EU Healthcare Compliance, Ethics & Regulation – The latest developments

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Foremost, corrupt countries are less safe.  Corruption thwarts economic development, traps entire populations in poverty, and leaves countries without a credible justice system.  Corrupt officials who put their personal enrichment before the benefit of their citizenry create unstable countries.”  Leslie Caldwel, Assistant US Attorney General, North Carolina, October 2014.

During the recent EU Healthcare Ethics & Regulation Compliance seminar held by the University of Seton Hall in Paris, I was able to acquire valuable information concerning all the latest and important legal developments in the Medical Law field, which I now have the pleasure to share with you. The seminar’s program, including the certification awarding, had a four-day duration presenting therefore a great variety of issues regarding compliance matters.  

The seminar focused on the following issues: the economic consequences arising from the medical field’s non-compliance, EFPIA’s recent legal developments in the pharma sector in correlation to the value transfer disclosure, EUCOMED’S expected developments regarding medical device companies, personal data protection as well as the investigation procedure concerning violations of compliance law in the United States, the EMA approval process, the advertisement of medicinal products and medical devices, the competition in medicines and its regulation. There were many interesting points raised by EFPIA, EUCOMED, professors of the Seton Hall University as well as American and European law firms. In particular, the seminar’s emphasis was given to the following.


FCPA’S consequences in Europe- EFPIA-EUCOMED

The provisions of FCPA (Foreign Corrupt Practices Act), which prohibits the bribery of foreign government officials and foresees the accountability of books, are beginning to  get implemented, with the appropriate legal  adjustments in the national laws of many countries, such as the UK, Russia, Mexico, France and India. In particular, the increase of anticorruption enforcement has as a result the cooperation among   investigative and prosecuting authorities all around the world.

State intervention in the healthcare industry in correlation with the existing high competition among pharmaceutical and medical device companies are the main aspects which have led to the conduction of thorough investigations on behalf of many countries. The relationship between pharmaceutical and medical device companies is being constantly investigated due to the high impact of these companies on national public health expenses. According to the latest statistics (October 2014) provided by the American Department of Justice, there are already over 120 ongoing FCPA investigations against 32 healthcare companies.

The special areas of investigation were:

I)                    Value exchanges on behalf of healthcare companies to HCP (consulting arrangements, product development agreements, grants, gifts, product training, travel, samples, free goods)

II)                  Clinical trials

III)                Services provided to third parties


EFPIA made very clear that the pharmaceutical industry is obliged to function in a way that promotes its transparency, responsibility and ethics. Is has become nowadays a great necessity for all EFPIA members as well as non-members to comply with the Federation’s provisions and rules; any breach or disobedience towards its opinions will not be tolerated.


Moreover, EFPIA has set out member guidelines in order to ameliorate important issues such as the way of providing information, healthcare practitioners, medical samples, events and relationships between HCP and patients. The initiatives taken on behalf of EFPIA clearly promote transparency all around Europe.

In particular, each member company shall document and disclose each Transfer of Values it makes, directly, or indirectly, to or for the benefit of a healthcare practitioner or healthcare organization.  The first Reporting Period shall be the calendar year 2015 (disclosure in 2016). The disclosure shall be made after the healthcare practitioner’s approval, via a platform disclosure either on the company’s website or via a special platform. Pharmaceutical companies shall be obliged to disclose their methodology concerning the disclosure of values while special attention should also be given to the protection of personal data. EFPIA’S provisions regarding value disclosure were also implemented in Greece’s code of SFEE which foresees the same rules as above, while the Department of Health is also preparing the upcoming legal adjustments.

As far as EUCOMED is concerned, in addition to its Code of Ethical Business Practices, Eucomed has created a centralized decision-making system, the CVS Conference Vetting system, to approve member sponsorships of individual healthcare professionals to conferences. The purpose of this system is to review the compliance of third-party educational conferences with the Eucomed Code of Ethical Business Practice (the “Code”) to determine the appropriateness for members of Eucomed and the national associations affiliated with Eucomed to sponsor Healthcare Professionals in order for them to participate in such conferences. The system also aims to include the organization of educational conferences in the European Economic Area as well as in Switzerland, Russia and Turkey. Extending this to conferences hosted in the Middle East is also under discussion. In this way, the scientific program will be thoroughly checked as it must be strictly educational, should not be excessive nor considered as an “entertainment event”, hospitality costs must be reasonable during the seminar’s duration, location and time should also be appropriate and not linked to vacation time. Meanwhile, EUCOMED is constantly preparing new approval procedures.

It was also mentioned that a new Medtech Code of Ethical Business Practice is expected to be published within 2015 in cooperation to EDMA and EUCOMED. Its purpose is the enforcement of high business ethical standards for healthcare practitioners as well as the abolishment of sponsorships granted for educational seminars organized by third parties.

The implementation of compliance programs according to the special needs and requirements of each pharmaceutical company should be an important priority for every company inside the healthcare industry. These compliance programs should be based on four basic rules: 1) Patients should always be set as top priority 2) The support of Ethical Research and Innovation 3) The insurance of Independence and Ethical behavior 4) The promotion of Transparency and Responsibility.


Our Law Firm’s comment

As a founding partner of “Michalopoulou & Associates” law firm, I would like to comment the following:

We consider the discussions and conclusions deducted from the EU Healthcare Compliance, Ethics & Regulation training organized and held by Seton Hall University very important for the adoption of new compliance programs. These conclusions work in tandem with FCPA, EFPIA, EUCOMEDA and intellectual property rules for healthcare companies to which we offer our legal advice.

In particular, we consider that pharmaceutical and medical device companies should focus their attention on the following matters:

  • The adoption of carefully designed compliance programs, appropriate to the needs and requirements of each company. These should be set as top priorities for all companies within the healthcare industry. 

Published on Health Daily on December 12 2014