organizations should brace themselves for an impact and will need to plan for a loss in revenue from any international delegations sponsored by Medical Technology Companies in Europe.

October 10, 2017

Belgian Sunshine Act Decrees Issued, Providing Guidance


On June 23, 2017, the Belgian “Sunshine Act” became law, requiring life science companies to disclose relationships with healthcare actors in the country. The Decree confirmed that the first publication of data under the statutory transparency regime will cover transfers of value for the year 2017 and will be published on by June 30, 2018.

The June 23 Decree notes that the provisions of the Sunshine Act apply to “premiums and benefits granted during calendar year 2017 to healthcare professionals, healthcare organizations and/or patient organizations.”

A second Decree was issued on August 22, 2017, which designated the ethical health platform Mdeon as the organization that will handle the practical aspects of disclosure on behalf of the Federal Agency for Medicines and Health Products (FAMHP). Mdeon will be managing theh publicly accessible website that will disclose the premiums and benefits that pharmaceutical and medical device companies grant to healthcare professionals and organizations, as well as patient organizations, annually.

It is unclear whether this determination causes the Sunshine Act to have retroactive effect in that it would require firms to notify and publish the transfers of value that occurred during all of 2017.

There are, however, certain benefits and premiums granted to these beneficiaries that do not have to be notified. These exceptions are (i) premiums and benefits of limited value that concern the practice of medicine, dentistry, pharmacy or veterinary medicine; (ii) meals and drinks supplied during scientific events; (iii) premiums and benefits that are part of ordinary-course purchases and sales of medicinal products or medical devices by and between a pharmaceutical or medical devices company and the beneficiary; and (iv) samples of medicines.

Before the implementation of the Sunshine Act, only industrial codes of conduct were adopted in order to enhance the transparency of transfers of value from pharmaceutical and medical devices companies to HCPs and HCIs. The transparency obligations were only mandatory for companies that were members of an association that had a code of conduct in place. 

The transparency obligations are now mandatory for all companies under the Sunshine Act. Considering the scope of the definition of “notifiers”, this practically covers all companies in the healthcare sector. Therefore, the scope of the notification obligation is very broad.

Sometime in September 2017, plans to organize an information session for the industry to explain – in detail – the new legal framework, including the differences with the current transparency in self-regulation.


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