Compliance

The free ride is over!

At Europe’s most prestigious medical conferences, as many as half of the doctors attending are only there because of the generous sponsorship by pharmaceutical and medical technology companies. The practice has been going on for decades, to the point that continuing medical education (CME) in Europe is heavily dependent on the largess of these companies. In 2018 it all comes to an end when a new Code of Conduct adopted by the European Medical Technology Industry Association comes into effect.

Report: John Brosky

Photo
Serge Bernasconi leads Europe MedTech, an alliance of European medical technology industry associations.

‘We are aligning our association’s code of conduct with the United States, China, and many countries of Latin America where the direct sponsoring of a physician is not allowed and you can only support CME through educational grants,’ said Serge Bernasconi, who leads Europe MedTech, an alliance of European medical technology industry associations. ‘This is making some of the medical societies very nervous,’ he added.

Annual medical congresses with large industry exhibitions have become a rich source of revenue for many professional medical societies, and what is worrying them is that without industry support, many congress participants simply would not have the budget to be able to attend.

The USA enacted the Physician Payments Sunshine Act Sunshine act in 2010, to create greater transparency in doctor-industry relations. When the law was put into effect in 2013 with enforcement by the Centers for Medicare & Medicaid Services, physician participation at annual congresses dropped by as much as 50 percent.

The European Society of Radiology, which puts on the annual European Congress of Radiology in Vienna, has discussed the impact of the new Code of Conduct internally, but has not made public any decision about actions it will take, according to a spokesperson.

Europe’s interventional cardiologists did go public with their protest with an editorial in EuroIntervention, urgently calling for a delay in enactment of the Europe MedTech rules.

Patrick Serruys, M.D., Editor-in-Chief of EuroIntervention, wrote in an Expedited Editorial Publication published in November, 2015 that the new Code of Conduct ‘will probably not affect key opinion leaders, but will affect the more vulnerable categories of healthcare professionals such as younger colleagues, nurses and technicians. The juniors of today may not benefit from the grants allocated to hospitals, especially at the early stages of their careers, nor will nurses and allied professionals.’

Joining Serruys as co-authors of the editorial were William Wijns, MD, Chairman of the PCR (Paris Revascularisation Course) group that organises a series of highly successful conferences for interventional cardiologists implanting stents and heart valves, and Stephan Windecker MD, President of the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

The cardiologists call for a postponement of the phase-out of payments to physicians, as the societies’ congresses are planned far in advance and they need an opportunity to determine how deeply the new rules will cut into attendance at meetings. The editorial followed a crash meeting held by the three authors and other leading cardiologists with Bernasconi and Europe MedTech executives in October, 2015 at a hotel in the Charles de Gaulle Airport (Paris, France).

What we have today are different legislation and recommendations at various country levels, which becomes very complex. We have 28 different ways to manage the relationship.

Serge Bernasconi

The physicians position in the discussion was that the proposed code of conduct is a one-sided document written by-and-for the interests of industry without consultation from the physicians and that this has provoked, ‘a lot of confusion and misunderstanding within our professional community,’ according to statements in an editorial.

‘Whilst both parties agree that direct sponsorship can be perceived by the public as an issue in creating inappropriate interactions, we as physicians are concerned that [the] proposal may significantly impact the future of CME, create major restrictions for smaller meetings, and severely impact larger conferences,’ the editorial states.

In Europe, France led the charge toward greater transparency passing a Sunshine Act in 2011 that was enacted in May 2013. Portugal, Denmark and Slovakia have also enacted rules for greater physician-industry transparency. The impact of these fragmented actions have not tipped the scale as the reformed Code of Conduct among Europe’s leading companies in the medical technology industry.

While there is not currently a movement by the European Union to enact a pan-European Sunshine law, Bernasconi said, ‘perhaps that would be better.’

‘What we have today are different legislation and recommendations at various country levels, which becomes very complex. We have 28 different ways to manage the relationship. In France every time you buy a cup of coffee for a physician you need to report it. ‘The Netherlands says you can subsidise half the expense of a physician going to a congress. The Italians say you cannot pay for a doctor going to a congress, unless he has the approval of his boss. The Nordic countries say you cannot pay for a physician to go to a meeting,’ Bernasconi added.

According to Bernasconi the pharmaceutical industry in Europe has taken an approach to transparency that leaves current practices in place, but requires sponsorships and financial support to be made public. ‘We looked at that, but saying it publically, posting it on a website does not address the conflict of interest that is evident to anyone, and no one today is going to believe there is not an influence,’ he said.

‘We have gone one step further into what we call transparency-plus. What we want is that if industry is going to continue supporting medical education, we want to be sure we are not going to be criticized for the way we do it. ‘The objective of industry is not to suddenly take away its funding of medical education, but to change to a different model,’ he said.

‘They will have two years to figure this out, to create educational activities and programs that industry wants to support,’ he concluded. Otherwise in a given specialty area, companies will figure out ways to create their own programs for CME.

22.07.2016

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