Pharma Codes, Euro-Style

 

Germany and Sweden have issued codes of conduct for relationships between CME providers, physicians, and pharmaceutical companies, announced speakers at the Tenth Annual Meeting of the Global Alliance for Medical Education, held June 19 to 21 at the Westin New York at Times Square. As in previous years, the conference, which brought together about 100 CME professionals from around the world, focused on major trends in global CME, including the development of guidelines for CME/industry collaboration and the spread of formalized CME systems.

In Germany, the voluntary guidelines, issued in February 2004, by three pharmaceutical industry associations, allow pharmaceutical companies to invite physicians to CME activities and pay registration fees, reasonable travel, and necessary accommodations costs as long as the event emphasizes education, said Edgar Ingold, MD, general manager, Thomson Physicians World GmbH, Mannheim, Germany. (Typically in Europe, unlike in the United States, pharma companies pay directly for physician travel and registration fees at CME events.) Under the code, pharma companies may provide food, but cannot pay for entertainment or for a guest's expenses.

Venues are also under the microscope, generating frustration that will sound familiar to U.S. CME organizers. One example: “Two weeks before an event at a five-star hotel, we had to relocate a meeting to a four-star hotel. It was a great mess. I didn't see any sense in that,” said Ingold.

In Sweden, guidelines implemented in stages from late 2003 through January 2005 are a coordinated effort among industry, the national medical association, and the regional statutory bodies that manage healthcare. The rules ban social activities at CME events and restrict travel and selection of venues, said Richard Bergstrom, CEO, Swedish Association of the Pharmaceutical Industry, Stockholm, Sweden. Industry can pay doctors' course fees, but can only pay a maximum of 50 percent of expenses, such as travel and lodging. In addition, “We now have these very tough restrictions on travel. Foreign travel [is prohibited.] You can't take doctors from the U.K. to the Riviera for a training course that could have been held in the United Kingdom,” said Bergstrom.

To further deter inappropriate relationships, “We are only allowed to send invitations to the employers at the National Health Service, not to individuals, because we're not supposed to hand-pick people,” he explained. As in the United States, part of the impetus for the codes is concern about government payment for medications. “The rules have been issued because of the whole debate about corruption and bribery,” said Bergstrom. “These physicians use government funds when they prescribe medicines.” While the guidelines are voluntary in theory, in reality “everyone has to follow them,” Bergstrom said. Violations can result in financial penalties for pharma companies.

More Mandatory CME

The increase in mandatory CME systems throughout Europe and the rest of the world, discussed at previous GAME conferences, continues. In Germany in 2004, CME became mandatory for ambulatory care physicians, and it will probably become mandatory for hospital-based physicians in 2006, said Daniela Jennifer Kempkens, MD, research assistant, Faculty of Medicine, University Witten/Herdecke, Witten, Germany. Although the specifics have not yet been worked out, Germany plans to institute penalties, such as reimbursement cuts, for doctors who fail to obtain the required 250 credits by 2009.

In India, while there is currently no structured system or statutory requirements, there is a move toward formalizing CME. In May 2001, the Indian Medical Association adopted a resolution that recommended that every physician should do 150 hours of CME every five years, on a voluntary basis, said Sanjiv Malik, MD, national president (elect), Indian Medical Association, New Delhi, India. Then, in 2003, the Union Health Ministry introduced a constitutional amendment making CME mandatory and recommended physicians' reregistration be based on certified CME. However, “That bill is still in the corridors of Parliament gaining dust,” said Malik. And, the present health minister has mooted a similar proposal. Despite the setbacks, “one must feel that CME will become mandatory a year from now, and recertification based on CME will become law,” he said.

Who Weeps for Africa?

Speakers also addressed how healthcare crises, such as the AIDs epidemic in Africa, affect CME. In an impassioned address, which moved some attendees to tears, Bruce Sparks, MD, professor and head, Department of Family Medicine, University of the Witwatersrand, Johannesburg, South Africa, said that the world mourns tragedies such as September 11, 2001, when 3,000 people died. Clarifying that he was not minimizing that disaster, he pointed out that every day in South Africa 1,500 people are infected with HIV. Three-quarters of those infected with HIV/AIDS live in sub-Saharan Africa; by 2010 there will be 20 million children who have lost one or both parents to HIV/AIDS — half of those orphans will be African. “But nobody weeps for Africa,” he said.

To cope effectively with such an enormous crisis, African CME must focus on the psychological and social aspects of healthcare, said Sparks. Physicians need the skills to provide emotional assistance to AIDS-devastated patients. “How are you going to help those families and support them? You look in their eyes and you see terror. Yes, you can look up treatment information on the Web — but you can't look up on the Web how to break bad news to somebody who's lost their whole family,” he said.

While there's a vast field of opportunities for CME in Africa, he said, it must be based on healthcare priorities in the individual countries. “We need to beware of educational neo-colonialism models from the developed world. Instead, CME must be developed by the people, for the people,” said Sparks.

CME for Caregivers

The need for CME to focus on families was also the theme of the keynote address. One of the biggest changes affecting healthcare in the United States and other countries is the growing role of family caregivers, said Mike Magee, MD, Senior Fellow in the Humanities, World Medical Association, Ferrey-Voltaire, France; and vice president, Pfizer Medical Humanities Initiative, New York. Driving that trend is the huge increase in the aging population. For example, in the United States, 50 percent of 60-year-olds have a parent alive. “This means that the four-generation family in the United States is pushing out the three generation family,” said Magee. Twenty-five percent of these four-generation families have an informal family caregiver; 85 percent of those are family members; almost all are women. These women are becoming a knowledgeable and activist group of consumers in the United States, who want to become part of the healthcare team, he said. “CME has a critical role to play in facilitating these changes and empowering caregivers. Let's create an educational system that educates your doctor and the care team,” Magee said. “The education that we provide has got to be purposeful, it's got to be real-time, it's got to be home-based, and it's got to be about the people who are caring for the people.”

GAME's 2006 conference will leave North America for the first time, and convene in Rome next June. Visit www.game-cme.org for more information.


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