Life Science Compliance Update

February 02, 2016

European Medicines Agency: Framework for Interaction with Industry

The European Medicines Agency's (EMA) Management Board has adopted a new framework to govern interaction between the Agency and industry stakeholders. The framework covers interactions involving human and veterinary medicine, however there are still unanswered questions about specific products and procedures that will be resolved by internal EMA departments. The adopted framework seeks to facilitate and streamline communication, structure interactions, increase accountability and transparency, and includes a plan to monitor and report on interactions.

According to the EMA's minutes, comments by the European Commission on the framework were supportive and emphasized the need for transparency and called for dialogue among stakeholders. By Q1 2016, the EMA's framework hopes to identify eligible organizations and set out the criteria for stakeholders to be included in the Agency register for participation in EMA activities. Also at this time, EMA aims to develop a stakeholder information webpage and a dedicated contact point within the Agency to coordinate interaction.

On an annual basis, the EMA will monitor and report on the interaction with stakeholders which will be organized by the EMA through an ongoing process. The discussions will focus on issues of common interest in cooperation with the European Commission as well as the European Medicines Regulatory Network. By Q4 2016, the EMA aims to share its experience with NCAs and other EU Agencies.

The EMA explains the need for such a framework by noting the pharmaceutical industry remains as one of the Agency's key stakeholders with whom communication is a major part of day-to-day operations. These communications range from contacts with companies through early innovation task forces and briefs to direct contact during regulatory procedures. Article 78 of Regulation (EC) No 726/2004 calls for the Agency, its Management Board, and Scientific Committees to develop contacts with industry stakeholders. Furthermore, the EMA has identified open communication with the pharmaceutical industry as a key goal that is increasingly changing as innovations in medicine grow across the health sector.

Now as the EMA increases in size, scope, and complexity, the Agency describes its current stakeholder management activities as "fragmented". This has resulted in "sub-optimal" results, spurring the EMA's interest in centralizing interactions with industry associations. The scope of this framework is intended to include organizations that support and operate in the pharmaceutical industry, including industry trade associations representing pharmaceutical companies; associations of professionals or service providers operating in or supporting the general interests of industry; organizations engaged early on in the innovation life-cycle from development; associations with multiple stakeholders including industry members; and stakeholders operating in domains related to pharmaceuticals such as medical devices or HTA.

January 15, 2016

The College of Family Physicians of Canada and Commercial Support for CME

Once again, the fact that the pharmaceutical industry helps financially support continuing medical education programs is in the spotlight. This time, the spotlight focuses on the College of Family Physicians of Canada (CFPC), where a small group of physicians are reiterating all of the partially misleading, and somewhat nonsensical, sound bites we have heard time and time again. Instead of again focusing on those accounts, we will instead focus on the good work the CFPC is doing, and the actions they have taken as a result of a 2010 Task Force review.

In 2010, the College of Family Physicians of Canada established a Task Force to review the CFPC's relationship with the healthcare and pharmaceutical industries (HPI), and to make recommendations about the College's relationship with HPI.

Task Force Results

The Task Force recognized the importance of industry financial assistance, and therefore made some of the following recommendations to the CFPC, some of which have been taken under advisement, and others that have been implemented. This is by no means a complete list of precautions the CFPC takes, but an overview.

Conflict of Interest (COI)

The Task Force recommended that the CFPC set out explicit and defined conflicts of interest in the CFPC's relationships with the HPI. Additionally, the Task Force recommended that where the scope and responsibilities of CFPC positions are broad, a judgment must be made to confirm if a disclosed COI rises to the level of preventing the individual from carrying out high-level roles such as Committee Chair, Section Chair, CFPC Executive, and Chapter Executive.

Financial Relationships

The CFPC must be explicit about, and in control of, the financial relationships it undertakes with HPI. For one, sponsorship terms must be publicly declared and requests to initiate or continue a sponsorship relationship must be assessed for impact on the CFPC's reputation. Additionally, the sponsorship of any food or other "gifts" from accredited educational activities will not be linked back to the HPI.

Access to Information

Several of these recommendations related to the CFPC website, and recommended that the website be used to post information related to the disclosure of relationships with HPI for members to review, as well as some public information on how the CFPC manages their relationships with the HPI.

CFPC Pushback

Dr. Jennifer Hall, the president of the CFPC, and Dr. Francine Lemire, the executive director and chief executive officer of the CFPC, together wrote a well thought-out response to the critics, focusing on how critical private sponsorship of continuing professional development is to Canadian physicians. As they state, "unlike medical undergraduate or residency education, continuing education receives almost no public funding." This lack of funding makes it difficult for physicians to afford and attend the continuing education courses required, and as such, the pharmaceutical industry has stepped in to fill the void in the funding vacuum.

Doctors Hall and Lemire set the record straight when they state that the CFPC Board has considered, on more than one occasion, whether to eliminate the healthcare and pharmaceutical industry-supported program, and that they have not done so because doing so might result in less high-quality opportunities for Canadian physicians to learn.

The CFPC has taken steps to mitigate the influence of pharmaceutical companies on the annual scientific program at Family Medicine Forum, as well as clearly articulate what counts as education versus what is considered to be marketing. The CFPC has changed their vetting guidelines and requirements for prospective exhibitors for their annual Family Medicine Forum in order to ensure transparency and clarity about the exhibitors' relationships with the healthcare and pharmaceutical industry.

Additionally, at the 2016 Family Medicine Forum, the Exhibit Hall will be clearly labeled "marketplace" so attendees are "acutely aware" that exhibitors are marketing their products and services in there. CFPC even went one step further, allowing attendees who are disinterested in any of the exhibitor's products and services to avoid the marketplace altogether by placing food and meals in a different location, away from the Exhibit Hall.

Lastly, Doctors Hall and Lemire highlighted the fact that the CFPC's peer-reviewed journal, Canadian Family Physician, carefully screens all advertisements and has a strict policy on the proximity of ads relative to editorial content.

In addition to the restraints already in place, the Task Force helped the CFPC to come to the conclusion that creating a continuing professional development program development fund might be a potential way to support the development, dissemination, and evaluation of accredited educational activities. This fund would include contributions in the form of subscriptions to access high-quality continuing professional development or unrestricted donations to the Research and Education Foundation.

Conclusion

In short, most patients enjoy knowing that the doctor who is taking care of them and their family has fulfilled continuing medical education requirements, and that the physician has knowledge about the most recent developments in healthcare. Industry support of the continuing education of the physicians who take care of our families is one of the main reasons we have such a thriving healthcare industry and a contributor to long life expectancy. High-quality continuing medical education is crucial to the continuation of such success, and industry financial support is just one of the important ways the success will continue.

January 07, 2016

EDMA and Eucomed Adopt Code of Business Practice Brings Changes to Medical Congresses

Members of both the European Diagnostic Manufacturers Association (EDMA) and the European Medical Technology Industry (Eucomed) approved a new Code of Ethical Business Practice. Both associations are members of MedTech Europe who are working to set high ethical standards for the medical technology industry all throughout Europe.

This new Code will replace the EDMA and Eucomed codes of business practice and will be known as the MedTech Europe Code of Business Practice. This decision to adopt a common and wide-reaching code was prompted by the fact that EDMA and Eucomed each had different codes, which created inconsistencies in the rules that were applied to the industry. Once EDMA and Eucomed began to heavily collaborate, both organizations saw the need to align their codes to create greater consistency industry-wide.

The new Code will regulate all aspects of industry's relationship with Healthcare Professionals (HCPs) and Healthcare Organizations (HCOs), and will introduce a common independent enforcement mechanism. The new code, establishing the new minimum standard by which industry members operate in Europe, will become binding for EDMA and Eucomed members by January 1, 2017, and the ban on direct sponsorship for doctors begins January 1, 2018.

Lisa Boch-Anderson, MedTech Europe's communications director, claims that the new Code will regulate all aspects of relationships with medical professionals. Boch-Anderson stated that MedTech Europe will be taking transparency to a new level, "[w]e will be banning direct sponsorship of medical professionals' being sent to events. The pharmaceutical sector has introduced transparency, but we opted for transparency plus – not only making it transparent, but ending direct sponsorship all together."

In addition to the direct sponsorship ban, educational grants to hospitals will become public and will be able to be found in a database hosted by MedTech Europe's website. According to Boch-Anderson, "hospitals will look after their own educational needs; we won't be pinpointing specific doctors." Part of the reason for the distinction is so that there is "a level of independence."

The code includes a Eucomed independently managed conference vetting system which reviews the compliance of third-party educational conferences with both Eucomed Code of Ethical Business Practice. The decisions rendered by the Compliance Officer are binding on Eucomed and Mecomed members. Which means that members of Eucomed and Mecomed may not directly sponsor or cover expenses of Healthcare Professionals to attend a third-party conference which is found to be not compliant with the system.  

While the Code does set out minimum standards appropriate to the activities, it is not meant to supersede any national laws or regulations, or any professional codes that may have more stringent requirements. MedTech Europe cautions members to be "mindful of the fact that they may be liable for the activities of third party intermediaries who interact with Healthcare Professionals or Healthcare Organizations in connection with the sale, promotion, or other activity involving Member Companies' products."

Leadership of both associations and MedTech Europe are pleased with the new Code. Rob Ten Hoedt, Chairman of MedTech Europe and Eucomed, said, "We are proud that the European medical technology industry has adopted one of the most modern and progressive codes of conduct, with strict, clear and transparent rules." Jurgen Schulze, Vice Chair of MedTech Europe and President of EDMA is also pleased, stating, "This is a landmark vote that reflects both how our industry is changing and how our partnership with healthcare professionals and healthcare organizations has evolved."

A group of European cardiologists, including the Editor-in-Chief of EuroIntervention, is one of several groups upset with the new regulation, stating that they believe the updated Code "may significantly impact the future of CME, create major restrictions for smaller meetings, and have a severe impact on larger conferences." They estimate that the new guidelines will reduce attendance at CME events by as much as thirty to fifty percent.

Gregg Stone, MD, of Columbia University Medical Center in New York, NY, believes that industry support of CME for physicians plays an important role in improving patient outcomes. Dr. Stone stated,

For those of us who have dedicated our lives to running high-quality, independent CME-accredited courses, we are concerned that these new rules will be counterproductive, and limit attendance at independent meetings, while paradoxically making it relatively easier to attend direct industry-sponsored events. Only time will tell if this initiative is a step backward or achieves its stated goals of greater transparency and fairness without slowing the remarkable progress we've collectively realized. In the meantime, we strongly encourage all physicians in Europe to continue to annually attend major physician-directed interventional meetings to ensure ongoing quality improvement and enhance patient care.

In addition to the new Code, which can be found here, MedTech Europe has issued a Guidance Document with questions and answers on the new Code.

The Guidance Document provides a quick summary of clarifications of the new changes in regulation, as well as some common questions, such as the definition of "Healthcare Professional." The Guidance Document is broken up into eight chapters, each of which highlights important distinctions of the new Code, including "Chapter 1: General Criteria for Events," "Chapter 2: Third Party Organized Educational Events," "Chapter 3: Company Events," "Chapter 4: Grants and Charitable Donations."

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